View clinical trials related to Observational.
Filter by:As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients who are treated with Soliris in normal clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Soliris under conditions of routine daily medical practice in Korea. This study will provide information on the population of Korean patients who are treated with Soliris.
The aim of the present study is to retrospectively investigate whether arthroscopic treatment in patients with TMD symptoms depending on internal derangement of the temporomandibular joint (TMJ) gives a satisfying result on the patient's quality of life. Based on previous studies it is hypothesized that patients suffering from TMD depending on internal derangement would through Patient Reported Outcome Measures (PROM) evaluate the treatment efficacy from an arthroscopic treatment as a benefit to their quality of life. Further, the study intends to find out if the patient reported outcome measures (PROM) on health-related quality of life (HRQoL) outcome correlates with clinical follow-up measures after arthroscopic treatment of internal derangement of the temporomandibular joint. The primary objective is to measure the correlation between the results from a HRQoL questionnaire and mouth opening. Secondary, the effect of mouth opening on HRQoL is being explored. The primary prediction variable is the surgical treatment. Outcome variables are treatment evaluation quality of life (PROM) based on a validated questionnaire; Jaw Functional Limitation Scale (JFLS), age, gender, time from diagnosis to treatment, severity of symptoms (pain, mouth opening ability) and time from treatment to evaluation.
Adenoviruses have been linked to severe hepatitis in children. They are non-enveloped, icosahedral viruses of medium size (90-100 nm) (5). Adenoviruses usually infect the respiratory tract, eyes, urinary tract, intestines, and central nervous system (6). These diseases are
To explore the genetic background of patients with HER2 positive breast cancer that benefit from trastuzumab combined with neoadjuvant chemotherapy, identify clinically actionable mutations that associated with trastuzumab resistance or drug efficacy, we designed this Observational phase II trial. The primary endpoint is genetic profile of HER2+ breast cancer patients treated with trastuzumab combined neoadjuvant chemotherapy. Secondary endpoints included pathological complete response (pCR) rate and safety.
A prospective, blinded multicenter study for evaluation of chest pain patients with severe coronary calcium (Agatston score > 399). The objective is to evaluate if an initial non-invasive strategy with coronary computed tomography angiography (CCTA) including functional flow reserve derived from CCTA (FFR-CT) is as effective as invasive coronary angiography (ICA) including functional flow reserve (FFR) for the detection and exclusion of obstructive coronary artery disease (CAD). Study hypothesis: initial non-invasive anatomic and functional testing is non-inferior to an invasive anatomic and functional testing strategy.
Prospective single arm, single center observational study to evaluate Quality of Life (Qol) after stereotactic body radiotherapy for patients with hepatocellular cancer. Patients will receive work-up, treatment and follow-up exclusively as routinely done except additional quality of life measurements. Qol will be measured by standardized and validated EORTC questionaires at different time points during routine follow-up.
This is a prospective observational study to follow a cohort of patients with Cystic Fibrosis and healthy controls for a period of two years. This study will include monitoring the subjects lung clearance index (by performing a breathing test called the multiple breath washout), as well as spirometry and their respiratory symptoms every three months as well as during a pulmonary exacerbation and after their recovery.
The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.
Purpose of this study is to determine whether keeping SAA on normal or near normal level will delay progression of renal failure in patients with amyloidosis secondary to FMF.
The purpose of this study is to reassure the clinical study data on atypical antipsychotics effect on quality of life in Korean Bipolar patients.