573 matching studies

Sponsor Condition of Interest
A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared...
Amgen Gout
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. The... expand

The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to < 6 mg/dL for at least 80% of the time.

Type: Interventional

Start Date: Jan 2024

open study

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. expand

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

open study

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive...
Bristol-Myers Squibb Progressive Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. expand

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.

Type: Interventional

Start Date: Oct 2023

open study

Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
Inhibrx Biosciences, Inc Alpha 1-Antitrypsin Deficiency Emphysema
Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD emphysema expand

Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD emphysema

Type: Interventional

Start Date: Oct 2023

open study

GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With...
Hoffmann-La Roche Huntington Disease
This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease. expand

This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease.

Type: Interventional

Start Date: Feb 2023

open study

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. expand

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

open study

Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma
University of Alabama at Birmingham High Grade Glioma
This feasibility study will assess the clinical potential of a new imaging approach to detect viable high grade glioma (HGG) in pediatric and adult patients after standard of care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study participants will undergo simultaneous positron... expand

This feasibility study will assess the clinical potential of a new imaging approach to detect viable high grade glioma (HGG) in pediatric and adult patients after standard of care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study participants will undergo simultaneous positron emission tomography/magnetic resonance imaging (PET/MRI) with O-([2-[F-18]fluoroethyl)-L-tyrosine (FET, amino acid transport) and 1H-1-(3-[F-18]fluoro-2-hydroxypropyl)-2-nitroimidazole (FMISO, hypoxia) at the time of standard of care imaging after completion of RT. The presence of viable tumor at this time point will be assessed on a per patient basis. Study participants will be followed clinically and with standard of care (SOC) imaging for up to 2 years after completion of PET/MRI to determine the nature of lesions seen on investigational imaging and to obtain patient outcome data. The imaging data will also be used to develop a semi-automated workflow suitable for implementation in clinical trials and standard of care PET/MRI studies.

Type: Interventional

Start Date: Mar 2024

open study

Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival (...
CSL Behring Traumatic Injury
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and /... expand

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion.

Type: Interventional

Start Date: Mar 2023

open study

Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes
University of Alabama at Birmingham PreDiabetes Obesity Insulin Resistance
We are evaluating whether intermittent use of continuous glucose monitors (CGMs) in addition to standard nutritional counseling and physical activity counseling is associated with improved metabolic health for youth with pre-diabetes (PD). expand

We are evaluating whether intermittent use of continuous glucose monitors (CGMs) in addition to standard nutritional counseling and physical activity counseling is associated with improved metabolic health for youth with pre-diabetes (PD).

Type: Interventional

Start Date: Jun 2023

open study

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. expand

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

open study

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). 2. To evaluate... 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

open study

To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients...
Shanghai Henlius Biotech Extensive Stage Small Cell Lung Cancer
This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: - Arm A (Serplulimab):... expand

This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: - Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) - Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)

Type: Interventional

Start Date: Nov 2022

open study

Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia
Novartis Pharmaceuticals Chronic Myelogenous Leukemia - Chronic Phase
This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP- binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may... expand

This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP- binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.

Type: Interventional

Start Date: Nov 2022

open study

Evolut™ EXPAND TAVR II Pivotal Trial
Medtronic Cardiovascular Moderate Aortic Valve Stenosis
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS. expand

Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.

Type: Interventional

Start Date: Apr 2022

open study

Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
Indiana University Gestational Diabetes Pregnancy, High Risk Overweight and Obesity
This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets. expand

This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.

Type: Interventional

Start Date: Mar 2022

open study

Combination Therapy for the Treatment of Diffuse Midline Gliomas
University of California, San Francisco Diffuse Intrinsic Pontine Glioma Diffuse Midline Glioma, H3 K27M-Mutant Recurrent Diffuse Intrinsic Pontine Glioma Recurrent Diffuse Midline Glioma, H3 K27M-Mutant Recurrent WHO Grade III Glioma
This phase II trial determines if the combination of ONC201 with different drugs, panobinostat or paxalisib, is effective for treating participants with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for participants with DMGs, and... expand

This phase II trial determines if the combination of ONC201 with different drugs, panobinostat or paxalisib, is effective for treating participants with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for participants with DMGs, and there are few treatment options. ONC201, panobinostat, and paxalisib are all enzyme inhibitors that may stop the growth of tumor cells by clocking some of the enzymes needed for cell growth. This phase II trial assesses different combinations of these drugs for the treatment of DMGs.

Type: Interventional

Start Date: Oct 2021

open study

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
Cogent Biosciences, Inc. Advanced Systemic Mastocytosis (AdvSM) SM With an Associated Hematologic Neoplasm (SM-AHN) Mast Cell Leukemia (MCL) Aggressive Systemic Mastocytosis (ASM)
This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL). expand

This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

Type: Interventional

Start Date: Nov 2021

open study

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. expand

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

open study

RA-PRO PRAGMATIC TRIAL
University of Alabama at Birmingham Rheumatoid Arthritis
The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm... expand

The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic, i.e., a second TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and/or physician experience and habit (TNFis launched 22 yrs ago vs. the first tsDMARD 8 years ago vs. first non-TNF-biologic launched 17 years ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic.

Type: Interventional

Start Date: Sep 2021

open study

Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Karyopharm Therapeutics Inc Myelofibrosis
This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed)... expand

This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended dose (RD) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). In Phase 3, JAKi treatment-naïve MF participants are enrolled in 2:1 ratio to receive the combination therapy of selinexor + ruxolitinib or the combination of placebo + ruxolitinib.

Type: Interventional

Start Date: Mar 2021

open study

Using Early Time Restricted Feeding and Timed Light Therapy to Improve Glycemic Control in Adults With...
University of Alabama at Birmingham Diabetes Mellitus, Type 2 Time Restricted Feeding Light; Therapy, Complications
The purpose of this study is to test whether eating earlier in the day and/or timed light therapy can improve blood sugar in people with type 2 diabetes. This study will also test whether these treatments improve other aspects of health, including the circadian (biological) clock, sleep, weight, body... expand

The purpose of this study is to test whether eating earlier in the day and/or timed light therapy can improve blood sugar in people with type 2 diabetes. This study will also test whether these treatments improve other aspects of health, including the circadian (biological) clock, sleep, weight, body composition, cardiovascular health, quality of life, and mood.

Type: Interventional

Start Date: Apr 2021

open study

A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Global Coalition for Adaptive Research Glioblastoma
Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. expand

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.

Type: Interventional

Start Date: Jul 2019

open study

ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
Boston Scientific Corporation Aortic Stenosis
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR. expand

To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.

Type: Interventional

Start Date: Jun 2019

open study

The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
National Institute of Allergy and Infectious Diseases (NIAID) HIV Infections
The purpose of this study is to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC). expand

The purpose of this study is to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).

Type: Interventional

Start Date: Mar 2019

open study

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 finding answers and insight... 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

open study