Search Clinical Trials
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Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Children's Hospital of Philadelphia
Failed or Difficult Intubation, Sequela
Intubation; Difficult
Intubation Complication
Advanced airway interventions are common high risk, high stakes events for children in
intensive care units (ICU) and emergency departments (ED), with risk for life and health
threatening consequences. expand
Advanced airway interventions are common high risk, high stakes events for children in intensive care units (ICU) and emergency departments (ED), with risk for life and health threatening consequences. Type: Observational Start Date: Mar 2010 |
The Mobility Toolkit: Electronically Augmented Assessment of Functional Recovery Following Lower-extremity...
Major Extremity Trauma Research Consortium
Gait
The study will prospectively enroll and follow 300 participants ages 18-60 surgically
treated for a lower-extremity articular injury including fractures of the tibial plateau,
pilon, ankle, and calcaneus. expand
The study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus. Type: Observational Start Date: Jan 2019 |
Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain
Isabel Moreno Hay
Neuropathic Pain
Onabotulinum toxin type A (BoNT-A) is a potent neurotoxin that has been reported to have
an effect on afferent (sensory) neurons independent of its action on muscle tone and
secretory glands at the periphery.In human studies, the use of BoNT-A has proven to
reduce the severity and intensity of attacks... expand
Onabotulinum toxin type A (BoNT-A) is a potent neurotoxin that has been reported to have an effect on afferent (sensory) neurons independent of its action on muscle tone and secretory glands at the periphery.In human studies, the use of BoNT-A has proven to reduce the severity and intensity of attacks in chronic tension type headaches and chronic neck pain. The PREEMPT study concluded that BoNT-A could be used as a preventive therapy in chronic migraine patients and FDA approval was obtained. According to the International Association for the Study of Pain (IASP), BoNT-A is recommended for the management of peripheral neuropathic pain with subcutaneous administration of 50-200 units (50-200U) to onabotulinum toxin A to the painful neuropathic area every 3 months as a third line of treatment. To our knowledge, there are no clinical trials published investigating the effect of intraoral administration of BoNT-A in continuous dentoalveolar neuropathic pain. The aim of this pilot study is to investigate the potential therapeutic effect of intraoral administration of BoNT-A in patients suffering from continuous neuropathic pain. HYPOTHESIS: There will be statistically significant differences in reported pain intensity after the intraoral administration of BOTOX® in patients suffering from chronic continuous dentoalveolar neuropathic pain. A single subject experiment will be conducted with 10 patients where 50 U of BonT-A will be injected into the painful dentoalveolar area. Eligible subjects will complete a pain diary indicating their pain intensity by means of a visual analog scale during one month to establish a baseline. After the first injection, subjects will continue to monitor the VAS daily for 3 months and the infiltration will be repeated a second time following the same protocol. Patient's response will be monitored with the daily pain diary. Type: Interventional Start Date: Sep 2019 |
Regulation of Mucosal Healing in Inflammatory Bowel Disease
Terrence A Barrett
Inflammatory Bowel Diseases
The objective of the current study is to compare non-healing colonic ulcers in patients
with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in
healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients
will be biopsied at baseline and again... expand
The objective of the current study is to compare non-healing colonic ulcers in patients with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients will be biopsied at baseline and again at a follow-up visit in a "biopsy of the biopsy" approach. These biopsies will be used to reveal patterns about gene expression and mitochondrial function during ulcer healing. Type: Interventional Start Date: Apr 2021 |
Alcohol and Opioids
Sharon Walsh
Opioid Use
Alcohol Drinking
This study will examine the effects of doses of alcohol/placebo and doses of
opioid/placebo, alone and in combination. The primary outcomes are related to
pharmacodynamic measures (subjective ratings of drug liking and other abuse-related
effects; physiological outcomes) to determine the interaction... expand
This study will examine the effects of doses of alcohol/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds. Type: Interventional Start Date: Mar 2021 |
Cisplatin + Radiation in SCCHN and Correlation With Oxidative Stress Markers
Susanne Arnold
Carcinoma, Squamous Cell
Head and Neck Cancer
Patients will receive standard of care radiation therapy to the primary tumor of the head
and neck and involved nodal metastasis and draining nodal basin and either weekly
cisplatin or every 3-week cisplatin in locally advanced SCCHN. The relationship between
cisplatin toxicity and the level of reactive... expand
Patients will receive standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin and either weekly cisplatin or every 3-week cisplatin in locally advanced SCCHN. The relationship between cisplatin toxicity and the level of reactive oxygen species generated by the drug in subjects with squamous cell carcinoma of the head and neck treated on this trial. Type: Interventional Start Date: Apr 2017 |
Spinal Cord Injury Neuroprotection With Glyburide
University of Kentucky
Acute Spinal Cord Injury
To assess the safety and efficacy of using oral Glyburide (Diabeta) as a neuroprotective
agent in patients with acute cervical or thoracic traumatic spinal cord injury. expand
To assess the safety and efficacy of using oral Glyburide (Diabeta) as a neuroprotective agent in patients with acute cervical or thoracic traumatic spinal cord injury. Type: Interventional Start Date: Jul 2022 |
Gene Therapy for Haemophilia A.
University College, London
Hemophilia A
The GO-8 study focuses on assessing safety and efficacy of gene therapy for patients with
severe haemophilia A expand
The GO-8 study focuses on assessing safety and efficacy of gene therapy for patients with severe haemophilia A Type: Interventional Start Date: Jun 2017 |
CSTOP Now! Child Sex Trafficking Stops With You
Ann Coker
Child Sex Trafficking
Focus: Intervention & prevention of child commercial sexual exploitation or trafficking
(CST) In Kentucky, familial SU/D increases risk of CST. Primary goal: Implement and
evaluate effectiveness of multi-level bystander-informed program (CSTOP Now!) aimed at
Kentucky public middle schools for staff. expand
Focus: Intervention & prevention of child commercial sexual exploitation or trafficking (CST) In Kentucky, familial SU/D increases risk of CST. Primary goal: Implement and evaluate effectiveness of multi-level bystander-informed program (CSTOP Now!) aimed at Kentucky public middle schools for staff. Type: Interventional Start Date: Sep 2023 |
Broad-spectrum Rapid Antidote: Varespladib IV to Oral Trial for Snakebite (BRAVIO)
Ophirex, Inc.
Snakebite
Envenoming, Snake
This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed
to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of
IV varespladib followed by transition to the oral dosage form, varespladib-methyl,
concurrently with SOC, in participants... expand
This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of IV varespladib followed by transition to the oral dosage form, varespladib-methyl, concurrently with SOC, in participants bitten by venomous snakes. Note: Funding Source - FDA-OOPD Type: Interventional Start Date: May 2023 |
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Massachusetts General Hospital
Myocarditis Acute
Cancer
The primary aim is to test whether abatacept, as compared to placebo, is associated with
a reduction in major adverse cardiac events (MACE) among participants hospitalized with
myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE,
is a composite of first occurrence... expand
The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure. Type: Interventional Start Date: Jun 2022 |
ArtemiCoffee in Patients With Rising PSA
Zin W Myint
Prostate Cancer
Until now, clinicians have been challenged to improve the treatment of biochemically
recurrent (BCR) prostate cancer in which prostatic specific antigen (PSA) rises without
radiological or clinical progression years after localized treatment (radical
prostatectomy or radiation therapy) with or without... expand
Until now, clinicians have been challenged to improve the treatment of biochemically recurrent (BCR) prostate cancer in which prostatic specific antigen (PSA) rises without radiological or clinical progression years after localized treatment (radical prostatectomy or radiation therapy) with or without hormonal treatment. Approximately 50-90% of men with high-risk prostate cancer will experience a BCR. Artesunate has demonstrated anti-tumor activity in both in vivo and in vitro cell lines. It is hypothesized that Artemisia annua (Aa) coffee has the potential to decrease rising PSA among patients with biochemical recurrence of prostate cancer. Type: Interventional Start Date: Aug 2023 |
Neural and Hormonal Influences on Sex Differences in Risk for AUD
Jessica Weafer
Alcohol Use Disorder
The sex gap in alcohol consumption is closing rapidly, due to alarming increases among
women. From 2002-2013, Alcohol Use Disorder (AUD) increased 84% for women, compared to
35% for men. As such, there is an urgent need to determine the factors underlying sex
differences in risk for AUD. Current addiction... expand
The sex gap in alcohol consumption is closing rapidly, due to alarming increases among women. From 2002-2013, Alcohol Use Disorder (AUD) increased 84% for women, compared to 35% for men. As such, there is an urgent need to determine the factors underlying sex differences in risk for AUD. Current addiction models propose three domains that drive problematic alcohol use and serve as candidate sex-specific risk factors: executive function, negative emotionality, and incentive salience. Data suggest that poor inhibitory control, a key component of executive function, is a stronger risk factor for women than for men. Moreover, there is have preliminary evidence that female drinkers show less engagement of neural inhibitory circuitry, and that this sex difference is influenced by estradiol. However, the degree to which hormonally-moderated sex differences in executive function extend to the negative emotionality and incentive salience domains, and how these sex differences influence current and future drinking is unknown. The goal of this study is to identify the mechanisms underlying sex-specific risk for AUD, and ultimately to help develop sex-specific prevention and treatment efforts. The overall objective of this trial is to determine the neural and hormonal factors contributing to sex-specific risk for AUD in three addiction domains: inhibitory control (executive function), negative emotionality, and alcohol cue reactivity (incentive salience). Type: Interventional Start Date: May 2021 |
Role of ASpirin in Placental and Maternal Endothelial Cell Regulation IN Pre-eclampsia
John O'Brien, MD
Pre-Eclampsia
Endothelial dysfunction and defective placental vascularization are hypothesized to be
significant causes of preeclampsia. In preeclampsia, due to vascular endothelial
dysfunction, vasoconstriction and platelet activation can result in severe features which
alter pregnancy outcomes. However, studies... expand
Endothelial dysfunction and defective placental vascularization are hypothesized to be significant causes of preeclampsia. In preeclampsia, due to vascular endothelial dysfunction, vasoconstriction and platelet activation can result in severe features which alter pregnancy outcomes. However, studies have shown that acetylsalicylic acid (Aspirin) can decrease endothelial dysfunction leading to decreased platelet aggregation which reduces adverse outcomes. The objective of our study is to determine if Aspirin has a dose-dependent response for modifying biomarkers reflective of maternal endothelial dysfunction when indicated for preeclampsia prevention in a cohort of women identified at risk for developing preeclampsia. Pregnant women who are at risk for preeclampsia will be randomized to receive either 81mg Aspirin or 162mg Aspirin daily starting from 11-16 weeks of gestation until 36 weeks of gestation. A third, control group of women at low risk for preeclampsia will not receive aspirin. All women will be assessed with uterine artery Doppler studies and mean arterial blood pressures at three time points during pregnancy. Blood, urine, and cord blood samples will also be collected. Type: Interventional Start Date: Apr 2019 |
MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
Carolyn M Hettrich
Other Instability, Shoulder
Dislocations
Subluxations
Recurrent Dislocation of Shoulder Region
This project will be a multi-center, prospective longitudinal cohort for all patients
undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will
be looking for risk factors for recurrent instability, revision surgery, and poor
outcomes. Patients will be asked to complete... expand
This project will be a multi-center, prospective longitudinal cohort for all patients undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be looking for risk factors for recurrent instability, revision surgery, and poor outcomes. Patients will be asked to complete the RAND-36, ASES, Shoulder Activity, EQ-5D and WOSI outcome measures, as well as demographic and socioeconomic information. Surgeons will complete a form after surgery with information on radiographic findings, physical exam, surgical findings, and the repair. Patients will wear a sling post-operatively, and follow standardized rehabilitation protocols, including physical therapy. Patients will be sent outcome questionnaires at 2, 6, 10, and 20 years after surgery. Type: Observational [Patient Registry] Start Date: Aug 2012 |
Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage
Delta-Fly Pharma, Inc.
Leukemia, Myeloid, Acute
Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients
with AML relapsed/refractory after 2, 3, or 4 prior induction regimens:
Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6
mg/m²/day followed by a 14-day resting period per 28-day... expand
Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed/refractory after 2, 3, or 4 prior induction regimens: Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6 mg/m²/day followed by a 14-day resting period per 28-day cycles. Control arm: Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment. Type: Interventional Start Date: Nov 2019 |
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Vertos Medical, Inc.
Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary
surgical and minimally invasive intervention post index procedure, as well as harms
associated with the MILD procedure, at 24 months post-treatment with MILD, tested against
a control group of similar patients... expand
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor. Type: Observational Start Date: Mar 2017 |
MC1R-targeted Alpha-particle Therapy Trial in Adults With Advanced Melanoma
Perspective Therapeutics
Melanoma (Skin)
Metastatic Melanoma
Melanoma Stage IV
Melanoma, Uveal
Mucosal Melanoma
In this first-in human, phase I/IIa study, the safety and efficacy of [212Pb]VMT01, an
alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor
(MC1R) is being evaluated in patients with unresectable and metastatic melanoma. expand
In this first-in human, phase I/IIa study, the safety and efficacy of [212Pb]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated in patients with unresectable and metastatic melanoma. Type: Interventional Start Date: Jun 2023 |
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients...
Gilead Sciences
Triple Negative Breast Cancer
The goal of this study is to find out if the experimental product, sacituzumab
govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective
and safe compared to the treatment of physician's choice (TPC) which includes either
pembrolizumab or pembrolizumab plus capecitabine... expand
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment. Type: Interventional Start Date: Dec 2022 |
Mandibular Advancement Device and Changes in Nocturia
Fernanda Yanez Regonesi
Obstructive Sleep Apnea
Nocturia
OSA
The main purpose of this study is to test is mandibular advacenment device (MAD) use is
associated with reductions in nocturia. expand
The main purpose of this study is to test is mandibular advacenment device (MAD) use is associated with reductions in nocturia. Type: Interventional Start Date: Dec 2023 |
Degenerative Cervical Myelopathy Repository
University of Kentucky
Cervical Myelopathy
To create a research repository of patients with known degenerative cervical myelopathy
(DCM) and a control cohort of subjects who have non-myelopathic spinal disease. This
repository will be used to assess functional and/or biological measures that may allow
for improved prediction of symptomatic... expand
To create a research repository of patients with known degenerative cervical myelopathy (DCM) and a control cohort of subjects who have non-myelopathic spinal disease. This repository will be used to assess functional and/or biological measures that may allow for improved prediction of symptomatic progression and response to treatment in patients with DCM. In addition, this repository will be used to develop a risk assessment scale to accurately predict functional outcomes following operative management of DCM. Type: Observational [Patient Registry] Start Date: Jul 2022 |
Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia
Novartis Pharmaceuticals
Chronic Myelogenous Leukemia - Chronic Phase
This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who
have been previously treated with one prior ATP- binding site TKI with discontinuation
due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly
diagnosed CML-CP patients who may... expand
This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP- binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort. Type: Interventional Start Date: Nov 2022 |
Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice
Joshua A. Lile, Ph.D.
Opioid Use Disorder
The objective of this protocol is to use probabilistic choice tasks, reinforcement
learning modeling and fMRI to determine the neurobehavioral mechanisms of decision-making
in individuals with opioid use disorder and physical opioid dependence. expand
The objective of this protocol is to use probabilistic choice tasks, reinforcement learning modeling and fMRI to determine the neurobehavioral mechanisms of decision-making in individuals with opioid use disorder and physical opioid dependence. Type: Interventional Start Date: May 2024 |
Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL)
Woolsey Pharmaceuticals
Amyotrophic Lateral Sclerosis
A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in
Patients with Amyotrophic Lateral Sclerosis (ALS) expand
A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients with Amyotrophic Lateral Sclerosis (ALS) Type: Interventional Start Date: Dec 2021 |
Loupe-Based Intraoperative Fluorescence Imaging
Guoqiang Yu
Glioblastoma Multiforme
Anaplastic Astrocytoma
Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are the most common primary
malignant brain tumors. Survival of patients with these brain tumors is directly related
to the extent of resection. Consequently, a great deal of effort has been directed at
developing techniques and technologies... expand
Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are the most common primary malignant brain tumors. Survival of patients with these brain tumors is directly related to the extent of resection. Consequently, a great deal of effort has been directed at developing techniques and technologies that allow more extensive, safe resections. This study will test a loupe-based wearable device in the clinical setting and compare its accuracy with a large operative microscope to identify tumor tissues. Postoperative histopathological analysis on tumor tissues will be used as gold standards for comparison. The outcome from this study will be a low-cost, miniaturized, easy-to-operate, loupe-based fluorescence imaging device for intraoperative guidance of brain tumor resection with the same level of accuracy as the large microscope. Type: Observational Start Date: Nov 2017 |
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