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Alzheimer's Disease Neuroimaging Initiative 4
Mild Cognitive Impairment
Alzheimer Disease
Dementia
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging
Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD)
clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3
studies that have combined public/private... expand
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD. Type: Observational Start Date: Jun 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, fluorouracil, oxaliplatin,... 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 |
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) and adenosine triphosphate... 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 |
Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment...
Refractory IPA
To assess the safety and efficacy of nebulized PC945 in combination with systemic
antifungal therapy for the treatment of refractory IPA expand
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA Type: Interventional Start Date: Jun 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 indolent systemic mastocytosis... 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 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 (IMP) administration. 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 |
AlloSure Lung Assessment and Metagenomics Outcomes Study
Lung Transplant Infection
Lung Transplant; Complications
Lung Transplant Failure and Rejection
ALAMO is a prospective, multi-center, perspective, registry of patients receiving
LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant.
This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung
(dd-cfDNA) to detect a spectrum of rejection... expand
ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant. This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung (dd-cfDNA) to detect a spectrum of rejection (ACR, AMR) and allograft infection (Bacterial, Viral, Fungal, Mycobacterial, Parasitic). Type: Observational [Patient Registry] Start Date: Oct 2021 |
Study of INBRX-109 in Conventional Chondrosarcoma
Conventional Chondrosarcoma
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or
metastatic conventional chondrosarcoma patients. expand
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. Type: Interventional Start Date: Sep 2021 |
Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against
placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52. expand
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52. Type: Interventional Start Date: Jun 2021 |
Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual...
Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
This phase II trial studies the effect of pembrolizumab alone compared to the usual
approach (chemotherapy [cisplatin and carboplatin] plus radiation therapy) after surgery
in treating patients with head and neck squamous cell carcinoma that has come back
(recurrent) or patients with a second head... expand
This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy [cisplatin and carboplatin] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma. Type: Interventional Start Date: Apr 2021 |
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Non Muscle Invasive Bladder Cancer
High-grade Ta/ T1 Papillary Disease Bladder Cancer
This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene
patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS
bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled
under the original protocol through Amendment... expand
This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C is closed to enrollment. Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1 papillary bladder cancer. Under Amendment 6, the target number of patients enrolled in Cohort P was increased to 75. Cohort P is open to enrollment Cohort C and Cohort P will be analyzed and reported separately. Patients will have had to fail prior BCG therapy which is defined as having persistent or recurrent disease within 12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG therapy for HGUC Type: Interventional Start Date: Oct 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 is a prospective, randomized,... 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 |
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration
Multiple Myeloma
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg
Step 2. Patients are followed until they will begin Maintenance and then registered to
Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2
years and Lenalidomide + Daratumumab/rHuPH20.... expand
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years. Type: Interventional Start Date: Aug 2019 |
Periprosthetic Fracture Registry (PPFx)
Periprosthetic Fractures
Periprosthetic Fracture Around Prosthetic Joint Implant
This registry supports international data collection and research on PPFx treatments
after hip and knee arthroplasty.
A registry such as this ultimately aims to provide far-reaching benefits to society
including reduced morbidity and mortality, improved patient safety, improved quality of
care... expand
This registry supports international data collection and research on PPFx treatments after hip and knee arthroplasty. A registry such as this ultimately aims to provide far-reaching benefits to society including reduced morbidity and mortality, improved patient safety, improved quality of care and medical decision-making, reduced medical spending, and advances in orthopaedic science. Type: Observational [Patient Registry] Start Date: Dec 2018 |
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
Lymphedema of the Head and Neck
The goal of this study is to evaluate the effectiveness of a standardized lymphedema and
fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce
LEF-associated symptom burden, functional deficits, and improve quality of life in head
and neck cancer (HNC) survivors. expand
The goal of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors. Type: Interventional Start Date: Mar 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: Dec 2023 |
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. A large-scale genome-wide... 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 |
Corticostriatal Contributions to Parkinson's Disease Cognitive Impairment
Parkinson Disease
The goal of this study is to learn more about the brain activity underlying Parkinson's
disease cognitive impairment. The investigators will utilize neural recordings from
corticostriatal structures performed during deep brain stimulation surgery to measure
neural activity underlying nonmotor symptoms... expand
The goal of this study is to learn more about the brain activity underlying Parkinson's disease cognitive impairment. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease. Type: Interventional Start Date: Jun 2021 |
A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors
Renal Cell Carcinoma
Ovarian Tumor
This clinical trial will evaluate raludotatug deruxtecan (R-DXd; DS-6000a) in
participants with advanced renal cell carcinoma (RCC) and ovarian cancer (OVC). The main
goals of this study will be to investigate the recommended dose of R-DXd that can be
given safely to participants, assess the side... expand
This clinical trial will evaluate raludotatug deruxtecan (R-DXd; DS-6000a) in participants with advanced renal cell carcinoma (RCC) and ovarian cancer (OVC). The main goals of this study will be to investigate the recommended dose of R-DXd that can be given safely to participants, assess the side effects of R-DXd, and evaluate the effectiveness of R-DXd. Type: Interventional Start Date: Dec 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 them from dividing, or by... 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 |
Identifying Best Approach in Improving Quality of Life and Survival After a Donor Stem Cell Transplant...
Hematopoietic and Lymphoid Cell Neoplasm
Non-Neoplastic Hematologic and Lymphocytic Disorder
This phase II/III trial studies the best approach in improving quality of life and
survival after a donor stem cell transplant in older, weak, or frail patients with blood
diseases. Patients who have undergone a transplant often experience increases in disease
and death. One approach, supportive and... expand
This phase II/III trial studies the best approach in improving quality of life and survival after a donor stem cell transplant in older, weak, or frail patients with blood diseases. Patients who have undergone a transplant often experience increases in disease and death. One approach, supportive and palliative care (SPC), focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects. While a second approach, clinical management of comorbidities (CMC) focuses on managing multiple diseases, other than cancer, such as heart or lung diseases through physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education. Giving SPC, CMC, or a combination of both may work better in improving quality of life and survival after a donor stem cell transplant compared to standard of care in patients with blood diseases. Type: Interventional Start Date: Aug 2019 |
Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
Kidney Calculi
The rationale for this study is to determine if there is a difference in complications
among patients undergoing ureteroscopy for renal stones who receive a stent compared to
not receiving a stent postoperatively. expand
The rationale for this study is to determine if there is a difference in complications among patients undergoing ureteroscopy for renal stones who receive a stent compared to not receiving a stent postoperatively. Type: Interventional Start Date: Nov 2019 |
Gastroschisis Outcomes of Delivery (GOOD) Study
Gastroschisis
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35
6/7 weeks in stable patients with gastroschisis is superior to observation and expectant
management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we
will complete a randomized, prospective,... expand
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days. Type: Interventional Start Date: Feb 2018 |
Project: Every Child for Younger Patients With Cancer
Adrenal Gland Pheochromocytoma
Carcinoma In Situ
Central Nervous System Neoplasm
Childhood Immature Teratoma
Childhood Langerhans Cell Histiocytosis
This study gathers health information for the Project: Every Child for younger patients
with cancer. Gathering health information over time from younger patients with cancer may
help doctors find better methods of treatment and on-going care. expand
This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care. Type: Observational Start Date: Nov 2015 |
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 three different conditions... 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 |
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