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A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Pati1
Eli Lilly and Company
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination
with standard of care anti-cancer drugs is more effective than standard of care in
participants with untreated advanced NSCLC. NSCLC must have a change in a gene called
KRAS G12C. Study participation, including f1 expand
The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing. Type: Interventional Start Date: Dec 2023 |
Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Pa1
AbbVie
Parkinson's Disease (PD)
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets
worse over time, but how quickly it progresses varies a lot from person to person. Some
symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this
study is to evaluate how effective ABBV1 expand
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to evaluate how effective ABBV-951 is in treating adult participants with advanced PD in real world setting. ABBV-951 (foslevodopa/foscarbidopa) is an approved drug for the treatment of Parkinson's Disease. The main ROSSINI study will have approximately 450 adult participants with PD (300 participants new to ABBV-951, up to 150 participants transitioning from open-label extension study) will be enrolled across approximately 60 sites. Decision to treat with ABBV-951 (or continue the treatment in Cohort B) will be made by the doctor prior to any decision to approach the participant to participate in this study. There will be a sub-study that will enroll 40 naïve participants who initiated Foslevodopa/Foscarbidopa treatment for the first time (Cohort A of the ROSSINI parent study only) from 6 to 15 centers in the United States, Germany and Spain. All participants will receive subcutaneous infusion of ABBV-951 for approximately 3 years. Participants will attend regular clinic visits during the course of the study. The effect of the treatment will be checked by medical assessments, and completing questionnaires. Type: Observational Start Date: Jan 2024 |
Texting to Reduce Human Immunodeficiency Virus (HIV) Risk
Boston University
HIV Infections
This is a 3-year study to test the efficacy of a text message-based intervention program.
Dental patients at 4 community health centers (n= 266) will be randomized to receive
either text messages (TMs) regarding HIV prevention or TMs regarding overall wellness.
Prior to enrolling the 266 participan1 expand
This is a 3-year study to test the efficacy of a text message-based intervention program. Dental patients at 4 community health centers (n= 266) will be randomized to receive either text messages (TMs) regarding HIV prevention or TMs regarding overall wellness. Prior to enrolling the 266 participants, the investigators will conduct a feasibility pilot (n=20) to test the TM delivery as well as all study procedures. For both the pilot and the randomized clinical trial (RCT), recruitment will be conducted at 4 Community Health Center dental clinics (Codman Square, East Boston (both East Boston and South End locations), Geiger Gibson, and Upham's Community Health Centers). Recruitment materials (flyers and permission to contact forms) may also be made available at other clinics within the health centers. The study will enroll English and Spanish-speaking patients who have at least one risk factor for HIV but are HIV-negative. Patients enrolled in the pilot will complete self-report surveys at baseline, 1 and 2 months. Participants enrolled in the RCT will complete self-report surveys baseline, 3, 6, and 12 months after baseline; receive and respond to TM assessments during the 6-month intervention. Type: Interventional Start Date: Aug 2024 |
An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Dox1
Hoffmann-La Roche
Large B-Cell Lymphoma
The purpose of this study is to compare the efficacy and safety of glofitamab in
combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and
prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated
CD20-positive large B-cell lymphoma (LBCL). expand
The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL). Type: Interventional Start Date: Sep 2023 |
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX1
Genentech, Inc.
Adenocarcinoma, Pancreatic Ductal
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene
cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan,
and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected
pancreatic ductal adenocarcinoma (PDAC)1 expand
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery. Type: Interventional Start Date: Oct 2023 |
Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN
Novartis Pharmaceuticals
IC-MPGN
This study is designed as a multicenter, randomized, double-blind, parallel group,
placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in
idiopathic immune complex mediated membranoproliferative glomerulonephritis. expand
This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis. Type: Interventional Start Date: Oct 2023 |
Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease1
Takeda
Alpha1-Antitrypsin Deficiency
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis)
compared to placebo. Other aims are to learn if fazirsiran slows down the disease
worsening in the liver, to get information on how fazirsiran affects the body (called
pharmacodynamics), to learn if fazirsiran re1 expand
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study. Type: Interventional Start Date: Mar 2023 |
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or C1
Janssen Research & Development, LLC
Relapsed or Refractory Multiple Myeloma
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1
and to further characterize safety and efficacy of an alternative dosing for teclistamab
in Part 2 in participants with relapsed or refractory multiple myeloma. expand
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in Part 2 in participants with relapsed or refractory multiple myeloma. Type: Interventional Start Date: Mar 2023 |
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal1
Janssen Research & Development, LLC
Carcinoma, Non-small-Cell Lung
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab
which will be administered as a co-formulation with recombinant human hyaluronidase PH20
(rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts
except Cohort 4) and to characteriz1 expand
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4). Type: Interventional Start Date: Nov 2022 |
Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
Rajshekhar Chakraborty, MD
AL Amyloidosis
The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax
in combination with dexamethasone in participants with t(11;14) positive relapsed (comes
back) or refractory (did not get better) light chain amyloidosis. expand
The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis. Type: Interventional Start Date: Oct 2022 |
(HALT) Embrace Hydrogel Embolic System (HES) Study of Embolization in Peripheral Arterial Bleeds
Instylla, Inc.
Arterial Bleeding in Solid Organs and Peripheral Arteries
To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the
transcatheter embolization of peripheral arterial bleeds. expand
To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the transcatheter embolization of peripheral arterial bleeds. Type: Interventional Start Date: Dec 2022 |
A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
Janssen Research & Development, LLC
Amyloidosis
The purpose of this study is to characterize cardiac safety of Daratumumab,
Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A:
daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly
diagnosed systemic amyloid light chain (AL) amyloidosi1 expand
The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2). Type: Interventional Start Date: Mar 2022 |
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
NRG Oncology
Stage III Colon Cancer
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to
patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery
for colon cancer. expand
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Type: Interventional Start Date: Mar 2022 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
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. expand
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. Type: Interventional Start Date: Aug 2022 |
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence1
NRG Oncology
Stage I Breast Cancer
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy
results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor
recurrence (IBTR) compared to breast conservation with breast radiation and endocrine
therapy. expand
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy. Type: Interventional Start Date: Jun 2021 |
Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation1
NRG Oncology
Metastatic Lung Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Brain
Recurrent Lung Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
This phase III trial compares the effect of stereotactic radiosurgery to standard of care
memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone
of the brain) for the treatment of small cell lung cancer that has spread to the brain.
Stereotactic radiosurgery is a s1 expand
This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine. Type: Interventional Start Date: Jun 2021 |
PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
Michael J. Fox Foundation for Parkinson's Research
Parkinson Disease
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational,
multi-center natural history study to assess progression of clinical features, digital
outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD)
progression in study participants with manifest1 expand
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability. Type: Observational Start Date: Jul 2020 |
A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Smal1
Genentech, Inc.
Non-small Cell Lung Cancer
This trial will evaluate the efficacy and safety of various therapies in patients with
Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung
cancer (NSCLC) tumors that meet protocol-specified biomarker criteria expand
This trial will evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria Type: Interventional Start Date: Nov 2020 |
Impact of Balance Training in Community-Dwelling Older Adults After Recovery From COVID-19
Cairo University
Community-dwelling Older Adults
This research investigates the impact of balance training on improving functional
performance and reducing fall risk in community-dwelling older adults who have recovered
from COVID-19. Post-COVID-19, many elderly individuals experience lingering physical
impairments, including muscle weakness, dec1 expand
This research investigates the impact of balance training on improving functional performance and reducing fall risk in community-dwelling older adults who have recovered from COVID-19. Post-COVID-19, many elderly individuals experience lingering physical impairments, including muscle weakness, decreased coordination, and balance deficits, which increase their vulnerability to falls. The study evaluates whether a structured balance training program can enhance stability, mobility, and overall quality of life in this population. Type: Interventional Start Date: Jun 2025 |
BoTox Into the Sternocleidomastoid Muscles (SCM)
Boston Medical Center
Neck Muscle Issue
Botulinum toxin injections have been used both in the face and neck for many years.
However, injection into the sternocleidomastoid muscle (SCM) has only been done to treat
neck spasms. In this study botulinum toxin will be injected into the SCM to determine if
this will result in a temporary slimm1 expand
Botulinum toxin injections have been used both in the face and neck for many years. However, injection into the sternocleidomastoid muscle (SCM) has only been done to treat neck spasms. In this study botulinum toxin will be injected into the SCM to determine if this will result in a temporary slimming effect on the neck and produce a more feminine, youthful neck contour. Type: Interventional Start Date: May 2025 |
Innovative Automated Insulin Delivery System for Type 2 Diabetes
Deka Research and Development
Type 2 Diabetes
Insulin Treated Type 2 Diabetes Mellitus
The goal of this clinical trial is to learn if the twiist insulin delivery system works
to treat adults with insulin-treated type 2 diabetes. expand
The goal of this clinical trial is to learn if the twiist insulin delivery system works to treat adults with insulin-treated type 2 diabetes. Type: Interventional Start Date: Apr 2025 |
Therapy Dog Visits for Patients Hospitalized With Traumatic Injuries
Boston Medical Center
Trauma Injury
Depression
Anxiety
Anger
Pain
Animal assisted therapy (AAT) with dogs has been shown to be beneficial for a wide range
of patients with both acute and chronic illnesses, including spinal cord injuries, heart
failure, myocardial infarctions, strokes, cancer, post-traumatic stress disorder, and
depression. Studies have also demon1 expand
Animal assisted therapy (AAT) with dogs has been shown to be beneficial for a wide range of patients with both acute and chronic illnesses, including spinal cord injuries, heart failure, myocardial infarctions, strokes, cancer, post-traumatic stress disorder, and depression. Studies have also demonstrated that even in healthy adults, the presence of dogs is associated with physiologic changes such as increased pain threshold, decreased blood pressure, and decreased heart rate. However, few studies have investigated the role of AAT in the post-operative course in adults. This study will investigate the impact of therapy dog visits on pain and anxiety scores for trauma patients at Boston Medical Center (BMC). Type: Interventional Start Date: Jun 2025 |
Cervical Preparation for Same-Day Dilation & Evacuation
Boston Medical Center
Abortion, Second Trimester
Procedural Pain
Procedural Complication
This is a noninferiority randomized control trial of two cervical preparation methods
prior to same-day Dilation & Evacuation (D&E). Cervical preparation is a process that
softens and dilates the cervix prior to a procedure.
The primary objective is to evidence noninferiority of cervical preparati1 expand
This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation & Evacuation (D&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure. The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D&E operative time. Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety. Type: Interventional Start Date: Jun 2025 |
Get Social Media and Risk-Reduction Training
University of Virginia
Infant Death
Sudden Infant Death
This study examines the implementation of the TodaysBaby™ mobile safe sleep intervention
program in US hospitals. The main aims of this study are to examine: 1) differences in
program penetration and the equity of penetration according to income and race/ethnicity;
2) differences in feasibility, ac1 expand
This study examines the implementation of the TodaysBaby™ mobile safe sleep intervention program in US hospitals. The main aims of this study are to examine: 1) differences in program penetration and the equity of penetration according to income and race/ethnicity; 2) differences in feasibility, acceptability, sustainability and fidelity top the intervention; and 3) the effectiveness of the intervention. Type: Interventional Start Date: May 2025 |
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Jaeb Center for Health Research
Amblyopia
Participants eligible for the study will be randomly allocated (1:1:1) to receive either
Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision
dichoptic treatment while wearing optical correction if needed, or continued optical
correction alone if needed, with clini1 expand
Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization. At the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization. The study will end for all other participants at 18 weeks. Type: Interventional Start Date: Oct 2024 |
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