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Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
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Women and Infants Hospital of Rhode Island
Urgency Urinary Incontinence
The goal of this clinical trial is to compare treatment outcomes between an oral
medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency
urinary incontinence (UUI).
Participants will be randomly selected to receive one of the two treatments. The primary
outcome measure1 expand
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months. Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity. The study will also have a long-term follow-up component (prospective cohort) including 346 participants from the parent trial to describe treatment continuation, treatment efficacy, patient direct costs and other secondary outcomes up to 5 years after treatment. Type: Interventional Start Date: Jun 2023 |
AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis
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University of Alabama at Birmingham
Spinal Cord Injuries
Multiple Sclerosis
Transverse Myelitis
Amyotrophic Lateral Sclerosis
The UAB Institute for Arts In Medicine (AIM) is currently implementing an expressive
emotional writing pilot project for adults with paralysis caused by neurological
conditions such as traumatic head or spinal cord injury. expand
The UAB Institute for Arts In Medicine (AIM) is currently implementing an expressive emotional writing pilot project for adults with paralysis caused by neurological conditions such as traumatic head or spinal cord injury. Type: Observational Start Date: Sep 2020 |
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve1
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Biogen
Lupus Erythematosus, Systemic
In this study, researchers will learn more about a study drug called litifilimab
(BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus
on participants who have active disease and are already taking standard of care
medications. These may include antimalarials, ster1 expand
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: - After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. - All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. - Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - There will be a follow-up safety period that lasts up to 24 weeks. - In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks. Type: Interventional Start Date: Jul 2021 |
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
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University of Alabama at Birmingham
Stroke
Cognitive Dysfunction
This study will compare two approaches to cognitive rehabilitation in adults with stroke
with persistent, mild to moderate, cognitive impairment. Both approaches will feature a
web-based computer "game" that trains cognitive processing speed, i.e., how quickly
individuals process information that t1 expand
This study will compare two approaches to cognitive rehabilitation in adults with stroke with persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based computer "game" that trains cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. This training is termed Speed of Processing Training (SOPT). One approach will add (A) in-lab training on everyday activities with important cognitive components and (B) procedures designed to transfer improvements in cognition from the treatment setting to everyday life. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will add (A) in-lab training on relaxation, healthy nutrition, and healthy sleep and (B) procedures designed to promote integration of these lifestyle changes into everyday life. This approach is termed Brain Fitness-Heath Education Lifestyle Program (BF-HELP). Both CICT and BF-HELP will involve 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life; The set of the latter procedures is termed the Transfer Package. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. Family caregivers in both groups will also receive training on how to best support participants in their therapeutic program. The study will also test if there is an advantage to placing follow-up phone calls after treatment ends. The purpose of the calls will be to support transition of any behavioral changes achieved during treatment into everyday life on a long-term basis. Participants will be randomly assigned to the interventions. Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. Type: Interventional Start Date: Jun 2022 |
Optimizing an Extended Care Intervention to Promote Weight Loss Maintenance
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University of Alabama at Birmingham
Obesity Prevention
Weight Change
Weight Loss
Weight Loss Maintenance
The purpose of this study is to find out what combination of components, if any, offers
the best support for keeping weight off after someone loses weight. Long term weight loss
maintenance is a challenge for many people who lose weight. There are many strategies, or
components, people may use to a1 expand
The purpose of this study is to find out what combination of components, if any, offers the best support for keeping weight off after someone loses weight. Long term weight loss maintenance is a challenge for many people who lose weight. There are many strategies, or components, people may use to avoid regain, but investigators do not know if there is a best, or optimal, combination of such components that can be done without adding a lot of cost or other burdens for people. - The primary goal of this clinical trial is to identify the optimal package that maximizes weight loss maintenance. - The study also wants to understand the reasons why these components may work and if certain components help specific sub-groups of people. Participants will engage in a 16-week Phase 1 Weight Loss Program. Participants who lose 5% or more of their weight during that program will continue to Phase 2 Extended Care and be randomly assigned to 0, 1, 2, 3, or all of four methods of weight loss maintenance. They will use their assigned package for 12 months. Researchers will compare 16 different possible combinations of components and learn which of the 16 packages offers the best support for keeping weight off. The four components participants could be assigned to in Phase 2 are: 1. Reduced Food Variety: Limiting the variety of foods participants eat by having them choose a few high-calorie, low nutrient foods to eat regularly 2. Home-based Resistance Training: Engaging in exercises that build strength from the comfort of the participant's own home 3. Buddy Training and Support: Having a friend or "buddy" get trained to support the participant 4. Acceptance and Commitment (ACT) Workshops: Having participants learn skills to handle tough thoughts and feelings about weight control in a healthy way Participants will have their weight measured and complete surveys 4 times if they complete both Phase 1 and Phase 2. During Phase 1, participants will attend weekly group sessions and be in touch with a study staff member investigators call a Wellness Coach. During Phase 2, participants will stay in touch with their Wellness Coach, use their assigned package, and answer questions about their experience periodically. Type: Interventional Start Date: May 2025 |
T1D Pregnancy & Me
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Jaeb Center for Health Research
Diabetes Mellitus, Type 1
Pregnancy in Diabetics
Pregnancy, High-Risk
Insulin Dependent Diabetes
T1D Pregnancy & Me will partner with pregnant participants living with type 1 diabetes
(T1D) in the United States to collect real-world data on management of T1D in pregnancy.
This is a remote study where participants can complete online surveys and share device
data (continuous glucose monitor (CG1 expand
T1D Pregnancy & Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes. Type: Observational Start Date: Apr 2025 |
Doxycycline for Emphysema in People Living With HIV (The DEPTH Trial)
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Weill Medical College of Cornell University
Emphysema
HIV
The purpose of this study is to determine if doxycycline will reduce progression of
emphysema in people living with HIV.
The secondary objectives are to examine the effects of doxycycline on change in quantity
of emphysema, six minute walk distance, patient reported outcomes, ratio of forced
expir1 expand
The purpose of this study is to determine if doxycycline will reduce progression of emphysema in people living with HIV. The secondary objectives are to examine the effects of doxycycline on change in quantity of emphysema, six minute walk distance, patient reported outcomes, ratio of forced expiratory volume in 1 second and forced vital capacity. Secondary objectives will also describe the safety and tolerability of doxycycline and determine if doxycycline is associated with development of antibiotic-resistant bacterial infections. Type: Interventional Start Date: Aug 2022 |
Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
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Duke University
Cognitive Impairment, Mild
Dementia
Cardiovascular Diseases
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority
study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large
study conducted in community-dwelling older adults without cardiovascular disease (CVD)
or dementia will demonstrate the1 expand
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events. Type: Interventional Start Date: Sep 2020 |
PRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis
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University of Alabama at Birmingham
Obesity
Cardiovascular Diseases
Hypertension
Nocturnal Blood Pressure
Natriuretic Peptides
Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping
blood pressure (BP). These conditions are associated with an increased risk of
cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by
the heart which directly regulate BP by causi1 expand
Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping blood pressure (BP). These conditions are associated with an increased risk of cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by the heart which directly regulate BP by causing dilation of blood vessels and by removing sodium and water from the body. NPs have a 24-hour day-night rhythm and this controls the day-night rhythm of BP as well. The NP-BP rhythm relationship is broken down in obese individuals. Obese individuals also have lower circulating NP levels. Lower circulating levels of NPs and elevated renin hormone (a part of the Renin-Angiotensin-Aldosterone System [RAAS]) at nighttime may contribute to the high nocturnal blood pressure in obese individuals which puts them at a higher risk of developing CV events. This current study seeks to determine the biological implications of chronopharmacology for synchronizing NP-RAAS-based blood pressure therapy with the physiological diurnal rhythms to restore the normal diurnal rhythm of blood pressure in obese individuals. Type: Interventional Start Date: Feb 2022 |
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
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Joseph Broderick, MD
Intracerebral Hemorrhage
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time
(FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral
hemorrhage (ICH) within a time window and subgroup of patients that is most likely to
benefit. The central hypothesis is tha1 expand
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. Type: Interventional Start Date: Dec 2021 |
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major1
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Janssen Research & Development, LLC
Depressive Disorder, Major
The purpose of this study is to know how well seltorexant works, and also to evaluate
safety and maintenance effect of seltorexant compared with placebo as an adjunctive
therapy to an antidepressant in improving depressive symptoms in participants with major
depressive disorder with insomnia sympto1 expand
The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) 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: Jul 2024 |
Development of an Inclusive Adaptive Treatment Strategy for Weight Loss in People With Prediabetes1
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University of Alabama at Birmingham
Disabilities
Obesity and Overweight
Prediabetes
This is a sub-study to NCT04745572 to include a new cohort of participants with
disabilities. This 16-week study will use an experimental approach called the Sequential
Multiple Assignment Randomized Trial to help determine which combination and sequence of
weight loss program features are most eff1 expand
This is a sub-study to NCT04745572 to include a new cohort of participants with disabilities. This 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. After 4 weeks, participants will be identified as Responders (greater than or equal to 2.5% weight loss) or Non-Responders (less than 2.5% weight loss). Responders will continue with their initial randomized group for the remainder of the trial. Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial. Type: Interventional Start Date: Jan 2026 |
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
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University of Alabama at Birmingham
Diabetes Mellitus
Cardiovascular Diseases
Insulin Sensitivity/Resistance
Metabolic Disease
Natriuretic Peptides
Black individuals are more likely to have decreased insulin sensitivity which results in
a high risk for the development of cardiometabolic disease. The reasons for this are
incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart
that play a role in regulating the met1 expand
Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease. The reasons for this are incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart that play a role in regulating the metabolic health of an individual. Low circulating level of NPs is an important contributor to increased risk for diabetes. The NP levels are relatively lower among Black individuals thus affecting their metabolic health and putting them at a higher risk for diabetes. This study aims to test the hypothesis that by augmenting NP levels using sacubitril/valsartan, among Black Individuals one can improve their metabolic health (as measured by insulin sensitivity & energy expenditure) and help establish the role of NPs in the underlying mechanism behind increased risk for cardiometabolic disease in these population. Type: Interventional Start Date: Aug 2020 |
American Lung Association (ALA) Lung Health Cohort
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Johns Hopkins University
Lung Diseases
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately
4,000 young adults between the ages of 25-35 who do not have severe lung disease. The
overarching objective of the ALA-LHC is to establish a national cohort of young adults
for the purpose of defining lung healt1 expand
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages. Type: Observational Start Date: Oct 2021 |
Accessible and Inclusive Diabetes Telecoaching Self-Management Program
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University of Alabama at Birmingham
Diabete Type 2
Disability Physical
The purpose of this study is to develop and pilot test an accessible and inclusive
Artificial Intelligence (AI)-assisted, individualized, family-focused lifestyle
modification intervention (AI4DM) for glycemic control in people with disabilities. expand
The purpose of this study is to develop and pilot test an accessible and inclusive Artificial Intelligence (AI)-assisted, individualized, family-focused lifestyle modification intervention (AI4DM) for glycemic control in people with disabilities. Type: Interventional Start Date: Oct 2022 |
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
Boehringer Ingelheim
Pyoderma Gangrenosum
The purpose of this study is to find out whether a medicine called spesolimab helps
people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to
closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1
ulcer that measures between 5 cm^2 to 81 expand
The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm^2 to 80 cm^2 in size. This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth. In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab. In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks. Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works. Type: Interventional Start Date: Feb 2025 |
GATE-251 or Placebo for the Reduction of Symptoms of Major Depressive Disorder
Syndeio Biosciences, Inc
Major Depressive Disorder
The goal of this clinical trial is to learn if GATE-251 works to treat depression in
adults. It will also learn about the safety of GATE-251. The main questions it aims to
answer are:
Does GATE-251 reduce depression scores in participants compared to participants who take
a placebo (a look-alike t1 expand
The goal of this clinical trial is to learn if GATE-251 works to treat depression in adults. It will also learn about the safety of GATE-251. The main questions it aims to answer are: Does GATE-251 reduce depression scores in participants compared to participants who take a placebo (a look-alike tablet that contains no GATE-251)? What medical problems are observed in participants who take GATE-251? Participants will take one tablet of GATE-251 or placebo every week for 6 weeks. Participants will visit the clinic every week of the 6 week period to have the severity of their depression evaluated. Type: Interventional Start Date: Feb 2025 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fib1
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease1
Takeda
Alpha1-Antitrypsin Deficiency
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis)
compared to placebo. Other aims are to learn if fazirsiran slows down the disease
worsening in the liver, to get information on how fazirsiran affects the body (called
pharmacodynamics), to learn if fazirsiran re1 expand
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study. Type: Interventional Start Date: Mar 2023 |
Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive End1
National Cancer Institute (NCI)
Endometrial Carcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Dedifferentiated Carcinoma
Endometrial Endometrioid Adenocarcinoma
Endometrial Mixed Cell Adenocarcinoma
This phase III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin
Hylecta [TM]) or pertuzumab, trastuzumab and hyaluronidase-zzxf (Phesgo [TM]) to the
usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with
HER2 positive endometrial cancer. Tras1 expand
This phase III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin Hylecta [TM]) or pertuzumab, trastuzumab and hyaluronidase-zzxf (Phesgo [TM]) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial cancer. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial cancer. Type: Interventional Start Date: Nov 2022 |
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Se1
Medtronic Cardiovascular
Mitral Valve Regurgitation
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All
subjects enrolled with receive the study device. expand
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Type: Interventional Start Date: Oct 2017 |
A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA F1
National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1-infection
This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and
DV701B1.1-RNA. This means it is the first time these study products are being tested in
people.
The purpose of this study is to see if the study products are safe, if people are able to
take them without becoming too un1 expand
This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Forty-five volunteers without HIV and in overall good health, aged 18 to 55 years, will be enrolled and be in this study for about 16 months (about 12 visits), Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes. Type: Interventional Start Date: Aug 2025 |
Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non1
Alliance for Clinical Trials in Oncology
Resectable Lung Non-Small Cell Carcinoma
Stage II Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
This phase III trial compares standard therapy given after surgery (adjuvant) to standard
therapy given before and after surgery (perioperative) in treating patients with stage
II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable).
The usual approach for patients wi1 expand
This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, 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 . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC. Type: Interventional Start Date: Dec 2024 |
A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease
Bristol-Myers Squibb
Anemia, Sickle Cell
Healthy Volunteers
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics
and pharmacodynamics, pH and food effect, and preliminary efficacy of BMS-986470 in
healthy volunteers and participants with sickle cell disease. expand
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, pH and food effect, and preliminary efficacy of BMS-986470 in healthy volunteers and participants with sickle cell disease. Type: Interventional Start Date: Jul 2024 |
ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation1
Mannkind Corporation
MAC Lung Disease
Treatment Refractory MAC Lung Disease
Mycobacterium Infections, Nontuberculous
This clinical trial is designed to compare the efficacy and safety of Clofazimine
Inhalation Suspension versus placebo when added to guideline-based therapy (GBT) expand
This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT) Type: Interventional Start Date: Sep 2024 |