Clinical Trials Logo

Filter by:
NCT ID: NCT03556566 Recruiting - Ovarian Cancer Clinical Trials

Open Label Immunotherapy Trial for Ovarian Cancer

V3-OVA
Start date: July 1, 2018
Phase: Phase 2
Study type: Interventional

This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumors of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.

NCT ID: NCT03550755 Recruiting - Cervical Cancer Clinical Trials

Immunotherapy of Cervical Cancer With V3-Cervix

V3-Cervix
Start date: July 1, 2018
Phase: Phase 2
Study type: Interventional

The goal of this trial is to evaluate the efficacy of immunotherapy for cervical cancer based on a fundamentally new approach. We will test new tableted preparation, V3-Cervix, obtained from hydrolyzed, inactivated blood and tumors of patients with cervical cancer. When administered orally, it should cause a specific anti-tumor immune response and an anti-inflammatory effect. Trial is planned to last 3 months, recruit 20 volunteers, administer daily pill of vaccine and evaluate effect on tumor size and tumor markers.

NCT ID: NCT03550703 Recruiting - Leiomyoma Clinical Trials

Open Label Immunotherapy of Myoma

V-myoma
Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

Myoma of the uterus is a benign tumor that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches more than 70%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.

NCT ID: NCT03340324 Enrolling by invitation - Endometriosis Clinical Trials

Open Label Immunotherapy of Endometriosis

Start date: October 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Endometriosis is a chronic gynecological disease characterized by sustained painful symptoms that are responsible for a decline in the quality of life of sufferers. Endometriosis is fairly common, affecting an estimated 10%-15% of women and girls, usually during their reproductive years. Based on these rough estimates, the latest epidemiological studies suggest that over 200 million women are might be affected who may commonly have infertility problems. V-Endo is a tableted preparation derived from hydrolyzed, heat-inactivated, pooled blood of women with endometriosis. When taken orally it is postulated to cause the immune tolerance and anti-inflammatory effect as a result.

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.