Search Clinical Trials
Sponsor Condition of Interest |
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Activating the Cholinergic Anti-Inflammatory Pathway in Healthy Volunteers and People with Inflamma1
Surf Therapeutics
Psoriatic Arthritis
Rheumatoid Arthritis
Ankylosing Spondylitis
This study is designed to investigate whether non-invasive ultrasound (US) that is
optimized for stimulation and can elicit an anti-inflammatory response in people with
Inflammatory Arthritis as compared to a sham intervention. The primary endpoint is the
change in pro-inflammatory cytokines in blo1 expand
This study is designed to investigate whether non-invasive ultrasound (US) that is optimized for stimulation and can elicit an anti-inflammatory response in people with Inflammatory Arthritis as compared to a sham intervention. The primary endpoint is the change in pro-inflammatory cytokines in blood drawn before and after US. Each participant receives 4 experimental US sessions, one of which is randomly assigned to be placebo. Type: Interventional Start Date: Aug 2024 |
Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Ty1
Endogenex, Inc.
Type 2 Diabetes Mellitus
Type2diabetes
Diabetes Mellitus, Type 2
Diabetes
Type 2 Diabetes
This study is designed to evaluate the safety and effectiveness of endoscopic intestinal
re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately
controlled on non-insulin glucose-lowering medications. expand
This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications. Type: Interventional Start Date: May 2024 |
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 Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Ped1
Hoffmann-La Roche
Atypical Hemolytic Uremic Syndrome
This study aims to evaluate the efficacy and safety of crovalimab in pediatric
participants with aHUS. expand
This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS. Type: Interventional Start Date: Nov 2021 |
Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients with Primary I1
Calliditas Therapeutics AB
IgA Nephropathy
The goal of this clinical trial is to assess the efficacy and safety of extended TARPEYO®
(delayed-release budesonide capsules) treatment in adult patients with primary IgA
nephropathy who have completed 9 months of TARPEYO® 16 mg once daily treatment in
real-world clinical practice. The main quest1 expand
The goal of this clinical trial is to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA nephropathy who have completed 9 months of TARPEYO® 16 mg once daily treatment in real-world clinical practice. The main question it aims to answer is: Is there a treatment benefit of TARPEYO® 16 mg QD extended use? Participants will - take part in this study for about 19 months - Have urine tests done - Have blood samples taken - Have physical examinations done Type: Interventional Start Date: Dec 2024 |
Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
The George Washington University Biostatistics Center
Obstetrical Complications
Labor and Delivery Complication
Cesarean Delivery
This is a phase-III multi-center double-blind randomized controlled trial of 8,000
individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to
either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive
standard of care preoperative antibiotics1 expand
This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection. Type: Interventional Start Date: Nov 2024 |
Humidity in Incubators for Tiny Infants
The University of Texas Health Science Center, Houston
Extremely Premature Infant
The objective of the study is to assess 2 different initial incubator humidification
protocols for infants <25 weeks' gestation admitted to the neonatal intensive care unit
(NICU). The hypothesis is that a higher starting humidity decreases dehydration and
results in no difference in survival or mo1 expand
The objective of the study is to assess 2 different initial incubator humidification protocols for infants <25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The hypothesis is that a higher starting humidity decreases dehydration and results in no difference in survival or morbidity. Higher (90%) and lower (70%) starting humidity will be compared. Type: Interventional Start Date: Jun 2024 |
A Study of MGC026 in Participants With Advanced Solid Tumors
MacroGenics
Advanced Solid Tumor
Advanced Cancer
Metastatic Cancer
Squamous Cell Carcinoma of Head and Neck
Non Small Cell Lung Cancer
The study is designed to understand the safety, tolerability, pharmacokinetics,
immunogenicity, and preliminary antitumor activity of MGC026 in participants with
relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The
study has a dose escalation portion and a cohort ex1 expand
The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes. Type: Interventional Start Date: Mar 2024 |
Study of the Research Medicine CIN-103 in Adults with Irritable Bowel Syndrome with Predominant Dia1
CinPhloro Pharma, LLC
Irritable Bowel Syndrome with Diarrhea
The goal of this clinical trial is to evaluate if the study drug, CIN-103, can help
reduce the symptoms associated with irritable bowel syndrome with predominant diarrhea
(IBS-D) in adult patients. The main questions it aims to answer are:
- To evaluate the efficacy of CIN-103 on symptoms of IB1 expand
The goal of this clinical trial is to evaluate if the study drug, CIN-103, can help reduce the symptoms associated with irritable bowel syndrome with predominant diarrhea (IBS-D) in adult patients. The main questions it aims to answer are: - To evaluate the efficacy of CIN-103 on symptoms of IBS-D when given to patients with IBS-D compared to a placebo. - To evaluate the safety and tolerability of CIN-103 when given to patients with IBS-D compared to a placebo Participants will attend the following visits: - Screening Period (1 Visit) - Baseline Period (1 Visit) - Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued participation. - 12-Week Treatment Period (5 Visits) - Study drug taken twice daily by mouth. - Will complete daily diaries and other PROs as described in the protocol. - Follow- Up Period (1 Visit) Researchers will compare CIN-103 Dose 1, CIN-103 Dose 2, and placebo, to evaluate the clinical response to multiple dose strengths of CIN-103 relative to placebo on abdominal pain and stool consistency along with safety and tolerability. Type: Interventional Start Date: Dec 2023 |
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic1
Janssen Research & Development, LLC
Ischemic Stroke; Ischemic Attack, Transient
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the
risk of recurrent ischemic stroke. expand
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke. Type: Interventional Start Date: Feb 2023 |
MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimula1
Merck Sharp & Dohme LLC
Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic
obstructive pulmonary disease (COPD). The goal of the study is to learn if people who
take MK-5475 can walk farther in 6 minutes at Week 24 compared to people who take
placebo. expand
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take MK-5475 can walk farther in 6 minutes at Week 24 compared to people who take placebo. Type: Interventional Start Date: Mar 2023 |
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Ca1
Basilea Pharmaceutica
Candidemia
Candidiasis, Invasive
The purpose of this clinical trial is to learn about the safety and effects of the study
medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive
candidiasis, a life-threatening fungal infection caused by several species of yeast
called Candida.
The study is seeking1 expand
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida. The study is seeking patients who have a diagnosis of candidemia and/or invasive candidiasis. Two-thirds of all patients will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all patients will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules. Fosmanogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmanogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if patients are well enough to be discharged from the hospital. The treatment effect in patients receiving fosmanogepix to those receiving caspofungin/ fluconazole will be compared. The primary aim is to show that fosmanogepix is not inferior (not worse) to caspofungin/ fluconazole with a noninferiority margin of 15%. The duration of study treatment and number of study visits will vary depending on how long the patient will be treated for the infection. Treatment will continue for a maximum of 6 weeks depending on when the infection is cleared and whether other symptoms related to the infection have improved. There will also be a follow-up visit 6 weeks after the study treatment was stopped. Type: Interventional Start Date: Dec 2024 |
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With an1
Theratechnologies
HIV Infections
Multi-Antiviral Resistance
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical
trials. This study will expand ibalizumab's clinical data set and allow a better
understanding of the virologic response durability on ARV regimens with or without
ibalizumab in a heterogeneous real-world pati1 expand
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end. Primary Objective: To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab. Secondary Objective: To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment. To assess the long-term safety and tolerability of ibalizumab. Other Objectives: To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll. Type: Observational Start Date: Mar 2022 |
A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ1
Eli Lilly and Company
Alzheimer Disease
The main purpose of this study is to evaluate the safety and efficacy of donanemab in
participants with preclinical Alzheimer's Disease (AD). Approximately 800 additional
participants will be enrolled in a 12-month addendum to assess safety of a different
titration regimen. expand
The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD). Approximately 800 additional participants will be enrolled in a 12-month addendum to assess safety of a different titration regimen. Type: Interventional Start Date: Aug 2021 |
Zenith® Fenestrated+ Clinical Study
Cook Research Incorporated
Aortic Aneurysm, Abdominal
Juxtarenal Aortic Aneurysm
Extent IV Thoracoabdominal
Pararenal Aneurysm
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and
effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with
the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2
for the treatment of patients with a1 expand
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries. Type: Interventional Start Date: Dec 2023 |
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Yale University
Intracerebral Hemorrhage
Atrial Fibrillation
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the
composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in
patients with recent ICH and atrial fibrillation (AF).
Secondary Aim: To determine if apixaban, compared with aspirin, results in1 expand
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale. Type: Interventional Start Date: Jan 2020 |
Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder
The University of Texas Health Science Center, Houston
Major Depressive Disorder
Epilepsy
The purpose of this study is to examine the feasibility and acceptability of an online
group Neuro-behavioral Therapy (NBT) with text messaging intervention for Veterans with
epilepsy and major depressive disorder (MDD). expand
The purpose of this study is to examine the feasibility and acceptability of an online group Neuro-behavioral Therapy (NBT) with text messaging intervention for Veterans with epilepsy and major depressive disorder (MDD). Type: Interventional Start Date: Dec 2024 |
A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy
Vertex Pharmaceuticals Incorporated
Acute Pain
The purpose of this study is to evaluate the efficacy, safety, tolerability and
pharmacokinetics of VX-993 in treating acute pain after a bunionectomy. expand
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy. Type: Interventional Start Date: Oct 2024 |
Code of Respect (X-CoRe): Trial of a Multi-level Sexual Assault and Sexual Harassment Prevention In1
The University of Texas Health Science Center, Houston
Sexual Assault
Sexual Harassment
The purpose of this study is to examine the efficacy of Code of Respect (X-CoRe)
multi-level sexual assault (SA) and harassment (SH) prevention program in improving
psychosocial determinants (e.g., knowledge, skills, self-efficacy, attitudes) related to
respectful/disrespectful relationships, to ex1 expand
The purpose of this study is to examine the efficacy of Code of Respect (X-CoRe) multi-level sexual assault (SA) and harassment (SH) prevention program in improving psychosocial determinants (e.g., knowledge, skills, self-efficacy, attitudes) related to respectful/disrespectful relationships, to examine the efficacy of X-CoRe in reducing SA and sexual harassment SH victimization and to examine the efficacy of X-CoRe increasing bystander behavior and improving unit cohesion and mission readiness by decreasing secondary risk and harmful behaviors (e.g., alcohol misuse, intimate partner violence, suicide ideation). The study will be conducted at at Joint Base McGuire Dix-Lakehurst (JBMDL) located in Burlington County, New Jersey, and participants will be cluster-randomized at the level of the squadron to one of two conditions: the X-CoRe program or a control condition. Type: Interventional Start Date: Dec 2024 |
The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry
Yale University
Cesarean Delivery
General Anesthesia
The SOAP registry is a prospective, multicenter, electronic registry. The goal is to
investigate the indications, mode of airway management, predisposing factors, and
obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for
cesarean delivery. expand
The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery. Type: Observational Start Date: Feb 2024 |
Strategy for Improving Stroke Treatment Response
Translational Sciences, Inc.
Ischemic Stroke
SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding
trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal
antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke. expand
SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke. Type: Interventional Start Date: Mar 2024 |
Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset
The University of Texas Health Science Center, Houston
Infant, Extremely Premature
Obstetric Labor, Premature
Premature Birth
Intensive Care, Neonatal
Intensive Care Units, Neonatal
The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal
Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and
practices for all deliveries and infants admitted to intensive care at 22-23 weeks'
gestation at participating hospitals. expand
The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals. Type: Observational [Patient Registry] Start Date: Jan 2019 |
GammaTile and Stupp in Newly Diagnosed GBM
GT Medical Technologies, Inc.
Glioblastoma
In summary, standard of care postoperative chemoradiation for patients with newly
diagnosed GBM does not routinely provide durable local control or prolonged overall
survival. As discussed above it seems unlikely that patient outcomes will be
significantly improved with radiation dose escalation gi1 expand
In summary, standard of care postoperative chemoradiation for patients with newly diagnosed GBM does not routinely provide durable local control or prolonged overall survival. As discussed above it seems unlikely that patient outcomes will be significantly improved with radiation dose escalation given at the time of the EBRT boost. However, as most failures are local, improving LC could potentially improve the OS of patients. To do this, we propose a shift in the traditional radiation paradigm. This study will assess the feasibility and tolerability of adding GT radiation therapy as an upfront boost at the time of maximum safe resection, along with the backbone of the current standard of care approach, concomitant and adjuvant temozolomide +/- TTF, for patients with newly diagnosed GBM. GT, a novel brain brachytherapy device utilizing Cs-131 embedded in bioresorbable collagen tiles, offers a more sophisticated carrier and a shorter half-life radioisotope, Cs-131. Use of this device allows for radiation initiation at an earlier time point and a more rapid dose delivery and possibly more effective tumor control particularly for rapidly proliferating tumors such as GBM. Two prospective studies have demonstrated the safety and efficacy of re-irradiation with GT in patients with recurrent GBM. The overarching goal of this single-arm, open label phase 4 study is to determine the feasibility and tolerability of treating patients with GammaTile in combination with the Stupp Protocol and how to proceed with testing this treatment in a future, larger, randomized clinical study. The aims of the study are to demonstrate that the use of GammaTile at the time of surgery is well tolerated and does not delay the start of the Stupp protocol. Efficacy outcomes (e.g., LC, OS, PFS) will also be described. Type: Interventional Start Date: Aug 2022 |
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left1
Abiomed Inc.
Left Ventricular Dysfunction
Coronary Artery Disease
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device
during high-risk PCI in patients with reduced left-sided heart function will result in an
improvement in symptoms, heart function and health after a heart procedure compared to
the current standard of care. expand
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care. Type: Interventional Start Date: Apr 2021 |
A Study of PBFT02 in Participants With FTD and Mutations in the Granulin Precursor (GRN) or C9ORF721
Passage Bio, Inc.
Frontotemporal Dementia
FTD
FTD-GRN
Dementia Frontotemporal
C9orf72
PBFT02 is a gene therapy for frontotemporal dementia intended to deliver a functional
copy of the GRN gene to the brain. This study will assess the safety, tolerability and
efficacy of this treatment in patients with frontotemporal dementia and mutations in the
granulin precursor (GRN) or chromosom1 expand
PBFT02 is a gene therapy for frontotemporal dementia intended to deliver a functional copy of the GRN gene to the brain. This study will assess the safety, tolerability and efficacy of this treatment in patients with frontotemporal dementia and mutations in the granulin precursor (GRN) or chromosome 9 open reading frame 72 (C9ORF72) genes Type: Interventional Start Date: Sep 2021 |
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