Search Clinical Trials
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Trial of Parkinson's and Zoledronic Acid
California Pacific Medical Center Research Institute
Parkinson Disease
Osteoporosis
Parkinsonism
Parkinson's Disease and Parkinsonism
Atypical Parkinsonism
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion
of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60
years and older with Parkinson's disease and parkinsonism with at least 2 years of
follow-up. A total of 3500 participants... expand
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 3500 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging. Type: Interventional Start Date: Nov 2019 |
Evaluation of K9 in Subjects With Thyroid Eye Disease (TED)
Peter Timoney
Thyroid Eye Disease
The objective of this clinical trial is to evaluate the plasma pharmacokinetics of K9 in
healthy subjects (Cohort 1) and the safety and treatment efficacy of K9 in patients with
active Thyroid Eye Disease (Cohort 2). Participants will receive study medication one
time or for up to 4 weeks. Participants... expand
The objective of this clinical trial is to evaluate the plasma pharmacokinetics of K9 in healthy subjects (Cohort 1) and the safety and treatment efficacy of K9 in patients with active Thyroid Eye Disease (Cohort 2). Participants will receive study medication one time or for up to 4 weeks. Participants will have blood drawn and/or complete eye exams and questionnaires. The planned duration of this study is 6 weeks. Type: Interventional Start Date: Aug 2024 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis...
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Zachary Warriner
Rib Fractures
This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy
versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and
oral outpatient) alone for patients with multiple rib fractures. The objective of this
study is to analyze the effect of... expand
This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and oral outpatient) alone for patients with multiple rib fractures. The objective of this study is to analyze the effect of continuous intercostal nerve block (CINB) in the treatment of patients admitted to the adult trauma service with rib fractures. The effectiveness of CINB as adjunctive treatment will be compared to standard medical therapy involving nonsteroidal and intravenous/oral opioid medications. Type: Interventional Start Date: Dec 2024 |
Alzheimer's Disease Neuroimaging Initiative 4
University of Southern California
Mild Cognitive Impairment
Alzheimer Disease
Dementia
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging
Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD)
clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3
studies that have combined public/private... expand
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD. Type: Observational Start Date: Jun 2023 |
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
Ellipses Pharma
Advanced Solid Tumor
The aim of this study is to assess the safety, side effects and effectiveness of EP0031
in patients with advanced RET-altered malignancies expand
The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies Type: Interventional Start Date: Sep 2022 |
Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
Nuwellis, Inc.
Heart Failure (for Example, Fluid Overload)
The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of
adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop
diuretics in patients with worsening heart failure (HF) and fluid overload. expand
The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload. Type: Interventional Start Date: Jun 2022 |
DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma
Giselle Sholler
Medulloblastoma
Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study as
Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory
Medulloblastoma. expand
Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma. Type: Interventional Start Date: Mar 2021 |
Bentracimab in Ticagrelor-treated Patients With Uncontrolled Bleeding or Requiring Urgent Surgery or...
SFJ Pharmaceuticals, Inc.
Hemorrhage
Urgent Surgery
Invasive Procedure
This is a multi-center, open-label, prospective single-arm study of reversal of the
antiplatelet effects of ticagrelor with bentracimab (PB2452) in patients who present with
uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive
procedure.
At least 200 patients... expand
This is a multi-center, open-label, prospective single-arm study of reversal of the antiplatelet effects of ticagrelor with bentracimab (PB2452) in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure. At least 200 patients will be enrolled from approximately 200 centers in North America, Europe, and Asia-Pacific regions, including mainland China. Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal will be eligible for enrollment. These populations will be enrolled based on separate inclusion criteria. Type: Interventional Start Date: Jul 2020 |
Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1
Mikhail N Koffarnus
Alcohol Use Disorder
Directly reinforcing abstinence from alcohol with monetary incentives is an effective
treatment for alcohol dependence, but barriers in obtaining frequent, verified
biochemical measures of abstinence limit the dissemination of this treatment approach.
The goal of this study is to use technological... expand
Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. The goal of this study is to use technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed smartphone app and breathalyzer. This treatment approach has the potential to facilitate the dissemination of an effective, evidence-based treatment for alcohol dependence to a broader population whose treatment needs are not currently being adequately met. Type: Interventional Start Date: Jun 2020 |
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Celgene
Neoplasms
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for
all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy
participating in a previous Celgene sponsored or Celgene alliance partner sponsored
study.
Participants who received at least... expand
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol. Type: Interventional Start Date: Jun 2018 |
A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease...
Alzheimer's Disease Cooperative Study (ADCS)
Alzheimer Disease
The purpose of this study is to learn more about the safety, effectiveness and
tolerability of the study drug called Benfotiamine which may delay or slow the
progression of the symptoms of early Alzheimer's disease. expand
The purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine which may delay or slow the progression of the symptoms of early Alzheimer's disease. Type: Interventional Start Date: Mar 2024 |
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against...
Regeneron Pharmaceuticals
Diffuse Large B-cell Lymphoma (DLBCL)
This study is researching an experimental drug called odronextamab, referred to as study
drug, when used in combination with chemotherapy. The study is focused on patients with
diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called
"previously untreated"). Patients with DLBCL... expand
This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug when combined with chemotherapy - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) - The impact from the study drug on quality of life and ability to complete routine daily activities Type: Interventional Start Date: Dec 2023 |
US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
CereVasc Inc
Hydrocephalus, Normal Pressure
Hydrocephalus
The eShunt® System is a minimally invasive method of treating communicating
hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the
eShunt Implant, a permanent implant deployed in a minimally invasive,
neuro-interventional procedure. The eShunt System is intended to... expand
The eShunt® System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence. Type: Interventional Start Date: Apr 2022 |
Suvorexant and Alcohol
University of Kentucky
Alcohol Use Disorder
This research will translate findings from preclinical research and provide the initial
clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other
alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study
will also provide basic science... expand
This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans. Type: Interventional Start Date: Jun 2024 |
Cocaine and Zolmitriptan
William Stoops
Cocaine Use Disorder
Cocaine potently inhibits the reuptake of serotonin (5-HT). Increased synaptic 5-HT
resulting from this reuptake inhibition activates multiple 5-HT receptor subtypes. Some
of these receptor subtypes have been implicated in the abuse-related effects of cocaine,
including its primary reinforcing effects... expand
Cocaine potently inhibits the reuptake of serotonin (5-HT). Increased synaptic 5-HT resulting from this reuptake inhibition activates multiple 5-HT receptor subtypes. Some of these receptor subtypes have been implicated in the abuse-related effects of cocaine, including its primary reinforcing effects (i.e., cocaine taking behavior). 5-HT1b receptors, which are autoreceptors on 5-HT nerve endings that regulate 5-HT release and heteroreceptors that also mediate other neurotransmitter release, play a particularly important role in cocaine effects, likely because they are highly expressed in the mesocorticolimbic system. The 5-HT1b system displays profound dysregulation during both active cocaine use and abstinence. Initial preclinical research showed that selective 5-HT1b agonists enhanced the reinforcing and locomotor effects of cocaine during ongoing cocaine administration, but subsequent research showed that these agents robustly attenuated reinstatement of cocaine- and cue-primed cocaine seeking behavior. These findings have been replicated in rigorously conducted studies using multiple schedules of reinforcement and negative sucrose reinforcement controls across laboratories. Notably, though, these preclinical studies used compounds not approved for use in humans, hindering translation. Recently published data show that zolmitriptan, a commercially available selective 5-HT1b agonist migraine medication, also selectively attenuates the reinforcing and other abuse-related effects of cocaine, regardless of stage of use (i.e., ongoing or extinguished cocaine self-administration). Although a robust preclinical literature supports the premise that 5-HT1b activation reduces a number of cocaine-associated behaviors (e.g., self-administration, cocaine seeking), this area remains unstudied in humans. The overarching goal of this project is to advance these promising preclinical findings, specifically those with zolmitriptan, to a clinical population, thereby demonstrating that the 5-HT1b system plays a key role in the effects of cocaine in humans Type: Interventional Start Date: Oct 2021 |
Nilotinib Plus Dabrafenib/Trametinib in Metastatic Melanoma
Ruta Arays
Metastatic Melanoma
BRAF Gene Mutation
This is a phase 1 dose-escalation study of nilotinib in combination with fixed-dose
dabrafenib and trametinib regimen for patients with metastatic or unresectable melanoma
carrying a BRAF V600 mutation and have relapsed on a BRAF/MEK inhibitor therapy. The goal
is to assess the toxicity and tolerability... expand
This is a phase 1 dose-escalation study of nilotinib in combination with fixed-dose dabrafenib and trametinib regimen for patients with metastatic or unresectable melanoma carrying a BRAF V600 mutation and have relapsed on a BRAF/MEK inhibitor therapy. The goal is to assess the toxicity and tolerability and determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the combination of nilotinib with dabrafenib and trametinib. Additionally, this study will assess pharmacokinetic parameters of dabrafenib and nilotinib when used in combination. Type: Interventional Start Date: Jun 2022 |
Spinal Decompression Plus Nerve Graft Implantation Following TSCI
H. Francis Farhadi
Spinal Cord Injuries
Acute Traumatic Spinal Cord Injury
This is a single-blinded (with outcome assessors blinded to treatment allocation),
12-month pilot study to evaluate of the safety, feasibility, and preliminary efficacy of
dorsal myelotomy and expansive duraplasty performed either without or with autologous
nerve graft implantation after acute traumatic... expand
This is a single-blinded (with outcome assessors blinded to treatment allocation), 12-month pilot study to evaluate of the safety, feasibility, and preliminary efficacy of dorsal myelotomy and expansive duraplasty performed either without or with autologous nerve graft implantation after acute traumatic spinal cord injury. Ten participants will be allocated to receive either DMED (n=5) or DMED + ANGI (n=5) based on a block design. Participants and assessors will be blinded to group allocation. Excess sural nerve samples will be collected for banking/analysis (may include proteomic, culturing, genomic, cellular analysis). Type: Interventional Start Date: Apr 2024 |
Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies
Jia-Rong Wu
Medication Adherence
Heart Failure
People with heart failure who do not take their medications as prescribed are at high
risk of complications leading to hospitalization, death and poor quality of life. In the
proposed intervention, nurses will use easy-to-understand language to coach patients and
their care partners to help them work... expand
People with heart failure who do not take their medications as prescribed are at high risk of complications leading to hospitalization, death and poor quality of life. In the proposed intervention, nurses will use easy-to-understand language to coach patients and their care partners to help them work together and build skills to overcome their individual barriers to adherence in order to 1) improve and sustain patient medication adherence; 2) reduce hospitalization; 3) improve quality of life. If effective, this intervention will support long-term medication adherence, thus reducing hospitalizations related to heart failure and quality of life. Type: Interventional Start Date: Jan 2023 |
Parkinson's Foundation PD GENEration Genetic Registry
Parkinson's Foundation
Parkinson's Disease
Development of a central repository for PD-related genomic data for future research. expand
Development of a central repository for PD-related genomic data for future research. Type: Observational [Patient Registry] Start Date: Dec 2020 |
K23- Physical Self Regulation vs Placebo
Ian Boggero, PhD
Temporomandibular Disorder
This study will use a between-person design. Participants will be treatment-seeking
patients with chronic masticatory muscle pain. Participants who are eligible for the
study and consent to participate will be randomly assigned to receive a brief behavioral
intervention for chronic orofacial pain... expand
This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, >75% retention, >95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects. Type: Interventional Start Date: Apr 2024 |
Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy
University of Kentucky
Geographic Atrophy
Age-Related Macular Degeneration
This interventional study is a single-center, open label, 26-week study, designed to
evaluate the safety and treatment efficacy of K8 in patients with geographic atrophy (GA)
due to age-related macular degeneration (AMD). Up to 5 subjects will receive study
medication. Study treatment will be administered... expand
This interventional study is a single-center, open label, 26-week study, designed to evaluate the safety and treatment efficacy of K8 in patients with geographic atrophy (GA) due to age-related macular degeneration (AMD). Up to 5 subjects will receive study medication. Study treatment will be administered by intravitreal injections. Participants will have 7 scheduled visits - Screening with baseline (injection), safety visit 2 days after injection, week 4, week 13 (injection), safety visit 2 days after injection, week 17, week 26. Exams will look for continuous changes in visual acuity, change in area of geographic atrophy lesions in diagnostic imaging, response measured by multifocal electroretinogram, change in reading speed, and change in microperimetry response. Type: Interventional Start Date: Apr 2024 |
Blood Flow Restriction Training After Patellar INStability
Caitlin Conley
Patellar Dislocation
Knee Injuries
Leg Injury
Wounds and Injuries
This research study is designed to allow health care professionals and researchers to
answer many questions about whether a new type of physical therapy called blood flow
restriction training (called BFRT) will improve recovery for those with patellar
instability. expand
This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability. Type: Interventional Start Date: Sep 2020 |
Restoration of Hypoglycemia Awareness With Metoclopramide
Simon Fisher
Hypoglycemia Unawareness
Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve
symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this
study is to determine whether metoclopramide can improve hypoglycemia awareness and
decrease the incidence of hypoglycemia... expand
Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this study is to determine whether metoclopramide can improve hypoglycemia awareness and decrease the incidence of hypoglycemia in type 1 diabetes patients with hypoglycemia unawareness. Type: Interventional Start Date: May 2019 |
Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With Subarachnoid Hemorrhage
Aaron Cook
Subarachnoid Hemorrhage, Aneurysmal
The proposed study aims to evaluate the CNS penetration of telavancin in a critically ill
population using cerebrospinal fluid (CSF) drawn from external ventricular drains (EVDs)
in patients who have had spontaneous subarachnoid hemorrhage (SAH). Patients with SAH
were chosen as the target population... expand
The proposed study aims to evaluate the CNS penetration of telavancin in a critically ill population using cerebrospinal fluid (CSF) drawn from external ventricular drains (EVDs) in patients who have had spontaneous subarachnoid hemorrhage (SAH). Patients with SAH were chosen as the target population because they frequently require prolonged admission to the intensive care unit and drainage of CSF in order to prevent hydrocephalus. The estimated sample size is 20 subjects. This is a prospective cohort of patients with SAH. Patients will be included if they have a spontaneous SAH, aged 18-65 years old, Hunt-Hess score of 1-4 & has an actively draining ventriculostomy. Subjects will receive telavancin 10mg/kg (maximum 1000mg) every 24 hours for 3 consecutive doses. Serial serum and CSF samples will be obtained. An 8-hour urine collection will be completed on study day 2 in order to define the patient's measured creatinine clearance. Type: Interventional Start Date: Feb 2024 |
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