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This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.
A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial. Approximately 400 children (males and females) with GHD will be included. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, b...
Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice
A randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetic characteristics of CKD-337 in healthy male volunteers
Appili Therapeutics Inc. is developing an oral suspension formulation of metronidazole (ATI-1501), a taste-masked reformulation of metronidazole. The purpose of this study is to compare the relative bioavailability of ATI-1501 with the Reference Listed Drug (RLD) in healthy, adult volunteers to determine that it is Bioequivalent.
This study aims to assess the diagnostic validity of a new minute-MRI sequence for neuroradiological evaluation in comparison to conventional MRI.
To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients given BPaMZ for 17 Weeks ( or 4 months) vs. Standard HRZE/HR treatment given for 26 weeks (or 6 months) and Drug Resistant TB (DR-TB) patients give...
This randomized, double-blind, placebo-controlled trial of doxazosin will assess doxazosin's effectiveness for PTSD nightmares, subjective sleep quality, and non-nightmare PTSD symptoms in adult men and women veterans with full and partial-syndromal PTSD.
This research targets four anti-infectives commonly prescribed in intensive care: ceftazidime, cefepime, cefotaxime and meropenem, used for severe infections For patient hospitalized in intensive care unit , there is little or no pharmacokinetic data for these four molecules.
This is a phase 4, randomized, double-blind, multicenter clinical trial to evaluate the efficacy and safety of YMC026 in respiratory disease patients with cough and sputum as the main symptoms
At antibiotic stewardship of the University Hospital of Schleswig-Holsten it was noticed that there are much less studies measuring drug levels in severe burned patients than are required. Especially, severe burned patient developing a capillary leak might show lower drug levels than patients without a capillary leak. To compare drug levels of beta-lactam antibiotics, it is...
This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.
A phase II multicenter, double-blinded clinical trial of the safety and efficacy of SP160412 in the temporary relief of mild to moderate, (i.e. first degree) sunburn
The proposed clinical trial study of rAAVrh74.MCK.GALGT2 for duchenne muscular dystrophy (DMD) patients. There will be a modified intravascular limb infusion (ILI) procedure that will be used to sequentially deliver vector to each whole lower limb of DMD subjects via a major lower limb artery.
The aim of the study is to demonstrate if using one procalcitonin (PCT)-guided rule of stop of antimicrobials, the incidence of infections by C.difficile and by Multi-Drug-Resistant (MDR) bacteria during the next six months may be significantly decreased.
Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.
This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp pso...
The clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives electroacupuncture in addition to the chemotherapy....
the purpose of thr study is to investigate the potential interation between multiple oral doses of SHR3824 and single oral dose of Simvastatin in healthy adult volunteers.
Despite all prevention efforts, many people in Australia continue to be infected with HIV. The Seventh National HIV Strategy 2014-2017 in Australia aims to work towards the elimination of HIV transmission by the year 2020. This project will evaluate a new additional way to lower people's chances of getting HIV. It will provide pre-exposure prophylaxis (PrEP) to people who a...
This study will assess the benefits and harms of screening for monoclonal gammopathy of undetermined significance (MGUS). The overall and disease-specific mortality will be compared between screened and not screened participants. All individuals registered as inhabitants in Iceland and born in 1975 or earlier have been invited to participate. The hypothesis is that an early...
The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.
This study will compare the effects of a novel web-based program (Joint Academy) to regular face-to-face treatment (OA-school) for people with osteoarthritis of the knee. Half of the participants will be randomized to the web-based program and half will receive regular face-to-face care.
ALS, also known as "Lou Gehrig's" disease, is a neurodegenerative disease which is fatal. Treatment for ALS is limited and currently consists of primary symptom relief or support. In addition, time from diagnosis to death averages 3-5 years. New Biotic, LLC has submitted an Orphan Drug Designation Application for an investigational probiotic and have indicated the need for ...
The aim of this multi-center, randomized, double-blind, placebo-controlled trial is to compare the efficacy and safety of Dorithricin® lozenge - a triple combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine - in repeat dosing for 3 days to matched placebo lozenges in the treatment of acute pharyngitis in adults.