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NCT ID: NCT01450332 Recruiting - Clinical trials for Anterior Cruciate Ligament Rupture

Safety and Efficacy of the Knee-T-nol Anterior Cruciate Ligament (ACL) Prosthesis

Start date: March 2011
Phase: N/A
Study type: Interventional

The study is designed to evaluate the safety and efficacy of implanting the Tavor ACL prosthesis in patients with a ruptured ACL by improvement of healing kinetics as well as major adverse treatment events (AEs). it is designed to test the hypothesis that there is a difference in healing kinetics of ACL deficient knees treated by ACL reconstruction using autografts and those in which such procedure was performed with the Tavor prosthesis.

NCT ID: NCT01450254 Completed - Hip Osteoarthritis Clinical Trials

Effects of Foot Center of Pressure Manipulation on Hip Osteoarthritis Patients During Gait

Start date: August 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to: 1. Analyze the short-term effects of external center of pressure manipulation of the foot in idiopathic hip osteoarthritis patients during gait on: 1. Gait parameters (spatiotemporal, kinematic, and kinetic) 2. Muscle activation patterns of the lower limbs and back 2. Analyze the long-term effects (during the period of one year) of external center of pressure manipulation of the foot in idiopathic hip osteoarthritis patients during gait on: 1. Gait parameters (spatiotemporal, kinematic, and kinetic) 2. Motor learning and muscle activation patterns 3. Energy consumption 4. Pain, physical function, and quality of life The hypotheses of the study, in reference to the aforementioned study objectives are: 1. Changes in foot center of pressure will have an immediate effect on gait parameters and muscle activation patterns of the lower limbs and back. 2. Long-term manipulation of foot center of pressure, as a result of a year-long rehabilitation program using the AposTherapy Biomechanical System, will result in improvement in gait parameters, changes in muscle activation patterns as a result of new motor learning, improvement in energy consumption, decrease in pain, improvement in physical function, and improvement in quality of life.

NCT ID: NCT01450241 Withdrawn - Febrile Neutropenia Clinical Trials

Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia

Start date: January 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer patients with febrile neutropenia.

NCT ID: NCT01449292 Terminated - Pulmonary Emphysema Clinical Trials

Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

ASPIRE
Start date: June 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.

NCT ID: NCT01449175 Terminated - Emphysema Clinical Trials

A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

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

The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.

NCT ID: NCT01448889 Recruiting - Nephropathy Clinical Trials

Normobaric Hyperoxygenation for Prevention of Contrast Induced Nephropathy

Start date: September 2009
Phase: N/A
Study type: Interventional

Acute renal failure induced by radiographic contrast agents is a known complication of coronary angiography.hypoxia plays a major role in the pathogenesis of Contrast induced nephropathy. The aim of the current study is to investigate the effect of normobaric hyperoxygenation therapy on renal functions in patients at high risk for CIN undergoing coronary angiography. The study is aimed to include 180 consecutive patients with estimated GFR base on the MDRD equation of less than 60 mL/min/1.73 m2 that are candidates for elective coronary angiography. Patients with acute renal failure, acute myocardial infarction, noncompensated congestive heart failure, hemodynamic instability, known sensitivity to contrast media and patients who had been exposed to contrast media during the last 3 months will be excluded. Patients with oxygen blood saturation of less than 94% at room air will also be excluded from the study. Study protocol Patients will be randomly assigned to receive either 100% oxygen by mask (treated group) or breath room air (control group) for duration of 4 hours starting at the beginning of the angiographic procedure. All patients will be treated with 0.9% salin and NAC. Coronary angiography will be performed using nonionic, low osmolar iodine (Ultravist®-370) (Schering, Berlin, Germany). All patients will be hospitalized 1 day before and at least 24 hours following angiography. Blood samples for urea, creatinine and cystatin- C will be drawn on admission, 6, 24 and 48 hours after coronary angiography. Urine sample will be taken 24 hours before angiography and 6, 24 and 48 hours post angiography. In those urine samples the ratio between creatinine to Isoprostanes and NO will be evaluated.

NCT ID: NCT01448707 Completed - Clinical trials for Human Immunodeficiency Virus (HIV) Infections

A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment

PROTEA
Start date: March 15, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function will be compared throughout the study.

NCT ID: NCT01448499 Withdrawn - Schizophrenia Clinical Trials

Clozapine Versus Amisulpride in Treatment-resistant Schizophrenia Patients

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

Background: schizophrenia is a debilitating mental disorder affecting about 1% of the general population. About 30% of patients will not react to current drug treatment and defined as treatment-resistant schizophrenia patients (TRSP). The best studied therapeutic option for this population is clozapine therapy. Clozapine was shown to be effective than any other antipsychotic drug in TRSP. Moreover, augmentation of clozapine was not demonstrated to be more effective than clozapine monotherapy. Albeit Clozapine superiority in TRSP, its use may be involved with many adverse effects, some of them are life-threatening, and need for routine blood tests. Amisulpride is an atypical antipsychotic drug with a different mechanism of action than clozapine, with less adverse effects. No study compared directly amisulpride and clozapine in TRSP. Study objective: to compare, for the first time, the broad clinical effectiveness of clozapine and amisulpride and their combination in TRSP. Study Design: a clinical, prospective, naturalistic, randomized, comparative study simulating a real-world approach of clinical decision making. Methods: a total of 140 TRSP will be recruited from a large regional mental health center. Participants will be randomized into two treatment groups (70 in each group): clozapine monotherapy and amisulpride monotherapy. Assessment will be done following 10 and 20 weeks of treatment. In case of treatment failure (insufficient clinical response or severe adverse effect) participants will be offered either to switch to clozapine treatment (for failed amisulpride treatment) or to augment clozapine with amisulpride (for failed clozapine monotherapy patients). Thereafter, participants will be followed-up for a year. Assessment will be made using clinician rated scales and self-completed questionnaires, rating the broad phenomenology of schizophrenia (psychosis, mood, anxiety, obsessive-compulsive, cognitive and quality of life) and drug-related adverse effects (objective and subjective). Analysis: comparison of the effectiveness of the three treatment groups: amisulpride, clozapine and their combination, in the various dimensions of TRSP.

NCT ID: NCT01448382 Terminated - Upper GI Bleeding Clinical Trials

Evaluation of PillCam With Blood-Sensing Feature: A Feasibility Study

Start date: October 2011
Phase: Phase 1
Study type: Interventional

1. Primary Scientific Objective - Collect human clinical data to sustain the development of blood detection sensor and optimize its algorithm and parameters - Preliminary evaluation of blood detection performances in human. 2. Secondary Scientific Objective - Assessment of blood detection sensor ability to identify the anatomical location (i.e. Stomach, SB or Colon) - Evaluation of capsule transit characteristics in the GI tract - Evaluation of BBC capsule safety Study Hypothesis: It is estimated that by implementing a spectrophotometer technology in capsule and utilizing the unique characteristics of light absorption by blood in specific spectrum, the capsule will be able to automatically detect blood in the GI tract with high accuracy. As such, the system may be an add-on to video capsules to provide efficient and quick detection of blood presence (for example in OGBI patients) or as stand alone low cost capsule (without video) which could serve as a tool similar to standard FOBT.

NCT ID: NCT01448252 Completed - Multiple Sclerosis Clinical Trials

T Cell Vaccination in Patients With Progressive Multiple Sclerosis

Start date: May 2002
Phase: Phase 1/Phase 2
Study type: Interventional

This is a double blind phase I-II clinical trial with multiple autologous T cell vaccinations using T cell lines reactive to 9 different myelin peptides of MBP, MOG and PLP, in patients with relapsing progressive Multiple Sclerosis.