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ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)
ProDa BioTech, LLC
Pancreatic Ductal Carcinoma
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the
safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine and
nab paclitaxel (G-nP) in previously untreated subjects with metastatic pancreatic ductal
adenocarcinoma (PDAC) expand
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic pancreatic ductal adenocarcinoma (PDAC) Type: Interventional Start Date: Sep 2023 |
Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation
University of Alabama at Birmingham
Parathyroid Dysfunction
Adenoma
The aim of this study is to determine if fluorescence with or without indocyanine green
can facilitate safe and accurate thyroid and parathyroid surgery. expand
The aim of this study is to determine if fluorescence with or without indocyanine green can facilitate safe and accurate thyroid and parathyroid surgery. Type: Interventional Start Date: Apr 2024 |
Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi)
University of Alabama at Birmingham
Kidney Diseases
Cardiometabolic Risk Factors
We seek to explore the feasibility and acceptability of participation in a
decision-support training program led by lay navigators. ImPart-Multi, an
education-telehealth-based, is designed to empower Black chronic kidney disease patients
(CKD) patients and their care partner to seek the resources... expand
We seek to explore the feasibility and acceptability of participation in a decision-support training program led by lay navigators. ImPart-Multi, an education-telehealth-based, is designed to empower Black chronic kidney disease patients (CKD) patients and their care partner to seek the resources and support needed to be activated allies when making health-related decisions. Participants, based on random assignment, will participate in survey completion at study start and at 12 and 24 weeks of enrollment, and will complete 1, 3, or 4 education sessions via telehealth or audio connection. Participants will also complete an interview to share their thoughts on the program and other factors of interest. Type: Interventional Start Date: Mar 2024 |
Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)
University of Texas Southwestern Medical Center
Cocaine Use Disorder
This is an 8-week, double-blind, randomized placebo-controlled trial of the efficacy of a
combination of extended-release naltrexone (XR-NTX) and extended-release buprenorphine
(XR-BUP) compared to matched placebo injections (PBO-Inj) for the treatment of cocaine
use disorder (CUD). expand
This is an 8-week, double-blind, randomized placebo-controlled trial of the efficacy of a combination of extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-BUP) compared to matched placebo injections (PBO-Inj) for the treatment of cocaine use disorder (CUD). Type: Interventional Start Date: Apr 2023 |
Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI
University of Alabama at Birmingham
HER2-positive Breast Cancer
The purpose of the study is to see if using an investigational drug called [18F]FMISO
with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin)
on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This
study is for imaging purposes only and... expand
The purpose of the study is to see if using an investigational drug called [18F]FMISO with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future. Type: Interventional Start Date: Apr 2025 |
Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression
Eyenovia Inc.
Myopia
This study evaluates the progression of myopia in participants using microdosed atropine
0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer
study medication daily in each eye for 48 months. Efficacy and safety assessments will be
performed at visits scheduled for... expand
This study evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months. Efficacy and safety assessments will be performed at visits scheduled for 1, 6, 12, 18, 24, 30 and 36 months after initiation of medication use. Subjects will be re-randomized at the 36 month visit, then followed at 6 month intervals for an additional year. Type: Interventional Start Date: Jun 2019 |
Cognitive Training Intervention and Attitudes Towards Genetics
University of Alabama at Birmingham
Cognitive Impairment
Hematologic Neoplasms
Hematopoietic Cell Transplant
A pilot study to evaluate feasibility of enrollment of patients in an intervention to
improve neurocognitive function in hematopoietic cell transplantation (HCT) survivors
using the cognitive training Lumosity program. In addition, patients' interest in
receiving information regarding genetic risk... expand
A pilot study to evaluate feasibility of enrollment of patients in an intervention to improve neurocognitive function in hematopoietic cell transplantation (HCT) survivors using the cognitive training Lumosity program. In addition, patients' interest in receiving information regarding genetic risk of cognitive impairment post-HCT will be measured. Type: Interventional Start Date: Aug 2017 |
Retraining and Control Therapy (ReACT) R33 Phase
University of Alabama at Birmingham
Convulsion, Non-Epileptic
The purpose of this study is to assess sense of control and catastrophic symptom
expectations as targets for Retraining and Control Therapy (ReACT- an intervention
focused on changing behaviors and thoughts) for treatment of pediatric psychogenic
non-epileptic seizures (PNES, episodes resembling epileptic... expand
The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of either ReACT or supportive therapy. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment, 7 days after 12th treatment session, and 2 months after the 12th treatment session. Long term follow-up assessments will occur 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment. Type: Interventional Start Date: Mar 2024 |
Cold Agglutinin Disease Real World Evidence Registry
Sanofi
Cold Agglutinin Disease (CAD)
Cold Agglutinin Syndrome (CAS)
This is a multinational, multi-center, observational, prospective, longitudinal disease
registry designed to collect data on participants with cold agglutinin disease (CAD) or
cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated
with sutimlimab are expected to take... expand
This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 [NCT02502903,CAD patients], BIVV009-03/EFC16215 [NCT03347396], and BIVV009-04/EFC16216 [NCT03347422]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry. Type: Observational [Patient Registry] Start Date: Dec 2019 |
Functional Outcomes From Diets in Multiple Sclerosis
University of Alabama at Birmingham
Relapsing Remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
The purpose of this study is to test the effects of two dietary interventions, glycemic
load and calorie restriction, on physical function, cognition, pain, fatigue, mood, and
anxiety in adults with multiple sclerosis (MS). The investigators will also explore the
how the diet interventions impact... expand
The purpose of this study is to test the effects of two dietary interventions, glycemic load and calorie restriction, on physical function, cognition, pain, fatigue, mood, and anxiety in adults with multiple sclerosis (MS). The investigators will also explore the how the diet interventions impact inflammation, immunity, and metabolic biomarkers. Type: Interventional Start Date: Mar 2023 |
Neurophysiological Mechanisms of Language Comprehension
University of Alabama at Birmingham
Language Disorders
First, in a recording-only self-paced reading experiment, patients with epilepsy
undergoing intracranial monitoring for clinical purposes will read or listen to sentences
presented to them one word at time while the investigators simultaneously record neural
activity through intracranial electrodes... expand
First, in a recording-only self-paced reading experiment, patients with epilepsy undergoing intracranial monitoring for clinical purposes will read or listen to sentences presented to them one word at time while the investigators simultaneously record neural activity through intracranial electrodes that are implanted for clinical purposes (see subject populations). At the end of the sentence, the subjects have to indicate how they comprehended the sentence by selecting which of several pictures matches the sentence they just read. Behavioral measures that the investigators record and analyze are their response times to advance to each next word in the sentence, and which picture they chose for each sentence. These behavioral measures are compared against the neural activity simultaneously recorded as they are made. Then, in a later session, the same participants will participate in a task-related stimulation experiment. This follows the exact same design as the recording-only reading experiment, the only difference is that on some trials, at controlled moments during the sentence presentation intracranial electrical stimulation is delivered through adjacent intracranial electrode contacts. The investigators will examine the effect of this stimulation on the subjects comprehension of the sentences measured by their behavior, and on the simultaneously recorded neural activity. Type: Interventional Start Date: Apr 2022 |
The Arteriovenous Vascular (AV) ACCESS Trial
Wake Forest University Health Sciences
End-Stage Kidney Disease
Hemodialysis Complication
This study is to prospectively compare the effectiveness and safety of the two types of
arteriovenous access placement (fistula or graft) in older adults with end stage kidney
disease and multiple chronic conditions expand
This study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions Type: Interventional Start Date: Aug 2022 |
A Phase II Trial of Poly-ICLC for Low-Grade Gliomas
University of Alabama at Birmingham
NF1
Low-grade Glioma
This is a phase II, prospective, longitudinal, multi-center trial of poly-ICLC (Hiltonol
®) treatment for progressive low-grade gliomas in pediatric patients with NF1. The
primary objective is to evaluate the efficacy of poly-ICLC in pediatric NF1 patients with
progressive low-grade glioma (LGG) as... expand
This is a phase II, prospective, longitudinal, multi-center trial of poly-ICLC (Hiltonol ®) treatment for progressive low-grade gliomas in pediatric patients with NF1. The primary objective is to evaluate the efficacy of poly-ICLC in pediatric NF1 patients with progressive low-grade glioma (LGG) as measured by objective tumor response rate (CR+PR) within the first 48 weeks (12 cycles) of therapy. There will also be secondary and exploratory objectives listed in the detailed description below. Type: Interventional Start Date: Dec 2021 |
Pulmonary Function Using Non-invasive Forced Oscillometry
University of Alabama at Birmingham
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bronchopulmonary Dysplasia
Respiratory Distress Syndrome, Newborn
Meconium Aspiration Syndrome
The purpose of this observational study is to measure pulmonary function in term and
preterm infants with and without pulmonary disease including respiratory distress
syndrome, bronchopulmonary dysplasia, transient tachypnea of the newborn, meconium
aspiration syndrome, and response to treatments... expand
The purpose of this observational study is to measure pulmonary function in term and preterm infants with and without pulmonary disease including respiratory distress syndrome, bronchopulmonary dysplasia, transient tachypnea of the newborn, meconium aspiration syndrome, and response to treatments given to newborn infants with lung diseases using a non-invasive airway oscillometry system. Type: Interventional Start Date: Dec 2017 |
Longitudinal Study of the Porphyrias
Icahn School of Medicine at Mount Sinai
Acute Porphyrias
Cutaneous Porphyrias
The objective of this protocol is to conduct a longitudinal multidisciplinary
investigation of the human porphyrias including the natural history, morbidity, pregnancy
outcomes, and mortality in people with these disorders. expand
The objective of this protocol is to conduct a longitudinal multidisciplinary investigation of the human porphyrias including the natural history, morbidity, pregnancy outcomes, and mortality in people with these disorders. Type: Observational Start Date: Nov 2010 |
Assessment of Endogenous Oxalate Synthesis
University of Alabama at Birmingham
Healthy
Kidney Stone
Obesity
This study aims to determine the daily rate of endogenous synthesis of oxalate using
carbon 13 oxalate isotope tracer technique and a low-oxalate controlled diet. expand
This study aims to determine the daily rate of endogenous synthesis of oxalate using carbon 13 oxalate isotope tracer technique and a low-oxalate controlled diet. Type: Interventional Start Date: Feb 2022 |
Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary...
University of Alabama at Birmingham
Chronic Obstructive Pulmonary Disease
The purpose of this study is to compare the efficacy and safety of a real time video
telehealth pulmonary rehabilitation intervention with standard of care in patients
hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD) to
determine the impact on hospital readmissions... expand
The purpose of this study is to compare the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD) to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention. Type: Interventional Start Date: Jun 2022 |
Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator...
TopAlliance Biosciences
Advanced Unresectable Solid Tumor
Metastatic Solid Tumor
The primary objective is to assess the safety and tolerability of TAB004 as monotherapy
and in combination with toripalimab in subjects with selected advanced solid
malignancies, including lymphoma, and to evaluate the recommended Phase 2 dose.
The secondary objectives are to: 1) describe the pharmacokinetic... expand
The primary objective is to assess the safety and tolerability of TAB004 as monotherapy and in combination with toripalimab in subjects with selected advanced solid malignancies, including lymphoma, and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of TAB004 monotherapy and in combination with toripalimab and to describe the PK profile of toripalimab when administered with TAB004, 2) evaluate antitumor activity of TAB004 monotherapy and in combination with toripalimab; and 3) determine the immunogenicity of TAB004 monotherapy and in combination with toripalimab and to determine the immunogenicity of toripalimab when administered with TAB004. The exploratory objectives are to: 1) evaluate pharmacodynamic effects of TAB004 on its target receptor BTLA, as well as effects on the immune system; 2) evaluate biomarkers that may correlate with activity of TAB004 as monotherapy and in combination with toripalimab; 3) evaluate the utility of BTLA ligand, herpesvirus-entry mediator (HVEM), and additional exploratory biomarkers that could aid in selection of appropriate subjects for TAB004 monotherapy and in combination with toripalimab. Type: Interventional Start Date: Oct 2019 |
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal...
W.L.Gore & Associates
Thoracoabdominal Aortic Aneurysm
Prospective, non-randomized, , multicenter study with two independent arms:
- Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System.
Hypothesis-driven analysis.
- Up to 65 additional subjects may be implanted in Continued Access Phase under
the... expand
Prospective, non-randomized, , multicenter study with two independent arms: - Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. - Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only - Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm) Type: Interventional Start Date: Jun 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 in both non-obese and... 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 |
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
30,000 participants have now enrolled into... 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 30,000 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 |
Clinical Reporting to Alleviate the Nocebo Effect
University of Alabama at Birmingham
Nocebo Effect
Terminology in radiology reports may cause patients harm by anchoring to or justifying a
particular diagnosis. This phenomenon is known as the nocebo effect. MRI may cause
patients to pursue more invasive procedures with little added benefit. This study aims to
reproduce a study to determine the impact... expand
Terminology in radiology reports may cause patients harm by anchoring to or justifying a particular diagnosis. This phenomenon is known as the nocebo effect. MRI may cause patients to pursue more invasive procedures with little added benefit. This study aims to reproduce a study to determine the impact of clinical reporting on patient care and outcomes for those suffering from lower back pain. Type: Interventional Start Date: Jan 2024 |
Scotoma Perimetry Oculomotor Training
University of Alabama at Birmingham
Macular Degeneration
Central Visual Impairment
The proposed research is relevant to public health because a greater understanding of
plasticity after central vision loss can inform new therapies for treating low vision and
has potential to benefit millions of individuals suffering from low vision. The treatment
of low vision is particularly relevant... expand
The proposed research is relevant to public health because a greater understanding of plasticity after central vision loss can inform new therapies for treating low vision and has potential to benefit millions of individuals suffering from low vision. The treatment of low vision is particularly relevant to the mission of the NEI to support research on visual disorders, mechanisms of visual function and preservation of sight. Declines in vision are particularly common in older adults and thus increasing our understanding of how to cre- ate effective means of improving vision is also highly relevant to the mission of the NIA to support research on aging and the health and well-being of older people. Type: Interventional Start Date: Nov 2022 |
Oxalate Formation From Ascorbic Acid
University of Alabama at Birmingham
Kidney Stone
The purpose of this basic research study is to determine the contribution of endogenous
ascorbic acid (AA) turnover to urinary oxalate excretion in both normal BMI and obese
adult non-stone formers and calcium oxalate stone formers. The studies proposed will use
diets of known nutrient composition,... expand
The purpose of this basic research study is to determine the contribution of endogenous ascorbic acid (AA) turnover to urinary oxalate excretion in both normal BMI and obese adult non-stone formers and calcium oxalate stone formers. The studies proposed will use diets of known nutrient composition, a stable isotope of ascorbic acid (13C6-AA) and mass spectrometric techniques to quantify ascorbic acid turnover to oxalate. Type: Interventional Start Date: Nov 2021 |
Compression Nail for Tibiocalcaneal Arthrodesis
University of Alabama at Birmingham
Subtalar Arthritis
Ankle Arthritis
The purpose of this study is to determine the clinical efficacy of a novel dynamic
compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis expand
The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis Type: Observational Start Date: Nov 2020 |
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