Search Clinical Trials
Sponsor Condition of Interest |
---|
BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
Penumbra Inc.
Deep Vein Thrombosis
DVT
The objective of this study is to demonstrate the safety and efficacy of the Indigo
Aspiration system for percutaneous mechanical thrombectomy in a population presenting
with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment. expand
The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment. Type: Interventional Start Date: Sep 2021 |
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
C. R. Bard
Open Midline Laparotomy
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at
the time of midline fascial closure compared to primary suture closure in preventing a
subsequent incisional hernia in subjects at risk for incisional hernia after open midline
laparotomy surgery. expand
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery. Type: Interventional Start Date: Dec 2019 |
Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
Jaeb Center for Health Research
Cystic Fibrosis
The goal of the study is to examine multiple markers of anthropometrics, body
composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry
(DXA) output, which is considered the current clinical gold-standard tool to measure body
composition. The result of this study will... expand
The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function. Type: Observational Start Date: Apr 2023 |
Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
Veronica Morgan Jones
Breast Cancer
HER2-negative Breast Cancer
Node-negative Breast Cancer
Breast Carcinoma
The goal of this study is to access whether treatment of early state estrogen-rich breast
cancers with neoadjuvant endocrine therapy will result in higher rates of margin
negativity on lumpectomy specimen. expand
The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen. Type: Interventional Start Date: Feb 2022 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian...
GOG Foundation
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Stage III Primary Peritoneal Cancer
Stage IV Primary Peritoneal Cancer
Stage III Fallopian Tube Cancer
Patients will be registered prior to, during or at the completion of neoadjuvant
chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1
every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant
chemotherapy will not be eligible for iCRS and will... expand
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC (Arm A) will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (Arm B) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per institutional standard (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 2-3 cycles) for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing until progression or 36 months (if no evidence of disease). Type: Interventional Start Date: Mar 2024 |
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With...
Perspective Therapeutics
Melanoma (Skin)
Metastatic Melanoma
Melanoma Stage IV
Mucosal Melanoma
Melanoma Stage III
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 as a monotherapy and in combination with Nivolumab in subjects
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 as a monotherapy and in combination with Nivolumab in subjects with unresectable and metastatic melanoma. Type: Interventional Start Date: Jun 2023 |
Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
Denise Fabian
Uterine Cervix Cancer
This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix
cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood
samples are obtained to detect circulating levels of deoxyribonucleotides, human
papillomavirus DNA, and circulating tumor... expand
This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells. Type: Observational Start Date: Jan 2023 |
Hepatitis C Treatment in Probation and Parole Office
Jens Rosenau
Hepatitis C
HCV
This prospective cohort study compares aims to determine the efficacy and effectiveness
of telemedicine-supported on-site linkage to care and treatment in a community probation
and parole office (P&P office) setting and compare the results with a historic control
with referral to care. Research participants... expand
This prospective cohort study compares aims to determine the efficacy and effectiveness of telemedicine-supported on-site linkage to care and treatment in a community probation and parole office (P&P office) setting and compare the results with a historic control with referral to care. Research participants will be followed in the P&P office when they report to their officer during regularly scheduled appointments. Participants will receive treatment without having to travel to a specialist's office. The telemedicine visit will include a consultation with an experienced HCV provider such as a hepatologist or an advanced practice provider and a specialty pharmacist who will educate about and monitor HCV treatment. The UK specialty pharmacy will be available to participants and the HCV management team through a 24-hour support line. Participants will be treated per HCV guidelines and insurance preference. Type: Interventional Start Date: Aug 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 |
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
Mirati Therapeutics Inc.
Advanced Cancer
Metastatic Cancer
Malignant Neoplastic Disease
This study will evaluate the safety, tolerability, drug levels, molecular effects, and
clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have
a KRAS G12C mutation. expand
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation. Type: Interventional Start Date: Jan 2019 |
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 |
- Previous
- Next