Search Clinical Trials
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EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)
Population Health Research Institute
Intracranial Hemorrhages
Atrial Fibrillation
To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical
therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk
of stroke (composite of ischemic, hemorrhagic and unspecified stroke, and systemic
thromboembolism) in high-risk atrial fibrillation... expand
To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke, and systemic thromboembolism) in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage. Type: Interventional Start Date: Sep 2019 |
A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace)
BioMarin Pharmaceutical
Phenylketonuria (PKU)
This is a 10-year multi-center, global, observational study to further characterize the
safety profile of pegvaliase, including hypersensitivity reactions, long-term safety and
tolerability, and the effectiveness of the additional risk minimization measures (aRMMs)
(European Union (EU) only) in subjects... expand
This is a 10-year multi-center, global, observational study to further characterize the safety profile of pegvaliase, including hypersensitivity reactions, long-term safety and tolerability, and the effectiveness of the additional risk minimization measures (aRMMs) (European Union (EU) only) in subjects receiving pegvaliase for the treatment of PKU. Subjects for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment (incident-users) or have previously started treatment with pegvaliase at the date of enrollment (prevalent-users) are eligible for participation in this study. Type: Observational Start Date: Jun 2022 |
Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
Tvardi Therapeutics, Incorporated
Idiopathic Pulmonary Fibrosis
The primary objective of this study is to evaluate the safety and tolerability of oral
daily administration of TTI-101 over a 12-week treatment duration in participants with
idiopathic pulmonary fibrosis (IPF). expand
The primary objective of this study is to evaluate the safety and tolerability of oral daily administration of TTI-101 over a 12-week treatment duration in participants with idiopathic pulmonary fibrosis (IPF). Type: Interventional Start Date: May 2023 |
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After...
NRG Oncology
Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
This phase III trial studies whether adding apalutamide to the usual treatment improves
outcome in patients with lymph node positive prostate cancer after surgery. Radiation
therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male
sex hormones, can cause the growth... expand
This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach. Type: Interventional Start Date: Mar 2020 |
Sodium Lowering Vascular Effects Trial
Tulane University
Endothelial Dysfunction
Vascular Stiffness
Left Ventricular Hypertrophy
Left Ventricular Dysfunction
The proposed mechanistic trial will test the effect of dietary sodium reduction on
cardiac and vascular structure and function in those with elevated blood pressure or
hypertension. Findings from this study will fill the knowledge gap on the underlying
mechanisms of dietary sodium intake on cardiovascular... expand
The proposed mechanistic trial will test the effect of dietary sodium reduction on cardiac and vascular structure and function in those with elevated blood pressure or hypertension. Findings from this study will fill the knowledge gap on the underlying mechanisms of dietary sodium intake on cardiovascular disease risk in addition to blood pressure and could provide further evidence on sodium reduction for the prevention of cardiovascular disease. Type: Interventional Start Date: Jan 2023 |
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With...
PharmaEssentia
Essential Thrombocythemia
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of
Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia expand
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia Type: Interventional Start Date: Sep 2022 |
Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health
Tulane University
Cardiovascular Diseases
Hypertension
Diabetes
Hypercholesterolemia
Cardiovascular disease (CVD) is the leading cause of death in the US general population.
Although CVD mortality rates declined for both Black and White populations during the
past two decades, they are still higher in Black adults than White adults. There are also
persistent disparities in CVD risk... expand
Cardiovascular disease (CVD) is the leading cause of death in the US general population. Although CVD mortality rates declined for both Black and White populations during the past two decades, they are still higher in Black adults than White adults. There are also persistent disparities in CVD risk factors with higher prevalence of obesity, hypertension, and diabetes in Black compared to White populations. In addition, CVD and risk factors are more prevalent in the residents of Louisiana compared to the US general population. The Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health (CHERISH) study will use a church-based community health worker (CHW)-led multifaceted intervention to address racial inequities in CVD risk factors in Black communities in New Orleans, Louisiana. The primary aim of the CHERISH study is to compare the impact of two implementation strategies - a CHW-led multifaceted strategy and a group-based education strategy - for delivering interventions recommended by the 2019 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on the Primary Prevention of Cardiovascular Disease on implementation and clinical effectiveness outcomes in Black community members over 18 months. Type: Interventional Start Date: Nov 2023 |
International Registry for Men With Advanced Prostate Cancer (IRONMAN)
Prostate Cancer Clinical Trials Consortium
Prostate Cancer
Our intent is to establish the International Registry to Improve Outcomes in Men with
Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum
5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to
establish a population-based registry and... expand
Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance. Type: Observational [Patient Registry] Start Date: Jul 2017 |
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to...
Merck Sharp & Dohme LLC
Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in
participants with moderately to severely active ulcerative colitis. Study 1's primary
hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the
proportion of participants achieving clinical... expand
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12. Type: Interventional Start Date: Oct 2023 |
A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed...
TeneoOne Inc.
Multiple Myeloma
Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer
is typically found in the bones and bone marrow (the spongy tissue inside of the bones)
and can cause bone pain, fractures, infections, weaker bones, and kidney failure.
Treatments are available, but MM can come... expand
Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 3 Arms; Arm A (Parts 1 and 2), Arm B and Arm C. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. "In Arm C, the step-up dose identified in Arm A will be used followed by the target dose of ABBV-383 to investigate outpatient administration of ABBV-383. Around 180 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 40 sites across the world. Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires. Type: Interventional Start Date: Mar 2023 |
A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced...
Janssen Research & Development, LLC
Prostatic Neoplasms
Adenocarcinoma
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of
JNJ-69086420 in Part 1 (Dose Escalation) and to determine safety and preliminary signs of
clinical activity at the RP2D(s) in Part 2 (Dose Expansion). expand
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of JNJ-69086420 in Part 1 (Dose Escalation) and to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion). Type: Interventional Start Date: Nov 2020 |
A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU...
BioMarin Pharmaceutical
Phenylketonuria (PKU)
This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating
immunologic, inflammatory and laboratory parameters associated with long-term Palynziq
treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in
the US for whom a clinical decision... expand
This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term Palynziq treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in the US for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment in Study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in Study 165-501 (prevalent-users) are eligible for participation in Study 165-503. Type: Observational Start Date: Jan 2024 |
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
Tulane University
Obesity
Gestational Diabetes
Lifestyle, Healthy
Glucose Intolerance During Pregnancy
PreDiabetes
The primary objective of the STRIVE study is to compare two implementation strategies for
Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24
in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach
implementation strategy (12 in-person... expand
The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women. Type: Interventional Start Date: Dec 2023 |
Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing...
Tulane University
Atrial Fibrillation
Atrial Arrhythmia
Atrial Flutter
Atrial Tachycardia
The study aims to evaluate and compare the incidence of atrial arrhythmias (including
Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia)
stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial
wall area. The investigators hypothesize... expand
The study aims to evaluate and compare the incidence of atrial arrhythmias (including Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. The investigators hypothesize that patients with a higher baseline Utah fibrosis staging will experience a higher incidence of POAF. The study also aims to evaluate and compare the in-hospital mortality, length-of-stay (LOS), complication rates (strokes, pneumonia, respiratory failure etc.) of the different Utah fibrosis stage cohorts. Perform cost analysis and compare between patients with POAF and patients without POAF. The investigators hypothesize that patients experiencing POAF will have a higher mortality rate, longer LOS, greater complications, and therefore, additional hospital costs. Type: Observational Start Date: Nov 2021 |
Advanced Cardiac Imaging To Predict Embolic Stroke On Brain MRI: A Pilot Study
Tulane University
Atrial Fibrillation
Stroke
Stroke, Cardiovascular
Vascular Cognitive Impairment
Strokes Thrombotic
Demonstrating the pathophysiological link between Left Atrial (LA) and Left Atrial
Appendage (LAA) pathology and embolic strokes in non-Atrial Fibrillation (AF) individuals
represents a major advance in stroke prevention strategies. Instead of relying on
non-specific criteria for stroke risk assessment,... expand
Demonstrating the pathophysiological link between Left Atrial (LA) and Left Atrial Appendage (LAA) pathology and embolic strokes in non-Atrial Fibrillation (AF) individuals represents a major advance in stroke prevention strategies. Instead of relying on non-specific criteria for stroke risk assessment, the investigators propose to identify individuals with high-risk of embolic stroke using imaging criteria that reflect the underlying pathophysiology of embolic stroke of cardiac origin. the investigators can therefore lay the groundwork for future anticoagulation strategies for stroke prevention beyond AF. Type: Interventional Start Date: Apr 2021 |
Emicizumab in Patients with Acquired Hemophilia a
University of Washington
Acquired Hemophilia a
This is a phase II multicenter open-label, single-arm prospective study to evaluate the
efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds
in patients with acquired hemophilia A (AHA). expand
This is a phase II multicenter open-label, single-arm prospective study to evaluate the efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds in patients with acquired hemophilia A (AHA). Type: Interventional Start Date: Aug 2022 |
Lupus Education Alliance Program
Tulane University
Systemic Lupus Erythematosus
COVID-19
The purpose of this study is to evaluate the evaluate the effect of education-only vs.
navigation interventions on COVID-19 testing and vaccination for people with systemic
lupus erythematosus. expand
The purpose of this study is to evaluate the evaluate the effect of education-only vs. navigation interventions on COVID-19 testing and vaccination for people with systemic lupus erythematosus. Type: Interventional Start Date: Nov 2023 |
Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)
Tulane University
Hypertension
The burden of hypertension and related cardiovascular diseases, stroke, and end-stage
kidney disease is disproportionately high in Black populations, especially in the South.
The Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)
cluster randomized trial aims to test... expand
The burden of hypertension and related cardiovascular diseases, stroke, and end-stage kidney disease is disproportionately high in Black populations, especially in the South. The Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster randomized trial aims to test the effectiveness, implementation, and sustainability of a community health worker (CHW)-led multifaceted intervention compared to enhanced usual care for hypertension control in Black communities. In the BLESSED trial, the investigators plan to recruit 1,176 Black adults with hypertension (approximately 28 per church) from 42 churches in the Greater New Orleans area. The multifaceted intervention will last for 18 months, followed by a post-intervention follow-up visit at 24 months. The BLESSED trial aims to generate evidence regarding the effectiveness, implementation, and sustainability of this CHW-led church-based multifaceted intervention in eliminating hypertension disparities in the United States (US) general population. Type: Interventional Start Date: Nov 2023 |
Evaluation of the Efficacy and Safety of DMR Using the Revita® in Subjects With Inadequately Controlled...
Fractyl Health Inc.
Type 2 Diabetes
The Revita® system is being investigated to assess the efficacy of DMR versus Sham on
improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2
Diabetes who are inadequately controlled on one or more glucose lowering agents. The
purpose of this study is to demonstrate... expand
The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled on one or more glucose lowering agents. The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post treatment. Type: Interventional Start Date: Mar 2021 |
M-O-M-S on the Bayou: Implementation of an Intervention for Mental Health in Pregnancy
Tulane University
Anxiety
Depression
Disasters have negative effects in the short term (physical trauma, adverse environmental
exposures, and unstable housing) and the long term (relocation, changes in family
functioning, and negative economic effects), which interact with social determinants to
worsen health among the most vulnerable... expand
Disasters have negative effects in the short term (physical trauma, adverse environmental exposures, and unstable housing) and the long term (relocation, changes in family functioning, and negative economic effects), which interact with social determinants to worsen health among the most vulnerable women, infants, and communities. Trauma and severe stress are directly linked to pregnancy complications, and raise blood pressure during pregnancy, alter stress hormones, and increase vulnerability to infection, all of which predispose to reduced fetal growth and preterm birth. Disasters also worsen mental health, and depression during pregnancy and postpartum, for instance, is associated with worse physical health during pregnancy, maternal impairment, poorer quality parenting, negative child behavior, and poorer infant cognitive development.The goal of this intervention is to improve mental health in pregnant women living in a disaster-affected region. The main questions this intervention aims to answer are: - Assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, and sustainability) of a pilot intervention in a disaster recovery environment. - Assess the effectiveness of the M-O-M-S pilot intervention in a disaster recovery environment. The study will recruit pregnant women in areas that have experienced a natural disaster. Women will be recruited in early pregnancy and attend a series of classes on the cognitive and relationship changes of pregnancy and motherhood, and mental preparation for labor, led by a "mentor," a mother who has experienced pregnancy, labor, and motherhood. Type: Interventional Start Date: Nov 2023 |
Quality Improvement and Clinical Utility PrecivityAD2(TM) Clinician Survey
C2N Diagnostics
Alzheimer Disease
Mild Cognitive Impairment
Dementia
Cognitive Decline
Cognitive Impairment
There is a major unmet need for timely, non-invasive, and low-burden evaluation of
patients presenting with mild cognitive impairment (MCI) and dementia. MCI impacts 12-18%
of people in the United States over age 60 years (Alzheimer's Association. Mild Cognitive
Impairment (MCI) available at
https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitiv
e-impairment.... expand
There is a major unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and dementia. MCI impacts 12-18% of people in the United States over age 60 years (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitiv e-impairment. Accessed August 16, 2022). MCI does not substantially interfere with daily activities, although complex functional tasks may be performed less efficiently (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 30% of MCI patients have Alzheimer's disease (AD) as a cause of their symptoms (Lopez,OL, Kuller LH, Becker JT, et al. Incidence of dementia in mild cognitive impairment in the cardiovascular health study cognition study. Arch Neurol. 2007;64(3):416-420.doi:10.1001/archneur.64.3.416)). In contrast, dementia is defined by chronic, acquired loss of two or more cognitive abilities caused by brain disease or injury, often associated with significant interference with the ability to function at work or at usual activities. (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 60-80% of dementia patients have AD as a cause of their symptoms (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitiv e-impairment. Accessed August 16, 2022). Type: Observational Start Date: Nov 2023 |
Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
Tulane University
Covid19
Collection of SARS-COV-2 Secretions and Serum for Countermeasure Development (aka
ClinSeqSer) is an observational study to understand natural history of SARS-COV-2
infections among special populations and characterise post-covid morbidity through immune
response, virus genome sequencing, cytokine... expand
Collection of SARS-COV-2 Secretions and Serum for Countermeasure Development (aka ClinSeqSer) is an observational study to understand natural history of SARS-COV-2 infections among special populations and characterise post-covid morbidity through immune response, virus genome sequencing, cytokine response, and virus shedding. Given the descriptions of infection course of patients over the outbreak of 2003 (SARS-Cov01) and since January 2019 in China and Europe, and now worldwide: 1. Acutely infected patients shed virus that could be of major interest to characterize (viral quantification, characterization of virus shedding -of infective and of non-infective virus) the former reflecting/predictive of severity of disease and the latter reflecting extent/source of contagiosity. 2. Convalescent infected patients develop a specific anti-virus antibody response that is (likely) protective and therefore suits the preliminary requirement for the potential benefits of the convalescent patient plasma therapeutic infusion approach. In addition, long term effects of COVID-19 commonly known as long-haulers remains clinically unclear. Thousands of patients have now been diagnosed with COVID-19 in Louisiana (444,000 cases, 10,122 deaths, 2.2% mortality in Louisiana (LA), as of March 2021), and numerous patients are now also complaining of post-acute sequelae of SARS-CoV-2 (PASC). The investigators want to further clarify questions surrounding rational confinement duration and therapeutic approach by collecting plasma of convalescent patients to identify optimal antibody titer by ELISA, specificity of naturally occurring inflammatory (protein/antibody and RNA) response, and possibly test in vitro antibody neutralization activity. Type: Observational Start Date: Mar 2020 |
Prospective Study of Pregnancy in Women With Cystic Fibrosis
Amalia Magaret
Pregnancy Related
Cystic Fibrosis
In this study, the investigators aim to evaluate changes in lung function in women with
cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure
to highly effective cystic fibrosis transmembrane conductance regulator (CFTR)
modulators. expand
In this study, the investigators aim to evaluate changes in lung function in women with cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators. Type: Observational Start Date: Sep 2021 |
Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
Harvard School of Public Health (HSPH)
HIV/AIDS
This is a prospective cohort study designed to define the impact of HIV infection and
antiretroviral therapy (ART) on young adults with perinatal HIV infection (YAPHIV) as
they transition into adulthood. A group of of perinatally exposed but uninfected young
adults from a similar sociodemographic... expand
This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection (YAPHIV) as they transition into adulthood. A group of of perinatally exposed but uninfected young adults from a similar sociodemographic background and age distribution will be enrolled for comparison. Type: Observational Start Date: Apr 2014 |
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV
PharmaEssentia
Polycythemia Vera
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV expand
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV Type: Interventional Start Date: Oct 2022 |
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