
Search Clinical Trials
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Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVC) Administered Rectally
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
The purpose of this study is to evaluate the safety and pharmacokinetics of rectal
administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels
in HIV-uninfected individuals.
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The purpose of this study is to evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals. Type: Interventional Start Date: Dec 2019 |
Influence of Obesity on Endogenous Oxalate Synthesis
University of Alabama at Birmingham
Kidney Stone
There is increasing evidence that obesity is associated with increased urinary oxalate
excretion, an important risk factor for calcium oxalate stone formation. By the
administration of a controlled low oxalate diet the investigators will estimate endogenous
oxalate synthesis... expand
There is increasing evidence that obesity is associated with increased urinary oxalate excretion, an important risk factor for calcium oxalate stone formation. By the administration of a controlled low oxalate diet the investigators will estimate endogenous oxalate synthesis in both non-obese and obese non-kidney-stone forming adults. This study seeks to thusly increase the understanding of the relationships between obesity and endogenous oxalate synthesis to serve as a platform to develop novel therapies for stone prevention. Type: Interventional Start Date: May 2019 |
Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care
University of Alabama at Birmingham
HIV
AIDS
Smoking Cessation
To determine the efficacy of an algorithm designed to recommend smoking cessation-related
pharmacotherapy options to the primary care providers of smokers living with HIV/AIDS.
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To determine the efficacy of an algorithm designed to recommend smoking cessation-related pharmacotherapy options to the primary care providers of smokers living with HIV/AIDS. Type: Interventional Start Date: Aug 2020 |
Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers
University of Alabama at Birmingham
Neuroendocrine Carcinoma of Pancreas
Carcinoid
The purpose of this study is to see if the use of 68Gallium- positron emission tomography and
computer tomography (PET/CT) scans along with NETSPOT® (Advanced Accelerator Applications
USA, Inc.) can better define the localization of Neuroendocrine tumors enhancing the surgical... expand
The purpose of this study is to see if the use of 68Gallium- positron emission tomography and computer tomography (PET/CT) scans along with NETSPOT® (Advanced Accelerator Applications USA, Inc.) can better define the localization of Neuroendocrine tumors enhancing the surgical removal of Neuroendocrine tumors (NETs). Type: Interventional Start Date: Jun 2019 |
Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease...
University of Alabama at Birmingham
PreDiabetes
One in three American adults have prediabetes, and up to 70% of adults with prediabetes
eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective
approaches are needed to reduce the incidence of diabetes. One new strategy may be to change... expand
One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted feeding; TRF) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRF also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRF can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRF depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRF' (eat between ~8 am-3 pm), (2) 'Mid-day TRF' (eat between ~1 pm - 8 pm), or (3) Control Schedule (~8 am - 8 pm) for 10 weeks. All food will be provided and matched between groups. Type: Interventional Start Date: Aug 2020 |
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic...
Juno Therapeutics, a Subsidiary of Celgene
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Small Lymphocytic
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of
JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a
Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with
relapsed... expand
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated. Type: Interventional Start Date: Dec 2017 |
Treatment Outcomes of CBT for PNES
University of Alabama at Birmingham
Convulsion, Non-Epileptic
This research study is examining the effects of a cognitive behavioral intervention (an
intervention focused on changing behaviors and thoughts) for psychogenic non-epileptic
seizures (PNES, episodes resembling epileptic seizures but with no medical explanation).
Participants... expand
This research study is examining the effects of a cognitive behavioral intervention (an intervention focused on changing behaviors and thoughts) for psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). Participants engage in 8 individual therapy sessions consisting of either cognitive behavioral therapy or supportive therapy. Healthy control participants also complete pre-questionnaires. Type: Interventional Start Date: Jun 2016 |
Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
HPV16 Associated Cervical Cancer
This study will be looking at what dose of the TA-CIN vaccine is safe and effective in
patients with a history of HPV16-associated cervical cancer.
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This study will be looking at what dose of the TA-CIN vaccine is safe and effective in patients with a history of HPV16-associated cervical cancer. Type: Interventional Start Date: Apr 2019 |
Study of Pegloticase in Patients With Uncontrolled Gout Who Have Had a Kidney Transplant
Horizon Therapeutics Ireland DAC
Uncontrolled Gout
Kidney Transplant
This is a Phase 4, multicenter study of pegloticase in adult participants with uncontrolled
gout who have undergone kidney transplantation. Approximately twenty participants will be
enrolled. Study duration will be approximately 41 weeks.
The purpose of this study is to... expand
This is a Phase 4, multicenter study of pegloticase in adult participants with uncontrolled gout who have undergone kidney transplantation. Approximately twenty participants will be enrolled. Study duration will be approximately 41 weeks. The purpose of this study is to assess the efficacy and safety of pegloticase in kidney transplant participants with uncontrolled gout refractory to conventional urate lowering therapy. Type: Interventional Start Date: Sep 2019 |
Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies
Sutro Biopharma, Inc.
B-cell Lymphoma
Non Hodgkin Lymphoma
Multiple Myeloma
Follicular Lymphoma
Mantle Cell Lymphoma
First-in-human Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy
of STRO-001 given intravenously every 3 weeks.
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First-in-human Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-001 given intravenously every 3 weeks. Type: Interventional Start Date: Feb 2018 |
To Compare the Effectiveness of 3 Different Types of Lens and Lens Coating in Eliminating Symptoms for...
University of Alabama at Birmingham
Concussion, Mild
Convergence Insufficiency
Accommodation; Insufficiency
Recent studies have shown children who sustain a concussion are susceptible to having chronic
symptoms (post-concussion syndrome). This chronicity can lead to delays in returning to learn
and returning to play. Blurry vision, double vision, eye strain and eye tracking problems are... expand
Recent studies have shown children who sustain a concussion are susceptible to having chronic symptoms (post-concussion syndrome). This chronicity can lead to delays in returning to learn and returning to play. Blurry vision, double vision, eye strain and eye tracking problems are some of the reported chronic symptoms that can affect patients' daily activities. Concussion awareness has increased recently and there is a surge of interest to better understand and treat the symptoms of post-concussion syndrome. Currently, ocular treatment for patients are often empirically determined. Common treatments are vision therapy and/or bifocal glasses. There has yet to be any standardization or prospective studies looking into treatment for these concussed patients with ocular symptoms and findings. The objective of this protocol is to compare three different types of glasses (typical prescription glasses for kids, typical glasses for kids with anti-glare coating, and progressive addition lenses with anti-glare coating) as treatment options for participants who are still symptomatic four weeks out from their concussion. The main outcome is the effectiveness of these three different options in reducing patients' symptoms and improving the participants' visual findings. Type: Interventional Start Date: Jan 2018 |
The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor
University of Alabama at Birmingham
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor
(VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis,
and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot,... expand
The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor (VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis, and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot, randomized (3:1, active:placebo), double-blind, placebo-controlled study. Approximately 40 subjects with COPD will be randomized. Type: Interventional Start Date: Mar 2017 |
Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL)
University of California, San Francisco
FTLD
Progressive Supranuclear Palsy (PSP)
Frontotemporal Dementia (FTD)
Corticobasal Degeneration (CBD)
PPA Syndrome
Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of
rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes:
frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration... expand
Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration syndrome (CBS) and progressive supranuclear palsy syndrome (PSPS). The goal of this study is to build a FTLD clinical research consortium to support the development of FTLD therapies for new clinical trials. The consortium, referred to as Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL), will be headquartered at UCSF and will partner with six patient advocacy groups to manage the consortium. Participants will be evaluated at 14 clinical sites throughout North America and a genetics core will genotype all individuals for FTLD associated genes. Type: Observational Start Date: Sep 2014 |
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Center for International Blood and Marrow Transplant Research
Hematologic Malignancies
Inherited Disorders of Metabolism
Inherited Abnormalities of Platelets
Histiocytic Disorders
Acute Myelogenous Leukemia (AML or ANLL)
This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications.
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This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications. Type: Observational Start Date: Oct 2011 |
The Innate Central Nervous System Immune Response to an Experimental Immune Challenge in People With...
University of Alabama at Birmingham
Fibromyalgia
The major goal of this study is to determine if the innate immune response is dysregulated in
people with fibromyalgia, compared to healthy controls. Magnetic resonance spectroscopy will
be used to measure changes in the brain's metabolic profile following an experimental immune... expand
The major goal of this study is to determine if the innate immune response is dysregulated in people with fibromyalgia, compared to healthy controls. Magnetic resonance spectroscopy will be used to measure changes in the brain's metabolic profile following an experimental immune stimulus, to test whether individuals with fibromyalgia show a heightened immune response in the brain. The ultimate goal of this research is to better understand the role of brain inflammation in the pathophysiology of chronic pain and fatigue, which will guide the development of more effective therapies for these conditions. Type: Interventional Start Date: Mar 2020 |
Incentive Spirometry Prehabilitation Study
University of Alabama at Birmingham
Pulmonary Disease
Postoperative pulmonary complications (PPCs) are the most common complication following
thoracic surgery. PPCs are associated with prolonged hospital stay, increased morbidity,
mortality, ICU admission, and healthcare costs (Azhar, 2015). Current preoperative
optimization... expand
Postoperative pulmonary complications (PPCs) are the most common complication following thoracic surgery. PPCs are associated with prolonged hospital stay, increased morbidity, mortality, ICU admission, and healthcare costs (Azhar, 2015). Current preoperative optimization in this patient group includes smoking cessation and management of Chronic Obstructive Pulmonary Disease with inhaled bronchodilators and inhaled steroids as indicated. There have been studies using preoperative incentive spirometry in patients undergoing laparotomy with conflicting results, but scant data on its use in patients undergoing one-lung ventilation (Tyson, et al., 2015; Cattano, et al., 2010). A study from 2013 investigated the effectiveness of incentive spirometry in patients following thoracotomy and found conflicting results, without significant improvement in lung function or reduction in PPCs, but a larger difference in frequency of PPC was noted, indicating possible benefit to intervention and a need for further study (Agostini, et al., 2013). Volume-based incentive spirometry pre- and postoperatively has also been found to improve pulmonary function and diaphragm excursion in patients undergoing laparoscopic surgery (Alaparthi, et al., 2016). Patients customarily receive an incentive spirometer for use postoperatively in the PACU. There is scant data in the thoracic surgery population concerning prehabilitation by dispensing the incentive spirometer at the PACT evaluation. Type: Interventional Start Date: Sep 2019 |
To Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting
University of Alabama at Birmingham
Gingival Recession
Palate; Wound
This randomized clinical comparative study will evaluate the postoperative pain following the
FGG graft harvest procedure technique covered by four different methods for coverage of the
palatal donor site.
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This randomized clinical comparative study will evaluate the postoperative pain following the FGG graft harvest procedure technique covered by four different methods for coverage of the palatal donor site. Type: Interventional Start Date: Jun 2020 |
Regional Anesthesia to Reduce Opioid Use Following FESS
University of Alabama at Birmingham
Pain Management
Opioids are prescribed for moderate to severe pain disorders; however, there are
contraindications and side effects that are common to all opioids. The investigators
hypothesize using regional anesthetic during sinus surgery will reduce surgical pain,
therefore decreasing... expand
Opioids are prescribed for moderate to severe pain disorders; however, there are contraindications and side effects that are common to all opioids. The investigators hypothesize using regional anesthetic during sinus surgery will reduce surgical pain, therefore decreasing the need for post-operative opioid medication. The primary of objective is to determine if a long-acting local regional anesthetic applied during a surgery will reduce post-operative oral opioid usage. Type: Interventional Start Date: May 2019 |
Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer
University of Oklahoma
Endometrial Cancer
This is a single arm, Phase II study using the combination of atezolizumab and bevicacizumab
in women with advanced, recurrent or persistent endometrial cancer. Safety and futility of
this drug combination will be assessed to see what effect this treatment has on this patient... expand
This is a single arm, Phase II study using the combination of atezolizumab and bevicacizumab in women with advanced, recurrent or persistent endometrial cancer. Safety and futility of this drug combination will be assessed to see what effect this treatment has on this patient population. Type: Interventional Start Date: Aug 2018 |
Precision High-Intensity Training Through Epigenetics (PHITE)
University of Alabama at Birmingham
Healthy
The PHITE collaborative team, consisting of Tim Broderick, MD (Overall PI), Wright State
University (WSU); Marcas Bamman, PhD (Site PI), The University of Alabama at Birmingham
(UAB); and Ron Evans, PhD and Joe Ecker, PhD, Salk Institute for Biological Studies, are
working... expand
The PHITE collaborative team, consisting of Tim Broderick, MD (Overall PI), Wright State University (WSU); Marcas Bamman, PhD (Site PI), The University of Alabama at Birmingham (UAB); and Ron Evans, PhD and Joe Ecker, PhD, Salk Institute for Biological Studies, are working with funding from the US Department of Defense (DoD), Office of Naval Research (ONR), to explore the link between physical training and epigenetics. This is a key interest area for the DoD ONR because it provides high-impact optimization of force readiness in warfighters with diverse backgrounds. The term epigenetics refers to heritable changes in gene expression (active versus inactive genes) that does not involve changes to the underlying DNA sequence; a change in phenotype (the set of observable characteristics of an individual resulting from the interaction of its genotype with the environment) without a change in genotype (the genetic constitution of an individual organism) . This in turn affects how cells read the genes. Epigenetic change is a regular and natural occurrence but can also be influenced by several factors including age, the environment/lifestyle, and disease state. Epigenetic modifications can manifest as commonly as the manner in which cells terminally differentiate to end up as skin cells, liver cells, brain cells, etc. New and ongoing research is continuously uncovering the role of epigenetics in a variety of human conditions. This study is designed to assess whether epigenetics is a primary mechanism modulating how individuals adapt to specific exercise training prescriptions designed to produce a warfighter phenotype. The PHITE team is organized around a shared test population of human subjects for which UAB will oversee recruitment, training, testing, and sampling. Healthy but untrained volunteers, both men and women, 18-27 y of age-phenotypical of the US warfighter-will participate in a 12-wk, two-arm, single-blind, randomized, exercise dose-response trial comparing two intensities of combined training: Moderate-Intensity vs. High-Intensity. Biospecimens are collected before and after an acute exercise bout in the pre-training state, and again after 12 weeks of 3 d/wk combined exercise training. Numerous phenotyping assessments are collected before after the 12-week intervention period to associate exercise training outcomes with molecular changes in the skeletal muscle and blood biospecimens. Type: Interventional Start Date: Feb 2017 |
Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study
University of Alabama at Birmingham
Back Pain Lower Back Chronic
It remains unclear whether certain disadvantaged subgroups of society may be at heightened
risk for poor chronic low back pain (cLBP) outcomes. The overall aim of this study is to
incorporate a socioeconomic framework to characterize racial differences in cLBP severity and... expand
It remains unclear whether certain disadvantaged subgroups of society may be at heightened risk for poor chronic low back pain (cLBP) outcomes. The overall aim of this study is to incorporate a socioeconomic framework to characterize racial differences in cLBP severity and disability. Further, guided by the theory of fundamental causes, we aim to examine racial and socioeconomic status differences in biopsychosocial predictors of cLBP outcomes, particularly endogenous pain modulation. Type: Observational Start Date: Oct 2017 |
Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
CHDI Foundation, Inc.
Huntington's Disease
Enroll-HD is a longitudinal, observational, multinational study that integrates two former
Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and
Australasia-while also expanding to include sites in Latin America. More than 20,000
participants... expand
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 20,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more. Type: Observational [Patient Registry] Start Date: Jul 2012 |
Suppression Of Bacterial Vaginosis (BV) [SUBVert]
National Institute of Allergy and Infectious Diseases (NIAID)
Bacterial Vaginosis
A Phase II randomized, double-blind, placebo-controlled study screening approximately 600
adult females, aged 18-55, with a goal to enroll approximately 250 participants to achieve
200 evaluable participants at the test of cure (TOC) visit. The study is designed to
determine... expand
A Phase II randomized, double-blind, placebo-controlled study screening approximately 600 adult females, aged 18-55, with a goal to enroll approximately 250 participants to achieve 200 evaluable participants at the test of cure (TOC) visit. The study is designed to determine the clinical efficacy of an investigational product (IP), TOL-463 Insert, in suppressing Recurrent Bacterial Vaginosis (RBV) when administered to women who have a history of RBV and have been successfully cleared of their current Bacterial Vaginosis (BV) infection administering 500 mg of oral metronidazole, twice a day for 7 days or another CDC-recommended BV treatment. Patient participation will be approximately 100 days while the study is conducted at 4 sites within the United States. The primary objective of the study is to evaluate the clinical efficacy of a twice-weekly application of TOL-463 vaginal insert in suppression of BV in women with a history of RBV following successful induction with oral metronidazole or a CDC-recommended BV treatment. Type: Interventional Start Date: Sep 2019 |
Daughters, dUdes, Mothers and othErs Fighting Cancer Together
University of Alabama at Birmingham
Cancer
Overweight and Obesity
The purpose of this protocol is to conduct a 2-arm, single-blinded randomized controlled
clinical trial (RCT) in which 56 dyads (defined as consisting of an overweight or obese
cancer survivor of an obesity-related cancer and an overweight or obese "buddy" of his or her
choosing)... expand
The purpose of this protocol is to conduct a 2-arm, single-blinded randomized controlled clinical trial (RCT) in which 56 dyads (defined as consisting of an overweight or obese cancer survivor of an obesity-related cancer and an overweight or obese "buddy" of his or her choosing) would be assigned either to a 6-month, diet- and exercise-based weight loss intervention delivered via an interactive website with tailored text messages, or to a 6-month wait-listed control group. The overall goals of the eHealth intervention are to reduce obesity and select circulating biomarkers (tumor necrosis factor alpha [TNFα], insulin, and insulin-like growth factor-1 [IGF-1]), as well as improve diet quality, physical activity, health-related quality of life (QoL), physical functioning and performance as compared to the control over the 6-month study period. Type: Interventional Start Date: May 2020 |
Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations
University of Alabama at Birmingham
Cystic Fibrosis
Based on previous clinical findings, the investigator hypothesize that ivacaftor will have
synergistic effects with drugs that facilitate truncated but partially active W1282X CFTR
protein processing (tezacaftor) in patients with W1282X CFTR. In the current study, the
investigators... expand
Based on previous clinical findings, the investigator hypothesize that ivacaftor will have synergistic effects with drugs that facilitate truncated but partially active W1282X CFTR protein processing (tezacaftor) in patients with W1282X CFTR. In the current study, the investigators propose to directly test the efficacy of tezacaftor/ivacaftor (TEZ/IVA) for W1282X CFTR therapy in the clinic in comparison to ivacaftor alone. Type: Interventional Start Date: Dec 2018 |