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NCT ID: NCT03579654 Not yet recruiting - Prostate Cancer Clinical Trials

Study of Proscavax Vaccine in Patients With Localized Prostate Cancer vs Active Surveillance

Start date: February 28, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of a prostate cancer vaccine named Proscavax (Prostate-specific antigen(PSA) / Interleukin-2(IL-2) / Granulocyte-macrophage colony-stimulating factor(GM-CSF)) in patients with localized prostate cancer. The goal of the study is to determine if vaccine administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. The researchers are interested in evaluating the proportion of participants with prostate cancer progression at 2 years following administration of Proscavax or active surveillance, the effect of the vaccine on prostate-specific antigen (PSA) doubling time and the assessment of adverse events in these patients. Eligible patients in this study will include men who are 18 years and older and who have a previously untreated early stage prostate cancer regardless of the date of diagnosis.

NCT ID: NCT03575000 Not yet recruiting - Schizophrenia Clinical Trials

Bromocriptine for Patients With Schizophrenia and Prediabetes

Start date: July 1, 2024
Phase: Phase 4
Study type: Interventional

This is a multicenter open-label, pilot study to evaluate the safety and tolerability of bromocriptine, a dopamine D2/D3 receptor and serotonin 5-HT2C receptor agonist, as an adjunct to preexisting standard-of-care antipsychotic drug (APD) regimens in the management of APD-associated impaired glucose tolerance (IGT)/insulin resistance (IR). The ultimate aim of the study team is to evaluate the efficacy of bromocriptine in treating the metabolic disturbances associated with APDs and the hypothesis is that bromocriptine will be a well-tolerated, safe, and inexpensive way to ameliorate these metabolic complications and prevent or delay the onset of type 2 diabetes (T2D). This study will be a small, short-duration pilot focusing on safety and tolerability. A total of 15 psychiatrically stable APD-treated adult outpatients, VA Pittsburgh , aged 18 to 65 years old, with a confirmed diagnosis of schizophrenia and comorbid IGT will be recruited and receive 6 weeks of bromocriptine (flexibly titrated, 2.5-5.0 mg PO daily). Key inclusion criteria are: 1) currently being treated with second generation APDs for 3 or more months with no change in dose in the 1 month prior to enrollment, 2) fasting glucose 100 to 125mg/dL and/or hemoglobin A1c (HbA1c) 5.7-6.4%. Key exclusions are: 1) prior APD nonadherence, 2) drug/alcohol abuse in the 3 months prior to screening, 3) a history of violent behavior/psychoses, 4) pregnancy, or 5) a diagnosis of diabetes. Subjects on other dopamine agonists or on medications that may interact with bromocriptine and those taking corticosteroids or other medications that may alter glucose levels will be excluded. The purposes of the study are to demonstrate safety/tolerability, demonstrate feasibility, provide proof of concept, and provide an open-label assessment of the metabolic and psychiatric effects of bromocriptine in patients with schizophrenia treated with APDs. The primary metabolic outcome measures will be change in IR as measured by the HOMA-IR and change in IGT measured by HbA1c. Secondary metabolic outcome measures include body weight, fasting lipids, and prolactin. The specific aims are as follows: Specific aim 1: To establish the safety and tolerability of bromocriptine in patients with schizophrenia and IGT/IR treated with APDs. Specific aim 2: To demonstrate feasibility/proof of concept for an improvement in APD-induced IGT/IR with bromocriptine.

NCT ID: NCT03570567 Not yet recruiting - Clinical trials for Esophageal Food Impaction

CLEANS Technique for the Treatment of Esophageal Food Impaction

Start date: June 2018
Phase: N/A
Study type: Interventional

This clinical investigation is to evaluate the safety, performance, and efficacy of a novel endoscopic technique for resolving esophageal food impactions by using a novel hollow suction catheter, Piranha GI Aspiration Catheter, to core out and suction food away from the center of an impaction. This technique includes hollowing out the center of the impaction, thus reducing the volume of the food bolus in the center, allowing the food to collapse into the hollow center, and then allowing for spontaneous food passage into the stomach. The study design is based on the experience of the investigators and the general knowledge of the food impaction field. In addition, consideration was given to previous studies of endoscopic treatments for esophageal food impaction.

NCT ID: NCT03554707 Not yet recruiting - Childhood CNS Tumor Clinical Trials

SGT-53 in Children With Recurrent or Progressive CNS Malignancies

Start date: June 2022
Phase: Early Phase 1
Study type: Interventional

An early phase 1 for pediatric patients with recurrent or progressive CNS malignancies

NCT ID: NCT03546660 Not yet recruiting - Clinical trials for Eosinophilic Esophagitis

Imaging of the Esophagus Using a SECM Capsule

Start date: January 1, 2025
Phase: N/A
Study type: Interventional

The goal of this validation study is to compare Spectrally Encoded Confocal Microscopy (SECM) Tethered Capsule Endoscopy (TCE) diagnosis of Eosinophilic Esophagitis to that of standard of care endoscopic biopsy.

NCT ID: NCT03545516 Not yet recruiting - Pain, Postoperative Clinical Trials

Wound Infiltration as Part of an Opioid Free Pain Management Pathway Following Cesarean Delivery

Start date: September 17, 2018
Phase: Phase 2
Study type: Interventional

This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway.

NCT ID: NCT03543007 Not yet recruiting - Venous Leg Ulcer Clinical Trials

Evaluating the Safety and Efficacy of GrafixPLâ„¢PRIME for the Treatment of Chronic Venous Leg Ulcers

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Approximately 200 patients (100 in each treatment group) nationally with chronic venous leg ulcers will be randomized to GrafixPLâ„¢PRIME plus standard compression therapy or standard compression therapy alone for up to 12 weeks in order to compare the clinical outcomes between the two groups. Specifically, at this Georgetown site, approximately 30 subjects will be recruited.

NCT ID: NCT03541486 Not yet recruiting - Pancreatic Neoplasm Clinical Trials

A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients

XACT-PANC-2
Start date: December 31, 2025
Phase: Phase 2
Study type: Interventional

Radiation therapy improves cancer cure rates by killing cancer cells but it also contributes to long-term side effects in cancer survivors by unintentionally damaging normal organs such as the intestine. This research will what side effects patients with cancer experience, if high dose vitamin C helps reduce these side effects, and if high dose vitamin C increases the survival of patients with pancreatic cancer. We will meet with patients during the study to better understand their experience during their cancer treatment. In the long term, our research could provide a new way help cancer survivors avoid many permanent side effects of cancer treatments.

NCT ID: NCT03531411 Not yet recruiting - Aging Clinical Trials

The Healthy Meal Program

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The Richmond Health and Wellness Program (RHWP) is an innovative and emerging nurse-led inter-professional wellness and care coordination model that represents a holistic and integrated approach to community based care. The model addresses unmet health care needs of vulnerable adults residing in low-income housing designated for older adults with a goal of helping them to "age in place" while improving quality of life through health equity. Through the promotion of wellness and care coordination among vulnerable older adults, RWHP will connect participants to resources that meet their health, nutritional, and safety needs and provide a meal to address nutritional needs and food insecurity.

NCT ID: NCT03531242 Not yet recruiting - Clinical trials for Venezuelan Equine Encephalomyelitis

Safety and Immunogenicity Study of Venezuelan Equine Encephalomyelitis (VEE) Vaccine as Booster Vaccine in Adults

VEE
Start date: June 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, C-84, TSI-GSD 205, Lot 7, Run 1, and collect data on the incidence of occupational VEE infection in vaccinated personnel.