Cohort

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Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease (Study P05464)

Recruitment status: 
Recruiting

This study is being performed to evaluate what variants of lipid-lowering therapy are used in Russian clinical practice in CHD patients with hypercholesterolemia in whom the initial statin dose did not achieve LDL-C goals. Additionally, the efficacy and safety of all variants of modified lipid-lowering therapy are to be evaluated..

Background information
Trial ID: 
NCT00730132
Other unique IDs: 
P05464
Official title: 

Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease

Detailed description: 

Given the observational nature of this study and the assessment of a specific hypothesis is not foreseen, statistical assumption is not planned and the sample size calculation is not performed. Exploratory nature of this study makes not easy to estimate precisely the number of patients entered by physicians in different treatment arms. The treatment effects will be characterized by descriptive and frequency parameters.

Number to be enrolled: 
750 patients

Endoscopic Findings in Patients With Typical Gastroesophageal Reflux Disease (GERD) Symptoms

Recruitment status: 
Recruiting

Gastroesophageal reflux disease (GERD) is diagnosed on the basis of characteristic reflux symptoms (i.e. troublesome heartburn and/or acid regurgitation). Empirical therapy without diagnostic endoscopy is suggested for those GERD patients presenting without alarm symptoms in Western countries. Whether such "treating instead of testing" strategy should be applied in Asia, an area with higher prevalence of Helicobacter pylori and gastric cancer, remains uninvestigated.

Background information
Trial ID: 
NCT00730106
Other unique IDs: 
OMCP-97-017
Official title: 

Endoscopic Findings in Taiwan Patients Presenting With Characteristic Symptoms of Gastroesophageal Reflux Disease

Detailed description: 

This study amis to investigate upper endoscopic findings of typical acid reflux patients with and without alarm symptoms in Taiwan During the period from May 2008 to December 2009, consecutive adult outpatients, who receive upper endoscopy for characteristic reflux symptoms of heartburn or acid regurgitation, are invited to participate. All study participants are evaluated for presence of pre-defined alarm symptoms including odynophagia or dysphagia, gastrointestinal bleeding, involuntary body weight loss and anemia.

Number to be enrolled: 
1000 patients

Observational Study to Observe the Safety of NovoMix® 30 Treatment in Patients With Type 2 Diabetes

Recruitment status: 
Recruiting

This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.

Background information
Trial ID: 
NCT00729898
Other unique IDs: 
BIASP-3512
Official title: 

Safety of NovoMix® 30 (Biphasic Insulin Aspart) Treatment in Patients With Type 2 Diabetes

Detailed description: 

 

Number to be enrolled: 
1800 patients

Bone Mineral Density Substudy - An Ancillary Study to MTN-003

Recruitment status: 
Not yet recruiting

The MTN-003 HIV prevention study include the use of microbicides, substances that kill microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on bone mineral density (BMD).

Background information
Trial ID: 
NCT00729573
Other unique IDs: 
MTN-003B
Official title: 

Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women

Detailed description: 

The effect of tenofovir on bone mineral density (BMD) has not yet been studied and is of potential concern. The purpose of this study is to determine the changes in BMD among individuals receiving TDF and FTC/TDF compared with a placebo. This substudy will enroll individuals currently participating in MTN-003. The expected duration of participation for each participant is approximately 33 months. Study treatment will be provided by MTN-003. Study treatment will not be provided by this substudy. Study visits will occur every 6 months after enrollment.

Number to be enrolled: 
300 patients

Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial

This study focuses on the validation of the Adaptation Index instrument as a measurement of adaptive behaviors used to reduce symptoms of FI and to describe the use of adaptive behaviors among women with FI.

Background information
Other unique IDs: 
1J06-FI
U01 HD41249
U10 HD41250
U10 HD41261
U10 HD41267
U10 HD54136
U10 HD54214
U10 HD54215
U10 HD54241

Additional Positron Emission Tomography (PET) Scan of Brain in Patients Undergoing PET Scan for Diseases Unrelated to Brain

Specific Aims:

  • The primary objective is to delineate the brain structures that are involved in pain using Positron Emission Tomography (PET) imaging.

Hypothesis: Pain will result in increases in metabolism and neuronal activity in specific delineated areas of the brain.

Background information
Other unique IDs: 
08042105

The Bowel Research Collaborative Data Tracking System Implementation Study

The project's primary purpose is to establish a network of Hospice Palliative Care settings using a common and consistent method of assessing and documenting bowel functioning in order to be able to carry out future collaborative studies of constipation treatments. The secondary goal is to gather normative data on current bowel care function and outcomes of current treatments which can be used to determine sample size calculations for future controlled trials of bowel management protocols. In order to complete this goal the project requires a thorough assessment of current nursing practice in regard to bowel care.

Background information
Other unique IDs: 
H08-01321

A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading.

Recruitment status: 
Active, not recruiting

This prospective, multicenter study evaluates the performance of the Osseotite Prevail implant when to support a short fixed bridge with immediate occlusal loading, providing the patient with the use of a temporary prosthesis until the final prosthesis is made. Study (null) hypothesis: This is an observational study in which no concurrent control group will be observed. Results of the study will be compared with the performance of other Osseotite implants from published Osseotite multicenter studies.

Background information
Trial ID: 
NCT00728962
Other unique IDs: 
2208
Official title: 

A Prospective, Observational Study of Osseotite Certain IOL Implants in Immediate Occlusal Loading of Short Span Fixed Restorations

Detailed description: 

This is a prospective, observational study in which all the patients will have implants placed and a provisional prosthesis attached within 24 hours of implant surgery. Each restorative case will consist of a posterior short span fixed bridge of four implants or less. The final prosthesis will be placed within five months or implant placement surgery. Overall success will be determined on the basis of procedural success, prosthesis success, and implant success.

Number to be enrolled: 
8 patients
Acronym: 
Fireball

Study of Certain Prevail Implants Used to Treat All Types of Edentulism in the Maxilla and Mandible

Recruitment status: 
Active, not recruiting

This observational, prospective clinical study evaluates the performance of the Certain Prevail implant system to show potential crestal bone and soft tissue preservation following the crestal bone. It will also evaluate implant performance. Study (null) hypothesis: The preservation of crestal bone for the Certain Prevail implants will be the same as that for standard non-platform switched implants from contemporaneous studies (historical controls).

Background information
Trial ID: 
NCT00728884
Other unique IDs: 
2406
Official title: 

Observational Study of Certain Prevail Implant System in Maxillary and Mandibular Regions

Detailed description: 

This is a prospective, observational study of patients with partial or complete edentulism treated with the Certain Prevail dental implants. Restorations will consist of single tooth replacements, short and long fixed bridges, and overdentures and full dentures. All implants are placed using a single stage approach and temporalization occurring after two months of healing (early loading). Each center will strive to enroll a total of 15 patients.

Number to be enrolled: 
15 patients
Acronym: 
PrevailMulti

Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)(COMPLETED)

Recruitment status: 
Completed

Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.

Background information
Trial ID: 
NCT00728494
Other unique IDs: 
P04671
Official title: 

Evaluation of Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron / Rebetol in Conjunction With a Patient Assistance Program - Non Interventional Observational Study.

Detailed description: 

Non-Probability Sample, Commercial product used according to EU label.

Number to be enrolled: 
99 patients
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