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NCT ID: NCT06299761 Recruiting - Solid Tumor Clinical Trials

Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications

STARMAP
Start date: March 28, 2024
Phase: Phase 1
Study type: Interventional

BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies.

NCT ID: NCT06299748 Recruiting - Myasthenia Gravis Clinical Trials

A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.

Start date: May 2, 2024
Phase:
Study type: Observational [Patient Registry]

This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the VYVGART IV or SC-exposed pregnancies were reported.

NCT ID: NCT06299709 Active, not recruiting - Cystic Fibrosis Clinical Trials

A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)

Start date: March 13, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.

NCT ID: NCT06299696 Completed - Cystic Fibrosis Clinical Trials

A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists

Start date: March 26, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of VNZ/TEZ/D-IVA fixed dose combination (FDC) granules.

NCT ID: NCT06299683 Recruiting - Clinical trials for Interstitial Cystitis

Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS.

NCT ID: NCT06299657 Not yet recruiting - Anxiety Clinical Trials

Intervention for Managing Physical Reactions to Overwhelming Emotions

IMPROVE
Start date: March 2024
Phase: N/A
Study type: Interventional

The clinical trial aims to conduct a feasibility, acceptability, and usability clinical trial of a modular CBT-based and technologically enhanced intervention for people with an SUD and recently enrolled in IOP, probe target engagement and change in clinical outcomes, and examine attrition rates in IOP. This study will enroll 40 adults who are currently enrolled in IOP, have a substance use disorder, and experience elevated anxiety. 20 individuals will be randomized to the experimental intervention, "Intervention for Managing Physical Reactions to Overwhelming Emotions" (IMPROVE), and 20 individuals will be randomized to the active control group, "Physical Health Education Treatment" (PHET). Participants will be asked to complete a baseline assessment of mood, substance use, and psychophysiology. Participants will then completed ecological momentary assessments (EMA) via smartphone technology 4 times a day for ~ 28 days (the day following the baseline assessment until the 3rd intervention session). Participants will complete one 45 minute - 1 hour intervention each week for 3 weeks (either the IMPROVE or PHET intervention, pending randomization). Following the last intervention session, participants will return to the lab to complete a post-intervention assessment that mirrors the baseline assessment and then complete follow-up surveys 1- and 3-months post intervention.

NCT ID: NCT06299644 Not yet recruiting - Obesity Clinical Trials

Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

Start date: May 1, 2025
Phase: N/A
Study type: Interventional

The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.

NCT ID: NCT06299592 Recruiting - Asthma Clinical Trials

Comparison of Microglial Activation in Severe Asthma and Healthy Controls

MAIA-SC
Start date: March 6, 2024
Phase:
Study type: Observational

The goal of this clinical trial is to learn about how asthma influences brain function. The main questions it aims to answer are: - How airway inflammation in asthma affects the brain; and, - Whether airway inflammation in asthma is related to symptoms of depression and anxiety Over the course of 3 visits, participants will: - Complete questionnaires - Complete computer tasks - Undergo allergy skin test and breathing tests - Give two blood samples - Give a sputum sample - Complete brain imaging scans Researchers will compare results between participants with asthma, and participants who do not have asthma.

NCT ID: NCT06299488 Completed - Insomnia Clinical Trials

Combined Effects of Prunus Cerasus and Apocynum Venetum On Sleep and Anxiety in Adults With Insomnia

Sip2Sleep
Start date: April 5, 2023
Phase: N/A
Study type: Interventional

Lay Summary: This study is about the effect of using a unique formula called Sip2Sleep®, a product currently available on the market which is a combination of montmorency tart cherry extract and Venetron® (Apocynum venetum leaf extract) on sleep. The purpose of this study is to evaluate the effects of taking this combination product on various aspects of sleep. This study is being conducted by People Science, and is sponsored by Lakshmi Nutraceuticals, LLC. The information we gather will help inform how people may use Sip2Sleep® to affect the quality of sleep. Participants in this study will complete a number of surveys about their difficulties falling asleep and staying asleep (insomnia), their energy level during the day and health status regarding their quality of sleep. There are no major risks associated with this study.

NCT ID: NCT06299410 Recruiting - Healthy Volunteers Clinical Trials

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects

Start date: April 11, 2024
Phase: Phase 1
Study type: Interventional

The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor in healthy subjects. Subjects will enroll in one of the 2 cohorts, will have a baseline PET/CT scan, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan.