Clinical Trials About "Valeant Surges Post Reassessment" RSS

22:53 EST 18th January 2019 | BioPortfolio

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Showing "Valeant Surges Post Reassessment" Clinical Trials 1–25 of 9,400+


Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis

The purpose of this study is to compare the safety and efficacy profiles of Watson Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two active creams over that of the placebo (Vehicle of test product), in the treatment of mild to moderate atopic dermatitis.

Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury

Paroxysmal sympathetic hyperactivity (PSH) is a frequent symptom after traumatic brain injury and concerns up to 30% of severely brain-injured patients. PSH is due to unbalanced autonomic nervous system activity, resulting in sympathetic surges causing hypertension, tachycardia, sweating and hypertonia. The affected patients suffer more pain, more cardiovascular distress, more infections and prolonged rehabilitation and mechanical ventilation; additionally it could lead to a w...

Gonadotropin-releasing Hormone Antagonist on Triggering Day: A Randomized Controlled Study

Gonadotropin-releasing hormone (GnRH) antagonists have been widely used for the prevention of premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH) for in vitro fertilization and embryo transfer (IVF-ET) since the late 1990's. Many years have passed since GnRH antagonists were introduced to prevent premature LH surges during stimulated cycles. However, there is still no consensus on the optimal GnRH antagonist protocol. Attempts at modifyin...

Cryolesion in Treatment of Phantom Limb Pain

Assessment of pain intensity on the NRS. Assessment of the quality of life by SF-36 and AIS. Diagnostic/prognostic nerve block with 5 ml of 2% lidocaine under real-time ultrasound control with confirmation of the correct position of the needle using a peripheral nerve stimulator. Reassessment of pain intensity on the NRS 30 minutes after local anesthetic block. Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points. If pain intensit...

Cerebral Microdialysis in Patients With Fulminant Hepatic Failure

Patients with fulminant hepatic failure (FHF) often develop cerebral edema, high intracranial pressure (ICP)that may result in fatal brain damage. The aim in this protocol is to determine if a rise in the brain concentration of glutamate, lactate and pyruvate are involved in development of surges of high ICP in patients with FHF. The study is observatory in nature and also record the influence of any intervention that may e instituted during the course of the critical illness.

Probably Relevant

Aerobic Exercise and Inhibitory Control

Although more than half of Canadian smokers in 2015 attempted to quit, with one-third attempting more than once, successful smoking cessation (quitting) remains a challenge. Relapse (return to smoking) has been attributed to failures in inhibitory control. Inhibitory control is the ability to suppress actions. Previous studies have identified that aerobic exercise improves inhibitory control and reduces the urge to smoke. This study will examine whether an acute bout of moderat...

A Local Clinical Study in Parallel Groups, for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol] and ANTI-ANGIN® FORMULA, Lozenges, in Treatment of Patients With a Sore Throat

The purpose of this study is to evaluate no less therapeutic efficacy and safety of the Angal, lozenges [Menthol], 1 mg + 5 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, lozenges, 0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.

Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis

This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).

Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets

The purpose of this study is to measure the amount of study drug present in blood after being administered a generic version of nifedipine extended-release tablets, 60 mg (Valeant Pharmaceuticals, LLC) and brand-name version PROCARDIA XL extended-release tablets, 60 mg (Pfizer Inc.) individually and in presence of stomach acid reducing drug (antacid), omeprazole/sodium bicarbonate capsules, 40 mg/1100 mg (generic) on separate occasions, on an empty stomach. This study also invo...

The Prevalence of Sleep Disordered Breathing in Hospitalized Patients With Acutely Decompensated Heart Failure Syndrome

OSA is associated with large negative swings in the intrathoracic pressure, significant increase in the sympathetic nerve activity and repetitive surges in blood pressure, along with episodic hypoxia and hypercapnea (8,9). These autonomic and respiratory changes may increase the cardiac muscle workload, cardiac dysrrhythmia, and exacerbate ischemia (10,11,12). Treatment with CPAP is the most successful therapeutic modality available for OSA. It is still not clear whether establ...

Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community

To reassess nutritional status of HIV-infected Thai children living in the family style community after receiving nutrition support program for 6 months.

Does Treating Anxiety Symptoms With ACT Improve Vascular Inflammation and Function?

The goal of this study is to evaluate the effectiveness of a brief, intensive 1-day psychotherapy group intervention (Acceptance and Commitment Therapy, ACT), compared to a 12 week time control group on anxiety symptoms, vascular function, inflammation, muscle sympathetic nerve activity (mSNA), and oxidant stress. Similar measures will be performed at baseline in individuals with low or no anxiety for comparison. Individuals who are interested in the study will be identified by...

Anti-PD-1 Antibody With HD IL-2 in Metastatic Melanoma

The primary objective of this single arm phase 2 trial is to assess the response rate [complete response (CR) + partial response (PR)] of sequential therapy of pembrolizumab followed by HD IL-2 in subjects with stage IV malignant melanoma. Response assessment will be performed after pembrolizumab therapy, and response reassessment will be performed after HD IL-2 therapy using revised RECIST 1.1.

SUNSET: SBRT for Ultra-central NSCLC- a Safety and Efficacy Trial

This multi-centre phase I dose-escalation study will use a time-to-event continual reassessment method (TIT-CRM). Accrual will start at level 1 (60 Gy in 8 fractions). Patients will be assigned to treatment doses using the TITE-CRM model. The model will use all available information from previously accrued patients to assign the highest dose with a predicted risk of grade 3 toxicity of 30% or less.

ReAssessment of Anti-Platelet Therapy Using an InDividualized Strategy Based on GENetic Evaluation

The objective of the RAPID GENE study is to evaluate the feasibility, efficacy and safety of a pharmacogenomic approach to anti-platelet therapy following coronary artery stenting using a CYP2C19*2 point-of-care genetic test.

Safety and Tolerability of Factor Xa Variant in Intracerebral Hemorrhage

This study employs a modified continual reassessment method (mCRM) design to estimate the maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes Bayesian methodology to continuously learn the dose-toxicity relationship, which is characterized by a parametric model. Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled...

Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied b

The purpose of this study is to evaluate no less therapeutic efficacy and safety of the Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.

Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery.

Prilocaine is a local anesthetic drug which as an intermediate duration of action shorter than bupivacain 0,5% that is usually used for spinal anesthesia in scheduled cesarean secton. No study has yet investigated the use of hyperbaric (HB) prilocain 2% for intrathecal anesthesia in cesarean section. The aim of this study is to determine the ED95 of hyperbaric (HB) prilocain 2% by using the Continual Reassessment Method (CRM)

Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy

The purpose of this current study is to prospectively enroll consecutive patients hospitalized with newly diagnosed severe left ventricular dysfunction (LVEF ≤ 35%) for which the likely etiology is uncontrolled atrial fibrillation or high burden of ventricular ectopy. Patients completing their established in-hospital treatment plan with rate or rhythm control, will be discharged with a WCD following informed consent and detailed counseling by healthcare personnel for a time-p...

A Study for Patients Previously Enrolled in Study U2971g to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to subjects previously enrolled in Genentech Study U2971g only.

National Guard Outreach and Linkage to Treatment

This project will add an evaluation/research component to an existing peer outreach program, now implemented for over 1100 soldiers in the Michigan Army National Guard. Preliminary work will be completed in three areas. We will conduct semi-structured interviews with soldiers, Buddies, and National Guard leadership and develop and pilot test survey items relevant to implementation. Further, we will develop and pretest survey items relevant to determining soldier symptomatic an...

Characterization and Epigenetics of Post-Partum Preeclampsia

This study will recruit women with post partum pre-eclampsia and match them to controls without postpartum pre-eclampsia to identify an epigenetic signature that is specific to women with post partum pre-eclampsia to help characterize the underlying pathophysiology of post partum pre-eclampsia.

Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia. The milademetan initial dose will be Level 1: 90 mg. No increase in the milademetan dose will be made in the same participant. Dose-limiting toxicity associated with milademetan occurring at each level will be assessed, and the maximum tolerated dose (MTD) will be decided using a modified c...

Study of Standard Maintenance POMP/D Plus Ixazomib Maintenance Therapy in Adult Patients With Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma or Mixed Phenotype Acute Leukemia in Complete Remission (CR)

This phase I trial will use a continual reassessment method (CRM) design with cohorts of three patients without intrapatient dose escalation. A maximum sample size of 18 patients will be enrolled over four potential doses to determine the maximum tolerated dose of ixazomib with POMP/D maintenance.

A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium

Post-operative delirium is a common and deleterious complication in elderly patients. The investigators have previously found lower levels of serum tryptophan in post-operative elderly patients who developed delirium in comparison to post-operative elderly patients who did not develop delirium. The investigators hypothesize that post-operative supplementation of L-tryptophan will reduce the duration and incidence of post-operative delirium. This study is a double-blinded placeb...

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