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NCT ID: NCT02408523 Completed - Epilepsy Clinical Trials

A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications

VALOR
Start date: April 2015
Phase: Phase 3
Study type: Interventional

Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.

NCT ID: NCT02408185 Completed - Critical Illness Clinical Trials

Optimization Dose Study on Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients

COLPHAR
Start date: October 2011
Phase: Phase 1
Study type: Interventional

Phase II clinical trial, open-labelled, prospective and single-center study directed to obtain blood samples in experimental detailed conditions in order to compare and optimize the dose of colistin in critically ill patients suffering from infections on which the indication of colistin would be accepted according to normal local protocols for severe infections treatment.

NCT ID: NCT02406794 Completed - Breast Neoplasms Clinical Trials

Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women Given Breast Cancer Survivors

KITMYCAN
Start date: May 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Background: It has been demonstrated that aromatase inhibitors (AIs) are more effective than tamoxifen in reducing breast cancer recurrence. However, despite the excellent results, the side effects associated with them cause between 24.5 and 31.3% therapy abandon. This study aimed to verify the effectiveness of Neuromuscular Taping (NMT) in the treatment of myalgia and arthralgia induced by AIs in women who have had breast cancer. Our goal is to improve their pain, decreasing by 20% the values of their Visual Analogue Scale (VAS) at various points in order to improve symptoms and increase adherence. Methods/Design: The study includes 156 breast cancer survivors treated with endocrine therapy (aromatase inhibitors or tamoxifen and aromatase inhibitors) from Virgen de la Victoria Hospital (Málaga, Spain) and musculoskeletal disorders resulting from such treatment. Clinical and patient data were obtained from medical histories, genetic and proteomic analysis, grip strength and algometry measured, questionnaires and the outcome of interest, their VAS. NMT is applied in four possible locations, according to the symptoms of each participant: carpal tunnel, cervical, lumbar or lumbar and cervical. There are several more interventions before repeating the readings from the last five weeks of the start of the study.

NCT ID: NCT02406742 Completed - Clinical trials for Leukemia, Lymphocytic, Chronic, B-Cell

A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

ENHANCE
Start date: July 27, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Safety, pharmacokinetics, and preliminary efficacy of CC-122 alone and in combination with ibrutinib and obinuzutumab. CC-122 has multiple activities, including immune modulation of several immune cell subsets and antiproliferative activity in CLL. CC-122 has also been shown to have a tolerable safety profile with some preliminary signs of efficacy with early human experience.

NCT ID: NCT02406625 Completed - Suicidal Behaviors Clinical Trials

Dialectical Behavioral Therapy in Adolescents With Suicidal Behaviors

DBT
Start date: November 2014
Phase: N/A
Study type: Interventional

Suicidal behaviors among adolescents represents a public health problem due to its high prevalence and its low predictability. It is also known that brain development continues during adolescence, therefore, a therapeutic intervention during this period might propitiate neural changes that might favor the emotional regulation involved in suicidal behaviors. Dialectical Behavioral Therapy has proved to be effective regarding this problem. For this reason, the investigators aimed to study the clinical, neuropsychological and neural effects of Dialectical Behavioral Therapy in adolescents with suicidal behaviors.

NCT ID: NCT02406547 Completed - Clinical trials for Colorectal Neoplasms

Study of Narrow Band Imaging in the Characterization of Serrated Lesions

CROMOSER
Start date: March 2015
Phase: N/A
Study type: Interventional

This study is designed to evaluate the utility of Narrow Band Imaging (NBI) compared with High Definition White Light colonoscopy (WLE) in subjects with serrated lesions who do not fulfill the diagnostic criteria of Serrated Polyposis Syndrome (SPS).

NCT ID: NCT02406495 Completed - Myopia Clinical Trials

Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week

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

Open label, 1-week daily disposable, dispensing study

NCT ID: NCT02406235 Completed - Clinical trials for Epithelial Ovarian/Fallopian Tube/Primary Peritoneal Cancer

Evaluating a Novel Onco-genetic BRCA Testing Counselling Model Among Patients With Ovarian Cancer

ENGAGE
Start date: April 21, 2015
Phase: N/A
Study type: Observational

The overall objective of this study is to assess turnaround time, pre-BRCA test onco-genetic counselling quality and satisfaction with a new onco-genetic BRCA testing model.

NCT ID: NCT02406144 Completed - Multiple Myeloma Clinical Trials

Trial Studying Maintenance Treatment With Lenalidomide and Dexamethasone Versus Lenalidomide, Dexamethasone and MLN9708 After Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly-diagnosed Symptomatic Multiple Myeloma

Start date: November 2014
Phase: Phase 3
Study type: Interventional

This protocol is a randomized, open-label, national, multicenter trial studying maintenance treatment with lenalidomide and dexamethasone versus lenalidomide, dexamethasone and MLN9708 after autologous hematopoietic stem cell transplantation in patients with newly-diagnosed symptomatic multiple myeloma. A total of 316 patients, from the study GEM2012MENOS65, will be enrolled in the study. The pre-treatment period includes the screening visit in which participants provide informed consent in writing in order to take part in the study. The patient is then assessed to determine his/her eligibility. The selection process will begin 21 days before the first dose of medication is administered (days -21 to 0). All procedures during the pre-treatment period will be carried out after completion of the two cycles of post-transplant consolidation with VRD which coincide with the end-of-study visit of clinical trial GEM2012MENOS65. During the treatment period, eligible patients will be included in the study and receive maintenance treatment with lenalidomide/dexamethasone versus lenalidomide/dexamethasone/MLN9708. Each cycle will last 28 days. Treatment arm A will consist of oral administration of 15 mg/day of oral lenalidomide on days 1-21, and 20 mg/day of dexamethasone administered orally on days 1-4 and 9-12 for a period of two years. Arm B of the maintenance treatment will be the same as arm A, with the addition of MLN9708 during the two year maintenance period, at a dose of 4 mg/day on days 1, 8 and 15 of the cycle. At two years, patients with negative MRD will finish maintenance treatment. Patients with positive MRD will continue treatment with lenalidomide/dexamethasone until they have completed five years of maintenance treatment. In this case, 20 mg/day of dexamethasone will only be administered on days 1-4 of the cycle. The dose of lenalidomide will not be adjusted. (unless necessary to treat adverse events) Once this phase of active treatment is complete, patients will begin the long-term follow-up phase, during which they will be visited every three months to evaluate progression and survival.

NCT ID: NCT02405949 Completed - Case-control Study Clinical Trials

GENETIC SUSCEPTIBILITY FACTOR AS A PREDICTOR OF TYPE 2 DIABETES REMISSION AND WEIGHT LOSS AFTER BARIATRIC SURGERY

OBEGEN
Start date: July 2013
Phase: N/A
Study type: Observational

Obesity is directly related to an increased risk of diabetes mellitus, hypertension, dyslipidemia, cardiovascular disease, and overall mortality. Weight loss is effective in decreasing these risks and to reduce disease severity. Bariatric surgery is an effective therapy for sustained weight loss and type 2 diabetes (T2D) remission in most of the morbidly obese patients. But there is also a significant number of individuals with an inappropriate response to bariatric surgery. Two recent retrospective studies assessed the role of genetic load as a predictor of this response, but the results are still unelucidated. The aim of this study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after bariatric surgery in terms of weight loss and T2D remission.