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NCT ID: NCT01957436 Active, not recruiting - Clinical trials for Metastatic Prostate Cancer

A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer

PEACE1
Start date: November 13, 2013
Phase: Phase 3
Study type: Interventional

This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.

NCT ID: NCT01957176 Completed - Thrombocytopaenia Clinical Trials

A Rollover Study to Provide Continued Treatment With Eltrombopag

Start date: October 15, 2013
Phase: Phase 4
Study type: Interventional

The objective of this study was to provide continued treatment with eltrombopag for subjects who were participating in a Novartis-sponsored investigational study with eltrombopag (parent studies 114968/ASPIRE (NCT01440374), PMA112509 (NCT00903422), and TRA105325/EXTEND (NCT00351468), receiving clinical benefit without unacceptable toxicity and to collect long-term safety data.

NCT ID: NCT01953926 Terminated - Clinical trials for Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

SUMMIT
Start date: September 30, 2013
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.

NCT ID: NCT01949311 Completed - Atopic Dermatitis Clinical Trials

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Start date: October 10, 2013
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

NCT ID: NCT01949012 Completed - Hypoxemia Clinical Trials

Capnography Monitoring During Intravenous Conscious Sedation Sedation With Midazolam for Oral Surgery

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

Dentists use sedation to help patients accept difficult procedures and to relieve anxiety. During sedation, the well-being of the patient is monitored by the dental team. When carried out according to recognised guidelines,intravenous dental sedation is considered to be very safe. For some patients, dental sedation is a useful alternative to general anaesthetic. It is cheaper and has the potential to be more accessible. Oximetry(measurement of oxygen status) is the current gold standard in dental sedation. The main risk to the patient during sedation is a slowing of breathing due to the effects of the sedative drug. Studies from other settings where sedation is practiced suggest that an additional monitor with capnography facilitates early detection of depressed breathing. However, the results of studies from other medical settings cannot be generalised to dental sedation, because of different techniques used and the types of patients. The depth of sedation may also be vary. For dental sedation, patients remain responsive at all times and breathe for themselves. Capnography gives breath by breath information using a simple device placed close to the nose and mouth. It has been recommended by several governing medical bodies that each area of medicine, should develop its own guidelines for sedation. Therefore, there is a need to research the application of capnography for dental sedation. The proposed study will take place at a university hospital site. Patients will be randomly divided into two groups. Both groups will receive sedation in the normal way. The study group will have capnography monitoring added. The study will look for differences in breathing between the two groups. Additional information regarding other aspects of monitoring will also be obtained. The results from the proposed study may help to improve patient safety and change current practice during sedation for dentistry.

NCT ID: NCT01945775 Completed - Breast Neoplasms Clinical Trials

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)

EMBRACA
Start date: October 14, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.

NCT ID: NCT01944241 Enrolling by invitation - Infertility Clinical Trials

Cervical Surgery and the Fertility Effect (c-SAFE)

c-SAFE
Start date: October 2012
Phase: N/A
Study type: Observational

Over the last 20 years, cervical screening programs have had huge success in reducing cervical cancer rates. These programs have done this by screening women at risk of developing cancer with regular smear tests. Women with abnormal smears are followed up in colposcopy clinics, and where needed, cervical surgery is performed to remove pre-cancerous areas on the cervix. Surgery to the cervix can include LLETZ (Large loop excision of the transformation zone) treatment or cone biopsy. Many studies in the last few years have looked at the impact that this necessary surgery can have on the function of the cervix. These studies have mainly found an association between LLETZ treatment and an increased risk of preterm labour. There have been no large studies investigating the effect cervical surgery may have on fertility. The investigators would like to examine the impact that cervical surgery may have on a woman's future fertility. It has been postulated that cervical surgery may cause the cervix to close, preventing sperm getting through or that it may cause changes in the secretions of the cervix, secretions that are necessary for normal interaction with sperm. The investigators would like to send a questionnaire to women who have attended colposcopy. The investigators will ask these women a series of questions relating to fertility desires and divide the women in to two groups depending on whether the women needed cervical surgery for pre-cancerous lesions or not. Hypothesis: That cervical surgery has an impact on the function of the cervix and on fertility.

NCT ID: NCT01943526 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Ireland Natalizumab (TYSABRI) Observational Program

iTOP
Start date: November 30, 2011
Phase:
Study type: Observational

The objectives of this study are to assess the long-term safety and impact on disease activity and progression of natalizumab (Tysabri) in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.

NCT ID: NCT01943344 Completed - Clinical trials for Percutaneous Closure of Arteriotomy in Common Femoral Artery

Safety and Performance Study of Large Hole Vascular Closure Device

FRONTIER-I
Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of this Clinical Investigation is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICEā„¢ in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures.

NCT ID: NCT01942135 Completed - Clinical trials for Metastatic Breast Cancer

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

Start date: September 26, 2013
Phase: Phase 3
Study type: Interventional

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).