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NCT ID: NCT00697814 Completed - Clinical trials for Hypogonadotropic Hypogonadism

Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

Start date: June 2004
Phase: Phase 2
Study type: Interventional

Prolactinomas are usually associated with hypogonadotropic hypogonadism in both sexes. Clomiphene citrate is a well known selective estrogen receptor modulator that increases gonadotropin secretion via hypothalamic-pituitary action. We conducted a prospective, open label clinical trial of CC to evaluate its effects in reverting persistent HH in male patients with prolactinomas under dopaminergic agonist treatment.

NCT ID: NCT00697528 Completed - Graves' Disease Clinical Trials

Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy

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

Orbital Venous flow study in patients with Grave's Orbitopathy in different manifestation forms and stages, made with Color Doppler Imaging

NCT ID: NCT00696436 Completed - Hypertension Clinical Trials

An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With Essential Hypertension.

Start date: April 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to placebo, valsartan and olmesartan in participants with essential hypertension.

NCT ID: NCT00694629 Completed - Clinical trials for Pulmonary Tuberculosis

TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment

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

Protocol Synopsis The goal of this Phase 2 clinical trial is to evaluate the antimicrobial activity and safety of an experimental intensive phase (first 8 weeks of treatment) tuberculosis treatment regimen in which rifapentine is substituted for rifampin. Primary Objective - To compare the antimicrobial activity and safety of standard daily regimen comprised of rifampin (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (RHZE) to that of an experimental regimen comprised of rifapentine (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (PHZE). Secondary Objectives - To determine and compare for each regimen the time to culture-conversion, using data from 2-, 4-, 6-, and 8-week cultures (10, 20, 30, 40 doses). - To determine and compare for each regimen the proportion of patients with any Grade 3 or 4 adverse reactions - To determine the correlation of the MGIT/BACTEC liquid culture growth index and other mycobacterial and clinical biomarkers with time to culture conversion and treatment failure - To store serum for future assessment of biomarkers of TB treatment response and hypersensitivity to study drugs. - To compare adverse events and 2-month culture conversion rates among HIV-infected patients vs. HIV-uninfected patients - To determine the tolerability and safety, and estimate the antimicrobial activity, of experimental regimens that include isoniazid + pyrazinamide + ethambutol plus either rifapentine 15 mg/kg/dose or rifapentine 20 mg/kg/dose, all administered daily. Assessment of these doses of rifapentine will be performed as an extension to the main study after enrollment in the main study has been completed. Design This will be a prospective, multicenter, open-label clinical study. Adults suspected of having pulmonary tuberculosis who meet eligibility criteria will be randomized to receive either the experimental intensive phase tuberculosis treatment regimen or the standard intensive phase tuberculosis treatment regimen. Randomization will be stratified by presence/absence of cavitation on baseline chest radiograph, and by geographic continent. All doses of study drugs will be given under direct observation and administered 5 days per week. After a subject completes intensive phase therapy, he/she then will be treated with a non-experimental continuation phase tuberculosis treatment regimen. The study extension will be a prospective, multicenter clinical trial. Eligibility criteria will be the same as for the main study. Participants will be randomized to one of four regimens: the standard intensive phase treatment regimen, an investigational regimen in which rifapentine 10 mg/kg/dose is substituted for rifampin, an investigational regimen in which rifapentine 15 mg/kg/dose is substituted for rifampin, or an investigational regimen in which rifapentine 20 mg/kg is substituted for rifampin. Randomization will be stratified by the presence/absence of cavitation on baseline chest radiograph, and by study site. Study drugs will be administered 7 days per week. After a subject completes intensive phase therapy, he/she then will be treated with a non-experimental continuation phase tuberculosis treatment regimen. Subjects will have blood drawn for one pharmacokinetic determination of rifapentine concentration at or after the week 2 visit during intensive phase therapy. This study is being conducted in 2 phases. 1. The main study compares a 10 mg/kg dose of rifapentine, open label, against 10 mg/kg rifampin in an otherwise standard intensive phase regimen of treatment for pulmonary tuberculosis. The projected sample size was 480 enrollments; 530 patients were actually enrolled. 2. The study extension evaluates higher doses of rifapentine, with the specific rifapentine doses (10 mg/kg, 15 mg/kg, and 20 mg/kg) blinded to patients and clinicians, with data collection and endpoints otherwise similar to the main study. The projected sample size for the study extension is 320 enrollments.

NCT ID: NCT00694382 Completed - Cancer Clinical Trials

Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy

SAVE-ONCO
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.

NCT ID: NCT00694109 Completed - Clinical trials for Hypercholesterolemia

An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia

Start date: April 2008
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) clinical drug trials.

NCT ID: NCT00692770 Completed - Clinical trials for Carcinoma, Hepatocellular

Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)

STORM
Start date: August 15, 2008
Phase: Phase 3
Study type: Interventional

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).

NCT ID: NCT00691483 Completed - Smoking Cessation Clinical Trials

Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

Start date: September 2008
Phase: Phase 4
Study type: Interventional

The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

NCT ID: NCT00690768 Completed - Clinical trials for Diabetic Retinopathy

Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)

IBETRA
Start date: March 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.

NCT ID: NCT00690599 Completed - Satisfaction Clinical Trials

Socioeconomic Profile and Patient Satisfaction Assessment

Satisfaction
Start date: April 2006
Phase: N/A
Study type: Observational

The aim of the study was to evaluate the socioeconomic patient's profile and their level of satisfaction in the general dental practice clinic. A cross-sectional quantitative study was accomplished with 80 patients assisted at the referred service. A solely-applied questionnaire was used regarding the following aspects: structure and environment, fear and anxiety, reliability, empathy and commitment, resolutivity and quality of the accomplished services. It was observed that the assisted patients' profile consisted predominantly of a female sample (71,2%), that completed the medium learning (31,2%) and/or that didn't finish the fundamental level (26,2%). Moreover 50% of them presented a family income of 1 to 2 minimum salaries and 41,2% were unemployed. As the quality of the rendered technical service, nearly 70% of the users considered it great, as well as the clinic's structure and environment. Regarding the satisfaction with to the received treatment, 76,2% of the interviewees gave the maximum score of 10 and 95% would recommend the attendance to others. It is concluded that the patients are satisfied with the clinical attendance accomplished by the students in the general practice dental clinic at UNIFOR, in what refers to its technical and functional quality.