There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study will evaluate the potential role of a long acting anesthetic (ropivacaine) in providing an extended period of pain relief for patients undergoing ultrasound guided core biopsy of the breast.
This is an open-study with a 26 week open label treatment period followed by an optional 26 week open label extension. The total treatment period will be 52 weeks.
The investigators hypothesize that a garment-integrated sensing system will be able to detect with clinical accuracy the position of the spine. The investigator will evaluate this using healthy adult volunteers, who will don sensing garments and assume a series of spinal postures. Concurrent with garment sensing, the participant's spine position will be measured using a motion-capture system that uses reflective markers to detect positions of markers in 3D space. The motion-capture system provides a gold-standard reference measure to which the sensing garments will be compared. Because the investigators are evaluating the accuracy of the sensing garment, it is only necessary that the investigator test the garments on participants with subtly different body shapes. Healthy adult volunteers provide an adequate input to the sensing signal.
The primary objective of this study is to gather post market data on the Penumbra Ruby Coil System in the treatment of visceral artery aneurysms and arteriovenous malformations. This study is a prospective, multi-center study of patients with visceral artery aneurysms and visceral arteriovenous malformations who are treated by the Penumbra Ruby Coil System. Data for each patient are collected up to 12 months post-procedure for the study.
This is an open label, two-arm, phase II trial to evaluate the anti-tumor activity, safety, and tolerability of ziv-aflibercept in combination with XELOX chemotherapy in the first-line treatment of subjects with mCRC. Two different schedules of ziv-aflibercept in combination with XELOX will be evaluated in this study: every 2 week schedule (Arm A) and the every 3 week schedule (Arm B). The choice between arm A and arm B will depend on the investigator's preference. Arm A (every 2 week schedule) Dosage and dosage regimen for all study periods - Capecitabine: will be administered 1,000 mg/m2 orally twice a day on Days 1 - 7 of each cycle, repeating every 14 days. - Oxaliplatin: will be administered 85 mg/m2 IV on Day 1 of each cycle, repeating every 14 days. - Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating every 14 days. Arm B (every 3 week schedule): Dosage and dosage regimen for all study periods - Capecitabine: will be administered 850 mg/m2 orally twice a day on Days 1 - 14 of each cycle, repeating every 21 days. - Oxaliplatin: will be administered 130 mg/m2 IV on Day 1 of each cycle, repeating every 21 days. - Ziv-aflibercept: will be administered 6 mg/kg IV on Day 1 of each cycle, repeating every 21 days.
Incisional hernias occur in nearly 20% of all laparotomy incisions accounting for almost 400,000 ventral hernia repairs annually in the United States. There is an even higher incidence of incisional hernia recurrence after prior repair if the patient is obese. Each subsequent hernia repair leads to increased morbidity and durability. It is not infrequent that many surgeons will advise overweight or obese patients to lose substantial weight prior to complex incisional hernia repair. However, it is quite difficult for any individual to lose more than 8 pounds a month in a safe, rapid, and sustainable fashion. This is based on losing 2 lbs. per week utilizing diet and exercise alone. Many patients with incisional hernia are physically debilitated that they cannot engage in any substantial physical activity to lose weight. Traditional laparoscopic bariatric surgery (i.e. Roux-en-Y gastric bypass (RYGB) and SG), while feasible, is a technically challenging endeavor since prior abdominal surgeries increase the amount of intra-abdominal adhesions. Furthermore, there is still a subset of patients who are not candidates for laparoscopic weight loss surgery because of inability to tolerate pneumoperitoneum due to underlying physiologic dysfunction. - Novel minimally invasive endoscopic technique may help obese patients with an incisional hernia lose weight in a safe and rapid fashion. Early case reports and small case series on gastric bypass revision utilizing such endoscopic technique have shown promise in efficacious weight loss. There have been reports of achieving nearly 20-25% excess weight loss. Abu Dayyeh and colleagues have also demonstrated that endoscopic gastric plication as a primary weight loss procedure is feasible, but their reported follow-up was only 3 months.8 Brethauer, et al. from Cleveland Clinic performed transoral gastric volume reduction for weight management in 18 patients (TRIM TRIAL). They utilized the Restore Suturing System (Restore device) and reported a mean decrease in BMI of -4.0 ± 3.5 kg/m2. Mean excess weight loss was 27.7% ± 21.9% with no reports of adverse events.9 There have also been reports of not only weight loss but improved insulin sensitivity and secretion.10 Laparoscopic gastric greater curvature plication afforded a mean 50.7% excess weight loss at 12 months.11 The intent of this study is not to demonstrate endoscopic suturing to be a primary option for weight-loss surgery. Preliminary reports have shown such procedure is technically feasible but not durable and the effects of the procedure varied widely among the study participants.12 The investigators view this technology as a bridge for morbidly obese patients, who will need subsequent surgery for another surgical disease, to improve their body habitus and decrease their postoperative morbidity and mortality. The aims of the investigators study are: - Feasibility of endoscopic gastric sleeve plication - Define the technical aspects of endoscopic suturing for sleeve plication - Provide long-term follow-up for both weight loss and resolution of their co-morbidities - Time from the endoscopic procedure to their incisional hernia repair - Photographic evidence of the stomach after endoscopic plication during the incisional hernia repair There are several advantages for the proposed study. First it avoids entering the intra-abdominal cavity. Second, the procedure is performed solely with sutures obviating the need for stapling which may increase the risk of gastric leak from the staple line.13 Lastly, it avoids placing endoscopic intra-luminal devices such as intragastric balloons or duodenal-jejunal sleeves. Limiting factor of such devices is a high rate of premature device withdrawal due to intolerance. Furthermore, their effects are short-lived as most devices will need to be removed by 12 weeks and they only offer a mean 23.6% excess weight loss.13, 14 The implications of this study can be far-reaching. Once efficacy is demonstrated where enough weight loss is achieved that patients can safely and quickly undergo their incisional hernia surgery, the investigators can then conduct a retrospective case-control cross-matched study to further delineate its true benefit. If there is a true benefit, then a randomized control study can be employed in the future.
Title: Measuring the impact of an interdisciplinary polypharmacy clinic within a patient-centered medical home Objectives: The primary objective of this project will be to track the types of interventions made in an interdisciplinary polypharmacy clinic to improve medication regimens and medication burden. Polypharmacy has been well documented in the literature as a risk for medication errors, adverse drug events, and morbidity. Team visits, including complete medication reviews, by pharmacists and physicians within a National Committee for Quality Assurance (NCQA) tier 3 patient-centered medical home (PCMH) at an academic medical center, can improve medication regimens. Secondary objectives include (1) measuring each patient's quality of life at baseline and one month post-intervention and (2) tracking the cost of medication additions and discontinuations. Methods: Patients taking ten or more chronic medications will be identified for referral to the polypharmacy clinic from a report generated from the electronic medical record. The polypharmacy clinic will be staffed by a pharmacist and medical resident with oversight from an attending physician who specializes in geriatrics. Drug-related problems identified during the visit will be resolved and categorized based upon indication, efficacy, cost, safety, and compliance. The numbers and types of interventions made, both during the primary visit and anticipated in the future, will be tracked. The 12-item short form (SF-12) survey will also be administered at baseline and one month post intervention. The increase or decrease in cost for medications added and removed during these visits will be captured using the average wholesale prices. Preliminary Results Using descriptive statistics, the types of drug-related problems identified and interventions made will be reported. Changes in quality of life and monthly medication costs will also be described.
The aim of this study is to determine whether heart failure patients can tolerate a four-weeks of a new exercise training regimen that targets peripheral tissues (Regional Specific Training Stimulus-RSTS) and has been show to produce significant benefits in aerobic capacity and strength in healthy subjects aged 70+years who were at risk for losing functional independence.
This study will compare the dosing regimen of oral rigosertib, which has been used in other studies of lower risk Myelodysplastic Syndrome (MDS), with 2 new dosing regimens to determine if one of the new regimens gives improved results as measured by disease status, side effects, and analyses of blood and urine samples.
Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors