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NCT ID: NCT03337724 Not yet recruiting - Breast Cancer Clinical Trials

A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

IPATunity130
Start date: December 12, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2−) breast adenocarcinoma who are not suitable for endocrine therapy.

NCT ID: NCT03309033 Not yet recruiting - Cervical Cancer Clinical Trials

Fifteen-Year Immunologic Follow-Up of Women Who Received One, Two and Three Doses of the Bivalent HPV Vaccine in the Costa Rica HPV-16/18 Vaccine Trial (CVT) the CVT EXTEND Study

Start date: December 20, 2017
Phase: N/A
Study type: Observational

Background: HPV is the human papillomavirus. Women who get infected with it can get cervical cancer. The Costa Rica vaccine trial (CVT) studied an HPV vaccine for young women. A Long Term Follow Up (LTFU) study was done 10 years later. Researchers want to follow up with the women in these studies for 5 more years. This will help them learn more about the risks and benefits of the HPV vaccine. Objectives: To study anti-HPV-16/18 antibodies over the long term in women who got an HPV vaccinate. To study how antibody levels have changed depending on the dose and type of vaccine. Eligibility: Women in the original CVT LTFU study Design: Staff will contact participants from the CVT LTFU study. This will be done by phone or in person at home. Participants will be asked about participating in a new study. Participants who agree will have their first study visit and sign the informed consent document. Participants will answer questions about sexual behavior, smoking, contraceptives, and reproductive history. Participants will have blood collected. Study visits will be conducted either in a clinic or at home.

NCT ID: NCT03308838 Completed - Clinical trials for Myocardial Infarction, Acute

A Case-control Study of Costa Rican Adults With Myocardial Infarction

Start date: August 1, 1994
Phase: N/A
Study type: Observational

This observational case-control trial sought to identify and characterize different exposures associated with nonfatal acute myocardial infarction in Costa Rican adults. Exposures assessed included dietary variables and adipose tissue fatty acids.

NCT ID: NCT03285763 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

TAIL
Start date: October 25, 2017
Phase: Phase 4
Study type: Interventional

This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 [anti-PD-1] therapy or after anti-PD-1 as monotherapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period.

NCT ID: NCT03180034 Not yet recruiting - Cervical Cancer Clinical Trials

Scientific Evaluation of One or Two Doses of the Bivalent or Nonavalent Prophylactic HPV Vaccines

Start date: November 15, 2017
Phase: Phase 4
Study type: Interventional

Background: Certain types of human papillomavirus (HPV) cause almost all cases of cervical cancer. Vaccines that protect against HPV can substantially reduce the risk of cervical cancer. However, HPV vaccination rates are too low, especially in countries with very high rates of cervical cancer. HPV vaccines are expensive-many countries cannot afford them-more than one dose is needed, and giving multiple doses is difficult. Researchers want to find out if one dose prevents HPV infection. If it does, more people might get the vaccine. Objective: To find out if giving only one dose of either the Cervarix or Gardasil9 HPV vaccines work the same as giving two doses of these vaccines to young women. Eligibility: Females ages 12-20 who live in Costa Rica. Design: There are two components to the study: (1) a controlled, randomized, double-blinded non-inferiority clinical trial to compare one-dose to two-dose vaccination; and (2) a concurrent epidemiologic survey for HPV status among unvaccinated women. The trial will enroll twenty thousand girls 12 to 16 years old residing in Costa Rica. Participants will be randomized in two stages to one of four arms (one dose of the bivalent vaccine, two doses of the bivalent vaccine, one dose of the nonavalent vaccine and two doses of the nonavalent vaccine); the first randomization at enrollment will assign participants to one of the two study vaccines and at the second visit they will be randomized to one or two doses. Girls randomized to the one dose arm will receive an active control (i.e.: Tdap) at the time of the second vaccine dose. After vaccination, girls will be followed every six months for four years. The epidemiologic HPV survey will enroll a group of unvaccinated girls from the same geographic areas; they will range in age from 17 to 20. These women will attend two study visits six months apart to determine their HPV DNA status, there will be no additional followup. These women will be offered HPV vaccination at the enrollment and six-month study visits. At each visit, participants will fill out a questionnaire and give a urine sample. They may give blood samples. The older participants will use a swab to collect cervical cells from their vagina.

NCT ID: NCT03144648 Recruiting - Clinical trials for Breast Cancer Female

PRECAMA: Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women

PRECAMA
Start date: October 12, 2012
Phase: N/A
Study type: Observational

Breast cancer has become a major public health problem in Latin America, as it is the most common form of cancer among women. Women are more likely to develop breast cancer at younger age, and to be diagnosed at an advanced stage compared to western women. Over the past twenty years, the mortality from breast cancer in Latin America has also been increasing very rapidly, and is currently the leading cause of cancer mortality. Little is known on specific risk factors for premenopausal breast cancer in general, and in Latin America in particular. There is a lack of specific knowledge on tumor molecular and pathological characteristics of breast cancer in Latin America premenopausal women, and this has major consequences on cancer treatment and survival. To improve our understanding on determinants of breast cancer incidence and mortality in young Latin America women and support preventive actions, we implemented an international, population-based multi-center study in Latin America: the PRECAMA study (Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women (PRECAMA): a multicenter population-based case-control study). PRECAMA is coordinated by the International Agency for Research on Cancer (IARC), and is conducted within 4 Latin American countries: Mexico, Costa Rica, Colombia and Chile. Major aims of the project are the following: 1. To develop a multi-centric population-based case-control study on breast cancer in premenopausal women in several countries in Latin America with structured collection of individual, clinical, pathological information and biological specimens, according to strictly controlled protocols 2. To characterize, in these populations, the subtypes of premenopausal breast cancer on the basis of their molecular and pathological phenotypes 3. To improve the identification of specific endogenous/exogenous factors, and disentangle the interplay of these different factors with regard to breast tumor subtypes. 4. Provide advanced training, induce a structuring effect on the breast cancer research community in Latin America and influence the public health agenda regarding the management of breast cancer. The results of our study will be of utmost importance to understand the etiology of breast cancer in Latin America countries, and would provide important information on the role of modifiable exposures for breast cancer prevention.

NCT ID: NCT03072238 Recruiting - Clinical trials for Metastatic Prostate Cancer

Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

IPATential150
Start date: June 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).

NCT ID: NCT03027297 Active, not recruiting - HIV-1 Infections Clinical Trials

TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV

Start date: August 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this trial is to continue the provision of darunavir/ low-dose ritonavir (DRV/rtv) to adult and pediatric patients who previously received DRV/rtv in the clinical trials TMC114-C211, TMC114-C214, TMC114-TiDP31-C229 or in the pediatric trial TMC114-TiDP29-C232 who continue to benefit from the use of DRV/rtv, in countries where DRV is not commercially available for the subject, is not reimbursed, or cannot be accessed through another source (e.g., access program, governmental program).

NCT ID: NCT03021499 Recruiting - Lupus Nephritis Clinical Trials

Aurinia Renal Response in Active Lupus With Voclosporin

AURORA
Start date: May 17, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.

NCT ID: NCT02914184 Recruiting - Rotavirus Vaccines Clinical Trials

Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Start date: October 27, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study