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NCT ID: NCT00831363 Completed - Clinical trials for Total Hip Arthroplasty

Minimal Invasive Versus Traditional Transgluteal Approach in Total Hip Arthroplasty: a Comparative Gait Analysis

Start date: n/a
Phase: N/A
Study type: Observational

The hypothesis for the present study was that patients receiving a minimally invasive total hip arthroplasty will show a faster improvement on walking ability and mobilization in the immediate postoperative period compared to patients with the standard Hardinge approach. Therefore, the main goal was to evaluate the differences in early rehabilitation of these two different surgical approaches by gait analysis and electromyographical examination as objective methods.

NCT ID: NCT00836316 Completed - Pain Clinical Trials

Levobupivacaine During Cholecystectomy

Start date: n/a
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the effects of intraperitoneal administration of levobupivacaine on pain after laparoscopic cholecystectomy.

NCT ID: NCT00842322 Completed - Clinical trials for Kidney Transplantation

Fluid Intake in Kidney Failure

Start date: n/a
Phase: N/A
Study type: Interventional

Patients with renal impairment are usually advised to increase their fluid intake. There is currently, however, no evidence supporting this recommendation. In contrast,high fluid intake could be dangerous if urine excretion is reduced. In this study the researchers investigate whether increasing fluid intake from 2 to 4 litres per day has any influence on long-term renal outcome.

NCT ID: NCT00842972 Completed - Type 2 Diabetes Clinical Trials

Is Carotid Intima-media Thickness Affected by A1C Variability?

Start date: n/a
Phase: N/A
Study type: Observational

This study was conducted to evaluate the effect of A1C variability on the progression of carotid artery intima-media thickness in type 2 diabetic patients.

NCT ID: NCT00847041 Completed - Clinical trials for Chronic Rhinosinusitis

Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis.

Start date: n/a
Phase: N/A
Study type: Observational

The purpose of this study is to compare the bacteria, fungi, and viruses that are present in the sinuses of patients with chronic rhinosinusitis to patients without sinus disease using a new technology, called a microarray, that will allow more accurate identification of microorganisms than current laboratory methods.

NCT ID: NCT00850512 Completed - Clinical trials for Diffuse Large B-Cell Lymphoma

Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) in Elderly (More Than 60 Years) Patients With Diffuse Large B Cell Lymphoma After 4 Cycles of CHOP21-Rituximab (CHOP21-R) Therapy

CHOP21+R-Z
Start date: n/a
Phase: Phase 2
Study type: Interventional

Study phase: Phase II Investigational product, dosage, and route of administration: Ibritumomab tiuxetan ("Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan. To prepare the active therapeutic agent [90Y]-ibritumomab tiuxetan, the antibody is chelated with the β-emitter yttrium-90 chloride immediately before intravenous administration. Treatment with [90Y]-ibritumomab tiuxetan is preceded by an infusion of rituximab (Rituxan, Mabthera) in order to optimize the biodistribution of radiolabeled antibody by depleting CD20 positive B-cells. Rituximab is a chimeric human/murine IgG1 monoclonal antibody. The Zevalin study regimen is given as an infusion of rituximab 250 mg/m2 and (where biodistribution imaging or dosimetry is compulsory) 185 MBq (5mCi) of [111In]-ibritumomab tiuxetan on Day 1 followed 7 to 9 days later by a single dose of 14.8 MBq/kg (0.4 mCi/kg) of [90Y]-ibritumomab tiuxetan, maximal dose of 1184 MBq (32 mCi), preceded by 250 mg/m2 of rituximab. Reference product, dosage, and route of administration: Not applicable Indication: stage II-IV diffuse large B-cell lymphoma (DLBCL) patients after 4 cycles of CHOP21-Rituximab (CHOP21-R) Study objectives: Evaluation of efficacy and safety of [90Y]-ibritumomab tiuxetan, as well as assessment of quality of life Patient population: Patients more than 60 years-of-age with DLBCL after 4 cycles of treatment with CHOP21-R Study design: Prospective, multicenter, open-label study designed to treat patients with a sequential front-line treatment represented by: 4 cycles CHOP21-R plus Zevalin Duration of treatment: Four months for CHOP21-R and two treatment days one week apart followed by a 12-week safety period for Zevalin Duration of study: Estimated duration of study is 18 months Methodology: Primary efficacy parameter: Overall response rate and complete response rate. Secondary efficacy parameters: Overall survival, disease-free survival, health-related quality of life. Safety parameters: Vital signs, adverse events (AEs), hematology, blood chemistry, and immunoglobulin levels Number of study centers: Planned total of 10 study centers in Italy Total number of patients, statistical rationale provided: Expected total of approximately 55 patients. The final sample size is based on the number of events observed for the primary efficacy endpoint as calculated in the sequential statistical model. Adverse events: AEs observed, mentioned upon open questioning and/or spontaneously reported will be documented. Planned start and end of recruitment: Start of recruitment: 19/12/2006. End of recruitment: 04/11/2008. Manufacturer(s) of the investigational /reference product(s): Ibritumomab tiuxetan is manufactured by Biogen IDEC, San Diego, CA and Cambridge, MA, USA. The isotopes yttrium-90 will be provided by European suppliers. There is no reference product in this study.

NCT ID: NCT00851708 Completed - Clinical trials for Deceased Kidney Transplantation

Impact of N-Acetylcysteine on Oxidative Stress and Renal Function in Deceased Kidney Transplant Recipients

Start date: n/a
Phase: N/A
Study type: Interventional

The aim of this interventional, prospective, randomized clinical trial is to evaluate the impact of the antioxidant N-acetylcysteine on oxidative stress in the first seven postoperative days and on renal function in the first three postoperative months in deceased kidney transplantation.

NCT ID: NCT00858741 Completed - Pain Clinical Trials

Palliative Radiotherapy for Bone Metastases: Single Versus Multiple Fractions.

Start date: n/a
Phase: Phase 3
Study type: Interventional

The aim of the investigators study was to determine whether 8 Gy in a single fraction provides equivalent pain and narcotic relief compared to 30 Gy in 10 fractions for patients with painful bone metastases. The secondary objectives were to evaluate the frequency, duration of pain relief, narcotic relief, toxicity and the effect on quality of life measures for each of the two treatment arms.

NCT ID: NCT00859001 Completed - Follicular Lymphoma Clinical Trials

Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) Study in Patients With Follicular Grade I-II Lymphoma After 4 Cycles of Fludarabine-Mitoxantrone-Rituximab (FMR) Therapy

FM+R-Z
Start date: n/a
Phase: Phase 2
Study type: Interventional

Study phase: Phase II Investigational product, dosage, and route of administration: Ibritumomab tiuxetan (Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan. To prepare the active therapeutic agent [90Y]-ibritumomab tiuxetan, the antibody is chelated with the β-emitter yttrium-90 chloride immediately before intravenous administration. Treatment with [90Y]-ibritumomab tiuxetan is preceded by an infusion of rituximab (Rituxan, Mabthera) in order to optimize the biodistribution of radiolabeled antibody by depleting CD20 positive B-cells. Rituximab is a chimeric human/murine IgG1 monoclonal antibody. The Zevalin study regimen is given as an infusion of rituximab 250 mg/m2 and (where biodistribution imaging or dosimetry is compulsory) 185 MBq (5mCi) of [111In]-ibritumomab tiuxetan on Day 1 followed 7 to 9 days later by a single dose of 14.8 MBq/kg (0.4 mCi/kg) of [90Y]-ibritumomab tiuxetan, maximal dose of 1184 MBq (32 mCi), preceded by 250 mg/m2 of rituximab. Indication: stage II-IV follicular lymphoma (FL) grade I-II after 4 cycles of FMR Study objectives: Evaluation of efficacy and safety of [90Y]-ibritumomab tiuxetan, as well as assessment of quality of life Patient population: Patients with after 4 cycles of treatment with FMR Study design: Prospective, multicenter, open-label study designed to treat patients with a sequential front-line treatment represented by 4 cycles FMR plus Zevalin Duration of treatment: Four months for FMR and two treatment days one week apart followed by a 12-week safety period for Zevalin Duration of study: Estimated duration of study is 18 months Primary efficacy parameter: Overall response rate and complete response rate Secondary efficacy parameters: Overall survival, Disease-free survival, health-related quality of life. Safety parameters: Vital signs, adverse events (AEs), hematology, blood chemistry,and immunoglobulin levels Number of study centers: 4 study centers in Italy T otal number of patients, statistical rationale provided: Expected total of 55 patients. The final sample size will be based on the number of events observed for the primary efficacy endpoint as calculated in the sequential statistical model. Adverse events: AEs observed, mentioned upon open questioning and/or spontaneously reported will be documented. Planned start and end of recruitment: Start of recruitment: 3rd quarter 2006. End of recruitment: 1st quarter of 2007

NCT ID: NCT00863005 Completed - Atopic Dermatitis Clinical Trials

Assessment of the Effects on Barrier Impairment, Clinical Features and Bacterial Colonization of Topical Formulations in Patients With Atopic Eczema; a Phase IIa, Single-center, Randomized, Observer-blind Study

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is the assessment of the barrier impairment, clinical skin condition and bacterial colonization status in patients with atopic eczema following topical treatment with K201 cream and a comparator twice daily over a 4-week treatment period.