This is a Phase 3, randomized, double-blind, comparator- and placebo-controlled study to evaluate analgesic efficacy and safety of TLC590 via local infiltration in adult subjects following bunionectomy.

Type: Interventional

Start Date: Nov 2025

open study

The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve System to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve System can more efficiently decongest ADHF patients in comparison to Control Therapy.

Type: Interventional

Start Date: Jul 2025

open study

The main purpose of this study is to create a longitudinal cohort of those with Sickle Cell Trait (SCT) to better understand the hematologic phenotype for those that carry HbS, assess for differences in those with varying quantities of HbS and assess for potential clinical complications of SCT.

Type: Observational

Start Date: Apr 2023

open study

The purpose of this study is to compare the efficacy and side effects magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD).

Type: Interventional

Start Date: Aug 2024

open study

The purpose of the study is to understand how culturally competent messaging on secure firearm storage and temporary out-of-home storage (TOHS) is perceived and accepted by firearm owners.

Type: Interventional

Start Date: Aug 2025

open study

The purpose of this study is to assess the effect of quantitative block monitoring versus less expensive qualitative monitoring treatment effects on the lowest SpO2/FiO2 ratio in the PACU. The results will be incorporated into an enhanced recovery pathway for surgical patients.

Type: Interventional

Start Date: Sep 2025

open study

The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty

Type: Observational

Start Date: Jun 2023

open study

The overall goal of the DISCOVERY study is to better understand what factors contribute to changes in cognitive (i.e., thinking and memory) abilities in patients who experienced a stroke. The purpose of the study is to help doctors identify patients at risk for dementia (decline in memory, thinking and other mental abilities that significantly affects daily functioning) after their stroke so that future treatments may be developed to improve outcomes in stroke patients. For this study, a "stroke" is defined as either (1) an acute ischemic stroke (AIS, or blood clot in the brain), (2) an intracerebral hemorrhage (ICH, or bleeding in the brain), (3) or an aneurysmal subarachnoid hemorrhage (aSAH, or bleeding around the brain caused by an abnormal bulge in a blood vessel that bursts). The investigators hypothesize that: 1. The size, type and location of the stroke play an important role in recovery of thinking and memory abilities after stroke, and pre-existing indicators of brain health further determine the extent of this recovery. 2. Specific stroke events occurring in individuals with underlying genetic or biological risk factors can cause further declines in brain heath, leading to changes in thinking and memory abilities after stroke. 3. Studying thinking and memory alongside brain imaging and blood samples in patients who have had a stroke allows for earlier identification of declining brain health and development of individualized treatment plans to improve patient outcomes in the future.

Type: Observational

Start Date: Mar 2021

open study

The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.

Type: Interventional

Start Date: Jul 2024

open study

This study will take a basic neuroscience approach to investigate pathological mechanisms underlying PTSD. Additionally, the study aims to identify how Transcranial Alternating Current Stimulation (tACS) brain stimulation can modulate and correct neural networks and related emotions of anxious arousal and hypervigilance, with the goal of assessing tACS brain stimulation technology as a novel intervention for symptoms of anxiety.

Type: Interventional

Start Date: Apr 2022

open study

The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.

Type: Interventional

Start Date: Nov 2021

open study

The purpose of this study is to determine the cultural, socioeconomic, inter/personal and work-related factors that influence COVID 19 mitigation practices including social distancing, hand-washing and Personal protective equipment (PPE) use, to adapt, implement, and test Vale+Tú Salud in a cluster randomized trial to assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention and to promote Vale+Tú Salud just-in-time results and increase its capacity to rapidly disseminate findings among groups that serve LDL and other Latino immigrants.

Type: Interventional

Start Date: Jul 2025

open study

The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with Observed/Expected (O/E) Lung to Head Circumference Ratio (LHR) < 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR < 45%,to compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR < 30% that receive FETO procedure performed at 27 weeks 0 days to 29weeks 6 days of gestation to those with intrathoracic liver herniation, isolated LCDH and o/e LRH < 30% that undergo expectant management, to compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCHD with o/e LHR < 45% that undergo FETO procedure performed at 27 weeks 0 days to 29 weeks 6 days gestation to those with intrathoracic liver herniation, isolated RCHD and o/e LHR < 45% that elect to proceed with expectant management, to evaluate the frequency of maternal and fetal complications associated with FETO procedure, to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated LCDH survivors with o/e LHR <30% when compared to isolated LCDH with o/e LRH <30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation and to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated RCDH survivors with o/e LHR ≤ 45% when compared to isolated RCHD with LHR < 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation

Type: Interventional

Start Date: Mar 2025

open study

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.

Type: Observational [Patient Registry]

Start Date: Apr 2017

open study

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes.

Type: Interventional

Start Date: Aug 2024

open study

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil combined with cognitive training for improving white matter integrity.

Type: Interventional

Start Date: Jun 2025

open study

The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.

Type: Interventional

Start Date: Jul 2024

open study

The purpose of this study is to precisely delineate human brain networks that modulate respiration and identify specific brain areas and stimulation techniques that can be used to prevent seizure-induced breathing failure.

Type: Interventional

Start Date: Jul 2023

open study

The purpose of this study is to evaluate whether the use of the Detection of Elder Mistreatment Through Emergency Care Technicians-Revised for Primary Care (DETECT-RPC) screening tool increases the average reporting of elder mistreatment (EM) by homebased primary care (HBPC) clinicians.

Type: Interventional

Start Date: Feb 2025

open study

The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.

Type: Interventional

Start Date: May 2021

open study

The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other AAA617 causally related serious adverse event(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.

Type: Interventional

Start Date: Aug 2023

open study

Perspiration or sweating is a normal physiological response to increased body temperature, environmental heat and humidity, emotions, nervousness, or physical exertion. Perspiration occurs when sweat is secreted from sweat glands, travels through sweat ducts and exits sweat pores to coat the skin's surface. The evaporation of sweat from the skin dissipates heat and is the primary thermoregulatory mechanism used by humans and primates. Excessive sweating beyond what is required for maintaining body temperature homeostasis is termed hyperhidrosis. Primary hyperhidrosis is idiopathic affecting the palmar, plantar, axillary, or craniofacial regions bilaterally, while secondary hyperhidrosis is less common and is often a side effect of medication or an underlying pathology. Primary hyperhidrosis may affect up to 4.8% of the US population, yet it is widely underreported and undertreated. Hyperhidrosis can negatively impact daily activities, cause significant stress, limit social interactions, and reduce the quality of life for patients. In particular, excessive palmar sweating interferes with professional activities (e.g., shaking hands, working with tools, or wearing exam gloves) and degrades sports performance. Hyperhidrosis (HH) is especially difficult to treat on the hands and feet, with clinical care beginning with prescription strength topical aluminum chloride hexahydrate antiperspirants such as DrySol or Secret Clinical, and OTC products (e.g., Carpe). However, prescription strength aluminum chloride antiperspirants are often ineffective, can be irritating and leave a residue that degrades skin texture and grip. Currently, iontophoresis is the only medical device approved for treating palmar and plantar HH, but these devices are expensive (~$1,500), uncomfortable to use and are time consuming (30 minutes sessions, 3-4 times a week for several months). Oral anticholinergic medicines such as oxybutynin are often prescribed but they have unwanted side effects including blurred vision, dry mouth, and headache. Topical anticholinergic wipes have shown promise, but they are expensive, take weeks to relieve symptoms and have unpleasant side effects in >18% of patients. Finally, invasive procedures such as Botox™ injections and endoscopic thoracic sympathectomy are used to treat the most severe palmar/plantar HH cases but these treatments are expensive, invasive, painful and can have significant adverse effects including persistent muscle weakness and compensatory sweating. Thus, a high unmet need exists for topical treatments that are fast-acting, safe, and effective. Cyanoacrylate (CA) tissue adhesives have been used for decades to close wounds, stop bleeding, and prevent infection. CA tissue adhesives bond to the skin through Michael's addition reactions to tissue amines, forming durable but flexible films. Despite CA being used for various medical applications, no CA-based antiperspirants are currently clinically approved or commercially available. Topical cyanoacrylate (TCA) is based on medical grade cyanoacrylate adhesives with decades of demonstrated safety clinical applications. TCA is cheap to produce which will improve affordability and treatment adoption. In addition, prototypical TCA formulations eliminate surface moisture within seconds and occlude eccrine sweat pores, anticipating a strong antiperspirant effect compared to current treatments which typically reduce sweating with variable efficacy. TCA is innovative because it is fast acting (acts within seconds) and does not degrade the surface of the skin or grip function. Current hyperhidrosis treatments typically require days to weeks to achieve clinical results, have a variety of undesirable side effects, and can negatively affect the surface feel of the skin. Aside from topical antiperspirants, Botox injections and anticholinergic agents are the only drugs approved by the FDA for treating hyperhidrosis. Due to their rapid polymerization and strong adhesion and low toxicity, n-Butyl and 2-Octly cyanoacrylate are widely used in thoracic, gastrointestinal, neurologic, cardiovascular, ophthalmologic, and vascular surgery. Although n-Butyl and 2-Octyl cyanoacrylate are considered safe, allergic contact dermatitis can occur after surgical wounds closure at an incident rate of 2.7% for 2-Octyl cyanoacrylate and 2.2% for n-Butyl cyanoacrylate, but risks are presumably lower for topical application on intact glabrous skin. Thus, a significant unmet need exists for fast-acting, cheap, effective, and safe treatments that leave the skin with a desirable surface feel and improve grip security. In this pilot study described in this proposal, investigators will evaluate the safety and efficacy of a topical application of generic cyanoacrylate (TCA, equivalent to FDA cleared GluStich® medical adhesive or Marathon No Sting Liquid Skin Protectant) to inhibit palmar perspiration.

Type: Interventional

Start Date: Jul 2024

open study

The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT). Primary Objective To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors. Secondary Objectives: - To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors. - To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors .

Type: Observational

Start Date: Dec 2022

open study

The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at a higher risk for HIV. The intervention is delivered within the mental health treatment setting and integrates knowledge, behavioral skills, and motivation to engage in and adhere to PrEP care. The purpose of this study is to assess the preliminary efficacy, feasibility, and acceptability of this intervention. The hypothesis is that, compared to standard treatment, the intervention will be feasible, acceptable, and associated with greater PrEP uptake and adherence.

Type: Interventional

Start Date: Oct 2024

open study

The goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. The main question it aims to answer is: • If the integrated intervention increase PrEP uptake and adherence compared to standard treatment Participants will - receive provision of PrEP information through 4 counseling sessions - prevention navigation - receive nurse practitioner prescribed PrEP in an addiction treatment setting Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence

Type: Interventional

Start Date: Jun 2022

open study