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Eliminating Monitor Overuse Trial (EMO Trial)
Children's Hospital of Philadelphia
Bronchiolitis Acute Viral
The purpose of this study is to identify the optimal deimplementation strategies for an
overused practice: continuous pulse oximetry monitoring of children hospitalized with
bronchiolitis who are not receiving supplemental oxygen. expand
The purpose of this study is to identify the optimal deimplementation strategies for an overused practice: continuous pulse oximetry monitoring of children hospitalized with bronchiolitis who are not receiving supplemental oxygen. Type: Interventional Start Date: Dec 2021 |
Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb...
Longeveron Inc.
Hypoplastic Left Heart Syndrome
The purpose of this study is to test whether Lomecel-B™ works in treating patients with
hypoplastic left heart syndrome (HLHS) and to gather additional information about the
safety of Lomecel-B. Lomecel-B contains human mesenchymal stem cells (MSCs) as the active
ingredient. MSCs are special cells... expand
The purpose of this study is to test whether Lomecel-B™ works in treating patients with hypoplastic left heart syndrome (HLHS) and to gather additional information about the safety of Lomecel-B. Lomecel-B contains human mesenchymal stem cells (MSCs) as the active ingredient. MSCs are special cells in the body that are able to change into other types of cells, such as heart, blood, and muscle cells. MSCs are found in various tissues of the body, such as the bone marrow, which is the spongy tissue inside of your bones. Lomecel-B uses MSCs from bone marrow of unrelated young healthy donors. These are called "allogeneic", and do not require donor matching to the patient. Type: Interventional Start Date: Jun 2021 |
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
American Thrombosis and Hemostasis Network
Hemophilia A With Inhibitor
Hemophilia B With Inhibitor
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with
Hemophilia A or B with inhibitors12 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... expand
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors12 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 |
An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients...
Shenzhen Ionova Life Sciences Co., Ltd.
Cancer
Solid Tumor, Adult
Cancer Metastatic
Solid Carcinoma
Solid Tumor, Unspecified, Adult
Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and
to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab.
The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with
pembrolizumab will be assessed... expand
Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab. The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with pembrolizumab will be assessed in adult patients with advanced solid tumors. Type: Interventional Start Date: Jun 2020 |
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children...
Duke University
Coronavirus Infection (COVID-19)
Pulmonary Arterial Hypertension
Urinary Tract Infections in Children
Hypertension
Pain
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... expand
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 |
VItamin C in Thermal injuRY: The VICToRY Trial
Clinical Evaluation Research Unit at Kingston General Hospital
Shock
Thermal Burn
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... expand
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 |
MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression...
Agendia
Breast Cancer
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... expand
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 |
Semaglutide for Post-Smoking Cessation Weight Management
The University of Texas Health Science Center, Houston
Obesity
Overweight
Cigarette Smoking
This trial will examine the effect of semaglutide 2.4mg on changes in body weight, body
composition, and peripheral and central mechanisms that control appetite, satiety, and
food intake in the context of smoking cessation. expand
This trial will examine the effect of semaglutide 2.4mg on changes in body weight, body composition, and peripheral and central mechanisms that control appetite, satiety, and food intake in the context of smoking cessation. Type: Interventional Start Date: Apr 2024 |
An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency...
The University of Texas Health Science Center, Houston
Respiratory Tract Infections
The purpose of this study is to evaluate overall changes in patient management and
longer-term resource utilization between control and test arms, including (but not
limited to) additional work-up (including other diagnostic tests and consults),
antimicrobial treatments, disposition decisions and... expand
The purpose of this study is to evaluate overall changes in patient management and longer-term resource utilization between control and test arms, including (but not limited to) additional work-up (including other diagnostic tests and consults), antimicrobial treatments, disposition decisions and hospital length of stay (LOS) Type: Interventional Start Date: Dec 2023 |
Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)
The University of Texas Health Science Center, Houston
Anesthesia
The purpose of this study is to assess the feasibility of SafeLM as a primary airway
device and as a conduit for intubation with and without the use of a bougie expand
The purpose of this study is to assess the feasibility of SafeLM as a primary airway device and as a conduit for intubation with and without the use of a bougie Type: Interventional Start Date: Sep 2023 |
Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical...
The University of Texas Health Science Center, Houston
Anesthesia
The purpose of this study is to assess and compare the conditions for tracheal intubation
obtained with Modified Time Principle Induction (MTPI) and that obtained with classic
induction (CI). This study will compare the efficiency of tracheal intubation with the
two induction techniques, as well as... expand
The purpose of this study is to assess and compare the conditions for tracheal intubation obtained with Modified Time Principle Induction (MTPI) and that obtained with classic induction (CI). This study will compare the efficiency of tracheal intubation with the two induction techniques, as well as evaluate for potential adverse events. Type: Interventional Start Date: Aug 2022 |
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Occlutech International AB
Stroke
Patent Foramen Ovale
The objective of this study is to investigate whether percutaneous PFO closure with the
Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore®
Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke,
and device/procedure related Serious... expand
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE). Type: Interventional Start Date: Apr 2022 |
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation...
The University of Texas Health Science Center, Houston
Pain Management
The purpose of this study is to compare the effectiveness of innovative intervention of
breathing controlled electrical stimulation (BreEStim) and conventional electrical
stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb
amputation. expand
The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb amputation. Type: Interventional Start Date: Apr 2021 |
Histological Evaluation in the Efficacy of GentleWave in Root Canal Pulp Tissue Debridement and Disinfection...
The University of Texas Health Science Center, Houston
Root Canal Treatment
The purpose of this study is to understand and learn better the efficacy of GentleWave
and obtain histological evidence of the efficacy of this new technology done in-vivo expand
The purpose of this study is to understand and learn better the efficacy of GentleWave and obtain histological evidence of the efficacy of this new technology done in-vivo Type: Interventional Start Date: Jul 2024 |
Magnetic Seizure Therapy in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD)
Edison Leung
Bipolar Disorder
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). expand
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: May 2024 |
Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Patients With Recurrent Posterior Fossa...
The University of Texas Health Science Center, Houston
Recurrent Ependymoma
This study seeks to determine the optimum dose frequency of 5-Azacytidin (5-AZA)
infusions into the fourth ventricle of the brain. The study's primary objective is to
establish the maximum tolerated dose for infusions of 5-Azacytidine into the fourth
ventricle in patients with recurrent ependymoma.... expand
This study seeks to determine the optimum dose frequency of 5-Azacytidin (5-AZA) infusions into the fourth ventricle of the brain. The study's primary objective is to establish the maximum tolerated dose for infusions of 5-Azacytidine into the fourth ventricle in patients with recurrent ependymoma. The study's secondary objective is to assess the antitumor activity of 5-Azacytidine infusions into the fourth ventricle based upon imaging studies and cytology. Type: Interventional Start Date: Feb 2019 |
PARTNER 3 Trial - Aortic Valve-in-Valve
Edwards Lifesciences
Aortic Stenosis
Aortic Stenosis, Severe
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra
transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve. expand
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve. Type: Interventional Start Date: Jan 2017 |
Methotrexate and Etoposide Infusions Into the Fourth Ventricle in Children With Recurrent Posterior Fossa...
The University of Texas Health Science Center, Houston
Brain Tumor Recurrent
The goal of this clinical research study is to establish the safety of simultaneous
infusions of methotrexate and etoposide into the fourth ventricle of the brain or
resection cavity in patients with recurrent malignant posterior fossa brain tumors. These
tumors include medulloblastoma, ependymoma,... expand
The goal of this clinical research study is to establish the safety of simultaneous infusions of methotrexate and etoposide into the fourth ventricle of the brain or resection cavity in patients with recurrent malignant posterior fossa brain tumors. These tumors include medulloblastoma, ependymoma, atypical teratoid/rhabdoid tumor or other malignant brain tumor with recurrence or progression involving anywhere in the brain and/or spine. Patients' disease must have originated in the posterior fossa of the brain. Type: Interventional Start Date: Oct 2016 |
Couple-Based Meditation for Metastatic Lung Cancer Patients and Their Partners
M.D. Anderson Cancer Center
Lung Cancer
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,... expand
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 |
Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal...
Rallybio IPA, LLC
Fetal and Neonatal Alloimmune Thrombocytopenia
A prospective, non-interventional, natural history study to assess the occurrence of
higher FNAIT risk across a broad population of different racial and ethnic
characteristics and the occurrence of HPA-1a alloimmunization in these women. expand
A prospective, non-interventional, natural history study to assess the occurrence of higher FNAIT risk across a broad population of different racial and ethnic characteristics and the occurrence of HPA-1a alloimmunization in these women. Type: Observational Start Date: Mar 2022 |
Inspiring New Science In Guiding Healthcare in Turner Syndrome Registry
University of Colorado, Denver
Turner Syndrome
INSIGHTS is a registry research study that collects key information on medical history
for girls and women with Turner syndrome and the clinical care they receive. This
includes genetic tests, imaging, medications, and more for hundreds of patients seen at a
number of clinics across the US. In addition... expand
INSIGHTS is a registry research study that collects key information on medical history for girls and women with Turner syndrome and the clinical care they receive. This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. In addition to learning a lot about the current state of health for individuals with TS, INSIGHTS serves as an infrastructure to conduct future studies are meaningful to patients and their families. Type: Observational [Patient Registry] Start Date: May 2020 |
Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies
Presage Biosciences
Solid Tumor
This is a multi-center, open-label Phase 0 Master Protocol designed to study the
localized pharmacodynamics (PD) of anti-cancer therapies within the tumor
microenvironment (TME) when administered intratumorally in microdose quantities via the
CIVO device in patients with surface accessible solid tumors... expand
This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients with surface accessible solid tumors for which there is a scheduled surgical intervention. CIVO stands for Comparative In Vivo Oncology. Multiple substudies will include specified investigational agents and combinations to be evaluated. Type: Interventional Start Date: Jul 2021 |
PRIME: PReservIng Memory in Epilepsy
The University of Texas Health Science Center, Houston
Mesial Temporal Lobe Epilepsy
In this study, participants will receive unilateral Deep Brain Stimulation (DBS) for
treatment of epilepsy, with network-based stimulation targets specifically defined using
a stereo-electro-encephalographic evaluation and chronic recordings using the Medtronic
Percept™ primary cell (PC) Neurostimulator... expand
In this study, participants will receive unilateral Deep Brain Stimulation (DBS) for treatment of epilepsy, with network-based stimulation targets specifically defined using a stereo-electro-encephalographic evaluation and chronic recordings using the Medtronic Percept™ primary cell (PC) Neurostimulator DBS System with BrainSense™ Technology. The hypothesis is that, compared to no stimulation or to standard duty cycle high frequency stimulation, epilepsy neuromodulation using low frequency stimulation and informed by network architecture in patients with epilepsy that arises in a hippocampus that also subserves memory - epilepsy in a precious hippocampus (EPH) - will result in a significant decrease in seizure frequency and severity, paralleled by a decrease in EEG spike counts and improved memory function. Type: Interventional Start Date: Nov 2023 |
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
Edwards Lifesciences
Aortic Stenosis, Severe
The objective of this study is to establish the safety and effectiveness of the Edwards
SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific
aortic stenosis (AS). expand
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS). Type: Interventional Start Date: Jun 2022 |
Developing and Testing an Implementation Strategy for Active Learning to Promote Physical Activity in...
The University of Texas Health Science Center, Houston
Physical Activity
The purpose of this study is to develop an implementation strategy to improve the use and
sustainment of active learning in elementary schools and to conduct a feasibility study
to evaluate the impact of the developed implementation strategy on the implementation and
effectiveness of active learning. expand
The purpose of this study is to develop an implementation strategy to improve the use and sustainment of active learning in elementary schools and to conduct a feasibility study to evaluate the impact of the developed implementation strategy on the implementation and effectiveness of active learning. Type: Interventional Start Date: Aug 2023 |
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