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NCT ID: NCT00993551 Completed - Cleft Palate Clinical Trials

Timing of Primary Surgery for Cleft Palate

TOPS
Start date: July 2010
Phase: N/A
Study type: Interventional

This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil. 650 infants with a diagnosis of isolated cleft palate who are considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and randomised to receive either: - Surgery at age 6 months, OR - Surgery at age 12 months. The main objective is to determine whether surgery for cleft palate, using a Sommerlad technique, at age 6 months, when compared to surgery using the same technique at age 12 months, improves velopharyngeal function at age 5 years. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes( at age 5 years) and secondary outcomes.

NCT ID: NCT00993473 Completed - Clinical trials for Type 1 Diabetes Mellitus

6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes

PRESCHOOL
Start date: October 2009
Phase: Phase 3
Study type: Interventional

The primary study objective was to compare the rate of "all hypoglycemia" (composite outcome of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG), low FSBG readings performed at other times) between children treated with Lantus (insulin glargine) and Neutral Protamine Hagedorn (NPH) insulin. Secondary objectives were to compare insulin glargine and NPH in terms of: - rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia - HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment - percentage of patients reaching HbA1c less than 7.5% (target value) at end of treatment - average blood glucose over whole trial and at end of trial, as estimated by continuous glucose monitoring (CGM), and blood glucose variability

NCT ID: NCT00992823 Completed - Anemia Clinical Trials

Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure

Start date: March 2006
Phase: N/A
Study type: Interventional

Aim: To evaluate the efficacy of iron supplements given at intervals corresponding to the mean life of red blood cells compared to weekly supplementation, in reducing the prevalence of preschool anemia. Method: Ninety-nine children from public day care centers with ages from 24 to 59 months old were randomly divided into two groups. All the children received 40 doses of 30 mg of ferrous sulfate during a 10-month intervention period. Group 1 received once weekly supplementation and Group 2 received supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.

NCT ID: NCT00992524 Completed - Labor, Induced Clinical Trials

Oral Titrated Misoprostol for Induction of Labour

OTISMISO
Start date: November 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to compare effectiveness and safety of an oral titrated solution of misoprostol with vaginal misoprostol for induction of labour with an alive fetus.

NCT ID: NCT00992368 Completed - Cost-effectiveness Clinical Trials

Cost-effectiveness of Reduction Mammaplasty

Start date: July 2008
Phase: N/A
Study type: Interventional

Several works show breast hypertrophy as pain cause, postural alterations, dermatitis and decrease of the functional capacity and of the self-esteem. The economical evaluations are destined to esteem the costs in alternative ways of attendance to the health, comparing, for instance, clinical strategies with surgical strategies. OBJECTIVE: To analyze cost-effectiveness in reduction mammaplasty.

NCT ID: NCT00992043 Completed - Diabetes Clinical Trials

Creatine Supplementation and Diabetes

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

Creatine supplementation is capable of improving glucose tolerance in healthy subjects. The researchers aim to investigate whether this supplement can affect metabolic control in diabetic patients.

NCT ID: NCT00991848 Completed - Chronic Pain Clinical Trials

Lidocaine on Manifestations of Fibromyalgia

LIMAFIBRO
Start date: January 2005
Phase: Phase 1
Study type: Interventional

Background and Objectives: Fibromyalgia is a pain syndrome characterized by numerous manifestations. The objective of this study was to evaluate the effect of the combination of intravenous lidocaine and amitriptyline on the manifestations of fibromyalgia. Methods: A prospective, randomized, double-blind, comparative study was conducted. All patient received 25 mg amitriptyline. Patients of group 1 (n = 15) received 125 mL 0.9% saline, and patients of group 2 (n = 15) received 240 mg lidocaine in 125 mL 0.9% saline once a week for 4 weeks. Manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a verbal numerical scale.

NCT ID: NCT00991042 Completed - Interleukines Clinical Trials

Study of Cytokines Serum Levels in Chronic Low Back Pain

cytokine
Start date: August 2003
Phase: Phase 1
Study type: Interventional

The purpose of this study is to: - evaluate if there is an association between elevated levels of cytokines and chronic pain due to herniated disk disease - measured cytokines levels in chronic low back pain and in healthy subjects.

NCT ID: NCT00990041 Completed - Periodontitis Clinical Trials

Release of Cytokines by Stimulated Peripheral Blood Mononuclear Cells (PBMC) From Chronic Periodontitis Subjects

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

Background and Objective: It has been reported that peripheral blood mononuclear cells (PBMC) from periodontal patients have a different profile of cytokine release when compared to the ones of healthy patients. Cigarette smoking is a recognized risk factor for periodontitis and is known to affect the systemic and local immune responses. Thus, the aim of the present study was to obtain preliminary data about the interaction of periodontal condition and smoking in the secretion of some cytokines by PBMC. Material and Methods: PBMC samples were isolated from 19 donors, divided into generalized chronic periodontitis (P; n=10) and periodontal health (H; n=9) groups. In addition, the smokers and non-smokers of each group were separately evaluated: SP- smokers with severe generalized chronic periodontitis (n=5); SH- periodontally healthy smokers (n=5); NSP- non-smokers with severe generalized chronic periodontitis (n=5) and NSH- periodontally healthy non-smokers (n=4). Cells were incubated for 24-48 hours in 500 µL wells containing RPMI 1640 and stimulated with 1.0 ng/mL of E. coli LPS. Supernatants were used to quantify the amounts of TNF-α, IL-6, IL-8 and IL-10 released using ELISA kits.

NCT ID: NCT00989885 Completed - Sleep Apnea Clinical Trials

ESS as a Diagnosis Resource Aid of the Syndrome of Obstructive Sleep Apnea

Start date: January 2007
Phase: N/A
Study type: Observational

The aim of this study was to analyze the effectiveness of the Epworth's sleepiness scale as a recourse aid in the diagnosis of the syndrome of obstructive sleep apnea. 475 patients attended this study, that sought the CESF to probable diagnosis of some sleep disorder. The data were collected from records, wich are of questionnaires, including the ESE, prepared by the CESF professionals and responded, previously, by the own patients. The study compared the result obtained in the scale of Epworth with the data of polysomnography. The analysis of data was performed using the SPSS, based on descriptive and inferential statistics, being used the average considering the standard deviation, and, to the crossing of variables, was used the chi-square test of Pearson, considering as significant statistically values of p<0.05. The results showed that gender, age and BMI are predisposing factors to SOSA.