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NCT ID: NCT01085487 Completed - Clinical trials for Idiopathic Menorrhagia

MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

Start date: April 2009
Phase: N/A
Study type: Observational

The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions.For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12 months will be documented by the treating physician on the case report form. Observations include the patient's demographic parameters (date of birth, height, weight, race and smoking habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline menstruation, result of insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment including number of weeks until improvement and reduction of menstrual bleeding with respect to duration and severity, and patient's satisfaction.

NCT ID: NCT01078298 Completed - Depression Clinical Trials

Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression

Start date: March 2010
Phase: Phase 4
Study type: Interventional

Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.

NCT ID: NCT01011738 Completed - Clinical trials for Hepatitis B, Chronic

An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys

Start date: April 2009
Phase: N/A
Study type: Observational

This observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and safety parameters will also be evaluated. Patients included in the study will be followed for the duration of their treatment and for up to 3 years thereafter.

NCT ID: NCT00988156 Completed - Clinical trials for Partial Epilepsy in Children and Adolescents

Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children

Start date: December 7, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.

NCT ID: NCT00976989 Active, not recruiting - Breast Cancer Clinical Trials

A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Patients With HER2-Positive Breast Cancer

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

This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in patients with locally advanced, inflammatory or early stage HER2-positive breast cancer. Before surgery, patients will be randomized to receive either A) 6 cycles of pertuzumab plus Herceptin, with FEC (5-fluorouracil/epirubicin/cyclophosphamide) for cycles 1-3 and docetaxel for cycles 4-6, or B) FEC for cycles 1-3 followed by pertuzumab plus Herceptin with docetaxel for cycles 4-6, or C) 6 cycles of pertuzumab plus Herceptin with docetaxel and carboplatin. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv, then 6mg/kg iv 3-weekly, docetaxel at 75mg/m2 iv, increased to 100mg/m2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard doses. Following surgery patients will receive Herceptin 6mg/kg iv 3-weekly for a total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on study treatment is 4-12 months, and target sample size is 200-300.

NCT ID: NCT00976911 Completed - Ovarian Cancer Clinical Trials

AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer

Start date: October 29, 2009
Phase: Phase 3
Study type: Interventional

This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals.

NCT ID: NCT00958776 Terminated - Headache Clinical Trials

A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza

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

A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of peramivir administered intravenously in addition to standard of care compared to standard of care alone in adults and adolescents who are hospitalized due to serious influenza.

NCT ID: NCT00949910 Completed - Clinical trials for Non-Small Cell Lung Cancer

An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

Start date: November 2004
Phase: Phase 4
Study type: Interventional

This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.

NCT ID: NCT00920816 Completed - Kidney Neoplasms Clinical Trials

Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

Start date: August 25, 2009
Phase: Phase 3
Study type: Interventional

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.

NCT ID: NCT00917384 Completed - Gastric Cancer Clinical Trials

Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma

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

The purpose of this study is to gather information about the use of an investigational drug called Ramucirumab in adenocarcinomas of the stomach or gastroesophageal junction.