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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: NCT02257905 Completed - AL Amyloidosis Clinical Trials

Allo SCT in Amyloidosis Non-interventional Study

Start date: December 2009
Phase: N/A
Study type: Observational [Patient Registry]

Light-chain (AL-) amyloidosis is a very rare monoclonal plasma cell disorder with poor prognosis. Rarity of disease has precluded performance of randomized controlled trials comparing various possible treatment modalities. In general, treatment of AL amyloidosis has been adapted from myeloma (MM) therapy. There is large experience with allo SCT in MM. Based on small series of patients and case reports allogeneic transplant has emerged as potentially effective. However, more formal proof of concept of using allogeneic hematopoietic transplantation for treatment of AL Amyloidosis is lacking. Therefore, given the limitations of conventionally collected registry data (dubious follow-up information and extreme heterogeneity), we developed the: "EBMT non-interventional prospective study on allogeneic transplantation in AL Amyloidosis" which means that transplant centers that already do perform allogeneic transplants for AL Amyloidosis will be encouraged to register their patients with AL Amyloidosis very timely with the EBMT, followed by mandatory submission of EBMT MedB and follow-up forms. The diagnosis of AL Amyloidosis would be based on uniform criteria. All EBMT centres performing allogeneic transplants for Amyloidosis will be invited to participate in this study and centres will be asked to report all AL Amyloidosis cases referred for transplantation using a simple registration form and then to submit Amyloidosis MED B forms for each transplanted patient and follow-up forms as necessary. In conclusion, it should be possible to largely improve the usual quality of registry-based data and to generate scientifically sound knowledge on HSCT in an orphan disease such as AL Amyloidosis.

NCT ID: NCT02257125 Terminated - Stroke Clinical Trials

ArmeoSenso - Reward

Start date: January 27, 2015
Phase: N/A
Study type: Interventional

This study investigates the use of motivating/rewarding features in a computer based arm rehabilitation program. Half of the subjects will take part, besides receiving standard therapy, in a computer based program delivering a game like scenario with visual effects and monetary rewards in case of successful level completion, while the other half will take part in a similar program without visual effects or the possibility to earn money.

NCT ID: NCT02256956 Completed - Chronic Pain Clinical Trials

Genetic Determinants of Amitriptyline Efficiency for Pain Treatment - Part II

Start date: November 2014
Phase: Phase 4
Study type: Interventional

Low dose tricyclic antidepressant drugs are routinely administered co-analgesics in pain medicine. Amitriptyline is largely considered as a gold standard. Amitriptyline underlies cytochrome CYP2D6 and CYP2D19 metabolism. CYP2D6 is highly polymorphic; numerous genetic variants result in 4 major classes characterizing enzymatic activity: poor metabolizers, intermediate metabolizers, extensive metabolizers and ultrarapid metabolizers. It is not known to which extent metabolizer classes determine pain outcomes or side-effects. As only one in three pain patients is considered to be a responder to amitriptyline's co-analgesic effect, prediction of treatment efficacy with a fast and easy to perform bedside test may contribute to the patients quality of life. The aim of this study is to determine the influence of cytochrome variants on experimental pain, drug related side-effects and finally identification of active metabolites.

NCT ID: NCT02256943 Completed - Chronic Pain Clinical Trials

Genetic Determinants of Amitriptyline Efficiency for Pain Treatment

Start date: November 2014
Phase: Phase 4
Study type: Interventional

Low dose tricyclic antidepressant drugs are routinely administered co-analgesics in pain medicine. Amitriptyline is largely considered as a gold standard. Amitriptyline underlies cytochrome CYP2D6 and CYP2D19 metabolism. CYP2D6 is highly polymorphic; numerous genetic variants result in 4 major classes characterizing enzymatic activity: poor metabolizers, intermediate metabolizers, extensive metabolizers and ultrarapid metabolizers. It is not known to which extent metabolizer classes determine pain outcomes or side-effects. As only one in three pain patients is considered to be a responder to amitriptyline's co-analgesic effect, prediction of treatment efficacy with a fast and easy to perform bedside test may contribute to the patients quality of life. The aim of this study is to determine the influence of cytochrome variants on experimental pain, drug related side-effects and finally identification of active metabolites.

NCT ID: NCT02256202 Completed - Pain Clinical Trials

Quality Assurance of Electronic Data Capturing (EDC) in Pain Treatment

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

There are actually no standardized quality assurance procedures included in pain treatment processes. In this observational, feasibility study the use of tablet-Personal Computer (PC) is tested in pain therapy centres using the validated questionnaire "Activity Index". The acceptance of electronic data capturing is tested in patients and therapy teams (doctors and nurses).

NCT ID: NCT02255942 Completed - Iron Deficiency Clinical Trials

The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate

Rice_FeZn
Start date: April 2015
Phase: N/A
Study type: Interventional

Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves as a Reference.

NCT ID: NCT02255812 Completed - Clinical trials for Exploratory Behavior

Taste Physiology in Healthy, Normal-weight Volunteers

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

Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and bitter. The receptors found on the tongue are also found in the entire gut. The correlation of stimulation of these gut receptors and brain activity has not yet been examined. The objectives are to investigate the effect of different taste substances on i) regional brain activity and ii) satiation peptide release.

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: NCT02254746 Active, not recruiting - Clinical trials for Prostate Adenocarcinoma

A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer

Start date: September 2014
Phase: N/A
Study type: Interventional

The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is the irradiation of the entire prostate gland with or without seminal vesicles accompanied or not by hormonal therapy. In light of the accumulating clinical evidence favoring the use of hypo fractionation, SBRT regimen might constitute a much more convenient non-invasive and highly efficient outpatient therapy.