The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).

Type: Interventional

Start Date: Dec 2022

open study

Post-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness/hospitalization. While half of US adults experience trauma in their lifetime, most do not develop PTSD. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance). This trial is a double-blind placebo controlled study of cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure Formulation (Nantheia ATL5). Participants complete three weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched healthy population participants are enrolled and complete baseline data collection only. All participants may complete optional functional magnetic resonance imaging (fMRI).

Type: Interventional

Start Date: Dec 2022

open study

The long-term objective of this project is to characterize how psilocybin affects visual perception and the brain's representation of the visual environment. It is known that psilocybin alters aspects of visual perception, but the underlying brain mechanisms contributing to these effects are poorly understood. The proposed work will address these questions in a large, diverse sample of healthy human subjects by using functional magnetic resonance imaging (fMRI) to measure the brain's responses to visual stimuli. The proposed research will document which brain areas mediate the effects of psilocybin. The technique of fMRI will be employed to measure brain activity in different brain areas while subjects are performing a visual perceptual task.

Type: Interventional

Start Date: Mar 2024

open study

The primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low/sarcopenic skeletal muscle area (SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal SMA at the end of a standard 1-hour infusion with the goal of determining whether lengthening the infusion in patients with low/sarcopenic SMA normalizes the levels to those of patients with normal SMA.

Type: Interventional

Start Date: Mar 2022

open study

To acquire blood samples from subjects for various purposes, including: i) determining the sensitivity and specificity of select DNA methylation markers for the detection of various types of cancer, ii) identifying benign conditions that may induce false positive or false negative results, and iii) defining the effects of potential interfering substances, such as chemotherapy drugs.

Type: Observational

Start Date: May 2019

open study

This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Type: Interventional

Start Date: Jul 2022

open study

The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine.

Type: Interventional

Start Date: Feb 2022

open study

Important information related to the visual assessment of patients, such as facial expressions, head and extremity movements, posture, and mobility are captured sporadically by overburdened nurses, or are not captured at all. Consequently, these important visual cues, although associated with critical indices such as physical functioning, pain, delirious state, and impending clinical deterioration, often cannot be incorporated into clinical status. The overall objectives of this project are to sense, quantify, and communicate patients' clinical conditions in an autonomous and precise manner, and develop a pervasive intelligent sensing system that combines deep learning algorithms with continuous data from inertial, color, and depth image sensors for autonomous visual assessment of critically ill patients. The central hypothesis is that deep learning models will be superior to existing acuity clinical scores by predicting acuity in a dynamic, precise, and interpretable manner, using autonomous assessment of pain, emotional distress, and physical function, together with clinical and physiologic data.

Type: Observational

Start Date: May 2021

open study

This study aims to evaluate the effectiveness of offering self-sampled human papillomavirus (HPV) tests in increasing participation in cervical cancer screening, compared to the standard of care clinician-sampled test. The primary study endpoints are (1) patients' acceptability of self-sampled HPV tests vs. clinician-sampled test, and (2) patients' completion of self-sampled HPV test. The secondary study endpoint to be measured is the increase in cervical cancer screenings of any type in the PSH St. Joseph's residency clinic patient population.

Type: Interventional

Start Date: Sep 2023

open study

The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma

Type: Interventional

Start Date: Nov 2021

open study

This is an investigation of possible relationships between daily physical activity (PA) and different measurements of fatigue in cancer survivors participating in a cancer exercise program.

Type: Observational

Start Date: Oct 2021

open study

Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig's Disease, is a progressive, terminal condition of muscle weakness that is associated with degeneration of neurons in the spinal cord and brain. This devastating disorder afflicts people in the prime of their lives. At the present time, there are no cures for this disorder, and current treatments are marginal at best. Despite years of intensive research, a fundamental understanding of this disease is still lacking. There is a need to identify both reliable markers of disease progression and effective treatments. The goal of this research is to bring a greater understanding of ALS patients closer to the research studies that can lead to new hypotheses and approaches.

Type: Observational [Patient Registry]

Start Date: Sep 2020

open study

This study uses [11C]NPA positron emission tomography (PET) and a d-amphetamine challenge to image amphetamine induced dopamine release in the striatum in subjects with cocaine use disorders (CUD). Amphetamine-induced dopamine release data from this study will be correlated with [11C]NOP-1A VT measured at baseline in the midbrain. [11C]NOP-1A PET data will be used from aim 1 (see, Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)

Type: Interventional

Start Date: Jan 2021

open study

This study uses [11C]NOP-1A positron emission tomography (PET) and a hydrocortisone challenge to image the interaction between nociceptive opioid peptide (NOP) receptors and cortisol/corticotrophin releasing factor (CRF) in subjects with cocaine use disorders (CUD) and matched healthy controls (HC). It will also examine whether alterations in CRF x NOP interactions predict relapse in subjects with CUD.

Type: Interventional

Start Date: Dec 2020

open study

The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).

Type: Interventional

Start Date: Jan 2025

open study

This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is no satisfactory standard treatment available.

Type: Interventional

Start Date: Sep 2021

open study

This study will test whether the combination of radiation and Dostarlimab is an effective treatment for women with MMR-D/MSI-H endometrial cancer who have recently undergone surgery.

Type: Interventional

Start Date: Apr 2021

open study

The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.

Type: Interventional

Start Date: Dec 2020

open study

This study's main specific aims are; 1. To develop robust acquisition and reconstruction methods specifically for the study of microvascular cardiac remodeling with MRI which will include very innovative quantitative perfusion methods, as well as fibrosis quantification, longitudinal strain, and phase contrast imaging for flow. 2. Test the new methods for identifying the clinical task of characterizing HFpEF.

Type: Interventional

Start Date: Mar 2017

open study

DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients. Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.

Type: Interventional

Start Date: Jun 2020

open study

This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.

Type: Observational

Start Date: Mar 2020

open study

The objective of this pilot study is to evaluate and compare the effect of three different perturbation based training devices on the reactive balance control among healthy young adults, healthy older adults, and neurologically impaired stroke individuals. Furthermore, the project aims to determine the feasibility and tolerability of 30-minutes of perturbation training using the SureFooted Trainer. Overall, the project directs to find out the long term effect of training on fall risk reduction and fall prevention. This study investigates the effects of perturbation training (slip and trip) based on the principles of motor learning. Perturbations in the form of slips and trips induced by the three different types of perturbation devices will displace the center of mass outside the base of support and challenge the stability, thereby inducing a fall and demand compensatory strategies in order to prevent it. Such perturbation training would train the motor system to improve stability control and vertical limb support. The project design aims to examine the ability of the central nervous system to mitigate the interference in stability control (if any) that is induced by opposing types of perturbations. The hypothesis of this study if supported by the results, will provide the difference in motor learning with training on three different perturbation devices. Furthermore, it would help to determine which of the three training devices is the most effective in developing defense mechanisms necessary to reduce fall-risk among community-living older adults and the neurological population.

Type: Interventional

Start Date: Feb 2018

open study

Stress urinary incontinence (SUI) is a condition that affects both men and women. SUI is the involuntary leakage of urine caused by an increase in intra-abdominal pressure from activities such as exercise, coughing, laughing, or sneezing. It can significantly affect quality of life as patients avoid activities or behaviors that cause leakage. This clinical trial will compare the efficacy of the Emsella chair to sham and determine if electromagnetic technology is effective in the treatment of SUI.

Type: Interventional

Start Date: Dec 2019

open study

The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug[s]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab. The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors. This study is looking at several other research questions, including: 1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab 2. How REGN5678 alone or in combination with cemiplimab works in the body 3. How much REGN5678 and/or cemiplimab are present in the blood 4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor

Type: Interventional

Start Date: Aug 2019

open study

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

Type: Interventional

Start Date: Aug 2019

open study