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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 |
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.
expand
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 |
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.
expand
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 |
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 |
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 |
(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. Type: Interventional Start Date: Jan 2022 |
Study to Assess Dose, Efficacy and Safety of Setrusumab in Participants With Osteogenesis Imperfecta
Osteogenesis Imperfecta
The primary objectives of the study are to identify a setrusumab dosing strategy in
participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in
fracture rate.
expand
The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate. Type: Interventional Start Date: Feb 2022 |
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 |
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine...
Pheochromocytoma/Paraganglioma
Pancreatic Neuroendocrine Tumor
Von Hippel-Lindau Disease
Advanced Gastrointestinal Stromal Tumor
HIF-2α Mutated Cancers
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants
with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET),
von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor... expand
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Type: Interventional Start Date: Aug 2021 |
Genetic Epidemiology of Rotator Cuff Tears: The cuffGEN Study
Rotator Cuff Tears
Rotator cuff tear is one of the most common reasons to seek musculoskeletal care, and cuff
repair is one of the fastest growing ambulatory surgery procedures. However, the etiology of
cuff tears, reasons for variability treatment success, and causes of FI are poorly
understood.... expand
Rotator cuff tear is one of the most common reasons to seek musculoskeletal care, and cuff repair is one of the fastest growing ambulatory surgery procedures. However, the etiology of cuff tears, reasons for variability treatment success, and causes of FI are poorly understood. A large-scale genome-wide association studies (GWAS) using imaging-verified rotator cuff tear cases and controls can address limitations in rigor of prior research and assess the genetic basis of FI and functional outcomes of cuff tear treatments. Primary Objective: To conduct a case-control GWAS of imaging-verified symptomatic rotator cuff tear in approximately 3000-6000 individuals and replicate findings in an independent set of 3000-6000 or more imaging-verified individuals to identify common variants in several genetic loci that increase risk for rotator cuff tears. Hypothesis: Common variants in several genetic loci increase risk for rotator cuff tears. Secondary Objectives: 1. To perform an imputed transcriptome-wide association study (TWAS) to identify and prioritize gene targets associated with rotator cuff tear by integrating GWAS summary statistics and gene-expression weights from muscle and adipose tissue available in the GTEx project. Hypothesis: Genetically predicted gene expression of multiple genes in muscle and adipose tissue are associated with rotator cuff tear. 2. To identify if single nucleotide polymorphisms (SNPs) associated with rotator cuff tear and their genetic risk score (GRS) predict improved pain and function as measured by American Shoulder and Elbow Surgeons Standardized Form (ASES) and other outcome measures. Hypothesis: Select SNPs and GRS predict ASES outcome. 3. To identify genetic variants associated with Fatty Infiltration (FI) in patients with cuff tears in a two stage GWAS of imaged rotator cuffs and to prioritize gene targets through an imputed-TWAS in muscle and adipose tissue. Hypothesis: Multiple genetic variants are associated with FI and some exert their influence by altering gene expression in the muscle and adipose tissue. Type: Observational Start Date: Mar 2021 |
A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)
Pulmonary Arterial Hypertension
PAH
This study is being conducted to assess the long-term safety, tolerability, and efficacy of
sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial
Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data
from... expand
This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies. Type: Interventional Start Date: May 2021 |
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching...
Primary Sclerosing Cholangitis
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.... expand
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. Type: Interventional Start Date: Dec 2020 |
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Hematologic Disorder
Bleeding Disorder
Connective Tissue Disorder
Hemophilia
Thrombosis
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical
studies, the number of new therapies for all congenital and acquired hematologic conditions,
not just those for bleeding and clotting disorders, is increasing significantly. Some of the... expand
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well-controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. ATHN Transcends is a cohort study to determine the safety, effectiveness, and practice of therapies used in the treatment of participants with congenital or acquired non-neoplastic blood disorders and connective tissue disorders with bleeding tendency. The study consists of 7 cohorts with additional study "arms" and "modules" branching off from the cohorts. The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.(7) Type: Observational Start Date: Sep 2020 |
Amplatzer Amulet LAAO vs. NOAC
Atrial Fibrillation
Stroke
Bleeding
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... expand
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. Type: Interventional Start Date: Jul 2020 |
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed...
B Acute Lymphoblastic Leukemia
B Lymphoblastic Lymphoma
Down Syndrome
This phase III trial studies how well blinatumomab works in combination with chemotherapy in
treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or
B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as
blinatumomab,... expand
This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, 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. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better than combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens. Type: Interventional Start Date: Jul 2019 |
Theophylline Treatment for Pseudohypoparathyroidism
Pseudohypoparathyroidism
Albright Hereditary Osteodystrophy
Pseudohypoparathyroidism is a genetic disorder with limited treatment options. Patients have
early-onset obesity, short stature and increased risk of type 2 diabetes. This phase 2
clinical trial will test the efficacy of theophylline, a phosphodiesterase inhibitor, in
pseudohypoparathyroidism.... expand
Pseudohypoparathyroidism is a genetic disorder with limited treatment options. Patients have early-onset obesity, short stature and increased risk of type 2 diabetes. This phase 2 clinical trial will test the efficacy of theophylline, a phosphodiesterase inhibitor, in pseudohypoparathyroidism. The investigators hypothesize that theophylline will cause weight loss, improve glucose tolerance and slow growth plate closure in children and young adults. Type: Interventional Start Date: Sep 2018 |
Treating Exacerbations of Asthma With Oral Montelukast in Children
Status Asthmaticus
This research will establish a mg/kg dose for a future RCT to determine the efficacy of
high-dose oral montelukast for children with moderate and severe acute asthma exacerbations.
Aim: Perform an adaptive, double-masked randomized controlled trial (RCT) of high-dose oral... expand
This research will establish a mg/kg dose for a future RCT to determine the efficacy of high-dose oral montelukast for children with moderate and severe acute asthma exacerbations. Aim: Perform an adaptive, double-masked randomized controlled trial (RCT) of high-dose oral montelukast, with escalating mg/kg dose levels determined by PK-guided dose modeling, added to standard treatment versus standard treatment alone, in children with exacerbations that are moderate or severe after initial treatment with inhaled albuterol. Hypothesis 1: High-dose oral montelukast achieves peak plasma concentration (Cmax) >1,700 ng/ml in >86% of at least one of three sequential participant groups with escalating weight-based (milligram/kilogram or mg/kg) doses between groups. Hypothesis 2: Participants randomized to high-dose oral montelukast have a 2 point or greater improvement of the validated Acute Asthma Intensity Research Score (AAIRS) at 4 hours post-treatment in comparison with control group participants. Hypothesis 3: Among montelukast recipients, Cmax correlates with change of the AAIRS at 4 hours, after adjustment for pre-treatment exacerbation severity and systemic leukotriene stress measured using urinary leukotriene E4 (LTE4). Type: Interventional Start Date: Nov 2023 |
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)
expand
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 |
Suture Repair vs Mesh Repair for Incisional Hernia
Incisional Hernia
The goal of this randomized controlled trial is to compare the difference in quality of life
at one year postoperatively for patients undergoing incisional hernia repair with mesh versus
suture repair using modern techniques.
The main question it aims to answer are:... expand
The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques. The main question it aims to answer are: • Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively. Type: Interventional Start Date: Nov 2022 |
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