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NCT ID: NCT00435240 Completed - Clinical trials for Diabetes Mellitus, Type 2

Paleolithic Diet in the Treatment of Diabetes Type 2 in Primary Health Care

Start date: January 2005
Phase: Phase 2
Study type: Interventional

There is uncertainty about the optimal diet in the prevention and treatment of diabetes type 2. Earlier studies have generally focused on intakes of fat, protein, carbohydrate, fiber, fruit and vegetables. This study is based on another approach which compares foods that were available during human evolution with more recently introduced ones. The basic tenet from evolutionary biology is that if human physiology is less adapted to a relatively recently introduced diet based on agriculture, this could cause disturbances to human physiology and ultimately lead to diseases. Epidemiological studies indicates that diabetes mellitus type 2 is absent or near absent in populations eating a Palaeolithic ("Old Stone Age") diet which is free from food items produced in agriculture or the food industry. Our study hypothesis is that a Palaeolithic diet is better than the standard diabetes diet recommended today in treating diabetes type 2. Fifteen patients with diabetes type 2 have been randomized to 1. a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts 2. a standard diabetes diet as recommended by national health authorities. The patients eat the diet they have been randomized to for three months and then switches to the other diet for another three months. The study is conducted in Primary Health Care stations.

NCT ID: NCT00435162 Completed - Hypertension Clinical Trials

Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure

Start date: March 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure [SSBP] ≥ 95th percentile ).

NCT ID: NCT00434577 Completed - Herpes Zoster Clinical Trials

Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects

Start date: February 14, 2007
Phase: Phase 2
Study type: Interventional

Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 & 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period. No new subjects will be enrolled during the extension phases of the study.

NCT ID: NCT00433836 Completed - Hypertension Clinical Trials

Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure

Start date: January 2007
Phase: Phase 3
Study type: Interventional

The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).

NCT ID: NCT00433290 Completed - Clinical trials for Osteoarthritis Knee Pain

Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

Start date: February 2007
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.

NCT ID: NCT00433212 Completed - Clinical trials for Respiratory Insufficiency of Prematurity

Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)

NIPPV
Start date: April 2007
Phase: Phase 3
Study type: Interventional

The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine. Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy. The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?

NCT ID: NCT00432575 Completed - Smoking Cessation Clinical Trials

Efficacy and Safety of Surinabant Treatment as an Aid to Smoking Cessation (SURSMOKE)

Start date: January 2007
Phase: Phase 2
Study type: Interventional

Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which might be clinically useful in the treatment of dependence to nicotine. The primary study objective is the assessment of efficacy of 3 doses of surinabant on abstinence from smoking in cigarette smokers. The main secondary objectives are the effect of surinabant on body weight and its clinical and biological safety.

NCT ID: NCT00431678 Completed - Pneumonia Clinical Trials

Efficacy and Safety of Sequential IV/PO Moxifloxacin in Comparison to IV Levofloxacin Plus IV Ceftriaxone Followed by PO Levofloxacin, in the Treatment of Patients With Community-acquired Pneumonia

Start date: January 2004
Phase: Phase 3
Study type: Interventional

Sequential therapy with intravenous to oral moxifloxacin, was tested at 69 study centres in 17 countries to determine if this treatment regimen is safe and effective in treating hospitalized adult patients with community-acquired pneumonia. 748 patients were participated in the study over an 18 months period. Individual patient involvement in the study was approximately 4-6 weeks. Moxifloxacin was compared to a combination treatment regimen of high dose intravenous ceftriaxone plus high dose intravenous levofloxacin followed by high dose oral levofloxacin.

NCT ID: NCT00431132 Completed - Menopause Clinical Trials

Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

Start date: January 2007
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

NCT ID: NCT00430352 Completed - Clinical trials for Non-Hodgkin's Lymphoma

MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

Start date: September 2006
Phase: Phase 4
Study type: Interventional

This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.