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Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery
University of Alabama at Birmingham
Obstetric; Injury Pelvic Floor
Sexual Dysfunction
Anal Incontinence
Urinary Incontinence
Obstetric anal sphincter injuries (OASIS) cause significant morbidity and are well known
risk factors for sexual dysfunction, urinary and anal incontinence. Postpartum and
breastfeeding are relative hypoestrogenic states with risk factors for dyspareunia and
vaginal atrophy. Estrogen deficiency results... expand
Obstetric anal sphincter injuries (OASIS) cause significant morbidity and are well known risk factors for sexual dysfunction, urinary and anal incontinence. Postpartum and breastfeeding are relative hypoestrogenic states with risk factors for dyspareunia and vaginal atrophy. Estrogen deficiency results in changes in the vaginal epithelium and poor tissue quality which results in poor wound healing. For postmenopausal women with vaginal atrophy undergoing surgery for pelvic organ prolapse, early administration of topical vaginal E2 therapy resulted in improved markers of tissue quality. Currently, there are limited studies to reference for proposed treatment modalities to improve sexual function and incontinence in this population. In this proposed randomized, placebo-controlled trial, women who sustain OASIS will be recruited and randomized to begin intravaginal estrogen therapy or placebo at their 2-week follow-up visit after hospital discharge. Participants will complete validated questionnaires relating to sexual function and pelvic floor disorders (urinary and anal incontinence) symptom distress and impact. The primary outcome of this study will be sexual dysfunction symptom severity measured by the female sexual function index (FSFI) at 6 months postpartum. Secondary outcomes will be urinary and anal incontinence distress and impact measured by St. Mark's score and the fecal incontinence quality of life (FIQOL) questionnaire for anal incontinence and urogenital distress inventory (UDI-6) for urinary incontinence. The objective of this study is to determine if intra-vaginal estrogen therapy improves sexual function and incontinence symptom distress and impact for postpartum women after OASIS. Type: Interventional Start Date: Jul 2022 |
The Impact of Hip Exercises on Pelvic Floor Muscle Strength and Function in Older Women With Urinary...
University of Alabama at Birmingham
Urinary Incontinence
Geriatric Syndrome
This is a prospective cohort study of 30 older women ages 65 and older with urinary
incontinence (UI) who will under go a standardized 12-week hip muscle exercises
(isometric strengthening of hip external rotators with progressive resistance training). expand
This is a prospective cohort study of 30 older women ages 65 and older with urinary incontinence (UI) who will under go a standardized 12-week hip muscle exercises (isometric strengthening of hip external rotators with progressive resistance training). Type: Interventional Start Date: Feb 2022 |
IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
Chris Goss
Nontuberculous Mycobacterium Infection
The purpose of this study is to assess the safety and tolerability of two 5-day infusion
cycles of IV gallium in adult patients with CF who are infected with NTM.
Funding Source - FDA Office of Orphan Products Development (OOPD) expand
The purpose of this study is to assess the safety and tolerability of two 5-day infusion cycles of IV gallium in adult patients with CF who are infected with NTM. Funding Source - FDA Office of Orphan Products Development (OOPD) Type: Interventional Start Date: Jun 2021 |
Psilocybin-facilitated Treatment for Chronic Pain
University of Alabama at Birmingham
Fibromyalgia, Primary
The primary purpose of this study is to preliminarily estimate the efficacy of
psilocybin-facilitated treatment for fibromyalgia. Investigators will assess the impact
of psilocybin-facilitated treatment on pain, fatigue, and other fibromyalgia symptoms, in
addition to the level of functioning and... expand
The primary purpose of this study is to preliminarily estimate the efficacy of psilocybin-facilitated treatment for fibromyalgia. Investigators will assess the impact of psilocybin-facilitated treatment on pain, fatigue, and other fibromyalgia symptoms, in addition to the level of functioning and quality of life. Investigators will also evaluate potential mediators of treatment (e.g., treatment expectations, pain characteristics, personality, beliefs/cognitions, emotions). Investigators hypothesize psilocybin treatment will significantly reduce symptom severity in fibromyalgia patients. Type: Interventional Start Date: Nov 2023 |
Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector...
University of Alabama at Birmingham
Cytokine Release Syndrome
ICANS
Lymphoma, Non-Hodgkin
Multiple Myeloma
Acute Lymphoblastic Leukemia
This study will evaluate the use of siltuximab to decrease the severity of cytokine
release syndrome (CRS) and immune effector cell-associated neurological syndrome (ICANS)
in patients who will receive chimeric antigen receptor (CAR) T-cell therapy for the
treatment of hematological malignancies. expand
This study will evaluate the use of siltuximab to decrease the severity of cytokine release syndrome (CRS) and immune effector cell-associated neurological syndrome (ICANS) in patients who will receive chimeric antigen receptor (CAR) T-cell therapy for the treatment of hematological malignancies. Type: Interventional Start Date: Nov 2021 |
Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia
University of Alabama at Birmingham
Gestational Diabetes
GDM is characterized by decreased insulin sensitivity, decreased insulin secretion, or a
combination of both. Women with GDM are at significant risk for overt T2DM later in life,
and postpartum insulin sensitivity and secretion in women with GDM has not been
quantified, limiting our ability to optimize... expand
GDM is characterized by decreased insulin sensitivity, decreased insulin secretion, or a combination of both. Women with GDM are at significant risk for overt T2DM later in life, and postpartum insulin sensitivity and secretion in women with GDM has not been quantified, limiting our ability to optimize screening for overt T2DM. In addition, compliance with currently recommended postpartum T2DM screening by OGTT is poor. Quantification of postpartum insulin sensitivity and secretion in women at high risk for T2DM will inform strategies to improve diagnostic strategies. Continuous glucose monitoring (CGM) is a new technology that may be useful to identify women with persistent hyperglycemia. Understanding maternal glycemia and physiology that drives glycemia in the postpartum period is limited. Completion of this study will define postpartum maternal glycemia, quantify insulin secretion versus insulin sensitivity defects, and demonstrate the feasiblity of using continuous glucose monitoring to identify women most at risk for overt T2DM. Type: Interventional Start Date: Sep 2021 |
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
University of Alabama at Birmingham
Fibromyalgia
Chronic Fatigue Syndrome
Multiple Sclerosis
Healthy
The primary objective of this study is to measure the concentration and the regional
brain distribution of activated brain microglia/macrophages using the PET
radiopharmaceutical [F-18]DPA-714 in individuals with chronic pain and fatigue suspected
to be associated with neuroinflammation. The PET tracer... expand
The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET radiopharmaceutical [F-18]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with neuroinflammation. The PET tracer [F-18]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The primary objective of this study is to determine if pain and fatigue patients have higher levels of neuroinflammation than HC individuals as measured with [F-18]DPA-714-PET/MRI. Type: Interventional Start Date: Feb 2019 |
SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs
University of Alabama at Birmingham
HIV Infections
Opioid-Related Disorders
Pre-Exposure Prophylaxis (PrEP)
The purpose of this study is to develop and test a serious injection-related injections
(SIRI) checklist aimed at increasing evidence-based treatment for rural people who use
drugs (PWUD) including innovative, long-acting injectable agents. The central hypothesis
is that hospital-based care models... expand
The purpose of this study is to develop and test a serious injection-related injections (SIRI) checklist aimed at increasing evidence-based treatment for rural people who use drugs (PWUD) including innovative, long-acting injectable agents. The central hypothesis is that hospital-based care models can successfully engage rural and Southern (PWUD) in effective addiction treatment and infection prevention. The activities in this study will be foundational to Ending the HIV epidemic in rural states. Type: Interventional Start Date: Oct 2022 |
Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics
University of Alabama at Birmingham
Chronic Widespread Pain
To determine if decreased production or release of endogenous opioid peptides by
peripheral immune cells contributes to hypersensitivity in people with HIV expand
To determine if decreased production or release of endogenous opioid peptides by peripheral immune cells contributes to hypersensitivity in people with HIV Type: Interventional Start Date: Nov 2021 |
Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant...
University of Alabama at Birmingham
Ovarian Cancer
Fallopian Tube
Primary Peritoneal Cancer
The proposed study design is a single arm Phase II trial to document the feasibility of
carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy
confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will
have their tumors evaluated for FRα receptor... expand
The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in >75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive surgery (iCRS). A total of 70 will be included in the study. Following completion of 4 cycles total of NACT and after allowing for appropriate recovery of cycle # 4, patients eligible for surgery, will undergo an iCRS. Patients will then complete 3 more cycles of mirvetuximab + carboplatin for a total of 7 intended cycles of treatment. It is up to the treating physician if they want to add bevacizumab to the last 2 cycles or use any type of maintenance therapy. The decision to add bevacizumab or use maintenance therapy does not need to be made upfront. Patients will sign a screening consent form prior to tissue biopsy. If a patient is found to be FRα negative, their treating physician can select the treatment they deem appropriate and the patient will be declared a screen failure. Patients with BRCA mutations are not excluded from this trial and are allowed to receive standard of care maintenance therapy including bevacizumab and/or PARP inhibitors. Type: Interventional Start Date: May 2021 |
Trajectories of Treatment Response as Window Into the Heterogeneity of Psychosis: a Longitudinal Multimodal...
University of Alabama at Birmingham
Psychosis
Psychosis is a heterogeneous disorder and present treatment only works for a limited
number of patients. In order to identify new therapeutic targets, this study will
longitudinally characterize the underlying pathologies in those with poor treatment
response using complimentary brain imaging modalities. expand
Psychosis is a heterogeneous disorder and present treatment only works for a limited number of patients. In order to identify new therapeutic targets, this study will longitudinally characterize the underlying pathologies in those with poor treatment response using complimentary brain imaging modalities. Type: Observational Start Date: Apr 2018 |
American Hepato-Pancreato-Biliary Association (AHPBA) Pancreatic Irreversible Electroporation (IRE) Registry
University of Louisville
Pancreatic Cancer
The purpose of this study is to create a registry to provide insight into treatment
selection and treatment outcome of pancreatic IRE in order to develop an evidence base
such that physicians can provide the best possible care to patients with pancreatic
cancer requiring surgical interventions.
The... expand
The purpose of this study is to create a registry to provide insight into treatment selection and treatment outcome of pancreatic IRE in order to develop an evidence base such that physicians can provide the best possible care to patients with pancreatic cancer requiring surgical interventions. The investigators seek a better understanding of the uses of ablation in the treatment of unresectable soft tissue pancreatic tumors and the limitations, concerns and complications that earlier users have. Type: Observational [Patient Registry] Start Date: Jan 2016 |
Making Intergenerational Connections Through Arts
University of Alabama at Birmingham
Older Adults
The purpose of the study is to evaluate the impact on older adults' wellbeing of
participating in a 10-week conversation about arts and culture with an international
university student whose native language is not English. expand
The purpose of the study is to evaluate the impact on older adults' wellbeing of participating in a 10-week conversation about arts and culture with an international university student whose native language is not English. Type: Observational Start Date: Oct 2023 |
Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
LG Chem
Gout
Hyperuricemia
Gout Flare
Tophi
The aim of this 12-month randomized multi-regional double-blind parallel group
allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of
three different doses of Tigulixostat in gout patients with hyperuricemia. expand
The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia. Type: Interventional Start Date: Mar 2023 |
Novel Dental Gel as an Adjunct to Scaling and Root Planing
University of Alabama at Birmingham
Periodontal Diseases
Gingival Diseases
Gingival Pocket
Gum Bleed
Plaque, Dental
This study will evaluate the use of Livionex Dental Gel (LDG) as a home care product in
reducing probing pocket depth (PD) beyond the effect achieved by the current standard of
care with SRP in periodontitis patients. expand
This study will evaluate the use of Livionex Dental Gel (LDG) as a home care product in reducing probing pocket depth (PD) beyond the effect achieved by the current standard of care with SRP in periodontitis patients. Type: Interventional Start Date: Oct 2022 |
Non-Encapsulated Heme Levels in Adult Cardiac Surgery
University of Alabama at Birmingham
Adult Cardiac Surgery
Non-encapsulated (free) heme, a breakdown component of hemoglobin, is associated with
oxidative stress and inflammation with consequent cellular and tissue injury (Ryter &
Tyrrell, 2000) (D T G Wagener, et al., 2001). Cardiopulmonary bypass is known to cause
trauma to cellular components of the blood,... expand
Non-encapsulated (free) heme, a breakdown component of hemoglobin, is associated with oxidative stress and inflammation with consequent cellular and tissue injury (Ryter & Tyrrell, 2000) (D T G Wagener, et al., 2001). Cardiopulmonary bypass is known to cause trauma to cellular components of the blood, to trigger an inflammatory response, and alter the rheology of the circulation. Prior research has demonstrated an increase in levels of free heme with cardiopulmonary bypass (Wetz, Richardt, Schotola, Bauer, & Bräuer, 2017) (Kubota, Egi, & Mizobuchi, 2017). The stress response to cardiac surgery and utilization of blood salvage techniques independent of cardiopulmonary bypass may affect plasma free heme levels as well as regulation of heme metabolism pathways. It is unclear whether and to what degree plasma levels of free heme may vary at discreet time points in the perioperative period during cardiac surgery involving both cardiopulmonary bypass and "off-pump" techniques. This is an observational, prospective cohort study in which we will assess for red blood cell trauma, free heme levels, and biomarkers for acute kidney injury at various time points throughout cardiac surgery. Urine and arterial blood samples will be collected at our routine, standard of care time points pre-, intra-, and post-operatively and in addition to the standard clinical tests that will be performed (arterial blood gas analysis and activated clotting time) several additional serum biomarkers will be analyzed. Clinical correlation will be performed with levels. Sub-analysis will be performed on the basis of off vs. on pump CABG cases and also in patient that do/not develop AKI post-operatively. Type: Observational Start Date: Jun 2019 |
A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study...
Minneamrita Therapeutics LLC
Advanced Cancer
Gastric Cancer
Breast Cancer
Pancreatic Cancer
Prostate Cancer Metastatic
A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and
Pharmacodynamic Study of Minnelide™Capsules given daily for 21 days followed by 7 days
off schedule in patients with Advanced Solid Tumors expand
A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™Capsules given daily for 21 days followed by 7 days off schedule in patients with Advanced Solid Tumors Type: Interventional Start Date: Oct 2017 |
Study of Pregnancy And Neonatal Health (SPAN)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Gestational Diabetes Mellitus
This study will conduct a randomized trial among women with gestational diabetes (GDM).
Study of Pregnancy And Neonatal health (SPAN), TIMing of dElivery (TIME) is a randomized
trial that will recruit up to 3,450 pregnant women with uncontrolled GDM and randomize
the timing of their delivery. Women... expand
This study will conduct a randomized trial among women with gestational diabetes (GDM). Study of Pregnancy And Neonatal health (SPAN), TIMing of dElivery (TIME) is a randomized trial that will recruit up to 3,450 pregnant women with uncontrolled GDM and randomize the timing of their delivery. Women with GDM who are approached for the trial and are found eligible but do not consent to participating in randomization for delivery will be asked to consent for chart review only (estimated additional n=3,000). The primary objective is to determine the best time to initiate delivery for GDM-complicated deliveries (defined as the time when risk of illness and death for the newborn is the lowest) between 37-39 weeks. Type: Interventional Start Date: Jan 2023 |
Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
LG Chem
Gout
Hyperuricemia
Gout Flare
Tophi
The aim of this 6-month randomized multi-regional double-blind parallel group
placebo-controlled phase 3 study is to assess the efficacy and safety of three different
doses of Tigulixostat in gout patients with hyperuricemia. expand
The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia. Type: Interventional Start Date: Oct 2022 |
Rare CFTR Mutation Cell Collection Protocol (RARE)
George Solomon
Cystic Fibrosis
Over 1,900 mutations in the gene for the cystic fibrosis transmembrane conductance
regulator (CFTR) protein are implicated in causing Cystic Fibrosis (CF). Potential
therapies that directly target defective CFTR are being evaluated in important clinical
trials, but most target the most common CFTR... expand
Over 1,900 mutations in the gene for the cystic fibrosis transmembrane conductance regulator (CFTR) protein are implicated in causing Cystic Fibrosis (CF). Potential therapies that directly target defective CFTR are being evaluated in important clinical trials, but most target the most common CFTR mutation F508del. Many patients with rare CF mutations are not able to participate in those studies. The RARE study is specifically designed for people with CF caused by rare mutations. Eligible rare mutations are listed below: • CF patients who are heterozygous for pre-mature stop codons as noted below: i. one allele must be a F508del ii. the other allele must be a pre-mature stop codon mutation • CF Patients with other genotypes that require Study PI permission: i. CF patients with two mutations that are not eligible for Trikafta ii. CF patients homozygous or heterozygous (other allele must be F508del) for rare mutations of special interest (e.g., 711+3A->G, 2789+5G->A, 3272-26A->G, 3849+10kbC->T). Other rare mutations will be considered on a case by case basis This is a multi-site, specimen collection study. Investigators will collect blood, intestinal cells and nasal cells from each participant. Cells from these specimens will be used to test future CFTR modulators to see if they might work for people with study eligible rare mutations. Having cells to test in the lab is an important first step in identifying potential new therapies for people with these mutations. Type: Observational Start Date: Oct 2017 |
UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy
University of Alabama at Birmingham
Alzheimer Disease
The primary objective of this study is to measure the concentration and the regional
brain distribution of pathologic tau deposition using the PET tracer AV-1451 in
participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain
will be correlated to demographic, clinical,... expand
The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled in an ongoing [C-11]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors. Type: Interventional Start Date: Jul 2020 |
Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset
The University of Texas Health Science Center, Houston
Infant, Extremely Premature
Obstetric Labor, Premature
Premature Birth
Intensive Care, Neonatal
Intensive Care Units, Neonatal
The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal
Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and
practices for all deliveries and infants admitted to intensive care at 22-23 weeks'
gestation at participating hospitals. expand
The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals. Type: Observational [Patient Registry] Start Date: Jan 2019 |
Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
University of Alabama at Birmingham
Idiopathic Pulmonary Fibrosis
The purpose of the study is to see if imaging with fluorine-18 Fluorodeoxyglucose ([18F]
FDG) and fluorine-18 Displacement Per Atom ([18F]DPA-714) using positron emission
tomography and computed tomography (PET/CT) will show lung inflammation and fibrosis in
patients diagnosed with idiopathic pulmonary... expand
The purpose of the study is to see if imaging with fluorine-18 Fluorodeoxyglucose ([18F] FDG) and fluorine-18 Displacement Per Atom ([18F]DPA-714) using positron emission tomography and computed tomography (PET/CT) will show lung inflammation and fibrosis in patients diagnosed with idiopathic pulmonary fibrosis (IPF). This study may help physicians and researchers better understand how best to treat patients with IPF in the future. Type: Interventional Start Date: Dec 2020 |
Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who...
Telios Pharma, Inc.
Myelofibrosis
Primary Myelofibrosis
Post-PV MF
Post-ET Myelofibrosis
This study evaluates TL-895, a potent, orally-available and highly selective irreversible
tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF
(PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a
suboptimal response to ruxolitinib. expand
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib. Type: Interventional Start Date: Jun 2022 |
HyperArc Registry Study
Varian, a Siemens Healthineers Company
Brain Metastases
CNS Neoplasm
CNS Disorder, Intracranial
The HyperArc registry is designed to collect data from which the efficacy of the HyperArc
procedure can be assessed and compared to alternative treatments. expand
The HyperArc registry is designed to collect data from which the efficacy of the HyperArc procedure can be assessed and compared to alternative treatments. Type: Observational [Patient Registry] Start Date: Mar 2022 |
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