This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.

Type: Interventional

Start Date: Jan 2023

open study

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from F8 coil or active rTMS from H coil for smoking cessation. Smoking and brain functional connectivity changes will be assessed at baseline, different stages of rTMS and/or follow-ups.

Type: Interventional

Start Date: Jun 2022

open study

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.

Type: Interventional

Start Date: Jan 2021

open study

This study aims to explore the mechanisms of how transcranial magnetic stimulation (TMS) impacts fear circuits. The overarching objectives are to understand how varying TMS parameters affect targeted brain regions in order to optimize its impact on enhancing fear extinction memory consolidation in a population with known fear extinction deficiencies: post-traumatic stress disorder (PTSD). 250 subjects will take part in this research study across UTHealth Houston. The study will include preliminary screenings, baseline visits, and experimental visits across four days

Type: Interventional

Start Date: Feb 2022

open study

The purpose of this research study is to study how the brain learns to avoid certain stimuli or situations using an experimental paradigm. The big goal is to measure brain responses and subject's feelings and expectations when they are learning to actively avoid experimental stimuli, and how fear extinction learning and monetary cost can change how and when subjects are to avoid.

Type: Interventional

Start Date: Sep 2021

open study

PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.

Type: Interventional

Start Date: Sep 2020

open study

REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.

Type: Interventional

Start Date: Jul 2023

open study

The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD).

Type: Interventional

Start Date: Apr 2022

open study

The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP. The primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.

Type: Observational

Start Date: Mar 2026

open study

The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.

Type: Interventional

Start Date: Feb 2026

open study

Vitiligo is a long-term autoimmune condition that causes the skin to lose its color. The body's germ-fighting system (immune system) mistakenly attacks the skin cells (melanocytes) which produce the pigment that gives the skin color (melanin). This leads to the formation of patches of skin with less or no pigment (depigmentation). These patches can occur anywhere on the body. In the nonsegmental form of vitiligo, similar patches occur on both sides of the body (symmetrical patches). The main aim of this study is to learn how safe zasocitinib is, how well it works and how well it is tolerated by adults with nonsegmental vitiligo. The participants will receive the study treatment (either zasocitinib or placebo) for up to 1 year (52 weeks). The placebo looks like the zasocitinib capsule but does not have any medicine in it. Participants who receive placebo at the beginning will change to zasocitinib after about 6 months. During the study, participants will visit their study clinic 11 times.

Type: Interventional

Start Date: Nov 2025

open study

The observational study titled "Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)" aims to evaluate the safety outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) who receive Impella CP during percutaneous coronary intervention (PCI) and who are managed with Impella best practices while receiving guideline-directed standard of care. This prospective, multicenter study will enroll up to 350 hemodynamically unstable patients with cardiogenic shock of less than 12 hours duration and acute myocardial infarction (AMI) of less than 24 hours duration. Cardiogenic shock will be confirmed by tissue hypoperfusion (lactate ≥ 2.5mmol/L and/or SvO2 <55% with a normal PaO2) and systolic blood pressure <100 mmHg and/or need for vasopressor therapy (dopamine/norepinepherine or epinephrine). Patients will be assessed for various safety endpoints, including a composite safety endpoint involving major bleeding, acute limb ischemia, and acute kidney injury. Secondary endpoints will evaluate all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), and hospitalizations through 1-year post-Impella implant. All patients presenting with AMICS at study sites will be screened for inclusion in the study after hospital discharge (or after death, if prior to hospital discharge). IRB approved consent waiver will be used to collect data from electronic health records from; Impella placement to discharge and post-discharge at 30 days post-Impella implant, 6 months post-Impella implant, and 1 year post-Impella implant.

Type: Observational [Patient Registry]

Start Date: Jul 2025

open study

Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).

Type: Interventional

Start Date: Jun 2025

open study

The purpose of this study is to test the feasibility and acceptability of an evidence-based treatment for depression delivered over an ipad, computer, or smartphone can help Adult Protective Services (APS) clients with their activities of daily living to evaluate whether reductions on measures of depression and apathy (a) mediate reduced Elder Neglect/Self Neglect (EN/SN) behaviors; and (b) whether secondary posited mediating mechanisms are also active in impacting depression and apathy

Type: Interventional

Start Date: May 2026

open study

Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Type: Interventional

Start Date: Sep 2025

open study

The goal of this clinical trial is to learn if DOC1021 + pIFN alongside standard of care (SOC) will improve survival in adult patients newly diagnosed with glioblastoma (IDH-wt). It will also evaluate the safety of DOC1021 + pIFN. Researchers will compare DOC1021 dendritic cell immunotherapy regimen added to SOC compared to SOC treatment alone. Participants in the DOC1021 + pIFN + SOC arm will: - Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection - Undergo ultrasound guided perinodal DOC1021 injections every 2 weeks for a total of 3 doses - Receive subcutaneous pIFN injections weekly for a total of 6 doses in parallel with the DOC1021 injections Both arms of the trial will: - Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive SOC treatment with surgery, temozolomide chemotherapy and radiation

Type: Interventional

Start Date: Mar 2025

open study

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

Type: Interventional

Start Date: Dec 2024

open study

The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).

Type: Interventional

Start Date: Oct 2024

open study

The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks. Rimegepant is a tablet that dissolves when you put it on or under your tongue. The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day. Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months. In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period. Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at all visits. Participants will have to complete a daily diary to record the migraine attacks.

Type: Interventional

Start Date: Nov 2024

open study

Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.

Type: Interventional

Start Date: Jan 2025

open study

This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin. This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.

Type: Interventional

Start Date: Aug 2024

open study

This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

Type: Interventional

Start Date: Jun 2024

open study

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

Type: Interventional

Start Date: Jul 2024

open study

This is a multicenter, prospective, retrospective, Post Market Clinical Follow-up (PMCF) study in subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared Instructions for Use (IFU).

Type: Observational

Start Date: Jan 2025

open study

Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.

Type: Interventional

Start Date: Oct 2023

open study