Clinical Trials About "Boston Biostatistics Incorporated" - Page: 4 RSS

05:03 EST 19th January 2019 | BioPortfolio

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Showing "Boston Biostatistics Incorporated" Clinical Trials 76–100 of 213

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Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following

The COGENT-4 Field Following Study will evaluate the clinical performance of the Boston Scientific TELIGEN 100 HE Implantable Cardioverter Defibrillator (ICD), the COGNIS 100 HE Cardiac Resynchronization Therapy ICD (CRT-D) systems and the RELIANCE 4-SITE defibrillation lead (when available). An optional sub-study will also evaluate the clinical performance of the Reverse Mode Switch (RMS) feature in the TELIGEN 100 HE DR ICD.

The HIP Impact Protection Program (HIP PRO)

HIP PRO is a multicenter randomized, controlled trial of an energy absorbing and distributing padding system designed to reduce the incidence of hip fractures in 546 nursing home (NH) residents. The trial is being conducted in three geographic regions of the US: Boston, St. Louis, and Baltimore. Non bed- or chair-bound residents over the age of 65 are given protective underwear containing a single pocket and hip pad so that each resident becomes his/her own control. During ...

A Trial of Esophageal and Gastric Stenting for Leak or Perforation

This study is written to evaluate our experience treating esophageal fistulas with occlusive self-expanding covered metal stents. The long-term outcomes of patients treated with this new type of stent are as yet unknown. The differences between these stents is also unknown, as well as the ease of removal, efficacy, and/or placement. The intent of this study is not to determine which stent is better, but to merely evaluate the use of both. With this in mind, there will be no r...

Impact of Low Fiber Diet on Colonic Cleansing Quality (DIETPREP)

This is a single center randomized controlled trial to compare bowel cleansing for outpatient colonoscopy in two groups of participants: one group will receive instructions of one-day structured low fiber diet whilst the other group will receive three-day low fiber diet. Both groups will receive the same bowel cleansing solution (polyethylene glycol plus ascorbic acid). Bowel cleansing will be assessed according the Boston Bowel Preparation Scale.

Alendronate Osteoporosis Study

This trial will test the hypothesis that among 20 children and adolescents from Children's Hospital, Boston with Crohn’s disease, ulcerative colitis, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus, mixed connective tissue disease and vasculitis, treatment of glucocorticoid-associated osteopenia and osteoporosis with 18 months of alendronate (FOSAMAX®, Merck & Co., Inc.) will result in greater improvement in the mean chang...

Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue DES

Hypothesis: Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with iopromide excipient (PCB) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES)

Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™

The primary objective of this study is to demonstrate the safety of the NexStent for treatment of carotid artery lesions undergoing stenting with adjunctive use of the FilterWire distal embolic protection device. The rates will be compared to an Objective Performance Criterion (OPC) derived from historic data from high-risk patients undergoing surgical intervention with Carotid endarterectomy. Patients included in this study are those at higher risk for complications associat...

Assessing Current Peripheral Nerve Block Catheter Fixation and Dressing Strategies: An Equivalence Study

The investigators' objective is to evaluate whether any of the various peripheral nerve block catheter dressing strategies currently employed by the Boston Children's Hospital Regional Anesthesia Service has any differential impact on specific outcome endpoints such as regional block catheter dislodgement, catheter occlusion, catheter leakage, skin irritation, and skin infection.

Korean Multicenter Registry of INNOVA Stent for Femoropopliteal Artery Disease: (K-INNOVA Registry)

- Prospective, single-arm, multi-center registry study - A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included. - Patients will be followed clinically for 12 months after the procedure. - Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months. - Presence of stent fracture will be evaluated by p...

High Pressure Balloon vs Cutting Balloon

Patients suspected of having AV access stenosis will be referred to the Division of Vascular and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who are found to have significant stenosis (more than 50%) at the venous end of the anastomosis will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon (Boston scientific Balloon). Angiograms will then be performed before and after intervention.

Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI

The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa, CA, USA) implantation in patients with AMI at 12 months.

Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).

Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.) to prevent device related thrombus.

Impact Ureteral Sheath Design During Ureteroscopy

The purpose of this study is to assess whether one of two ureteral access sheaths is safer for patients undergoing ureteroscopy. Both sheaths are FDA approved devices and commercially available. We will compare the ability of sheaths to access the kidney through the ureter and will compare damage done to the ureter after completion of the procedure. Access sheaths are standard of care for this procedure; this study seeks to optimize outcomes for patients. Patients undergoing u...

Child HCAHPS: Automated Day of Discharge Survey

The goal of this study is to identify effective ways to assess the patient and family experience. Specifically, the study will examine automated administration of the Child Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey on the day of discharge through an electronic interactive patient care system. The will be a multisite study that will take place at Boston Children's Hospital (BCH) as well as at several other hospitals across the United States...

Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage

The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary care clinic at Boston medical center on the serotype specific carriage of Streptococcus pneumoniae in children < 5 and their parents. Specifically the investigators will measure the decline in vaccine serotypes, the proportion of children receiving vaccine required to achieve 50% reduction in serotype specific carriage and the correlation between immunogenicity of the specific serotype...

Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I

The purpose of this research study is to determine the number of children who have symptoms of a concussion at the time they are scheduled for orthopedic surgery at Boston Children's Hospital. It is currently unknown if anesthesia affects a child with a previously diagnosed concussion. This study is the first phase of a two-part study looking at the effects of anesthesia in children undergoing orthopedic surgery with a previous concussion. Currently, the decision to continue wi...

Preventing Bacterial and Viral Infections Among Injection Drug Users

We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an assessment-only condition (both groups receive rapid HIV testing, a review of testing results, and brief HIV prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at Boston Medical Center. In the general hospital setting, injection drug users who otherwise might not seek care are accessible and teachable, and the presence of a drug-related il...

TOURIST 2: Tracking Of Urgent Risks In Swiss Travelers

New mobile Health (mHealth) technology creates an opportunity to approach travel medicine research in a different way, revolutionising our understanding of risks to travellers. Using mHealth technology, the Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich (UZH), developed a TRAVEL app in collaboration with the Eidgnössische Technische Hochschule (ETH) Zurich. By using this new technology, an extensive collection of data (prospective collection...

Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy

In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 3L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by a single endoscopist who was blinded to the intervention. Visibility was blindly a...

A Tele-mental Health Intervention to Support Parents Caring for a Technology-dependent Child at Home

The need for assisted-technology at home reflects some of the most serious health-related conditions faced by children with physical and developmental disabilities. 'Technology-dependent' is often used in the literature to describe children "who need both a medical device to compensate for the loss of a vital body function and substantial and ongoing nursing care to avert death or further disability". Parenting a child is stressful and challenging, and even under ideal circumst...

Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis

Adolescent Idiopathic scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. The design is made relatively corsets empirically, hence the relative efficiency of this treatment. Our team has developed innovative methods for design, optimization and computer aided manufacturing-based numerical simulation models customized to each patient, and a system of evaluation and adjustment of corsets. In this project,...

Efficacy Study of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression

The primary objective of this multicenter, randomized, sham-controlled, double blind (patient and observer blinded) clinical trial is to assess the antidepressant effect of Deep Brain Stimulation (DBS) in patients with treatment resistant major depression using the Boston Scientific implantable Vercise™ GEVIA™ DBS system compared to sham.

Hydration Status Evaluation of Dehydrated Children With Experimental Devices

A pediatric study in collaboration with Boston Children's Hospital to review the performance of two novel hydration status measurement devices against standard clinical assessment methods, through repeated measurement of hydration status of dehydrated children admitted to the emergency department receiving rehydration therapy, followed by an at-home follow-up measurement once symptoms have resolved.

Yoga for Chronic Low Back Pain

Chronic low back pain is the most common cause of pain in the United States. Common treatments such as medication, physical therapy, and surgery often do not provide adequate relief. Yoga has shown promise for improving low back pain in studies of predominantly middle class white individuals. We will assess the feasibility and collect preliminary data on yoga for chronic low back pain in predominantly minority individuals in a community health center setting in a low income ...

Compare the Efficacy of Acupuncture Therapy and Carbamazepine Oral Dosage in Patients With Carpal Tunnel Syndrome by Multiple Excitability Test

The goal of the study is to utilize BCTQ(Boston Carpal Tunnel Questionnaire), VAS (Visual Analog Scale), NCS (Nerve Conduction Study), and MET(Multiple Excitability Test) to evaluate and compare the efficacy of Acupuncture Therapy and Carbamazepine in Patients with Carpal Tunnel Syndrome.

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