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TSC Biosample Repository and Natural History Database
National Tuberous Sclerosis Association
Tuberous Sclerosis
Lymphangioleiomyomatosis
The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that
scientists can request to use in their research. The samples we collect are all linked to
clinical data in the TSC Natural History Database. The TSC Natural History Database
captures clinical data to document... expand
The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that scientists can request to use in their research. The samples we collect are all linked to clinical data in the TSC Natural History Database. The TSC Natural History Database captures clinical data to document the impact of the disease on a person's health over his or her lifetime. This data may be collected retrospectively or prospectively. Type: Observational [Patient Registry] Start Date: Jan 2016 |
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With...
Bristol-Myers Squibb
Systemic Lupus Erythematosus
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib
compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE)
population. expand
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population. Type: Interventional Start Date: Jan 2023 |
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Hoffmann-La Roche
Chronic Obstructive Pulmonary Disease (COPD)
This study will evaluate the efficacy and safety of astegolimab compared with placebo in
participants with chronic obstructive pulmonary disease (COPD) who are former or current
smokers and have a history of frequent exacerbations. expand
This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations. Type: Interventional Start Date: Dec 2022 |
A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
Janssen Research & Development, LLC
Leukemia, Myeloid, Acute
The purpose of this study is to determine the recommended Phase 2 dose (RP2D)
candidate(s) of bleximenib in combination with AML directed therapies (dose selection)
and further to evaluate safety and tolerability of bleximenib in combination with AML
directed therapies at the RP2D(s) (dose expansion). expand
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion). Type: Interventional Start Date: Oct 2022 |
A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19
Pfizer
COVID-19
The purpose of this clinical trial is to learn about how study medicine (Paxlovid, which
contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as
its safety, and the extent to which side effects can be tolerated for treatment of
pregnant women with mild or moderate... expand
The purpose of this clinical trial is to learn about how study medicine (Paxlovid, which contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as its safety, and the extent to which side effects can be tolerated for treatment of pregnant women with mild or moderate COVID-19 compared to non-pregnant women with mild or moderate COVID-19. This study is seeking participants who: - are expecting a healthy baby and are in their second or third trimester pregnancy and have mild or moderate COVID-19 - are not pregnant and have mild or moderate COVID-19. All participants in this study will take Paxlovid by mouth every 12 hours for 5 days. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe. All participants will take part in this study for at least 34 days; pregnant participants will take part until their delivery, so that the study duration may be up to 6 months, depending on their delivery date. During this time, participants will have 7to 8 visits and, if pregnant, a visit at delivery. Around 2 to 3 visits and the delivery visit will be done in person (at the clinic or at the participant's home). The other 5 visits may be done over the phone, unless in-person visit is necessary as decided by the doctor. Blood samples will be collected on the first 4 to 5 study visits (and at other study visits, if necessary). Type: Interventional Start Date: Jun 2022 |
Novel Dental Gel as an Adjunct to Scaling and Root Planing
University of Alabama at Birmingham
Periodontal Diseases
Gingival Diseases
Gingival Pocket
Gum Bleed
Plaque, Dental
This study will evaluate the use of Livionex Dental Gel (LDG) as a home care product in
reducing probing pocket depth (PD) beyond the effect achieved by the current standard of
care with SRP in periodontitis patients. expand
This study will evaluate the use of Livionex Dental Gel (LDG) as a home care product in reducing probing pocket depth (PD) beyond the effect achieved by the current standard of care with SRP in periodontitis patients. Type: Interventional Start Date: Oct 2022 |
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
NRG Oncology
Stage III Colon Cancer
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to
patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery
for colon cancer. expand
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Type: Interventional Start Date: Mar 2022 |
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants...
Novartis Pharmaceuticals
Lupus Nephritis
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.)
ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in
combination with SoC, in adult participants with active LN expand
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN Type: Interventional Start Date: Jul 2022 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death. expand
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Type: Interventional Start Date: Aug 2022 |
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
BeiGene
B-cell Malignancy
Marginal Zone Lymphoma
Follicular Lymphoma
Non-Hodgkin Lymphoma
Waldenström Macroglobulinemia
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1
monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety
expansion of selected doses, and a Phase 2 (expansion cohorts) expand
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts) Type: Interventional Start Date: Sep 2021 |
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia...
Genmab
Relapsed/Refractory Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Richter's Syndrome
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody
also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be
studied as:
- Monotherapy, or
- Combination therapy:
- epcoritamab + venetoclax
- epcoritamab... expand
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as: - Monotherapy, or - Combination therapy: - epcoritamab + venetoclax - epcoritamab + lenalidomide - epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine (Oncovin®) and prednisone). The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter's Syndrome (RS). Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase. Epcoritamab will be injected subcutaneously (under the skin). Standard-of-care and combination treatments (venetoclax, lenalidomide, and R-CHOP) will be given either orally (by mouth) or intravenously (in a vein). Study details include: - Study duration will be up to 5 years. - The treatment duration for each participant will be between 18 months (1.5 years) and 24 months (2 years), depending upon the treatment arm assigned. - The visit frequency will be either weekly, every other week, or monthly, depending upon the part of the study. All participants will receive active drug; no one will be given placebo. Type: Interventional Start Date: Nov 2020 |
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory...
Janssen Research & Development, LLC
Multiple Myeloma
The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and
schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for
the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab +
teclistamab in participants with... expand
The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or refractory multiple myeloma and extramedullary disease (EMD) (Part 3). Type: Interventional Start Date: Dec 2020 |
Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
University of Alabama at Birmingham
Idiopathic Pulmonary Fibrosis
The purpose of the study is to see if imaging with fluorine-18 Fluorodeoxyglucose ([18F]
FDG) and fluorine-18 Displacement Per Atom ([18F]DPA-714) using positron emission
tomography and computed tomography (PET/CT) will show lung inflammation and fibrosis in
patients diagnosed with idiopathic pulmonary... expand
The purpose of the study is to see if imaging with fluorine-18 Fluorodeoxyglucose ([18F] FDG) and fluorine-18 Displacement Per Atom ([18F]DPA-714) using positron emission tomography and computed tomography (PET/CT) will show lung inflammation and fibrosis in patients diagnosed with idiopathic pulmonary fibrosis (IPF). This study may help physicians and researchers better understand how best to treat patients with IPF in the future. Type: Interventional Start Date: Dec 2020 |
UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy
University of Alabama at Birmingham
Alzheimer Disease
The primary objective of this study is to measure the concentration and the regional
brain distribution of pathologic tau deposition using the PET tracer AV-1451 in
participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain
will be correlated to demographic, clinical,... expand
The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled in an ongoing [C-11]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors. Type: Interventional Start Date: Jul 2020 |
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous...
AiCuris Anti-infective Cures AG
HSV Infection
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety
in immunocompromised subjects with acyclovir resistant or acyclovir susceptible
mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a
loading dose of 400 mg as first dose to rapidly... expand
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved). Type: Interventional Start Date: May 2017 |
A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of BMS-986393 in Novel Combinations...
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Multiple Myeloma
The purpose of this study is to establish a safe and tolerable dose of BMS-986393 in
combinations with alnuctamab, mezigdomide, and iberdomide in participants with relapsed
and/or refractory multiple myeloma (RRMM). expand
The purpose of this study is to establish a safe and tolerable dose of BMS-986393 in combinations with alnuctamab, mezigdomide, and iberdomide in participants with relapsed and/or refractory multiple myeloma (RRMM). Type: Interventional Start Date: Feb 2024 |
Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based...
HELP for NOWS Consortium
Neonatal Opiate Withdrawal Syndrome
This clinical trial will help us learn more about how to best care for babies with
Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have
tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that
have NOWS need medicine. Doctors have two ways... expand
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need medicine. Doctors have two ways of providing medicine that are widely used today: 1. Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms get better, the amount of medicine the baby gets decreases until the baby no longer needs medicine. This is called a medicine taper. 2. Symptom-based approach. The baby will only get medicine when they show signs of NOWS, instead of at regular times. If the baby is showing no signs of NOWS, no medicine will be given. We are doing the OPTimize NOW study to figure out the best way to give medicine to babies with NOWS. Type: Interventional Start Date: Mar 2024 |
Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive...
National Cancer Institute (NCI)
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic HER2-Negative Breast Carcinoma
Metastatic Hormone Receptor-Positive Breast Carcinoma
This phase II ComboMATCH treatment trial compares the usual treatment alone (fulvestrant)
to using binimetinib plus the usual treatment in patients with hormone receptor positive
breast cancer that has spread from where it first started to other places in the body
(metastatic) and has an NF1 genetic... expand
This phase II ComboMATCH treatment trial compares the usual treatment alone (fulvestrant) to using binimetinib plus the usual treatment in patients with hormone receptor positive breast cancer that has spread from where it first started to other places in the body (metastatic) and has an NF1 genetic change. Fulvestrant is a hormonal therapy that binds to estrogen receptors in tumor cells, resulting in estrogen receptor destruction and decreased estrogen binding, which may inhibit the growth of estrogen-sensitive tumor cells. Binimetinib is a targeted therapy that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of binimetinib to fulvestrant in breast cancers with an NF1 genetic change could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to fulvestrant alone. Type: Interventional Start Date: Sep 2024 |
A Study of Cabozantinib as a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric...
Nationwide Children's Hospital
Neuroblastoma
Sarcoma
This study will expand the types of pediatric cancers being evaluated for response to
cabozantinib. The current COG study is restricted to Ewing sarcoma, osteosarcoma,
rhabdomyosarcoma, Wilms tumor, and a handful of uncommon tumors. The proposed study will
extend this evaluation to tumors that have... expand
This study will expand the types of pediatric cancers being evaluated for response to cabozantinib. The current COG study is restricted to Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, Wilms tumor, and a handful of uncommon tumors. The proposed study will extend this evaluation to tumors that have been shown to either express known targets of cabozantinib or with preclinical evidence of efficacy, including specifically neuroblastomas. These tumors have high morbidity and mortality, particularly in the relapse setting, and few or no proven therapeutic options. As such, evaluation of cabozantinib in these studies is warranted. The study hypothesizes that use of cabozantinib in patients with ultra-high-risk pediatric solid tumors with minimal disease burden, as defined in the inclusion criteria below, can prevent and/or slow recurrent tumor formation in pediatric solid tumors and thereby significantly extend the period of disease control and/or induce a durable cure. Type: Interventional Start Date: Jul 2022 |
Olorofim Aspergillus Infection Study
F2G Biotech GmbH
Invasive Aspergillosis
The purpose of this study is to compare treatment with olorofim versus treatment with
AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or
probable lower respiratory tract disease Aspergillus species (invasive aspergillosis,
IA). expand
The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA). Type: Interventional Start Date: Mar 2022 |
INSPIRE Pipeline™ Shield Post Approval Study
Medtronic Neurovascular Clinical Affairs
Intracranial Aneurysm
The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post
Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients
undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Flex
Embolization Device with Shield Technology™ ("Pipeline™... expand
The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Flex Embolization Device with Shield Technology™ ("Pipeline™ Shield Device") in a real-world post approval setting within the United States. Type: Observational [Patient Registry] Start Date: Dec 2021 |
Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures At High Risk of...
Major Extremity Trauma Research Consortium
Post Operative Surgical Site Infection
The overall objective is to compare the effect of Vancomycin and Tobramycin powder
combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation
infections of tibial plateau and tibial pilon fractures at high risk of infection
(collectively considered the "study injuries"). expand
The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries"). Type: Interventional Start Date: May 2021 |
Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal...
National Institute of Allergy and Infectious Diseases (NIAID)
Gonococcal Infection
This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of
the FDA licensed rMenB+OMV NZ vaccine, Bexsero. The targeted study population is men and
women 18-50 years of age who are disproportionately vulnerable to N. gonorrhoeae
infection. Approximately 2,200 participants... expand
This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of the FDA licensed rMenB+OMV NZ vaccine, Bexsero. The targeted study population is men and women 18-50 years of age who are disproportionately vulnerable to N. gonorrhoeae infection. Approximately 2,200 participants are expected to be enrolled to achieve at least 202 evaluable participants. Data will be collected in an observer-blind manner. Study product recipients and study staff responsible for the evaluation of any study endpoint will be unaware of whether Bexsero or placebo were administered. The duration of the study for participants who are enrolled and randomized will be approximately 16 months. Study participation is expected to be completed in approximately 36 months. The primary objective of the study is to demonstrate efficacy of Bexsero in prevention of urogenital and/or anorectal gonococcal infection. Type: Interventional Start Date: Dec 2020 |
Rare CFTR Mutation Cell Collection Protocol (RARE)
George Solomon
Cystic Fibrosis
Over 1,900 mutations in the gene for the cystic fibrosis transmembrane conductance
regulator (CFTR) protein are implicated in causing Cystic Fibrosis (CF). Potential
therapies that directly target defective CFTR are being evaluated in important clinical
trials, but most target the most common CFTR... expand
Over 1,900 mutations in the gene for the cystic fibrosis transmembrane conductance regulator (CFTR) protein are implicated in causing Cystic Fibrosis (CF). Potential therapies that directly target defective CFTR are being evaluated in important clinical trials, but most target the most common CFTR mutation F508del. Many patients with rare CF mutations are not able to participate in those studies. The RARE study is specifically designed for people with CF caused by rare mutations. Eligible rare mutations are listed below: • CF patients who are heterozygous for pre-mature stop codons as noted below: i. one allele must be a F508del ii. the other allele must be a pre-mature stop codon mutation • CF Patients with other genotypes that require Study PI permission: i. CF patients with two mutations that are not eligible for Trikafta ii. CF patients homozygous or heterozygous (other allele must be F508del) for rare mutations of special interest (e.g., 711+3A->G, 2789+5G->A, 3272-26A->G, 3849+10kbC->T). Other rare mutations will be considered on a case by case basis This is a multi-site, specimen collection study. Investigators will collect blood, intestinal cells and nasal cells from each participant. Cells from these specimens will be used to test future CFTR modulators to see if they might work for people with study eligible rare mutations. Having cells to test in the lab is an important first step in identifying potential new therapies for people with these mutations. Type: Observational Start Date: Oct 2017 |
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
National Cancer Institute (NCI)
Stage III Cutaneous Melanoma AJCC v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
This phase II/III trial studies the side effects of nivolumab and ipilimumab when given
together with or without sargramostim and to see how well they work in treating patients
with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may
have spread from where it first... expand
This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma. Type: Interventional Start Date: Nov 2015 |
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