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Predicton of Sepsis Recovery Performance Subtypes Pilot Study
University of Alabama at Birmingham
Sepsis
This study addresses critically ill sepsis patients' current literature reports of
ongoing post-hospital discharge weakness and hospital readmissions. This study is aimed
at capture and interpretation of a complex set of tests, administered during a subject's
sepsis functional recovery trajectory,... expand
This study addresses critically ill sepsis patients' current literature reports of ongoing post-hospital discharge weakness and hospital readmissions. This study is aimed at capture and interpretation of a complex set of tests, administered during a subject's sepsis functional recovery trajectory, particularly capturing hospital readmission's effects on survivors' physical function recovery. Type: Observational Start Date: Jul 2023 |
The ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy.
University of Alabama at Birmingham
Preeclampsia
Gestational Hypertension
Hypertensive Disorder of Pregnancy
The Achieve Trial is a randomized clinical trial to test whether lowering blood pressure
to less than 140/90 mmHg in women with hypertensive disorders of pregnancy will prolong
pregnancy. expand
The Achieve Trial is a randomized clinical trial to test whether lowering blood pressure to less than 140/90 mmHg in women with hypertensive disorders of pregnancy will prolong pregnancy. Type: Interventional Start Date: Feb 2023 |
TSC Biosample Repository and Natural History Database
National Tuberous Sclerosis Association
Tuberous Sclerosis
Lymphangioleiomyomatosis
The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that
scientists can request to use in their research. The samples we collect are all linked to
clinical data in the TSC Natural History Database. The TSC Natural History Database
captures clinical data to document... expand
The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that scientists can request to use in their research. The samples we collect are all linked to clinical data in the TSC Natural History Database. The TSC Natural History Database captures clinical data to document the impact of the disease on a person's health over his or her lifetime. This data may be collected retrospectively or prospectively. Type: Observational [Patient Registry] Start Date: Jan 2016 |
Cognitive Remediation Intervention to Prepare for Transition of Care
University of Alabama at Birmingham
Sickle Cell Disease
Cognitive Impairment
Adolescent Behavior
Self Efficacy
Health-Related Behavior
Randomized Controlled Trial (RTC) testing the efficacy of a telehealth adaptation of the
Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) intervention
to prepare adolescents with sickle cell disease for transition of care. expand
Randomized Controlled Trial (RTC) testing the efficacy of a telehealth adaptation of the Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) intervention to prepare adolescents with sickle cell disease for transition of care. Type: Interventional Start Date: Jul 2022 |
CARBON: UAB Cardiovascular Research Biobank
University of Alabama at Birmingham
Natriuretic Peptides
Cardiovascular Diseases
Hypertension
Diabetes
Obesity
The UAB Cardiovascular Research Biobank (CARBON) will be a resource that contains
biological materials, such as DNA samples, in addition to health and personal information
on a large number of people over time. It will be set up so that it can be used in the
future as a resource for researchers undertaking... expand
The UAB Cardiovascular Research Biobank (CARBON) will be a resource that contains biological materials, such as DNA samples, in addition to health and personal information on a large number of people over time. It will be set up so that it can be used in the future as a resource for researchers undertaking a wide range of medical research. Type: Observational Start Date: Jan 2022 |
An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr...
Viracta Therapeutics, Inc.
Epstein-Barr Virus Associated Lymphoproliferative Disorder
EBV-Related PTLD
EBV Related Non-Hodgkin's Lymphoma
EBV-Positive DLBCL, NOS
EBV Associated Lymphoma
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with
valganciclovir in patients with relapsed/refractory EBV-positive lymphomas expand
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas Type: Interventional Start Date: May 2021 |
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous...
AiCuris Anti-infective Cures AG
HSV Infection
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety
in immunocompromised subjects with acyclovir resistant or acyclovir susceptible
mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a
loading dose of 400 mg as first dose to rapidly... expand
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved). Type: Interventional Start Date: May 2017 |
Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry
Duke University
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
The Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry started
recruiting in 2014 with the objective of studying Idiopathic Pulmonary Fibrosis. In 2018,
the registry expanded to include recruitment of participants with other chronic fibrosing
interstitial lung diseases (ILDs) with... expand
The Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry started recruiting in 2014 with the objective of studying Idiopathic Pulmonary Fibrosis. In 2018, the registry expanded to include recruitment of participants with other chronic fibrosing interstitial lung diseases (ILDs) with progressive phenotype also referred to as progressive fibrosing interstitial lung diseases in the Chronic Fibrosis Interstitial Lung Disease with Progressive Phenotype (ILD-PRO) Registry. When the third phase of the registry begins, the IPF-PRO registry will enroll additional patients with idiopathic pulmonary fibrosis. This IPF-PRO registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) or of another chronic fibrosing interstitial lung disease (ILD) with progressive phenotype established at the enrolling centers. In addition, blood samples and chest image studies will be collected and banked for future research projects. Type: Observational [Patient Registry] Start Date: Jun 2014 |
Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South
University of Alabama at Birmingham
HIV Infections
Sexually Transmitted Diseases
The goal of this study is to adapt evidence-based curriculum on HIV epidemiology and PrEP
prescription to train family medicine physician trainees to take a thorough sexual
history and discuss HIV/STI prevention and PrEP options with adolescent patients in
Alabama. The primary outcomes of the study... expand
The goal of this study is to adapt evidence-based curriculum on HIV epidemiology and PrEP prescription to train family medicine physician trainees to take a thorough sexual history and discuss HIV/STI prevention and PrEP options with adolescent patients in Alabama. The primary outcomes of the study are: - Feasibility of the PrEP Pro training intervention - Acceptability of the PrEP Pro training intervention Secondary outcomes include: - Behavioral changes in sexual history taking performed by physician trainees - PrEP knowledge and prescribing practices - HIV and STI screening practices Participants will receive training on sexual history taking and HIV prevention options, including PrEP prescription and management. They will complete a pre-training survey (enrollment) and post-training survey (6 months post enrollment) to understand differences in knowledge and practice before and after receiving the training intervention. The post training survey will also assess acceptability and feasibility of the intervention. A subset of participants will complete qualitative in-depth interviews to further discuss their experiences with the program and suggestions for future adaptations. Type: Interventional Start Date: Apr 2023 |
RECOVER-ENERGIZE Platform Protocol
Duke University
Long COVID
Long Covid19
Long Covid-19
This is a platform protocol designed to be flexible so that it is suitable for a range of
interventions and settings within diverse health care systems and community settings with
incorporation into clinical COVID-19 management programs and treatment plans if results
achieve key study outcomes.
This... expand
This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC. Type: Interventional Start Date: Jul 2024 |
Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.
University of Alabama at Birmingham
Recurrent Acute Pancreatitis
This clinical will evaluate the safety, tolerability and early efficacy of pirenidone in
patients with recurrent acute pancreatitis. expand
This clinical will evaluate the safety, tolerability and early efficacy of pirenidone in patients with recurrent acute pancreatitis. Type: Interventional Start Date: Jun 2024 |
A Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia...
University of Alabama at Birmingham
Frontal Fibrosing Alopecia
The goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in
the treatment of frontal fibrosing alopecia (FFA). expand
The goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in the treatment of frontal fibrosing alopecia (FFA). Type: Interventional Start Date: Apr 2024 |
Describing Treatment Outcomes and Responses in Lymphoma-associated Hemophagocytic Lymphohistiocytosis
University of Alabama at Birmingham
Lymphoma
Hemophagocytic Lymphohistiocytoses
The purpose of the study is to describe Hemophagocytic lymphohistiocytosis (HLH) in
patients with lymphoma to identify possible therapeutic strategies to improve overall
survival of the patients with lymphoma associated hemophagocytic lymphohistiocytosis. expand
The purpose of the study is to describe Hemophagocytic lymphohistiocytosis (HLH) in patients with lymphoma to identify possible therapeutic strategies to improve overall survival of the patients with lymphoma associated hemophagocytic lymphohistiocytosis. Type: Observational Start Date: May 2023 |
A New Training to Enhance Physical Activity in Adolescents With Cerebral Palsy
University of Alabama at Birmingham
Cerebral Palsy
Muscle Disorder
Physical Disability
Posture Disorders in Children
Spina Bifida
The purpose of this research study is to test the feasibility and response of a new
exercise protocol on improving physical activity in adolescents with cerebral palsy. expand
The purpose of this research study is to test the feasibility and response of a new exercise protocol on improving physical activity in adolescents with cerebral palsy. Type: Interventional Start Date: Aug 2023 |
Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease
Afimmune
Sickle Cell Disease
To assess the pharmacokinetics, pharmacodynamics and safety of Epeleuton capsules in
adult SCD patients who are aged ≥18 years. expand
To assess the pharmacokinetics, pharmacodynamics and safety of Epeleuton capsules in adult SCD patients who are aged ≥18 years. Type: Interventional Start Date: Jan 2024 |
Doxycycline for Emphysema in People Living With HIV (The DEPTH Trial)
Weill Medical College of Cornell University
Emphysema
HIV
The purpose of this study is to determine if doxycycline will reduce progression of
emphysema in people living with HIV.
The secondary objectives are to examine the effects of doxycycline on change in quantity
of emphysema, six minute walk distance, patient reported outcomes, ratio of forced
expiratory... expand
The purpose of this study is to determine if doxycycline will reduce progression of emphysema in people living with HIV. The secondary objectives are to examine the effects of doxycycline on change in quantity of emphysema, six minute walk distance, patient reported outcomes, ratio of forced expiratory volume in 1 second and forced vital capacity. Secondary objectives will also describe the safety and tolerability of doxycycline and determine if doxycycline is associated with development of antibiotic-resistant bacterial infections. Type: Interventional Start Date: Aug 2022 |
Equity in Prevention and Progression of Hypertension by Addressing Barriers to Nutrition and Physical...
University of Alabama at Birmingham
Prehypertension
Hypertension
Blood Pressure
The goal of this study is to test an intervention to prevent high blood pressure among
rural, Black adults living in Alabama. Black adults in this region have one of the
highest rates of high blood pressure in the US. Eating fruits and vegetables and
exercising daily lowers the chance of getting high... expand
The goal of this study is to test an intervention to prevent high blood pressure among rural, Black adults living in Alabama. Black adults in this region have one of the highest rates of high blood pressure in the US. Eating fruits and vegetables and exercising daily lowers the chance of getting high blood pressure. Many problems get in the way of eating a healthy diet and exercising like a lack of grocery stores with fresh foods, few gyms, little money, lack of transportation, and limited support for keeping healthy habits. One place where many Black adults in rural Alabama meet weekly and feel supported is their church. The investigators will connect with 30 churches in rural Alabama. The investigators plan to hold health fairs to find 12 Black adults from each church with blood pressure that is higher than normal but not high enough to need blood pressure lowering medications. The investigators will randomly select 15 churches to get group health education and tablets to access online cooking shows and exercise classes. Adults in the other 15 churches will get support from a health coach over the telephone to help set and meet diet and physical activity goals as well as the group health education and tablets to access online cooking shows and exercise classes. In this study, the investigators will ask church members to sign up to be a health coach. These 15 churches will also get money to help bring healthy foods and/or physical activity opportunities to their communities. The investigative team will train 2 to 3 of their church members to learn how to coach others to eat more healthy food and be more physically active. This study answers two questions. 1) Will this intervention designed to reduce barriers to a healthy lifestyle lower blood pressure among rural, Black adults? 2) Can churches and participants complete the whole two-year study, and can the intervention be used in other communities in a cost-effective way to improve blood pressure? This project will add to the health equity mission of the American Heart Association by finding out if an intervention using health coaches lowers blood pressure among rural Black adults. Type: Interventional Start Date: Aug 2022 |
Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft...
University of Alabama at Birmingham
Gingival Recession
Lack of Keratinized Attached Peri-implant Mucosa
Thin Gingiva
This study is to compare the two techniques to achieve change in the tissue quality at
areas of lack of Keratinized Tissue (KT) using soft tissue grafting with autogenous graft
material (Free Gingival Graft)(FGG) vs Strip gingival graft with acellular dermal matrix
(ADM) (SGG+ADM). expand
This study is to compare the two techniques to achieve change in the tissue quality at areas of lack of Keratinized Tissue (KT) using soft tissue grafting with autogenous graft material (Free Gingival Graft)(FGG) vs Strip gingival graft with acellular dermal matrix (ADM) (SGG+ADM). Type: Interventional Start Date: Sep 2021 |
(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic...
Blueprint Medicines Corporation
Indolent Systemic Mastocytosis
Monoclonal Mast Cell Activation Syndrome
Smoldering Systemic Mastocytosis
This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the
efficacy and safety of elenestinib (BLU-263) + best supportive care (BSC) with placebo +
BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not
adequately controlled by BSC. Parts 1 and... expand
This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of elenestinib (BLU-263) + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. Parts 1 and 2 will enroll patients with ISM. Patients enrolled in Part 1 or Part 2 will roll over onto Part 3 to receive treatment with elenestinib in an open-label fashion following completion of the earlier Part. Part M will enroll patients with monoclonal mast cell activation syndrome (mMCAS). Part S will enroll participants with smoldering systemic mastocytosis (SSM). The study also includes PK groups that will enroll patients with ISM. Type: Interventional Start Date: Nov 2021 |
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
University of Alabama at Birmingham
Primary Open Angle Glaucoma
Mobility refers to a person's purposeful movement through the environment from one place
to another and can be conceptualized as a continuum from bed bound (immobility) on one
extreme to making excursions to distant locations on the other extreme. Primary
open-angle glaucoma (POAG) is a chronic, progressive... expand
Mobility refers to a person's purposeful movement through the environment from one place to another and can be conceptualized as a continuum from bed bound (immobility) on one extreme to making excursions to distant locations on the other extreme. Primary open-angle glaucoma (POAG) is a chronic, progressive optic neuropathy that can lead to gradual loss of vision in the peripheral field and central vision. Older adults with POAG have an increased risk for motor vehicle collisions and falls. Moreover, existing studies suggest that patients with POAG exhibit more postural sway while standing as measured by a balance platform and also tend to walk more slowly than those who are normally sighted and free of ocular disease. While these disturbances likely influence mobility, there has been little research directly assessing the impact of POAG on mobility. This study will assess the impact of POAG on life space (one aspect of mobility) and will determine whether difficulties with life space are associated with difficulties experienced under conditions of dim lighting. Type: Observational Start Date: Jun 2019 |
Comparing Two Methods to Follow Patients With Pancreatic Cysts
ECOG-ACRIN Cancer Research Group
Pancreatic Carcinoma
The purpose of this study is to compare the two approaches for monitoring pancreatic
cysts. The study doctors want to compare more frequent monitoring vs less frequent
monitoring in order to learn which monitoring method leads to better outcome for patients
with pancreatic cysts. expand
The purpose of this study is to compare the two approaches for monitoring pancreatic cysts. The study doctors want to compare more frequent monitoring vs less frequent monitoring in order to learn which monitoring method leads to better outcome for patients with pancreatic cysts. Type: Interventional Start Date: Jun 2020 |
Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering...
ECOG-ACRIN Cancer Research Group
Smoldering Plasma Cell Myeloma
This phase III trial studies how well lenalidomide and dexamethasone works with or
without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in
chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the
growth of tumor cells, either by killing... expand
This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma. Type: Interventional Start Date: Sep 2019 |
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis
SpliSense Ltd.
Cystic Fibrosis
The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with
cystic fibrosis (CF). It will also learn if the drug works to treat works to treat CF
with a specific mutation.
The purpose of this research study is to:
- test the safety and effectiveness of multiple... expand
The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with cystic fibrosis (CF). It will also learn if the drug works to treat works to treat CF with a specific mutation. The purpose of this research study is to: - test the safety and effectiveness of multiple doses of the study drug, SPL84 - test how multiple doses of the drug are processed by the body Researchers will compare drug SPL84 to a placebo (a look-alike substance that contains no drug) to see if drug SPL84 is safe and if it works to treat CF. Participants will: Take drug SPL84 or a placebo by inhalation every week for 9 weeks months Visit the clinic approximately 14 times over 17.5 weeks for checkups and tests Type: Interventional Start Date: Jul 2024 |
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
University of Alabama at Birmingham
Infant Malnutrition
Light-For-Dates With Signs of Fetal Malnutrition
Premature
Nutrition Disorder, Infant
Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM)
deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further
declines in DHA concentrations during the initial three weeks post-birth while advancing
enteral feeds and receiving lipid... expand
Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants. Type: Interventional Start Date: May 2024 |
Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice
Rutgers, The State University of New Jersey
Periodontitis
Periodontal Diseases
Periodontal Pocket
Periodontitis is a bacterial inflammatory disease and antibiotic use is being empirically
used as part of its treatment. However, a clinical practice guideline on periodontal
treatment adjuncts published in 2015 identified weak evidence on the use of systemic
antibiotics and large heterogeneity across... expand
Periodontitis is a bacterial inflammatory disease and antibiotic use is being empirically used as part of its treatment. However, a clinical practice guideline on periodontal treatment adjuncts published in 2015 identified weak evidence on the use of systemic antibiotics and large heterogeneity across small scale studies, suggesting that larger pragmatic clinical trials would benefit clinical decision making. This will be a prospective, randomized, placebo-controlled trial, stratified by practice and practitioner. The study will investigate the effectiveness of adjunctive antibiotics as adjunct to scaling and root planing (SRP) compared to SRP with placebo for the treatment of generalized stage II-III, grades A-C periodontitis in approximately 544 patient participants from about 34 National Dental PBRN practices. Periodontal data will be collected at baseline, re-evaluation (6 weeks), and final (12 months) study visits. Changes in periodontal clinical and patient-reported outcomes will be assessed to determine the effectiveness of SRP plus adjunctive systemic Amoxicillin / Metronidazole antibiotics (AMXM) versus SRP with Placebo. Type: Interventional Start Date: Apr 2024 |
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