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RECOVER-AUTONOMIC Platform Protocol
Kanecia Obie Zimmerman
Long COVID
Long Covid19
Long Covid-19
This study is a platform protocol designed to be flexible so that it is suitable for a
wide range of settings within health care systems and in community settings where it can
be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center, multi-arm,... expand
This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. Type: Interventional Start Date: Mar 2024 |
Study Evaluating SC262 in Subjects with R/r Non-Hodgkin's Lymphoma (VIVID)
Sana Biotechnology
Non Hodgkin's Lymphoma
Large B-cell Lymphoma
SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor
activity, cellular kinetics, immunogenicity, and exploratory biomarkers. expand
SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers. Type: Interventional Start Date: Oct 2024 |
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
GB002, Inc.
Pulmonary Arterial Hypertension
This open-label extension study will evaluate the long-term safety, tolerability and
efficacy of orally inhaled seralutinib in subjects who have completed a previous
seralutinib study expand
This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study Type: Interventional Start Date: Sep 2024 |
IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation
University of Kansas Medical Center
Benign Prostatic Hyperplasia
To evaluate postoperative outcomes of BPH/Lower urinary tract symptoms, erectile
function, and ejaculatory capacity of simultaneous UroLiftTM and Holmium laser
enucleation of the prostatic median lobe. expand
To evaluate postoperative outcomes of BPH/Lower urinary tract symptoms, erectile function, and ejaculatory capacity of simultaneous UroLiftTM and Holmium laser enucleation of the prostatic median lobe. Type: Observational Start Date: Feb 2023 |
Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High...
National Cancer Institute (NCI)
Breast Atypical Hyperplasia
Breast Carcinoma
Breast Ductal Carcinoma In Situ
Breast Lobular Carcinoma In Situ
This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in
preventing breast cancer in premenopausal women at high risk for developing breast
cancer. The usual approach for patients at increased risk for breast cancer is to undergo
yearly breast magnetic resonance imaging... expand
This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging (MRI) or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts. Premenopausal women age 35 or older with a prior diagnosis of atypical hyperplasia, lobular carcinoma in situ, or an estimated 10-year risk of greater than or equal to 3% or estimated 10-year risk of greater than or equal to 2-5 times that of the average woman (depending on age) may be advised to consider five years of standard dose tamoxifen. Standard dose tamoxifen is four times the dose used in this study. Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen blocks the use of estrogen by breast cells. This study may help researchers measure the effects of acolbifene and low dose tamoxifen on markers of breast cancer risk in mammogram imaging, breast tissue, and in blood samples. Type: Interventional Start Date: Aug 2024 |
Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
GB002, Inc.
Pulmonary Arterial Hypertension
The primary objective of the study is to determine the effect of seralutinib on improving
exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary
objective for this trial is to determine time to clinical worsening. expand
The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening. Type: Interventional Start Date: Dec 2023 |
A Study of GEn-1124 in Subjects with Acute Respiratory Distress Syndrome (ARDS)
GEn1E Lifesciences
Respiratory Distress Syndrome, Acute
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of
GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible
after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after
the first dose and will continue with... expand
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first dose and will continue with twice daily dosing (BID regimen) for 5 days. Type: Interventional Start Date: Apr 2023 |
Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian...
GOG Foundation
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Stage III Primary Peritoneal Cancer
Stage IV Primary Peritoneal Cancer
Stage III Fallopian Tube Cancer
Patients will be registered prior to, during or at the completion of neoadjuvant
chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1
every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant
chemotherapy will not be eligible for iCRS and will... expand
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC (Arm A) will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (Arm B) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per institutional standard (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 2-3 cycles) for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing until progression or 36 months (if no evidence of disease). Type: Interventional Start Date: Mar 2024 |
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric...
Vertex Pharmaceuticals Incorporated
Proteinuric Kidney Disease
The purpose of this study is to evaluate the efficacy, safety, tolerability, and
pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein
L1 (APOL1)-mediated proteinuric kidney disease. expand
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. Type: Interventional Start Date: Mar 2022 |
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Poseida Therapeutics, Inc.
Breast Cancer
Ovarian Cancer
Non Small Cell Lung Cancer
Colorectal Cancer
Pancreatic Cancer
A Phase 1, open label, dose escalation and expanded cohort study of P-MUC1C-ALLO1 in
adult subjects with advanced or metastatic epithelial derived solid tumors, including but
not limited to the tumor types listed below. expand
A Phase 1, open label, dose escalation and expanded cohort study of P-MUC1C-ALLO1 in adult subjects with advanced or metastatic epithelial derived solid tumors, including but not limited to the tumor types listed below. Type: Interventional Start Date: Feb 2022 |
International Weight Control Registry
Tufts University
Weight Loss
Overweight
Obesity
The IWCR is a global scientific study aimed at better understanding the opportunities and
barriers for reducing the prevalence of obesity by collecting information from people who
have experience with weight management in their everyday lives. The investigators seek to
gather information on a wide... expand
The IWCR is a global scientific study aimed at better understanding the opportunities and barriers for reducing the prevalence of obesity by collecting information from people who have experience with weight management in their everyday lives. The investigators seek to gather information on a wide range of weight management experiences, ranging from weight loss and weight loss maintenance to weight gain and inability to lose weight. Type: Observational [Patient Registry] Start Date: Dec 2020 |
A Phase 1/2 Study in Patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma...
Hookipa Biotech GmbH
HPV-Related Squamous Cell Carcinoma
This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study
of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with
HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose
Expansion. expand
This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion. Type: Interventional Start Date: Dec 2019 |
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
Mirati Therapeutics Inc.
Advanced Cancer
Metastatic Cancer
Malignant Neoplastic Disease
This study will evaluate the safety, tolerability, drug levels, molecular effects, and
clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have
a KRAS G12C mutation. expand
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation. Type: Interventional Start Date: Jan 2019 |
Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
Beat AML, LLC
Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic
screening followed by assigning and accruing simultaneously to a multi-study "Master
Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine
which sub-study, within this protocol,... expand
This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. Type: Interventional Start Date: Nov 2016 |
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
University of Kansas Medical Center
Down Syndrome
Physical Inactivity
The investigators are assessing acceptability, appropriateness, and feasibility of an
remote choreographed exercise intervention using validated scales alongside qualitative
data among young adults with Down Syndrome. Participants will take part in a 12-week
exercise program with two 35-minute session... expand
The investigators are assessing acceptability, appropriateness, and feasibility of an remote choreographed exercise intervention using validated scales alongside qualitative data among young adults with Down Syndrome. Participants will take part in a 12-week exercise program with two 35-minute session per week delivered in a group setting. The aims of the project are to: - Assess the feasibility of a 12 week remotely delivered group dance intervention. - Assess changes in aerobic fitness and cognitive function in response to a 12 week remotely delivered group dance intervention. - Assess the intensity and total energy expenditure of remotely delivered group dance sessions. Type: Interventional Start Date: Aug 2024 |
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With...
University of Kansas Medical Center
Multiple Sclerosis
Insomnia
The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to
insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated
with reduced cognitive performance, physical function, psychological well-being, quality
of life, and occupational function,... expand
The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3). Type: Interventional Start Date: Jul 2024 |
Parkinson's Disease Progression Study
Koneksa Health
Parkinson Disease
Disease Progression Study expand
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Burn Pivotal Study
SpectralMD
Burns
Wound Heal
Wounds and Injuries
The purpose of this study is to validate the algorithm for burn healing assessment by the
Spectral MD DeepView device which would provide burn healing potential assessment. expand
The purpose of this study is to validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment. Type: Observational Start Date: Dec 2023 |
Changes in Resting Metabolic Rate Following Orthopedic Surgery
University of Kansas Medical Center
Metabolism; Disorder, Postprocedural
Resting Metabolic Rate
Post Operative Nutrition
This project is intended to determine the magnitude and duration of RMR changes in
patients receiving orthopedic surgery. The result will help to guide postoperative
nutrition recommendations in patients receiving orthopedic surgery. expand
This project is intended to determine the magnitude and duration of RMR changes in patients receiving orthopedic surgery. The result will help to guide postoperative nutrition recommendations in patients receiving orthopedic surgery. Type: Observational Start Date: Oct 2023 |
Donor-Derived Anti-CD33 CAR T Cell Therapy (VCAR33) in Patients With Relapsed or Refractory AML After...
Vor Biopharma
Leukemia, Myeloid, Acute
This is a Phase 1/2, multicenter, open-label, first-in-human (FIH) study of donor-derived
anti-CD33 Chimeric Antigen Receptor (CAR) T cell therapy (VCAR33) in patients with
relapsed or refractory Acute Myeloid Leukemia (AML) after human leukocyte antigen
(HLA)-matched allogeneic hematopoietic cell... expand
This is a Phase 1/2, multicenter, open-label, first-in-human (FIH) study of donor-derived anti-CD33 Chimeric Antigen Receptor (CAR) T cell therapy (VCAR33) in patients with relapsed or refractory Acute Myeloid Leukemia (AML) after human leukocyte antigen (HLA)-matched allogeneic hematopoietic cell transplant (alloHCT). Type: Interventional Start Date: Dec 2023 |
A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
CARGO Therapeutics
Cancer
Relapsed/Refractory Large B-cell Lymphoma (LBCL)
This is a prospective, open-label, multi-center clinical study designed to evaluate the
safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of
firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor
(CAR) T-cell therapy for the treatment... expand
This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL). Type: Interventional Start Date: Aug 2023 |
Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer
National Cancer Institute (NCI)
Refractory Prostate Carcinoma
This phase II trial tests how well M1774 works in treating patients with prostate cancer
that does not respond to treatment (refractory) and that has a mutation in the gene
responsible for making the speckle type BTB/POZ protein (SPOP). M1774 may stop the growth
of tumor cells by blocking some of... expand
This phase II trial tests how well M1774 works in treating patients with prostate cancer that does not respond to treatment (refractory) and that has a mutation in the gene responsible for making the speckle type BTB/POZ protein (SPOP). M1774 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving M1774 may be able to shrink or stabilize refractory SPOP-mutant prostate cancer. Type: Interventional Start Date: Oct 2023 |
Myositis Interstitial Lung Disease Nintedanib Trial
Rohit Aggarwal, MD
Myositis Associated Interstitial Lund Disease (MA-ILD)
This research study will evaluate safety and how well the study drug, nintedanib improve
symptoms in participants with myositis associated interstitial lung disease (MA-ILD).
Interstitial lung disease is a disorder caused by the abnormal accumulation of cells
structures between air sacs of the lungs... expand
This research study will evaluate safety and how well the study drug, nintedanib improve symptoms in participants with myositis associated interstitial lung disease (MA-ILD). Interstitial lung disease is a disorder caused by the abnormal accumulation of cells structures between air sacs of the lungs resulting in thickening, stiffness and scarring of the tissues of the lung. This study will enroll a total of 134 participants across 15 clinical sites located in the United States. A subset of participants will be enrolled remotely via telemedicine utilizing certified mobile home research nurses and various remote monitoring devices. The research visits may include a physical exam, vital signs (such as blood pressure, heart rate, etc.), pulmonary function tests (PFT and/or home spirometry), Computerized Tomography (or CT) scans of the chest, blood draws, wearing a physical activity monitor and completing questionnaires. Some of these events may be done at home, at a local facility or remotely (via telemedicine). Type: Interventional Start Date: Aug 2023 |
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
Verismo Therapeutics
Ovarian Cancer
Cholangiocarcinoma Recurrent
Mesothelioma, Malignant
This first-in-human (FIH) trial is designed to assess the safety, feasibility, and
potential activity of a single intravenous (IV) dose of SynKIR-110 administered to
subjects with mesothelin-expressing advanced ovarian cancer, mesothelioma, and
cholangiocarcinoma. expand
This first-in-human (FIH) trial is designed to assess the safety, feasibility, and potential activity of a single intravenous (IV) dose of SynKIR-110 administered to subjects with mesothelin-expressing advanced ovarian cancer, mesothelioma, and cholangiocarcinoma. Type: Interventional Start Date: Mar 2023 |
Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy...
Alliance for Clinical Trials in Oncology
B Acute Lymphoblastic Leukemia
B Lymphoblastic Lymphoma
This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to
the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or
B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called
inotuzumab, linked to a drug, called... expand
This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs 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. Giving inotuzumab ozogamicin with chemotherapy may help shrink the cancer and stop it from returning. Type: Interventional Start Date: Feb 2023 |
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