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NCT ID: NCT01143571 Completed - BMI Clinical Trials

Evaluation of Skin, Colonic, and Oral Microbiome and Effect of Time and Antibiotic Treatment on Organism Diversity at Each Site

Start date: November 20, 2009
Phase:
Study type: Observational

Background: - Most studies of infectious agents have focused on specific microbes, such as human papillomaviruses and cervical cancer, and the hepatitis B and C virus and liver cancer. The skin and many internal areas (including the mouth and the gastrointestinal tract) also contain large numbers of naturally occurring microbes, but these areas have not received as much study. - Some of the infectious agents that naturally reside in the body may have an effect on health. The study of naturally occurring microbes in the human body is a new area of research, and much remains to be learned regarding the extent and pattern of their appearance and appropriate techniques for testing them. - Researchers are interested in collecting human samples from areas known to contain naturally occurring microbes. These samples will provide baseline information for further studies. Objectives: - To collect a set of study samples from individuals who have applied to participate in a study assessing the relationship among the bacteria H. pylori, peptic ulcer disease, and gastric cancer. Eligibility: - Individuals between the ages of 21 and 65 who are participating in the clinical trial entitled A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori. Design: - Researchers will collect oral (saliva), colonic, and skin swab samples from study participants who tested positive for the presence of the H. pylori bacteria. These samples will be collected at the three study visits (enrollment, 6 weeks, and 1 year). - Researchers will also collect samples from people who applied for the clinical trial but did not test positive for H. pylori. These samples will be collected at the enrollment visit and 1 year later. - Blood samples will be collected at each study visit.

NCT ID: NCT01086709 Completed - HPV Infections Clinical Trials

Crossover Vaccination of Women Previously Randomized Into Protocol 04-C-N191

Start date: January 27, 2010
Phase:
Study type: Observational

Background: - National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial, was a double-blind controlled study of the effectiveness of an experimental human papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica. Costa Rica was part of the first large study to show the association between HPV and cervical cancer, and the study contributed greatly to the understanding of this association. The women who have participated in the vaccine trial in Costa Rica are reaching the end of the follow-up period offered in the vaccine trial protocol, and as a result they are being offered the chance to have complementary vaccinations against HPV, hepatitis A, and hepatitis B. Objectives: - To offer participants in the Costa Rica Vaccine Trial the vaccine that they did not receive during the masked portion of the trial (HPV vaccine or hepatitis A vaccine) and hepatitis B vaccination. - To collect information about exposure to known and suspected risk factors for HPV infection and cervical cancer from women who are receiving vaccination against HPV at crossover. Eligibility: - Women who participated in National Cancer Institute Protocol 04-C-N191. Design: - All participants will be offered vaccination against hepatitis B. - Women who received the hepatitis A vaccine during the trial will be offered vaccination against HPV. - Women who received the HPV vaccine during the trial will be offered vaccination against hepatitis A. - Appropriate vaccinations (including a combined hepatitis A and hepatitis B vaccine) will be available to reduce the number of injections that participants will be asked to receive. - All vaccines will be given according to the manufacturer's specifications for appropriate length of time between vaccine doses.

NCT ID: NCT01061437 Completed - Clinical trials for Helicobacter Pylori Infection

S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori)

Start date: June 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori).

NCT ID: NCT01051661 Completed - Influenza Clinical Trials

Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age

Start date: February 12, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age.

NCT ID: NCT01041404 Completed - Gastric Cancer Clinical Trials

ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

Start date: September 2005
Phase: Phase 3
Study type: Interventional

This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.

NCT ID: NCT01039688 Completed - Clinical trials for Arthritis, Rheumatoid

Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX

ORAL1069
Start date: January 2010
Phase: Phase 3
Study type: Interventional

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

NCT ID: NCT01003990 Completed - HIV Clinical Trials

Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

Start date: October 2002
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial

NCT ID: NCT00973700 Completed - Clinical trials for Novel 2009 Influenza H1N1

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

Start date: August 2009
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.

NCT ID: NCT00968812 Completed - Clinical trials for Diabetes Mellitus, Type 2

CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

Start date: September 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.

NCT ID: NCT00968669 Completed - Asthma Clinical Trials

A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults

Start date: December 2009
Phase: Phase 2
Study type: Interventional

To study the effectiveness and safety of multiple-doses of MEDI-528 on asthma control in adult participants with uncontrolled, moderate-to-severe, persistent asthma.