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Clinical and Genetic Evaluation of Individuals With Undiagnosed Disorders Through the Undiagnosed Diseases...
National Human Genome Research Institute (NHGRI)
Genetic Disease
Without an explanation for severe and sometimes life-threatening symptoms, patients and their
families are left in a state of unknown. Many individuals find themselves being passed from
physician to physician, undergoing countless and often repetitive tests in the hopes of... expand
Without an explanation for severe and sometimes life-threatening symptoms, patients and their families are left in a state of unknown. Many individuals find themselves being passed from physician to physician, undergoing countless and often repetitive tests in the hopes of finding answers and insight about what the future may hold. This long and arduous journey to find a diagnosis does not end for many patients- the Office of Rare Diseases Research (ORDR) notes that 6% of individuals seeking their assistance have an undiagnosed disorder. In 2008, the National Institutes of Health (NIH) Undiagnosed Diseases Program (UDP) was established with the goal of providing care and answers for these individuals with mysterious conditions who have long eluded diagnosis. The NIH UDP is a joint venture of the NIH ORDR, the National Human Genome Research Institute Intramural Research Program (NHGRI-IRP), and the NIH Clinical Research Center (CRC) (1-3). The goals of the NIH UDP are to: (1) provide answers for patients with undiagnosed diseases; (2) generate new knowledge about disease mechanisms; (3) assess the application of new approaches to phenotyping and the use of genomic technologies; and (4) identify potential therapeutic targets, if possible. To date, the UDP has evaluated 3300 medical records and admitted 750 individuals with rare and undiagnosed conditions to the NIH Clinical Center. The NIH UDP has identified more than 70 rare disease diagnoses and several new conditions. The success of the NIH UDP prompted the NIH Common Fund to support the establishment of a network of medical research centers, the Undiagnosed Diseases Network (UDN), for fiscal years 2013-2020. The clinical sites will perform extensive phenotyping, genetic analyses, and functional studies of potential disease-causing variants. The testing performed on patients involves medically indicated studies intended to help reach a diagnosis, as well as research investigations that include a skin biopsy, blood draws, and DNA analysis. In addition, the UDN will further the goals of the UDP by permitting the sharing of personally identifiable phenotypic and genotypic information within the network. By sharing participant information and encouraging collaboration, the UDN hopes to improve the understanding of rare conditions and advance the diagnostic process and care for individuals with undiagnosed diseases.... Type: Observational Start Date: Sep 2015 |
RESTORE: An RCT to Evaluate the Efficacy of the Revi System
BlueWind Medical
Urinary Urge Incontinence
The Revi System is indicated for the treatment of patients with symptoms of urgency
incontinence alone or in combination with urinary urgency.
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The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. Type: Interventional Start Date: Feb 2024 |
Investigating Dynamic Interactions in Distributed Cognitive Control Networks
University of Alabama at Birmingham
Cognitive Impairment
Dementia
ADD
Depression
The purpose of this study is to investigate the brain activity associated with cognitive
tasks (thinking, reasoning, remembering) in order to understand how the brain works during
certain tasks and to improve treatment for diseases like dementia and attention deficit
disorders.... expand
The purpose of this study is to investigate the brain activity associated with cognitive tasks (thinking, reasoning, remembering) in order to understand how the brain works during certain tasks and to improve treatment for diseases like dementia and attention deficit disorders. Cognitive (thinking) impairment may include poor memory function, poor attention span, or psychiatric disorders (ex: ADD, depression). The investigators are interested in the brain activity related to these issues, and want to investigate changes in brain activity while we record activity from specific areas of the brain. These recordings are in addition to clinical (routine or standard of care) recordings being performed to monitor for seizures and do not impact the clinical care. Type: Observational Start Date: Mar 2023 |
Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL
Affimed GmbH
Relapsed or Refractory Hodgkin Lymphoma
Peripheral T Cell Lymphoma
AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in
followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13 in
combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL.
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AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL. Type: Interventional Start Date: Oct 2023 |
Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
Inhibrx, Inc.
Alpha 1-Antitrypsin Deficiency
Emphysema
Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD
emphysema
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Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD emphysema Type: Interventional Start Date: Oct 2023 |
A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis...
Genentech, Inc.
Idiopathic Pulmonary Fibrosis
Systemic Sclerosis With Lung Involvement
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with
placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in
participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Participants... expand
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Type: Interventional Start Date: May 2023 |
Vestibular Balance Therapy Intervention for Children
University of Alabama at Birmingham
Vestibulocochlear Nerve Diseases
Vestibular Disorder
Bilateral Vestibular Loss
The goal of this within groups clinical trial is to determine the feasibility of a home-based
vestibular balance therapy program for children with vestibular hypofunction. The main
questions to be answered are: 1) what is the intervention's feasibility and 2) what is the
intervention's... expand
The goal of this within groups clinical trial is to determine the feasibility of a home-based vestibular balance therapy program for children with vestibular hypofunction. The main questions to be answered are: 1) what is the intervention's feasibility and 2) what is the intervention's preliminary impact on function? Participants will receive a comprehensive battery of vestibular function and balance tests, then an 8-week home-based intervention to be done 5 times/week with weekly checks from the physical therapist. Data will be used to design a larger clinical trial with a comparison group. Type: Interventional Start Date: Mar 2023 |
Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase...
Hansa Biopharma AB
Kidney Transplantation in Highly Sensitized Patients
The goal of this follow-up study is to learn about long-term patient survival and graft
function in highly sensitized patients who have received desensitization treatment with
imlifidase or standard of care (SoC) in order to enable kidney transplantation in clinical
study... expand
The goal of this follow-up study is to learn about long-term patient survival and graft function in highly sensitized patients who have received desensitization treatment with imlifidase or standard of care (SoC) in order to enable kidney transplantation in clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177). Type: Observational Start Date: Apr 2023 |
18F-rhPSMA-7.3 PET/MRI in Prostate Cancer Active Surveillance: A Pilot Study
University of Alabama at Birmingham
Prostate Cancer
The purpose of this study is to investigate the usefulness of PET/MRI with an investigational
radioactive drug, 18F-rhPSMA-7.3, and MRI contrast in evaluating patients with prostate
cancer eligible for active surveillance. This study is for imaging purposes only and is not a... expand
The purpose of this study is to investigate the usefulness of PET/MRI with an investigational radioactive drug, 18F-rhPSMA-7.3, and MRI contrast in evaluating patients with prostate cancer eligible for active surveillance. This study is for imaging purposes only and is not a treatment study. Type: Interventional Start Date: Apr 2025 |
Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer
Arcus Biosciences, Inc.
Advanced Non-Small Cell Lung Cancer
The purpose of this study is to assess the objective response rate (ORR) of
immunotherapy-based combination therapy and to assess the safety and tolerability of
immunotherapy-based combination therapy.
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The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy. Type: Interventional Start Date: Feb 2023 |
The Impact of a Virtual Magic Trick Training Program
University of Alabama at Birmingham
Autism
Pervasive Developmental Disorder
The proposed project will attempt to confirm the benefits of a structured magic trick
training program (MTTP) experience in adolescents with autism. Benefits of participating in a
6-week virtual MTTP will be evaluated using validated assessments to measure social-emotional... expand
The proposed project will attempt to confirm the benefits of a structured magic trick training program (MTTP) experience in adolescents with autism. Benefits of participating in a 6-week virtual MTTP will be evaluated using validated assessments to measure social-emotional competencies. Type: Interventional Start Date: Mar 2023 |
Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid...
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or without
panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have
spread from where it first started to nearby tissue, lymph nodes, or distant parts of the
body... expand
This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or without panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Sotorasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells. Panitumumab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. Giving combination panitumumab and sotorasib may kill more tumor cells in patients with advanced solid tumors with KRAS G12C mutation. Type: Interventional Start Date: Oct 2024 |
A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With Moderate-to-severe...
Janssen Research & Development, LLC
Depressive Disorder, Major
Anhedonia
The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as
adjunctive therapy to an antidepressant in improving depressive symptoms in adult
participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+)
who have... expand
The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). Type: Interventional Start Date: Dec 2022 |
Study of Tecovirimat for Human Monkeypox Virus
National Institute of Allergy and Infectious Diseases (NIAID)
Monkeypox
MPOX
A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of
tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV
disease.
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A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV disease. Type: Interventional Start Date: Sep 2022 |
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Janssen Research & Development, LLC
Depressive Disorder, Major
The purpose of this study is to assess the long-term safety and tolerability of aticaprant
administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake
inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all
participants... expand
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD). Type: Interventional Start Date: Sep 2022 |
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients...
Hoffmann-La Roche
NMDAR Autoimmune Encephalitis
LGI1 Autoimmune Encephalitis
The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and
pharmacodynamics of satralizumab in participants with anti-N-methyl-D-aspartic acid receptor
(NMDAR) and anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis.
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The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab in participants with anti-N-methyl-D-aspartic acid receptor (NMDAR) and anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis. Type: Interventional Start Date: Sep 2022 |
To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
Novartis Pharmaceuticals
Idiopathic Pulmonary Fibrosis
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter,
platform study to investigate efficacy, safety, and tolerability of various single treatments
in participants with idiopathic pulmonary fibrosis
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A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis Type: Interventional Start Date: Nov 2022 |
Add-on Reparixin in Adult Patients With ARDS
Dompé Farmaceutici S.p.A
Acute Respiratory Distress Syndrome, Adult
Study objectives
1. To characterize the efficacy of reparixin in ameliorating lung injury and systemic
inflammation and expediting clinical recovery and liberation from mechanical ventilation
in adult patients with moderate to severe ARDS (PaO2/FIO2 ratio ≤ 200).... expand
Study objectives 1. To characterize the efficacy of reparixin in ameliorating lung injury and systemic inflammation and expediting clinical recovery and liberation from mechanical ventilation in adult patients with moderate to severe ARDS (PaO2/FIO2 ratio ≤ 200). 2. To evaluate the safety of reparixin vs. placebo in patients enrolled in the study. Type: Interventional Start Date: Feb 2023 |
Sensory Filtering in the Human Basal Ganglia as a Mechanism of Parkinson's Disease
University of Alabama at Birmingham
Parkinson Disease
The investigators are investigating the brain activity associated with sensory information in
movement disorders in order to improve treatment of these symptoms beyond what is currently
available.
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The investigators are investigating the brain activity associated with sensory information in movement disorders in order to improve treatment of these symptoms beyond what is currently available. Type: Observational Start Date: Jun 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... 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 |
Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy...
Alliance for Clinical Trials in Oncology
B Acute Lymphoblastic Leukemia
B Lymphoblastic Lymphoma
This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the
usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell
lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab,... expand
This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may help shrink the cancer and stop it from returning. Type: Interventional Start Date: Feb 2023 |
Evolut™ EXPAND TAVR II Pivotal Trial
Medtronic Cardiovascular
Aortic Stenosis Symptomatic
Moderate Aortic Valve Stenosis
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR
System to include patients with moderate, symptomatic AS.
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Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, symptomatic AS. Type: Interventional Start Date: Apr 2022 |
Embolization of the Splenic Artery After Trauma
Andrew J. Gunn
High-grade Splenic Injuries
Our aim is to conduct a multi-center, Bayesian, randomized clinical trial to evaluate the
primary technical success of coils and vascular plugs for proximal splenic artery
embolization in the setting of high-grade splenic trauma. The investigator has previously
demonstrated... expand
Our aim is to conduct a multi-center, Bayesian, randomized clinical trial to evaluate the primary technical success of coils and vascular plugs for proximal splenic artery embolization in the setting of high-grade splenic trauma. The investigator has previously demonstrated the feasibility of such a study in a single center pilot trial. Type: Interventional Start Date: May 2022 |
A Phase 1b/2 Study of BGB-11417in Monotherapy and in Various Combinations With Dexamethasone and Carfilzomib...
BeiGene
Relapsed/Refractory Multiple Myeloma
Study consists of two parts, a part 1 dose escalation and a part 2 cohort expansion in
combination with dexamethasone and carfilzomib intravenously across two cohorts with a
monotherapy component as well.
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Study consists of two parts, a part 1 dose escalation and a part 2 cohort expansion in combination with dexamethasone and carfilzomib intravenously across two cohorts with a monotherapy component as well. Type: Interventional Start Date: Sep 2021 |
Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic...
Colette Shen
Breast Cancer
Brain Metastases, Adult
This study is a Phase I/II study evaluating the safety and effectiveness of focused radiation
therapy (radiosurgery) together with olaparib, followed by immunotherapy, for patients with
brain metastases from triple negative or BRCA-mutated breast cancers.
This study will... expand
This study is a Phase I/II study evaluating the safety and effectiveness of focused radiation therapy (radiosurgery) together with olaparib, followed by immunotherapy, for patients with brain metastases from triple negative or BRCA-mutated breast cancers. This study will have a Phase I portion in which subjects will be enrolled based on 3+3 dose escalation rules. Three dose levels of olaparib will be studied. Cycle 1 of study treatment will consist of Olaparib given twice daily concurrently with stereotactic radiosurgery (SRS). Olaparib will start one week prior to SRS and continue during and following SRS (1-5 fractions) for up to 28 days total. The number of doses of Olaparib will be dependent on how long it takes a subject to recover from SRS (ideally the subject will be off steroids, if they are required, at the start of Cycle 2, with exceptions outlined later in this section). Once the subject has recovered from SRS (based on investigator discretion) that will be considered the DLT period. Cycle 2 will be initiated with physician's choice systemic therapy and durvalumab. Cycle 2+ will equal 21 days. During Cycles 2 and 3, physician's choice systemic monotherapy will be given along with durvalumab per protocol. Each cycle will last 21 days. Imaging to evaluate intracranial and extracranial disease will be performed after Cycle 3, and subjects with response will continue with the systemic therapy and durvalumab until progression (intracranial or extracranial), unacceptable toxicity or death. Type: Interventional Start Date: Mar 2022 |
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