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NCT ID: NCT01943760 Completed - Children Clinical Trials

Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty

Start date: September 2012
Phase: Phase 4
Study type: Interventional

Tramadol is a centrally acting analgesic, is primarily Indicated for the treatment of acute pain, moderate to severe. The hernioplasty in children is an outpatient procedure, and the possibility of postoperative analgesia with fewer systemic adverse effects such as nausea and vomiting make the tramadol infiltration a technique of interest. There is controversy about its effectiveness. The local effect of tramadol in hernioplasty was also studied by researchers with some better postoperative analgesia than with local anestetic . There are few studies with administration of tramadol for hernioplasty, Which led to the interest in this study.

NCT ID: NCT01942707 Active, not recruiting - Seroma Clinical Trials

Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery

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

46 female postbariatric patients will be submitted to anchor-line abdominoplasty with drains insertion. Patients will be randomized to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.

NCT ID: NCT01942291 Completed - Clinical trials for Hypoalphalipoproteinemia

Short-term Effect of Extended-release Niacin on Endothelial Function.

Start date: March 2012
Phase: Phase 4
Study type: Interventional

Individuals with reduced plasma concentration of high-density lipoprotein (HDL) cholesterol are more susceptible to oxidative stress and often present reduced endothelial function, which has been mainly related to this susceptibility. Studies in animal and cell models have demonstrated that niacin activates both GPR-109A in leukocytes and heme oxygenase-1 (HO-1) pathway promoting strong anti-inflammatory and anti-oxidative effects. . In this context, the aim of this study was to investigate the short-term effect of niacin on endothelial function and verify the existence of interaction of PGD2 receptor antagonist, i.e. laropiprant (LRPT), in subjects with low HDL-cholesterol (HDL -C).

NCT ID: NCT01941979 Recruiting - Rectal Cancer Clinical Trials

A Study Comparing Adjuvant Chemotherapy Versus Observation for Patients With Rectal Adenocarcinoma After Neoadjuvant Chemo-Radiotherapy Treatment.

Start date: September 2011
Phase: Phase 3
Study type: Interventional

Surgery is the most indicated curative treatment for rectal cancer when disease is diagnosed early, however local recurrence risk increases when the disease is diagnosed at advanced stage.T1-2 tumors have a recurrence rate lower than 10%, while T3N0 tumors have 15% - 35% and positive lymph nodes T3-4 45% to 67% of recurrence rate within 5 years. These data indicate that patient who have a high risk of tumor recurrence should receive an adjuvant therapy treatment. It is possible that adjuvant chemotherapy has a positive impact on survival of patients already treated with neoadjuvant combination therapy. However it is necessary to identify those patients that might have this benefit. An exploratory analysis of the European Organization for Research and Treatment of Cancer (EORTC) 22921 study showed that the addition of adjuvant chemotherapy has benefited only the group of patients who had a reduction of tumor stage to ypT0-2. In the group who had no reduction (ypT3-4), there was no benefit. Retrospective analyzes suggest that the response to neoadjuvant chemoradiotherapy is a predictor of prognosis and even benefit to adjuvant chemotherapy. However the benefit of adjuvant chemotherapy for patients with rectal cancer remains controversial. Therefore, a randomized trial is needed to answer this question. Based on these data the investigators proposed a phase III study, randomized, unblinded, adjuvant chemotherapy based on Fluorouracil(5-FU) and Oxaliplatin versus observation in patients with rectal adenocarcinoma T3-4, N0-1, M0 previously treated with neoadjuvant chemoradiotherapy and who did not presented complete response. The investigator believes that this subgroup of patients, who have not achieved complete response, will be benefit from adjuvant therapy. Study objective: The main objective of this study is verify if adjuvant chemotherapy with 5-FU and oxaliplatin, for 4 months, increases recurrence-free survival versus the observation. Secondary objectives include the evaluation of toxicity, overall survival and assessment of biomarkers (study protocol separately). The study's primary endpoint is disease-free survival (DFS) to be defined as time from randomization to radiological detection of distant disease and / or locoregional recurrence. Isolate carcinoembryonic antigen (CEA) increase will not be consider as recurrence until a new measurable lesion be found. NOTE: The TNM system is based on the size and/or extent (reach) of the primary tumor (T), the amount of spread to nearby lymph nodes (N), and the presence of metastasis (M) or secondary tumors formed by the spread of cancer cells to other parts of the body.

NCT ID: NCT01941966 Completed - Anal Canal Cancer. Clinical Trials

A Study of Substitution of 5-FU (Fluorouracil) by Capecitabine in Scheme of Chemo-radiotherapy in Patients With Squamous Cell Carcinoma of the Anal Canal.

Start date: November 2010
Phase: Phase 2
Study type: Interventional

The squamous cell carcinoma (SCC) of the anal canal is an uncommon neoplasia which corresponds to 1-5% of intestinal tumors. However the risk of SCC of the anal canal has been growing recently. The standard treatment of anal cancer stage II-III is multimodal and consists of combined chemotherapy (infusional 5-fluorouracil and mitomycin) and radiotherapy. This scheme currently used was proposed in 1974, and since then no other effective treatment has been developed. The purpose of this study is to determine the efficacy and toxicity of the combination of capecitabine and mitomycin with radiotherapy in patients with carcinoma of the anal canal. For this will be selected 51 patients to be treated with chemo-radiotherapy. The primary endpoint will be local control rate after 6 months of the end of radiotherapy and chemotherapy, defined by the rate of radiological and clinical neoplasia.

NCT ID: NCT01941953 Completed - Clinical trials for Metastatic Colorectal Cancer

Metformin and 5-fluorouracil for Refractory Colorectal Cancer.

Start date: November 2012
Phase: Phase 2
Study type: Interventional

This is a phase II trial to evaluate efficacy and safety of Metformin and Fluorouracil in patients with metastatic colorectal cancer (CRC) who have progressed after Oxaliplatin and Irinotecan based chemotherapy.

NCT ID: NCT01940887 Terminated - Clinical trials for Age-Related Macular Degeneration

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy

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

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with either Avastin® or Eylea® compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

NCT ID: NCT01940107 Completed - Shoulder Pain Clinical Trials

Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation

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

To observe the effect of domiciliary physiotherapy on the upper limb applied during the period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was significant difference between the ipsilateral and contralateral limbs for flexion, abduction and external rotation. There was no difference in perimetry in either group

NCT ID: NCT01940003 Completed - Clinical trials for Diabetes, Gestational

Effects of an Aquatic Physical Exercise Program on Glycaemic Control and Perinatal Outcomes of Gestational Diabetes: Study Protocol for a Randomized Controlled Trial

Start date: September 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to verify the efficacy of an aquatic physical exercise program on GDM control and adverse maternal and fetal outcomes.

NCT ID: NCT01939795 Completed - Heart Failure Clinical Trials

Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients

Start date: January 2009
Phase: N/A
Study type: Interventional

The investigators hypothesis that exercise training would potentiate the effects of cardiac resynchronization therapy in heart failure patients.