400 matching studies

Sponsor Condition of Interest
S-Equol in Alzheimer's Disease 2 Trial
Russell Swerdlow, MD Alzheimer Disease
By doing this study researchers hope to learn if S-equol, a compound that acts like estrogen in the body, causes an increase in mitochondrial activity. Researchers also hope to determine the safety and tolerability of a therapeutic dose of S-equol and whether or not it influences... expand

By doing this study researchers hope to learn if S-equol, a compound that acts like estrogen in the body, causes an increase in mitochondrial activity. Researchers also hope to determine the safety and tolerability of a therapeutic dose of S-equol and whether or not it influences cognition.

Type: Interventional

Start Date: May 2017

open study

Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome
University of Kansas Medical Center Chronic Pain
The purpose of this study is to learn whether or not certain risk factors and patient characteristics are linked with and possibly can predict the development of chronic pain after lumbar spine surgery. expand

The purpose of this study is to learn whether or not certain risk factors and patient characteristics are linked with and possibly can predict the development of chronic pain after lumbar spine surgery.

Type: Observational

Start Date: Jun 2018

open study

Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
Daehwa Pharmaceutical Co., Ltd. Recurrent or Metastatic Breast Cancer
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer. expand

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer.

Type: Interventional

Start Date: Jul 2018

open study

Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients
Novartis Pharmaceuticals Diffuse Large B-cell Lymphoma
A multi-center, open-label, phase Ib study to evaluate the safety and efficacy of the administration of tisagenlecleucel in combination with pembrolizumab in patients with r/r DLBCL who have received 2 or more lines of systemic therapy, including an anti-CD20 and anthracycline... expand

A multi-center, open-label, phase Ib study to evaluate the safety and efficacy of the administration of tisagenlecleucel in combination with pembrolizumab in patients with r/r DLBCL who have received 2 or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy and having failed to or are not candidates for ASCT. The study will consist of 2 parts: dose timing selection part and expansion part.

Type: Interventional

Start Date: Oct 2018

open study

Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC
BeyondSpring Pharmaceuticals Inc. Non-Small Cell Lung Cancer
To compare the overall survival of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease. Secondary purposes of the study are: -... expand

To compare the overall survival of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease. Secondary purposes of the study are: - To compare the neutropenia (incidence of Grade 4 neutropenia [absolute neutrophil count (ANC) < 0.5 × 10^9/L]) on Day 8 (+/- 1 day) of Cycle 1), DoR, neutrophil count on Day 8 (+/- 1 day) of Cycle 1, incidence of docetaxel dose reduction and/or docetaxel dose withheld in Cycle 2 due to neutropenia in Cycle 1, QoL (EORTC QLQ-C30 [item 30, average overall quality of life over all observable weeks]), ORR, and PFS in patients with NSCLC treated in the DP Arm to patients treated in the D Arm as 2nd- or 3rd-line therapy for advanced or metastatic disease. - To compare the safety and adverse events profile of the DP Arm to D Arm. - To compare dose intensity of docetaxel (percent dose administered compared to dose assigned) between the 2 treatment arms. - To evaluate population pharmacokinetics in patients enrolled in China and rest of world (RoW).

Type: Interventional

Start Date: Dec 2015

open study

MDM2 Inhibitor AMG-232 (KRT-232) and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
National Cancer Institute (NCI) Soft Tissue Sarcoma
This phase Ib trial studies the side effects of MDM2 inhibitor AMG-232 (KRT-232) and radiation therapy in treating patients with soft tissue sarcoma. MDM2 inhibitor AMG-232 (KRT-232) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving... expand

This phase Ib trial studies the side effects of MDM2 inhibitor AMG-232 (KRT-232) and radiation therapy in treating patients with soft tissue sarcoma. MDM2 inhibitor AMG-232 (KRT-232) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving MDM2 inhibitor AMG-232 (KRT-232) and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Type: Interventional

Start Date: Nov 2017

open study

Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations
University of Kansas Medical Center Colorectal Cancer
The goal of this study is to find the best ways to increase colorectal cancer (CRC) screening. expand

The goal of this study is to find the best ways to increase colorectal cancer (CRC) screening.

Type: Interventional

Start Date: Jan 2018

open study

Omission of Radiation in Patients With Her-2 Positive Breast Cancer
University of Kansas Medical Center HER2-positive Breast Cancer
The primary objective of this study is to describe the rate of local control in patients with her-2 positive early stage breast cancer with a complete response to chemotherapy and lumpectomy alone. expand

The primary objective of this study is to describe the rate of local control in patients with her-2 positive early stage breast cancer with a complete response to chemotherapy and lumpectomy alone.

Type: Interventional

Start Date: Feb 2018

open study

Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation
University of Kansas Medical Center Breast Cancer
The primary objective of this study is to document lymphedema rates in patients requiring regional nodal irradiation (RNI) who receive hypofractionated radiation as compared to conventional radiation. expand

The primary objective of this study is to document lymphedema rates in patients requiring regional nodal irradiation (RNI) who receive hypofractionated radiation as compared to conventional radiation.

Type: Interventional

Start Date: Oct 2017

open study

Weight Loss Physical Disabilities
University of Kansas Medical Center Physical Disability
The objective of this study is to compare weight loss (6 mos.) and maintenance (18 mos.) between an individual home visit intervention (IH) and an intervention delivered remotely via video conferencing to groups of overweight/obese adults with Mobility Related Disabilities (MRDs)... expand

The objective of this study is to compare weight loss (6 mos.) and maintenance (18 mos.) between an individual home visit intervention (IH) and an intervention delivered remotely via video conferencing to groups of overweight/obese adults with Mobility Related Disabilities (MRDs) in their homes (GR). The primary aim will be to compare weight loss (0-6 mos.) between the two interventions (IH vs. GR). Secondarily, the study team will compare the mean weight loss from 0-18 mos., the proportion of participants achieving >=5% weight loss from baseline, changes in cardiovascular risk factors and quality of life, and conduct a cost analysis. In addition, factors that will be explored include the influence of behavioral session attendance, compliance with the recommendations for diet (energy intake, number of entrees/shakes, servings of fruits/vegetables), Physical Activity (PA, min of moderate vigorous PA, min sedentary time), and self-monitoring of diet and PA, self-efficacy for dietary change and PA, dietary self-regulation, social support for diet/PA, barriers to PA, sleep and medications on weight loss at 6 and 18 mos.

Type: Interventional

Start Date: Feb 2020

open study

A Study to Confirm Safety and Efficacy of BAN2401 in Participants With Early Alzheimer's Disease
Eisai Inc. Early Alzheimer's Disease
This study will be conducted to evaluate the efficacy of BAN2401 in participants with early Alzheimer's disease (EAD) by determining the superiority of BAN2401 compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months... expand

This study will be conducted to evaluate the efficacy of BAN2401 in participants with early Alzheimer's disease (EAD) by determining the superiority of BAN2401 compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of BAN2401 in participants with EAD in the Extension Phase and whether the long-term effects of BAN2401 as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.

Type: Interventional

Start Date: Mar 2019

open study

Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human...
Grifols Therapeutics LLC Acute-On-Chronic Liver Failure
This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects. The study will involve approximately 40 study centers... expand

This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects. The study will involve approximately 40 study centers in the United States, Canada, and Europe with expertise in the management of subjects with ACLF. Subjects with ACLF at a high risk of hospital mortality will be enrolled. The study will consist of a Screening Period during which subjects will be randomized (1:1) to receive either standard medical treatment (SMT) + PE-A 5% (treatment group) or SMT only (control group), followed by a Treatment Period, and a Follow-up Period. The Treatment Period for subjects in the SMT+ PE-A 5% treatment group will be between 7 and 17 days, depending on ACLF evolution. The Treatment Period for subjects in the SMT control group will be a minimum of 7 days for all subjects and up to 17 days depending on the ACLF evolution. Subjects in this group will receive SMT according to the institution's standards. The Follow-up Period for subjects in both groups will be 90 days.

Type: Interventional

Start Date: Feb 2019

open study

P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
Poseida Therapeutics, Inc. Multiple Myeloma
Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed... expand

Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed / refractory MM. Followed by a Phase 2, open-label, efficacy and safety study. Rimiducid may be administered as indicated.

Type: Interventional

Start Date: Sep 2017

open study

Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF...
Stereotaxis Tachycardia, Ventricular
The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population. expand

The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.

Type: Interventional

Start Date: Jan 2016

open study

Cognitive Impairment and Imaging Correlates in End Stage Renal Disease
Aditi Gupta, MD End Stage Renal Disease
The purpose of this study is to understand cognitive impairment in end stage renal disease before and after a kidney transplant. expand

The purpose of this study is to understand cognitive impairment in end stage renal disease before and after a kidney transplant.

Type: Observational

Start Date: Mar 2013

open study

Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry
University of Kansas Medical Center Breast Cancer Hereditary Breast and Ovarian Cancer
PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes). expand

PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).

Type: Observational [Patient Registry]

Start Date: Mar 2011

open study

Bladder Cancer Longitudinal Biorepository for Development of Novel Therapeutics/Biomarkers
University of Kansas Medical Center Bladder Cancer
The purpose of this study is to create a registry, which is a "bank" of information about patients who have had similar medical conditions and treatments. The registry will be used by researchers to learn more about long term outcome of patients with bladder cancer, how bladder... expand

The purpose of this study is to create a registry, which is a "bank" of information about patients who have had similar medical conditions and treatments. The registry will be used by researchers to learn more about long term outcome of patients with bladder cancer, how bladder cancer tissues are related to tumor development, recurrence and survival.

Type: Observational [Patient Registry]

Start Date: Nov 2017

open study

Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects...
Genmab Cervical Cancer
This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer. The trial consists of two-parts a dose escalation part and an expansion part.... expand

This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer. The trial consists of two-parts a dose escalation part and an expansion part. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the combinations have been determined in the dose escalation part.

Type: Interventional

Start Date: Feb 2019

open study

Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites
Grifols Therapeutics LLC Decompensated Cirrhosis and Ascites
This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The study population... expand

This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The study population will consist of subjects being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.

Type: Interventional

Start Date: Jul 2018

open study

A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)
Annexon, Inc. Guillain-Barré Syndrome
This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS. expand

This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS.

Type: Interventional

Start Date: Jan 2020

open study

CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
Nicole Hamblett Cystic Fibrosis
This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR)... expand

This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator therapies.

Type: Observational

Start Date: Jan 2018

open study

Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of FN-1501...
Shanghai Fosun Pharmaceutical Development Co, Ltd. Advanced Cancer Solid Tumor
This research study is being done in people with advanced-stage solid tumor cancer. Advanced stage solid tumor cancer is a cancer that forms an abnormal mass of tissue that usually does not contain cysts or liquid areas. Different types of solid tumors are named for the type of... expand

This research study is being done in people with advanced-stage solid tumor cancer. Advanced stage solid tumor cancer is a cancer that forms an abnormal mass of tissue that usually does not contain cysts or liquid areas. Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors include lung cancer, breast cancer, prostate cancer, kidney cancer, colorectal cancer, melanoma and sarcoma. The purpose of this research study is to evaluate the safety of the investigational study drug, FN-1501, at different dose levels. FN-1501 has not previously been given to human subjects. It is intended for the treatment in this study of patients with advanced solid tumor cancers. This study will determine the effects, good and/or bad, on patients' cancer. The main objective of this study is to define the recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of FN-1501. The MTD is the highest dose a person can take without having bad side effects, and the RP2D will be the dose of FN-1501 used in future studies.

Type: Interventional

Start Date: Jul 2018

open study

Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and...
University of Kansas Medical Center Acute Myeloid Leukemia Chronic Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes
Gamma delta T-cells are part of the innate immune system with the ability to recognize malignant cells and kill them. This study uses gamma delta T-cells to maximize the anti-tumor response and minimize graft versus host disease (GVHD) in leukemic and myelodysplastic patients... expand

Gamma delta T-cells are part of the innate immune system with the ability to recognize malignant cells and kill them. This study uses gamma delta T-cells to maximize the anti-tumor response and minimize graft versus host disease (GVHD) in leukemic and myelodysplastic patients who have had a partially mismatched bone marrow transplant (haploidentical).

Type: Interventional

Start Date: Jan 2020

open study

The Inotrope Evaluation and Research Patient Registry
Coram Clinical Trials Heart Failure
The INTERPRET Inotrope Evaluation and Research Patient Registry is a longitudinal, observational study designed to look at the demographics and outcomes of heart failure patients on inotropic therapy administered in the home or infusion suite setting. The data gathered in this... expand

The INTERPRET Inotrope Evaluation and Research Patient Registry is a longitudinal, observational study designed to look at the demographics and outcomes of heart failure patients on inotropic therapy administered in the home or infusion suite setting. The data gathered in this registry will provide information on how a patient's quality of life and symptoms change over time while on inotrope therapy, and help healthcare providers to have a better understanding of the benefits and risks associated with bridge-to-treatment and palliative care.

Type: Observational [Patient Registry]

Start Date: Aug 2014

open study

Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer
Southwest Oncology Group Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7
This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow... expand

This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.

Type: Interventional

Start Date: Oct 2017

open study