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NCT ID: NCT00144339 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients

Start date: December 2002
Phase: Phase 3
Study type: Interventional

The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.

NCT ID: NCT00144170 Completed - HIV Infections Clinical Trials

Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)

Start date: February 2003
Phase: Phase 3
Study type: Interventional

The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load > =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.

NCT ID: NCT00143650 Completed - Clinical trials for Upper Airway, Irritation Inflammation, Discomfort

SENOC-I Det Sunda Huset II - Sensitization of Occupants of Water Damaged Buildings.

Start date: January 2001
Phase: Phase 1/Phase 2
Study type: Interventional

The study is focussed on two main questions: 1. The importance of dampness of the building and home dust as a factor of the subjects= responses. 2. Can measures used in KLINIR predict the subjects’ responses to the dust? This study therefore was arranged to test the following hypotheses: 1. Does dust in general cause inflammatory/body perceptions through e.g. an irritation symptoms index. 2. Does the dust include effective odorants which affects an IAQ index? 3. Does dampness increase the content of organic or inorganic compounds e.g. of microbial origin that causes the dust to be more reactive? (Differences between the two types of dust) 4. Is the sensitivity of the subjects explaining the responses to exposures in a, b, or c? (Subject group and sensitivity index) As explorative investigations biomarkers for exposures and sensitivity for practical usage are tested.

NCT ID: NCT00143637 Completed - Discomfort Symptoms Clinical Trials

Dose Response Relations for Health Effects Caused by Office Dust

Start date: May 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The study is focused at the dose response relation for office dust and such office dust spiked with components from fungi known from damp buildings. The first aim of this study is to investigate if dust causes objective changes such as changes of lung function, nasal geometry, inflammatory indicators in tears and nasal lavage, tear film stability and cells at exposure levels relevant to indoor air. The controlled exposure variable is air concentration of office dust spiked with Glucan to simulate a worse case scenario. Aim 1: Confirm or support the causality between objective effects and exposures to dust spiked with Glucan with focus on inflammatory responses. This is done by negation of the hypothesis that no significant effects are found for the variables in question. Aim 2 is to estimate the thresholds and slopes of the DR relation for effect measures which show effects of exposures. At best the study will supply for each variable a zero response to clean air and three non-zero responses to dust. Thresholds and slopes are estimated graphically by linear regression or by an accumulated response model. Aim 3 is a confirmation that atopic persons and histamine sensitive persons in nasal provocation tests have different responses in the effect measures showing significant effects of exposures to dust spiked with Glucan. Risk group status is therefore included in the analyses of the main variables as explaining variable. Potential additional aim 4: Chemical and biological characterization of the office dust used in the study. Aim 4 is an investigation of dose response relations for explorative measures, which in previous investigations have showed indications of a dose response relation. For these no a priory hypotheses exists and the analyses must be arranged ad hoc. The explaining variables are exposure and risk group status. One challenge in investigations of unspecific effects caused by mixed exposures is that few specific objective effects measures are available and subjective measures have to be introduced. Therefore there is a need for developments of new objective measures of health effects of air pollution. Some of these are related to new biomarkers of respiratory effects in a bio-sample taken as condensed exhaled breath. Aim 5: Developments of new objective measures of health effects of air pollution. After the experiment it will be investigated by logistic regression if a sensitivity index can be established.

NCT ID: NCT00143403 Completed - Clinical trials for Colorectal Neoplasms

Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer

Start date: December 2001
Phase: Phase 3
Study type: Interventional

To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.

NCT ID: NCT00143286 Completed - Smoking Cessation Clinical Trials

A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

Start date: April 2003
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.

NCT ID: NCT00143052 Completed - Hirsutism Clinical Trials

Bone Status and Insulin Resistance in Hirsutism

Start date: January 2002
Phase: N/A
Study type: Observational

The purpose of this study is to investigate how the bones of hirsute women are different from bones of healthy women. The change in hormone content in the blood will also be investigated. The study can be used to evaluate whether it will be relevant to bone scan all newly referred hirsute women. Hirsute women are often over-weight and often have an increased amount of the male sex hormone in their blood. Their blood tests often show changes reminding of the ones seen in diabetic patients. All hirsute women referred to the department will undergo an investigation revealing the reason for the increased hair growth. The investigation includes clinical investigation (height, weight and degree of hair growth), blood tests (for hormone status and bone status analysis) and bone scanning of the abdomen (body composition). The trial includes a group of 50 strongly hairy women and a control group of 50 healthy women with normal hair growth. They are matched by body weight, since weight has great importance for the bone mineral content and thereby for osteoporosis in the long run.

NCT ID: NCT00141323 Completed - Osteoporosis Clinical Trials

Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

PEARL
Start date: November 2001
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.

NCT ID: NCT00141193 Completed - Colorectal Adenoma Clinical Trials

Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

PRESAP
Start date: February 2001
Phase: Phase 3
Study type: Interventional

This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.

NCT ID: NCT00141180 Completed - Clinical trials for Dermatitis, Allergic Contact

CP-481,715 Nickel Allergy Study.

Start date: September 2003
Phase: Phase 1
Study type: Interventional

To evaluate the suitability of contact allergy as a method for the evaluation of c-chemokine receptor-1 antagonist.