1256 results
Page 18 of the protocol (v1.0, 4-Nov-2013):The primary objectives of this study are:- To evaluate the efficacy of ciprofloxacin DPI administered BID intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study…
To improve the response rate to treatment of severe acute GVHD (grade II-IV with gut involvement ) by adding infusion of Mesenchymal Stroma Cells to standard high dose prednisolone.
To determine the efficacy and safety of laser therapy in diabetes patients with risk factors for developing diabetic foot complications.
Primary:• To prove the superiority of a 12-week add-on treatment with 3.2 g/daygastro-resistant phosphatidylcholine granules (LT-02) in at least one of twodifferent dosing regimens versus LT-02 placebo for the induction ofremission in patients with…
The primary objective of this study is to compare PFS of ramucirumab in combination with capecitabine (or 5-fluorouracil [5-FU]) and cisplatin versus placebo in combination with capecitabine (or 5-FU) and cisplatin as first-line treatment in…
Evaluation of the histologically proven adenoma or carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets. The lack of mucosal contrast,…
Primary Objectives:- To evaluate and compare the overall survival (OS) of subjects with advanced or metastatic adenocarcinoma of the pancreas when treated with JAK 1/2 Inhibitor in combination with capecitabine versus capecitabine alone.Secondary…
PRIMAIRYThe primary objective of this trial is to evaluate the efficacy of atacicept compared to placeboin preventing new flares in subjects with SLE.SECONDARYSecondary objectives of the trial are:• To evaluate the safety and tolerability profile of…
A complete list of objectives is presented in Section 2.1 Objectives of the Study Protocol. In summary, the primary objective of this study is to demonstrate a superior LDL-C lowering effect of PF 04950615 150 mg administered by the SC route Q2wks…
Primary Objective:To assess whether the clinical efficacy of RPC1063 is superior to interferon (IFN) *-1a (Avonex®) inreducing the rate of clinical relapses in patients with RMS.Secondary Objectives:- To assess the effect of RPC1063 on the…
The primary objective is to demonstrate the efficacy using 2 co-primary endpoints (as measured by thechanges from baseline to the end of Week 16 in Western Ontario and McMaster UniversityOsteoarthritis Index [WOMAC] pain and physical function…
• The primary objective of this study is to establish the efficacy of fostamatinib as compared with placebo in achieving a stable platelet response in subjects with persistent/chronic ITP.• Secondary objectives include assessment of the incidence of…
The primary objectives of the clinical trial are:1. To estimate the treatment benefit (AMG0001 compared to placebo), in terms of a combined endpoint (major amputations or all-cause death)2. To evaluate the overall safety and efficacy of AMG0001.
Primary objective:The primary objective of the trial is to evaluate efficacy, as measured by overall survival (OS), of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with previously untreated…
EFFICACY OBJECTIVESThe primary efficacy objective of this study is to evaluate the efficacy of intravitreal injections of 10 mg lampalizumab administered Q4W or Q6W in CFI profile biomarker positive and CFI profile biomarker-negative patients…
In the present study, we first want to investigate whether BCG-vaccination enhances the innate immune response in humans in vivo during human endotoxemia. In the second experiment we want to investigate whether BCG-vaccination can reverse the…
The primary objective is to minimize fluid reaccumulation in the hepatic cyst after aspiration sclerotherapy in order to reduce cyst size. The secondary objectives are to reduce symptoms, improve health-related quality of life (HRQL), and reduce…
The purpose of this research study is to compare 1 dose (15 ng/kg/minute) of Ularitide with a placebo-substance, to see whether Ularitide is safe and effective for the treatment of acute decompensated heart failure.
Primary:To demonstrate the efficacy of LMTM as assessed by the change from Baseline on:* Addenbrooke*s Cognitive Examination Revised (ACE-R)* Symptomatic effect as reflected by the Functional Activities Questionnaire (FAQ)* Disease-modifying effect…
Primary Objectives:* For the European Union (EU) regulatory assessment, the primary objective of Period 1 is to evaluate theefficacy of tadalafil compared with placebo, as measured by time to clinical worsening (CW) in pediatricPAH patients through…