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NCT ID: NCT01320761 Completed - Healthy Clinical Trials

A Study to Assess Injection Comfort of Two Formulations of ATX-101

Start date: n/a
Phase: Phase 1
Study type: Interventional

To assess the safety and injection comfort of ATX-101-BA versus ATX-101-BA-free immediately following injection and at regular intervals up to 24-hours post-injection following subcutaneous administration into the submental area.

NCT ID: NCT01321294 Completed - Clinical trials for Gastroesophageal Reflux Disease

Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial

Start date: n/a
Phase: N/A
Study type: Interventional

The aim of this study is to compare subjective and objective outcome and surgical "side effects" of Nissen and Toupet fundoplication performed in a single institution by only two surgeons and to compare pre and postoperative findings to healthy individuals.

NCT ID: NCT01321983 Completed - Obesity Clinical Trials

Effects of Preoperative Inspiratory Muscle Training (IMT) in Obese Women Undergoing Open Bariatric Surgery

Start date: n/a
Phase: N/A
Study type: Interventional

OBJECTIVE: to determine whether preoperative inspiratory muscle training (IMT) is able to attenuate the impact of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion in obese women undergoing open bariatric surgery. Therefore, the hypothesis of the present study was that preoperative IMT is able to attenuate the negative effects of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion, thus reducing the risk of PPC, in obese patients undergoing open bariatric surgery. DESIGN: Randomized controlled trial. SETTING: Meridional Hospital, Cariacica/ES, Brazil. SUBJECTS: Thirty-two obese women undergoing elective open bariatric surgery were randomly assigned to receive preoperative inspiratory muscle training (IMT group) or usual care (control group). MAIN MEASURES: Respiratory muscle strength (maximal inspiratory pressure - MIP and maximal expiratory pressure - MEP), lung volumes and diaphragmatic excursion.

NCT ID: NCT01324791 Completed - Clinical trials for Gastroesophageal Reflux Disease

Laparoscopic Antireflux Surgery Versus Endoscopic Full-thickness Gastroplication for Gastroesophageal Reflux Disease (GERD)

Start date: n/a
Phase: N/A
Study type: Interventional

Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of GERD. This prospective randomized study compares objective and subjective outcome parameters of Plicator with that of LARS.

NCT ID: NCT01324986 Completed - Clinical trials for Gastroesophageal Reflux Disease (GERD)

A Study on the Effectiveness of Laparoscopic Fundoplication on Extraesophageal Manifestations of Gastroesophageal Reflux Disease (GERD)

Start date: n/a
Phase: N/A
Study type: Interventional

Available data regarding the effectiveness of laparoscopic antireflux surgery on extraesophageal symptoms of gastroesophageal reflux disease (GERD) are scarce and mostly controversial. The aim of the present study was to evaluate the clinical effect of partial and total fundoplication on extraesophageal symptoms in a selected cohort of patients with GERD.

NCT ID: NCT01327833 Completed - Cardiac Arrest Clinical Trials

CODE Registry - Cardiac Arrest Outcomes Data Evaluation

CODE
Start date: n/a
Phase: N/A
Study type: Observational

The purpose of this study is based on method Utstein, registering all recommended items of that model, in addition to adding more information, characterizing this way using a template Utstein modified for the epidemiology of PCR-hospital in Brazil. Objectives: establish a registry of patients suffering from respiratory (PCR)-hospital to assess demographic and clinical variables such as morbidity, mortality and standard practice in cardiopulmonary resuscitation (CPR). In addition, assess independent predictors associated with survival in several times and survival curves.

NCT ID: NCT01333592 Completed - Type 2 Diabetes Clinical Trials

Long-term Study of KAD-1229 in Type 2 Diabetes Patients

Start date: n/a
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.

NCT ID: NCT01338844 Completed - Infertility Clinical Trials

Role of Myo-inositol and D-chiro-inositol on Oocyte Quality

Start date: n/a
Phase: Phase 4
Study type: Interventional

Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other Assisted Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI). The hormonal control of multiple follicular growth and maturation is a critical part of ART procedures since it maximizes the yield of embryos to be transferred, thus increasing the cumulative pregnancy rate. Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and highly effective treatment in order to improve oocyte quality in patients undergoing IVF. Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable predictor of oocyte quality. High MI concentration in the FF directly correlates with high oocyte and embryo quality. Another stereoisomer of Inositol was successfully used into clinical practice D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in hyperglycemic PCOS patients. In the present study we aim to compare MI versus DCI supplementation on oocyte quality of women undergoing IVF-ET

NCT ID: NCT01344603 Completed - Cardiac Disease Clinical Trials

Epidural and Cardiac Surgery

Start date: n/a
Phase: N/A
Study type: Observational

In the present study the investigators test the hypothesis that the epidural anesthesia added on the general anesthesia is able to improve patient's outcome.

NCT ID: NCT01351090 Completed - Postoperative Pain Clinical Trials

Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine (IN) for Postoperative Pain

Start date: n/a
Phase: Phase 2
Study type: Interventional

This was a randomized, double blind, placebo-controlled study in subjects who have undergone major surgery. Each subject's study participation consisted of a screening visit, a 2-day treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned to receive intranasally (IN) ketorolac 10 mg, IN ketorolac 30 mg, or placebo when the pain intensity (PI) rating equaled at least 40 on a 100-mm visual analog scale (VAS). Thereafter, subjects received study drug every 8 hours, with the last dose given at 40 hours. For pain not relieved by the study drug, the subjects had access to morphine sulfate (MS) administered via patient controlled analgesia (PCA). The primary objective was to evaluate the analgesic efficacy of multiple intranasal (IN) doses of ketorolac over 2 days. The secondary objective was to evaluate the safety and tolerability of this dosing regimen.