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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: August 23, 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: Participants will be screened in a clinic with a physical exam and medical history. Participants will have one clinic visit every 6 months for 4 years. Participants will be randomly divided into 4 groups. Two vaccines will be tested. Vaccines will be given in the arm at the first and second visits. In the first visit, half the participants will randomly get the first dose of one of the vaccines. In the second visit, six months later, participants will either get the second dose of their initial vaccine or a control vaccine called Tdap, a booster vaccine against tetanus, diphtheria, and whooping cough. This is so no one knows who received one dose of an HPV vaccine and who received two. 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

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

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

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: NCT02847637 Active, not recruiting - Hemophilia A Clinical Trials

A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors

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

This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or older. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this population with emphasis on efficacy, safety, and pharmacokinetics.

NCT ID: NCT02795767 Enrolling by invitation - Hemophilia A Clinical Trials

A Study of Once-Weekly Emicizumab in Children and Adolescents With Hemophilia A and Factor VIII (FVIII) Inhibitors

Start date: July 22, 2016
Phase: Phase 3
Study type: Interventional

This single-arm, multicenter, open-label, Phase III clinical study will enroll children (less than [<] 12 years of age) and adolescents (12 to 17 years of age) with hemophilia A and FVIII inhibitors who are currently receiving treatment with bypassing agents. Participants will receive prophylactic treatment with emicizumab as weekly subcutaneous (SC) doses for 52 weeks. All participants will continue to receive episodic treatment for breakthrough bleeds as needed. Breakthrough bleeds should preferably be treated with recombinant factor VIIa (rFVIIa) only at the lowest dose expected to achieve hemostasis and use of activated prothrombin complex concentrate (aPCC) or other bypassing agents (e.g., Byclot®) should be avoided.

NCT ID: NCT02789540 Completed - Clinical trials for Stable COPD Patients

Latin American Study of 24-hs Symptoms in Chronic Obstructive Pulmonary Disease (COPD) Patients; LASSYC Study

Start date: June 2016
Phase: N/A
Study type: Observational

This is a multi-country, multicentre, observational prospective data collection cross sectional study of patients with stable COPD in Latin America. Primary objective is to assess and characterize COPD symptoms over a period of 24 hours, by collecting information about the respiratory symptoms experienced at different times of the day and night-time in patients with stable COPD under real clinical practice conditions. Correlation between each of these symptoms and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification, adherence to respiratory treatment, level of dyspnea, disease severity, comorbidities and physical activity as well direct costs will be done as secondary objectives. Study population are patients of 40 years and older, smokers or ex smokers of >= 10 pack/years with previous COPD diagnosis, attending outpatient specialists consults in Argentina, Chile, Colombia, Uruguay, Costa Rica, Guatemala and Mexico. Sample size is targeted to 900 enroled patients in order to ensure 860 patients to achieve statistical power to primary objective.

NCT ID: NCT02783001 No longer available - HIV Infections Clinical Trials

Expanded Access Program for Maraviroc At Multiple Centers

Start date: n/a
Phase: Phase 3
Study type: Expanded Access

To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

NCT ID: NCT02670083 Recruiting - Alzheimer's Disease Clinical Trials

CREAD Study: A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)

Start date: March 22, 2016
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (q4w) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose.