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Drug Discovery Clinical Trials

10:33 EDT 20th September 2017 | BioPortfolio

The Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients with Primary Hypercholesterolemia

A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Patients With Rosacea

The objectives of this study were to compare the safety and efficacy profiles of a generic Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to demonstrate therapeutic equivalence and safety of the two active foams in the treatment of moderate facial rosacea, and to demonstrate superiority of the Reference and Test products over the Vehic...

Study Title: Assess the Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease

Study Title: A Phase 4 Study to Assess the Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects with Dry Eye Disease

A Clinical Trial on the Efficacy and Safety of Topical 0.5% Ivermectin Lotion for the Treatment of Head Lice Infestation in Filipinos

This is a randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of a single application of 0.5% ivermectin lotion in Filipino subjects with head lice.

A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users

The purpose of this study is to assess the abuse potential of study drug lasmiditan. Lasmiditan will be compared to a marketed benzodiazepine, alprazolam (positive control), as well as to placebo (dummy substance that looks like lasmiditan or alprazolam without any active drug) to determine the potential for drug abuse. The dosages will be in tablet form and will be taken ...

Clinical Decision Support System to Define 30 Day Adverse Clinical Events for Emergency Department Acute Coronary Syndromes

Acute coronary syndromes are among main complains for patients presenting to emergency department. Risk classification systems are used to classify patients to appropriate risks and help physicians manage diagnosis strategies and treatments. Purpose of this study is to develop a clinical decision support system for patients presenting to emergency department with the help o...

Comparison of Immunity Following IPV Versus fIPV: a Community Based Randomized Controlled Trial in Pakistan

This study will be conducted in four low-income areas of Bin Qasim Town Karachi. This will be a community based randomized control trial of 21 months duration. The trial will include four arms; arm A and B will enroll children age 14-18 weeks and randomize them to either full dose IPV (0.5ml) or fractional IPV (0.1ml). Arms C and D will enroll children at 9 months of age an...

BioheartRapamycin Drug-Eluting Bioresorbable Coronary Stent System RCT Study

The Bioheart Randomized Controlled Trial is a prospective multicentred paralleled study, which will enroll 430 patients and randomized 1:1 to study group and control group. aim to compare the efficacy and safety of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System to XIENCE stent in the treatment of patients with up to two coronary lesions.

Postoperative Hypersensitivity and Digital Radiographic Assessment of a Zinc Modified Versus a Conventional Glass Ionomer Cement in Deep Carious Lesion: Randomized Controlled Clinical Trial

The study aim to evaluate the difference between the effect of zinc modified glass ionomer and conventional glass ionomer on the success of partial caries removel technique

Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients

This open-label study assessed the safety, tolerability and pharmacokinetics of ALT-P7(HM2-Drug Conjugate) in patients with HER2-positive metastatic breast cancer who have progressed on previous Trastuzumab-based therapy. Patients received ALT-P7(0.3 mg/kg~5.4 mg/kg, 7 groups) intravenously on Day 1 of each 3-week cycle.

Uncontrolled Hypertension Management (TEAM-HTN)

Current guideline directed medical therapies (GDMT) for hypertension (HTN) endorse a trial and error approach based on drug class. This pilot study will evaluate the efficacy of a Clinical Decision Support (CDS) program to assist providers with delivering a more personalized approach using individual renin-aldosterone levels and the mechanism of action of medications includ...

Gastric Emptying During Labor at Term: Non-inferiority Clinical Trial

This study evaluates the gastric emptying of pregnant woman at term who received one of the three solutions: maltodextrin, orange juice or coffee with milk.

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments.

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps

The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments.

Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding

The investigators will establish an evidence base for the Nifty Feeding Cup by evaluating its effectiveness and caregiver satisfaction. The investigators will conduct a randomized crossover trial that compares the Nifty Feeding Cup to a standardized, generic medicine cup used to feed preterm infants with breastfeeding difficulties at Komfo Anokye Teaching Hospital (KATH) in...

Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine

The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time after vaccination

The Impact of Point-of-Care Ultrasound

Point-of-care ultrasound (POCUS) has been found to be useful for aiding in the prediction of fluid responsiveness. It is unknown if trainees can effectively utilize this tool to improve their assessment of fluid responsiveness. In this prospective, observational study, pulmonary and critical care fellows are asked to make 2 assessments of fluid responsiveness in adults wit...

Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents

The main objective of this research is to demonstrate the possible use of erythroferrone (ERFE) as a potential marker of recombinant human erythropoietin (rHuEpo) use to be included in the Athlete Biological Passport (PBA) developed by the World Anti-Doping Agency (WADA).

Clinical Trial of the Use of the Nasal Spray of Patients With Recurrence of Glioblastoma

This is a study to determine the efficacy, safety and clinical benefit (how well the drugs works), of the pharmaceutical compositions in Nasal Spray NST-4G for the treatment of brain tumors( Recurrent Glioblastoma, Gliosarcoma,Anaplastic Gliomas, Previously Treated). All drugs target the inhibition of the growth factors and neo-angiogenesis as one the main reasons for the ...

Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

Primary Objective: To demonstrate the benefit of isatuximab in combination with carfilzomib and dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to carfilzomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM) previously treated with 1 to 3 lines of therapy. Secondary Objectives: - To evalua...

Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.

The retinopathy of prematurity (ROP) is a public health problem, the main causes of ROP are prematurity, use of oxygen, malnutrition and oxidative stress. Vitamin E was used beforehand however its use was stopped because of its association with sepsis and enterocolitis caused by the excipient of vitamin E. The purpose of this study is to use vitamin E to prevent ROP, withou...

Post Approval Study of the CyPass System

The purpose of this study is to demonstrate that the rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability using the CyPass 241-S applier, as determined at 36 months in the postmarket setting, is less than the pre-specified performance target, which is based on experience with the CyPass Model E applier in the COMPASS (TMI-09-0...

Observation Study: Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients

The purpose of this multicenter registry is to gather the safety, efficacy and survival data in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order to provide clinical evidence in HCC management to physicians in the region, and to support the application of deTACE in treating advanced HCC patients.

Statin Therapy in Patients With Early Stage ADPKD

This study plans to learn if pravastatin is helpful in slowing down the progression of kidney disease in adults with autosomal dominant polycystic kidney disease (ADPKD). Pravastatin has been approved by the Food and Drug Administration (FDA) for adults for treatment of hyperlipidemia (high cholesterol levels). The investigators are using pravastatin in this study as an inv...

Endometriosis Biomarker Discovery Study

This is a prospective, Single time point, discovery study intending to identify biomarkers that can differentiate endometriosis from other underlying reasons for pelvic pain. Patients undergoing laparoscopy for evaluation of chronic pelvic pain or elective tubal ligation will be enrolled for collection of tissue samples at the time of laparoscopy.

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