This trial is a pilot-scale, single institution randomized, placebo-controlled trial to assess the feasibility, acceptability, and efficacy of administering dapagliflozin for cardiovascular risk reduction in the postpartum period. The target population is patients at high risk of adverse cardiovascular outcomes within five years post-delivery. Eligible participants will be randomized to receive either: 1) dapagliflozin (10mg daily) for six months (DAPA group) or 2) an orally administered, daily placebo (Control group). The study hypothesizes: The dapagliflozin group will have higher cardiovascular risk reduction scores than the Control Group.

Type: Interventional

Start Date: Mar 2025

open study

To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.

Type: Interventional

Start Date: Sep 2025

open study

This study is for people who have geographic atrophy due to age-related macular degeneration (AMD). AMD happens when the macula, the light-sensitive layer at the back of the eye called the retina, becomes damaged and causes a person's central vision to worsen. Geographic atrophy is an advanced form of AMD where cells in the retina waste away and die. Over time this can lead to permanent loss of vision. Avacincaptad pegol can help slow down the worsening or progression of geographic atrophy. Avacincaptad pegol is a treatment approved in the US to treat geographic atrophy. This study is about collecting information on how people with geographic atrophy are treated in routine clinical practice. This includes recording any medical problems from avacincaptad pegol. This is known as an observational study. Information will be collected from the peoples' medical records during and after treatment. The people in this study will have geographic atrophy in 1 or both eyes and they and their doctor has decided they will be treated with avacincaptad pegol. The individual's doctor decides on treatment, not the study sponsor (Astellas). People that want to take part in the study will have eye examinations that they would usually have as part of their routine care. People will also be asked to complete surveys about their eye health. These surveys will occur when treatment starts and then every 6 months for the first 2 years. After 2 years the surveys will happen once a year. The people on the study can take part if their doctor provides treatment with avacincaptad pegol and they want to continue with the study. The people on the study can take part for up to 3 years or up to 5 years, depending on when they start the study.

Type: Observational

Start Date: Jan 2025

open study

This is a phase 0, non-interventional, longitudinal, electronic data capture (EDC) study to facilitate the HEARTBEAT Study project has set out to explore the potential use of smartwatches in collecting and analyzing biometric data to improve the detection, identification, and understanding of cardiovascular diseases and related conditions by SAMSUNG and Tulane. The study will include up to ten thousand adult subjects tasked with wearing a smartwatch to collect digital biomarker data over a 1 year period. Concurrent to smartwatch data collection, subjects will be instructed to complete questionnaires via the Huma Decentralized Clinical Trials (HUMADCT) platform. There are no investigational drugs or interventions administered as part of this study.

Type: Observational

Start Date: Oct 2024

open study

The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of AZD7760 when given as an intravenous infusion to healthy participants (Phase I) or participants with end-stage kidney disease receiving hemodialysis through a central venous catheter (Phase IIa).

Type: Interventional

Start Date: Dec 2024

open study

The Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services (BICEPS) study aims to understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain electrical waves (EEG) data from individuals who have experienced these disorders in recent years. Participants will be involved for about a year, with four visits over this period. Screening procedures, lasting approximately 3 hours, include tests for drug use, a pregnancy test for eligible women, clinical interviews about feelings and experiences, psychiatric and family history interviews, and a medical history review. Research procedures for eligible participants include DNA collection, a neuropsychological test battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand brain function, genetics, and cognitive abilities related to psychotic disorders. Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical interviews and repeating neuropsychological tests to track changes over time. Participants may opt to provide DNA samples for genetic analysis, undergo various cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and MRI scans to visualize brain structure. Follow-up visits at regular intervals will help researchers track changes in symptoms and cognitive function. This study provides comprehensive insight into the onset and progression of psychotic disorders and offers valuable information for patients, families, and healthcare providers involved in managing these conditions. Our goal is to better understand whether a combination of biological markers and different types of people (BT1, BT2, BT3) can help us predict how well individuals with early psychosis respond to specialized care. We expect that those in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive issues, their biology might lead to different responses to treatment. This research can help us understand which treatments work best for different people with early psychosis.

Type: Observational

Start Date: Jan 2023

open study

This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks. Pemigatinib is administered at 13.5 mg orally daily 2 weeks on and 1 week off. Durvalumab is administered at 1500 mg intravenously once every 3 weeks. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur every 9 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months (about 35 cycles) of pemigatinib and durvalumab treatment from Cycle 1 Day 1 is allowed.

Type: Interventional

Start Date: Jan 2026

open study

This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment. The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine [T3] or free triiodothyronine [FT3]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.

Type: Interventional

Start Date: Dec 2024

open study

The goal of this clinical trial is to learn if polymer-induced liquid precursor (PILP) can be used safely to treat dentin caries (cavities) in adults. The main question it aims to answer is: Is PILP (conditioner or liner) safe in adult teeth with dental caries? Researchers will compare PILP to a placebo (a look-alike substance that contains no drug) to see if PILP safely treats cavities in teeth. Participants will: 1) Have PILP or placebo applied to their tooth prior to the placement of a filling in the tooth, 2) Complete two telephone calls within three months of filling placement and 3) Visit the clinic at three months and six months after the placement of the filling.

Type: Interventional

Start Date: Feb 2025

open study

The primary purpose of this study is to explore the feasibility of conducting a clinical trial on the effects of psilocybin for individuals with prolonged grief disorder (PGD).

Type: Interventional

Start Date: Mar 2026

open study

This is a Phase 3 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in patients undergoing major elective, urgent, or emergent surgeries in a hospital setting. The main outcomes are to: 1. compare the efficacy, and 2. estimate the safety of applying nasal (aPDT) before surgery in reducing the incidence of SSIs within the initial 30 days after surgery compared to standard of care (SOC). Participants in the intervention group will receive aPDT prior to surgery on the day of surgery. Participants in the control group will receive standard of care surgical site prevention measures prior to surgery.

Type: Interventional

Start Date: Dec 2024

open study

Brief motivational interviewing intervention to address alcohol use among diverse teens 12-17.

Type: Interventional

Start Date: Apr 2025

open study

This pilot study will enroll 20 patients with septic shock and require emergent vasopressor support in the emergency department (ED). The primary objective of the study is to determine the feasibility of early peripheral administration of angiotensin II for treatment of septic shock in the ED

Type: Interventional

Start Date: Apr 2025

open study

This study evaluates the use of SMS001 in patients with lung cancer. SMS001 is a new form of drug Paclitaxel. Doctors want to decide an appropriate safe dose for SMS001 administration, and to see how well it works in treating lung cancer patients.

Type: Interventional

Start Date: Nov 2024

open study

The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy [ARDT]).

Type: Interventional

Start Date: Dec 2024

open study

This study is being done to answer the following question: Can the chance of lung cancer growing or spreading be lowered by adding targeted radiotherapy to the usual combination of drugs? This study is being done to find out if this approach is better or worse than the usual approach for lung cancer. The usual approach is defined as the care most people get for non-small cell lung cancer.

Type: Interventional

Start Date: Dec 2025

open study

Randomized phase 2, multicenter, biomarker directed clinical trial with a safety lead-in to assess the efficacy of Stenoparib plus Temozolomide (TMZ) in relapsed Small Cell Lung Cancer patients. Participants will receive either a combination of oral Stenoparib at the highest tolerated dose with oral Temozolomide 40mg daily or standard of care Lurbinectedin for 21-day cycles. The Dose limiting toxicity period will be 1 cycle of 21 days. This study will explore if the biomarkers the investigators test predict sensitivity to the combination of Stenoparib plus TMZ and therefore leads to a better treatment response. There are two potential tests of biomarkers that can predict who would benefit from the oral combination of Stenoparib with Temozolomide (TMZ), but they have not been evaluated. This study will test for this sensitivity using a biomarker (found in the blood that may be related to how a person reacts to a drug). The study will include 9 participants for the safety evaluation of the Stenoparib+TMZ group and 5 participants for the standard of care Lurbinectedin safety group. We will first determine safety dose for the experiment arm which, will include 3 groups with 3 participants in each group. Three doses of Stenoparib will be evaluated for toxicity. The initial starting dose of Stenoparib will be 200mg po QD. Once the maximum tolerated dose has been determined, participants will be assigned to one of the two groups in the phase 2 portion. Group 1 will be patients that test negative for the biomarker and will receive treatment with Lurbinectedin as per standard of care guidelines. Group 2 will be patients that test positive for the biomarker that will be randomly assigned to either the combination of Stenoparib plus Temozolomide (TMZ) or Lurbinectedin.

Type: Interventional

Start Date: Feb 2026

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

This clinical trial compares the effect of a narrow surgical excision (removal) to a wide excision for the treatment of adults with invasive cutaneous melanoma. Currently the standard of care is to take wide margins (boarder of healthy tissue surrounding the melanoma) when removing melanoma. Narrow margin excision removes a smaller amount of healthy tissue when surgically removing the melanoma. Narrow margin excision may be effective in removing the melanoma while also reducing surgical complications and improving quality of life for adults with invasive cutaneous melanoma.

Type: Interventional

Start Date: Dec 2024

open study

The goal of this clinical research study is to learn about the safety and tolerability of giving olutasidenib to patients with IDH1-mutated myeloid malignancies as maintenance therapy after they receive a stem cell transplant.

Type: Interventional

Start Date: Dec 2024

open study

This (DEEp SEA Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.

Type: Interventional

Start Date: Sep 2024

open study

This study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of Allogeneic Hope Biosciences Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) to prevent progression of trauma-induced Acute Kidney Injury (AKI).

Type: Interventional

Start Date: Feb 2026

open study

This clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer.

Type: Observational

Start Date: Apr 2021

open study

The goal of this observational study is to investigate the development of vulvovaginal graft-versus-host- disease (GVHD), an under-reported and under-recognized manifestation of chronic GVHD. This study aims to characterize the vaginal microbiome in participants undergoing allogeneic hematopoietic cell transplantation (HCT). The main questions it aims to answer are: - Is the vaginal microbiome altered during allogeneic HCT? - What changes may help researchers understand the development of vulvovaginal GVHD? Participants will be asked to undergo an assessment of vulvovaginal symptoms through a vulvovaginal symptom questionnaire once pre-transplant, 6 months post-transplant, and twelve12 months post- transplant. Participants will also be asked to undergo a vaginal microbiome (collection of bacteria, fungi, and viruses that live on our bodies) evaluation through a vaginal exam performed by a gynecologist with collection of vaginal samples once pre-transplant and again six months post-treatment and twelve months post-transplant. If a participant develops symptoms of vulvovaginal GVHD at any point in time during the post-transplant follow up, the participant may partake in additional vaginal exams to diagnose GVHD at the time of symptom onset.

Type: Observational

Start Date: Dec 2024

open study

This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Type: Interventional

Start Date: Oct 2024

open study