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NCT ID: NCT03165591 Recruiting - Clinical trials for Pancreatic Cancer Non-resectable

Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer

V3-P
Start date: May 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the United States, with a survival rate of less than 7%.There are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses. Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving patients with practically no options except surgery. We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients with PDA in line with similar highly promising approach we have adopted for patients with hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given one tablet per day of V3-P and followed up to see the outcome.

NCT ID: NCT03042741 Recruiting - Atherosclerosis Clinical Trials

Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity

V6
Start date: February 1, 2017
Phase: Phase 3
Study type: Interventional

Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical trials. It has shown significant improvement in lipid profile in patients with overweight or obesity

NCT ID: NCT03042182 Recruiting - Cholangiocarcinoma Clinical Trials

Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma

cholangio
Start date: February 20, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Cholangiocarcinoma (CCA) is a malignant neoplasm originating from the epithelial cells lining the intra- or extrahepatic biliary ducts. It is the second-most common liver cancer, after hepatocellular carcinoma (HCC). About 6,000 people in the United States develop bile duct cancer each year. One-year survival is less than 25% and no effective and safe systemic treatments are currently available. Last year the completion of open-label phase 2 trial (NCT02256514) of hepcortespenlisimut-L (V5) has been reported, which has shown that two-third of Mongolian patients with advanced HCC had a favorable clinical response, including complete remissions and with overall survival over 90% after 1 year. So far a few patients with CCA were treated with V5, but it appeared that their response rate was somewhat inferior to patients with HCC since two (both with hemochromatosis) out six patients died within 6 months. In one patient who had improved clinically, the improvement was correlated with decrease in CA19-9 tumor marker, but no marker profile information is available in regard to other CCA patients. As V5 tablets are made from pooled blood of patients with HCC, in theory, they will be not very useful to patients with CCA. The goal of this project is to manufacture an immunotherapeutic formulation made from pooled heat- and chemically-inactivated blood from donors with CCA and initiate pilot open-label trial in 20 cholangiocarcinoma patients. This clinical trial will be conducted in collaboration with the National Cancer Center.

NCT ID: NCT02409290 Recruiting - MDR-TB Clinical Trials

The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

STREAM
Start date: April 2016
Phase: Phase 3
Study type: Interventional

Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. MDR-TB leads to a considerable reduction in the effectiveness of standard short-length treatments and currently the standard treatments for MDR-TB can last as long as 24 months. With the incident rate of MDR-TB on the rise (511,000 new cases in 2007) and the lengthy duration of current treatments there is a need to investigate whether a shorter-length treatment using effective drugs is a global possibility. Three short course regimens of drugs will be evaluated alongside the World Health Organisation recommended 24 month regimen for the treatment of MDR-TB. A total of at least 1155 participants with MDR-TB will be recruited and followed for a total of 132 weeks.

NCT ID: NCT02395081 Completed - Pregnancy Clinical Trials

Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia

Start date: February 2015
Phase: N/A
Study type: Interventional

A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU, or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16 weeks' gestation and continue throughout pregnancy. Umbilical cord 25(OH)D levels will also be determined. The investigators will generate preliminary data regarding Vitamin D intake and hypertensive disorders, blood pressure, and arterial function measured by tonography. The investigators will independently test blood pressure and proteinuria to identify preeclampsia cases.

NCT ID: NCT02276755 Active, not recruiting - Latent Tuberculosis Clinical Trials

Vitamin D Suplementation in TB Prevention

Start date: September 2015
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to investigate the preventive role of vitamin D supplementation in school age children in a high transmission setting. The investigators hypothesis is that (1) vitamin D supplementation will reduce rate of acquisition of LTBI, (2) vitamin D supplementation will lead to greater reductions in active TB incidence, and (3) children with the lowest vitamin D status at baseline will gain most from the intervention.

NCT ID: NCT02256514 Enrolling by invitation - Liver Cirrhosis Clinical Trials

Open Label Trial of Immunotherapy for Advanced Liver Cancer

HCC
Start date: September 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate daily dosing of oral immunotherapy hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical intervention or with recurrent tumor after surgery.

NCT ID: NCT02232490 Recruiting - Clinical trials for Hepatocellular Carcinoma

Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L

Hepko-V5
Start date: January 2015
Phase: Phase 3
Study type: Interventional

Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma.

NCT ID: NCT01973829 Recruiting - Sepsis Clinical Trials

The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of the study is to test whether the health care provider access and training in CERTAIN (Checklist for Early Recognition and Treatment of Acute Illness), would facilitate timely and error free best-practice delivery and minimize preventable death and costly complications in critically ill patients.

NCT ID: NCT01861431 Completed - HIV Infection Clinical Trials

Evaluating a Microfinance Intervention for High Risk Women in Mongolia

Start date: April 2010
Phase: N/A
Study type: Interventional

The proposed study aims to test the feasibility and preliminary efficacy of a combined 4-session HIV sexual risk reduction (HIVSRR) and microfinance intervention (including 34 training session and matched savings) to reduce unprotected sex and to increase proportion of income from sex work among women engaged in high risk sexual activity in Ulaanbaatar, Mongolia. Feasibility and preliminary efficacy will be tested using a randomized clinical trial (RCT) with 134 women sex workers meeting eligibility criteria. Following eligibility screening, eligible women will complete informed consent, a baseline assessment, and be randomized to one of 2 study conditions: 1) the combination HIV sexual risk reduction plus microfinance (HIVSRR+MF); or 2) a 4-session HIVSRR alone control condition. The study design will permit us to: 1. Examine and enhance the feasibility (i.e. recruitment, engagement, attendance, retention data collection) of a combination HIV sexual risk reduction and MF intervention with high risk women in Ulaanbaatar, Mongolia; 2. Examine the preliminary outcomes of the interventions on decreasing unprotected acts of vaginal and anal intercourse; increasing the proportion of protected vaginal and/or anal acts using barrier protection and decreasing number of sexual partners with repeated measures at baseline, immediately post-intervention, and 3 and 6 month follow-up assessments. 3. Use the results of the pilot study to inform the design of a future R01 application.