66 matching studies

Sponsor Condition of Interest
Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell...
Washington University School of Medicine Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Cancer of the Head and Neck
The purpose of this research study is to look at the effect of a treatment regimen called CACTUX on head and neck cancer. The CACTUX regimen is a combination of three drugs called cisplatin, nab-paclitaxel, and cetuximab (although carboplatin may be given in place of cisplatin... expand

The purpose of this research study is to look at the effect of a treatment regimen called CACTUX on head and neck cancer. The CACTUX regimen is a combination of three drugs called cisplatin, nab-paclitaxel, and cetuximab (although carboplatin may be given in place of cisplatin if participants have previously had problems receiving cisplatin). The use of nab-paclitaxel in this combination is different from routine care, in which a drug called 5FU is often given instead, but the investigators group has conducted previous research where the investigators incorporated nab-paclitaxel into routine treatment with cisplatin, 5FU, and cetuximab. The investigators are looking at the incidence of side effects with the CACTUX regimen as well as response of the disease and health status.

Type: Interventional

Start Date: Feb 2015

open study

Vaccination of High Risk Breast Cancer Patients
University of Arkansas Breast Neoplasms
The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients with clinical stage I, II or III estrogen-receptor (ER)-positive breast cancer. This is a single-arm,... expand

The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients with clinical stage I, II or III estrogen-receptor (ER)-positive breast cancer. This is a single-arm, multi-site Phase I/II study designed with the two goals being (1) to evaluate the feasibility of combining vaccination with the P10s-PADRE formulation with neoadjuvant chemotherapy and (2) to determine if the polymerase chain reaction (pCR) rate among ER-positive breast-cancer patients treated with the combination is significantly higher than the 8% rate observed among ER-positive breast-cancer subjects in a pooled analysis of seven randomized clinical trials. P10s-PADRE vaccine with MONTANIDE™ ISA 51 VG as adjuvant will be given in combination with neoadjuvant chemotherapy in female patients with clinical stage I, II or III ER-positive breast cancer.

Type: Interventional

Start Date: Jan 2015

open study

A Dose Ranging Study Evaluating Efficacy and Safety of NI-03
Stason Pharmaceuticals, Inc. Chronic Pancreatitis
The purpose of this study is to determine the safety and efficacy of NI-03. expand

The purpose of this study is to determine the safety and efficacy of NI-03.

Type: Interventional

Start Date: Dec 2015

open study

In Vivo Real-time Detection of Circulating Melanoma Cells
University of Arkansas Melanoma
The objective of this clinical trial is to determine whether a Photoacoustic flow cytometry (PAFC)-based prototype device can detect circulating tumor cells (CTCs) in the blood of melanoma patients in vivo, in real time, and do so at detection limits at least one order of magnitude... expand

The objective of this clinical trial is to determine whether a Photoacoustic flow cytometry (PAFC)-based prototype device can detect circulating tumor cells (CTCs) in the blood of melanoma patients in vivo, in real time, and do so at detection limits at least one order of magnitude below the detection limits of currently existing ex vivo methods.

Type: Observational

Start Date: Feb 2013

open study

Targeting Abdominal Perfusion Pressure in Septic Shock
Potrero Medical Acute Kidney Injury Septic Shock Resuscitations
A randomized control trial among patients with septic shock, studying the incidence, progression and recovery of AKI. expand

A randomized control trial among patients with septic shock, studying the incidence, progression and recovery of AKI.

Type: Interventional

Start Date: Feb 2019

open study

Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult...
Children's Oncology Group Adult Germ Cell Tumor Childhood Extracranial Germ Cell Tumor Childhood Germ Cell Tumor Extragonadal Embryonal Carcinoma Grade 2 Ovarian Teratoma
This phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their... expand

This phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, 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.

Type: Interventional

Start Date: May 2017

open study

Vaccination of Advanced-Stage Lung Cancer Patients
University of Arkansas Lung Neoplasms
The overarching purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung Cancer. Vaccine will... expand

The overarching purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung Cancer. Vaccine will consist of P10s-PADRE admixed with an adjuvant, MONTANIDETM ISA 51 VG. Up to one hundred fifty (150) subjects with advanced-stage Lung Cancer of any histologic type will be enrolled for this vaccine trial. This single-arm, multi-site trial is designed to evaluate the therapeutic benefits of the vaccine in subjects with advanced-stage lung cancer. The primary objectives of the study are: (1) to monitor the safety and tolerability of the vaccine when it is administered in combination with SoC therapy; and (2) to determine whether immunization with vaccine can successfully elicit a robust immune response in subjects with advanced-stage lung cancer.

Type: Interventional

Start Date: Oct 2015

open study

Vaccination of Triple Negative Breast Cancer Patients
University of Arkansas Breast Neoplasms
The purpose of this research is to compare the effect on breast cancer of using a new experimental breast cancer vaccine (used to stimulate immune cell production) with chemotherapy and surgery versus the usual treatment of chemotherapy and surgery. expand

The purpose of this research is to compare the effect on breast cancer of using a new experimental breast cancer vaccine (used to stimulate immune cell production) with chemotherapy and surgery versus the usual treatment of chemotherapy and surgery.

Type: Interventional

Start Date: Jan 2019

open study

Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain
Nevro Corp Painful Diabetic Neuropathy
This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy... expand

This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective, randomized comparison of the two treatments.

Type: Interventional

Start Date: Jul 2017

open study

A Feasibility Study to Further the Development of Lung Cancer-based Precision Medicine
University of Arkansas Lung Cancer Head and Neck Cancer
The purpose of this study is to further advancements in biospecimens (blood cellular free component, e.g., plasma, serum, tissue, urine), in order to develop precision medicine, for lung cancer management and lung cancer screening (synergy with imaging). A co-clinical trial approach,... expand

The purpose of this study is to further advancements in biospecimens (blood cellular free component, e.g., plasma, serum, tissue, urine), in order to develop precision medicine, for lung cancer management and lung cancer screening (synergy with imaging). A co-clinical trial approach, with integrative analyses leveraging data from the treatment of genetic mouse models of lung cancer along with clinical samples and data from lung cancer patients, will be used to elucidate genomic background metrics, identify cell free DNA mutations, and further refine the liquid biopsy approach. Blood and urine samples will be analyzed for different genetic components. The tissue biopsy will be implanted into a mouse and after the cancer grows in the mouse the cancer DNA from the mouse will be compared with the human blood.

Type: Interventional

Start Date: Jan 2016

open study

Improving Treatment Outcomes for Prescription Opioid Dependence
University of Arkansas Drug Dependence
Overall, this proposal seeks to improve treatment strategies for the significant public health problem of prescription opioid dependence by determining whether gabapentin, a non-narcotic pharmaceutical agent with minimal abuse potential and preliminary efficacy, will be effective... expand

Overall, this proposal seeks to improve treatment strategies for the significant public health problem of prescription opioid dependence by determining whether gabapentin, a non-narcotic pharmaceutical agent with minimal abuse potential and preliminary efficacy, will be effective in ameliorating withdrawal symptoms, craving and illicit drug use in prescription opioid dependent participants undergoing a 10-day detoxification from buprenorphine. In addition, the acceptability and feasibility of transitioning to depot naltrexone therapy will also be determined. If successful, this study would provide data to support further development of gabapentin as a pharmacological tool for improved outcomes during opioid detoxification as well as an integrated outpatient approach for treating prescription opioid dependence.

Type: Interventional

Start Date: Feb 2016

open study

Mucosal Innate Immune Activation in Chronic Intestinal Disorders
University of Arkansas Irritable Bowel Syndrome Inflammatory Bowel Diseases
Crohn's disease and ulcerative colitis are types of chronic intestinal disorder called inflammatory bowel diseases (IBD) that can affect the small and large bowel causing symptoms of abdominal pain, diarrhea, blood in the stool, and weight loss. Irritable bowel syndrome (IBS)... expand

Crohn's disease and ulcerative colitis are types of chronic intestinal disorder called inflammatory bowel diseases (IBD) that can affect the small and large bowel causing symptoms of abdominal pain, diarrhea, blood in the stool, and weight loss. Irritable bowel syndrome (IBS) is a milder form of IBD, with symptoms of abdominal pain, bloating, diarrhea or constipation, and blood in the stool. It is not known what causes diseases such as IBD and IBS. This study will look at the events in the gut that leads to leaky gut and inflammation in patients with IBD and IBS. The study will also see if medications such as rifaximin and mesalamine may reduce the amount of leaky gut.

Type: Observational

Start Date: Sep 2018

open study

Effect of rTMS on Resting State Brain Activity in Tinnitus
University of Arkansas Tinnitus
One out of every five people experiences tinnitus (a ringing, buzzing, or roaring sound in the ear) ranging from mild to severe impairment. To date, there are no effective therapies available that have been shown to decrease tinnitus loudness. The purpose of this study is to... expand

One out of every five people experiences tinnitus (a ringing, buzzing, or roaring sound in the ear) ranging from mild to severe impairment. To date, there are no effective therapies available that have been shown to decrease tinnitus loudness. The purpose of this study is to develop a new treatment option for tinnitus using a technique called Repetitive Transcranial Magnetic Stimulation (rTMS), which will hopefully prove to be an effective means of alleviating or reducing the symptoms of tinnitus.

Type: Interventional

Start Date: Jan 2009

open study

An Open-label Treatment Protocol for VTS-270 in Patients With Neurologic Manifestations of NPC
Vtesse, Inc., a Mallinckrodt Pharmaceuticals Company Niemann-Pick Type C Disease
Prospective, open-label, treatment protocol to provide expanded access to VTS-270 to eligible Niemann-Pick type C disease (NPC) patient expand

Prospective, open-label, treatment protocol to provide expanded access to VTS-270 to eligible Niemann-Pick type C disease (NPC) patient

Type: Expanded Access

open study

A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
Eisai Inc. Persistent or Recurrent Cutaneous T-Cell Lymphoma
The purpose of this trial is to assess the efficacy and safety of E7777 (improved purity ONTAK) in patients with persistent and recurrent cutaneous T-cell lymphoma. A lead-in dose-finding part was used to determine dose level 9 microgram per kilogram (mcg/kg) E7777 that is being... expand

The purpose of this trial is to assess the efficacy and safety of E7777 (improved purity ONTAK) in patients with persistent and recurrent cutaneous T-cell lymphoma. A lead-in dose-finding part was used to determine dose level 9 microgram per kilogram (mcg/kg) E7777 that is being used to test efficacy and safety.

Type: Interventional

Start Date: May 2013

open study

Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or...
Chimerix Adenovirus
Provide patients with serious AdV infection or disease access to treatment with BCV. expand

Provide patients with serious AdV infection or disease access to treatment with BCV.

Type: Expanded Access

open study