This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia

Type: Interventional

Start Date: Oct 2024

open study

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

Type: Interventional

Start Date: Sep 2024

open study

The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Type: Interventional

Start Date: Apr 2025

open study

The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS). Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.

Type: Interventional

Start Date: Jun 2026

open study

This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.

Type: Interventional

Start Date: Nov 2024

open study

This is a Phase I dose finding study of GTB-3650 (anti-CD16/IL-15/anti-CD33) Tri-Specific Killer Engager (TriKE®) for the treatment of select CD33-expressing refractory/relapsed myeloid malignancies in adults ≥ 18 years of age who are not a candidate for potentially curative therapy, including hematopoietic stem cell transplantation, and are refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit. The hypothesis is GTB-3650 TriKE will induce natural killer (NK) cell function by targeting malignant cells, as well as, CD33+ myeloid derived suppressor cells (MDSC) which contribute to a tumor induced immunosuppression. Because CD16 is the most potent activating receptor on NK cells, this single agent may induce a targeted antiCD33+ tumor response

Type: Interventional

Start Date: Nov 2024

open study

The main goal of this study is to find out if supplementing with resveratrol improves skeletal muscle adaptations to strengthening exercise (resistance training or strength training) in adults age 60+, and to determine whether circulating vehicles of inter-organ communication (extracellular vesicles) and their cargo might help explain those responses. The investigators will also examine whether resveratrol supplementation improves blood vessel function and cognitive function (brain health) in response to strength training.

Type: Interventional

Start Date: Jun 2025

open study

The purpose of this study is to address the gap in maternal OUD treatment and infant neonatal opioid withdrawal syndrome care. The research team will develop a treatment model and a set of strategies to provide evidence-based OUD treatment to postpartum mothers in NICUs. First, the investigators will conduct a needs assessment via in-depth qualitative interviews with NICU mothers and clinicians. Then, with the expertise of the advisory board, the the researchers will create a protocol for implementing maternal OUD treatment at the NICU bedside. The researchers will then implement the protocol in two partner NICUs and evaluate the acceptability and feasibility to patients, providers, and clinical, and administrative leaders. The goal of this research study is to integrate maternal mental health and substance abuse treatment in pediatric settings and to refine, test, and examine the acceptability and feasibility of applying the adapted model.

Type: Interventional

Start Date: Jul 2024

open study

This study will assess whether a quantitative, HER2 assay can accurately and reliably discriminate between responders and non-responders among patients with HER2 IHCI+ metastatic breast cancer who are receiving T-Dxd.

Type: Observational

Start Date: Oct 2024

open study

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.

Type: Interventional

Start Date: Aug 2024

open study

A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets

Type: Interventional

Start Date: Jun 2024

open study

Patients with stroke frequently suffer from aphasia, a disorder of expressive and/or receptive language, that can lead to serious health consequences, including social isolation, depression, reduced quality of life, and increased caregiver burden. Aphasia recovery varies greatly between individuals, and likely relies upon the capacity for neuroplasticity, both at a systems level of reorganized brain networks and a molecular level of neuronal repair and plasticity. The proposed work will evaluate genetic and neural network biological markers of neuroplasticity associated with variability in aphasia, with a future goal to improve prognostics and identify therapeutic targets to reduce the long-term burdens of aphasia.

Type: Interventional

Start Date: Mar 2025

open study

The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Type: Interventional

Start Date: Jul 2024

open study

MAGNETS is a prospective, randomized, parallel-design, sham-controlled clinical trial of accelerated, functional magnetic resonance imaging (fMRI)-guided intermittent theta burst stimulation (iTBS) to the right dorsolateral prefrontal cortex (dlPFC) for chronic symptoms of posttraumatic stress disorder (PTSD) in a comorbid Veteran population.

Type: Interventional

Start Date: Jun 2024

open study

This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab versus ramucirumab plus paclitaxel for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.

Type: Interventional

Start Date: Aug 2024

open study

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH [previously known as nonalcoholic steatohepatitis, NASH]).

Type: Interventional

Start Date: May 2024

open study

The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. The investigators plan on randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively both in the hospital and at home. The investigators will measure the outcome of two drugs, Zynrelief, and Exparel on postoperative pain score -using the NRS pin score up to 72 hours after surgery. The total opioid use will be recorded in forms that will be used to measure pain score and total opioid use and will be collected to the Excel sheet. The cost of the drug will be calculated for internal use for Hospital purpose only.

Type: Interventional

Start Date: Nov 2024

open study

This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses.

Type: Observational

Start Date: Mar 2020

open study

It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery.

Type: Observational

Start Date: Mar 2024

open study

2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.

Type: Interventional

Start Date: Mar 2025

open study

This project will evaluate the ability of Mirtazapine (MZP), a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the treatment of methamphetamine (MA) use among medication for opioid use disorder (MOUD) patients, to significantly decrease MA use and related health-impairing behaviors. MZP has already successfully been used in the treatment of methamphetamine (detailed further below and in the Appendices). The investigators hypothesize that those assigned to the MZP plus treatment as usual (TAU) MZP+TAU arm will demonstrate significantly increased rates of biochemically verified abstinence from MA and other substances of abuse and experience improvements in health impairing behaviors relative to the placebo (PLO)+TAU arm across the 10-week treatment and follow-up periods.

Type: Interventional

Start Date: Jun 2024

open study

This phase I/II trial tests the safety, side effects, and effectiveness of axatilimab in combination with retifanlimab and paclitaxel for the treatment of patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Axatilimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Giving axatilimab in combination with retifanlimab and paclitaxel may be safe, tolerable and/or effective in treating patients with advanced or metastatic solid tumors.

Type: Interventional

Start Date: May 2024

open study

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Type: Interventional

Start Date: Mar 2024

open study

The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections [SC]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone. The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial. The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.

Type: Interventional

Start Date: Jun 2024

open study

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, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects.

Type: Interventional

Start Date: Apr 2024

open study