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 evaluate the acceptability, feasibility (e.g., satisfaction, completion rate, barriers to recruitment, treatment fidelity) of the culturally refined Launching! to Adulthood (¡Iniciando! la Adultez) program, to test for a preliminary signal of effect between baseline and post-treatment for the Launching! to Adulthood (¡Iniciando! la Adultez) program and to identify preliminary neural mechanisms of action, including biomarkers of brain structure and connectivity, in terms of treatment response for 15 Latino young adults participating in the ¡Iniciando! therapy program.

Type: Interventional

Start Date: Apr 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 purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

Type: Interventional

Start Date: Sep 2023

open study

This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.

Type: Interventional

Start Date: Aug 2022

open study

To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.

Type: Interventional

Start Date: Jan 2022

open study

The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.

Type: Interventional

Start Date: Feb 2022

open study

The proportion of noncardiac surgeries performed as same-day surgery is increasing worldwide, with more complex surgeries being performed on higher risk patients in the outpatient setting. Little is known on the risk factors, incidence and prognosis of patients undergoing same-day noncardiac surgery. The main objective of this study is to inform on the incidence and risk factors of cardiovascular and other adverse events after same-day surgery and to develop risk prediction tools to better inform on the risk and selection of patients undergoing same-day surgery.

Type: Observational

Start Date: Nov 2021

open study

Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.

Type: Interventional

Start Date: Jun 2019

open study

The goal of the ATX101-TKA-004 clinical trial aims to evaluate the efficacy and safety of ATX101 1,500 mg in participants undergoing primary unilateral total knee arthroplasty. The study will compare the effectiveness of ATX101 with a saline placebo and bupivacaine, an active comparator. Additionally, it will assess opioid consumption among participants receiving ATX101 versus those given the saline placebo and bupivacaine. The trial will also focus on the safety and tolerability of ATX101 in the participants.

Type: Interventional

Start Date: Feb 2025

open study

The purpose of this study is to determine whether Motivating Youth to Reduce Infections, Disconnections, and Emotion dysregulation (MY-RIDE) decreases substance use , to determine whether MY-RIDE increases human immunodeficiency virus (HIV) prevention strategies and to evaluate MY-RIDE effects on willingness to take Pre-Exposure Prophylaxis (PrEP), stress, substance use urge, and use of mental health and substance use services when compared to attention control youth

Type: Interventional

Start Date: Nov 2024

open study

The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device. The study will learn about standard device use in adult patients who have a functional deltoid muscle and massive and non-repairable rotator cuff tear. The main questions it aims to answer are: - What is the average improvement in patient-reported shoulder function after 2 years when compared to before the surgery, and - What is the rate of surgical revisions needed over a 10 year period Patients will be asked to will be asked to regularly attend their check-up visits with their surgeon (including having x-rays or CT images taken to check their shoulder and implant), to complete questionnaires to report how their shoulder is doing, and to tell their surgeon when they notice any changes.

Type: Observational

Start Date: Oct 2023

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

This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo.

Type: Interventional

Start Date: Jul 2020

open study

Objectives: Our specific aims are to: Aim 1: Examine the feasibility of a couple-based meditation program in 50 patients with metastatic lung cancer and their partners. Aim 2: Establish the initial efficacy of a couple-based meditation program in patients and their partners regarding physical, psychological, and spiritual quality of life outcomes.

Type: Interventional

Start Date: Apr 2016

open study

The purpose of this study is to assess impact of repetitive transcranial magnetic stimulation (rTMS)+Episodic Future Thinking (EFT) vs. sham rTMS+EFT on delay discounting and methamphetamine (MA) demand, on vividness of future positive events during EFT training and on frequency of episodic thinking during the week following EFT training

Type: Interventional

Start Date: Mar 2025

open study

The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices. This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).

Type: Interventional

Start Date: Jul 2024

open study

Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions.

Type: Interventional

Start Date: Jul 2024

open study

The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS).

Type: Interventional

Start Date: Aug 2023

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 main goal of this trial is to evaluate the safety and tolerability of mRNA-3745 via intravenous (IV) administration in adult and pediatric participants with GSD1a.

Type: Interventional

Start Date: Jun 2022

open study

Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE.

Type: Interventional

Start Date: Jun 2021

open study

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Type: Observational

Start Date: Mar 2020

open study