Oct 1st, 2015 - The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients
Mar 25th, 2018 - The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of OBE2109 alone and in combination with add-back therapy for the treatment of uterine fibroids. Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.
Dec 18th, 2013 - OBJECTIVES: I. Determine the maximum tolerated dose of weekly irinotecan in combination with weekly fluorouracil and cisplatin in patients with locally advanced or metastatic solid tumors. II. Determine the dose limiting toxicity for this combination regimen in this patient population. III. Establish a recommended phase II dose for this combination regimen in these patients. IV. Evaluate the sa...
Mar 27th, 2011 - OBJECTIVES: I. Evaluate the quantitative and qualitative toxicities of oxaliplatin combined with fluorouracil and leucovorin calcium in patients with advanced adenocarcinoma of the colon or rectum. OUTLINE: Patients receive leucovorin calcium IV over 10-20 minutes followed within 10 minutes by fluorouracil IV bolus on days 1, 8, 15, 29, 36, and 43. Patients receive oxaliplatin IV over 2 hours p...
Apr 21st, 2013 - This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.
Apr 9th, 2018 - A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
Apr 19th, 2017 - Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated Peritoneal Dialysis (APD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels. Secondary Objectives: To demonstrate that use of glucos...
Mar 6th, 2017 - Use of dipole density mapping to identify activation in complex supraventricular tachycardias
Apr 22nd, 2014 - This is a randomized (study drug assigned by chance), double-blind (neither physician, patient nor the sponsor knows the assigned treatment), placebo-controlled, single and multiple (14 days) ascending dose, parallel group study in 3 study centers (United States, Germany and South Korea). Five cohorts (groups) of patients with Type 2 diabetes mellitus (T2DM) will be studied. One dose level will...
Nov 13th, 2012 - This is a Phase 3, multicenter, randomized, double-blind, parallel, comparative efficacy and safety study of single-dose IV oritavancin/IV placebo versus IV vancomycin for 7 to 10 days in adults with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. Approximately 960 patients will be randomized at 100 centers globally. In add...
Dec 27th, 2016 - Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring effective cardiopulmonary resuscitation (CPR). About 16,000 pediatric cardiac arrests occurs in the United States annually. Only 8% of the patients survive to hospital discharge and of these, up to two-thirds have neurological sequelae. Majority of pediatric cardiac arrest are below age of two and have poorer ...
Sep 14th, 2017 - Although pain must be assessed to be treated, it has been challenging to obtain consistent, objective, and quantifiable measurements. The best methods currently available are subjective scales communicated by the patient such as standardized sentences, visual analog scales (VAS), or plain numeric scales. When a patient is unable to communicate, methods used to monitor pain are inadequate. A dev...
Emergency airway management during resuscitation is a critical skill in emergency medicine. According to the European Resuscitation Council (ERC) guidelines for resuscitation 2010 , endotracheal intubation (ETI) is considered the gold standard during resuscitation.
The aim of this prospective randomized clinical trial is the comparison of two surgical treatment options for talar avascular necrosis (analogical to Ficat and Arlet stage II and III). The randomized study design allows direct comparability of the outcome after either core decompression and nonvascularized osseous autografting from the iliac crest or core decompression and osseous autografting ...
Apr 5th, 2017 - Participants randomised to the experimental group are exposed to one blog post each week for a period of 6 months. Blog posts focus on the improvement of fruits and vegetables consumption targeting four main determinants of the behavior: (1) knowledge; (2) attitude; (3) self-efficacy; and (4) motivation/goals. Each post included a step-by-step recipe developed by the research team and featuring...
Mar 28th, 2018 - OBJECTIVES: Deficits in memory, attention, cognitive, and executive functions are the most common disabilities after traumatic brain injury (TBI). Dopamine (DA) neurotransmission is implicated in these neural functions and dopaminergic pathways are recognized to be frequently disrupted after TBI. One of the most widely used DAergic drugs is methylphenidate (Ritalin ). Methylphenidate increases ...
Nov 16th, 2014 - This is a follow-up study to a multi-centre, randomised, double-blind, placebo controlled, parallel group clinical study (TG002) which evaluated the efficacy, safety and tolerability of three doses of ToleroMune Grass versus placebo in grass allergic subjects. Subjects who completed TG002 in calendar year 2012 will undergo a further single exposure to grass allergens in an EEU.
Mar 5th, 2015 - The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Oct 7th, 2015 - RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age in the world. RSV illness can range from mild upper respiratory tract illness (URI) to severe LRI, including bronchiolitis and pneumonia. Severe RSV disease in infancy may also predispose children to develop reactive airway disease during childhood. The purpose of thi...
Jun 24th, 2018 - Eligible participants, with both a history of recurrent BV and a current episode of BV, will receive a seven-day course of oral metronidazole. Participants who are successfully treated for their BV, and continue to be eligible, will be randomly assigned to receive either 1% SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks. The primary endpoint will be determined...