The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1.

Type: Interventional

Start Date: Nov 2024

open study

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with advanced solid tumors. The study will be conducted in two phases: Phase 1a (Monotherapy Dose Escalation, and Safety Expansion; Combination Dose Confirmation and Safety Expansion) and Phase 1b (Dose Expansion).

Type: Interventional

Start Date: Dec 2024

open study

The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.

Type: Interventional

Start Date: May 2021

open study

The overarching intention of the Eating Disorder Genetics Initiative 2 (EDGI2) is to increase sample size, diversity, and eating disorder phenotypes. The investigators are enrolling 20,000 new participants with anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), avoidant/restrictive food intake disorder (ARFID), and controls in the US, Mexico, Australia, New Zealand, Sweden, and Denmark. A primary study goal is to enroll at least 30% of participants from underrepresented groups. Participants are asked to complete a series of questionnaires and submit a saliva sample for genotyping. The goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.

Type: Observational

Start Date: Oct 2024

open study

This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

Type: Interventional

Start Date: Jan 2025

open study

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Type: Interventional

Start Date: Dec 2024

open study

The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.

Type: Interventional

Start Date: Nov 2024

open study

Attention deficits (AD) frequently co-occur with posttraumatic stress disorder (PTSD). The presence of AD is associated with greater PTSD clinical severity and poorer clinical outcomes. Knowledge regarding the mechanism underlying this association is limited, though the emerging evidence has indicated that executive function deficit (EFD) is strongly correlated with AD and PTSD symptoms. While treatments developed for PTSD have existed for years, a substantial portion of individuals do not fully respond to conventional treatment. Accumulating evidence suggest that attention deficit (AD) and EFD may be a driving force for PTSD treatment resistance. However, treatment of executive impairment in PTSD is very limited. As a result, untreated co-occurring AD and EFD in PTSD poses severe negative impacts on patients' functional recovery, treatment outcomes, and quality of life (QoL). Given that up to 50% of patients do not respond well to the first-line pharmacological PTSD treatments, it is imperative to seek novel treatment strategies to improve EF that may improve both standard treatment response and QoL, social function. The proposed study directly addresses this knowledge gap by testing the efficacy of atomoxetine (ATX) in improving EF and attention among Veterans with PTSD, which will further improve Veterans' QoL and social function. ATX represents a promising novel candidate pharmacotherapy for individuals with PTSD. ATX is a non-stimulant selective norepinephrine reuptake inhibitor (SNRI), approved by the FDA for the treatment of ADHD. Studies suggest that ATX, unlike stimulants, lacks addictive properties and shows efficacy in the treatment of comorbid depression and anxiety, which is ideal in the treatment of PTSD. Data from the investigators' preliminary study provides encouraging support for the therapeutic potential of ATX in improving EF in Veterans with comorbid PTSD/ADHD. The investigators' recent research uncovered a higher rate of ADHD among Veterans with PTSD, and the comorbid AD symptoms were correlated with PTSD severity and poorer treatment outcomes. Treatment with ATX showed significant symptoms reduction in ADHD and improvement in inhibitory function in Veterans with ADHD/PTSD. In the proposed study, the investigators will focus on ATX in improvement of EF and attention, and further psycho-social life function and QoL. The investigators will (1) employ a randomized, double-blind design that will consist of 12 weeks of treatment with ATX or placebo medication; (2) use standardized, repeated dependent measures to rigorously assess AD and EFD symptomatology; (3) measure impairment in associated mental and behavioral health problems (e.g., attention deficit, depression, anxiety, suicidality, QoL, family/social functioning); and (4) use response inhibition task GoNogo, working memory and attention tests Digit Span and Trail Making to investigate the underlying pathophysiology of PTSD and prognostic indicators of treatment outcome. To achieve these goals, the investigators have assembled a multidisciplinary team with expertise in PTSD, ADHD clinical trials, and human laboratory paradigms who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation. The proposed project is directly responsive to the mission of the VA-RRD "to maximize Veterans' functional independence, quality of life and participation in their lives and community." Successful completion of this study will provide a platform for a large multi-center trial to further confirm the important role of EF in PTSD treatment outcomes. The findings from this study will provide critically needed evidence to help inform clinical practice guidelines on the treatment of PTSD. The outcome of the proposed research will be significant, because it provides a knowledge base to allow for development of new PTSD intervention strategies. More importantly, this clinical trial may immediately benefit Veterans by enhancing their cognitive function, reducing AD related disability, and further improving quality of life for Veterans who suffer from PTSD.

Type: Interventional

Start Date: Apr 2026

open study

To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.

Type: Interventional

Start Date: Dec 2024

open study

More than 110,000 US Veterans living with Parkinson's disease (PD) currently receive PD-related care and services from the VA. Fall prevention is a priority for Veterans living PD. Gait disturbances are a major cause for functional dependence and the largest risk factor for falls, institutionalization, and death in PD. This SPiRE addresses the need to advance nonpharmacological rehabilitative health care of Veterans and maximizing functional outcomes by developing a non-invasive, neuromodulatory transcutaneous cervical Vagal Nerve Stimulation as an at-home intervention to improve gait and balance. This pilot clinical trial will assist with future efforts and priorities of the VA to prolong independent living and quality of life by minimizing gait and balance dysfunction experienced by Veterans living with PD.

Type: Interventional

Start Date: Mar 2026

open study

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-NNS309 and the safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).

Type: Interventional

Start Date: Oct 2024

open study

Individuals with Fragile X Syndrome show differences in how they understand and learn language from infancy. They frequently have lifelong delays in speech and language as well. In addition, they experience other auditory symptoms, including being very sensitive to certain sounds as well as being more sensitive than others to loud sounds. The underlying brain activity for sound perception and speech learning in Fragile X is not well understood, especially in the infant and toddler years. This study uses behavioral assessment of speech and language abilities, neuroimaging, and hearing tests to understand how speech and hearing are different in children with Fragile X Syndrome.

Type: Interventional

Start Date: Oct 2022

open study

This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure. The main question this study aims to answer is: - Are temperature measurements from a forward looking infrared (FLIR) camera of the lower extremity useful in predicting outcome of revascularization procedures?

Type: Observational [Patient Registry]

Start Date: Apr 2025

open study

This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead). The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug(s) - How much study drug(s) are in the blood at different times - Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Type: Interventional

Start Date: Oct 2024

open study

Skin health is influenced by the microbiome, lipids, oxidative stress, inflammation, and UV exposure. A 12-week trial with 48 women aged 45-65 will test if polyphenol-rich pulses improve skin health by affecting these factors. Using a white rice control diet, the study will measure skin parameters and analyze correlations with changes in lipids and microbiome, potentially proving the benefits of pulses.

Type: Interventional

Start Date: May 2026

open study

The original purpose of this study was to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC. In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitor and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomized in either autogene cevumeran + nivolumab or the nivolumab monotherapy arm. Following the Sponsor's decision to phase out the study, as of Protocol Version 5, the primary purpose of the study is to ensure treatment continuity and safety for the participants who continue to participate in the study and receive study treatment.

Type: Interventional

Start Date: Dec 2024

open study

This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease. The hypothesis of the trial is that synthetic long peptide personalized cancer vaccines will be safe and capable of generating measurable neoantigen-specific T-cell responses enabling ctDNA clearance. The personalized cancer vaccines are composed of synthetic long peptides corresponding to prioritized cancer neoantigens and will be co-administered with poly-ICLC.

Type: Interventional

Start Date: Mar 2025

open study

An increasing number of guideline-directed medical therapies (GDMT) have been developed for patients with chronic heart failure with reduced ejection fraction (HFrEF). When used in combination at recommended doses, patients often experience significant improvements in cardiac function, quality of life, and survival.1,2 However, GDMT underuse occurs for the vast majority of patients with HFrEF. Two recent trials demonstrated improved GDMT prescribing during a clinic visit, each using automated delivery of a patient-centered decision support tool to promote a proactive and holistic approach to prescribing: EPIC-HF (NCT03334188) tested a brief video and checklist document sent to patients just prior to a clinic visit encouraging them to work with their clinicians to make at least 1 positive change to their GDMT; PROMPT-HF (NCT05433220) tested tailored electronic health record (EHR) alerts for GDMT intensification delivered to clinicians during clinic visits. The current I-I-CAPTAIN-HF study aims to broadly implement and test the EPIC-HF patient-facing and PROMPT-HF clinician-facing tools for HFrEF medication intensification at 5 health systems around the country through a pragmatic cluster-randomized implementation-effectiveness trial. This will occur through an initial phase of adaptation of the 2 tools at each health system. Once ready, the 2 tools will be tested using a 2x2 randomization at the clinician-level. In parallel, formal assessment of the implementation of EPIC-HF and PROMPT-HF will work to understand the most effective means of intervention design and delivery, as well as adaptations due to contextual factors to optimize use.

Type: Interventional

Start Date: Mar 2025

open study

The study will be a non-randomized, non-blinded pilot study to analyze the safety and feasibility of a non-significant risk device, transcutaneous spinal cord stimulation. The aim is to include 30 total patients, 10 patients in each of 3 groups: 1. Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy and offered surgical intervention. 2. Early tSCI screened during the hospital admission when cervical/thoracic spinal injury was diagnosed. 3. Delayed tSCI (control) screened 6-24 months after acute cervical/thoracic spinal injury.

Type: Interventional

Start Date: Oct 2024

open study

To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.

Type: Interventional

Start Date: Oct 2024

open study

The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo

Type: Interventional

Start Date: Oct 2024

open study

The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.

Type: Interventional

Start Date: Jul 2024

open study

Cerebral palsy (CP) is the most common physical disability in early childhood causing serious motor and sensory impairments. Effective interventions for the recovery of motor functions are of profound significance to children with CP, their families, caregivers, and health professionals. Robot-assisted rehabilitation represents a frontier with potential to improve motor functions and induce brain reorganization in children with CP.

Type: Interventional

Start Date: Sep 2021

open study

The purpose of this study is to compare the plasma pharmacokinetics (PK) of nemtabrutinib (MK-1026) following a single oral dose of nemtabrutinib in participants with moderate hepatic impairment to that of healthy matched control participants and to evaluate the safety and tolerability of nemtabrutinib.

Type: Interventional

Start Date: Jul 2024

open study

This observational study aims to look at the connections between kidney stones, insulin resistance, and inflammation. The researchers hypothesize that people who form calcium kidney stones and have insulin resistance may have higher levels of inflammation because they have more visceral fat (fat around the abdominal organs). The study will recruit 20 people who have had calcium kidney stones but don't have diabetes, and 20 healthy people who haven't had kidney stones. All the participants will come to the research center at the University of Chicago Medicine. Participants will have a dual-energy X-ray absorptiometry (DEXA) scan to measure their visceral fat, and give blood and urine samples. The blood will be tested for insulin resistance, inflammatory markers, and other metabolic factors. The urine will be analyzed for substances that increase kidney stone risk. The main goal is to see if the kidney stone formers with insulin resistance have more visceral fat compared to those without insulin resistance and the healthy participants. The researchers will also compare inflammatory marker levels between groups, and look at how visceral fat, inflammatory markers, insulin resistance, and urine stone risk factors are related. The findings may help explain how kidney stones are connected to metabolic conditions like diabetes and cardiovascular disease. Researchers hope this information will help identify stone formers at risk early and develop preventive treatments in the future.

Type: Observational

Start Date: Jun 2024

open study