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Avexitide for Treatment of Post-Bariatric Hypoglycemia
Amylyx Pharmaceuticals Inc.
Post Bariatric Hypoglycemia
AVX-001 (LUCIDITY) is a Phase 3 study to evaluate avexitide compared to placebo in
participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass
(RYGB). The study will assess avexitide compared to placebo for safety and efficacy,
measured by reduction of hypoglycemic event1 expand
AVX-001 (LUCIDITY) is a Phase 3 study to evaluate avexitide compared to placebo in participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass (RYGB). The study will assess avexitide compared to placebo for safety and efficacy, measured by reduction of hypoglycemic events. The study includes a Screening period with a Run-in period (of up to 6- and 3-weeks, respectively); a randomized, double-blind, placebo-controlled study treatment period of 16 weeks; and a two-part open-label extension (OLE) period with a duration of approximately 32 weeks. Type: Interventional Start Date: Apr 2025 |
Comparing Radiation Therapy to Usual Care for Patients With High-Risk Bone Asymptomatic Metastases,1
NRG Oncology
Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Solid Neoplasm
This phase III trial compares the effect of adding radiation therapy to usual care on the
occurrence of bone-related complications in cancer patients with high-risk bone
metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are
defined by their location (including hip,1 expand
This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger). These bone metastases appear to be at higher risk of complications such as fracture, spinal cord compression, and/or pain warranting surgery or radiation treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. The total dose of radiation can be delivered in a single day or divided in smaller doses for up to 5 days of total treatment. Usual care for asymptomatic bone metastases may include drugs that prevent bone loss, in addition to the treatment for the primary cancer or observation (which means no treatment until symptoms appear). Evidence has shown that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications, however, it is not known if this approach is superior to usual care. Adding radiation therapy to usual care may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases. Type: Interventional Start Date: Apr 2025 |
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Karuna Therapeutics
Alzheimer Disease
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult
participants with mild to severe Alzheimer's Disease (AD) with moderate to severe
psychosis related to AD. expand
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. Type: Interventional Start Date: Sep 2024 |
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Merck Sharp & Dohme LLC
Essential Thrombocythemia
The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared
with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET)
participants for whom cytoreductive therapy is indicated. Its primary objective is to
compare bomedemstat to hydroxyurea with respe1 expand
The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR. Type: Interventional Start Date: Jul 2024 |
A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagno1
National Cancer Institute (NCI)
High Grade Osteosarcoma
Localized Osteosarcoma
Metastatic Osteosarcoma
Secondary Osteosarcoma
This phase II/III trial tests the safety, side effects, and best dose of the drug
cabozantinib in combination with standard chemotherapy, and to compare the effect of
adding cabozantinib to standard chemotherapy alone in treating patients with newly
diagnosed osteosarcoma. Cabozantinib is in a clas1 expand
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma. Type: Interventional Start Date: Mar 2023 |
Comparing Antipsychotic Medications in LBD Over Time
The University of Texas Health Science Center at San Antonio
Parkinson's Disease Psychosis
Dementia With Lewy Bodies
The primary objective of this study is to determine whether treatment with pimavanserin
or quetiapine is associated with a greater improvement in psychosis when used in a
routine clinical setting to treat hallucinations and/or delusions due to Parkinson's
disease (PD) or dementia with Lewy bodies (1 expand
The primary objective of this study is to determine whether treatment with pimavanserin or quetiapine is associated with a greater improvement in psychosis when used in a routine clinical setting to treat hallucinations and/or delusions due to Parkinson's disease (PD) or dementia with Lewy bodies (DLB) - collectively referred to as Lewy body disease (LBD). Type: Interventional Start Date: Apr 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 |
A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With Fir1
National Cancer Institute (NCI)
Down Syndrome
Recurrent B Acute Lymphoblastic Leukemia
This phase II trial studies the effect of nivolumab in combination with blinatumomab
compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic
leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed
B-ALL are included in this study. Blinatumoma1 expand
This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer. Type: Interventional Start Date: Dec 2020 |
The Effects of Bariatric Surgeries on Glucose Metabolism
The University of Texas Health Science Center at San Antonio
Post Bariatric Surgery
Gastric Bypass
Sleeve Gastrectomy
Hypoglycemia After Gastric Bypass
The purpose of this study is learn the effect of gastric bypass surgery and sleeve
gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after
eating. expand
The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating. Type: Interventional Start Date: Jul 2015 |
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-91
Shenzhen Ionova Life Sciences Co., Ltd.
Advanced Metastatic Castration Resistant Prostate Cancer
This is a Phase 1 and Phase 2 study to determine the safety profile, RDR and/or MTD, DLT,
PK/PD, and preliminary antitumor activity of INV-9956 in adult patients with advanced
mCRPC. expand
This is a Phase 1 and Phase 2 study to determine the safety profile, RDR and/or MTD, DLT, PK/PD, and preliminary antitumor activity of INV-9956 in adult patients with advanced mCRPC. Type: Interventional Start Date: Jan 2025 |
Investigations of Reproductive Cancers in Women
PinkDx, Inc.
Uterine Cancer
The goal of this study is to create a non-invasive diagnostic test to rule out
gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal
bleeding. expand
The goal of this study is to create a non-invasive diagnostic test to rule out gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal bleeding. Type: Observational Start Date: Jul 2024 |
A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young A1
Eli Lilly and Company
Glioma
The purpose of this study is to measure the benefit of adding abemaciclib to the
chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy.
Your participation could last approximately 11 months and possibly longer depending upon
how you and your tumor respond. expand
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond. Type: Interventional Start Date: Oct 2024 |
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis1
Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive
pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a
previous study with a medicine called nerandomilast or BI 1015550.
The goal of this study is to find out how well people with1 expand
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests. Type: Interventional Start Date: May 2024 |
Combining Stellate Ganglion Block With Prolonged Exposure for PTSD
The University of Texas Health Science Center at San Antonio
Stress Disorders, Post-Traumatic
The goal of this clinical trial is to compare the combination of Massed Prolonged
Exposure (PE); a behavioral therapy for PTSD) and a stellate ganglion block (SGB; an
injection of a local anesthetic into the front of the neck) with Massed Prolonged
Exposure and a sham injection in a sample of milit1 expand
The goal of this clinical trial is to compare the combination of Massed Prolonged Exposure (PE); a behavioral therapy for PTSD) and a stellate ganglion block (SGB; an injection of a local anesthetic into the front of the neck) with Massed Prolonged Exposure and a sham injection in a sample of military service members or retirees with PTSD. The main questions it aims to answer are: (1) Does the addition of an SGB improve treatment outcomes associated with Massed PE and (2) Do differences in psychophysiological arousal during the exposure portion of treatment help explain treatment outcomes for PTSD. Participants will receive ten 90-minute session of Massed PE. Between the first and second Massed PE sessions, half of the participants will receive a SGB, and half will receive a sham SGB. Type: Interventional Start Date: Feb 2024 |
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezo1
Celgene
Relapsed or Refractory Multiple Myeloma
The purpose of this study is to compare the efficacy and safety of mezigdomide
(CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and
dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM)
who received between 1 to 3 prior lines of the1 expand
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure. Type: Interventional Start Date: Sep 2022 |
Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymph1
SWOG Cancer Research Network
Recurrent T Acute Lymphoblastic Leukemia
Refractory T Acute Lymphoblastic Leukemia
Refractory T Lymphoblastic Lymphoma
T Lymphoblastic Lymphoma
This phase I/II trial studies the safety, side effects and best dose of OBI-3424 and how
well it works in treating patients with T-cell acute lymphoblastic leukemia or T-cell
lymphoblastic lymphoma that has come back (relapsed) or does not respond to treatment
(refractory). Chemotherapy drugs, such1 expand
This phase I/II trial studies the safety, side effects and best dose of OBI-3424 and how well it works in treating patients with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Chemotherapy drugs, such as OBI-3424, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. OBI-3424 may reduce the amount of leukemia in the body. Type: Interventional Start Date: Feb 2021 |
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Yale University
Intracerebral Hemorrhage
Atrial Fibrillation
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 in1 expand
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. Type: Interventional Start Date: Jan 2020 |
Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metast1
Plus Therapeutics
Leptomeningeal Metastasis
This is an open-label, multicenter, Phase 1 study to determine the safety and efficacy of
multiple doses at defined intervals of rhenium (186Re) obisbemeda (rhenium-186
nanoliposome, 186RNL) administered via intraventricular catheter for any primary solid
tumor cancer with leptomeningeal metastases1 expand
This is an open-label, multicenter, Phase 1 study to determine the safety and efficacy of multiple doses at defined intervals of rhenium (186Re) obisbemeda (rhenium-186 nanoliposome, 186RNL) administered via intraventricular catheter for any primary solid tumor cancer with leptomeningeal metastases to identify an MTD/MFD for a given dose, interval duration, and number of doses. Type: Interventional Start Date: Jul 2025 |
Bionic Pancreas in CFRD
Jaeb Center for Health Research
Cystic Fibrosis-related Diabetes
This multi-center randomized controlled trial (RCT) will compare efficacy and safety
endpoints using the insulin-only configuration of the iLet Bionic Pancreas System (BP)
versus a control group using their usual care insulin delivery method and continuous
glucose monitoring (CGM) during a 13-week1 expand
This multi-center randomized controlled trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas System (BP) versus a control group using their usual care insulin delivery method and continuous glucose monitoring (CGM) during a 13-week study period in individuals ≥14 years old with cystic fibrosis-related diabetes (CFRD). After 13 weeks, participants will continue in a 13-week Extension Phase in which the BP group will continue to use the BP system and the Usual Care group will initiate use of the BP system. Type: Interventional Start Date: Sep 2024 |
Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001
University of Nebraska
Rectal Cancer
In this Phase 2 study, we will conduct an efficacy and safety study of the combination of
investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course
chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal
adenocarcinoma (RAC) patients. expand
In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal adenocarcinoma (RAC) patients. Type: Interventional Start Date: Aug 2022 |
Transformative Research in Diabetic Nephropathy
University of Pennsylvania
Diabetic Nephropathies
Diabetic Glomerulosclerosis
This is a prospective, observational, cohort study of patients with a clinical diagnosis
of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to
collect, process, and study kidney tissue and to harvest blood, urine and genetic
materials to elucidate molecular pathways an1 expand
This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol. Type: Observational Start Date: Dec 2016 |
Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
Children's Oncology Group
Hematopoietic Cell Transplantation Recipient
Leukemia
Solid Tumor
This clinical trial keeps track of and collects follow-up information from patients who
are currently enrolled on or have participated in a Children's Oncology Group study.
Developing a way to keep track of patients who have participated in Children's Oncology
Group studies may allow doctors learn1 expand
This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life. Type: Observational Start Date: Jul 2008 |
A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumoma1
National Cancer Institute (NCI)
B Acute Lymphoblastic Leukemia
This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or
imatinib and standard chemotherapy for treating patients with Philadelphia chromosome
positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute
lymphoblastic leukemia (B-ALL). Blinatumoma1 expand
This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy. Type: Interventional Start Date: May 2025 |
SGLTi, Hepatic Glucose Production and Ketogenesis
The University of Texas Health Science Center at San Antonio
Type 2 Diabetes
In this study, we will test the hypothesis that distinct mechanisms account for the
SGLT2i-induced stimulation of ketogenesis and lipolysis versus endogenous (hepatic)
glucose production in patients with type 2 diabetes (T2D) and type 1 diabetes (T1D), and
that the increases in ketone production an1 expand
In this study, we will test the hypothesis that distinct mechanisms account for the SGLT2i-induced stimulation of ketogenesis and lipolysis versus endogenous (hepatic) glucose production in patients with type 2 diabetes (T2D) and type 1 diabetes (T1D), and that the increases in ketone production and lipolysis can be prevented by concomitant administration of the thiazolidinedione pioglitazone. We will conduct five distinct experiments to test this hypothesis in patients with T2D and T1D. MAIN STUDY: To examine the effect of empagliflozin versus empagliflozin/pancreatic clamp on EGP (6,6, D2-glucose), gluconeogenesis (D2O), lipolysis (U-2H-glycerol), ketogenesis (13C-palmitate conversion to 3-betahydroxybuyrate), and norepinephrine turnover (3H-NE) in type 2 diabetes subjects. Type: Interventional Start Date: Oct 2023 |
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
RECORDATI GROUP
Post-Bariatric Hypoglycemia
The Total duration of trial participation for each participant with post-bariatric
hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods
- 19 weeks for the Core Phase. It is composed of:
- a Screening period: a maximum of 3 weeks
- a Run-in p1 expand
The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods - 19 weeks for the Core Phase. It is composed of: - a Screening period: a maximum of 3 weeks - a Run-in period (no treatment): 4 weeks - a Blinded Treatment Phase: 12 weeks - 36 weeks Extension Phase = an open-label Treatment period - 4 weeks for the safety follow-up period (without any treatment). Type: Interventional Start Date: Jan 2024 |
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