Clinical Trials About "FDAnews Announces Five Case Studies Using E2500 Approach" RSS

02:17 EST 20th January 2019 | BioPortfolio

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Showing "FDAnews Announces Five Case Studies Using E2500 Approach" Clinical Trials 1–25 of 7,800+


Optimal Approach for Analysis of Case-Control Genetic Association Studies

The purpose of this study is to examine the effectiveness of approaches to correct for the effects of population stratification on case-control genetic association studies.

Effects of Bedside Compared to Outside the Room Case Presentation

Patient case presentations during ward rounds can take place at the bedside or outside the room. The best approach to patient case presentation is yet unclear. Thus, the overall aim of this multicenter, randomized-controlled study is to test the hypothesis that outside the room patient case presentation compared to bedside patient case presentation results in better outcomes across different dimensions including patient understanding and perception of quality of care as well as...

Case Series on Using Bone Marrow Concentrate for Alar Ligament Injuries

A prospective case series of 200 patients who have been treated with Bone Marrow Concentrate using anterior approach through posterior oropharynx for treating alar, accessory, and transverse injuries for patients with craniocervical junction instability.

Drainage of Tubo - Ovarian Abscess: DTOA

The treatment of the acute phase of the complicated abscess tubo-ovarian relies on antibiotics more or less associated with surgical management in case of visible abscess, poor clinical tolerance (sepsis) and resistance to medical treatment. The CNGOF recommended in 2012 that the tubo-ovarian abscess are not within one antibiotic, and should be drained by interventional radiology, preferably by transvaginal or laparoscopic. Furthermore the efficiency of drainage by ultrasound ...

Catheter Ablation of All Inducible AT Post AF Ablation

In the treatment of symptomatic drug resistant persistent atrial fibrillation (Ps AF), catheter ablation has a class IIA indication. During the follow-up, a significant amount of patients (~50%) will experience atrial tachycardias (AT) recurrence. The endpoint of AT ablation during the second procedure has not been validated. At present, several strategies are considered as good clinical practice. Main objective: To evaluate if ablation of all inducible AT post AF ablation (AT...

Proactive Diabetes Case Management

Despite a growing array of therapeutic options and efficacious treatment strategies to prevent or delay some of the most severe complications of type 2 diabetes, there continue to be many individuals with outcomes that are far from optimal. Interventions to improve diabetes care by educating providers and patients have been disappointing. In the past several years, case management has been widely advocated as a cost-effective approach to coordinate diabetes care and improve o...

Tailored Beta-catenin Mutational Approach in Extra-abdominal Sporadic Desmoids Tumor Patients

This is a prospective, multicenter observational study under the umbrella of the ISG (Italian Sarcoma Group) evaluating local progression-free survival at 3 years of patients affected by extra-abdominal primary fibromatosis managed with front-line conservative approach and treated only in case of demonstrated progressive disease. All patients included will be placed on wait and see approach and then shifted to treatment in case of documented radiological progressive disease. ...

A Novel PET Approach to Measuring Myocardial Metabolism

Studies of myocardial fuel selection using a novel palmitate-based PET probe

Case Management in HCV Infected PWID

To study the impact of case management on the outcome of the care of chronic hepatitis C in people who inject drugs (PWID). By creating the function of case manager, the investigators will target all the barriers to care of the HCV care continuum. Partial objectives are to measure the impact of case management on the uptake for screening, the uptake and outcome of treatment, and the rate of reinfection.

The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Medial vs Lateral in Anteroposterior View

Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 (sacrum 1) TFESI between method using medial approach and method using lateral approach in anteroposterior view, the result can be crucial factor in selecting...

Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS

This study will examine the effects of having a case manager help PHAs access and use health, social services and practical resources that are helpful to their needs as compared to the usual more PHA self-managed approach of deciding and using services as they see necessary. New and existing users of HIV/AIDS services in Wellington-Dufferin, Waterloo and Grey-Bruce Regions who consent to this study will be randomized to receive their usual self-directed supportive, educational...

Posterolateral Surgical Approach Compared With Modified Lateral Approach

It has been reported that the operative approaches have an effect on clinical outcome in total hip arthroplasty. The purpose of this prospective study was to compare clinical and radiological outcomes between anterolateral approach and posterolateral approach in total hip arthroplasty.

Stage-specific Case Management for Early Psychosis

One of the commonly adopted strategies in improving outcome in psychotic disorders is by focused, specific and intensive intervention in the initial few years of the disorder. However the effects of intervention and the optimal duration of intervention have seldom been examined in randomized studies. This study uses a randomized controlled study design to investigate the effectiveness of stage-specific case-management in improving outcome of first episode psychotic disorders. I...

Randomized Trial to Evaluate the Effectiveness of Nurse Case Management

The management of high-risk pregnancies require substantial use of medical resources. Our goal is to determine the effectiveness of a nurse case management program in which case managers are assigned to patients with high-risk conditions. Our hypothesis is that women with diabetes in pregnancy or hypertension who are assigned a nurse case manager will have lower glucose levels and lower blood pressure levels

Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (Study P05553)

This study will be performed to directly compare the efficacy and safety of the classical "Step-Up" approach for treatment of moderate to severe active ulcerative colitis using prednisolone and 5-aminosalicylic acid (5-ASA) and oral Azathioprine (AZA) with a more intensive and early "Top-Hold" approach with infliximab (5 mg/kg) continuously given every 8 weeks following induction at weeks 0, 2, and 6. Investigational Medical Product: Infliximab at 5 mg/kg body weight intraveno...

Perception-Action Approach Intervention for Infants With Congenital Muscular Torticollis

Infants with congenital muscular torticollis (CMT) display postural and functional asymmetry that interferes with their development. The use of the Perception-Action Approach (P-AA) intervention in infants with CMT is supported by a single case report and needs to be researched further to determine its efficacy. This study will investigate the immediate effects of the P-AA intervention on habitual head deviation from midline, active head rotation range of motion, and functional...

Telemonitoring and Protocolized Case Management for Hypertensive Community Dwelling Seniors With Diabetes

Diabetes affects over 20% of Canadians over the age of 65y. Seniors with diabetes are at high risk for cardiovascular disease and death. Most of this risk is mediated through high blood pressure (BP). However, seniors are also at risk for side effects from BP lowering medication. These can be life threatening and costly. Therefore, BP monitoring is required to ensure BP levels are in the recommended range (neither too high nor low). Home BP monitoring can be used to ensure tha...

Effectiveness of Case Management Versus Case Management Plus Problem-solving Therapy to Treat Depression in Low-income Elders

This study will compare the effectiveness of case management combined with problem-solving therapy (CM-PST) versus case management (CM) alone for assisting elderly people with depression.

Transitional Case Management Study

To address the issues involved in treatment participation by substance-abusing parolees, the CJ-DATS Transitional Case Management (TCM) study proposes to test a parole re-entry model that consists of (1) completion by the inmate of a strengths and goals assessment as part of discharge planning, (2) a telephone case conference call that includes the inmate and significant members of the inmate's aftercare plan (including the parole officer), and (3) strengths case management (fo...

Artificial Intelligence vs Physicians for Breast Cancer Patients' Information

Chatbots (contraction of "chat" and "robot") are a computer software program that use statistical learning and aim to simulate a conversation by text or voice message. The use of these chatbots was evaluated as part of the increase in therapeutic adherence and information on well-being and mental health. In clinical studies, chatbots are useful in gathering information through questionnaires directly submitted during conversations or through keyword analyzes. There is no longe...

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Framingham Nutrition Studies

To examine hypotheses concerning the relationships between nutrient intake (in particular, specific fatty acids, antioxidant nutrients, and B vitamins), dietary patterns, plasma lipoproteins, and heart disease endpoints in the population-based Framingham Offspring Studies.

Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics

The investigators propose a Type I hybrid effectiveness/implementation study to evaluate two population-based approaches for increasing use of Quitlines and text messaging at two VA sites. Specifically, the investigators will test the default bias, examining whether an opt-out approach to referral is more effective than an opt-in approach. The investigators will randomly assign teams to either an opt-out or opt-in approach to referring smokers to treatment. In the opt-out appro...

A Communication Tool to Assist Severely Injured Older Adults

The purpose of this study is to test the effect of the "Best Case/Worse Case" (BC/WC) communication tool on the quality of communication with older patients admitted to two trauma units. The intervention was developed and tested with acute care surgical patients at the University of Wisconsin (UW) and we are now testing whether the intervention will work in a different setting. We will test the intervention with severely injured older adults at Oregon Health Sciences University...

Direct Anterior Approach Versus Direct Lateral Approach in Total Hip Arthroplasty

The purpose of this study is to compare the direct anterior approach and the direct lateral approach in primary total hip arthroplasty, regarding the postoperative function and pain, complications, radiological finds (X-ray), postoperative hemorrhage, markers for muscle damage (i.e creatine kinase (CK), lactate dehydrogenase(LDH/LD) , aspartate aminotransferase(AST), C-reactive protein (CRP),Troponin and Myoglobin) or other clinical outcomes.

Clinical Utility of the SPEAC® System: A Case Series

The primary objective is to collect preliminary data related to the clinical utility of the SPEAC System in patients with a history of motor seizures. This trial is primarily an observational investigation. This protocol describes a series of observational case studies. Each case study is intended to be interpreted independent from the other case studies. Self-reported seizure frequency will be compared to observed seizure frequency using the SPEAC System.

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