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NCT ID: NCT01431196 Completed - Clinical trials for Stage II Breast Cancer

Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer

Start date: February 2011
Phase: Phase 2
Study type: Interventional

Molecular expression in breast cancer (BC) defines special fenotypes with different prognostic and predictive features.Since the addition of trastuzumab and lapatinib to chemotherapy, HER2 overexpressing tumors have become the best responders to systemic therapies, reaching pathologic complete response rates (pCR) around 50%. But HER2 negative tumors (luminal A and triple negative) are characterized by low chemosensitivity (luminal A) or early distant relapse after diagnosis (triple negative BC) . In this open, prospective, non-randomized and multicentric phase II study the investigators include stage II and III HER2 negative BC patients that are going to receive neoadjuvant sequential chemotherapy Epirubicin+Ciclofosfamide x 4 and then Docetaxel x 4)with an individualized vaccination with autologous dendritic cells pulsed with their own tumor. The hypothesis is that the reinforcement of the immune system with the autologous dendritic cell vaccination against HER2 negative BC could increase pathologic complete responses (pCR) and disease free survival(DFS), when added to chemo, surgery and radiation therapy and in a maintenance schedule.

NCT ID: NCT01430650 Completed - Sterility Clinical Trials

Endometrial Priming for Embryo Transfer

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

The aim of this trial is compare two different endometrial priming protocols - women that receive oral estrogens - women that receive transdermal estrogens

NCT ID: NCT01430494 Completed - Clinical trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

OVERTURE
Start date: June 2011
Phase: N/A
Study type: Observational

To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.

NCT ID: NCT01430117 Completed - Clinical trials for Allergy to Grass Pollen

Biological Standardization of Poa Pratensis Allergen Extract

Start date: October 2011
Phase: Phase 2
Study type: Interventional

The objective of this study is to determine the biologic activity of a Poa pratensis allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

NCT ID: NCT01429844 Completed - Immunosuppression Clinical Trials

Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation

EAILTX
Start date: January 2001
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare efficacy and safety of two different immunosuppressive regimens for prevention of bronchiolitis obliterans syndrome (BOS) (chronic lung allograft rejection)after lung transplantation: tacrolimus versus cyclosporine, both in combination with mycophenolate mofetil and steroids. The study was powered to detect a 15% reduction in BOS in tacrolimus treated patients. Study design: open-label, randomized, comparative, multi-center, investigator driven

NCT ID: NCT01428934 Completed - Stroke Clinical Trials

Improving Intermediate Risk Management. MARK Study

MARK
Start date: July 2011
Phase: N/A
Study type: Observational

Cardiovascular risk functions fail to identify more than 50% of patients who develop cardiovascular disease. This is especially evident in the intermediate-risk patients in which clinical management becomes difficult. The purpose of this study is to analyze if ankle-brachial index (ABI), measures of arterial stiffness, postprandial glucose, glycosylated hemoglobin, self-measured blood pressure and presence of comorbidity are independently associated to incidence of vascular events and whether they can improve the predictive capacity of current risk equations in the intermediate-risk population.

NCT ID: NCT01428882 Completed - Drug Safety Clinical Trials

Propofol vs. Midazolam-based Balanced Propofol for Nonanesthesiologist Moderate Sedation in Colonoscopy

MIDAPROP
Start date: June 2011
Phase: Phase 4
Study type: Interventional

Nonanesthesiologist administration of propofol for sedation is actually a field of growing interest for endoscopists, as demonstrated by recent American and European guidelines on this issue. Propofol is a hypnotic drug with rapid onset and offset of action. Used as a single agent, it is commonly titrated to deep sedation, whereas balanced propofol sedation (BPS), which combines propofol with small doses of a benzodiazepine and/or an opioid, can be successfully titrated to moderate sedation. However, nonanesthesiologists propofol administration remains controversial on account of the possibility of deep sedation/general anesthesia related adverse events. On the other hand, the use of longer elimination half-life drugs, such as opioids and benzodiazepines, may theoretically prolong sedation and recovery. Up to date, no study has addressed a head-to-head comparison of both regimens administered by non-anesthesiologists and titrated to moderate sedation. This study aims to evaluate the impact on propofol sedation of premedication with a fixed dose of midazolam (2 mg)2 minutes before propofol administration targeted to moderate sedation, in terms of depth of sedation, recovery times, safety and satisfaction. The onset of sedative action of midazolam has been reported to be 1-2.5 minutes and the peak effect of midazolam occurs 8-12 minutes. Taking into account that colonoscopy usually lasts a minimum of 15-20 minutes, our hypothesis is that synergy between propofol and midazolam may increase the depth of sedation through the initial phases of the procedure, diminishing propofol requirements, but not prolonging significantly recovery times.

NCT ID: NCT01428765 Completed - Atrial Fibrillation Clinical Trials

GLORIA-AF Registry Program (Phase I)

Start date: May 2011
Phase: N/A
Study type: Observational

This study constitutes Phase I of the Registry Program. The main objective of this study is to characterize the newly diagnosed non-valvular AF patient population at risk for stroke and the selection of antithrombotic treatment for stroke prevention in a real-world setting before dabigatran etexilate is approved for the prevention of strokes and systemic emboli in patients with non-valvular AF in different regions of the world.

NCT ID: NCT01428726 Completed - Clinical trials for Relapsing Remitting Multiple Sclerosis

A Phase IIa Study of NT-KO-003 for Multiple Sclerosis

Start date: June 2011
Phase: Phase 2
Study type: Interventional

The aim of the study is to assess the efficacy and safety of NT-KO-003 in the treatment of relapsing remitting multiple sclerosis, comparing two doses versus placebo.

NCT ID: NCT01428453 Completed - Alzheimer's Disease Clinical Trials

A Phase 2a Study to Evaluate the Effect of Rilapladib (SB-659032) in Alzheimer's Disease

Start date: October 1, 2011
Phase: Phase 2
Study type: Interventional

The study is designed to investigate the effects of rilapladib on biomarkers related to the Alzheimer's disease, and cognitive function.