576 matching studies

Sponsor Condition of Interest
Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS CoV-2 RNA Vaccine Candidate (BNT162b2)...
BioNTech SE SARS-CoV-2 Infection COVID-19 Maternal Immunization
This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability, and immunogenicity of 30 µg of BNT162b2 or placebo administered in 2 doses, 21 days apart, in approximately 700 healthy pregnant women 18 years of age or older... expand

This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability, and immunogenicity of 30 µg of BNT162b2 or placebo administered in 2 doses, 21 days apart, in approximately 700 healthy pregnant women 18 years of age or older vaccinated at 24 to 34 weeks' gestation. Participants will be randomized 1:1 to receive BNT162b2 or placebo (saline).

Type: Interventional

Start Date: Feb 2021

open study

A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
Pfizer Respiratory Tract Infection
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants. expand

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.

Type: Interventional

Start Date: Jun 2020

open study

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed...
Juno Therapeutics, a Subsidiary of Celgene Multiple Myeloma
This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in subjects with relapsed and/or refractory multiple myeloma. The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The... expand

This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in subjects with relapsed and/or refractory multiple myeloma. The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-98633 to establish a recommended Phase 2 dose (RP2D); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-98633 at the RP2D.

Type: Interventional

Start Date: Aug 2020

open study

CHAMPION-AF Clinical Trial
Boston Scientific Corporation Atrial Fibrillation Stroke Bleeding
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation. expand

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

Type: Interventional

Start Date: Oct 2020

open study

Randomized, Double-blind, Efficacy, and Safety Study of Doravirine/Islatravir (DOR/ISL) in Treatment-naïve...
Merck Sharp & Dohme Corp. HIV-1 Infection
This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type-1... expand

This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

Type: Interventional

Start Date: Feb 2020

open study

An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent...
AbbVie Cancer Non-small Cell Lung Cancer (NSCLC)
This study is being done to determine the efficacy and safety of cofetuzumab pelidotin in the PTK7-expressing, recurrent non-small cell lung cancer (NSCLC) population. expand

This study is being done to determine the efficacy and safety of cofetuzumab pelidotin in the PTK7-expressing, recurrent non-small cell lung cancer (NSCLC) population.

Type: Interventional

Start Date: Feb 2020

open study

Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection
University of Alabama at Birmingham Influenza
The purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (LAIV). The investigators will administer LAIV to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure... expand

The purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (LAIV). The investigators will administer LAIV to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure influenza virus and inflammatory/immune responses.

Type: Interventional

Start Date: Sep 2020

open study

Belimumab With Rituximab for Primary Membranous Nephropathy
National Institute of Allergy and Infectious Diseases (NIAID) Membranous Nephropathy Nephrotic Syndrome
The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete remission (CR) compared to rituximab alone in participants with PM. Background: Primary membranous nephropathy (MN)... expand

The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete remission (CR) compared to rituximab alone in participants with PM. Background: Primary membranous nephropathy (MN) is among the most common causes of nephrotic syndrome in adults. MN affects individuals of all ages and races. The peak incidence of MN is in the fifth decade of life. Primary MN is recognized to be an autoimmune disease, a disease where the body's own immune system causes damage to kidneys. This damage can cause the loss of too much protein in the urine. Drugs used to treat MN aim to reduce the attack by one's own immune system on the kidneys by blocking inflammation and reducing the immune system's function. These drugs can have serious side effects and often do not cure the disease. There is a need for new treatments for MN that are better at improving the disease while reducing fewer treatment associated side effects. In this study, researchers will evaluate if treatment with a combination of two different drugs, belimumab and rituximab, is effective at blocking the immune attacks on the kidney compared to rituximab alone. Rituximab works by decreasing a type of immune cell, called B cells. B cells are known to have a role in MN. Once these cells are removed, disease may become less active or even inactive. However, after stopping treatment, the body will make new B cells which may cause disease to become active again. Belimumab works by decreasing the new B cells produced by the body and, may even change the type of new B cells subsequently produced. Belimumab is approved by the US Food and Drug Administration (FDA) to treat systemic lupus erythematosus (also referred to as lupus or SLE). Rituximab is approved by the FDA to treat some types of cancer, rheumatoid arthritis, and vasculitis. Neither rituximab nor belimumab is approved by the FDA to treat MN. Treatment with a combination of belimumab and rituximab has not been studied in individuals with MN, but it is currently being tested in other autoimmune diseases, including lupus nephritis and Sjögren's syndrome.

Type: Interventional

Start Date: Dec 2019

open study

RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line...
Agenus Inc. Cervical Cancer
This is a randomized, blinded, non-comparative, two-arm Phase 2 clinical trial to assess the efficacy and safety of AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2- combination therapy) for treatment of patients with advanced... expand

This is a randomized, blinded, non-comparative, two-arm Phase 2 clinical trial to assess the efficacy and safety of AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2- combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line platinum-based chemotherapy. The study is not intended to compare the efficacy of the 2 experimental arms. Rather, the efficacy of each arm will be evaluated against its relevant historical controls as appropriate.

Type: Interventional

Start Date: Jun 2019

open study

Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea
Nyxoah S.A. Obstructive Sleep Apnea
A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects. expand

A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.

Type: Interventional

Start Date: Sep 2020

open study

A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants...
Eli Lilly and Company Psoriasis
The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis. expand

The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.

Type: Interventional

Start Date: Sep 2018

open study

A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in...
AbbVie Myelofibrosis (MF)
This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis. expand

This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.

Type: Interventional

Start Date: Oct 2017

open study

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer
Seagen Inc. Metastatic Colorectal Adenocarcinoma
This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body.... expand

This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.

Type: Interventional

Start Date: Jun 2017

open study

ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)
Nico Corporation Intracerebral Hemorrhage Cerebral Hemorrhage Intracerebral Haemorrhage
This is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early (<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.... expand

This is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early (<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.

Type: Interventional

Start Date: Dec 2016

open study

Risk Underlying Rural Areas Longitudinal Cohort Study (RURAL) Heart and Lung Study
Boston University Rural Health Pulmonary Disease Heart Diseases
The Boston University Medical Campus (BUMC) will serve as the site for the RURAL Study Coordinating Center, led by PI Vasan Ramachandran, MD, and the Pulmonary Core, led by George O'Connor, MD. The primary function of the Study Coordinating Center (SCC) is to serve as an... expand

The Boston University Medical Campus (BUMC) will serve as the site for the RURAL Study Coordinating Center, led by PI Vasan Ramachandran, MD, and the Pulmonary Core, led by George O'Connor, MD. The primary function of the Study Coordinating Center (SCC) is to serve as an administrative liaison between all of the RURAL study's cores. The SCC schedules, facilitates, and hosts, all RURAL meetings including preparation for Observational Study Monitoring Board (OSMB) meetings, and maintains direct communication with the study's program officers at NHLBI. The SCC monitors the overall progress of RURAL and keeps all RURAL cores abreast of study updates through meetings, emails, newsletters. It also maintains the official RURAL website and serves as an administrator for investigators seeking to collaborate with RURAL through the submission of Ancillary Studies. The SCC will have no direct interaction with any participants, nor will it have access to identifiable data. The RURAL pulmonary core's primary function will be to read the daily Pulmonary Function Tests (PFTs) performed by participants at each of RURAL's recruiting sites (Alabama, Kentucky, Louisiana, Mississippi). The BUMC Pulmonary Core investigators will receive de-identified data on a daily basis sent by the Statistical Data Coordinating Center at the University of Pennsylvania and will provide a clinical interpretation for each test and "score" the results for quality assurance purposes. Although the Pulmonary Core investigators will not have direct interaction with any participants, in rare circumstances, there may be a need to review identifiable results in the case of a medical emergency at one of the recruiting sites. The pulmonary core will also provide training for all staff who will carry out PFTs.

Type: Observational

Start Date: Jan 2021

open study

Pegloticase and Methotrexate Co-administered in Patients With Uncontrolled Gout Who Have Previously Failed...
Horizon Therapeutics Ireland DAC Uncontrolled Gout
This is a Phase 4, multicenter, open-label trial of pegloticase with MTX (methotrexate) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped pegloticase due to failure to maintain sUA (serum... expand

This is a Phase 4, multicenter, open-label trial of pegloticase with MTX (methotrexate) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped pegloticase due to failure to maintain sUA (serum uric acid) response and/or a clinically mild IR (infusion reaction). Approximately 30 participants will be enrolled. Pegloticase + MTX will be administered for approximately 24 weeks, with an optional extension up to 48 weeks. The trial design will include 5 distinct components: 1. Screening Period, lasting up to 42 days; 2. 6-week MTX Tolerability Assessment Period (hereafter referred to as the MTX Run-in Period); 3. 24-week Pegloticase + MTX Treatment Period, which will include a Week 24/End of Trial/Early Termination Visit (subjects that end MTX and pegloticase treatment prior to the Week 24 will remain on trial for follow up until the Week 24 visit); 4. Optional Pegloticase + MTX Extension Period up to 24 weeks 5. 30-Day Post Treatment Follow -up

Type: Interventional

Start Date: Mar 2021

open study

Prevention of Colorectal Cancer Through Multiomics Blood Testing
Freenome Holdings Inc. Colon Cancer Rectal Cancer Colon Neoplasm Colon Diseases Colon Lesion
The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy. expand

The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Type: Observational

Start Date: May 2020

open study

Decreased Neuraxial Morphine After Cesarean Delivery
University of Alabama at Birmingham Anesthesia
The purpose of this study is to compare 50mcg to 150mcg morphine in epidural for the goal of decreasing side effects of medication with lower dose in patients who receive a QL block expand

The purpose of this study is to compare 50mcg to 150mcg morphine in epidural for the goal of decreasing side effects of medication with lower dose in patients who receive a QL block

Type: Interventional

Start Date: Sep 2020

open study

Micra AV Transcatheter Pacing System Post-Approval Registry
Medtronic Bradycardia
Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release. The Micra... expand

Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release. The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

Type: Observational [Patient Registry]

Start Date: Feb 2020

open study

Zephyr Valve Registry (ZEVR)
Pulmonx Corporation Emphysema
The purpose of this Post-Approval Registry is to gather ongoing safety and effectiveness assessment of the Zephyr Valve treatment in a real-world setting. expand

The purpose of this Post-Approval Registry is to gather ongoing safety and effectiveness assessment of the Zephyr Valve treatment in a real-world setting.

Type: Observational [Patient Registry]

Start Date: Nov 2019

open study

Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum...
National Institute of Allergy and Infectious Diseases (NIAID) HIV Infections
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults. expand

The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.

Type: Interventional

Start Date: Jan 2020

open study

A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions
Lung Therapeutics, Inc Pleural Effusion
The LTI-01-2001 study is a double-blind, placebo-controlled, Phase 2 study to evaluate LTI-01 (single-chain urokinase plasminogen activator, scuPA) in patients with infected, non-draining pleural effusions. expand

The LTI-01-2001 study is a double-blind, placebo-controlled, Phase 2 study to evaluate LTI-01 (single-chain urokinase plasminogen activator, scuPA) in patients with infected, non-draining pleural effusions.

Type: Interventional

Start Date: Sep 2020

open study

Optimize PRO Study
Medtronic Cardiovascular Symptomatic Aortic Stenosis
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices. expand

The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices.

Type: Observational

Start Date: Sep 2019

open study

TRC-PAD Program: In-Clinic Trial-Ready Cohort
University of Southern California Preclinical Alzheimer's Disease Prodromal Alzheimer's Disease Alzheimer Disease Dementia
The purpose of the TRC-PAD study is to develop a large, well-characterized, biomarker-confirmed, trial-ready cohort to facilitate rapid enrollment into AD prevention trials utilizing the APT Webstudy and subsequent referral to in-clinic evaluation and biomarker confirmation.... expand

The purpose of the TRC-PAD study is to develop a large, well-characterized, biomarker-confirmed, trial-ready cohort to facilitate rapid enrollment into AD prevention trials utilizing the APT Webstudy and subsequent referral to in-clinic evaluation and biomarker confirmation. Participants with known biomarker status may have direct referral to the Trial-Ready Cohort. If you are interested in being selected for the TRC-PAD study, you should first enroll in the APT Webstudy (https://www.aptwebstudy.org/welcome).

Type: Observational

Start Date: Jun 2019

open study

A Study of SHP655 (rADAMTS13) in Sickle Cell Disease
Shire Sickle Cell Disease
SHP655 is a medicine used to treat sickle cell disease (SCD). The main aim of the study is to measure the safety and tolerability of SHP655 in SCD participants. Study participants will receive SHP655 or placebo on Day 1. Their SCD will be treated by their doctor according... expand

SHP655 is a medicine used to treat sickle cell disease (SCD). The main aim of the study is to measure the safety and tolerability of SHP655 in SCD participants. Study participants will receive SHP655 or placebo on Day 1. Their SCD will be treated by their doctor according to their doctor's usual clinical practice. During the study, participants will be asked to follow-up on 13 days following SHP655 or placebo administration for safety assessment. Maximum duration of participation is expected to be about 2 months

Type: Interventional

Start Date: Oct 2019

open study