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NCT ID: NCT02258451 Completed - Breast Neoplasms Clinical Trials

Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer

Start date: June 4, 2015
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.

NCT ID: NCT02257931 Completed - Clinical trials for Allogeneic or Autologous HSCT

Gram-negative Bacteremia in HSCT Recipients

GNB
Start date: February 2014
Phase: N/A
Study type: Observational [Patient Registry]

A significant increase in resistant bacteria emerging in HSCT recipients. For example, 25% - 42% of all enterobacteriaceae produce extended spectrum beta-lactamases; 8 - 72% of Pseudomonas aeruginosa are resistant to at least one and 25 - 62% to three or more antibiotic classes, 13% of Gram-negative bacteria are caused by a multidrug-resistant (MDR) strain (Trecarichi JI 09, Mikulska BBMT 09, Oliveira BMT 07, Caselli Haemat 10, Gudiol, JAC 11). These resistant bacteria may be associated with increased mortality and have limited treatment options (Caselli Haemat 10, Poutsiaka BMT 07, DiazGranadoz JID 05). To provide the currently best empirical coverage and to control the growing resistance, knowledge of trends in antibiotic susceptibility, as well as risk factors is essential. For this reason we propose to perform non-interventional prospective multicentre study in EBMT centres.

NCT ID: NCT02256410 Completed - Clinical trials for Chronic Low Back Pain

Pain Detecting and Analgesic Stimulating Device on Low Back Pain

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

Purpose of study is to test in a randomized controlled trial (RCT) the effects of the Nervomatrix device on various clinical outcomes of patients with low back pain, as well as its mechanisms of action.

NCT ID: NCT02255656 Completed - Clinical trials for Relapsing Remitting Multiple Sclerosis

Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409

TOPAZ
Start date: January 7, 2015
Phase: Phase 4
Study type: Interventional

Primary Objective: To evaluate long-term safety of alemtuzumab. Secondary Objectives: - To evaluate long term efficacy of alemtuzumab. - To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment. - To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab. - To evaluate as needed re-treatment with alemtuzumab and other DMTs.

NCT ID: NCT02254967 Completed - Clinical trials for Clostridium Difficile

A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population

EXTEND
Start date: November 6, 2014
Phase: Phase 4
Study type: Interventional

The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).

NCT ID: NCT02253134 Completed - Syncope Clinical Trials

Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)

ITHO04
Start date: August 2010
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of suspected arrhythmic origin, within 30 days before enrollment.

NCT ID: NCT02252679 Completed - Osteoporosis Clinical Trials

Study of the Diagnostic Value of Stable Calcium Isotope Profiling in Bone and Calcium Disorders

eCaSIS
Start date: October 2014
Phase:
Study type: Observational

The purpose of this study is to determine whether mass spectrometry analysis of stable (non-radioactive) calcium isotopes in plasma or urine samples can help in the diagnosis of bone and calcium disorders.

NCT ID: NCT02252653 Completed - Clinical trials for Familial Amyloidotic Cardiomyopathy (FAC)

DISCOVERY: A Study Examining the Prevalence of TTR Mutations in Subjects Suspected of Having Cardiac Amyloidosis

Start date: June 2014
Phase: N/A
Study type: Observational

The purpose of this study is to characterize the frequency of TTR mutations in subjects suspected of having cardiac amyloidosis

NCT ID: NCT02252107 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

10-day Decitabine, Fludarabine and 2 Gray TBI as Conditioning Strategy for Poor and Very Poor Risk AML in CR1

Start date: October 2014
Phase: Phase 2
Study type: Interventional

This study examines whether the addition of decitabine to the standard Flu/TBI conditioning regimen prior to allogeneic stem cell transplantation in poor and very poor risk AML patients, reduces the risk of recurrence of the disease. Because decitabine has hardly any side effects, it will likely have little impact on the occurrence of Graft Versus Host Disease. The investigators are looking for a pre-treatment for transplantation which reduces the chance of recurrence of the disease without involving severe damage to normal tissues.

NCT ID: NCT02251275 Completed - Clinical trials for Polycystic Kidney, Autosomal Dominant

Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

Start date: October 17, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (ADPKD).