Search Clinical Trials
Sponsor Condition of Interest |
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Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment...
University of Alabama at Birmingham
Major Depressive Disorder
Suicidal Ideas
Suicide, Attempted
MDD
Depression
This study is dedicated to help identify biomarkers for depression and suicide. The purpose
of the study is to better understand these links to improve medical and psychiatric care in
the future. This research is also to test the effects of standard treatment of depression on... expand
This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders. Type: Interventional Start Date: Oct 2022 |
Exploratory Study of Low Dose Psilocybin
University of Alabama at Birmingham
Demoralization
The purpose of the present study is to evaluate the feasibility, initial signals of efficacy,
and potential mechanisms of action of "microdoses" of psilocybin (i.e., low doses of
psilocybin that are not believed to produce mystical-type, transcendent, hallucinogenic, or
other... expand
The purpose of the present study is to evaluate the feasibility, initial signals of efficacy, and potential mechanisms of action of "microdoses" of psilocybin (i.e., low doses of psilocybin that are not believed to produce mystical-type, transcendent, hallucinogenic, or other overtly salient subjective effects that limit functionality) in the treatment of moderate to severe demoralization (feelings of hopelessness and meaningless that frequently accompany medical illness and other life hardship). Type: Interventional Start Date: Aug 2023 |
Reducing Vertical Transmission of Hepatitis B in Africa
University of Alabama at Birmingham
Hepatitis B Infection
Hepatitis B virus is an infection that can be easily transmitted from women to newborns at
the time of delivery. Our objective is to identify novel options that are effective and safe
in preventing perinatal transmission of hepatitis B in Africa. The REVERT-B study (Reducing... expand
Hepatitis B virus is an infection that can be easily transmitted from women to newborns at the time of delivery. Our objective is to identify novel options that are effective and safe in preventing perinatal transmission of hepatitis B in Africa. The REVERT-B study (Reducing Vertical Transmission of Hepatitis B in Africa) is a clinical trial designed to test a new strategy of using antiviral medication in high-risk pregnant women and newborns to reduce the risk of hepatitis B transmission. The study will measure efficacy, safety, tolerability and adherence to medication. Type: Interventional Start Date: Sep 2021 |
Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes
University of Alabama at Birmingham
Diabetes Mellitus, Type 2
Preterm Birth
Pregnancy, High Risk
Diabetes, Gestational
There is a fundamental gap in understanding the maternal and neonatal effects of antenatal
corticosteroid (ACS) administration in women with threatened preterm birth (PTB) who have
diabetes. Since the initial discovery of ACS for neonatal benefit in 1972, more than 40
randomized... expand
There is a fundamental gap in understanding the maternal and neonatal effects of antenatal corticosteroid (ACS) administration in women with threatened preterm birth (PTB) who have diabetes. Since the initial discovery of ACS for neonatal benefit in 1972, more than 40 randomized controlled trials have been performed evaluating its efficacy. However, none of these trials have included women with T2DM, and there is limited data among women with gestational diabetes. While ACS have been shown to reduce neonatal morbidity associated with PTB in non-diabetic women, the side effects of ACS (maternal hyperglycemia and fetal hyperinsulinemia) may mitigate the neonatal benefit of ACS in women with diabetes. Before neonatal benefit of ACS can be evaluated in this population, the first step is to optimize maternal glycemic control after ACS. Previous studies evaluating maternal hyperglycemia after ACS have been limited by small sample size, retrospective study design, or insufficient glucose data. Use of continuous glucose monitoring (CGM) in a randomized clinical trial provides a unique opportunity to overcome these challenges. Our long-term goal is to improve maternal and child health among women with diabetes as an independently funded clinical researcher. The research objectives of this proposal are to test the efficacy of three treatment strategies at achieving maternal glycemic control after ACS and evaluate the association between maternal glycemic control and neonatal outcomes. Our central hypothesis is that treatment with a continuous insulin infusion will improve maternal glycemic control, which is key to improving neonatal outcomes, but at the cost of less patient satisfaction and more health resource utilization. This hypothesis will be tested by pursuing the following specific aims: 1) Test the efficacy of three treatment strategies (addition of sliding scale insulin, up-titration of home insulin, and continuous insulin infusion) at achieving maternal glycemic control after ACS and 2) Quantify the association between maternal glycemic control after ACS and neonatal morbidity. Completion of these aims will determine the optimal strategy to achieve maternal glycemic control after ACS and inform a larger, multicenter trial to improve neonatal outcomes among women with diabetes and threatened PTB. Type: Interventional Start Date: Feb 2022 |
KT Tape for Pediatric Clavicle Fractures
University of Alabama at Birmingham
Clavicle Fracture
Clavicle fractures in children are mostly managed non-operatively since they have an overall
high union rate (95%) and a "good" functional outcome following nonoperative treatment.
However, the downside of such a conservative approach is that patients have to live with pain... expand
Clavicle fractures in children are mostly managed non-operatively since they have an overall high union rate (95%) and a "good" functional outcome following nonoperative treatment. However, the downside of such a conservative approach is that patients have to live with pain and disability until the fracture heals. To minimize this, fractures are usually immobilized with a sling. There have been no studies looking at clavicle fractures treated with kinesiology (elastic) tape. No adverse effects (skin irritation, redness, etc.) are observed with the application of this tape. Elastic tape has previously been examined regarding muscular advantages rather than for healing fractures. Since this tape should immobilize fractures better than a sling, patients should experience less pain and disability associated with their fracture. Type: Interventional Start Date: Oct 2020 |
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib...
Aptose Biosciences Inc.
Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of the Safety,
Tolerability, Pharmacokinetics, and Pharmacodynamics of Tuspetinib (HM43239) in Patients with
Relapsed or Refractory Acute Myeloid Leukemia (AML)
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A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tuspetinib (HM43239) in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) Type: Interventional Start Date: Mar 2019 |
Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS)
Johns Hopkins University
Inflammatory Bowel Disease
The investigators are doing the research to discover genes that cause Inflammatory Bowel
Disease (IBD) specifically in the African American population. African Americans with or
without Crohn's disease or ulcerative colitis are eligible to join. If you agree to join the
study,... expand
The investigators are doing the research to discover genes that cause Inflammatory Bowel Disease (IBD) specifically in the African American population. African Americans with or without Crohn's disease or ulcerative colitis are eligible to join. If you agree to join the study, the investigators will ask for information about your health. The investigators will also ask you to give us a blood sample so that they may discover the genes that cause IBD. The blood sample may be collected at Johns Hopkins or any local facility convenient to you. Type: Observational Start Date: Jun 2003 |
DiAL Health Research Study
Pennington Biomedical Research Center
Aging
Weight Loss
Treatment Adherence
The purpose of this study is to conduct a five-arm pilot and feasibility trial in healthy,
young individuals without obesity to evaluate the feasibility and efficacy of dietary
intervention approaches to slow mechanisms of aging.
expand
The purpose of this study is to conduct a five-arm pilot and feasibility trial in healthy, young individuals without obesity to evaluate the feasibility and efficacy of dietary intervention approaches to slow mechanisms of aging. Type: Interventional Start Date: Dec 2022 |
Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse...
Yale University
Depression and Suicide
This is a rater-blinded, randomized controlled trial. All patients will receive esketamine
for treatment of Major Depression with Suicidal Ideation (MDSI). Subjects will be randomized
(1:1) to receive CBT (computer-assisted) or TAU alone following esketamine.
expand
This is a rater-blinded, randomized controlled trial. All patients will receive esketamine for treatment of Major Depression with Suicidal Ideation (MDSI). Subjects will be randomized (1:1) to receive CBT (computer-assisted) or TAU alone following esketamine. Type: Interventional Start Date: Mar 2021 |
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
NYU Langone Health
Chronic Postsurgical Pain
The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in
reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive
a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (up to... expand
The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (up to a maximum of 6 hours) and continued for 2 hours postoperatively. Participants in the second arm will receive a single dose of 0.6 mg/kg of ketamine in the post-anesthesia care unit, and the final group will serve as the control group and receive saline (no ketamine). Type: Interventional Start Date: Jan 2022 |
Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove...
SWOG Cancer Research Network
Metastatic Clear Cell Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
This phase III trial compares the effect of adding surgery to a standard of care
immunotherapy-based drug combination versus a standard of care immunotherapy-based drug
combination alone in treating patients with kidney cancer that has spread to other places in
the body (metastatic).... expand
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer. Type: Interventional Start Date: Mar 2021 |
Food Assistance, Diabetes, and HIV
University of Alabama at Birmingham
Diabetes
HIV/AIDS
FOOD SECURITY
Diabetes prevalence is increasing among people living with HIV (PLWH), yet blood glucose
control is less successful in this population who are also often food insecure. Food
assistance programs often provide nutrient-poor foods. This proposal asses the feasibility of
monitoring... expand
Diabetes prevalence is increasing among people living with HIV (PLWH), yet blood glucose control is less successful in this population who are also often food insecure. Food assistance programs often provide nutrient-poor foods. This proposal asses the feasibility of monitoring diabetes-related health outcomes among food insecure PLWH who are receiving food boxes higher in dietary protein and fiber and lower in simple carbohydrates. Type: Observational Start Date: Oct 2018 |
Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis
University of Alabama at Birmingham
Idiopathic Pulmonary Fibrosis, Acute Fatal Form
Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF)
that presents with rapidly worsening respiratory function over days to weeks. AE account for
about 1/2 the deaths in IPF patients, and are refractory to all medical therapies attempted... expand
Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF) that presents with rapidly worsening respiratory function over days to weeks. AE account for about 1/2 the deaths in IPF patients, and are refractory to all medical therapies attempted to date. Considerable preliminary data shows pathological B-cell abnormalities and autoantibodies are present in AE-IPF and associated with disease severity. The experimental therapy here (therapeutic plasma exchange plus rituximab plus intravenous immunoglobulin) is mechanistically targeted to ameliorate autoantibody-mediated pulmonary injury. Anecdotal pilot studies indicate these treatments have significant benefit for a disease syndrome that has, until now, been almost invariably inexorable. This clinical trial has the potential to profoundly affect current paradigms and treatment approaches to patients with AE-IPF. Type: Interventional Start Date: Sep 2018 |
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients...
Celcuity Inc
Breast Cancer
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety
of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients
with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after... expand
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Type: Interventional Start Date: Sep 2022 |
ARrest RESpiraTory Failure From PNEUMONIA
Stanford University
Pneumonia
Hypoxemia
Acute Respiratory Failure
COVID-19 Pneumonia
This research study seeks to establish the effectiveness of a combination of an inhaled
corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory
failure (ARF) in hospitalized patients with pneumonia and hypoxemia.
expand
This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia. Type: Interventional Start Date: Jun 2020 |
Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
University of Calgary
Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection
Hemolytic-Uremic Syndrome
The objective of this study is to determine if early high volume intravenous fluid
administration (hyperhydration) may be effective in mitigating or preventing complications of
shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with
traditional... expand
The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management). Type: Interventional Start Date: Sep 2022 |
Evaluating the Implementation and Impact of Navigator-delivered ePRO System
University of Alabama at Birmingham
Cancer
1) Evaluate implementation of navigator-delivered Home ePRO for all cancer patients across
multiple practice sites; 2) examine the barriers, facilitators, and implementation strategies
used in implementing navigator-delivered Home ePRO; and 3) assess the impact of Home ePRO on... expand
1) Evaluate implementation of navigator-delivered Home ePRO for all cancer patients across multiple practice sites; 2) examine the barriers, facilitators, and implementation strategies used in implementing navigator-delivered Home ePRO; and 3) assess the impact of Home ePRO on clinical and utilization outcomes. Type: Interventional Start Date: May 2021 |
Renal Metabolism of Glycolate to Oxalate
University of Alabama at Birmingham
Healthy
This study will determine the contribution of glycolate metabolism to urinary oxalate
excretion in healthy subjects, using carbon 13 isotope glycolate tracer technique and a
low-oxalate controlled diet.
expand
This study will determine the contribution of glycolate metabolism to urinary oxalate excretion in healthy subjects, using carbon 13 isotope glycolate tracer technique and a low-oxalate controlled diet. Type: Interventional Start Date: Mar 2020 |
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)... 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 |
DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)
Cellphire Therapeutics, Inc.
Cardiac Surgery
A randomized, parallel group, active comparator-controlled trial to evaluate the
non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in
controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery.
expand
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery. Type: Interventional Start Date: Sep 2021 |
Follow-up Visit of High Risk Infants
NICHD Neonatal Research Network
Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which
surviving extremely low birth-weight infants born in participating network centers receive
neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age
(Infants... expand
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment. Type: Observational Start Date: Jan 1993 |
ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Neonatal Opioid Withdrawal Syndrome
The objective of this longitudinal cohort study is to quantify the effects of antenatal
opioid exposure on the trajectory of brain development over the first 2 years of life,
examine associations with developmental and neurobehavioral outcomes, and explore how
specific factors... expand
The objective of this longitudinal cohort study is to quantify the effects of antenatal opioid exposure on the trajectory of brain development over the first 2 years of life, examine associations with developmental and neurobehavioral outcomes, and explore how specific factors (differing antenatal and postnatal exposures, severity of neonatal opioid withdrawal, maternal stress/depression/parenting) modify these effects Type: Observational Start Date: Aug 2020 |
International Weight Control Registry
Tufts University
Weight Loss
Overweight
Obesity
The IWCR is a global scientific study aimed at better understanding the opportunities and
barriers for reducing the prevalence of obesity by collecting information from people who
have experience with weight management in their everyday lives. The investigators seek to
gather... expand
The IWCR is a global scientific study aimed at better understanding the opportunities and barriers for reducing the prevalence of obesity by collecting information from people who have experience with weight management in their everyday lives. The investigators seek to gather information on a wide range of weight management experiences, ranging from weight loss and weight loss maintenance to weight gain and inability to lose weight. Type: Observational [Patient Registry] Start Date: Dec 2020 |
HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network...
University of Utah
Pediatric Hydrocephalus
The Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic
funding to conduct multi-institutional research (clinical trials and observational studies)
on pediatric hydrocephalus. In addition to philanthropic funding, the HCRN has also received... expand
The Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic funding to conduct multi-institutional research (clinical trials and observational studies) on pediatric hydrocephalus. In addition to philanthropic funding, the HCRN has also received an NIH NINDS Challenge Grant to support the network infrastructure which allows for the conduct of this and other network studies. The HCRN consists of multiple Clinical Centers and the Data Coordinating Center (DCC). The HCRN Core Data Project will obtain data about all neurosurgical hydrocephalus events from the network Clinical Centers, and create a database to be used by HCRN investigators. The ongoing maintenance of the Core Data Project serves two main purposes: 1) it will help investigators understand the variability, progression, and current treatment practices for hydrocephalus in children, with an ultimate goal of better guiding and assessing therapeutic intervention and providing recommendations on patient care and, 2) it will provide pilot and descriptive data necessary for hypothesis generation and study design (i.e. preliminary power analyses, recruitment projections) for studies under development by the HCRN. This multi-institutional database will be maintained throughout the lifetime of the HCRN, and may be useful for tracking trends in pediatric hydrocephalus over time. The Core Data Project will be an invaluable resource to the HCRN and will help stimulate new research protocols, identify potential need for future expansion of the network to incorporate additional patient populations, and provide a descriptive understanding of children with hydrocephalus cared for within the network. Type: Observational Start Date: Apr 2008 |
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents,...
Children's Hospital Los Angeles
B-cell Acute Lymphoblastic Leukemia
This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL
patients with low risk of relapse as defined by absence of NGS-MRD (next generation
sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT).
Patients... expand
This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL patients with low risk of relapse as defined by absence of NGS-MRD (next generation sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT). Patients diagnosed with B-ALL who are candidates for HCT will be screened by NGS-MRD on a test of bone marrow done before the HCT. Subjects who are pre-HCT NGS-MRD negative will be eligible to receive a non-TBI conditioning regimen as part of the treatment cohort of the study. Subjects who are pre-HCT NGS-MRD positive will be treated as per treating center standard and will be followed in an observational cohort (HCT center standard of care). Type: Interventional Start Date: Aug 2018 |
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