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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 |
Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced...
University of Alabama at Birmingham
HER2-positive Breast Cancer
The purpose of the study is to see if a new group of imaging tests can help identify
response to stage IV HER2+ breast cancer before treatment. expand
The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment. Type: Interventional Start Date: Mar 2025 |
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 propose to directly... 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) and Trikafta for W1282X CFTR therapy in the clinic in comparison to ivacaftor alone. Type: Interventional Start Date: Dec 2018 |
Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent...
Regeneron Pharmaceuticals
Recurrent Ovarian Cancer
Recurrent Fallopian Tube Cancer
Recurrent Primary Peritoneal Cancer
Recurrent Endometrial Cancer
The main purpose of this study is to:
- Learn about the safety of REGN4018 and to find out what dose of REGN4018 can be
given alone or with cemiplimab to patients with ovarian cancer or cancer of the
uterus
- The study will also look at the levels of REGN4018 and/or cemiplimab... expand
The main purpose of this study is to: - Learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus - The study will also look at the levels of REGN4018 and/or cemiplimab in your body and measure how well your body can remove the study drug(s). This is called pharmacokinetics - The study will also look at any signs that REGN4018 alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus - To find out how safe and tolerable the sarilumab pretreatment is, in combination with REGN4018 and cemiplimab Type: Interventional Start Date: May 2018 |
Rapid HCV Treatment Access for Persons Who Use Drugs
Johns Hopkins University
Hepatitis C Virus Infection, Response to Therapy of
This study is being done to compare two strategies to deliver HCV treatment to persons
with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient
opioid treatment program (OTP). Participants will be randomized into one of two treatment
groups:
1. Test and treat plus... expand
This study is being done to compare two strategies to deliver HCV treatment to persons with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient opioid treatment program (OTP). Participants will be randomized into one of two treatment groups: 1. Test and treat plus peer-mentors: This treatment group will be offered 8 weeks of glecaprevir/pibrentasvir (an FDA approved HCV treatment) within days of HCV diagnosis at the OTP. Participants in this group will receive treatment adherence support from a peer-mentor who is someone who has been cured of HCV infection. 2. Standard of care HCV treatment referral: This treatment group will be referred to an offsite HCV treatment location. This is the usual care for anyone who tests positive for HCV at the OTP who is not participating in this study. Type: Interventional Start Date: Aug 2021 |
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
Ascentage Pharma Group Inc.
Leukemia, Myeloid, Chronic
Myeloid Leukemia
Chronic Myeloid Leukemia
Philadelphia Positive Acute Lymphoblastic Leukemia
B Cell Precursor Type Acute Leukemia
A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics
(PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in
subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with
Ph+ ALL, who have experienced resistance... expand
A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI. Type: Interventional Start Date: Jan 2020 |
Early Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell Transplantation
Emory University
Sickle Cell Disease
This study aims to enroll 58 pre-adolescent (<13 years) pediatric participants with
sickle cell disease (SCD) who have a pre-adolescent sibling bone marrow donor. All
participants will go through a pre-transplant evaluation to find out if there are health
problems that will keep them from being able... expand
This study aims to enroll 58 pre-adolescent (<13 years) pediatric participants with sickle cell disease (SCD) who have a pre-adolescent sibling bone marrow donor. All participants will go through a pre-transplant evaluation to find out if there are health problems that will keep them from being able to receive the transplant. It usually takes 2 to 3 months to complete the pre-transplant evaluation and make the arrangements for the transplant. Once they are found to be eligible for transplant, participants will be admitted to the hospital and will start transplant conditioning. Conditioning is the chemotherapy and other medicines given to prepare them to receive donor cells. It prevents the immune system from rejecting donor cells. Conditioning will start 21 days before transplant. Once they complete conditioning, participants will receive the bone marrow transplant. After the transplant, participants will stay in the hospital for 4-6 weeks. After they leave the hospital, participants will be followed closely in the clinic. Outpatient treatment and frequent clinic visits usually last 6 to 12 months. Routine medical care includes at least a yearly examination for many years after transplant by doctors and nurses familiar with sickle cell disease and transplant. The researchers will collect and study information about participants for 2 years after transplant. Type: Interventional Start Date: Mar 2019 |
South-seq: Deoxyribonucleic Acid (DNA) Sequencing for Newborn Nurseries in the South
University of Alabama at Birmingham
Whole Genome Sequencing
2,000 infants with signs suggestive of a genetic disorder being treated at a neonatal
intensive care unit (NICU) in which African-American and rural populations are highly
represented will be enrolled. Whole genome sequencing (WGS) will be used to identify
pathogenic variation in DNA from these infants.... expand
2,000 infants with signs suggestive of a genetic disorder being treated at a neonatal intensive care unit (NICU) in which African-American and rural populations are highly represented will be enrolled. Whole genome sequencing (WGS) will be used to identify pathogenic variation in DNA from these infants. Stakeholders, including parents, clinicians, and community leaders, will be engaged to develop culturally adapted educational materials and to equip non-genetics providers to return WGS results. Parents will be provided with these materials through a web portal, the Genome Gateway, and will be placed into one of two arms of a randomized trial to compare the effectiveness technology-assisted WGS result delivery by non-genetics providers relative to result delivery from genetic counselors. Type: Interventional Start Date: Apr 2019 |
PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium...
Beth Israel Deaconess Medical Center
Delirium in Old Age
Delirium
Coronary Artery Disease
Our objective is to find an effective prophylactic intervention by evaluating IV
acetaminophen's impact in reducing the frequency of postoperative delirium, one of the
most common and detrimental complications of cardiac surgery in older adults. expand
Our objective is to find an effective prophylactic intervention by evaluating IV acetaminophen's impact in reducing the frequency of postoperative delirium, one of the most common and detrimental complications of cardiac surgery in older adults. Type: Interventional Start Date: Aug 2020 |
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or...
Alliance for Clinical Trials in Oncology
Advanced Esophageal Adenocarcinoma
Advanced Gastric Adenocarcinoma
Advanced Gastroesophageal Junction Adenocarcinoma
Clinical Stage III Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Gastric Cancer AJCC v8
This phase III trial compares the effect of modified fluorouracil, leucovorin calcium,
oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium,
and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2
negative esophageal, gastroesophageal... expand
This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers. Type: Interventional Start Date: Jan 2023 |
KRT-232 in Combination With TL-895 for the Treatment of R/R MF and KRT-232 for the Treatment of JAKi...
Kartos Therapeutics, Inc.
Myelofibrosis
Post-PV MF
Post-ET Myelofibrosis
Primary Myelofibrosis
This study evaluates KRT-232 in Combination With TL-895 for the Treatment of Relapsed or
Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant
Myelofibrosis. expand
This study evaluates KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis. Type: Interventional Start Date: Nov 2020 |
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
Sanofi
Multiple Sclerosis
The purpose of each study is to independently measure the annualized relapse rate (ARR)
with administration of frexalimab compared to a daily oral dose of teriflunomide in male
and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years
at the time of enrollment). People... expand
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized. - The study intervention duration will vary ranging from approximately 12 to 40 months. - The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months. Type: Interventional Start Date: Dec 2023 |
A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)
Incyte Corporation
NonSegmental Vitiligo
This study is being conducted to determine the efficacy and safety of povorcitinib in
participants with nonsegmental vitiligo. expand
This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo. Type: Interventional Start Date: Nov 2023 |
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary...
Pliant Therapeutics, Inc.
Idiopathic Pulmonary Fibrosis
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the
efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary
fibrosis (BEACON-IPF). expand
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF). Type: Interventional Start Date: Nov 2023 |
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in...
Genentech, Inc.
Locally Advanced Solid Tumors
Recurrent Solid Tumors
Metastatic Solid Tumors
This is a first-in-human Phase I, open-label, dose-escalation and expansion study
designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity,
pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and
in combination with atezolizumab in participants... expand
This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion. Type: Interventional Start Date: Nov 2023 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive...
Bristol-Myers Squibb
Progressive Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986278 in Participants with Progressive Pulmonary Fibrosis. expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. Type: Interventional Start Date: Oct 2023 |
A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
Pfizer
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
The purpose of this study is to learn about the effects, safety and how PF-06823859 is
processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus
erythematosus (SLE) showing some skin symptoms.
This study is seeking for participants who:
- are adults of 18 years of age... expand
The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms. This study is seeking for participants who: - are adults of 18 years of age or older. - are confirmed to have CLE or SLE with involvement of the skin. - have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score of at least 8. About 48 participants will be selected to receive active study medicine (PF-06823859) or placebo (an infusion without drug). About 32 are grouped to receive the active study medicine and 16 are to receive placebo. They will be receiving the treatments by intravenous infusion (injected directly into the veins). At week 16 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication. Patients who have received placebo since Day 1 and who have had a clinical response will continue to receive placebo till week 40. All participants will have last follow-up visit at Week 60. The study will compare participants receiving PF-06823859 to participants who receive placebo. This will help us see if PF-06823859 is safe and effective to treat CLE or SLE with skin symptoms and improve participant's CLASI-A score. Participants will take part in this study for about 65 weeks. This includes up to a 5-week selection period, a 12-week Q4Wk treatment period, a 36-week Q8Wk treatment period, and a 12-week follow-up period. Type: Interventional Start Date: Jul 2023 |
A Study to Evaluate the Efficacy and Safety of RO7434656 in Participants With Primary Immunoglobulin...
Hoffmann-La Roche
Primary IgA Nephropathy
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of
RO7434656, a novel Antisense Oligonucleotide (ASO) therapy in participants with primary
IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite
optimized supportive care. expand
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of RO7434656, a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care. Type: Interventional Start Date: Aug 2023 |
A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis...
Genentech, Inc.
Idiopathic Pulmonary Fibrosis
Systemic Sclerosis With Lung Involvement
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with
placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in
participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Participants who complete 52-weeks of... expand
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Type: Interventional Start Date: May 2023 |
Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer
Gilead Sciences
Advanced Non-Small Cell Lung Cancer
The purpose of this study is to assess the objective response rate (ORR) of
immunotherapy-based combination therapy and to assess the safety and tolerability of
immunotherapy-based combination therapy. expand
The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy. Type: Interventional Start Date: Feb 2023 |
A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With Moderate-to-severe...
Janssen Research & Development, LLC
Depressive Disorder, Major
Anhedonia
The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo
as adjunctive therapy to an antidepressant in improving depressive symptoms in adult
participants with major depressive disorder (MDD) with moderate to severe anhedonia
(ANH+) who have had an inadequate response... expand
The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). Type: Interventional Start Date: Dec 2022 |
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Janssen Research & Development, LLC
Depressive Disorder, Major
The purpose of this study is to assess the long-term safety and tolerability of
aticaprant administered as adjunctive therapy to a current antidepressant (selective
serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor
[SNRI]) in all participants with major depressive... expand
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD). Type: Interventional Start Date: Sep 2022 |
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