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Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/M1
Faeth Therapeutics
HR+ HER2- Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the
safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant
and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic
breast cancer. expand
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the
safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant
and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic
breast cancer.
Type: Interventional
Start Date: Apr 2026
open study
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OCD LIFU Target Engagement
University of Pennsylvania
Obsessive Compulsive Disorder (OCD)
The investigators will conduct a pilot study to evaluate the safety and feasibility of
low-intensity focused ultrasound on obsessive-compulsive disorder (OCD) symptoms when
delivered to subcortical brain targets. The investigators will use the ATTN201 device to
deliver single sessions of unfocused1 expand
The investigators will conduct a pilot study to evaluate the safety and feasibility of
low-intensity focused ultrasound on obsessive-compulsive disorder (OCD) symptoms when
delivered to subcortical brain targets. The investigators will use the ATTN201 device to
deliver single sessions of unfocused and focused ultrasound to up to three brain targets
over 4 study visits and assess the intervention through self-rated scales of OCD
symptoms.
Type: Interventional
Start Date: Mar 2026
open study
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Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease
University of Alabama at Birmingham
PARKINSON DISEASE (Disorder)
The purpose of this study is to find out whether a type of gentle nerve stimulation,
called transcutaneous auricular Vagus Nerve Stimulation (taVNS), can help improve how the
body regulates heart rate and blood pressure in people with Parkinson's Disease (PD).
Problems with heart rate and blood pre1 expand
The purpose of this study is to find out whether a type of gentle nerve stimulation,
called transcutaneous auricular Vagus Nerve Stimulation (taVNS), can help improve how the
body regulates heart rate and blood pressure in people with Parkinson's Disease (PD).
Problems with heart rate and blood pressure control are common and can make it harder for
people to exercise or do daily activities. By using this non-invasive form of nerve
stimulation and testing how it affects the body's natural responses, this study hopes to
learn if taVNS could be a helpful tool to support physical therapy and improve overall
function.
Type: Interventional
Start Date: Sep 2025
open study
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Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube
Mayo Clinic
Diffuse Alveolar Hemorrhage
Antineutrophil Cytoplasmic Antibody Positive Vasculitis
The purpose of this study is to determine the 72-hour pharmacokinetics of emulsified
avacopan at a dose of 30 mg twice daily given to up to 6 patients with active severe GPA
or MPA with diffuse alveolar hemorrhage (DAH) requiring mechanical ventilation for
respiratory support. expand
The purpose of this study is to determine the 72-hour pharmacokinetics of emulsified
avacopan at a dose of 30 mg twice daily given to up to 6 patients with active severe GPA
or MPA with diffuse alveolar hemorrhage (DAH) requiring mechanical ventilation for
respiratory support.
Type: Interventional
Start Date: May 2026
open study
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Post-Radiation Oral Health in Underserved Head and Neck Cancer Patients
University of California, San Francisco
Head and Neck Cancer
Head and Neck Carcinoma
Head and Neck Neoplasms
This is a pilot study evaluates the feasibility and outcomes of providing fluoride
varnish treatment during routine cancer surveillance visits for post-radiation head and
neck cancer patients with limited access to dental care. expand
This is a pilot study evaluates the feasibility and outcomes of providing fluoride
varnish treatment during routine cancer surveillance visits for post-radiation head and
neck cancer patients with limited access to dental care.
Type: Interventional
Start Date: Oct 2024
open study
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Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy
Jessica Mezzanotte Sharpe
Breast Cancer (Triple Negative Breast Cancer (TNBC))
Renal Cell Carcinoma (Kidney Cancer)
Melanoma (Skin Cancer)
Non-Small Cell Lung Cancer
MSI-H/dMMR Rectal Cancer
Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by
blocking protein interactions that normally prevent the immune system from recognizing
and destroying cancer cells. However, these agents, now approved for over 15 types of
cancers and for both early-stage and meta1 expand
Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by
blocking protein interactions that normally prevent the immune system from recognizing
and destroying cancer cells. However, these agents, now approved for over 15 types of
cancers and for both early-stage and metastatic disease, are capable of causing
inflammation in any organ system of the body that can lead to organ damage, dysfunction,
and even death in rare cases. Some patients may suffer acute and treatable complications
like joint pain, but some may have irreversible complications like hypothyroidism that
requires daily, life-long medication. It is therefore important to fully understand the
different types of damage ICIs can cause to better monitor patients receiving ICI
therapy.
A rising concern from recent reports in the literature is that ICIs may weaken bone and
increase the risk of fractures. In this study, we aim to characterize how ICIs impact the
bone by examining several factors in patients undergoing curative-intent ICI treatment
either alone or in combination with chemotherapy: bone mineral density, bone volume, and
markers of bone turnover in the blood. We will use two imaging techniques to assess bone
mineral density and volume. DXA (dual X-ray absorptiometry) imaging uses low-dose X-rays
to measure how dense (or strong) bones are and is often used to diagnose or assess the
risk of osteoporosis. High-resolution peripheral quantitative computed tomography
(HRpQCT) is a 3D imaging technology that can quantify bone structure and volume and
offers high resolution that can be used to assess bone in smaller bones of the peripheral
skeleton.
We hypothesize that ICI treatment will weaken bones and increase the risk of fractures.
As ICI therapy is relatively new, a rising number of patients may be at risk of fractures
or have low bone density that is not being monitored because there are not guidelines in
place notifying physicians of this potential risk to patients. Our study will provide
important preliminary data that will be the basis for larger studies in the future aiming
to better monitor and potentially treat bone weakening in patients treated with ICIs to
reduce the pain, inconvenience, and complications from fragility fractures.
Type: Interventional
Start Date: Aug 2025
open study
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ALTO-207 in Adults With Treatment-resistant Depression (TRD)
Alto Neuroscience
Treatment-resistant Depression (TRD)
The purpose of this trial is to measure depressive symptoms following treatment with
ALTO-207 compared with placebo in participants with TRD. expand
The purpose of this trial is to measure depressive symptoms following treatment with
ALTO-207 compared with placebo in participants with TRD.
Type: Interventional
Start Date: May 2026
open study
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Does Joint Immobilization Following Revision Total Knee Arthroplasty Improve Range of Motion Follow1
Hospital for Special Surgery, New York
Aseptic Revision Knee Arthroplasty
Stiffness Following Revision Knee Arthroplasty
The goal of this study is to evaluate if knee immobilization for 10 days following
revision total knee arthroplasty (rTKA) improves knee joint range of motion at 3 months
postoperatively compared to standard of care postoperative protocol.
Participants will be assigned to one of two groups.
One g1 expand
The goal of this study is to evaluate if knee immobilization for 10 days following
revision total knee arthroplasty (rTKA) improves knee joint range of motion at 3 months
postoperatively compared to standard of care postoperative protocol.
Participants will be assigned to one of two groups.
One group will wear a knee brace that keeps the knee straight for 10 days after surgery
and will not perform knee range of motion exercises during that time. The other group
will not wear a brace and will follow the standard physical therapy program, including
knee range of motion exercises, starting after surgery.
Type: Interventional
Start Date: Apr 2026
open study
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Suction vs Underwater Seal for HemoPneumoThoraX Trial
Vanderbilt University Medical Center
Hemothorax; Traumatic
Hemopneumothorax; Traumatic
Traumatic pneumothorax and hemothorax are common consequences of chest injury, often
requiring prompt tube thoracostomy to re-expand the lung and drain accumulated blood or
air. Current practice varies widely regarding whether chest tubes should initially be
placed to suction or to water seal, and1 expand
Traumatic pneumothorax and hemothorax are common consequences of chest injury, often
requiring prompt tube thoracostomy to re-expand the lung and drain accumulated blood or
air. Current practice varies widely regarding whether chest tubes should initially be
placed to suction or to water seal, and prior studies have reported mixed findings. While
suction may theoretically improve drainage and lung expansion, some studies suggest it
may prolong air leaks and chest tube duration. Conversely, initial water seal has been
associated with shorter tube duration without an increase in complications. The
predecessor to this trial, the SEAL IT Trial, demonstrated that water seal reduced chest
tube duration in patients with pneumothorax without an increase in complication, but
excluded those with significant hemothorax. This single-center, randomized controlled
trial (SUS-HPTX) will expand upon those findings by evaluating the effect of initial
chest tube management strategy, suction versus water seal, in trauma patients with
hemopneumothorax or hemothorax. Patients will be assigned to one of the two groups based
on calendar month of enrollment, with clinicians able to adjust management as needed. The
primary outcome is chest tube duration. Secondary outcomes include chest tube-related
complications (e.g., empyema, pneumonia, re-accumulation of pneumothorax or hemothorax,
need for additional procedures), hospital length of stay, readmissions, and mortality.
Because both suction and water seal are accepted standards of care, the study involves
minimal incremental risk. Findings will expand prior evidence and inform best practices
for chest tube management in trauma
Type: Interventional
Start Date: Apr 2026
open study
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Effects of an Independent Walking Program With Walking Poles in People With Parkinson Disease
East Tennessee State University
PARKINSON DISEASE (Disorder)
Study Purpose: The purpose of the study is to compare changes in walking in people with
Parkinson disease after an 8-week independent walking program with or without using
walking poles.
Major parts of the Study:
Before the walking program: Measurements will be taken of you while you are walking.1 expand
Study Purpose: The purpose of the study is to compare changes in walking in people with
Parkinson disease after an 8-week independent walking program with or without using
walking poles.
Major parts of the Study:
Before the walking program: Measurements will be taken of you while you are walking. You
will be given tests and questionnaires about your movement and thinking. You will be
trained on how to use walking poles.
Independent walking program: You will be asked to walk at least 3 times each week for 8
weeks and keep a log of your walking. If you are in the walking pole group, you will walk
with the poles. After the walking program: Your walking, movement, and thinking
measurements will be collected as before the walking program.
Follow-up: The same measures of walking, movement, and thinking will be taken 3-months
after ending the walking program.
Type: Interventional
Start Date: Apr 2026
open study
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Peri-implantitis Management: Surgical and Maintenance Outcomes
University of Pittsburgh
Peri-implantitis
The goal of this clinical trial is to learn how two standard surgical treatments for
peri-implantitis affect inflammation around dental implants. Participants will be
randomly assigned to receive resective surgery with implantoplasty or resective surgery
with mechanical debridement only. Participan1 expand
The goal of this clinical trial is to learn how two standard surgical treatments for
peri-implantitis affect inflammation around dental implants. Participants will be
randomly assigned to receive resective surgery with implantoplasty or resective surgery
with mechanical debridement only. Participants will provide blood samples before surgery,
about 48 hours and 2 weeks after surgery. Participants will also provide a small gum
tissue sample and fluid from around the implant at baseline and about 3 months after
surgery. Participants will be followed in a maintenance program for up to 5 years.
Type: Interventional
Start Date: Feb 2026
open study
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The Black Immigrant Project
University of Minnesota
Dementia
This stage I trial will examine if the culturally adapted ACES intervention affects
cognitive appraisal (self-efficacy and dysfunctional thoughts) and behavioral activation
with Black immigrant living with dementia and their care partners over a 1-month and
3-month period. expand
This stage I trial will examine if the culturally adapted ACES intervention affects
cognitive appraisal (self-efficacy and dysfunctional thoughts) and behavioral activation
with Black immigrant living with dementia and their care partners over a 1-month and
3-month period.
Type: Interventional
Start Date: Mar 2026
open study
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Yoga for Black and Brown Women Who Have Experienced Abuse From an Intimate Partner
The University of Akron
Intimate Partner Violence (IPV)
Psychological Well Being
Psychological Trauma, Historical
The goal of this clinical trial is to determine if a culturally tailored and
trauma-informed yoga (CT-TIY) program improves the overall well-being of Black and Brown
women who have experienced IPV. The main questions it aims to answer are:
- What is the feasibility, acceptability, and safety of1 expand
The goal of this clinical trial is to determine if a culturally tailored and
trauma-informed yoga (CT-TIY) program improves the overall well-being of Black and Brown
women who have experienced IPV. The main questions it aims to answer are:
- What is the feasibility, acceptability, and safety of delivering the CT-TIY program?
- Do participants randomized to the CT-TIY program experience increases in our primary
outcome of psychological well-being relative to women randomized to an enhanced
care-as-usual control condition?
- Do participants randomized to the CT-TIY program experience improvements in our
secondary outcomes of empowerment, resilience, health-related quality of life,
collective self-esteem, and culturally specific coping relative to participants
randomized to an enhanced care-as-usual control condition? Researchers will compare
CT-TIY to enhanced care-as-usual to see if CT-TIY to determine the feasibility,
acceptability, safety, as well as initial efficacy of the yoga program.
Participants randomized to the CT-TIY program will:
- Have 15 weeks to complete a target of 10 CT-TIY yoga classes
- Provide feedback on the CT-TIY program after each class they attend
- Complete assessments at Baseline, after completing the CT-TIY program (week 16), as
well as 3-months (week 27) after completing the CT-TIY program
- Complete an exit interview where they provide feedback on their experiences in the
yoga program
Participants randomized to the enhanced care-as-usual control condition will:
- Receive a referral to a domestic violence provider and the Futures without Violence
General Health Safety Card, designed to help women recognize how their relationship
impacts their health and the lives of their children, and provides information on
safety planning and hotlines for support.
- Complete assessments at Baseline, week 16, and week 27 of the study.
Type: Interventional
Start Date: May 2026
open study
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Comparing Sarecycline and Doxycycline Effects on the Skin and Gut Bacteria in Acne.
Integrative Skin Science and Research
Acne Vulgaris
This study is being done to help better understand how the gut and skin bacteria of the
body change when people with acne are treated with Sarecycline or Doxycycline. The
bacteria in the gut and on the skin will be studied to see how each treatment may affect
them and whether they change the profil1 expand
This study is being done to help better understand how the gut and skin bacteria of the
body change when people with acne are treated with Sarecycline or Doxycycline. The
bacteria in the gut and on the skin will be studied to see how each treatment may affect
them and whether they change the profile of the bacteria that is present.
Type: Interventional
Start Date: Apr 2026
open study
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A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lu1
Memorial Sloan Kettering Cancer Center
Non-Small Cell Lung Cancer
The researchers are doing this study to find out whether ivonescimab in combination with
datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in
people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. The researchers
will test different doses of the1 expand
The researchers are doing this study to find out whether ivonescimab in combination with
datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in
people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. The researchers
will test different doses of the Dato-DXd or osimertinib with an unchanging (fixed) dose
of ivonescimab to find the best dose that causes few or mild side effects in
participants. Once the dose is found the researchers will test ivonescimab with Dato-DXd
or osimertinib in a new group of participants to see if it is effective in treating their
NSCLC with an EGFR mutation.
Type: Interventional
Start Date: Apr 2026
open study
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Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease
Fred Hutchinson Cancer Center
Chronic Graft Versus Host Disease
Acute Graft Versus Host Disease
Hematopoietic and Lymphatic System Neoplasm
This clinical trial evaluates the feasibility and effectiveness of a post-transplant
dental cleaning for the prevention of chronic graft versus host disease (GVHD) in
patients undergoing an allogeneic hematopoietic cell transplant (HCT). HCT is the only
curative treatment for some types of blood ca1 expand
This clinical trial evaluates the feasibility and effectiveness of a post-transplant
dental cleaning for the prevention of chronic graft versus host disease (GVHD) in
patients undergoing an allogeneic hematopoietic cell transplant (HCT). HCT is the only
curative treatment for some types of blood cancer. Unfortunately, this approach can lead
to the development of GVHD, which is a disease caused when cells from a donated stem cell
graft attack the normal tissue of the transplant patient. Some research has shown that
the bacteria that is present in the dental plaque soon after transplant may affect the
development of chronic GVHD. Dental cleanings prior to transplant are part of the normal
standard of care for patients undergoing HCT. Adding an additional cleaning shortly after
HCT may be effective for preventing the development of chronic GVHD.
Type: Interventional
Start Date: May 2026
open study
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Acute Amino Acid Response of Proprietary Beverages
Shaklee Corporation
Healthy
The primary objective of this study is to evaluate post-meal amino acid in response to a
proprietary beverages in generally healthy adults. expand
The primary objective of this study is to evaluate post-meal amino acid in response to a
proprietary beverages in generally healthy adults.
Type: Interventional
Start Date: Apr 2026
open study
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Implementing AI-Assisted, Patient-Friendly Imaging Report Summaries to Enhance Oncology Care Delive1
University of Wisconsin, Madison
Oncology
The implementation of the AI-assisted radiology summary tool into clinical workflows is
being conducted as part of a standard-of-care quality improvement (QI) initiative at UW
Health. The evaluation of this tool's impact via structured feedback from patients and
providers is being undertaken as a p1 expand
The implementation of the AI-assisted radiology summary tool into clinical workflows is
being conducted as part of a standard-of-care quality improvement (QI) initiative at UW
Health. The evaluation of this tool's impact via structured feedback from patients and
providers is being undertaken as a prospective research study.
Type: Observational
Start Date: Feb 2026
open study
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ASCEND: Safety and Tolerability of ION337 for the Treatment of Dravet Syndrome
Ionis Pharmaceuticals, Inc.
Dravet Syndrome
The primary purpose of this study is to evaluate the safety and tolerability of ION337 in
participants with Dravet syndrome (DS). expand
The primary purpose of this study is to evaluate the safety and tolerability of ION337 in
participants with Dravet syndrome (DS).
Type: Interventional
Start Date: Apr 2026
open study
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Radioembolization Versus External Radiation Therapy
Henry Ford Health System
Heptocellular Cancer
The proposed study is a single site, prospective, randomized phase 2 study to evaluate
the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic
body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial
will involve standard SBRT delivered1 expand
The proposed study is a single site, prospective, randomized phase 2 study to evaluate
the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic
body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial
will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total
therapy adjusted as needed for safety. The TARE arm of the trial will involve a planning
arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental
(≤2) artery supplying the tumor. Administered activity will be an amount prescribed to
deliver a dose ≥200 Gy to the perfused tissue. The primary endpoint is the rate of
re-treatment of the index lesion over 12 months.
Type: Interventional
Start Date: Dec 2025
open study
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ACT Group for Family Caregivers of Stroke Survivors
The Wright Institute
Caregiver Stress
Caregiver Stress Syndrome
Caregiver Burnout
Caregiver Distress
Caregiver Exhaustion
The goal of this study is to evaluate the efficacy of group-based ACT intervention in
improving the levels of psychological distress in caregivers of stroke survivors. The
main questions it aims to answer are:
1. Does group-based ACT intervention improve the levels of psychological distress and1 expand
The goal of this study is to evaluate the efficacy of group-based ACT intervention in
improving the levels of psychological distress in caregivers of stroke survivors. The
main questions it aims to answer are:
1. Does group-based ACT intervention improve the levels of psychological distress and
QoL in family caregivers of stroke survivors?
2. Do the levels of psychological flexibility and experiential avoidance in family
caregivers of stroke survivors mediate the outcome of the ACT Group?
The researcher will compare the experimental group (i.e., participants who received
group-based ACT intervention) with the control group (i.e., participants who did not
receive group-based ACT intervention) to assess whether the group-based ACT intervention
is effective in mitigating caregiver stress and improving caregivers' QoL.
Participants in the experimental group will:
1. Receive a 5-weekly, 1.5-hour group intervention based on the ACT Model;
2. Complete study measures at pre-treatment, immediate post-treatment, and 2-month
follow-up.
Participants in the control group will not receive the group intervention but will
complete the same study measures.
Type: Interventional
Start Date: Sep 2025
open study
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A Study Of Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dyspl1
Mayo Clinic
Fibromuscular Dysplasia
Spontaneous Coronary Artery Dissection
The purpose of this study is to assess the cardiopulmonary, hemodynamic, and symptom
responses to acute bouts of varying intensity aerobic and resistance exercise in people
with Spontaneous Coronary Artery Dissection (SCAD) and/or Fibromuscular Dysplasia (FMD). expand
The purpose of this study is to assess the cardiopulmonary, hemodynamic, and symptom
responses to acute bouts of varying intensity aerobic and resistance exercise in people
with Spontaneous Coronary Artery Dissection (SCAD) and/or Fibromuscular Dysplasia (FMD).
Type: Interventional
Start Date: Apr 2026
open study
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Brain Stimulation and Cognitive Training for MCI
Medical University of South Carolina
Mild Cognitive Impairment (MCI)
Mild Neurocognitive Disorder
Neurocognitive Disorders
Cognitive Dysfunction
Cognition Disorders
This is a randomized clinical trial of a treatment that combines non-invasive brain
stimulation with computerized cognitive training (CCT) for people with mild cognitive
impairment (MCI). The form of brain stimulation used in this study is accelerated
intermittent theta burst stimulation (iTBS). Al1 expand
This is a randomized clinical trial of a treatment that combines non-invasive brain
stimulation with computerized cognitive training (CCT) for people with mild cognitive
impairment (MCI). The form of brain stimulation used in this study is accelerated
intermittent theta burst stimulation (iTBS). All participants receive the same amount of
iTBS and are randomly assigned to engage in one of two types of CCT. The goals of the
study are to see if this combined treatment is feasible and acceptable to people with MCI
and whether combined iTBS and CCT improves memory, thinking skills, mood, and daily
function.
Type: Interventional
Start Date: Mar 2026
open study
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A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the S1
Novo Nordisk A/S
Overweight
Obesity
The purpose of this clinical study is to find out if NNC0662-0419 is safe and effective
to be taken together with other medicines, like birth control pills, and emptying of the
stomach in women not able to become pregnant living with overweight or obesity. There are
3 study treatments in this study1 expand
The purpose of this clinical study is to find out if NNC0662-0419 is safe and effective
to be taken together with other medicines, like birth control pills, and emptying of the
stomach in women not able to become pregnant living with overweight or obesity. There are
3 study treatments in this study, participants will get all of the treatments,
NNC0662-0419 the treatment being tested, Altavera a type of birth control pill,
Acetaminophen a common type of mild painkiller.
Type: Interventional
Start Date: Apr 2026
open study
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Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD)
Acacia Clinics
PTSD
Post Traumatic Stress Disorder PTSD
PTSD - Post Traumatic Stress Disorder
Post Traumatic Stress Disorder
Post Traumatic Stress Disorders
The goal of this clinical trial is to evaluate the safety and effectiveness of the
gammaCore non-invasive vagus nerve stimulation (nVNS) device as an additional treatment
for symptoms of post-traumatic stress disorder (PTSD) in adults.
The vagus nerve connects the brain with many organs and system1 expand
The goal of this clinical trial is to evaluate the safety and effectiveness of the
gammaCore non-invasive vagus nerve stimulation (nVNS) device as an additional treatment
for symptoms of post-traumatic stress disorder (PTSD) in adults.
The vagus nerve connects the brain with many organs and systems in the body and plays a
role in regulating stress and emotional responses. The gammaCore device is a handheld,
rechargeable medical device that delivers gentle electrical stimulation to the vagus
nerve through the skin on the side of the neck. By stimulating this nerve, the device may
help reduce PTSD symptoms.
gammaCore is cleared by the U.S. Food and Drug Administration (FDA) for the treatment and
prevention of migraine and cluster headache. It has not yet been approved for the
treatment of PTSD. This study is being conducted to better understand whether this type
of stimulation may help improve PTSD symptoms and to evaluate its safety when used for
this purpose.
The main questions this study aims to answer are:
- Is non-invasive vagus nerve stimulation safe for people with PTSD when used
regularly at home?
- Does treatment with the gammaCore device improve PTSD symptom severity over time?
In this study, approximately 40 adults with PTSD will participate in an open-label pilot
study.
Participants will first complete a 4-week baseline period in which their PTSD symptoms
are monitored. This allows researchers to understand each participant's symptoms before
starting the intervention.
Participants will then begin a 12-week treatment period using the gammaCore device at
home. During this time, participants will apply the device to the side of the neck for
short stimulation sessions each day as instructed by the study team.
Participants will attend six study visits, some conducted remotely and some in person.
These visits include screening, training on how to use the device, and follow-up
assessments. During the study, participants will complete questionnaires and
clinician-administered assessments that measure PTSD symptoms and quality of life.
Researchers will also monitor participants for any side effects or medical problems
related to the device.
By collecting information on symptoms, safety, and device use, this study will help
researchers understand whether non-invasive vagus nerve stimulation could become a useful
treatment option for people living with PTSD.
Type: Interventional
Start Date: Mar 2026
open study
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