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A Clinical Study Evaluating Licaminlimab for Dry Eye Disease
Oculis
Dry Eye Disease (DED)
The primary objective of this study is to evaluate the efficacy and safety of the topical
ophthalmic administration of licaminlimab as compared to vehicle in participants with Dry
Eye Disease and a specific genotype. expand
The primary objective of this study is to evaluate the efficacy and safety of the topical
ophthalmic administration of licaminlimab as compared to vehicle in participants with Dry
Eye Disease and a specific genotype.
Type: Interventional
Start Date: Apr 2026
open study
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A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
EyeBiotech Ltd.
Macular Degeneration
Age-Related Macular Degeneration
Choroidal Neovascularization
Wet Macular Degeneration
Researchers are looking for new ways to treat neovascular age-related macular
degeneration (NVAMD).
Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for
every person. Researchers want to learn if a trial medicine called tiespectus (also
called MK-8748 or EYE201) c1 expand
Researchers are looking for new ways to treat neovascular age-related macular
degeneration (NVAMD).
Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for
every person. Researchers want to learn if a trial medicine called tiespectus (also
called MK-8748 or EYE201) can treat NVAMD.
The goal of this trial is to learn if tiespectus works as well as aflibercept to treat
NVAMD.
Type: Interventional
Start Date: Mar 2026
open study
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A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin1
Novartis Pharmaceuticals
Primary Immune Thrombocytopenia (ITP)
Primary Evans Syndrome (ES)
The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with
investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants
diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least
one but no more than four prior treatme1 expand
The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with
investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants
diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least
one but no more than four prior treatments, and with no change in IC TPO-RA dose in at
least the last 14 days prior to the start of ianalumab.
Type: Interventional
Start Date: Jun 2026
open study
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An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works1
Complement Therapeutics
Geographic Atrophy Secondary to Age-related Macular Degeneration
This is a clinical study to evaluate the safety, tolerability and efficacy of CTx001,
administered via a single subretinal injection, for GA (secondary to AMD).
Safety and efficacy will be measured at regular intervals for 2 years after which
long-term safety will be assessed annually for up to 51 expand
This is a clinical study to evaluate the safety, tolerability and efficacy of CTx001,
administered via a single subretinal injection, for GA (secondary to AMD).
Safety and efficacy will be measured at regular intervals for 2 years after which
long-term safety will be assessed annually for up to 5 years.
Type: Interventional
Start Date: Dec 2025
open study
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A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopath1
Mannkind Corporation
Idiopathic Pulmonary Fibrosis (IPF)
MKC-NI-002 is a Phase 1b, randomized, double-blind, placebo-controlled study of
nintedanib inhalation powder (MNKD-201) in patients with Idiopathic Pulmonary Fibrosis
(IPF). The trial consists of Multiple Ascending Doses (MAD) with the primary objective to
evaluate safety, tolerability and pharmaco1 expand
MKC-NI-002 is a Phase 1b, randomized, double-blind, placebo-controlled study of
nintedanib inhalation powder (MNKD-201) in patients with Idiopathic Pulmonary Fibrosis
(IPF). The trial consists of Multiple Ascending Doses (MAD) with the primary objective to
evaluate safety, tolerability and pharmacokinetics (PK) of MNKD-201 compared to placebo
in patients with IPF.
Type: Interventional
Start Date: Dec 2025
open study
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Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer
Genmab
Non-small Cell Lung Cancer (NSCLC)
This Phase 2 study will be conducted in different countries around the world with up to
about 240 participants.
The purpose of this study is to evaluate how well Rina-S works against lung cancer.
The treatment in this study is Rina-S monotherapy (by itself). All participants will
receive active d1 expand
This Phase 2 study will be conducted in different countries around the world with up to
about 240 participants.
The purpose of this study is to evaluate how well Rina-S works against lung cancer.
The treatment in this study is Rina-S monotherapy (by itself). All participants will
receive active drug; no one will be given placebo.
The treatment duration will be different for every participant, but an average of 12
months is expected. Participants will be asked to attend 1 to 5 visits at the study
clinic for each cycle (duration of cycle is 3 weeks). If a participant's cancer stays the
same or gets better, and there are not any serious problems, participants can keep
getting study treatment for as long as the study is open.
Participation in the study will require visits to the study site(s). During site visits,
there will be various tests (such as blood draws) and procedures (such as recording of
heart activity, imaging/X-rays) to monitor whether the study treatment is safe and
effective.
Type: Interventional
Start Date: Jan 2026
open study
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Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colo1
Summit Therapeutics
Metastatic Colorectal Cancer (CRC)
A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of
Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil)
versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic
Colorectal Cancer(HARMONi-GI3) expand
A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of
Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil)
versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic
Colorectal Cancer(HARMONi-GI3)
Type: Interventional
Start Date: Nov 2025
open study
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Telemedicine to Support Living Kidney Donor Candidates
University of California, Irvine
Healthy
Living Kidney Donation
The goal of this feasibility clinical trial is to learn if telemedicine can be used to
provide education and evaluation and counseling for people who are considering living
kidney donation. The study will also learn how participants improve decision-making about
living kidney donation. The main que1 expand
The goal of this feasibility clinical trial is to learn if telemedicine can be used to
provide education and evaluation and counseling for people who are considering living
kidney donation. The study will also learn how participants improve decision-making about
living kidney donation. The main questions to answer are:
- Is telemedicine a practical way to facilitate donor education and evaluation and
counseling?
- Does telemedicine shared decision making help improve donor candidate decision and
engagement during the donor evaluation process?
Researchers will compare standard care with a telemedicine care coordination approach.
Participants will:
- Receive either standard care or telemedicine video visits to support shared decision
making.
Type: Interventional
Start Date: May 2026
open study
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Project DEDUCE: Digital Envirotyping to Develop Understanding of Cigarette Smoking and the Environm1
Duke University
Smoking
Tobacco use is a chronic relapsing condition. That is, even with state-of-the-art
treatment, >70% of smoking cessation attempts end in a return to regular smoking.
Research demonstrates that everyday environments associated with smoking trigger craving
for cigarettes, provoke smoking, and lead to r1 expand
Tobacco use is a chronic relapsing condition. That is, even with state-of-the-art
treatment, >70% of smoking cessation attempts end in a return to regular smoking.
Research demonstrates that everyday environments associated with smoking trigger craving
for cigarettes, provoke smoking, and lead to relapse. However, despite this knowledge,
understanding of environmental correlates of smoking has been limited by a reliance on
self-report, leading to imprecise information about the physical environments in which
people live. To overcome this challenge, the research team has pioneered the development
of digital envirotyping, which uses digital tools (e.g., sensors, cameras, artificial
intelligence) to efficiently and accurately characterize and categorize environments with
the goal of identifying environmental markers of behavior and health. Foundational to the
digital envirotyping research is computer vision (CV), a type of artificial intelligence
(AI) that enables computer systems to recognize objects and scenes in digital images,
mimicking how humans perceive and understand visual information. With CV researchers can
extract detailed and accurate information (i.e., objects and location types) about the
everyday environments of people who smoke (PWS) and relate that information to smoking
behavior. After validating the use of CV, the researchers used CV to develop
enviromarkers of relapse risk. Importantly, they identified a novel enviromarker in which
people at greater risk for relapse when they quit are exposed to a more consistent level
of environment-related smoking risk as they move between their smoking and nonsmoking
environments.
Research is now needed to advance digital envirotyping and enviromarker development in
the field of tobacco addiction. The study will recruit a diverse, national sample of
n=500 adults who are interested in quitting smoking. For two weeks prior to quitting,
they will undergo photoEMA in which they will take two pictures of their current
environment when they smoke, and randomly 10 times per day resulting in >300,000 images
total. Cessation will be supported by nicotine replacement therapy (i.e., nicotine
patch). The primary clinical outcome will be days to relapse. Specific aims are to (1)
further develop, refine, and validate methods for efficient digital envirotyping at
scale, (2) leverage CV and AI approaches to develop enviromarkers of smoking relapse, and
(3) conduct analyses to increase understanding of environmental smoking risk in women and
individuals with low socioeconomic status.
Type: Interventional
Start Date: May 2026
open study
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Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patie1
Pravat Mandal
Parkinsons Disease (PD)
This study is designed l to evaluate the effects of GGC oral supplementation in early
Parkinson's disease (PD) patients. The main objectives of the study are to evaluate:
1. To study the enrichment of master antioxidant, glutathione (GSH) levels in brain and
blood of these PD patients compa1 expand
This study is designed l to evaluate the effects of GGC oral supplementation in early
Parkinson's disease (PD) patients. The main objectives of the study are to evaluate:
1. To study the enrichment of master antioxidant, glutathione (GSH) levels in brain and
blood of these PD patients compared to baseline due to GGC supplementation.
2. To study the changes in motor function, cognitive skills in PD patients due to GGC
oral supplementation
3. To study impact of GGC on gut health on the PD patients.
Type: Interventional
Start Date: Mar 2026
open study
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A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Imm1
Pfizer
COVID-19 Infection
This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy,
superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in
combination with remdesivir IV compared to remdesivir IV alone for the treatment of
symptomatic COVID-19 in severely immunocompromised1 expand
This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy,
superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in
combination with remdesivir IV compared to remdesivir IV alone for the treatment of
symptomatic COVID-19 in severely immunocompromised adult participants who are
non-hospitalized or are hospitalized for observation or study intervention administration
but do not require supplemental oxygen for COVID-19.
Type: Interventional
Start Date: Jul 2025
open study
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A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2401
Merck Sharp & Dohme LLC
Prostate Cancer
Prostatic Neoplasms
Researchers are looking for new ways to treat metastatic castration-resistant prostate
cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan
(also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if
people who receive I-DXd live longer ov1 expand
Researchers are looking for new ways to treat metastatic castration-resistant prostate
cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan
(also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if
people who receive I-DXd live longer overall and live longer without the cancer growing
or spreading than people who receive chemotherapy.
Type: Interventional
Start Date: May 2025
open study
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A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubici1
Merck Sharp & Dohme LLC
Lymphoma, Large B-Cell, Diffuse
Researchers are looking for ways to treat germinal center B-cell-like diffuse large
B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells.
GCB is a type of DLBCL that affects young B-cells that are still maturing.
The goal of this study is to learn if more people w1 expand
Researchers are looking for ways to treat germinal center B-cell-like diffuse large
B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells.
GCB is a type of DLBCL that affects young B-cells that are still maturing.
The goal of this study is to learn if more people who receive zilovertamab vedotin
(MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab
vedotin and R-CHP.
Type: Interventional
Start Date: Apr 2025
open study
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A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration o1
Pfizer
RSV Infection
This study aims to check how safe and well-tolerated a second dose of RSVpreF is when
given during later pregnancies, and to see how long the immunity lasts from a single dose
given during a previous pregnancy by examining the blood of nonpregnant participants who
had the vaccine before. expand
This study aims to check how safe and well-tolerated a second dose of RSVpreF is when
given during later pregnancies, and to see how long the immunity lasts from a single dose
given during a previous pregnancy by examining the blood of nonpregnant participants who
had the vaccine before.
Type: Interventional
Start Date: Apr 2025
open study
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Study to Evaluate CAY001 in Healthy Volunteers
Cayuga Biotech, Inc.
Healthy
This is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single
ascending dose, sequential group study to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of CAY001 when administered to healthy male and
female subjects. Three dose levels will be eval1 expand
This is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single
ascending dose, sequential group study to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of CAY001 when administered to healthy male and
female subjects. Three dose levels will be evaluated with a total of approximately 24
subjects.
Type: Interventional
Start Date: Dec 2025
open study
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Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT
University of Pittsburgh
Concussion, Mild
Mild Traumatic Brain Injury (mTBI)
Vestibular
Psychological Health
The primary objective of this multi-site randomized clinical trial (RCT) is to compare
Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) with
usual care vestibular rehabilitation (VESTIB CONTROL) in 250 individuals with
mTBI-related vestibular symptoms attributable to1 expand
The primary objective of this multi-site randomized clinical trial (RCT) is to compare
Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) with
usual care vestibular rehabilitation (VESTIB CONTROL) in 250 individuals with
mTBI-related vestibular symptoms attributable to mild traumatic brain injury (mTBI)
treated at one of two sites (1) the University of Pittsburgh Medical Center, or (2) the
Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Hood, Texas. Both
interventions will be delivered weekly over 4 weeks. Assessments will be administered
prior to the start of treatment (Baseline) and at 4-weeks, 3- and 6-months following the
completion of treatment.
Type: Interventional
Start Date: Feb 2025
open study
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A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO71
Hoffmann-La Roche
Moderately to Severely Active Crohns Disease
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will
evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart
(also known as RO7790121) in participants with moderately to severely active Crohn's
disease (CD). expand
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will
evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart
(also known as RO7790121) in participants with moderately to severely active Crohn's
disease (CD).
Type: Interventional
Start Date: Mar 2025
open study
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Splanchnic X: Splanchnic Nerve Block in Heart Failure With Reduced Ejection Fraction
Duke University
Heart Failure
Heart failure (HF) affects more than 6 million adults in the U.S. alone, with increasing
prevalence. Cardiovascular congestion with resultant limitation in physical activity is
the hallmark of chronic and decompensated HF. The current HF physiologic model suggests
that congestion is the result of v1 expand
Heart failure (HF) affects more than 6 million adults in the U.S. alone, with increasing
prevalence. Cardiovascular congestion with resultant limitation in physical activity is
the hallmark of chronic and decompensated HF. The current HF physiologic model suggests
that congestion is the result of volume retention and, therefore, therapies (such as
diuretics) have generally been targeted at volume overload. Yet therapeutic approaches to
reduce congestion have failed to show significant benefit on clinical outcomes,
potentially due to an untargeted approach of decongestive therapies. The investigators'
preliminary work suggested a complimentary contribution of volume redistribution to the
mechanism of cardiac decompensation. The investigators identified the splanchnic nerves
as a potential therapeutic target and showed that short-term interruption of the
splanchnic nerve signaling could have favorable effects on cardiovascular hemodynamics
and symptoms.
As part of the investigators' proposal, the investigators will test the safety and
efficacy of prolonged splanchnic nerve block in a randomized, controlled, blinded study
in patients with HF and reduced ejection fraction (HFrEF). The results will help test the
hypothesis of volume redistribution as a driver of cardiovascular congestion and
functional limitations and pave the way for splanchnic nerve blockade as a novel
therapeutic approach to HF.
Type: Interventional
Start Date: Apr 2025
open study
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A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patien1
Hoffmann-La Roche
Lymphoma
The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in
participants in the United States, including under-represented racial and ethnic
populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma
(DLBCL). expand
The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in
participants in the United States, including under-represented racial and ethnic
populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma
(DLBCL).
Type: Interventional
Start Date: Apr 2025
open study
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A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive Di1
Genentech, Inc.
Non-cystic Fibrosis Bronchiectasis
Chronic Obstructive Pulmonary Disease
This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in
participants with muco-obstructive disease. expand
This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in
participants with muco-obstructive disease.
Type: Interventional
Start Date: Nov 2024
open study
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Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Exam1
University of Kansas Medical Center
Kidney Stone
Nephrolithiasis
The goal of this study is to evaluate the influence of real-time intrarenal pressure
measurement availability on surgeons' behavior during ureteroscopy while using the
ureteroscope LithoVue Elite. expand
The goal of this study is to evaluate the influence of real-time intrarenal pressure
measurement availability on surgeons' behavior during ureteroscopy while using the
ureteroscope LithoVue Elite.
Type: Interventional
Start Date: Jan 2025
open study
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Brain Mechanisms of Reducing Polysubstance Use
Arizona State University
Multiple Drug Use
The proposed study will test whether neurofeedback (NF) could optimize integrative
body-mind training (IBMT) practice. expand
The proposed study will test whether neurofeedback (NF) could optimize integrative
body-mind training (IBMT) practice.
Type: Interventional
Start Date: Sep 2023
open study
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Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors
University of Memphis
Suicidal Behaviors
Suicide Ideation
Depression/Anxiety
The primary aim of the project is to test the efficacy of BCBT delivered via a digital
platform (i.e., smartphone) to Servicemembers with recent suicidal ideation and/or
suicide attempts presenting to primary care clinics. Given existing challenges of scaling
empirically-supported treatments/interv1 expand
The primary aim of the project is to test the efficacy of BCBT delivered via a digital
platform (i.e., smartphone) to Servicemembers with recent suicidal ideation and/or
suicide attempts presenting to primary care clinics. Given existing challenges of scaling
empirically-supported treatments/interventions for suicidality with fidelity, this
project could lead to markedly expanded access to BCBT, along with improving our
understanding about what intervention strategies are most effective and how they can be
delivered with meaningful fidelity. Aviva, the digital version of BCBT, was developed for
use with patients across the full spectrum of healthcare settings, including primary
care. Aviva is not an emergency alert system, rather a digital platform for delivery of
the full scope of BCBT treatment components. An open-label single group Phase I clinical
trial has demonstrated the safety, tolerability, feasibility, fidelity, and potential
efficacy of Aviva, with participants completing modules over 8 weeks, and follow-up
assessments at weeks 1, 4, and 8. Subsequent refinements included the addition of
technical features that would allow patients to revisit and/or repeat previously
completed modules, along with integration of more characters for delivering video
vignettes and greater opportunities for skills practice and treatment engagement. These
modifications have further enhanced Aviva safety, tolerability, and fidelity, consistent
with the original BCBT protocol. Not only is it hypothesized that Aviva will result in
significantly larger reductions in severity of suicidal ideation than participants
randomized to the control condition, but also that greater app engagement will be
negatively correlated with severity of suicidal thinking. Moderators and mediators (i.e.
suicidal beliefs, wish to live, impulsive decision-making) of intervention effects will
also be examined. The study will be conducted at the primary care clinics at Fort Carson,
with a goal of enrolling 720 patients across a two-year timeframe. Participants will be
identified using each clinic's existing suicide risk assessment methods, including the
PHQ-9 suicide risk item and a score of 1 or higher on the CSSRS Screener (Recent).
Participants will be randomly assigned to one of two treatment conditions, Aviva or
control (i.e., development of a safety plan consistent with local procedures and
policies, along with referral for standard mental health care and suicide risk management
in accordance with local policies and procedures). In an effort to address potential
performance bias specific to smartphone use, participants in the control condition will
download the Suicide Safety Plan app to their smartphones. Those in the Aviva condition
will also complete weekly check-ins with Project 2 research clinicians to review
treatment adherence, identify and respond to any logistical/operational problems, and
respond to any unexpected emergencies and/or participant safety concerns. Participants
will have up to five data points: baseline, 3, 6, 9, and 12 months. All data available
from all participants and all time points will be included in the analyses, consistent
with the intent-to-treat principle. Across our two previous clinical trials and our
in-progress RCT, attrition during the first 12 months postbaseline was <30% and we
anticipate similar rates in this trial.
Type: Interventional
Start Date: Feb 2024
open study
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A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (1
89bio, Inc.
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared
to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with
MASH. expand
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared
to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with
MASH.
Type: Interventional
Start Date: Mar 2024
open study
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Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in M1
Merck Sharp & Dohme LLC
Non-small Cell Lung Cancer (NSCLC)
The primary objective of the study is to compare sacituzumab tirumotecan combined with
pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary
hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is
superior to pembrolizumab alone with resp1 expand
The primary objective of the study is to compare sacituzumab tirumotecan combined with
pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary
hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is
superior to pembrolizumab alone with respect to OS.
All participants who have completed the first course of pembrolizumab may be eligible for
up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent
central review (BICR)-verified progressive disease by Response Evaluation Criteria In
Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
Type: Interventional
Start Date: Dec 2023
open study
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