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Study to Investigate the Pharmacokinetics and Safety and to Provide Proof of Mechanism of Alogabat in...
Angelman Syndrome
This is a two-part, Phase IIa, multicenter, 12-week, open-label study. Up to 56 participants
with deletion Angelman Syndrome (AS) aged 5-17 years (inclusive) will be enrolled in the
study.
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This is a two-part, Phase IIa, multicenter, 12-week, open-label study. Up to 56 participants with deletion Angelman Syndrome (AS) aged 5-17 years (inclusive) will be enrolled in the study. Type: Interventional Start Date: Jul 2023 |
A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML
Myelodysplastic Syndromes
Chronic Myelocytic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome/Neoplasm
Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of
an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose
levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time)... expand
Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a randomized open-label crossover study comparing the final oral ASTX030 dose to SC azacitidine. The duration of the study is expected to be approximately 48 months. Type: Interventional Start Date: May 2020 |
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk...
Ovarian Carcinoma
This clinical trial studies how well two surgical procedures (bilateral salpingectomy and
bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals
with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian
tubes,... expand
This clinical trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations. Type: Interventional Start Date: Sep 2020 |
Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol
Malignant Solid Neoplasm
This trial studies how well iohexol works in helping doctors calculate the dose of
carboplatin given to patients with cancer. Drugs used in chemotherapy, such as carboplatin,
work in different ways to stop the growth of tumor cells, either by killing the cells, by
stopping... expand
This trial studies how well iohexol works in helping doctors calculate the dose of carboplatin given to patients with cancer. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Understanding how to best calculate the dose of carboplatin given to patients with cancer may help doctors learn how to improve the use of carboplatin in the future. Type: Interventional Start Date: Jan 2020 |
GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab
Type 1 Diabetes
The goal of this study is to determine how a drug class called glucagon-like peptide-1
receptor agonists (GLP-1Ra) affects people during an early stage of Type 1 Diabetes
undergoing clinical teplizumab treatment. This study involves giving participants a liquid
meal under... expand
The goal of this study is to determine how a drug class called glucagon-like peptide-1 receptor agonists (GLP-1Ra) affects people during an early stage of Type 1 Diabetes undergoing clinical teplizumab treatment. This study involves giving participants a liquid meal under three different conditions and observing how their bodies respond, focusing on blood sugar levels, insulin effectiveness, and blood vessel function. The first meal test is pre-teplizumab, followed by two post-treatment tests, one with the GLP-1Ra drug and the other with a placebo. Each test involves blood draws before and during the meal test, GLP-1Ra or placebo administration, and an ultrasound to measure blood vessel function. The goal is to see if GLP-1Ra can help manage blood sugar levels and improve cardiovascular health in this population. Type: Interventional Start Date: Jun 2024 |
The Effect of Clinic Visit Audio Recordings for Self-management in Older Adults
Diabetes
The objective of this study is to conduct a multisite trial evaluating the impact of adding
an audio recording of clinic visits (AUDIO) to usual care in older adults with
multimorbidity, including diabetes, compared to After Visit Summary (AVS) alone (Usual Care;
UC).... expand
The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to After Visit Summary (AVS) alone (Usual Care; UC). Type: Interventional Start Date: Sep 2023 |
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation...
COVID-19
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that
immune modulation can improve outcomes in hospitalized patients. This trial is designed to
determine whether intensification of immune modulation early in the course of the disease
(while... expand
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement. Type: Interventional Start Date: Jul 2023 |
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Coronary Artery Disease
Post-market, prospective, multi-center, single-arm observational study to generate real-world
clinical evidence associated with coronary IVL in a population of female subjects with
calcified coronary artery disease.
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Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease. Type: Observational Start Date: May 2023 |
A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
Advanced or Metastatic Solid Tumors
The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101
alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.
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The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors. Type: Interventional Start Date: Mar 2023 |
Genetics of Appendix Cancer Study
Appendix Cancer
Appendiceal Cancer
Appendiceal Neoplasms
Appendiceal Mucinous Neoplasm
Appendiceal Adenocarcinoma
The GAP Study is a prospective cohort study designed to comprehensively investigate genetic
variations that may contribute to cancer development among individuals diagnosed with
appendix/appendiceal cancer who are ages 18+ years.
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The GAP Study is a prospective cohort study designed to comprehensively investigate genetic variations that may contribute to cancer development among individuals diagnosed with appendix/appendiceal cancer who are ages 18+ years. Type: Observational Start Date: Nov 2022 |
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma
Metastatic Breast Cancer
This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the
impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal
A hormone receptor-positive (HR+) metastatic breast cancer (MBC)
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This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC) Type: Interventional Start Date: Sep 2023 |
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX)...
Locally Advanced Rectal Carcinoma
Stage II Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course
chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs,
such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX
(leucovorin,... expand
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer. Type: Interventional Start Date: Dec 2022 |
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Pulmonary Arterial Hypertension
The primary objectives of the study are to evaluate the safety and tolerability, and
pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to <18 years
of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is
no formal... expand
The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to <18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis. Type: Interventional Start Date: Jan 2023 |
Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas
Liposarcoma, Dedifferentiated
Study SPH4336-US-01 is an open-label (no placebo), multicenter clinical trial to evaluate the
safety, blood levels (pharmacokinetics) and preliminary anti-tumor effects of SPH4336, a
selective enzyme blocker, in patients with specific types of liposarcomas (tumors expressing... expand
Study SPH4336-US-01 is an open-label (no placebo), multicenter clinical trial to evaluate the safety, blood levels (pharmacokinetics) and preliminary anti-tumor effects of SPH4336, a selective enzyme blocker, in patients with specific types of liposarcomas (tumors expressing the target of the study drug). Type: Interventional Start Date: Aug 2023 |
Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies
Relapsed/Refractory Waldenstrom Macroglobulinemia
Relapsed/Refractory Richter Transformation
Relapsed/Refractory Burkitt Lymphoma
Relapsed/Refractory Hairy Cell Leukemia
Master protocol: The goal of this master clinical study is to test how well the study drug,
brexucabtagene autoleucel, works in participants with rare B-cell malignancies:
relapsed/refractory Waldenstrom macroglobulinemia (r/r WM) (Substudy A - no longer
recruiting), relapsed/refractory... expand
Master protocol: The goal of this master clinical study is to test how well the study drug, brexucabtagene autoleucel, works in participants with rare B-cell malignancies: relapsed/refractory Waldenstrom macroglobulinemia (r/r WM) (Substudy A - no longer recruiting), relapsed/refractory Richter transformation (r/r RT) (Substudy B), relapsed/refractory Burkitt lymphoma (r/r BL) (Substudy C and relapsed/refractory hairy cell leukemia (r/r HCL) (Substudy D - no longer recruiting). Type: Interventional Start Date: Nov 2022 |
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active...
Active Idiopathic Inflammatory Myopathy
Myositis
Dermatomyositis
Polymyositis
Immune-Mediated Necrotizing Myopathy
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared
with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with
the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or... expand
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/. Type: Interventional Start Date: Oct 2022 |
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Fistulizing Crohns Disease
Perianal Crohns Disease
The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing,
perianal Crohn's disease and to assess the overall safety of guselkumab.
expand
The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab. Type: Interventional Start Date: Sep 2022 |
EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction
Cardiovascular Disease
Myocardial Infarction
Stroke
Coronary Revascularization
The primary objective of this study is to evaluate the effectiveness of early treatment with
evolocumab plus routine lipid management vs routine lipid management alone when administered
in the acute setting to reduce myocardial infarction, ischemic stroke, arterial
revascularization,... expand
The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]). Type: Interventional Start Date: Oct 2022 |
Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors
Advanced Cancer
RBS2418 (investigational product) is a specific immune modulator, working through
ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1), designed to lead to anti-tumor
immunity by increasing endogenous 2'-3'-cyclic guanosine monophosphate-adenosine
monophosphate (cGAMP)... expand
RBS2418 (investigational product) is a specific immune modulator, working through ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1), designed to lead to anti-tumor immunity by increasing endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) and adenosine triphosphate (ATP levels) and reducing adenosine production in the tumors. RBS2418 has the potential to be an important therapeutic option for subjects both as monotherapy and in combination with checkpoint blockade. This study is an open-label, multi-site Phase 1a/1b study of RBS2418, a selective ENPP1 inhibitor, in combination with pembrolizumab or as a monotherapy in subjects with advanced unresectable, recurrent or metastatic tumors. Type: Interventional Start Date: Jul 2022 |
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent...
SSM
Mastocytosis, Indolent
Mastocytosis, Systemic
Mastocytosis
This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study
comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC)
with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM),
including... expand
This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM), including indolent systemic mastocytosis and smoldering systemic mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be conducted in three parts. Patients in Parts 1a, 1b and 2 will receive bezuclastinib or placebo, and may roll over onto Part 3 to receive treatment with bezuclastinib. Type: Interventional Start Date: Jun 2022 |
A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed...
DLBCL
Diffuse Large B-Cell Lymphoma
The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and
expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in
combination with standard of care options for the treatment of rrDLBCL. This study will be
divided... expand
The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR. With protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab [BR] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B. Type: Interventional Start Date: Jan 2022 |
EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway
Obesity
Genetic Obesity
The protocol describes a randomized, double-blind, placebo-controlled trial with independent
sub-studies of setmelanotide in patients with obesity and at least one of the specific gene
variants in the Melanocortin-4 Receptor pathway:
- POMC or PCSK1 (Sub-study 035a)... expand
The protocol describes a randomized, double-blind, placebo-controlled trial with independent sub-studies of setmelanotide in patients with obesity and at least one of the specific gene variants in the Melanocortin-4 Receptor pathway: - POMC or PCSK1 (Sub-study 035a) - LEPR (Sub-study 035b) - SRC1 (Sub-study 035c) - SH2B1 (Sub-study 035d) The objectives and endpoints are identical for these sub-studies. Type: Interventional Start Date: Dec 2021 |
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age...
Stereotypical Prolonged Seizures
The purpose of the study is to assess the success of a single administration of Staccato
alprazolam compared with placebo both in rapidly terminating a seizure episode within 90
seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal
product... expand
The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration. Type: Interventional Start Date: Dec 2021 |
Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)
Pulmonary Disease
Benign central airway stenosis (BCAS) is an important cause of both pulmonary morbidity and
mortality. Notable causes include post-intubation stenosis, collagen vascular diseases,
airway trauma, infectious and idiopathic subglottic stenosis (iSGS). Surgery is the preferred... expand
Benign central airway stenosis (BCAS) is an important cause of both pulmonary morbidity and mortality. Notable causes include post-intubation stenosis, collagen vascular diseases, airway trauma, infectious and idiopathic subglottic stenosis (iSGS). Surgery is the preferred definite option; however, the first therapeutic attempt is usually endoscopic to temporarily restore airway patency and symptomatic improvement. Several endoscopic modalities exist for treatment. Most commonly, thermal or laser therapy to make radial incisions into the stenotic lesion, followed by balloon dilation to increase the area of patency. Clinicians may also inject steroids or antineoplastic agents such as mitomycin C. All of these methods have benefits and associated risks. Symptomatic stenosis frequently reoccurs with these methods. For example, the investigators have been doing 3-4 ballon dilations procedures a week at our institution. Spray cryotherapy (SCT) is a novel FDA-cleared technique that allows for liquid nitrogen to be delivered through the working channel of a bronchoscope. Few retrospective studies exist without more robust clinical trial data to reduce the risk of bias and support its widespread use. The investigators postulate that SCT and standard of care techniques will improve airway patency volume at six months than the standard of care techniques alone. Some of the proposed advantages include improved wound healing which may translate to less scar tissue and thus improvements in airway patency for a longer duration of time. Type: Interventional Start Date: Oct 2021 |
Competency Based Approaches for Community Health 2
Obesity
One-size-fits-all approaches have failed to demonstrate sustained effects on childhood
obesity, especially among low-income minority families, who experience constantly changing
barriers to engaging in health behavior. Addressing obesity in these populations requires
intervening... expand
One-size-fits-all approaches have failed to demonstrate sustained effects on childhood obesity, especially among low-income minority families, who experience constantly changing barriers to engaging in health behavior. Addressing obesity in these populations requires intervening in early childhood and situating interventions in the context of families and communities. Developing personalized childhood obesity prevention interventions with sustained effectiveness that support families in health behaviors despite dynamic barriers could address chronic disease risk and health disparities in low-income and minority communities. Type: Interventional Start Date: Nov 2021 |
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