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NCT ID: NCT01234337 Completed - Breast Cancer Clinical Trials

Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer

Start date: February 21, 2011
Phase: Phase 3
Study type: Interventional

The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated. After signing consent there can be up to 28 days before starting the treatment during which time a number of tests will be carried out which will include tumor evaluations and medical history. The following tests and evaluations will have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a complete physical exam and vital signs. Treatment will be given in 21 day cycles with sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every cycle after the first 2 cycles. During the weekly visits the subjects will be check for any side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will be followed for overall survival.

NCT ID: NCT01234311 Completed - Prostate Cancer Clinical Trials

A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer

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

This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo. Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).

NCT ID: NCT01234259 Completed - Clinical trials for Circumference Reduction

Evaluation of Safety and Efficacy of Using Venus Freezeā„¢ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment

Start date: December 2010
Phase: N/A
Study type: Interventional

Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis. Radio-frequency (RF) devices have been used for many years for a variety of surgical applications. The energy delivery systems of these established monopolar devices used a 'conductive coupling' delivery system in which energy is concentrated at the periphery of the electrode. Venus Concept has developed the Venus Freeze (MP)2 V2 system for wrinkles, rhytides and temporary cellulite and circumference reduction treatments. While treating wrinkles rhytides and cellulite, the treatments creates enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis.

NCT ID: NCT01234168 Completed - Clinical trials for Neuroendocrine Tumors

A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea

SYMNET
Start date: October 2010
Phase:
Study type: Observational

The purpose of the protocol is to to assess subject's overall satisfaction regarding control of diarrhea. The study aims to supplement results obtained through clinical trials with data obtained from a population of patients receiving treatment with Somatuline Autogel in routine practice.

NCT ID: NCT01233908 Completed - Clinical trials for Stress Disorders, Post-Traumatic

Diagnosis of Posttraumatic Stress Disorder Following Primary Rhegmatogenous Retinal Detachment

Start date: January 2010
Phase: N/A
Study type: Observational

To investigate the prevalence of posttraumatic stress disorder (PTSD) in patients that underwent surgery for primary rhegmatogenous retinal detachment (RRD) and to determine variables associated with the disorder. Design: Consecutive prospective observational study.

NCT ID: NCT01233440 Completed - Hemophilia B Clinical Trials

Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time. The secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rIX-FP.

NCT ID: NCT01233310 Completed - Crohn Disease Clinical Trials

Evaluation of Small Bowel Colon Capsule for Bowel Visualization in Crohn's Disease Patients

SBC-CD
Start date: October 2010
Phase:
Study type: Observational

Study Hypothesis: It is estimated that by re-programming some of the PillCam COLON2 system parameters it can serve as tool for visualizing both small bowel and colon. As such, the system may be utilized in CD patients for monitoring mucosal healing. Primary objectives: To evaluate two different video output methods in the visualization of the SB and colon in CD patients Secondary objectives: - Evaluate the level of agreement between PillCam system and ileocolonoscopy on the assessment of CD findings. - Evaluate the effectiveness of PillCam regimen in CD patients Inclusion criteria - Patient is 18 years of age and above - Patient with a diagnosis of ileocolonic or colonic Crohn's Disease documented by endoscopical, histopathological and/or radiological parameters - Patients' CDAI >150. - Patient is clinically indicated to undergo ileocolonoscopy for assessment of Crohn's disease - Proven patency by Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 3 months prior to enrollment - Patient is able and agrees to sign the Informed Consent Form Exclusion criteria - Patient has dysphagia - Patient has congestive heart failure - Patient has renal insufficiency - Patient has cirrhosis - Patient is known or is suspected to suffer from intestinal obstruction - Patient has known previous stricture/obstruction of the SB or colon - Patient has taken NSAID medications less than one month before enrollment - Patient suffers from hypertension and is taking one or more of the following medications used for control of hypertension: diuretics, ACE inhibitors, Angiotensin II blockers - Chronic use of laxatives - Patient has a cardiac pacemakers or other implanted electro medical devices. - Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception. - Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule. - Patient has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator. - Patient has any condition, which precludes compliance with study and/or device instructions. - Patient suffers from life threatening conditions - Patient is currently participating in another clinical study - Patient has known slow gastric emptying time - Patient is allergic or contraindicated to any of the study medications

NCT ID: NCT01233245 Completed - Clinical trials for Secondary Progressive MS (SPMS)

BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program

Start date: April 2004
Phase: N/A
Study type: Observational

This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.

NCT ID: NCT01232894 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

12-week Open-label Evaluation of Efficacy and Safety of Indacaterol

MOVE-ON
Start date: March 2011
Phase: Phase 3
Study type: Interventional

In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.

NCT ID: NCT01232712 Completed - Multiple Myeloma Clinical Trials

A Study to Assess the Safety and Efficacy of MUC1 Peptide Vaccine and hGM-CSF in Patients With MUC1-positive Tumor Malignancies

Start date: September 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The scientific approach behind this study is to develop novel anti-cancer therapeutic vaccine to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes populations and can be be applicable to the majority of the target population.