Active Non-Cancer Clinical Trial List
Title: Evaluation of Long-term Neuropsychologic and Cognitive Outcomes in Patients with Unruptured Intracranial Aneurysms
Brief Title: Neuropsychologic Outcomes for UIAs
Brief Summary: The aim of this study is to investigate neurocognitive effects of UIA treatment in patients receiving elective treatment at BIDMCs Neurosurgical Department for UIAs. Therefore, a longitudinal study design has been chosen, in which 200 patients across two sites will be evaluated neuropsychologically on 3 separate occasions: on first clinic visit, 3 months after diagnosis or treatment, and 1 year after diagnosis or treatment. This information will be gathered and evaluated for outcomes of neurocognitive functioning after treatment.
For info regarding 2025P001062
please contact Mark Rotondo, MS at 617-632-7025 or
mrotondo@bidmc.harvard.edu
Title: The impact of dry needling on electrophysiological and ultrasound-based biomarkers for myofascial pain
Brief Title: The impact of dry needling on biomarkers for myofascial pain
Brief Summary: The goal of this interventional study is to determine how well dry-needling can treat
pain in people with Myofascial Pain Syndrome. The main questions it aims to answer are:
- Does dry needling improve pain for people with a trigger point (a tender, tight spot
in the muscle)?
- How well can Electrical Impedence Myography (EIM), Myofiber Threshold Tracking (TT),
and Ultrasound (US) detect changes in the muscle related to dry needling treatment?
Researchers will compare dry needling to a placebo (a treatment that does not enter the
trigger point) to see if dry needling works to treat Myofascial Pain Syndrome with
trigger points in the trapezius muscle (the muscle that extends over the back of the neck
and shoulders), as measured by these three outcome measures (EIM, US, TT).
Participants will:
- Visit the clinic twice: once to receive dry needling treatment, and once for a
follow-up
- Have muscle measurements taken before treatment and at follow-up
- Have a daily survey to record the intensity of their pain
For info regarding 2025P000944
please contact Seward Rutkove at 617-667-8130 or
srutkove@bidmc.harvard.edu
Title: A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-407 in Subjects with Autosomal Dominant Polycystic Kidney Disease Who Have a Subset of PKD1 Gene Variants
Brief Title: Efficacy and Safety of VX-407 in Subjects with ADPKD
Brief Summary: The purpose of the study is to evaluate the effect of VX-407 on height-adjusted total
kidney volume (htTKV), safety, tolerability, and pharmacokinetics (PK) of VX-407.
For info regarding 2025P000876
please contact Colton Wright at 617-975-8692 or
cwrigh14@bidmc.harvard.edu
Title: A prospective long term follow-up study to evaluate the use of the Minder device to aid in treatment after actionable event identification in patients diagnosed with epilepsy
Brief Title: Long-term follow-up of Minder device in epilepsy
Brief Summary: The purpose of this research is to address the challenges of correctly monitoring,
managing, and diagnosing epilepsy in participants whose seizures are not well captured by
standard electroencephalography (EEG) tests and who cannot use or are not able to use
more standard monitoring techniques. This research is being done to understand how the
Minder System helps physicians make decisions about participant's epilepsy treatment
after an actionable event. The Minder System was granted De Novo classification by the
U.S. Food and Drug Administration (FDA) and is not investigational.
Participants that have completed the DETECT study and received the Minder System
previously will consent to join this long-term follow-up observational study. The study
will collect information about general wellbeing, use of healthcare services, and
experience using the Minder data over time to support long-term epilepsy care.
All participants will continue to be followed by their treating physician and undergo
assessments and visits every six (6) months until two (2) years after receiving the
Minder device.
For info regarding 2025P000783
please contact Niravkumar Barot at
nbarot@bidmc.harvard.edu
Title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety and Efficacy of LB-P8 in Patients with Primary Sclerosing Cholangitis (PSC)
Brief Title: LB08-211 Trial
Brief Summary: The study is designed to assess the safety and efficacy of LB-P8 in patients with primary
sclerosing cholangitis.
For info regarding 2025P000764
please contact Alan Bonder at 617-632-1070 or
abonder@bidmc.harvard.edu
Title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety and Efficacy of LB-P8 in Patients with Primary Sclerosing Cholangitis (PSC)
Brief Title: LB08-211 Trial
Brief Summary: The study is designed to assess the safety and efficacy of LB-P8 in patients with primary
sclerosing cholangitis.
For info regarding 2025P000764
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: A multicenter, prospective trial evaluating the safety and efficacy of the Implantable Artificial Bronchus (IAB) in adults suffering from severe emphysema
Brief Title: Pulmair
Brief Summary: A study taking place at multiple sites in the United States, Europe and Brazil to
evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.
For info regarding 2025P000749
please contact Adnan Majid at 617-632-8252 or
amajid@bidmc.harvard.edu
Title: A Study to Assess Safety and Effectiveness ofthe JenaValve Trilogy
Transcatheter Heart Valve System Versus Surgical Valve Replacement in
Patients with Aortic Regurgitation
Brief Title: ARTIST JENAVALVE
Brief Summary: To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System
compared with surgical aortic valve replacement (SAVR) for treatment of subjects with
clinically significant native aortic regurgitation (AR)
For info regarding 2025P000709
please contact Marie-France Poulin at
mpoulin@bidmc.harvard.edu
Title: A prospective, randomized controlled, blinded, multi-center study to evaluate the use of the Minder device to aid in developing a treatment plan after inconclusive prolonged EEG in patients with epilepsy
Brief Title: Diagnosing epilepsy using Minder
Brief Summary: The purpose of this research is to address the challenges of diagnosing and long-term
management of epilepsy in participants whose seizures are not well captured by standard
electroencephalography (EEG) tests and who cannot use or are not able to use more
standard monitoring techniques. This research will compare the Minder System to standard
of care in providing reliable seizure data. The Minder System was granted De Novo
classification by the U.S. Food and Drug Administration (FDA) and is not investigational.
Participants will consent to join the study and be implanted with the Minder device; or
consent to join the study and continue with their Standard of Care (SOC) as a control
group. Participants chose to be implanted with the Minder device will have the device
implanted under their scalp. After implantation, participants will be randomly assigned
to a group where their treating physician will have access to the EEG data collected by
the Minder System or a group where their treating physician does not have access to the
EEG data collected by the Minder System. Participants receiving the Minder System will
not know which group they are in (blinded) until the study ends.
All participants will continue to be followed by their treating physician and undergo
assessments and visits until enough information is available to determine a treatment
plan or the 6-month follow-up visit.
For info regarding 2025P000700
please contact Niravkumar Barot at
nbarot@bidmc.harvard.edu
Title: Mechanisms Of Orbitofrontal stimulation in Depression (MOOD)
Brief Title: Mechanisms Of Orbitofrontal stimulation in Depression (MOOD)
Brief Summary: The orbitofrontal cortex (OFC), a region involved in emotional regulation, decision
making, and reward processing, is a key area linked to antidepressant response. This
study tests whether noninvasive stimulation of the OFC using transcranial magnetic
stimulation (TMS) can improve depressive symptoms. TMS uses magnetic fields generated by
a coil placed next to the scalp to alter brain activity.
For info regarding 2025P000673
please contact Subha Subramanian at 617-667-2702 or
ssubram5@bidmc.harvard.edu
Title: The Magenta Elevate High-Risk PCI Pivotal Study
Brief Title: ELEVATE III
Brief Summary: The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional,
randomized, controlled study with an active control group. The study is intended to
assess the safety and efficacy of the Elevate™ percutaneous Left Ventricular Assist
Device System in patients referred to high-risk percutaneous coronary interventions
(HR-PCI).
For info regarding 2025P000653
please contact Hector Tamez Aguilar at
htamez@bidmc.harvard.edu
Title: AGENT Drug-Coated Balloon for Stent Avoidance in PCI for De Novo Coronary Artery Disease
Brief Title: AGENT DCB Stance
Brief Summary: AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled
study designed to assess the safety and effectiveness of a treatment strategy with the
AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention
(PCI) treatment with drug eluting stent (DES) and/or balloon angioplasty in patients with
de novo coronary lesions.
Subjects must have a de novo target lesion located in a native coronary artery.
For info regarding 2025P000648
please contact Robert Yeh at 617-632-7653 or
ryeh@bidmc.harvard.edu
Title: A Phase 2, Open-label, Proof-of-Concept Study to Investigate the Efficacy, Safety, and Tolerability of TAK-411 in Adult Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (The CASCA Study)
Brief Title: The CASCA Study
Brief Summary: CIDP is an autoimmune disease. This means that the body's germ fighting (immune) system
attacks itself. In CIDP, the immune system attacks the protective covering around the
nerves called myelin. Over time, these nerves lose their ability to send signals to the
muscles in the body. This leads to muscle weakness and loss of sensation in arms and legs
among other symptoms. Participants with CIDP can be treated with a protein called
immunoglobulin (or IG).
TAK-411 is a special type of immune globulin G (hsIgG) that has been chemically changed.
It is made from IG that comes from human plasma. This study will test if TAK-411 can
decrease inflammation and improve symptoms of CIDP.
The main aim of this study is to check how TAK-411 affects the physical functioning of
adults with CIDP when compared with results of the placebo group of a historical trial.
Participants may be treated with TAK-411 for up to 1 year (51 weeks) and will be followed
up for 3 weeks after last dose.
During the study, participants may visit their study clinic up to approximately 21 times.
For info regarding 2025P000641
please contact Fernanda Wajnsztajn Yungher at
fwajnszt@bidmc.harvard.edu
Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderate to Severe
Hidradenitis Suppurativa
Brief Title: Evaluate Tulisokibart for Hidradenitis Suppurativa
Brief Summary: This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and
efficacy of tulisokibart in participants with moderate to severe hidradenitis
suppurativa. The primary hypothesis is that at least 1 dose of tulisokibart is superior
to placebo with respect to the proportion of participants achieving a 50% reduction in
Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (ie, at end of
double-blind treatment).
For info regarding 2025P000635
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: Characterizing body temperature across the menstrual cycle in reproductive-age day and night shift working nurses
Brief Title: Temperature in day and night shift working women
Brief Summary: We invite female nurses in the Longwood Medical Area between the ages of 18-35 to consider participating in this study. Specifically, we are seeking nurses who work only day or only night shifts, who are not taking hormonal birth control, and who are not pregnant or actively trying to become pregnant. The study will be conducted in the BIDMC Clinical Research Center and will involve brief, in-person study visits, body temperature collection across the menstrual cycle using different types of temperature collection devices, questionnaires, and urine sample collection.
This study is being done to understand whether female nurses between the ages of 18 and 35, who work night-shifts, show temperature irregularities across their menstrual cycle, compared to those nurses who work more standard, day shifts. The study will also help us determine whether peripheral temperature recording devices accurately reflect the internal core body temperature (and potential temperature irregularities that may occur when working night shifts). Learning more about temperature dynamics across the menstrual cycle of both day and night-shift working females could help with future fertility treatments, given that many night-shift working women experience infertility.
For info regarding 2025P000624
please contact Sydney Aten, PhD at
saten@bidmc.harvard.edu
Title: An open label pilot study of infrared photobiomodulation in humans with epilepsy
Brief Title: photobiomodulation in epilepsy
Brief Summary: Drug-resistant epilepsy represents roughly 40% of people with epilepsy. It is very
challenging to stop seizures in this condition, and the treatment options are limited.
This study aims to investigate a new treatment that involves using infra-red light. In
animals, this treatment has shown promise as a possible way to reduce seizures, but it
has not been tested in humans for this. The investigators are interested to know if it
can reduce seizures, and how comfortable it is to be treated with this therapy.
For info regarding 2025P000606
please contact Daniel Goldenholz at 617-632-8934 or
dgoldenh@bidmc.harvard.edu
Title: A Phase 2, Multi-Center Study Consisting of a Randomized, Placebo-Controlled Period, Followed by an Open-Label Extension Period to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Hidradenitis Suppurativa
Brief Title: Tibulizumab in Adults with Hidradenitis Suppurativa
Brief Summary: The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study
to evaluate the effects of tibulizumab over 16 weeks (Period 1) in adults with
hidradenitis suppurativa, followed by a 16-week open-label extension period in which all
participants will receive tibulizumab (Period 2)
For info regarding 2025P000578
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa
Brief Title: Sonelokimab in Adults with Hidradenitis Suppurativa
Brief Summary: This is a study to evaluate the long-term safety, tolerability, and efficacy of
sonelokimab in participants with moderate to severe hidradenitis suppurativa who were
previously enrolled in a parental study.
For info regarding 2025P000575
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: Transforming Adolescent Perception and Mental Health through Meditation and Cognitive Reappraisal A Mixed Method Study
Brief Title: THRIVE
Brief Summary: This study will evaluate how a comprehensive meditation-based program, Inner Engineering,
supports teens ages 15-18 in becoming more joyful, focused, resilient, and better
equipped to manage stress and thrive. Through this study, researchers will examine
whether practices like meditation, yoga, and cognitive reframing can help adolescents
view and respond to challenges with greater clarity and balance. The study will assess
mental and physical impacts through self-report, physiological, and neuroimaging methods.
For info regarding 2025P000560
please contact Hemavarne Shankhar at
hshankha@bidmc.harvard.edu
Title: A Prospective Randomized Basket Trial Evaluating the Clinical Utility of Plasma-Based Microbial Cell-Free Metagenomic Sequencing for Infection Diagnosis in Adult Immunocompromised Outpatients
Brief Title: Optimum
Brief Summary: This clinical trial is designed to evaluate if adding the Karius Spectrum™ plasma test to
usual care diagnostic tests, compared to usual care testing alone, among
immunocompromised participants presenting with suspected infection in the outpatient
setting leads to faster infection diagnosis and treatment. Participants will give a blood
sample one time to be used for the testing. Information about the participant's illness
and any treatments within 30 days following enrollment will be recorded.
For info regarding 2025P000549
please contact Aliyyah Catyb at
acatyb@bidmc.harvard.edu
Title: CLEAR-AKI: A multicenter, randomized, double-blind, placebo-controlled, four-arm, parallel-group, dose-finding phase 2b study to investigate the safety and efficacy of TIN816 via a single intravenous infusion in the treatment of participants with sepsis-associated acute kidney injury (SA-AKI)
Brief Title: Phase 2b study to investigate the safety and efficacy of TIN
Brief Summary: The purpose of this Ph2b study is to characterize the dose-response relationship and to
evaluate the safety and efficacy of three different single doses of TIN816 in
hospitalized adult participants in an intensive care setting with a diagnosis of
sepsis-associated acute kidney injury (SA-AKI).
For info regarding 2025P000519
please contact Tatyana Shvilkina at 617-732-5638 or
tshvilki@bidmc.harvard.edu
Title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa: Topical Ruxolitinib Evaluation in Hidradenitis Suppurativa (TRuE-HS1)
Brief Title: Phase 3 Topical Ruxolitinib Evaluation in HS
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in
participants with hidradenitis suppurativa.
For info regarding 2025P000510
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: Prospective Multicenter Clinical Performance Study of a Single-use Large Channel Digital Pancreaticobiliary Scope (DPS) with Compatible Accessories
Brief Title: Dragonfly Pancreaticobiliary Scope
Brief Summary: This study plans to enroll up to 75 research subject who have a biliary disorder such as
bile duct stones or intermediate biliary strictures. The purpose of this research is to
assess whether the Dragonfly™ Pancreaticobiliary Scope functioned as intended in
combination with the commercially available accessories during your scheduled endoscopy
procedure. This includes achieving stone fragmentation of difficult biliary stone(s)
while obtaining adequate tissue specimens for analysis. There will also be a Product
performance evaluation as rated by the endoscopist operating the DPS System and
evaluation of ergonomics and usability.
For info regarding 2025P000505
please contact Douglas Pleskow at 617-632-8623 or
dpleskow@bidmc.harvard.edu
Title: Facial Affect and Cortical Electrical Stimulation
Brief Title: Facial Affect & Cortical Electrical Stimulation (FACES)
Brief Summary: By participating, you will help us investigate brain activity patterns associated with emotion processing. We will also evaluate the potential of non-invasive brain stimulation as a tool to alter brain activity patterns with the goal of improving the ability to recognize emotions. We are looking for individuals with a diagnosis of schizophrenia, schizoaffective disorder, bipolar I disorder with psychotic features, or other symptoms of psychosis.
For info regarding 2025P000498
please contact Dr. Rebekah Trotti, PhD at 617-754-1262 or
rtrotti@bidmc.harvard.edu
Title: Global pilot study of rEnal and hepatic coMbINed denervatIon in subjects with Uncontrolled Hypertension with and without High Cardiovascular Risk (SPYRAL GEMINI Pilot Study)
Brief Title: SPYRAL Gemini
Brief Summary: The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation
with the Gemini System is safe and provide evidence of blood pressure reduction when
studied in an uncontrolled hypertensive population with and without high cardiovascular
risk.
For info regarding 2025P000492
please contact Eric Secemsky at 617-632-7701 or
esecemsk@bidmc.harvard.edu
Title: The HIgh-fidelity hydraulic couPling Upper-arm cuff assessment of Limits, Safety, and Effectiveness (HIPULSE) (Blood Pressure): A Multicenter, Prospective, Non-randomized, Single arm, Self-controlled Observational Trial
Brief Title: HIPULSE
Brief Summary: The purpose of this study is to compare measurements of blood pressure (BP) and fluid
responsiveness between the Philips AMC and invasive radial arterial line in surgical
patients.
For info regarding 2025P000484
please contact Somnath Bose at 617-667-7600 or
sbose2@bidmc.harvard.edu
Title: Development of the Tremor Exam for the Office (TEO)
Brief Title: 3-Minute Tremor Exam for the Office (TEO)
Brief Summary: The purpose of this study is to develop a potential new clinical rating scale for essential tremor. Participation in this observational study requires one in-person study visit at BIDMC in which you will answer survey questions and have your tremor symptoms recorded on video.
For info regarding 2025P000479
please contact Jackie Forbes at 617-667-9885 or
jforbes1@bidmc.harvard.edu
Title: Pilot Study of Protection And Repair of Endothelial Glycocalyx in Sepsis
Brief Title: SPARES
Brief Summary: Sepsis damages the blood vessel lining and its protective "glycocalyx," contributing to
organ failure and death. This pilot, randomized, blinded study will test whether giving
fresh frozen plasma (FFP)-either as intermittent boluses or as a continuous
infusion-protects or repairs the glycocalyx compared with look-alike placebo fluid
(lactated Ringer's with multivitamins), and whether this leads to better clinical
outcomes. We will measure blood and urine biomarkers of glycocalyx injury and track organ
support needs, ICU/hospital-free days, and survival through 28-90 days.
For info regarding 2025P000466
please contact Nathan Shapiro at 617-754-2334 or
nshapiro@bidmc.harvard.edu
Title: A Phase 2b Randomized, Single-Center, Double blind, Placebo Controlled, 2-Arm Study to Investigate Orally Administered Combination Therapies (5-alpha reductase inhibitor + Raloxifene) Compared with Monotherapy (5-alpha reductase inhibitor + Placebo) in Adult Patients with Benign Prostatic Hyperplasia (BPH)
Brief Title: 5-ARI + Raloxifene Trial
Brief Summary: SRD5A2 is a critical enzyme for prostatic development and growth, and the SRD5A2
inhibitor, finasteride, is used to treat benign prostatic hyperplasia (BPH). SRD5A2 is
absent in 30% of normal adult men, which explains the resistance of a subset of patients
to this commonly prescribed drug. This project proposes new combination therapies
(5-ARI+raloxifene) and evaluates novel non-invasive biomarkers, based on alternative
pathways that lead to prostatic enlargement.
For info regarding 2025P000440
please contact Aria Olumi at 617-667-4075 or
aolumi@bidmc.harvard.edu
Title: A Phase 4, Open-label, Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine As Part of Multimodal Therapy for Acute Pain After Aesthetic or Reconstructive Surgeries
Brief Title: SUZ After Aesthetic Procedures
Brief Summary: The purpose of this study to evaluate the effectiveness, safety, and tolerability of SUZ
as part of multimodal therapy (MMT) in treating acute postoperative pain.
For info regarding 2025P000427
please contact Samuel Lin at 617-632-7830 or
sjlin@bidmc.harvard.edu
Title: A Global Phase 3 Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Intravenous AOC 1001 for the Treatment of Myotonic Dystrophy Type 1
Brief Title: Harbor OLE
Brief Summary: A Global Phase 3 Open-Label Extension Study to Assess the Long-Term Safety, Tolerability,
and Efficacy of Intravenous Delpacibart Etedesiran (abbreviated del-desiran, formerly AOC
1001) for the Treatment of Myotonic Dystrophy Type 1
For info regarding 2025P000422
please contact Seward Rutkove at 617-667-8130 or
srutkove@bidmc.harvard.edu
Title: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Efficacy And Safety Of Brensocatib In Adults With Moderate To Severe Hidradenitis Suppurativa-The Cedar Study - Ins1007-231
Brief Title: EFFICACY AND SAFETY OF BRENSOCATIB IN ADULTS WITH HS
Brief Summary: The primary purpose of the study is evaluate the effect of brensocatib compared with
placebo.
For info regarding 2025P000373
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Stylet-Driven ICD Lead Intended for Conduction System Pacing IDE Study
Brief Title: ASCEND CSP
Brief Summary: This is a prospective, multi-center, global, single-arm, pivotal investigational study
designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject
population indicated for ICD or CRT-D therapy.
The clinical investigation will enroll up to 414 subjects at up to 70 participating
centers from the United States, Canada, Europe, and Asia Pacific.
For info regarding 2025P000365
please contact Peter Zimetbaum at 617-667-0000 or
pzimetba@bidmc.harvard.edu
Title: A Phase II, 26-week, double-blind, placebo-controlled study to assess the safety, tolerability,
pharmacokinetics, and efficacy of ONO-2020 in patients with mild to moderate Alzheimer’s
Disease
Brief Title: A Phase II study to assess the safety, tolerability, pharmac
Brief Summary: This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess
safety, tolerability, pharmacokinetics, and efficacy of ONO-2020 in participants with
mild to moderate Alzheimer's disease (AD). This study aims to determine whether
administering ONO-2020, an epigenetic regulator, may improve cognitive functions like
memory and cognition in individuals with Alzheimer's disease dementia.
For info regarding 2025P000361
please contact Daniel Press at 617-667-0459 or
dpress@bidmc.harvard.edu
Title: Community and Household Acute Respiratory Illness Monitoring (CHARM) Study
Brief Title: CHARM Study
Brief Summary: The CHARM Study is an observational study to gather important data on respiratory viral illnesses in communities in the Greater Boston Area. We will study how often respiratory viral illnesses occur - like COVID19 and influenza - and how these viruses are spread. Our goal is to improve public health interventions to prevent disease.
For info regarding 2025P000360
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: Brain Age Sleep Indices of Longitudinal Cognition
Brief Title: BASILsC
Brief Summary: The main goal of this study is to explore how sleep affects memory, attention, and overall brain function in adults by using two wearable and non-invasive devices called Muse S, and Oura Ring. The Muse S is a headband that tracks your brain activity; and the Oura Ring is a ring that tracks your breathing, heart rate, sleep quality, recovery, and overall wellness. Well collect data on your sleep and heart health for up to 20 nights within 3
months and will also ask you to complete mental tasks the morning after. By doing this, we hope to find patterns that could help us understand what healthy brain aging looks like and to spot early signs of memory or thinking problems. This research could lead to ways to support brain health and prevent issues as we get older.
For info regarding 2025P000336
please contact Kaileigh Gallagher at
kgallag2@bidmc.harvard.edu
Title: Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung – Study 3
Brief Title: BREATHE - 3
Brief Summary: The objective of this study is to assess the safety and efficacy of Apreo BREATHE system
when used to support native airways and release trapped air in the treatment of adult
COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal
medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to
tent open native airways. The study will include up to 250 participants at up to 25 study
centers located in the United States and Europe. Study subjects will be followed for 3
years. The main questions it aims to answer are: Is it safe? Does it work?
For info regarding 2025P000295
please contact Adnan Majid at 617-632-8252 or
amajid@bidmc.harvard.edu
Title: exPDite-2: A Phase 3 Study to Assess the Efficacy and Safety of Midbrain
Dopaminergic Neuronal Cell Therapy (Bemdaneprocel) for Participants
With Parkinson’s Disease
Brief Title: exPDite-2
Brief Summary: Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled,
double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102
adults with Parkinson's Disease (PD).
For info regarding 2025P000294
please contact Ludy Shih at 617-667-2822 or
lshih@bidmc.harvard.edu
Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABBV-CLS-628 in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Brief Title: Study of ABBV-CLS-628 in Adults with ADPKD
Brief Summary: Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of
kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of
this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of
ADPKD in adult participants.
ABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD.
Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a
different treatment. There is a 1 in 4 chance that participants will be assigned to
placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100
sites worldwide.
Participants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks.
Participants will be followed for up to 15 weeks.
There may be higher treatment burden for participants in this trial compared to their
standard of care . Participants will attend regular visits during the study at a hospital
or clinic. The effect of the treatment will be checked by medical assessments, blood
tests, checking for side effects and completing questionnaires.
For info regarding 2025P000270
please contact Peter Czarnecki at 617-667-8378 or
pczarnec@bidmc.harvard.edu
Title: A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaLuate the effIcacy and safety of abeLacimab in high-risk patients with Atrial fibrillation who have been deemed unsuitable for oral antiCoagulation (LILAC)
Brief Title: Abelacimab vs placebo in Afib
Brief Summary: A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic
stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been
deemed by their responsible physicians or by their own decision to be unsuitable for oral
anticoagulation therapy.
For info regarding 2025P000250
please contact Rushad Patell at 617-667-2100 or
rpatell@bidmc.harvard.edu
Title: Imaging Biomarkers of Glymphatic Function in Patients with Migraine
Brief Title: Glymphatic MRI
Brief Summary: The main goal is to determine whether glymphatic imaging biomarkers are altered in migraine patients (compared to healthy controls), and whether those markers differ in chronic vs. episodic migraine patients. The study activities include a screening visit, at which you will answer some questions about your migraines (if you have a diagnosis of migraines), and an MRI scan.
For info regarding 2025P000195
please contact Narjes Jaafar at
njaafar@bidmc.harvard.edu
Title: A Phase 4, Open-label, Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine As Part of Multimodal Therapy for Acute Pain After Laparoscopic Procedures of the Intraperitoneal or Retroperitoneal Cavities or Arthroscopic Orthopedic Procedures
Brief Title: SUZ After Laparoscopic Procedures
Brief Summary: The purpose of this study is to evaluate the effectiveness, safety, and tolerability of
SUZ for acute pain after laparoscopic procedures of the intraperitoneal or
retroperitoneal cavities or arthroscopic orthopedic procedures.
For info regarding 2025P000191
please contact Samuel Lin at 617-632-7830 or
sjlin@bidmc.harvard.edu
Title: Using High Definition transcranial Direct Current Stimulation to Treat Verbal Retrieval Deficits Secondary to Chronic Traumatic Brain Injury (STIM-CTBI)
Brief Title: HDtDCS for verbal deficits in chronic TBI
Brief Summary: The purpose of this study is to learn more about how brain stimulation affects word
finding problems in people who have a traumatic brain injury (TBI). The type of brain
stimulation used is called transcranial direct current stimulation (tDCS). tDCS delivers
low levels of electric current to the brain and high definition tDCS (HD-tDCS) delivers
the current with multiple electrodes on the scalp. This current is delivered with HD-tDCS
to parts of the brain that may help with remembering things. The investigators hope that
this can help to improve word finding and memory problems in people with TBI.
For info regarding 2025P000171
please contact Hsueh-Sheng Chiang at 617-667-8289 or
hchiang3@bidmc.harvard.edu
Title: Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt System in the Treatment of Normal Pressure Hydrocephalus (STRIDE)
Brief Title: STRIDE E-Shunt Study
Brief Summary: Prospective, multi-center, randomized, controlled trial of the eShunt System in the
treatment of patients with normal pressure hydrocephalus.
For info regarding 2025P000157
please contact Christopher Ogilvy at 617-111-1111 or
cogilvy@bidmc.harvard.edu
Title: A randomized, double-blind, double-dummy, placebo-controlled, multicenter, Phase 3 study assessing the efficacy, safety, and tolerability of 2 doses of remibrutinib over a 68-week treatment period in adult and adolescent patients with moderate to severe hidradenitis suppurativa
(RECHARGE-2)
Brief Title: A randomized, double-blind, double-dummy, placebo-controlled
Brief Summary: The purpose of this study is to establish the efficacy, safety, and tolerability of
remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate
to severe hidradenitis suppurativa (HS).
For info regarding 2025P000136
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: Detection of Novel Urine Biomarkers During Inflammation and Infection
Brief Title: AccUrine testing for host response to infection
Brief Summary: The purpose of this study is to explore a new laboratory test that measures specific proteins in urine to determine the presence of a bacterial or viral infection. This study involves collecting urine and blood for research testing and comparing the results to the results of any tests patients have done for their regular clinical care. We hope the information that we learn from this study can be used to develop a new way of diagnosing an infection.
For info regarding 2025P000133
please contact ED Research Team at (617)-650-0042 or
edresearch@bidmc.harvard.edu
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Iii Study To Evaluate The Efficacy And Safety Of Anifrolumab In Adults With Chronic And/Or Subacute Cutaneous Lupus Erythematosus Who Are Refractory And/Or Intolerant To Antimalarial Therapy
Brief Title: ANIFROLUMAB CHRONIC/ SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS
Brief Summary: This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab
versus placebo in adult participants with chronic and/or subacute cutaneous lupus
erythematosus (CLE).
For info regarding 2025P000097
please contact Peter Chien at 617-667-2851 or
pchien@bidmc.harvard.edu
Title: A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR 014 PTCA Drug Eluting Balloon in the Treatment of Subjects with De Novo Coronary Lesions in Small Vessels
Brief Title: SELUTION4DeNovo Small Vessel
Brief Summary: Prospective, randomized controlled, single-blind, multicenter, clinical trial to
demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de
novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of
2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United
States (US) FDA.
The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel
angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy,
at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the
subjects will be enrolled in the US.
For info regarding 2025P000068
please contact Marie-France Poulin at
mpoulin@bidmc.harvard.edu
Title: A Pilot Study To Assess The Effect Of Antepartum Perineal Massage Using A Pelvic Wand On Labor Agency And Pelvic Health
Brief Title: Perineal Massage Intervention
Brief Summary: There is limited research on the optimal strategy to reduce obstetric laceration,
postpartum urinary retention, and postpartum pelvic pain. In systematic reviews,
clinician-directed massage of the perineal muscles at the time of birth and patient
directed massage of the perineal muscles in the third trimester to inconsistently reduce
the incidence of severe obstetric laceration.1,2 However, there is significant
heterogeneity of these studies is due in large part to the lack of a standardized
protocols and unpredictability of clinician availability to perform perineal massage
around the time of birth.
The purpose of this study is to understand how perineal massage with a pelvic wand in
late pregnancy and during labor influences one's sense of self-control over the labor
process and birth experience.
For info regarding 2025P000062
please contact Sarah Little at 617-667-2636 or
slittl10@bidmc.harvard.edu
Title: Medtronic Safety and Performance Assessment of the Sphere-9TM Catheter and Affera Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT)
Brief Title: Sphere-9 VT
Brief Summary: Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility
study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia due
to prior myocardial infarction will be enrolled and treated with the Sphere-9 Catheter
and Affera Ablation System.
For info regarding 2025P000054
please contact Andre Luiz DAvila at 617-732-9210 or
adavila@bidmc.harvard.edu
Title: Interventional, randomized, double-blind, placebo-controlled, optional open-label extension trial of Lu AF82422 in participants with Multiple System Atrophy
Brief Title: Lu AF82422 – Phase III clinical trial for MSA (MASCOT)
Brief Summary: The main goal of this trial is to evaluate the efficacy and safety of amlenetug for the
treatment of participants with Multiple System Atrophy (MSA).
For info regarding 2025P000043
please contact Roy Freeman at 617-632-8454 or
rfreeman@bidmc.harvard.edu
Title: A Phase 2 Double-Blind Placebo-Controlled Single-Dose Study of Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of REGN7544, an NPR1 Antagonist Monoclonal Antibody, in Patients with Postural Orthostatic Tachycardia Syndrome
Brief Title: Phase 2 NPR1 Antagonist in Patients with POTS
Brief Summary: This study is researching an experimental drug called REGN7544 (called "study drug"). The
study is focused on participants with POTS.
The aim of the study is to see how safe, tolerable, and effective the study drug is.
The study is looking at several other research questions, including:
- How the study drug changes heart rate and blood pressure in participants with POTS
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the study
drug less effective or could lead to side effects)
For info regarding 2025P000042
please contact Roy Freeman at 617-632-8454 or
rfreeman@bidmc.harvard.edu
Title: Evaluating Comprehension of Emergency Department Discharge Instructions Translated by Large Language Models using Spanish-Speaking Patients
Brief Title: Machine Translated Spanish Discharge Instructions
Brief Summary: This study is being done to evaluate the safety and impact of providing Spanish-speaking patients with machine translations of their discharge instructions after an Emergency Department (ED) visit. When patients are discharged from the ED, they are provided with a summary of their diagnosis, the results of their tests (e.g. blood tests, imaging studies), and instructions on how to care for themselves at home and when to return to the hospital. Because we dont have enough interpreters to translate every single discharge instruction document for patients who dont speak English, we are testing a computer program that can translate these instructions automatically.
For info regarding 2025P000001
please contact ED Research Team at (617)-650-0042 or
edresearch@bidmc.harvard.edu
Title: Utility of the Thopaz+ System in Evaluating Persistent Air Leaks
Brief Title: Thopaz+ for PALs
Brief Summary: Persistent air leaks (PALs) are a common postoperative complication resulting from tears
in the visceral pleura or peripheral lung resections. Although highly prevalent with
significant consequences, traditional assessment methods lack the capability to
objectively quantify air leaks, which further complicates management, results in
inconsistent decision making, and prolongs hospital stays. By incorporating the Thopaz+
system, the investigators can introduce a reliable approach to objectively quantify air
leaks, potentially improving clinical outcomes.
The purpose of this protocol is to perform a pilot prospective controlled clinical trial
to evaluate the utility of incorporating the Thopaz+ system and its volume quantification
ability in evaluating patients with persistent air leaks (PALs) to guide treatment
decisions, specifically endobronchial valves (EBVs).
In the targeted cohort, the Thopaz+ will be connected to the chest tube and the data
collected will be combined with that of serial balloon occlusion testing with a Fogarty
balloon to accurately localize the air leak source, and subsequently consider the correct
placement of EBVs. The investigators will thereby determine whether this experimental
strategy will yield a more accurate and objective assessment of air leaks, facilitating
timely interventions and improved patient outcomes.
For info regarding 2024P001113
please contact Kai Swenson at 206-841-1986 or
kswenso1@bidmc.harvard.edu
Title: Bradycardia Pacemaker with AV Interval Modulation for Blood Pressure Treatment
Brief Title: The Backbeat Study
Brief Summary: A prospective, multinational, randomized, double-blind, clinical trial evaluating the
safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm
downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.
For info regarding 2024P001073
please contact Timothy Maher at 617-667-8800 or
tmaher@bidmc.harvard.edu
Title: Sysmex CN-6000 – D-dimer Studies for VTE Exclusion Claim
Brief Title: CN6000-DD-VTE Exclusion-01
Brief Summary: We are studying an investigational blood test that may be used to rule out clots in the lungs or legs. The main purpose of this study is to determine whether the investigational blood test can be used to rule out blood clots in the lungs or legs. We are inviting people to take part in this study if they have been suspected to have a clot in a blood vessel (venous thromboembolism [VTE]) in the lungs and/or in the deep veins in their legs.
For info regarding 2024P001071
please contact ED Research Team at (617) 650-0042 or
cottanel@bidmc.harvard.edu
Title: Assessment of the Carillon Mitral Contour System in Treating Heart Failure with Functional Mitral Regurgitation
Brief Title: EMPOWER
Brief Summary: The objective of this prospective, randomized, blinded clinical trial is to assess the
safety and efficacy of the Carillon Mitral Contour System in treating heart failure with
functional regurgitation (FMR).
For info regarding 2024P001052
please contact Arthur Garan at 917-374-3346 or
agaran@bidmc.harvard.edu
Title: Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections (LYTICS +)
Brief Title: LYTICS +
Brief Summary: The purpose of this protocol is to conduct a pilot prospective non-blind clinical trial
to evaluate the efficacy and safety of a novel saline irrigation technique as an adjunct
to standard interventions for treating retained pleural infections. Intrapleural
fibrinolytic therapy (IPFT) is commonly used for infections not adequately managed with
antibiotics and intercostal tube drainage, while saline irrigation serves as an
alternative for cases with a high bleeding risk where IPFT is not feasible. The efficacy
of saline irrigation combined with IPFT remains unexplored. The hypothesis is that saline
irrigation could be an effective and safe addition to IPFT for patients with persistent
pleural infections.
The specific aims of the study include:
Determine the efficacy of saline irrigation as add-on therapy to IPFT: Compare the
clinical outcomes of patients receiving saline irrigation combined with IPFT to those
receiving IPFT alone to determine if the addition of saline irrigation offers significant
benefits. Outcomes include changes in inflammatory markers, imaging characteristics
(echography and CT), volume of pleural fluid drained, chest tube duration, hospital
length of stay, and the need for subsequent surgical intervention.
Assess the safety and tolerability of saline irrigation plus IPFT: Compare complications
and patient comfort in those receiving saline irrigation combined with IPFT to those
receiving IPFT alone.
For info regarding 2024P001043
please contact Adnan Majid at 617-632-8252 or
amajid@bidmc.harvard.edu
Title: Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study of the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Coronary IVL Catheter (FORWARD CAD IDE Study)
Brief Title: FORWARD CAD IDE Study
Brief Summary: The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational
Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary IVL Catheter
for the treatment of calcified, stenotic de novo coronary artery lesions prior to
stenting.
For info regarding 2024P001040
please contact Hector Tamez Aguilar at
htamez@bidmc.harvard.edu
Title: A Phase 1/2, Randomized, Sequential, Dose Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of a One-Time, Bilateral, Intraparenchymal Infusion of SPK10001 Into the Caudate and Putamen in Participants With Huntington’s Disease
Brief Title: AAVAIL-HD
Brief Summary: The main goal of this study is to evaluate the safety, tolerability, and preliminary
efficacy of SPK-10001 in participants with Huntington's Disease.
For info regarding 2024P000988
please contact Clementina Ullman at 617-667-2355 or
cullman@bidmc.harvard.edu
Title: A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T-cells (CABA-201) in Participants with Generalized Myasthenia Gravis (CAB-201-004)
Brief Title: RESET-MG
Brief Summary: RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in
Participants with Generalized Myasthenia Gravis
For info regarding 2024P000986
please contact Amy Lewandowski at 617-667-2545 or
alewand2@bidmc.harvard.edu
Title: Clinical Validation of the NeXGen Fungal/AFB NGS Test for Diagnosis of Invasive Mold Disease (IMD) in Immunocompromised Hosts
Brief Title: Validation of NeXGen Fungal Test for IMD
Brief Summary: The purpose of this study is to validate the efficacy and validity of a new type of invasive mold disease test in patients who are immunocompromised. A one-time blood draw will be collected from subjects while they are at the hospital for an inpatient admission or outpatient visit.
For info regarding 2024P000982
please contact Audrey Mahajan at 617-632-0827 or
amahaja1@bidmc.harvard.edu
Title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Hidradenitis Suppurativa
Brief Title: Evaluate SBT777101 in Subjects With Hidradenitis Suppurativa
Brief Summary: This study will test the safety and effects of SBT777101 when given as a single dose to
subjects with hidradenitis suppurativa. Increasing dose levels will be given after the
safety at lower dose levels is shown.
For info regarding 2024P000968
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN7544, an Antagonist Monoclonal Antibody to NPR1, in Patients with Sepsis-Induced Hypotension
Brief Title: R7544-SIH-2435
Brief Summary: This study is researching an experimental drug called REGN7544 (called "study drug"). The
study is focused on adult patients (18 to 85 years) hospitalized due to a serious
infection (called "sepsis") and receiving standard-of-care medications for low blood
pressure (called "vasopressors") due to sepsis.
The aim of the study is to see how safe, tolerable, and effective the study drug is by
observing the effects on blood pressure and the total amount of vasopressor dose received
during the stay in the hospital.
The study is looking at several other research questions, including:
- How the study drug changes the blood pressure and the amount of intravenous (IV)
fluids given to participants with low blood pressure due to sepsis
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug
less effective or could lead to side effects)
For info regarding 2024P000957
please contact Nathan Shapiro at 617-754-2334 or
nshapiro@bidmc.harvard.edu
Title: Investigating Electrophysiological Markers for Depressive Rumination as Noninvasive Brain Stimulation (NIBS) Treatment Targets
Brief Title: FLEX Rumination
Brief Summary: By participating, you will help us investigate brain activity patterns associated with cognitive flexibility, a process which allows humans to switch tasks or perspectives. An additional, optional part of this study also seeks to evaluate the potential of non-invasive brain stimulation as a tool to alter brain activity patterns, with the goal of reducing depressive rumination and suicidal ideation. We are looking for individuals with recent (6 months) diagnosis of major depressive disorder or persistent depressive disorder, and healthy volunteers
For info regarding 2024P000910
please contact Ling-Yu Huang, PhD at 617-754-1259 or
lhuang11@bidmc.harvard.edu
Title: Prospective Non-Interventional, Phase Iv Multicentre Study To Assess The Effectiveness, Safety And Tolerability Of Elafibranor 80 Mg/Day In Patients With Primary Biliary Cholangitis Receiving Treatment In A Real-World Setting
Brief Title: ELFINITY CLIN-60190-461
Brief Summary: This study will collect information from participants with Primary Biliary Cholangitis
(PBC) as they use the drug elafibranor in real world setting.
PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are
damaged.
The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with
multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may
require liver transplant or may die if the disease progresses and a liver transplant is
not done.
In this study the main aim is to observe the effectiveness, safety and tolerability of
elafibranor in participants with PBC who are receiving treatment in real world setting.
The total study duration for each participants will be 60 months (approximately 5 years).
For info regarding 2024P000905
please contact Alan Bonder at 617-632-1070 or
abonder@bidmc.harvard.edu
Title: Prospective Non-Interventional, Phase Iv Multicentre Study To Assess The Effectiveness, Safety And Tolerability Of Elafibranor 80 Mg/Day In Patients With Primary Biliary Cholangitis Receiving Treatment In A Real-World Setting
Brief Title: ELFINITY CLIN-60190-461
Brief Summary: This study will collect information from participants with Primary Biliary Cholangitis
(PBC) as they use the drug elafibranor in real world setting.
PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are
damaged.
The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with
multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may
require liver transplant or may die if the disease progresses and a liver transplant is
not done.
In this study the main aim is to observe the effectiveness, safety and tolerability of
elafibranor in participants with PBC who are receiving treatment in real world setting.
The total study duration for each participants will be 60 months (approximately 5 years).
For info regarding 2024P000905
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS): A Multi-Center Randomized Controlled Trial
Brief Title: Cryo-BAS
Brief Summary: The goal of this clinical trial is to compare spray cryotherapy plus balloon dilatation
versus current standard of Care (SoC - steroid injection, radial cuts and balloon
dilatation) in patients with benign airway stenosis with simple stenosis. The main
question[s] investigators aim to answer are:
1. What is the need for reintervention and time to reintervention in participants with
benign airway stenosis with simple stenosis who receive spray cryotherapy plus
balloon dilatation versus standard of care alone?
2. To evaluate patient experience, physiological, anatomical changes, health care
utilization and safety of the SCT plus balloon dilatation versus standard of care
alone.
Researchers will compare spray cryotherapy plus balloon dilatation versus current
standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in
patients with benign airway stenosis with simple stenosis to see if it reduces the need
of re intervention.
Participants will surgery and receive one of the two interventions.
For info regarding 2024P000875
please contact Adnan Majid at 617-632-8252 or
amajid@bidmc.harvard.edu
Title: A Phase 2b, multicenter, randomized, double-blind study of safety and efficacy of TAK-755 (rADAMTS13) with minimal to no plasma exchange (PEX) in the treatment of immune-mediated thrombotic thrombocytopenic purpura (iTTP)
Brief Title: TAK-755 in iTTP
Brief Summary: This is a study of TAK-755 in adults with immune-mediated thrombotic thrombocytopenic
purpura (iTTP). The main aim of this study is to determine the percentage of participants
with a clinical (Part 1) or platelet (Part 2) response without plasma exchange during the
study. Participants who have an acute attack of iTTP will receive TAK-755 and
immunosuppressive therapy during their stay at the hospital until they achieve a clinical
response in Part 1 or platelet response in Part 2. Participants will also be treated with
TAK-755 for an additional time of up to 6 weeks after the acute phase. In total,
participants will stay in the study for approximately 3 months.
For info regarding 2024P000872
please contact Brian Carney at 617-735-2003 or
bjcarney@bidmc.harvard.edu
Title: A Phase 2, Randomized, Double-blind, Placebocontrolled, Parallel-group Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients with Moderate to Severe Hidradenitis Suppurativa (LOTUS)
Brief Title: Evaluate AVTX-009 in adults with hidradenitis suppurativa
Brief Summary: The main purpose of this study is to evaluate the efficacy and safety of AVTX-009
compared with placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).
For info regarding 2024P000871
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression
Brief Title: ADVENT LTO Study
Brief Summary: The (ADVENT LTO) is an observational, non-significant risk study to assess the
progression of atrial fibrillation in subjects who received ablation treatment with
either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT
Trial.
For info regarding 2024P000833
please contact Jonathan Waks at 617-632-8946 or
jwaks@bidmc.harvard.edu
Title: A Pilot Assessment of the Safety and Efficacy of Pleural Irrigation for Retained Pleural Infection Using a Novel Irrigation Device
Brief Title: Pleural Irrigation
Brief Summary: Single-arm pilot trial of the use of intrapleural saline irrigation to treat retained
pleural infections for patients with contraindications to standard of care intrapleural
enzymatic therapy.
For info regarding 2024P000822
please contact Adnan Majid at 617-632-8252 or
amajid@bidmc.harvard.edu
Title: CALM: Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
Brief Title: CALM
Brief Summary: Following completion of the ALS Early Feasibility Study of the MyoRegulator® device for
treatment of ALS (NCT06165172), the CALM study will further assess the feasibility of the
MyoRegulator® device to treat ALS in an expanded number of individuals with ALS. CALM
will gather additional preliminary evidence of clinical safety and potential
effectiveness in this patient population with a longer follow-up period and additional
secondary endpoints in a single-arm study prior to commencing a larger sham-controlled
pivotal trial.
For info regarding 2024P000805
please contact MIa Hemme at 617-667-3069 or
mhemme@bidmc.harvard.edu
Title: Mind Body Intervention for Chronic Migraine Headaches
Brief Title: PSRT for Migraines
Brief Summary: The goal of this exploratory study is to test a mind-body interventional approach for the
treatment of chronic migraines. The main goal is to obtain feasibility information on the
protocol which has been used in other similar conditions. We will also evaluate multiple
measurement tools in order to optimize a follow-up pilot study evaluating the impact of
the protocol on migraines.
For info regarding 2024P000778
please contact Michael Donnino, MD at
mindbodystudy@bidmc.harvard.edu
Title: Cardiac Resynchronization Therapy Using His/Left BundleBranch Pacing vs Biventricular Pacing with a Left VentricularEpicardial Lead in Patients with Heart Failure (HF) with LeftVentricular Ejection Fraction (LVEF) = 50% and with either aWide QRS Complex (> 130 ms) or with/anticipated > 40%Pacing Randomized Clinical Trial
Brief Title: L vs L RCT
Brief Summary: The investigators aim to prospectively test the comparative effectiveness of His or Left
bundle branch pacing in relation to patient centered outcomes (quality of life, physical
activity, heart failure hospitalization, mortality) and comparative safety in relation to
device-related complications and re-interventions (e.g., lead dislodgement, infection)
relative to standard of care biventricular pacing in patients with heart failure due to
left ventricular systolic dysfunction (LVEF=50%) and with either a wide QRS (=130 ms) or
with/anticipated >40% pacing who are already receiving current standard heart failure
pharmacological therapy.
For info regarding 2024P000735
please contact Andrew Locke at 617-667-8800 or
ahlocke@bidmc.harvard.edu
Title: A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa
Brief Title: Evaluate Lutikizumab in Adults with Hidradenitis Suppurativa
Brief Summary: Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease
which includes the forming of lumps, abscesses and scars in areas of the skin such as
under the breasts, under armpits, inner thighs, groin and buttocks. This study will
compare lutikizumab versus placebo for the treatment of adult and adolescent participants
with the signs and symptoms of moderate to severe HS .
Lutikizumab is an investigational drug being developed for the treatment of HS. During
Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms.
There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult
and adolescent participants with moderate to severe HS will be enrolled in the study at
approximately 275 sites world wide. During Period 2, participants that were part of the
lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab
treatment arms. Participants that were part of the Placebo arm in Period 1 will start
Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2
lutikizumab treatment arms.
In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo
every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in
Period 1 will receive subcutaneous injections of lutikizumab every week or every other
week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will
receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every
week or every other week for 20 weeks.
Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will
continue to receive lutikizumab SC using the same assigned dosing regimen from the end of
Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks.
Participants in the US that complete Periods 1 & 2 will have the option to enroll in a
156-week open-label Sub-Study that will assess the long term safety and efficacy of
lutikizumab in a prefilled pen.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital
or clinic. The effect of the treatment will be checked by medical assessments, blood
tests, checking for side effects and completing questionnaires and diaries.
For info regarding 2024P000711
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: Neuromodulation and cognitive behavioral therapy for insomnia in MCI
Brief Title: Insomnia in MCI
Brief Summary: The goal of this study is to test a new way to improve sleep quality in persons living
with mild cognitive impairment. The treatment combines a safe and gentle way to stimulate
the brain, called transcranial magnetic stimulation, with a psychological treatment,
called cognitive behavioral therapy for insomnia.
For info regarding 2024P000708
please contact Alex Diamond at 617-667-0386 or
adiamon2@bidmc.harvard.edu
Title: A Phase 2a Randomized, Dose Ranging, Double-Blind, 3-Arm Study to Investigate Orally Administered Abrocitinib Compared with Placebo in Non-Hospitalized Symptomatic Adult Participants with Severe Fatigue from Post COVID Condition
Brief Title: CLEAR-LC CLinical Eval Abrocitinib Recovery from Long COVID
Brief Summary: The primary purpose of this phase 2a study is to compare the efficacy of abrocitinib to
placebo in improving severe fatigue in non-hospitalized adults with symptomatic
Post-COVID Condition (PCC) (also called Long COVID). We are also interested in learning
if abrocitinib is effective in improving overall health status in people suffering from
severe fatigue from PCC. Eligible participants with a confirmed history of COVID19
infection who also have PCC according to the World Health Organization definition, will
be randomized to receive abrocitinib at a dose of 50 mg, 100 mg, or placebo by mouth
daily for 12 weeks (84 days).
For info regarding 2024P000700
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: Measurement of interstitial fluid analytes using noninvasive Cambridge Medical Technologies biosensor
Brief Title: CMT biosensor
Brief Summary: In this study, we will learn how well a new device made by Cambridge Medical Technologies (CMT), called the CMT biosensor, is able to measure the amount of glucose and lactate in your body. The current way of measuring these substances is by drawing blood. The downside of blood draws is that they can cause discomfort, increased risk of infection, damage to blood vessels, and delay in measurement. The CMT biosensor uses a new way to sample fluid from your body without the pain associated with a blood draw using a gentle (painless) electrical pulse. The data we get from this study will be used to see how well the CMT biosensor works compared to standard blood draw testing and improve it, so one day, it can be used without the need to draw blood.
For info regarding 2024P000674
please contact Carlo Ottanelli at 617-650-0042 or
cottanel@bidmc.harvard.edu
Title: RAPID-PE Study: RESCUE Advanced Protocol without ICU stay and no lytic Drip - for the Treatment of Pulmonary Embolism
Brief Title: RAPID-PE Study
Brief Summary: To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and
the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of
pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the
pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).
For info regarding 2024P000664
please contact Jeffrey Weinstein at 617-667-7000 or
jlweinst@bidmc.harvard.edu
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in CompanionDiagnostic-Positive Participants with Early Parkinson’s Disease
Brief Title: Early Parkinson’s Disease Therapy with NEU-411
Brief Summary: The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of
NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have
predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for
short) pathway based on their genetic profile. A DNA test will be used to identify the
"LRRK2-driven" population with predicted elevation in the LRRK2 pathway.
Participants will:
• Take NEU-411 or placebo every day for 52 weeks
For info regarding 2024P000654
please contact Hannah Babcock at 617-667-9890 or
hbabcock@bidmc.harvard.edu
Title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson’s Disease (LRRK2-PD)
Brief Title: Safety and Pharmacodynamic Effects of BIIB122 in Participant
Brief Summary: This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled,
parallel-group study, followed by an OLE, is designed to evaluate the safety,
tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD.
LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or
homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.
For info regarding 2024P000639
please contact Hannah Babcock at 617-667-9890 or
hbabcock@bidmc.harvard.edu
Title: Development of a clinical experimental heat stress protocol and exploration of the effect of Niacinamide on physiologic, metabolic, and biochemical responses to heat stress
Brief Title: Experimental heat stress metabolomics and the effect of Nam
Brief Summary: The goal of this clinical trial is to learn about the processes occurring in the kidneys
while under heat stress in healthy volunteers. The main questions it aims to answer are:
- How do the chemicals produced by the body change under conditions of higher versus
lower heat stress?
- What role does a specific area of the body's metabolism, known as NAD+ metabolism,
play in the body's response to heat stress, and can this response be modified by
taking vitamin B3?
For info regarding 2024P000637
please contact Nathan Raines at 617-632-9880 or
nraines@bidmc.harvard.edu
Title: An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients with Severe Emphysema: The CONVERT II Trial
Brief Title: CONVERT II
Brief Summary: This is a prospective, open-label, multi-center, single-arm study planned to enroll 200
subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe.
Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent
assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV-
status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic
lung volume reduction (BLVR) and be followed for 24 months.
For info regarding 2024P000635
please contact Adnan Majid at 617-632-8252 or
amajid@bidmc.harvard.edu
Title: Treatment Resistant Depression Subcallosal Cingulate Network DBS
Brief Title: TRANSCEND Study
Brief Summary: The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral
stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain
Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive
Disorder (MDD) in adults.
For info regarding 2024P000577
please contact Joshua Aronson at 617-632-7023 or
jaronson@bidmc.harvard.edu
Title: Investigating Changes in Anxiety, Sleep Duration and Quality after Shoonya Meditation Practice
Brief Title: RESET
Brief Summary: This study aims to investigate the effects of Shoonya Meditation (taught by the Isha Foundation) on sleep, anxiety, and stress through validated surveys, and sleep data. The control group will consist of individuals who have learned and practice Shambhavi Mahamudra Kriya, also offered by the Isha Foundation.
For info regarding 2024P000521
please contact Alex-Maree Roberts at
amrobert@bidmc.harvard.edu
Title: Sleep, Cognition, and Pain bundle vs ERAS-cardiac [enhanced recovery after cardiac surgery] for postoperative delirium (POD)
Brief Title: SCOPE
Brief Summary: Sleep disturbances, cognitive reserve, and continuing pain and inflammation are other
risk factors contributing to delirium (confusion and agitation) and neurocognitive
decline (in the long term) following heart surgery. Investigators aim to test a bundle of
sleep optimization, cognitive exercise before surgery, and extended pain relief for 48
hours with intravenous acetaminophen combined with enhanced recovery after surgery
protocols (SCOPE bundle). SCOPE will fill significant gaps in evidence by testing the
value of a patient and care-provider-focused intervention that can potentially minimize
POD and improve outcomes (cognitive & physical function, sleep quality, pain, depression
or anxiety, and survival) important to patients and families.
The SCOPE trial will address many heart surgery outcome-related questions commonly asked
by patients:
What can I do to reduce my chances of developing confusion, hallucinations, or delirium
after surgery? How can I best prepare before surgery to improve my long-term health and
avoid disability? Are there exercises I can participate in that improve my sleep, pain,
and mood after surgery? Intellectual pursuits, physical activity, and social interactions
support cognitive reserve, while poor health, poor sleep hygiene, poor nutrition, and
mental health disease can diminish reserve. Various interventions with different
intensities and timing to augment cognitive reserve have been associated with positive
outcomes on neuropsychological testing. Adaptive video gaming for as little as 10 hours
leads to the maintenance of independence in activities of daily living and sustained
improvements in speed of processing, attention, and working memory in older people.
Likely through the increased cognitive reserve, perioperative brain exercise aims to
protect against morbid cognitive recovery after surgery.
Sleep is vital for memory and cognitive function. Poor sleep traits in older adults that
are potentially modifiable, including short/long duration, daytime napping, and
associated sleepiness, led to an almost 2-fold increase in delirium risk. Patients will
complete an evidence-based course on healthy sleep habits and will complete guided
exercises designed to restructure behaviors and thinking. They are encouraged to follow a
set of recommendations to improve their sleep (e.g., optimal sleep duration, advice for
habits such as daytime napping, maintaining a regular sleep schedule, avoiding caffeine,
regular daylight exposure, dimming lights or electronics and relaxation and thought
exercises for optimal sleep); many of these sleep behaviors have been strongly linked to
increased risk for cognitive decline. Investigators propose that sleep optimization
before AND after (an established best practice sleep bundle) surgical insult will
contribute to cognitive reserve leading to decreased delirium risk and key
patient-centered outcomes (postoperative sleep, pain, cognition, mood, and survival).
Inadequate pain relief and opioids are both risk factors for delirium. Surgery on the
chest is a significant pain source. Approximately 30-75% of patients suffer from moderate
to severe pain in the postoperative period. Almost half of the patients have severe pain
at rest, and three-quarters have severe pain during coughing and movement. Pain and
inflammation are closely biochemically linked.
Sleep, brain exercise, and adequate pain control with opioid-sparing can be additive or
synergistic interventions to prevent delirium following heart surgery.
Investigators propose three specific aims by conducting a 1:1 randomized controlled trial
in 406 heart surgery patients 60 or older undergoing heart surgery. They will be
administered perioperative sleep optimization, brain exercise training, and intravenous
acetaminophen over 48 hours. A trained expert will administer the sleep and cognitive
exercise protocols at least two weeks before surgery. This expert will handhold the
patients for two weeks until the surgery. Thus, the gains made before surgery with better
sleep quality and improved brain reserve will be sustained with postoperative pain
control to lower the ongoing inflammation. Through this trial, investigators will
evaluate if the SCOPE bundle can reduce 1) in-hospital delirium, 2) long-term (one, six,
and twelve months) cognitive, physical, and self-care function, and 3) barriers to
implementation of this bundle.
Currently, no options are routinely available to patients to optimize their sleep and
cognition before cardiac surgery. The proposed research is significant because it will be
the first to test the bundled behavioral intervention approach (sleep optimization, brain
exercise) before surgery with extended, scheduled pain management with non-opioids
following surgery. The SCOPE trial will yield relevant and immediately actionable data to
improve care for over 900,000 adults in the U.S. each year.
For info regarding 2024P000520
please contact Balachundhar Subramaniam at 617-754-2721 or
bsubrama@bidmc.harvard.edu
Title: FREXALT: Master Protocol of Two Independent, Randomized, Double-Blind, Phase 3 Studies Comparing Efficacy And Safety Of Frexalimab (Sar441344) To Teriflunomide In Adult Participants With Relapsing Forms Of Multiple Sclerosis
Brief Title: FREXALT (EFC17919)
Brief Summary: The purpose of each study is to independently measure the annualized relapse rate (ARR)
with administration of frexalimab compared to a daily oral dose of teriflunomide in male
and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years
at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis
are eligible for enrollment as long as they meet all the inclusion criteria and none of
the exclusion criteria.
Study details include:
- This event-driven study will have variable duration depending on the recruitment
rate, the event rate, the study discontinuation rate and the 12-month minimum
treatment duration. Different participants will have different study durations. The
last participant randomized will have at least 12 months of study duration, and
assuming a 28-month recruitment period, the first participant randomized will have
40 months or longer of study duration.
- The study intervention duration will vary similarly as the study duration.
- The assessment of scheduled visits will include 1 common end of study [EOS] visit
and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6
months and then every 3 months.
For info regarding 2024P000493
please contact Jacob Sloane, MD at 617-667-3726 or
vsingh4@bidmc.harvard.edu
Title: ENABLE: Real world experience with BRIUMVI (ublituximAB-xiiy) treated patients: a longitudinal registry study
Brief Title: ENABLE
Brief Summary: The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into
the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the
real-world setting
For info regarding 2024P000481
please contact Vikrum Singh at 617-667-3726 or
vsingh4@bidmc.harvard.edu
Title: Implementation of Low-Cost Single-Use Flexible Bronchoscopes for Routine Interventional Pulmonary Procedures: A Feasibility Study
Brief Title: Vathin Human
Brief Summary: The goal of this pilot single-arm crossover trial is to investigate the feasibility and
safety of using single-use flexible bronchoscopes (SUFB) for routine diagnostic and
therapeutic interventional pulmonary procedures instead of reusable flexible
bronchoscopes (RFB). The main questions it aims to answer are:
Was a decision to crossover from SUFB to RFB (at the discretion of the clinical
bronchoscopist) made ?
Bronchoscopist's assessment of the SUFB for each procedure (using a Likert scale 0-10)
including:
1. Overall assessment
2. Scope quality
3. Scope handling
4. Scope maneuverability
5. Tool compatibility
6. Suction
7. Lavage
8. Safety
9. Image quality
Participants will undergo bronchoscopy with single use bronchoscopes.
For info regarding 2024P000471
please contact Adnan Majid at 617-632-8252 or
amajid@bidmc.harvard.edu
Title: Development of physical therapy telehealth program for patients at risk of falls NIA-JHAITC
Brief Title: NIA-JHAITC
For info regarding 2024P000470
please contact Dennis Anderson, PhD at 617-975-7623 or
danders7@bidmc.harvard.edu
Title: Assessment of Long Term, Endovascular AAA Intervention using the GORE EXCLUDER Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis; Gore Together Aortic Registry Protocol
Brief Title: GORE EXCLUDER Conformable
Brief Summary: A prospective, observational post-market registry collecting outcomes through a 10-year
post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA
Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE
Device) as a part of routine clinical practice.
For info regarding 2024P000457
please contact Marc Schermerhorn at 617-632-9971 or
mscherme@bidmc.harvard.edu
Title: Wearable Evaluation of Ambulatory Readings for Blood Pressure
Brief Title: WEAR - BP
Brief Summary: The aim of this project is to serve as a quality control measure, assessing the accuracy and reliability of novel cuffless Blood Pressure monitoring devices. These devices will be evaluated in comparison to the established standard, Spacelabs Ambulatory Blood Pressure Monitoring (ABPM) device. This assessment is crucial to ensure the trustworthiness and suitability of the new devices for upcoming research projects. Up to 250 participants (at least 100) will be involved in this study each wearing up to 7 devices (6 BP and 1 activity monitor). The assignment of devices will be randomized by day and by the arm or wrist on which they are worn.
For info regarding 2024P000441
please contact Frederick Labri Kwapong at
flarbitw@bidmc.harvard.edu
Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Subjects with Progressive Pulmonary Fibrosis (PPF)
Brief Title: A Randomized, Placebo-Controlled, Study with Pirfenidone Sol
Brief Summary: A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and
efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of
care in participants with PPF over 52 weeks.
For info regarding 2024P000407
please contact Sean Levy at 617-726-8554 or
sdlevy@bidmc.harvard.edu
Title: Multicenter SymphonyTM IL-6 Monitoring Sepsis ICU Validation Study
Brief Title: CES-0008
Brief Summary: The primary objective of this discarded/blood draw study is to validate an IL-6 concentration cutoff and optimal time points for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.
For info regarding 2024P000354
please contact ED Research Team at 617-754-2287 or
cottanel@bidmc.harvard.edu
Title: Therapeutic Amyloid Reduction and Cortical Excitability in Alzheimers disease
Brief Title: TRACE-AD
Brief Summary: The purpose of this study is to understand how amyloid removal is beneficial to the brain in Alzheimers Disease. We hope this will help us improve future treatment options. We will enroll 40 Alzheimers disease participants who are planning to start lecanemab (an anti-amyloid agent) through BIDMCs clinical treatment program. TMS and EEG measures of cortical excitability will be assessed at Baseline and periodically over 18 months of treatment. This study will allow us to determine the extent to which the beneficial effects of amyloid removal on cognitive decline may be mediated through improvements in cortical excitablity. If you qualify for and take part in the study, you would undergo all study related visits and testing at no
charge. The study requires approximately 12 in-person visits. You will be compensated for your time and transportation will be provided for any in-person visits.
For info regarding 2024P000337
please contact Stephanie Buss at 617-975-8542 or
sbuss@bidmc.harvard.edu
Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study with Extension Phase to Evaluate the Efficacy and Safety of Dysport for the Prevention of Episodic Migraine in Adult Participants
Brief Title: E-BEOND
Brief Summary: The purpose of this study is to understand the safety and effectiveness of the study
drug, Dysport® when compared with placebo in preventing episodic migraine.
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on
one side of the head, and is often accompanied by feeling or being sick and a sensitivity
to bright lights and sound.
Episodic Migraine is defined as having less than 15 days of headache a month with at
least 6 days with migraine headaches.
Migraines are caused by a series of events which cause the brain to get stimulated /
activated, which results in the release of chemicals that cause pain.
Dysport® is a formulation of Botulinum toxin type A (BoNT-A), a medication that stops the
release of these chemical messengers.
The study will consist of 3 periods:
1. A 'screening period' of 6 to 12 weeks to assess whether the participant can take
part to the study and requires 1 visit.
2. A first Treatment Phase of 24 weeks. On Day 1 and at Week 12 of the first Treatment
Phase, participants will receive injections into various muscles across the head,
neck, face and shoulders.
The injections will contain either a dose "A" or a dose ''B'' of Dysport® or a
placebo (an inactive substance or treatment that looks the same as, and is given in
the same way as, an active drug or intervention/treatment being studied).
Participants will make 4 visits to the clinic in person and have 4 remote (online)
visits.
3. A second Treatment Phase of 24 weeks (extension phase). At Week 24 and at Week 36,
all participants will get Dysport® (dose "A" or dose "B").
There will be 3 in person visits and 4 remote visits.
Participants will need to complete an e-diary and questionnaires throughout the study.
Participants will undergo blood samplings, urine collections, physical examinations, and
clinical evaluations. They may continue some other medications, but the details need to
be recorded.
The total study duration for a participant will be up to 60 weeks (approx. 14 months).
For info regarding 2024P000238
please contact Sait Ashina at 617-667-6000 or
sashina@bidmc.harvard.edu
Title: AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion AAA - SHAPE Pivotal Trial CRD 1029 November 7, 2023, Version 12
Brief Title: AAASHAPE MEMORY
Brief Summary: To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the
percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as
an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial
subjects considered candidates for elective EVAR.
For info regarding 2024P000223
please contact Su Huang at 617-632-7448 or
shuang9@bidmc.harvard.edu
Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study with Extension Phase to Evaluate the Efficacy and Safety of Dysport for the Prevention of Chronic Migraine in Adult Participants
Brief Title: C-BEOND
Brief Summary: The purpose of this study is to understand the safety and effectiveness of the study
drug, Dysport® when compared with placebo in preventing chronic migraine.
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on
one side of the head, and is often accompanied by feeling or being sick and a sensitivity
to bright lights and sound.
Chronic migraine is defined as having at least 15 days of headache a month with at least
8 of those days being migraine headache days.
Migraines are caused by a series of events which cause the brain to get
stimulated/activated, which results in the release of chemicals that cause pain. Dysport®
is a formulation of Botulinum toxin type A (BoNT-A), a medication that stops the release
of these chemical messengers.
The study will consist of 3 periods:
1. A 'screening period' of 6 to 12 weeks to assess whether the participant can take
part to the study and requires 1 visit.
2. A first Treatment Phase of 24 weeks. On Day 1 and at Week 12 of the first Treatment
Phase, participants will receive injections into various muscles across the head,
neck, face and shoulders.
The injections will contain either a dose "A" or dose "B" of Dysport® or a placebo
(an inactive substance or treatment that looks the same as, and is given in the same
way as, an active drug or intervention/treatment being studied). Participants will
make 4 visits to the clinic in person and have 4 remote (online) visits.
3. A second Treatment Phase of 24 weeks (extension phase). At Week 24 and at Week 36,
all participants will get Dysport® (dose "A" or dose "B").
There will be 3 in person visits and 4 remote visits.
Participants will need to complete an e-diary and questionnaires throughout the study.
Participants will undergo blood samplings, urine collections, physical examinations, and
clinical evaluations.
They may continue some other medications, but the details need to be recorded. The total
study duration for a participant will be up to 60 weeks (approx. 14 months).
For info regarding 2024P000220
please contact Sait Ashina at 617-667-6000 or
sashina@bidmc.harvard.edu
Title: Real time neurofeedback, its neurotransmitter underpinnings, and therapeutic effects, in clinical high risk individuals (CHR)
Brief Title: Neurofeedback and therapeutic effects in CHR
Brief Summary: The goal of this trial is to test whether fMRI based neurofeedback from default mode
network (DMN) will reduce DMN hyperconnectivity in clinical high risk individuals, which
will lead to reductions in clinical symptoms and improve cognitive performance.
For info regarding 2024P000177
please contact William Stone at 617-754-1235 or
wstone@bidmc.harvard.edu
Title: Immune and metabolic characterization of patients with alcohol-associated hepatitis
Brief Title: Characterization of AH
Brief Summary: This research study aims to establish a clinical database and biorepository to gain a deeper understanding of the causes and mechanisms of illnesses like alcoholic-associated hepatitis and other diseases. This involves the collection of blood samples (referred to as biological samples) and personal health information from both healthy and sick participants for potential use in future investigations into alcoholic-associated hepatitis or other diseases. A biological sample typically refers to blood but may include any bodily fluid. Personal Health Information encompasses details such as name, age, gender, race, and medical history, as well as data from prior research participation or routine medical examinations.
For info regarding 2024P000164
please contact Ruchi Chauhan at 617-735-2886 or
rchauhan@bidmc.harvard.edu
Title: A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants with Moderate to Severe Hidradenitis Suppurativa
Brief Title: Evaluate Eltrekibart in Adults with Hidradenitis Suppurativa
Brief Summary: This study aims to find the appropriately safe and effective dose and dosing frequency
for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for
further clinical development. The study will last approximately 62 weeks and may include
up to 31 visits.
For info regarding 2024P000158
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: Enhancing Sleep in Older Adults Using Auditory and Transcranial Stimulation: A Machine Learning Approach
Brief Title: Enhancing sleep in older adults with noninvasive stimulation
Brief Summary: The main purpose of this study is to explore the effects of noninvasive brain stimulation (neuromodulation) on slow wave sleep and cognition. The types of brain stimulation that will be used are auditory stimulation (AS) and transcranial alternating current stimulation (tACS). The AS device, SleepLoop, and tACS device, Starstim, involved in this study are investigational. This study will investigate whether AS and tACS can affect slow waves (a type of brain activity that occurs during deep sleep and is closely linked to memory and learning) during sleep to improve short-term cognition.
For info regarding 2024P000148
please contact Stephanie Buss, MD at
sbuss@bidmc.harvard.edu
Title: A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason in Patients with Sub-Optimal Unenhanced Echocardiography
Brief Title: Lumason bolus vs infusion
Brief Summary: A phase III study designed as a randomized, within-patient comparison of continuous
infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for
degree of LVO and assessment of LV EBD (co-primary endpoints).
For info regarding 2024P000127
please contact Jordan Strom at 617-667-7000 or
jstrom@bidmc.harvard.edu
Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study toDetermine the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for StrokePrevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack-LIBREXIA-STROKE (Sponsor protocol 70033093STR3001)
Brief Title: LIBREXIA Stroke
Brief Summary: The purpose of this study is to evaluate whether milvexian compared to placebo reduce the
risk of recurrent ischemic stroke.
For info regarding 2024P000117
please contact Jennifer Dearborn-Tomazos at 617-667-1803 or
jtomazos@bidmc.harvard.edu
Title: stAAAble Trial: Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy
Brief Title: STAAABLE TRIAL
Brief Summary: The purpose of this randomized clinical trial is to treat patients with small to
mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a
locally delivered, single-dose endovascular treatment. The main question the study aims
to answer is to demonstrate efficacy of the product for stabilization of these small to
mid-sized AAA.The study will compare the treatment group to the typical standard of care
for these patients, surveillance. All subjects will be followed at designated intervals
at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5
years.
For info regarding 2024P000038
please contact Su Huang at 617-632-7448 or
shuang9@bidmc.harvard.edu
Title: Ultrasound-based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation - Redo Ablation Procedure: A Pilot Study
Brief Title: Ultra HFIB REDO
Brief Summary: This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control)
clinical trial. The purpose of the study is to determine the role of adjunctive renal
sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in
patients with hypertension scheduled for a redo AF ablation procedure for paroxysmal or
persistent AF. Patients will be randomized to either i) AF ablation (Control) or ii) AF
ablation + renal sympathetic denervation (Intervention).
For info regarding 2024P000018
please contact Timothy Maher at 617-667-8800 or
tmaher@bidmc.harvard.edu
Title: Metabolomic changes after mixed meal tolerance test as novel markers of heart failure with preserved ejection fraction disease severity
Brief Title: Metabolomic changes after MMTT in HFpEF
Brief Summary: In this study, we will look at how treatment with a class of medication called sodium glucose cotransporter 2 (SGLT2) inhibitors effects the bodys metabolic health in patients who have heart failure with preserved ejection fraction. We will test metabolism by giving a person a meal and measure how levels of small molecules change before and after the meal. We will repeat this test again after 12 weeks of treatment with SGLT2 inhibitors and
see how the molecules responses to a meal change with drug treatment.
For info regarding 2023P001112
please contact Michael Mi, MD at 617-667-8800 or
mmi@bidmc.harvard.edu
Title: Family-based epidemiological study of Helicobacter pylori prevalence in the United States
Brief Title: Family-based study of Helicobacter pylori prevalence
Brief Summary: The goal of this study is to evaluate the prevalence of H. pylori infection within the household. H. pylori is a bacterial infection of the stomach that can cause stomach ulcers and increase risk of stomach cancers. H. pylori infection is spread between people in close contact. We want to test family members of patients who have had H. pylori to see if they also have H. pylori infection.
For info regarding 2023P001092
please contact Brian Li at 617-297-8819 or
bli3@bidmc.harvard.edu
Title: A Data and Tissue Repository to Facilitate Infectious Diseases Research and Advance Pandemic Preparedness, with a Focus on Respiratory Pathogens
Brief Title: A Data and Tissue Repository for Respiratory Pathogens
Brief Summary: The purpose of this study is to collect samples and clinical information from people with symptoms of an acute respiratory illness, such as cough, fever and muscle pain. These are symptoms that are typical of influenza, COVID-19 and other viral infections. We are also collecting samples from people without any symptoms. The goal of the study is to store these samples to help researchers prepare for future outbreaks of infectious diseases.
For info regarding 2023P001078
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: Evaluation of Vaccine induced Immune Activity against SARS-CoV-2 and RSV (IVY-6-sera)
Brief Title: IVY-6 Vaccine Activity
Brief Summary: The purpose of this study is to understand immune responses in people who receive FDA-approved SARS-CoV-2 (COVID) or RSV vaccines. This will help figure out if the SARS-CoV-2 or RSV vaccines will work against the viruses. We also want to figure out if your immune response is protective against new forms of the virus. We will obtain blood from individuals vaccinated against SARS-CoV-2 or RSV who meet eligibility criteria before
vaccine dose, at 3 to 6 weeks after a vaccine dose and/or 12 to 16 weeks after a vaccine dose. For SARS-CoV-2, the collection of blood from fully vaccinated individuals will help ensure that the data generated from antigenic studies is consistent and can be compared over time.
For info regarding 2023P001072
please contact ED Research Team at 6170650-0042 or
cottanel@bidmc.harvard.edu
Title: Expectations and Experiences of Narcolepsy Symptoms in Pregnancy
Brief Title: Narcolepsy Symptoms in Pregnancy
Brief Summary: This study seeks to fill the critical knowledge gap on the evidence-based management of narcolepsy type 1 (narcolepsy with cataplexy) during pregnancy. By gathering data on the severity and impact of narcolepsy symptoms before, during, and after pregnancy, this mixed-methods study aims to better define symptom trajectory, treatment approaches, and current gaps in care for pregnant people with narcolepsy. This study will
include an on-line questionnaire plus an optional interview.
For info regarding 2023P001041
please contact Margaret Blattner, MD PhD at 617-667-3237 or
mblattne@bidmc.harvard.edu
Title: A prospective, multicenter, randomized, and controlled study to evaluate the safety and effectiveness of the STIMIT ACTIVATOR 1 System
Brief Title: STIMIT
Brief Summary: The study is a prospective, multi-center, randomized, controlled study using adaptive
design to assess the evidence of safety and performance of the STIMIT Activator 1 System
in the treatment of patients who have been mechanically ventilated for up to 7 days and
are predicted to require additional minimum 48 hours of mechanical ventilation or longer.
For info regarding 2023P000981
please contact Elias Baedorf Kassis at 617-667-0000 or
enbaedor@bidmc.harvard.edu
Title: Zenith Fenestrated+ Endovascular Graft Clinical Study Global Clinical Number 17-07
Brief Title: FEN PLUS
Brief Summary: The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and
effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with
the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2
for the treatment of patients with aortic aneurysms involving one or more of the major
visceral arteries.
For info regarding 2023P000909
please contact Su Huang at 617-632-7448 or
shuang9@bidmc.harvard.edu
Title: Parkinsons Disease Repository
Brief Title: Parkinsons Disease Repository
Brief Summary: The purpose of this protocol is to establish a repository of patients with Parkinsons disease (PD) or parkinsonism and collect a range of variables to inform future research project development, future research questions and overall program development. This repository will also aid in the facilitation and coordination of patient engagement in research protocols, collect screening information, and track patients through ongoing and completed studies and study-related procedures.
For info regarding 2023P000893
please contact Aine Russell at 617-667-2351 or
arussel2@bidmc.harvard.edu
Title: CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State - CERBERUS
Brief Title: CERBERUS
Brief Summary: The goal of this observational study is to learn the how to determine the mean arterial
pressure(MAP) or blood pressure level to be maintained during non-cardiac surgery for
optimal brain health in patients above the age of 60 undergoing major non-cardiac
surgery. The main question[s] it aims to answer are:
- Is there a way to tailor the blood pressure to be maintained in such patients during
surgery for optimal brain health using non-invasive monitors that check the brains
electrical activity, the electroencephalogram(EEG) monitor, and the brain's blood
oxygen levels, the cerebral oximetry(CO) monitor?
- How much does this optimal blood pressure level vary between patients?
Participants will be asked to:
- Complete a questionnaire at the time they enroll into the study, as well as a daily
questionnaire to help determine their level of thinking and brain health. This
questionnaire will be administered by a member of the study team.
- They will also have an EEG and CO monitoring sticker placed on their foreheads. This
will be connected to a monitor that will collect this data just before, during, and
after their surgery. The data collected through these monitors will help us with our
study goals.
For info regarding 2023P000843
please contact Samir Kendale at
skendale@bidmc.harvard.edu
Title: Brown Adipose Tissue Function in Adults with Hypothyroidism and with Hyperthyroidism
Brief Title: Brown Adipose Tissue Function in Adults with Hypothyroidism
For info regarding 2023P000830
please contact Alina Gavrila, MD at 617-667-9344 or
agavrila@bidmc.harvard.edu
Title: Sponsor-Initiated OCS Heart Perfusion (OHP-II) Registry
Brief Title: N/A
Brief Summary: This Registry is a sponsor initiated, multi-center, observational post-approval registry
with independent academic oversight.
For info regarding 2023P000774
please contact Masashi Kai at 617-667-1803 or
mkai1@bidmc.harvard.edu
Title: The GORE VBX FORWARD Clinical Study: A Comparison of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX) to Bare Mental Stenting for Patients with Complex Iliac Occlusive Disease
Brief Title: GORE VBX
Brief Summary: The objective of this prospective, multicenter, randomized, controlled clinical trial is
to demonstrate the superiority of the VBX Device for primary patency when compared to
bare metal stenting in complex iliac occlusive disease.
For info regarding 2023P000760
please contact Su Huang at 617-632-7448 or
shuang9@bidmc.harvard.edu
Title: PREVENT VILI: Prevention of Ventilator Induced Lung Injury
Brief Title: PREVENT VILI: a multicenter RCT of ventilation for ARDS
Brief Summary: The goal of this interventional study is to compare standard mechanical ventilation to a
lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress
Syndrome (ARDS). Participants will be ventilated according to one of two different
strategies. The main question the study hopes to answer is whether the personalized
ventilation strategy helps improve survival.
For info regarding 2023P000682
please contact Daniel Talmor at 617-754-3257 or
dtalmor@bidmc.harvard.edu
Title: A prospective observational study comparing antepartum and postpartum range of motion(ROM) in adults with limited joint mobility
Brief Title: A prospective observational study of antepartum and postpart
Brief Summary: BIDMC Orthopedics and BIDMC OB/GYN researchers are investigating whether pregnancy may improve the bodys range of motion, after an old injury that caused stiffness or lack of mobility in the arm or leg joints, We hope to improve bone and joint care for future patients.
For this study, were looking for healthy people in the first trimester of pregnancy, who had prior injuries to their shoulder, elbow, wrist, knee or ankle, where the body part did not regain the full range of motion after the injury healed.
The study involves one screening phone call where we will explain the study and collect some information, which takes about 15 minutes. If you choose to participate, we will schedule the first research video call, where we will ask questions about your injury and measure your range of motion. This call takes about 30 minutes. After that, we will schedule 3 video sessions during the year to see whether your range of motion changes during and after pregnancy, which will take about 15 minutes each.
You may receive up to $100 if you complete all visits. The payments will be loaded to a reusable debit card. You will receive $50 after your first session, and $50 after your last session.
For info regarding 2023P000634
please contact Julia Aguiar at 617-667-9750 or
jaguiar@bidmc.harvard.edu
Title: Mindful Steps: A Web-Based Mind-Body Exercise Intervention to Promote Physical Activity in Chronic Cardiopulmonary Disease
Brief Title: Mindful Steps 20
Brief Summary: The goal of this fully-remote randomized controlled trial is to test the efficacy of
Mindful Steps in facilitating physical activity compared to usual standard of care among
136 patients with COPD and/or HF. The main question it aims to answer is can this
intervention promote physical activity as measured by daily step counts in sedentary
patients with COPD and/or HF. Participants will be randomized (1:1 ratio) to receive
either the Mindful Steps intervention or usual care for 12 months, with both arms
receiving a Walking for Health education booklet.
For info regarding 2023P000595
please contact Gloria Yeh at 617-754-1419 or
gyeh@bidmc.harvard.edu
Title: Medacta M-Vizion Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study
Brief Title: Medacta M-Vizion
Brief Summary: Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem
subsidence in the femoral canal.
For info regarding 2023P000592
please contact Michael Baratz at
mbaratz@bidmc.harvard.edu
Title: Cognitive Function and Affective Regulation in Meditators
Brief Title: CALM
Brief Summary: This research is being done to assess the impact of meditation practice on cognitive function and emotional regulation. We are also looking to assess its impact on positive and negative emotions, feelings of stress, anxiety, and depression. You will be asked to complete a set of online cognitive tasks as well as a detailed survey at a singular time-point after the time of consent.
For info regarding 2023P000588
please contact Ashwin Swaminathan at 617-278-8150 or
Sadhgurucenter_research@bidmc.harvard.edu
Title: Mind Body Intervention for Chronic Upper Extremity Pain
Brief Title: PSRT for CUEP
Brief Summary: We are recruiting for a research study to test a mind-body approach to reduce or eliminate chronic upper extremity pain and improve the quality of life for people suffering from chronic upper extremity pain and who do not respond well to pharmacological (medicine) or surgical interventions
For info regarding 2023P000579
please contact Mind Body Study Team at 617-754-2882 or
mindbodystudy@bidmc.harvard.edu
Title: AFFIRM: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Brief Title: AFFIRM: CB8025-41837
Brief Summary: To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary
Biliary Cholangitis (PBC) and Compensated Cirrhosis.
For info regarding 2023P000565
please contact Alan Bonder at 617-632-1070 or
abonder@bidmc.harvard.edu
Title: AFFIRM: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Brief Title: AFFIRM: CB8025-41837
Brief Summary: To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary
Biliary Cholangitis (PBC) and Compensated Cirrhosis.
For info regarding 2023P000565
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: Eyecontrol coMmunication platform for dEliRium manaGemEnt in intensive care units (EMERGE) : A Multicenter Randomized Controlled Trial
Brief Title: EMERGE
Brief Summary: The purpose of this research is to investigate whether addition of the EyeControl-Pro
platform as an adjunct to standard guideline-based intensive care unit management of
critically ill patients is effective in reducing delirium incidence and severity.
For info regarding 2023P000563
please contact Somnath Bose at 617-667-7600 or
sbose2@bidmc.harvard.edu
Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy andSafety of Upadacitinib in Adult and Adolescent Subjects with Moderate to Severe HidradenitisSuppurativa Who Have Failed Anti-TNF Therapy
Brief Title: Abbvie M23-698: Evaluation of Upadacitinib in HS Adults
Brief Summary: Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions
in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This
study will assess how safe and effective upadacitinib is in treating adult and adolescent
participants with moderate to severe HS who have failed to respond to or are intolerant
of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease
activity will be assessed.
Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid
arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the
treatment of HS. This study is "double-blinded", meaning that neither the trial
participants nor the study doctors will know who will be given upadacitinib and who will
be given placebo. This study is comprised of 3 periods. In Period 1, participants are
randomized into 2 groups called treatment arms where each group receives a different
treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In
Period 2, participants are placed into 6 different groups depending on their placement
and results in Period 1. Period 3 is the long-term extension period where participants
will continue treatment from Period 2. Approximately 1328 adult and adolescent
participants diagnosed with HS will be enrolled in approximately 300 sites worldwide.
Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks
in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter
Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks.
Participants will be followed up for approximately 30 days.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular outpatient visits during the study.
The effect of the treatment will be checked by medical assessments, checking for side
effects and completing questionnaires.
For info regarding 2023P000553
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: Mind Body RCT for Long COVID
Brief Title: RCT for LC
Brief Summary: We are testing if a mind-body approach will help to reduce symptoms in patients living with Long Covid and who have had an unrevealing medical workup for their persistent symptoms. The study is offered remotely via a HIPAA-compliant video platform. This is a randomized trial; patients initially
randomized to the control group (no intervention) will be offered the intervention after the initial study period.
For info regarding 2023P000529
please contact Michael Donnino, MD at
mindbodystudy@bidmc.harvard.edu
Title: Cognitive Neurology Unit Clinical Registry
Brief Title: CNU Registry
Brief Summary: A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's
Disease
For info regarding 2023P000494
please contact Daniel Press at 617-667-0459 or
dpress@bidmc.harvard.edu
Title: Identifying dynamic biomarkers associated with rTMS response in depression: a pilot study
Brief Title: Dynamic biomarkers of rTMS response in depression
Brief Summary: Repetitive transcranial magnetic stimulation (rTMS) is a highly effective for medication-resistant depression. For treatment to be effective, individuals invest extensive time and money undergoing rTMS daily for six weeks. However, rTMS is only 30-50% effective, and individuals may not know if they have responded until the middle or end of treatment course. Here, we aim to collect EEG and MRI data throughout rTMS treatment in patients undergoing rTMS at the Berenson-Allen Center - by doing so, we hope to identify signals that predict response early on in treatment course.
For info regarding 2023P000469
please contact Roscoe Brady Jr. MD PhD at 617-754-1261 or
robrady@bidmc.harvard.edu
Title: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients with Chronic Limb Threatening Ischemia (CLTI
Brief Title: SELUTION BTK
Brief Summary: This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION
SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of
peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.
For info regarding 2023P000457
please contact Su Huang at 617-632-7448 or
shuang9@bidmc.harvard.edu
Title: Linking HIV Prevention and Postpartum Care: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a High-Risk Breastfeeding Population in Botswana
Brief Title: Tshireletso
Brief Summary: The goal of this this hybrid safety/implementation study is to evaluate whether using
long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and
safe in post-partum people who are breastfeeding. The main question[s] it aims to answer
are:
- Will CAB-LA injections work well as a way to prevent HIV infection in post-partum
people?
- Will CAB-LA injections be safe in post-partum people and their infants who will be
breastfeeding?
Participants without HIV who are admitted to the maternity ward after having delivered a
baby will be offered to start CAB-LA PrEP. Those who choose to participate will receive
their first dose (injection) at the maternity ward and their follow up doses (injections)
at their local clinic when they come for routine post-partum and pediatric care.
Participants and their infants will be followed in the study for 24 months. We will be
following how many people come on-time for their CAB-LA injections, how often they keep
coming back, and the reasons they continue (or stop) these injections. We will also test
people for HIV at all of their visits to see how many people get HIV during the study. We
will also measure the levels of the medication in the blood of the post-partum people and
their infants (who may be getting some of the CAB-LA in breastmilk) and evaluate to see
if their is any impact of CAB-LA on the health of the post-partum person or their
infants.
For info regarding 2023P000415
please contact Rebecca Zash at 617-632-7706 or
rzash@bidmc.harvard.edu
Title: Cardiometabolic disease and heart failure with preserved ejection fraction
Brief Title: BI HFpEF
Brief Summary: This is a prospective observational study of 250 patients receiving care at BIDMC who have heart failure with preserved ejection fraction (HFpEF). The aim of the study is to better understand the link between cardiometabolic disease and HFpEF. At each visit, we will conduct a physical exam and perform a blood draw, and participants will complete a health questionnaire to assess quality of life. There will be up to 3 study visits over the course of 3 months. About 1 year after enrollment, participants will be re-contacted for a telephone health survey.
For info regarding 2023P000392
please contact Ndidi Owunna at 617-735-4126 or
nowunna@bidmc.harvard.edu
Title: Psychiatric Screening Repository: Data Collection for Mental Health
Brief Title: Psychiatric Screening Repository
Brief Summary: This study aims to assess changes in thinking, mood, or behavior through a semi-structured clinical interview using well-established mental health research tools. Your data will be securely stored and may be used with your permission for other research studies. The analysis of this information will help us better understand mental health challenges in adults aged 18-65 for improved diagnoses and treatment
For info regarding 2023P000390
please contact Paolo Lizano, MD at 617-754-1227 or
plizano@bidmc.harvrd.edu
Title: Treatment In Thoracic Aortic Aneurysm: Surgery versus Surveillance (TITAN: SvS)
Brief Title: TITAN: SvS
Brief Summary: The ascending aorta conducts blood from the heart to the rest of the body. The ascending
aorta can become enlarged, and the risk of tearing and rupturing becomes higher with
larger aorta. When the ascending aorta tears or ruptures, the risk dying is high even if
surgery is done as soon as possible. Traditionally, when the ascending aorta gets above
5.5 cm, surgery is recommended to replace the aorta. However, this threshold is based
relatively weak evidence, and sometimes patients with smaller aorta can tear or rupture.
On the other hand, surgery carries its own risk as well. Since there are risk of waiting
or doing surgery, there is currently no great support for either approach for patients
with a smaller aorta. In the TITAN SvS trial, patients with an ascending aorta between
5.0 to 5.5 cm is assigned by chance to the early surgery group, in which they will
undergo replacement of aorta, or the surveillance group, in which they will be closely
monitored. The chance of dying or suffer tearing or rupture of aorta between the two
groups will be compared. The result of the trial will guide future practice for patients
with enlarged ascending aorta.
This is a prospective, multi-centre randomized control trial that compares the all-cause
mortality, aneurysm-related aortic events, rate of stroke, and quality of life for those
patients undergoing early elective ascending aortic surgery to those patients undergoing
surveillance. Patients referred for an ascending aortic aneurysm that meets the inclusion
criteria will be randomized to the early elective surgery group or the surveillance
group. Recruitment will end when the desired sample size is reached, and the patients
will be followed for a minimum 2-year period. The primary objective of the trial is to
compare the composite outcome of the all-cause mortality and incidence of acute aortic
events between surveillance and elective ascending aortic surgery for patients with
degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow
up. The hypothesis is that the early surgery group will have a significantly lower
all-cause mortality and incidence of acute aortic events at 2 years of follow up compare
to the surveillance group. The result of this trial will provide evidence based guidance
in the appropriate management of ascending aortic aneurysm based on the size criteria,
and establish a large database for future investigations.
For info regarding 2023P000361
please contact Brett Carroll at 617-123-4567 or
bcarrol2@bidmc.harvard.edu
Title: A First-in-human (FIH) Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
Brief Title: NTE001
Brief Summary: This clinical trial is designed to test whether a single image-guided intracerebral
administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects
with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without
mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective
(seizure frequency). NRTX-1001 comprises human interneurons that secrete a
neurotransmitter, gamma-aminobutyric acid (GABA).
For info regarding 2023P000349
please contact Joshua Aronson at 617-632-7023 or
jaronson@bidmc.harvard.edu
Title: Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
Brief Title: Nitrous Oxide during Vasectomy
Brief Summary: A vasectomy is a common procedure done as a form of permanent male birth control. For some patients, a vasectomy can cause anxiety or pain. Nitrous oxide (or laughing gas) is a well-known sedative which is frequently used in dental offices and for pediatric procedures to reduce anxiety and pain. This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful for improving experience of care during vasectomy. We use the term SANO to describe participants holding a mask to their face and using a remote control to adjust the nitrous oxide levels up or down to their desired effect. The system limits the nitrous oxide levels so that the level cannot go above a fixed limit (50% nitrous oxide).
For info regarding 2023P000328
please contact Heidi Rayala at 617-903-0153 or
SANO@bidmc.harvard.edu
Title: Video-Assisted Frailty Measurement in the Emergency Department
Brief Title: Frailty
Brief Summary: A prospective, observational cohort study of a convenience sample of adults aged 65 or older who present to the
Beth Israel Deaconess Medical Center ED. This study will help us determine whether a video recording taken in
the emergency department accurately measures frailty.
For info regarding 2023P000306
please contact ED Research Team at 617-754-2287 or
cottanel@bidmc.harvard.edu
Title: Tablet application for the screening and monitoring of movement disorders
Brief Title: Drawing Analysis for Screening of Parkinsons Disease
Brief Summary: We are trying to develop a way to measure movement disorders in people (e.g. Parkinsons Disease). We are testing people on a variety of drawing tasks using an iPad and a stylus. We plan to analyze how people perform on the tasks. We will use this information to create more accurate, faster, and more convenient tasks and determine whether these drawing tasks will provide us with information that is useful in understanding which movement disorder a patient has or whether they do not have a movement disorder.
For info regarding 2023P000280
please contact Jay Iyer at
jiyer@bidmc.harvard.edu
Title: General Pre-Trial Screening Protocol for Enrollment of Volunteers into Infectious Diseases Research Protocols
Brief Title: General Pre-Trial Screening Protocol
Brief Summary: The purpose of this general screening protocol is to facilitate recruitment into studies conducted at the Center for Virology and Vaccine Research (CVVR) at BIDMC. This protocol will help us to determine whether a volunteer is eligible for completing the screening process, and which protocols they may be good candidates for.
For info regarding 2023P000266
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: A Phase 1a/1b Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Topical OA-3, a PAR2 Inhibitor, in Adult Healthy Volunteers and Subjects with Atopic Dermatitis and Pruritus
Brief Title: Phase 1a/1b Study Efficacy of Topical OA-3, a PAR2 Inhibitor
Brief Summary: The purpose of this study is to help us understand the safety and the potential effectiveness a new topical study drug called OA-3 hydrogel for the treatment of atopic dermatitis (AD), or eczema. This study will be open to atopic dermatitis patients and healthy patients.
For info regarding 2023P000228
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: Narrow band green light effects on cortical excitability and responsivity in migraine
Brief Title: Narrow band greenlight
For info regarding 2023P000201
please contact Rami Burstein, PhD at
rburstei@bidmc.harvard.edu
Title: Feasibility of the comfort measures only time out (CMOT) to reduce distress during Palliative Withdrawal of Mechanical Ventilation
Brief Title: Feasibility of comfort measures only time out (CMOT)
Brief Summary: Nearly 25% of Americans die in intensive care units (ICUs). Most deaths in ICUs are
expected and involve the removal of ventilator support, or palliative withdrawal of
mechanical ventilation (WMV). Prior work by the Principal Investigator (PI) found that
patient suffering can be common; with 30-59% of patients going through this process
experiencing distress. Thus, experts and national organizations have called for evidence
to inform guidelines for WMV. This research study will 1) develop and refine a Comfort
Measures Only Time out (CMOT) intervention consisting of a structured time out with
check-list protocol for the ICU team (nurse, physician, respiratory therapist) to improve
the process of WMV. and 2) Pilot test the CMOT intervention in 4 ICUs (2 medical/2
surgical) among 40 WMV patients.
For info regarding 2023P000160
please contact Corey Fehnel at 617-667-7000 or
cfehnel@bidmc.harvard.edu
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis
Brief Title: DaeWoong DWN12088
Brief Summary: This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate
the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
For info regarding 2023P000113
please contact Clinical Research Center at 617-975-7600 or
crc@bidmc.harvard.edu
Title: Department of Neurology Biorepository
Brief Title: Department of Neurology Biorepository
Brief Summary: The purpose of this study is to collect and store samples (for example, blood and saliva) in patients with different neurologic disorders (for example, Parkinsons Disease, Epilepsy, Stroke) to be used for future research to learn more about diagnosing, preventing and treating neurologic disorders.
For info regarding 2023P000108
please contact Neurology Biorepository Research Team at 617-667-0605 or
NeuroRepository@bidmc.harvard.edu
Title: Targeted group-based psychotherapy to address emotional stress in at risk ICU-survivors: A pilot feasibility study
Brief Title: Addressing mental health in ICU-survivors
Brief Summary: This study is a pilot clinical trial to assess the feasibility of implementing a
group-psychotherapy intervention to modify emotional stress (e.g., anxiety, depression,
post-traumatic stress) following ICU hospitalization
For info regarding 2023P000087
please contact Katherine Berg at 617-667-5864 or
kberg@bidmc.harvard.edu
Title: A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)
Brief Title: ENGULF
Brief Summary: Evaluation of initial safety and clinical feasibility of the Helo PE Thrombectomy System
for thrombectomy in acute submassive pulmonary embolism (PE).
For info regarding 2023P000008
please contact Salomao Faintuch at 617-754-2523 or
sfaintuc@bidmc.harvard.edu
Title: A Proof of Concept Trial of a Sirtuin-NAD+ Activator in Alzheimer’s Disease
Brief Title: MIB - AD
Brief Summary: The investigational product, MIB-626, which is not FDA approved, is being studied for its ability to treat or prevent Alzheimers Disease. As a first step we want to find out if MIB-626 can get into the brain and increase the levels of a related chemical in parts of the brain that are affected in Alzheimers Disease. We also want to make sure that MIB-626 is safe to take without causing too many side effects.
For info regarding 2023C001160
please contact Daniel Press at 617-667-0459 or
dpress@bidmc.harvard.edu
Title: Cerebellar Modulation of Cognition in Psychosis
Brief Title: TMS Processing Speed
Brief Summary: The goal of this clinical trial is to learn about cognition in psychotic disorders
(schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it
aims to answer is: Can we use magnetic stimulation to change processing speed (how
quickly people can solve challenging tasks).
Participants will be asked to perform cognitive tasks (problem-solving) and undergo brain
scans before and after transcranial magnetic stimulation (TMS). TMS is a way to
non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression
and obsessive compulsive disorder. In this study, we will use a different form of TMS to
temporarily change brain activity to observe how that changes speed in problem-solving.
For info regarding 2023C001134
please contact Roscoe Brady at 617-632-7933 or
robrady@bidmc.harvard.edu
Title: HVTN 307: A phase 1 clinical trial to evaluate the safety and immunogenicity of ferritin nanoparticles expressing native-like HIV-1 envelope trimers followed by boost with mRNA lipid nanoparticles encoding a native-like HIV-1 envelope trimer in adults without HIV
Brief Title: HVTN 307
Brief Summary: This first-in-human (FIH) phase 1 clinical trial will evaluate a prime-boost regimen of
immunogens designed to induce HIV-1 Env V3-glycan-specific broadly neutralizing
antibodies (V3G bNAbs). The priming immunogen (V3G CH848 Pr-NP1) consists of ferritin NPs
expressing 8 copies of an Env trimer. This immunogen will be boosted with an mRNA LNP
(V3G CH848 mRNA-Tr2), encoding a soluble Env trimer which does not utilize the ferritin
NP design.
For info regarding 2023C000500
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: HVTN 142: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the HCMV-HIV Vaccine Candidate VIR-1388 in Adult Participants with Overall Good Health and Without HIV
Brief Title: HVTN 142
Brief Summary: The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity
of VIR 1388 in adults in good health without HIV.
For info regarding 2023C000259
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial
Brief Title: APOLLO Trial
Brief Summary: Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All
subjects enrolled with receive the study device.
For info regarding 2022P001137
please contact Roger Laham at 617-667-8800 or
rlaham@bidmc.harvard.edu
Title: Characterizing non-restorative sleep in post-viral disease to advance intervention innovations
Brief Title: Nonrestorative sleep in post-viral disease
Brief Summary: This study is being done to understand why people with (ME/CFS) and Long COVID may experience nonrestorative sleep. Non-restorative sleep means that you do not feel refreshed or well rested after sleeping. We hope to learn more about things that might affect your sleep. For example, how your bodys systems, such as your immune system (the system that helps you fight infections) and hormones (chemicals that signal different functions in your body) are related to non-restorative sleep. We hope that learning more about non-restorative sleep can help with future treatment.
For info regarding 2022P001036
please contact Janet Mullington, PhD at 617-667-5243 or
postviralsleep@bidmc.harvard.edu
Title: Tai Chi Exercise and Wearable Feedback Technology to Promote Physical Activity in Acute Coronary Syndrome Survivors
Brief Title: Tai Chi for ACS
Brief Summary: This projects studies the role of tai chi exercise and wearable fitness trackers to
promote physical activity in acute coronary syndrome (ACS) survivors.
For info regarding 2022P000891
please contact Gloria Yeh at 617-754-1419 or
gyeh@bidmc.harvard.edu
Title: Infant Vaccine Biorepository
Brief Title: Infant Vaccine Biorepository
Brief Summary: The Infant Vaccine Biorepository is an observational study and the purpose is to better understand how long infant immune protection transferred through the placenta (from mother to baby) after maternal infection or vaccination lasts. We will research infections like influenza (the flu), pertussis (Whooping Cough), and SARS-CoV-2 (COVID-19), and others. You will be asked to collect a blood sample from your baby at home at 3-5 months-old, 6-8 months-old, and 9-12 months-old, using an investigational device for blood collection. The device will collect blood from the smallest blood vessels (the capillaries). The consenting parent will also have the option to test the device. Participation in this study will last until your baby is 1 year old. Compensation for participation is included.
For info regarding 2022P000765
please contact Dr. Ai-ris Collier at
CVVRtrials@bidmc.harvard.edu
Title: Physio-Anatomy Clinical Data Collection
Brief Title: Gentuity Study
Brief Summary: This is an on-label clinical study design intended for the collection of three different
types of interventional procedural data using FDA-cleared cardiac catheterization
technologies and drugs, each used according to its product labeling and standard practice
of medicine.
For info regarding 2022P000757
please contact Eric Osborn at 617-632-7722 or
eosborn@bidmc.harvard.edu
Title: Accelerated TMS for Psychosis
Brief Title: Accelerated TMS for Psychosis
Brief Summary: This study is to determine the tolerability and efficacy of an accelerated schedule of
Transcranial Magnetic Stimulation for treating symptoms of psychotic disorders such as
schizophrenia.
For info regarding 2022P000689
please contact Roscoe Brady at 617-632-7933 or
robrady@bidmc.harvard.edu
Title: Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services
Brief Title: BICEPS
Brief Summary: The Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services (BICEPS) study
aims to understand the early stages of psychotic disorders like Schizophrenia,
Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health
information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain
electrical waves (EEG) data from individuals who have experienced these disorders in
recent years. Participants will be involved for about a year, with four visits over this
period. Screening procedures, lasting approximately 3 hours, include tests for drug use,
a pregnancy test for eligible women, clinical interviews about feelings and experiences,
psychiatric and family history interviews, and a medical history review. Research
procedures for eligible participants include DNA collection, a neuropsychological test
battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand
brain function, genetics, and cognitive abilities related to psychotic disorders.
Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical
interviews and repeating neuropsychological tests to track changes over time.
Participants may opt to provide DNA samples for genetic analysis, undergo various
cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and
MRI scans to visualize brain structure. Follow-up visits at regular intervals will help
researchers track changes in symptoms and cognitive function. This study provides
comprehensive insight into the onset and progression of psychotic disorders and offers
valuable information for patients, families, and healthcare providers involved in
managing these conditions. Our goal is to better understand whether a combination of
biological markers and different types of people (BT1, BT2, BT3) can help us predict how
well individuals with early psychosis respond to specialized care. We expect that those
in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will
have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive
issues, their biology might lead to different responses to treatment. This research can
help us understand which treatments work best for different people with early psychosis.
For info regarding 2022P000622
please contact Lola Nedic at 617-863-0886 or
lnedic@bidmc.harvard.edu
Title: BRANCH: Brain Age and Sleep Architecture in Meditators
Brief Title: BRANCH: Brain Age and Sleep Architecture in Meditators
Brief Summary: This is a single-center, cross-sectional study that will recruit approximately fifty
seven (57) meditators and fifty one (51) controls. Individuals that have learned at least
the Shambhavi Mahamudra Kriya practice and live in Massachusetts will be mailed a DREEM
EEG device, and a sleepimage ring. Participants will be asked to wear the two devices
while sleeping for three consecutive weekday nights (Sunday night to Thursday night) and
two weekend nights (Friday and Saturday nights). While meditating during the day,
participants will only wear the DREEM EEG headband. Participants will also undergo
neurocognitive tests from the NIH toolbox during one virtual visit via video call.
Meditators who join the study will be asked to invite a control subject to the study,
matched for age and comorbidities.
For info regarding 2022P000597
please contact Sepideh Hariri, PhD at 617-667-2721 or
sadhugurucenter_research@bidmc.harvard.edu
Title: Mpox Tissue and Data Repository
Brief Title: Mpox Tissue and Data Repository
Brief Summary: The purpose of this study is to collect samples and clinical information for storage in a repository from individuals with a suspected or confirmed diagnosis of Monkeypox, individuals who recovered from Monkeypox, and individuals who received or plan to receive a vaccine against
Monkeypox.
For info regarding 2022P000577
please contact Center for Virology & Vaccine Research at 617-735-4610 or
CVVRtrials@bidmc.harvard.edu
Title: Prospective validation of electronic seizure diary forecasting
Brief Title: Prospective validation of electronic seizure diary forecasti
Brief Summary: This study hopes to be able to find a method to forecast, or predict, when seizures will happen in those with temporal lobe epilepsy. This would allow someone to take the necessary precautions in order to alleviate, or even prevent, a seizure event. This is a virtual study, and participants will be using a website and an app to track their seizures and medications. Participation is approximately 10 months.
For info regarding 2022P000548
please contact Daniel Goldenholz at 617-632-8930 or
EpilepsyPlusDataScience@bidmc.harvard.edu
Title: A Phase 2/3 Adaptive, Double-blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adults and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease
Brief Title: Phase 2/3 Adaptive Study of VX-147 in Adults With APOL1-medi
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, and
pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein
L1 (APOL1)-mediated proteinuric kidney disease.
For info regarding 2022P000526
please contact Liz Roy at (617) 975-8684 or
eroy2@bidmc.harvard.edu
Title: EndurAnt Stent Graft system vs ExcluDer endoprothesis: a global, prospectiVe, rANdomized Clinical trial in sac rEgression (ADVANCE Study)
Brief Title: ADVANCE Trial
Brief Summary: The purpose of this trial is to generate clinical evidence related to key performance
outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder
Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are
randomized and imaging collected at all follow-up time points to assess the primary
endpoint.
For info regarding 2022P000523
please contact Su Huang at 617-632-7448 or
shuang9@bidmc.harvard.edu
Title: Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI (REFINE PCI)
Brief Title: Physiological Assessment for Optimizing PCI
Brief Summary: Traditionally, the severity of a blockage (stenosis) in a coronary artery has been
determined by visual angiographic assessment of the diameter of the artery at the level
of a blockage compared to a normal healthy area of the same artery. With the advent of
invasive physiological testing to assess coronary blood flow, multiple clinical trials
have demonstrated a clinical benefit to a physiology-guided percutaneous coronary
intervention (PCI) approach. However, despite this and the potential for significant
variation in the interpretation of coronary artery stenosis severity by visual
angiography alone to guide PCI, invasive physiologic indices remain significantly
under-utilized.
The purpose of this study is to investigate the physiologic significance of coronary
lesions deemed angiographically severe by visual estimation that are planned for PCI. The
investigators plan to perform blinded physiologic assessment pre and post PCI. The
primary aim of the study is to determine whether a subset of lesions visually estimated
as severe by angiography treated with stent placement/PCI may in fact not be
physiologically significant when assessed invasively, and thus PCI could safely be
deferred in these patients. A secondary aim is to evaluate physiologic assessment post
PCI to detect residual ischemia that could be utilized to optimize stent placement.
For info regarding 2022P000479
please contact Eric Osborn at 617-632-7722 or
eosborn@bidmc.harvard.edu
Title: Abbott DBS Post market Study of Outcomes for Indications over Time
Brief Title: ABT-CIP-10300
Brief Summary: The purpose of this international study is to evaluate long-term safety and effectiveness
of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's
disease, essential tremor or other disabling tremor and dystonia.
For info regarding 2022P000324
please contact Aine Russell at 617-667-1337 or
arussel@bidmc.harvard.edu
Title: Brain Health with Inner Engineering- Longitudinal Study of Shambhavi Mahamudra Kriya Meditation (BLISS)
Brief Title: BLISS
Brief Summary: This study will explore whether a 21-minute meditation practice called Shambhavi
Mahamudra Kriya leads to changes in brain health and explore how it affects cognitive and
physiological function.
For info regarding 2022P000296
please contact Sepideh Hariri at 617-278-8082 or
shariri1@bidmc.harvard.edu
Title: Meditation and Breathing for Mental Health in Parkinson’s Disease Patients
Brief Title: Yoga for Parkinson’s
Brief Summary: This study is a waitlisted randomized controlled trial. We aim to assess the level of
compliance for those learning the intervention and to evaluate the impact of the practice
on neuropsychological and somatic outcomes using validated scales. Enrollment into the
study will be ongoing until we are able to get a sufficient sample size as described in
the "Statistical Consideration" section. Upon enrollment and randomization, surveys will
be administered to both the intervention and control groups at four time-points:
baseline, T2, T3, and T4, each of which are 6 weeks apart. Compliance data will be
collected weekly for 12 weeks for both groups.
For info regarding 2022P000212
please contact Sadhguru Center for a Conscious Planet Study Team at
SadhguruCenter_Research@bidmc.harvard.edu.
Title: What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia
Brief Title: What the Nose Knows
Brief Summary: This project proposes to conduct the first study of the predictive utility of olfactory
hedonic measurement for targeted psychosocial rehabilitation in schizophrenia. The
information gathered from the project is of considerable public health relevance, in
that, through simple, reliable olfactory assessment, it will provide knowledge about
which individuals are most likely to benefit from these psychosocial interventions. Such
information is crucial for tailoring existing interventions and developing new approaches
to optimize outcomes in schizophrenia.
For info regarding 2022P000199
please contact Sunny Lee at 617-754-1203 or
slee54@bidmc.harvard.edu
Title: Audio Markers of Speech and Cognition in Neurodegenerative Disease (Audio-ND)
Brief Title: Audio-HD
Brief Summary: The purpose of this research is to establish biomarkers (a medical sign that can be measured reliably) for both speech and cognitive impairment in Huntingtons disease using a speech analyzing application. Participants must either have a confirmed genetic diagnosis of Huntingtons disease or be
a heathy volunteer. Participants will undergo demographics and medical history review, cognitive tests, questionnaires, and a 10-minute speech assessment.
For info regarding 2022P000181
please contact Luis Sierra at 617-667-2351 or
hdresearch@bidmc.harvard.edu
Title: The Impact of Insufficient Sleep and Insomnia Disorder on Behavioral and Neural Markers of Emotion Regulation
Brief Title: The Effect of Sleep Loss on Emotion
Brief Summary: The study is designed to investigate the impact of three nights of sleep restricted to 4
hours per night, on the processing and regulation of emotional information compared to
Insomnia Disorder and control. The investigators will address and attempt to answer two
questions.
(i) How do three nights of reduced sleep or a diagnosis of Insomnia Disorder affect the
processing and regulation of emotional information compared to typical, undisturbed
sleep? (ii) What overlapping and distinct neural mechanisms are engaged and associated
with behavioral effects when attempting to process and regulate emotions in a sleep
restricted state or with a clinical diagnosis of Insomnia Disorder? This study will
investigate sleep's role in emotion processing and regulation. The findings will help
further understanding of the role of sleep in healthy emotional functioning.
For info regarding 2022P000120
please contact Anthony Cunningham, PhD at (617)667-4702 or
acunnin4@bidmc.harvard.edu
Title: A Pilot Study Utilizing Transcranial Direct Current Stimulation (tDCS) during Sleep to Enhance Slow Waves and Cognitive Function in Psychosis
Brief Title: tDCS Stimulation during Sleep: Pilot Study
Brief Summary: The Center for Sleep and Cognition at Beth Israel Deaconess Medical Center (BIDMC) is seeking patients with a diagnosis of Schizophrenia and healthy control participants for a sleep study involving 3 afternoon nap sessions. The main purpose of this study is to explore whether transcranial electrical stimulation (tES), a device that introduces a weak electrical current to the brain, can enhance physiological markers of sleep. We will examine if tES can influence brain electrical activity (measured using electroencephalogram (EEG) patterns) during sleep, and we will also explore if these changes in sleep are related to performance on variety of cognitive tasks pre- and post-nap.
For info regarding 2022P000117
please contact Anthony Cunningham, PhD at 617-667-4702 or
acunnin4@bidmc.harvard.edu
Title: Inter-lobar Fissure Completion as a Salvage Treatment in Patients with Failed Lung Volume Reduction (SAVED-1)
Brief Title: Rescue lung fissure closure after failed EBV therapy in COPD
Brief Summary: The purpose of this protocol is to perform a pilot prospective controlled clinical trial
to evaluate the potential role of lung fissure completion with pleural adhesiolysis
strategy (experimental intervention) in severe emphysema/COPD patients with failed
bronchoscopic lung volume reduction (BLVR) via the use of endobronchial valves (EBVs)
therapy. In select patients, the lung fissure completion with adhesiolysis strategy will
be performed by video-assisted thoracoscopic surgery (VATS) guided stapling along the
lung fissures to reduce collateral ventilation with adhesions removal and determine
whether this experimental strategy will improve outcomes after failed BLVR in patients
with severe emphysema/COPD.
For info regarding 2022P000048
please contact Adnan Majid at 617-632-8252 or
amajid@bidmc.harvard.edu
Title: Understanding components of mind-body exercise for physical activity engagement in metabolic syndrome: Pilot RCT
Brief Title: Mind-body exercise for physical activity
Brief Summary: The aim of this study is to assess the feasibility and acceptability (e.g., enrollment,
adherence, retention, acceptability of procedures and interventions) of a pilot factorial
study design that will help elucidate components of mind-body exercise interventions. The
study involves completing a walking program, a mindful attention program, a walking
program that includes mindful attention, or no program at all. A "pilot" study is a
smaller study that helps researchers to understand whether the study design can be
carried out and what participants think about the study.
For info regarding 2022P000037
please contact Kristen Kraemer at 617-754-1465 or
kkraemer@bidmc.harvard.edu
Title: SARS-CoV-2 Household Transmission Study
Brief Title: SARS-CoV-2 Household Transmission Study
Brief Summary: We are conducting this study to see how SARS-CoV-2 is transmitted from one person to another within a household, and to see if COVID-19 vaccination can help prevent SARS-CoV-2 transmission. We are enrolling people who have recently tested positive for COVID-19 (or were recently exposed or have symptoms of COVID-19), as well as people who live in a household with someone who potentially might have COVID-19. The study lasts up to 4 weeks. If you participate, we will ask you to swab your nose every day for 14 days so we can test for COVID19. We will also ask for a couple blood draws, but these are optional. You would receive up to $50 to compensate you for participation.
For info regarding 2022P000021
please contact Center for Virology and Vaccine Research at 617-735-4610 or
cvvrtrials@bidmc.harvard.edu
Title: Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Brief Title: CAPTIVA
Brief Summary: The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death.
For info regarding 2022C000315
please contact Sarah Marchina at
smarchin@bidmc.harvard.edu
Title: The Spiration Valve System (SVS) Post-Market Registry Study for Severe Emphysema
Brief Title: STRIVE SVS Registry Trial
Brief Summary: This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term
safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe
emphysema in a post-market setting.
For info regarding 2021P001015
please contact Adnan Majid at 617-632-8252 or
TSIPResearchStaff@bidmc.harvard.edu
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE)
Brief Title: Mirum VLX-601 VANTAGE Study
Brief Summary: The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression
of PBC.
For info regarding 2021P000960
please contact Julie Shea at 617-632-1125 or
jmshea@bidmc.harvard.edu
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE)
Brief Title: Mirum VLX-601 VANTAGE Study
Brief Summary: The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression
of PBC.
For info regarding 2021P000960
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
Brief Title: Elegance
Brief Summary: The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including
populations previously not represented in Peripheral Vascular Disease (PVD) trials,
health economics data, and to support the safe use of commercially available Boston
Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in
the peripheral vasculature.
For info regarding 2021P000937
please contact Jenifer Kaufman at 617-632-8956 or
cardscto@bidmc.harvard.edu
Title: Measures of maternal immune function in fresh and stored blood samples
Brief Title: Immune response in fresh and stored blood
Brief Summary: This prospective cohort study seeks to determine whether immune function throughout pregnancy can be measured at the time of blood collection and also on blood that has been stored. The samples are analyzed using Treg assays on fresh peripheral blood samples and cytokine assays on stored plasma. Results will be compared to determine how measures of immune function from stored samples correlated to results from fresh samples. Participants must be pregnant with plans to deliver at BIDMC.
For info regarding 2021P000926
please contact Anna Modest, PhD MPH at
ammodest@bidmc.harvard.edu
Title: Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants
Brief Title: Clinical trial of atrial fibrillation patients comparing lef
Brief Summary: The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA
occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for
ischemic stroke and who are recommended for long-term NOAC therapy.
The clinical investigation is a prospective, randomized, multicenter active control
worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA
occlusion device ("Device Group") and a commercially available NOAC medication ("Control
Group"). The choice of NOAC in the Control Group will be left to study physician
discretion.
For info regarding 2021P000891
please contact Jenifer Kaufman at 617-632-8956 or
cardscto@bidmc.harvard.edu
Title: Visual restoration of losses caused by cortical damage: a new protocol to promote fast recovery
Brief Title: Reduction of Visual Field Deficits
Brief Summary: This is a randomized, pilot interventional study in participants with visual field
deficit (VFD) caused by cortical lesion. Damage to the primary visual cortex (V1) causes
a contra-lesional, homonymous loss of conscious vision termed hemianopsia, the loss of
one half of the visual field. The goal of this project is to elaborate and refine a
rehabilitation protocol for VFD participants. It is hypothesized that visual restoration
training using moving stimuli coupled with noninvasive current stimulation on the visual
cortex will promote and speed up recovery of visual abilities within the blind field in
VFD participants. Moreover, it is expected that visual recovery positively correlates
with reduction of the blind field, as measured with traditional visual perimetry: the
Humphrey visual field test or an eye-tracker based visual perimetry implemented in a
virtual reality (VR) headset. Finally, although results will vary among participants
depending on the extent and severity of the cortical lesion, it is expected that a bigger
increase in neural response to moving stimuli in the blind visual field in cortical
motion area, for those participants who will show the largest behavioral improvement
after training. The overarching goals for the study are as follows: Group 1a will test
the basic effects of transcranial random noise stimulation (tRNS) coupled with visual
training in stroke cohorts, including (i) both chronic/subacute ischemic and chronic
hemorrhagic VFD stroke participants, and (ii) longitudinal testing up to 6 months
post-treatment. Group 1b will test the effects of transcranial tRNS coupled with visual
training on a Virtual Reality (VR) device in stroke cohorts, including both
chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants. Group 2 will
examine the effects of tRNS alone, without visual training, also including chronic and
subacute VFD stroke participants and longitudinal testing.
For info regarding 2021P000804
please contact Lorella Battelli at 617-667-0203 or
lbattell@bidmc.harvard.edu
Title: Yogic Breathing and Guided Meditation for Long Covid Symptoms
Brief Title: Covid No Longer
Brief Summary: This study aims to assess the impact of brief digitally delivered breathing practice and
guided meditation on post-Covid physical and mental symptoms in Long Covid Patients.
For info regarding 2021P000552
please contact Balachundhar Subramaniam at 617-754-2721 or
bsubrama@bidmc.harvard.edu
Title: REST: Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators
Brief Title: Sleep Architecture in Shoonya Meditators
Brief Summary: This study aims to investigate the effect of a 15-minute meditation practice on sleep
architecture and high-frequency Heart Rate Variability (HF-HRV), as well as cognitive
performance after both a well-rested and sleep-deprived night.
For info regarding 2021P000544
please contact Akshaj Joshi at 617-278-8058 or
sadhgurucenter_research@bidmc.harvard.edu
Title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
Brief Title: Volixibat VLX-301 Study
Brief Summary: The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease
progression of PSC.
For info regarding 2021P000450
please contact Julie Shea at 167-632-1125 or
jmshea@bidmc.harvard.edu
Title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
Brief Title: Volixibat VLX-301 Study
Brief Summary: The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease
progression of PSC.
For info regarding 2021P000450
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: Parkinson’s Foundation PD GENEration Genetic Registry
Brief Title: Parkinson’s Foundation PD GENEration Genetic Registry
Brief Summary: To assess the feasibility, impact, and participant satisfaction of offering Clinical
Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical
care for People with Parkinson's disease (PWP).
For info regarding 2021P000373
please contact Aine Russell at 617-667-9885 or
arussel2@bidmc.harvard.edu
Title: Variable anatomy & function of the arm’s alternate lymphatic pathway
Brief Title: The M-S Pathway: anatomy and function
For info regarding 2021P000209
please contact Angela Chen at 617-632-7827 or
lymphaticresearch@bidmc.harvard.edu
Title: Combined Zephyr Valve System with Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema: A Pilot Randomized Controlled Trial
Brief Title: COMPLETE-1
Brief Summary: The purpose of this protocol is to perform a pilot prospective randomized controlled
clinical trial to evaluate the potential role of lung fissure completion strategy
(experimental intervention) in addition to endobronchial valve (EBV) placement
(representing "standard-of-care") in select patients with severe COPD/emphysema and with
evidence for <95% fissure completion between adjacent lung lobes. In select patients,
lung fissure completion strategy will be performed by either video-assisted thorascopic
surgery (VATS)-guided or robotic-guided stapling along the lung fissures in an attempt to
reduce collateral ventilation and determine whether or not this experimental strategy
will improve outcome following subsequent EBV placement. EBV placement will follow
successful VATS-guided or robotic-guided fissure stapling.
The study will enroll approximately 20 patients at BIDMC, and outcomes will focus on
procedure-related complications, physiological measurements (ex., FEV1 by pulmonary
function testing) and clinical symptoms (i.e., questionnaires). Patient will be followed
for 3-month period, receiving usual standard of care during the 3 months of follow-up.
The goal of this protocol is to determine if elimination of significant collateral lung
ventilation between lung lobes is possible, and whether such strategy to eliminate
collateral lung ventilation between lobes improves outcomes following subsequent EBV
placement (i.e. promotes atelectasis of diseased lung segments) in the management of
severe COPD/emphysema in appropriate candidates. For subjects in the medical management
control group, upon completion of the 3-month F/U period, they will be eligible for EBV
if they choose.
For info regarding 2021P000049
please contact Christine Conley at 617-632-8386 or
cconley@bidmc.harvard.edu
Title: Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty
Brief Title: VR in the OR: TKA
Brief Summary: The objective of this study is to investigate whether the use of virtual reality (VR)
during total knee arthroplasty (TKA) can facilitate reductions in intraoperative sedative
requirements while maintaining high levels of patient satisfaction as compared to both a
music and sham VR + usual care control.
For info regarding 2020P001176
please contact Center for Anesthesia Research Excellence at
vgoodspe@bidmc.harvard.edu
Title: Brain Plasticity in Type-2 Diabetes
Brief Title: Brain Plasticity in Type-2 Diabetes
Brief Summary: The overall goal of this research is to learn more about changes in the structure and physiology (function) of the brain that occur in people with diabetes as they get older and how these changes relate to cognition (thinking) and other markers of brain health. By comparing the results from the diabetes groups with people who do not have diabetes, we hope to increase our understanding of why some people with diabetes develop problems with their cognition as they get older and have a higher risk of developing Alzheimers disease. You are invited to take part in this research study if you have type-2 diabetes or are in good overall health and you have not been diagnosed with mild cognitive impairment or dementia. The study includes about 6 in-person research visits, to be completed in about 8-10 weeks.
For info regarding 2020P001152
please contact Andrew Northrop at (617)667-0271 or
anorthro@bidmc.harvard.edu
Title: Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)
Brief Title: The CORCINCH-HF Study
Brief Summary: Prospective, randomized, open-label, international, multi-center clinical study to
evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in
patients with heart failure and reduced ejection fraction (HFrEF).
For info regarding 2020P000833
please contact Jenifer Kaufman at 617-632-8956 or
cardscto@bidmc.harvard.edu
Title: COVID-19 and Other Respiratory Pathogens Biorepository
Brief Title: COVID-19 and Other Respiratory Pathogens Biorepository
Brief Summary: The purpose of this study is to establish a biorepository of specimens and clinical data from potential, confirmed, or convalescent Coronavirus disease 2019 (COVID-19) cases and from those vaccinated with a COVID-19 vaccine. The study recruits and enrolls special populations including individuals who are pregnant or lactating and who are receiving vaccines against COVID-19 infection.
For info regarding 2020P000361
please contact Ai-Ris Collier, MD at (617) 735-4610 or
CVVRtrials@bidmc.harvard.edu
Title: 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI therapy
Brief Title: 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI therap
Brief Summary: The study is being conducted to learn why some patients with Benign Prostatic Hyperplasia
(BPH) do not respond to a commonly used treatment drug, Finasteride. The hope is to find
ways to predict which patients will not respond to Finasteride so that, in the future,
these patients can be identified prior to offering this treatment and they can be offered
alternative treatment strategies in its place. The aim is to see if noninvasive
techniques such as MRI can detect inflammation of the prostate to assist with early
detection of those who will and who will not respond to Finasteride.
For info regarding 2020P000202
please contact Christopher Mistretta at 617-632-8432 or
cmistret@bidmc.harvard.edu
Title: Mind Body Back Pain Study
Brief Title: treatment of Chronic Pain
Brief Summary: The goal of this study is to determine if a mind-body intervention can help people
suffering from chronic back pain. The study is a randomized, partially blinded trial
examining the effectiveness of a mind body intervention in reducing disability from back
pain and alleviating back pain in participants as compared to usual care and an active
control (second mind body intervention). The investigators will secondarily investigate
whether the intervention alleviates anxiety related to the pain and other quality of life
parameters.
For info regarding 2020P000147
please contact Michael Donnino, MD at 617-754-2884 or
mindbodystudy@bidmc.harvard.edu
Title: Predicting anemia in conjunctiva using a smartphone app
Brief Title: Conjunctiva app
Brief Summary: The purpose of the study is to help us learn if a color scale mobile application (app) is able to give researchers useful information to use in a medical setting in diagnosing patients with anemia (low red blood cell levels). You may help the study doctors gather data to develop an inexpensive and faster system that could be used in other medical settings to diagnose anemia at the bedside where lab results cannot be easily obtained.
For info regarding 2020P000111
please contact ED Research Team at 617-754-2287 or
cottanel@bidmc.harvard.edu
Title: Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial
Brief Title: Family-Focused Therapy for Individuals at High Clinical Ris
Brief Summary: This study is being conducted by researchers from UCLA, BIDMC, and 5 other research sites to compare two different kinds of therapy for teenagers and young adults (ages 12-25) who may have experienced changes in their thinking or mood. The study seeks to determine whether family and individual counseling sessions help people to feel better and function better in school, work, and in relationships. It involves a full mental health evaluation, including diagnostic impressions and feedback, 6 months of one type of treatment for participant and involving their family members, and follow-up wellness/research check-ups for 18 months.
For info regarding 2020C000558
please contact Colette Potts at 617-754-1209 or
ResponsetoRisk@bidmc.harvard.edu
Title: HEALEY ALS Platform Trial
Brief Title: HEALEY ALS Platform Trial
Brief Summary: The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial
evaluating the safety and efficacy of investigational products for the treatment of ALS.
For info regarding 2020C000221
please contact Seward Rutkove at 617-667-8130 or
srutkove@bidmc.harvard.edu
Title: A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD
Brief Title: HEPA RCT in COPD
Brief Summary: This study evaluates the influence of home air purification on the lung health of adults
with eosinophilic COPD. Half of the participants will receive real air purifiers (HEPA
filters) and half will receive sham air purifiers.
For info regarding 2019P001129
please contact Mary Rice at 617-667-0000 or
mrice1@bidmc.harvard.edu
Title: Examining the gastric emptying halftime of water versus a carbohydrate in early labor
Brief Title: Gastric emptying in labor
Brief Summary: To determine the half time of the emptying of the stomach of women in early labor with
and without epidural pain relief when drinking either water or a carbohydrate-based
sports drink.
For info regarding 2019P001110
please contact Philip Hess at 617-667-3112 or
phess@bidmc.harvard.edu
Title: Effect of Continuous Positive Airway Pressure (CPAP) on 6-Minute Walk Test Outcomes in Patients With Excessive Central Airway Collapse (ECAC)
Brief Title: Effect of CPAP on 6MWT in Patients with ECAC
Brief Summary: The purpose of this protocol is to perform a prospective, randomized, double-blinded,
pacebo-controlled clinical trial to determine the influence of a non-invasive positive
pressure ventilation device on exercise capacity and symptoms in adult patients with
ECAC. Primary outcome will include the total distance traversed by the study subject
during a standard 6-minute walk test, and secondary outcomes will include peak flow
measurement and symptom reporting before and after the exercise testing. The study will
focus on the use of continuous positive airway pressure (CPAP) device. CPAP is
FDA-approved for the treatment of various medical conditions, including obstructive sleep
apnea and heart failure, but is not FDA-approved for the treatment of ECAC. The study
will enroll 32 ambulatory study subjects with confirmed ECAC at the BIDMC, and each study
subject will be monitored for up to 3 months.
For info regarding 2019P001034
please contact Christine Conley at 617-632-8252 or
TSIPResearchStaff@bidmc.harvard.edu
Title: Neurophysiological Patterns of mindfulness meditation for Insomnia
Brief Title: Mindfulness meditation for Insomnia
Brief Summary: This is a pilot study evaluating the feasibility and acceptability of a
non-pharmacological, mind-body intervention to improve sleep quality, including a
preliminary evaluation of neurophysiological signals. The study involves 4 weeks of
guided mind-body practice at home using a smartphone app during bedtime and pre/post
in-lab sleep study visits.
For info regarding 2019P000984
please contact Ivy Ma at
yma3@bidmc.harvard.edu
Title: Retinal Layer, Microvascular and Electroretinographic Determinants of Early Course Psychosis
Brief Title: Retinal Determinants of Early Course Psychosis
Brief Summary: Schizophrenia is a chronic disorder and is among the most highly disabling diseases in all of medicine, impacting approximately 1.5% of the population. This study will use novel state-of-the-art Electroretinography (ERG), Optical Coherence Tomography (OCT) and angiography (OCTA) imaging to capture retinal biomarkers that inform pathophysiology and clinical outcome in early course psychosis. This study is expected to have an impact on the growing consensus in psychiatry and neuro-ophthalmology that the retina provides a window into the brain that can be useful for understanding brain pathophysiology and for developing biomarkers of illness progression and possibly treatment response.
For info regarding 2019P000815
please contact Brendan Stiltner at 617-754-1232 or
bstiltne@bidmc.harvard.edu
Title: The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity
Brief Title: The Effect of Sleep Deprivation on Emotional Processing
Brief Summary: To further understand the impact of acute sleep deprivation and recovery sleep on the
processing of emotional information the investigators will address and attempt to answer
three questions, (i) how both undisturbed sleep and sleep deprivation affect the
processing and retrieval of emotional information, (ii) what neural and
psychophysiological mechanisms are associated with these behavioral effects, and (iii) to
explore the ability of recovery sleep to reverse the effects of sleep deprivation.
Together, these studies will provide a greater breadth and depth of knowledge concerning
sleep's role in emotion processing and regulation. Given the growing societal tendency to
view sleep as unproductive-foregoing it to lengthen work days and increase social
opportunities- such knowledge would be of practical importance for understanding the role
of sleep in healthy emotional functioning, particular for individuals experiencing
periods of increased stress and emotional distress (e.g., new parents, hospital staff, or
combat troops).
For info regarding 2019P000062
please contact Robert Stickgold at 617-632-7926 or
rstickgo@bidmc.harvard.edu
Title: Alcoholic Hepatitis Network Clinical Study
Brief Title: AlcHepNet Clinical Study
Brief Summary: The purpose of this research study is to create a clinical database and bio-repository.
To do this, we will obtain blood, urine, saliva, and stool samples (e.g., biological
samples) and personal health information from you to use in future research studies
related to alcoholic hepatitis or other diseases. Part of your blood sample will be used
to extract your DNA. DNA is the genetic material that gives us unique characteristics. We
are doing this research study because we are trying to find out more about how and why
illnesses related to alcoholic hepatitis or other diseases occur in people. To do this,
we will study the biological samples and personal health information from healthy and
sick people.
A "biological sample" is usually blood, but can be any body fluid. "Personal Health
Information" includes such items as your name, age, gender, race, and/or your medical
information. It can also include data from measurements and tests that you had while
participating in another research study or that were done during the course of your
regular medical care or doctor visits.
For info regarding 2019C000971
please contact Liver Center Trials Office at 617-667-9050 or
gszabo1@bidmc.harvard.edu
Title: Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
Brief Title: ASPIRE
Brief Summary: Primary Aim: To determine if apixaban is superior to aspirin for prevention of the
composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in
patients with recent ICH and atrial fibrillation (AF).
Secondary Aim: To determine if apixaban, compared with aspirin, results in better
functional outcomes as measured by the modified Rankin Scale.
For info regarding 2019C000787
please contact Magdy Selim at 617-632-8913 or
mselim@bidmc.harvard.edu
Title: Optimizing Family Counseling for Anticipated Extremely Preterm Delivery
Brief Title: Optimizing Family Counseling for Preterm Delivery
Brief Summary: Antenatal family counseling for anticipated extremely preterm deliveries remains
ethically and practically challenging for maternal-fetal medicine specialists and
neonatologists alike. The overall goal of this project is to improve antenatal counseling
and counseling outcomes for families facing anticipated extremely preterm delivery
through innovative, interdisciplinary simulation-based education for maternal fetal
medicine specialists and neonatologists, using language preferred by families, and
focusing on eliciting values and building partnerships through advanced communication and
relational skills.
For info regarding 2019C000598
please contact NICU Research Team at 617-355-7260 or
NICUResearch@bidmc.harvard.edu
Title: Sleep for Stroke Management And Recovery Trial
Brief Title: SleepSMART
Brief Summary: The purpose of this study is to determine whether treatment of obstructive sleep apnea
(OSA) with positive airway pressure starting shortly after acute ischemic stroke (1)
reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after
the event, and (2) improves stroke outcomes at 3 months in patients who experienced an
ischemic stroke.
For info regarding 2019C000228
please contact Sarah Marchina at
smarchin@bidmc.harvard.edu
Title: The Functional Neuroanatomy of the Human Physiological Stress Response
Brief Title: Functional Neuroanatomy of Physiological Stress
Brief Summary: The purpose of this study is to examine the effect of a moderately low blood sugar stress
on the nervous system. The investigators hope that information obtained from completing
this study will help to reveal information about how a non-psychological stress impacts
the parts of the brain that react to stress and the autonomic nervous system. The
autonomic nervous system is the part of the nervous system that provides the body with
involuntary or automatic control of heart rate, blood pressure, and breathing.
For info regarding 2019C000177
please contact Roy Freeman at 617-632-8454 or
rfreeman@bidmc.harvard.edu
Title: Edwards PASCAL TrAnScatheter Mitral Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitation
Brief Title: Edwards PASCAL CLASP IID Pivotal Clinical Trial
Brief Summary: To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve
Repair System in patients with degenerative mitral regurgitation (DMR) who have been
determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in
patients with functional mitral regurgitation (FMR) on guideline directed medical therapy
(GDMT)
For info regarding 2018P000760
please contact Jenifer Kaufman at 617-632-8956 or
cardscto@bidmc.harvard.edu
Title: The Liver Incytes System, evaluation of liver fibrosis and steatosis versus MRE and MRI-PDFF SI-CLIN-02
Brief Title: Fibroscan Study
Brief Summary: Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in
healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory
ability of elasticity measurements generated by Liver Incyte for healthy volunteers
versus patients with liver fibrosis in comparison to FibroScan measurements.
For info regarding 2018P000730
please contact Liver Center Trials Office at 617-632-1118 or
mcurry@bidmc.harvard.edu
Title: A Prospective Registry Study in a Global Huntingtons Disease Cohort
Brief Title: A Prospective Registry Study in a Global Huntingtons Diseas
Brief Summary: Enroll-HD is a longitudinal, observational, multinational study that integrates two
former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North
America and Australasia-while also expanding to include sites in Latin America. More than
30,000 participants have now enrolled into the study. With annual assessments and no end
date, Enroll-HD has built a large and rich database of longitudinal clinical data and
biospecimens that form the basis for studies developing tools and biomarkers for
progression and prognosis, identifying clinically-relevant phenotypic characteristics,
and establishing clearly defined endpoints for interventional studies. Periodic cuts of
the database are now available to any interested researcher to use in their research -
visit www.enroll-hd.org/for-researchers/access-data/ to learn more.
For info regarding 2018P000332
please contact Samuel Frank at 617-667-4889 or
sfrank2@bidmc.harvard.edu
Title: StATins Use in intRacereberal hemorrhage patieNts
Brief Title: (Statins in ICH (SATURN Trial)
Brief Summary: The SATURN trial aims to determine whether continuation vs. discontinuation of statin
drugs after spontaneous lobar intracerebral hemorrhage (ICH) is the best strategy; and
whether the decision to continue/discontinue statins should be influenced by an
individual's Apolipoprotein-E (APOE) genotype.
An MRI ancillary study (SATURN MRI), in a subset of SATURN participants , will evaluate
the effects of continuation vs. discontinuation of statin drugs on hemorrhagic and
ischemic MRI markers of cerebral small vessel disease, and whether the presence/burden of
hemorrhagic markers (i.e. cerebral microbleeds and/or cortical superficial siderosis) on
baseline MRI influences the risk of ICH recurrence on/off statin therapy.
For info regarding 2018C000515
please contact Magdy Selim at 617-632-8913 or
mselim@bidmc.harvard.edu
Title: MRI Evaluation of Aging Related Changes to the Brain
Brief Title: MRI Evaluation of Aging Related Changes to the Brain
Brief Summary: The purpose of this study is to develop new magnetic resonance imaging (MRI) techniques that can be used to clinically evaluate patients across a spectrum of ages 18+. This study will test magnetic resonance techniques on FDA approved MRI machines. Newly developed MRI sequences will be
validated on normal subject brains and compared to standard techniques. This study will evaluate different brain imaging techniques including Arterial Spin Labeling (ASL) perfusion and Inhomogeneous Magnetization Transfer (ihMT) imaging.
For info regarding 2017P000491
please contact David Alsop at 617-667-0275 or
dalsop@bidmc.harvard.edu
Title: Patient reported outcomes assessment in coronary and peripheral artery diseases
Brief Title: Patient reported outcomes in coronary and peripheral
Brief Summary: The Patient Reported Outcomes Assessment in Coronary and Peripheral Artery Diseases study (referred to as PAD PROMs in short) is a longitudinal study that assesses patient outcomes with treatment following peripheral artery disease (PAD) diagnosis. The study involves a baseline survey and surveys taken 1 month, 6 months, and 1 year after intervention and will ask questions relating to the participants symptoms in relation to their peripheral artery disease.
For info regarding 2016P000377
please contact Shylie Ati at
sati@bidmc.harvard.edu
Title: The evolution of memories across wake and sleep
Brief Title: The evolution of memories across wake and sleep
Brief Summary: To further understanding of the relationship between sleep and memory the investigators
will address and attempt to answer three questions, (1) how memories evolve across wake
and sleep, (2) how different aspects of this memory evolution are reflected both
behaviorally and in the EEG signal, and (3) what stages and features of sleep affect
memory evolution. Together, these studies will provide a greater breadth and depth of
knowledge concerning sleep's role in memory consolidation. Such knowledge would be of
practical importance for educational practices, whether in schools, on the job, or in the
military, and would also provide valuable information to the fields of sleep medicine and
psychiatry, where interactions between sleep disorders and cognitive functioning are of
great importance.
For info regarding 2016P000222
please contact Anthony Cunningham, PhD at 617-667-4702 or
acunnin4@bidmc.harvard.edu
Title: Studies of Immune Cell Signaling and Gene Transcription in Systemic Lupus Erythematosus, Other Autoimmune Diseases and Healthy Volunteers
Brief Title: Blood Samples in Lupus, other Autoimmune Diseases
Brief Summary: This study is being done to study the natural history of Systemic Lupus Erythematosus (SLE). The causes of and the treatments for the disease will be investigated and compared to those of other autoimmune diseases and healthy controls without any autoimmune disease. Participants will be asked to donate blood (less than or equal to 100 mLs) and/or urine while they are having their clinical labs drawn, no less than every 6 weeks.
For info regarding 2006P000298
please contact Rheumatology Clinical Research Specialist at 617-632-8658 or
skrishfi@bidmc.harvard.edu