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NCT ID: NCT01971034 Completed - Clinical trials for Pancreatic Adenocarcinoma Advanced or Metastatic

Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

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

In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an uncommon disease, however very aggressive.Only 20% of cases are indicated for curative surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first line, with survival around 6 months approximately.There is no standard treatment regimen for second-line, however Paclitaxel demonstrated effect on second-line phase II study. Metformin is an oral hypoglycemic drug used for treatment of diabetes mellitus. There is a growing number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma, probably due to the effect of anti-insulin growth factor (IGF-1). This study will add metformin to standard treatment for second line of locally advanced or metastatic pancreatic adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to evaluate whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical and radiological evaluation.

NCT ID: NCT01968512 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder

NAADHD
Start date: October 2013
Phase: N/A
Study type: Interventional

Evaluating neurobiological disorder associated with Attention Deficit Hyperactivity Disorder (ADHD) and the contribution of transcranial direct current stimulation (tDCS) in the adaptation of inhibitory control.

NCT ID: NCT01968343 Completed - Trichotillomania Clinical Trials

Trichotillomania: Group Cognitive-Behavioral Therapy

Start date: January 2008
Phase: Phase 2
Study type: Interventional

Objective: Trichotillomania is a psychiatric condition characterized by chronic pulling and plucking of one's own hair. Cognitive behavioral therapy shows promise as a treatment. However, there have been no randomized, controlled studies of the efficacy of group cognitive-behavioral therapy. Methods: We evaluated 44 subjects, whom met the criteria for a diagnosis of trichotillomania. Subjects were randomized to receive 22 sessions of either group cognitive-behavioral therapy or group supportive therapy (control).

NCT ID: NCT01966471 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer

Start date: January 31, 2014
Phase: Phase 3
Study type: Interventional

This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.

NCT ID: NCT01966042 Completed - Refractory Angina Clinical Trials

Study Protocol of Intramyocardial Injection of Autologous Bone Marrow Stem Cells for Refractory Angina

ReACT
Start date: July 2005
Phase: Phase 2
Study type: Interventional

Therapeutic neovascularization is an innovative strategy for cardiac tissue recovery due to chronic, intense ischemia. Thus stem cell therapy has become a promising procedure for the large number of patients with refractory angina due to coronary disease, despite of the use of multiple anti-angina medications, remain severely symptomatic with disabling angina. Stem cell therapy using autologous cells from the patient's bone marrow, has been shown to be safe and associated with improved myocardial perfusion, reducing the symptoms of advanced coronary artery disease and increasing the functional capacity of patients whose therapeutic armamentarium available today has been exhausted. The study hypothesis was that the infusion of autologous mononuclear cells derived from the patient's bone marrow and delivered via intramyocardial injection in patients with refractory angina and normal or slightly depressed ventricular function, promote improvement in the anginal symptoms and myocardial perfusion by the inducing neoangiogenesis.

NCT ID: NCT01965483 Completed - Breast Neoplasms Clinical Trials

Phase 2 Study of Adjuvant Radiotherapy in Breast Cancer Using a Once a Week Hypofractionated Regimen

Start date: November 2013
Phase: Phase 2
Study type: Interventional

The implementation of a weekly hypofractionated radiation could be an advantageous alternative. The convenience of less treatment days could cause a greater adherence, decrease of costs and increase the offer of radiotherapy to major number of patients in underserved areas. The purpose of this study is to determine in women with diagnosis of initial breast cancer undergoing breast-conserving surgery the effects of the adjuvant radiotherapy using a once a week regimen, with 5 fractions in total. The study will analyze the acute toxicity of radiation, the patient's self referred quality of life, the cosmetic breast appearance, as well the oncological safety. It will also be analyzed the viability of this more contracted regimen in our community setting, regarding the patient's adherence to the treatment.

NCT ID: NCT01965379 Completed - Clinical trials for End-stage Renal Disease

Effect of Restriction of Foods Containing Phosphorus Additives

Start date: January 2012
Phase: N/A
Study type: Interventional

Hyperphosphatemia is related to the increase in morbidity and mortality. There is greater risk for cardiovascular disease, atherosclerotic disease, secondary hyperparathyroidism, and bone disease . The serum phosphorus level can be controlled by a combination of factors, such as: reduction of ingestion, reduction of intestinal absorption with chelating agents and increase in elimination by dialysis. The purpose of this study is to evaluate the effect of dietary intervention consisting of the restriction of industrialized foods with phosphorus additives in chronic kidney disease patients treated with hemodialysis.

NCT ID: NCT01964833 Completed - Periodontitis Clinical Trials

PDT and Periodontal Treatment in DMT2 Patients

PDTDMT2
Start date: October 2013
Phase: N/A
Study type: Interventional

The relationship between diabetes mellitus (DM) and periodontal disease is bidirectional. DM is a predisposing and modifying factor of periodontitis, which, in turn, worsens glycemic control and increases proteins found in the acute phase of inflammation. The gold standard for the treatment of periodontal disease is oral hygiene orientation, scaling and planing. Moreover, systemic antibiotic therapy may be employed in some cases. In an effort to minimize the prescription of antibiotics, photodynamic therapy (PDT) has been studied as an antimicrobial technique and has demonstrated promising results. The aim of the proposed study is to determine whether PDT as a complement to periodontal therapy (PT) is helpful in the metabolic control of individuals with type 2 diabetes and the reduction of acute phase inflammatory markers. The patients will be randomized using a proper software program into two groups: 1) PT + placebo PDT or 2) PT + active PDT. All patients will first be examined by a specialist, followed by PT performed by two other healthcare professionals. At the end of each session, PDT (active or sham) will be administered by a fourth healthcare professional. The following will be the PDT parameters: diode laser (660 nm); power output = 110 mW; exposure time = 90 seconds per point (9 J/point); and energy density = 22 J/cm2. The photosensitizer will be methylene blue (50 µg/mL). The patients will be re-evaluated 15, 30, 90 and 180 days after treatment. Serological exams with complete blood count, fasting glucose, glycated hemoglobin and crevicular fluid exams to screen for tumor necrosis factor alpha, interleukin 1, interleukin 6, osteocalcin, osteoprotegerin/RANKL will be performed at each evaluation. At baseline and 180 day periapical radiographs will be performed to evaluate the alveolar bone crest level. The data will be statistically evaluated using the most appropriate tests.

NCT ID: NCT01964560 Completed - Epilepsy Clinical Trials

A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures

Start date: August 13, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.

NCT ID: NCT01963507 Completed - Hypertension Clinical Trials

Effects of a Resistance Training Period on Blood Pressure of Hypertensive Elderlies: Influence of the Polymorphism of the Angiotensin Converting Enzyme

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

The study aimed to evaluate the chronic effects of resistance training on blood pressure and biochemical exams in hypertensive elderlies and the influence of the polymorphism of the angiotensin converting enzyme in these response.