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NCT ID: NCT01461928 Completed - Clinical trials for Non-Hodgkin's Lymphoma

A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab

MabCute
Start date: December 20, 2011
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter [mg/m^2] intravenously [IV] in Cycle 1, then 1400 mg subcutaneous [SC] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first.

NCT ID: NCT01460732 Completed - Hypertension Clinical Trials

Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers

Start date: November 2010
Phase: N/A
Study type: Interventional

This is a cross-sectional study, including adults, either untreated for hypertension, or under stable treatment for more than four weeks. Assessment will include: Clinic blood pressure measurements with an automated oscillometric device, 24-hour ambulatory blood pressure monitoring Home blood pressure monitoring during morning, evening and nocturnal measurements with the same device.

NCT ID: NCT01460277 Completed - Hemiplegics Clinical Trials

Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients

hydro
Start date: October 2011
Phase: N/A
Study type: Interventional

The purpose of this current prospective study is to assess and compare the effects of a hydrotherapy exercise programme against a conventional land-based exercise programme in individuals with hemiplegia. Both exercise interventions aim at improving posture, balance and weight-bearing capability. Patients were randomized to the hydrotherapy or conventional therapy groups according to balance function (Berg Balance Scale score) and age (age<59 and >60 years). The physical examination consisted of (1) a lower-limb motor function recovery of the paretic side score according to the 6-stage Brunnstrom scale, (2) the hemiplegic limb strength measured by the Motricity Index, (3) the strength of ankle dorsiflexors and plantarflexors by manual muscle testing, (4) the spasticity of the ankle score by Modified Ashworth Scale, (5) the trunk function through the Trunk Control Test, (6) the postural control assessed by Postural Assessment Scale for Stroke Patients and (7) the functional status measured with the Functional Independence Measure. Postural sway was evaluated with a pressure platform by using the variables of center of pressure (COP) displacements in the mediolateral (ML) and anteroposterior (AP) directions. The results will be collected and evaluated using statistical programme SPSS.

NCT ID: NCT01454284 Completed - Clinical trials for Diabetes Mellitus, Type 1

A Study in Participants With Type I Diabetes Mellitus

IMAGINE 3
Start date: January 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is: - To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. - To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment. - To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment. - To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment

NCT ID: NCT01452919 Completed - Schizophrenia Clinical Trials

A Physical Dependence Study in Schizophrenia

Start date: November 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether or not people with schizophrenia who take LY2140023 become physically dependent on it, and experience a series of symptoms such as craving to have the drug when they stop using it. This trial consists of two phases: An open-label phase consisting of up to 4 weeks and a double-blind phase consisting of up to 3 weeks.

NCT ID: NCT01448837 Completed - Glaucoma Clinical Trials

24-Hour Intraocular Pressure Control With Bimatoprost/Timolol Versus Latanoprost as First Choice

Start date: April 2010
Phase: Phase 4
Study type: Interventional

The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan) administered once in the evening (20:00) in newly-diagnosed patients with exfoliation syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated and IOP greater than 29 mm Hg.

NCT ID: NCT01448408 Completed - Keratoconus Clinical Trials

Corneal Biomechanical Properties and Anterior Segment Parameters, in Forme Fruste Keratoconus

Start date: May 2007
Phase: N/A
Study type: Observational

The present study attempts to evaluate the diagnostic capacity of a) anterior segment parameters b) biomechanical metrics and c) a combination model, in differentiating Forme Fruste Keratoconus (FFK) from healthy corneas. The study adhered to the tenets of the Declaration of Helsinki and written informed consent was given by all participants. The study was conducted at the Eye Institute of Thrace (ΕΙΤ), in Alexandroupolis, Greece. EΙΤ is a Democritus University research institute focusing primarily on the conditions of the anterior segment of the eye. All participants underwent a complete clinical evaluation including review of medical history, visual acuity measurements, uncorrected and best corrected visual acuity, placido disc topography, Scheimpflug camera measurements, ORA measurements , slitlamp biomicroscopy and fundoscopic examination. All study participants were divided in two groups. The FFK group (FFKG) consisted of patients with unilateral KC. The control group (CG) was formed by refractive surgery candidates who visited EIT's outpatients service for their preoperative examination. CRF and CH parameters were obtained while the patient was sitting on a chair in front of the Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY, USA) device. Upon successful fixation of the patient's eye on a red blinking target, the operator activated the device. An air puff was released by a non-contact probe, which scanned the central area of the eye and sent a signal to the ORA. In brief, the air puff causes the cornea to move inward, past applanation, and into slight concavity. After milliseconds, the air pumps shut off, the pressure decreases, and the cornea begins to return in its normal state. The system monitors the entire process and measures two pressure values, which are determined from the inward and outward applanation processes. The aforementioned measuring procedure enables the determination of CH which is related to the viscoelastic structure of the corneal tissue, and is calculated as the difference between the two pressure values at the two applanation processes, and CRF which is indicative of the overall resistance of the cornea and is calculated as a linear function of the two pressures associated with the two applanation. In order to ensure accurate results, ORA was done four times for each eye, by the same operator. Signals that differ significantly in appearance from the other signals from the same eye were deleted. Corneal Astigmatism (Cyl), Anterior Chamber Depth (ACD), Corneal Volume at 3mm (CV3), at 5mm (CV5), and overall (CV), Central Corneal Thickness (CCT), Thinnest Corneal Thickness (TCT) and TCT co-ordinates (TCTx, TCTy) were obtained using Pentacam. KISA index was calculated using Pentacam derived topography. Pentacam is based on a rotating Scheimpflug camera and monochromatic slit light source (a blue light emitted diode at 475 nm) which rotate together. After proper alignment of the patient's head, a fixation target is shown which guides the patients gaze. A real time image of the patient's eye is shown to the examiner on the computer screen, and the image is manually focused and centered. Acceptable maps had at least 10.0mm of corneal coverage. Moreover, images with extrapolated data in the central 9.0mm zone were excluded. Regarding the measuring procedure itself, patients were asked to blink and then look at the fixation device. In case of low-quality image, the procedure was repeated until the acceptable criteria were met. The data from the FFKG were compared with those from the CG in separate series analyses. Receiver operating characteristics (ROC) curves were applied to determine the overall predictive accuracy of the test for each studied parameter, as described by the area under the curve. We also used this approach to identify the cut-off points for studied parameters to maximize sensitivity and specificity in discriminating FFK cases from normal corneas. Logistic regression was used to support the cut-off point identified in the ROC curve analysis. We determined a cutoff value that will gave us the best predictive fit for our sample data. Furthermore, logistic regression analysis was performed to determine the predictive capability of a model that combined both corneal biomechanical properties and pentacam derived anterior segment parameters. Differences between groups were evaluated using the Welch modified Student's two sample t-test and Mann-Whitney U test, according to normality of distribution for each parameter. A Kolmogorov-Smirnov test of normality was applied to all variables of each group. The level of significance for each parameter was set at p<0.05. The Pearson and Spearman tests were performed in order to assess correlations between anterior segment parameters and biomechanical properties, depending on their parametric evaluation.

NCT ID: NCT01448044 Completed - Hepatitis C Clinical Trials

Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

Start date: December 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

NCT ID: NCT01447446 Completed - Clinical trials for Hepatitis C, Chronic

An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

Start date: September 2011
Phase: N/A
Study type: Observational

This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of peginterferon alfa (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in patients with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from patients receiving treatment according to current Summary of Product Characteristics and local labeling for the duration of their treatment and a 24-week follow-up.

NCT ID: NCT01444456 Completed - Breast Cancer Clinical Trials

Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia

Start date: October 2011
Phase: N/A
Study type: Observational

This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia. Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL