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NCT ID: NCT01560091 Withdrawn - Kidney Stones Clinical Trials

Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy

Start date: March 2012
Phase: Phase 3
Study type: Interventional

Tamsulosin is an alpha blocker usually prescribed for urinary complaints that has been shown to have some benefit in allowing kidney stones to pass through the ureter. Silodosin is a new alpha blocker that acts more rapidly than tamsulosin and has been shown to have specific receptors on the ureter. The investigators would like to see if there is some benefit to taking silodosin over tamsulosin after extra-corporeal shock wave lithotripsy (ESWL) to break kidney stones in terms of allowing the ureteral fragments to pass through the ureter. Our hypothesis is that silodosin will be at least as effective as tamsulosin in terms of allowing stones to pass, but may allow them to pass more quickly because of the rapid onset of action. The side effect profile for both drugs is quite similar and tolerable. Patients may experience some common side effects associated with tamsulosin, including abnormal ejaculation, dizziness, rhinitis (runny nose, sneezing), and somnolence (sleepiness). Serious reactions include orthostatic hypotension, syncope (fainting), and priapism (prolonged undesired erection). Patients may experience some common side effects with both silodosin and tamsulosin including ejaculatory dysfunction, dizziness, postural hypotension, diarrhea, and headache. Serious side effects are rare and include orthostatic hypotension, intra-operative floppy iris syndrome, syncope, and priapism. Patients will experience the discomfort normally associated with kidney stones. All efforts will be made to alleviate these discomforts, including the use of the study medications. Patients will be able to take their routine prescribed pain medications, and will be asked to keep a record of their pain medication use. The investigators will be randomly enrolling patients from all racial backgrounds and of both genders. They must have kidney stones ranging in size from 4mm to 1.0 cm and have no prior treatment for the study. The primary endpoint of this study is the clearance rate of kidney stones. That is, in what period of time does the patient achieve clearance, is stone free and has all residual stones gone. The secondary endpoints of this study include analgesic use, residual stones remaining, need for re-treatment, need for intervention, steinstrasse clearance, and the need for hospitalization.

NCT ID: NCT01559051 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease

Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the health of patients with human Chronic Obstructive Pulmonary Disease.

NCT ID: NCT01556568 Withdrawn - Cardiomegaly Clinical Trials

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy

Start date: February 2012
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine whether the ability of MEK162 to antagonize MEK activation in NS HCM patients, who usually have upstream mutations in the Ras-Raf-Mek-Erk pathway that lead to MEK activation, would be beneficial over a 6 month treatment period in hypertrophy regression.

NCT ID: NCT01556464 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Initiation of Auto-adjusting CPAP for Newly Diagnosed OSA in Hospitalized Patients

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

This study will test the following hypotheses: 1. Treatment of newly diagnosed Obstructive Sleep Apnea (OSA) in acutely ill patients with auto-adjusting Continuous Positive Airway Pressure (CPAP) would result in fewer in-hospital complications, as compared to no treatment (primary outcome). 2. Treatment of newly identified OSA in acutely ill patients with auto-adjusting CPAP would result in shorter length of stay, lower re-admission rate, better blood pressure (BP) control, better long term compliance with OSA treatment, as compared to no treatment (secondary outcomes).

NCT ID: NCT01556334 Withdrawn - Clinical trials for Preterm Premature Ruptured Membranes

Erythromycin Versus Azithromycin in Preterm Premature Rupture of Membranes

PEACE
Start date: April 2010
Phase: Phase 3
Study type: Interventional

Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in stomach upset in some patients, causing them to stop taking the medication. Therefore, azithromycin is often prescribed instead. Azithromycin is usually taken only once and stomach upset is not seen or greatly reduced. The goal of this study is to see if there is a difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin) in prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The working hypothesis is that there is no difference in the clinical effectiveness between antibiotic regimens containing the macrolides azithromycin and erythromycin for prolonging latency in PPROM.

NCT ID: NCT01555216 Withdrawn - Hallux Valgus Clinical Trials

Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

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

Foot surgery often causes severe and prolonged pain postoperatively. Prior methods of postoperative pain control included oral narcotics, single injection regional techniques and more recently continuous nerve catheters. Recent studies have demonstrated a benefit with continuous popliteal catheters when compared to single injection techniques in regards to postoperative pain control and patient satisfaction for foot surgeries. Nerve blocks in the popliteal fossa involve both the common peroneal nerve and the tibial nerve. The innervation to the plantar surface of the forefoot involves the tibial nerve and does not involve the peroneal nerve. The purpose of this study is to compare the continuous posterior tibial nerve catheter with a single injection posterior tibial nerve block when used as part of a surgical ankle block for forefoot surgery.

NCT ID: NCT01554644 Withdrawn - Clinical trials for Diabetic Complications

Prontosan Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients

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

This is a randomized controlled double blinded study involving two (2) investigational sites in the United States. All subjects (n=40) will receive either Prontosan Wound Irrigation Solution and Gel treatment or standard of care treatment (0.9% saline) and placebo gel. This is a 12-week study.

NCT ID: NCT01554254 Withdrawn - Clinical trials for Hematologic Malignancy

Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Pediatric Patients Undergoing Single or Double Umbilical Cord Blood Transplantation

Start date: March 2012
Phase: Phase 2
Study type: Interventional

Engraftment failure is a major obstacle to the success of cord blood transplantation in children with malignancies and inherited metabolic disorders, despite the fact that they receive relatively high doses of nucleated cells from UCB. TXA127 is pharmaceutically formulated Angiotensin 1-7 [A(1-7)], a non-hypertensive derivative of Angiotensin-II (which contains the 8th amino acid conferring receptor binding to blood pressure receptors). TXA127 has multilineage effects on hematopoietic progenitors in vitro and in vivo. Preclinical data show that TXA127 is a novel stimulator of early multilineage hematopoietic progenitors, increases engraftment of committed hematopoietic progenitors, and induces more rapid production of platelets and neutrophils in the peripheral circulation, especially in limited cell number transplants. Treatment with TXA127 following UCBT is expected to increase the numbers of hematopoietic progenitors and accelerate engraftment.

NCT ID: NCT01554020 Withdrawn - Prediabetes Clinical Trials

Blood Sugar Take Care and Glucose Metabolism

Start date: June 2012
Phase: Phase 2
Study type: Interventional

This prospective international clinical trial is a two-arm, double-blind, randomized, placebo-controlled, parallel-group, multicenter study. 112 prediabetic subjects will be randomized to Blood Sugar Take Care or placebo. Randomization will be stratified by gender. The intervention period is 12 weeks. The primary outcome is fasting glucose levels.

NCT ID: NCT01553123 Withdrawn - Leiomyomas Clinical Trials

Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma

Start date: April 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated.