CRU-RHUH

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CRU-RHUH

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1-     A Prospective, Multicenter, Investigator-blinded, Randomized, Comparative Study to Estimate the Safety, Tolerability and Efficacy of NXL104/Ceftazidime vs. Imipenem Cilastatin Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections in Hospitalized Adults.

2-     Assessment of Venous Thromboembolism Management in Middle-East Hospitals

3-     Efficacy and safety of irbesartan/hydrochlorothiazide combination: A comparison of active and usual titration regimen in the treatment of hypertensive patients insufficiently controlled by monotherapy.

4-     Efficacy and safety of irbesartan/amlodipine fixed combination therapy compared with amlodipine monotherapy in hypertensive patients uncontrolled on amlodipine 5 mg monotherapy. A prospective, randomized, open-label with blinded endpoint evaluation, multicenter.

5-     A Multi-National, Double Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HQK-1001 in Subjects with Beta Thalassemia Intermedia, including Hemoglobin E Beta Thalassemia

6-     Determination of Liver and Cardiac Iron Overload in Patients with Sickle Cell Disease using MRI Technique

7-     A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to estimate the safety, tolerability and efficacy of NXL104/ceftazidime plus metronidazole vs. meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults

8-     Evaluation of the Prevalence of Methicilin Resistant Staphylococcus   Aureus  (MRSA) IN Middle East Hospitalized Patients, DIREG_L_05218

9-     An Open Label, Randomized Naturalistic Study to Evaluate  the Incidence of Hypoglycemia Comparing Sitagliptin with Sulfonylurea Treatment in Patients with Type 2 Diabetes During Ramadan Fasting

10-     A prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel group, Phase III study to compare efficacy and safety of AB1010 at 9 mg/kg/day in combination with gemcitabine, to placebo in combination with gemcitabine, in treatment of patients with advanced/metastatic pancreatic cancer in progression

11-     A prospective, multicenter, randomized, open-label, active-controlled, 2-parallel group, phase III study to compare efficacy and safety of AB1010 at 7.5 mg/kg/day to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumor in first line medical treatment

12-     Centralized Pan-Levant Survey on the Under treatment of    Hypercholesterolemia

13-     Changing: Efficacy and Safety of Intensive Insulin Therapy with Insulin Glulisine in Patients with Type 2 Diabetes Inadequately Controlled with Basal Insulin and Oral Glucose –Lowering Drugs

14-     A Phase IV open-label Observational study to evaluate the efficacy and tolerance of Glucovance Æ prescribed by diabetic endocrinologists for type II diabetes patients in Middle East

15-     Identifying Predictors of Blood Pressure Control in the Lebanese Population. I-Predict (DIREG_L_05149)

16-     International Diabetes Management Practices Study. IDM PS

17-     A multicenter, prospective, observational, non-interventional cohort study evaluating on-treatment predictors of response in subjects with HBeAg negative chronic hepatitis receiving therapy with PegasysÆull ® (Peginterferon alfa-2a 40KD

18-     Use of Plavix LD in Clinical Practice in Lebanon (300)

19-     Named Patient Program Usketinumab

20-     A Phase 3,Multicenter, Randomized Double Blind, Controlled Study to Evaluate the Efficacy and Safety of Peramivir Administered Intravenously in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents who are Hospitalized due to Serious Influenza

21-     A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children with Sickle Cell Disease Previously Immunized With 23-valent Pneumococcal Polysaccharide Vaccine

22-     A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients with HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer

23-     Combination therapy of Insulin glargine and sitagliptin in patients with type 2 diabetes not adequately controlled by a previous treatment with metforminand either insulin glargine or sitagliptine

24-     Superiority study of insulin glargine over sitagliptin in insulin-naÔve patients with type 2 diabetes treated with metformin and not adequately controlled

25-     Hypovitaminosis D: A Link between Bone/Mineral and Fat/Fuel Metabolism

26-     WSA-CS-003 Open Label Study of Isavuconazole in the Treatment of Patients with Aspergillosis and Renal Impairment or of Patients with Invasive Fungal Disease Caused by Rare Molds, Yeasts or Dimorphic Fungi

27-     Trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness in Assessing the Risk Factors of Atherosclerosis

28 -      Cabazitaxel Cohort Compassionate Use Program in patients with  metastatic hormone refractory prostate cancer   previously treated with a docetaxel-containing regimen

29-     Randomized, Double-blind, Triple-dummy Trial to Compare the Efficacy of    Otamixaban with Unfractionated Heparin + Eptifibatide, in Patients with Unstable angina/Non ST  Segment Elevation Myocardial Infarction Scheduled to Undergo an Early Invasive Strategy

30-     Trial of Laflavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in Lowering Triglycerides and Raising HDL

31-     An Open-Label, Randomized, Multicenter Phase IIIb Study to assess the Efficacy, safety and Tolerance of BERIPLEXÆ P/N Compared with Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects requiring an urgent Surgical Procedure

32-     A Phase 3, Randomized, Double –Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum –or Fluoropyrimidine-Containing Combination Therapy

33-     Prosurf: The Natural Surfactant of High Biological Specific  Activity and Low Cost

34-     A Phase 2, Multicenter, Randomized , double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered  Ceftaroline Fosamil and NXL104 Versus Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections

35-     A Cluster Randomized Trial on Cardiovascular Risk Factor Mnagement: CADUETÆ Versus Usual Care in Subjects with Hypertension and Additional Cardiovascular Risk Factors in Clinical Practice

36-     A Randomized, Open-Label, Multi-Dose Study of HQP-1001 in Subjects with Sickle Cell Disease

37-     An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medications

38-     A Phase 3 Randomized, Double Blind, Placebo-Controlled Study of Tasquinimod in Men  with Metastatic Castrate-Resistant Prostate Cancer

39-     A Prospective, Multi-centre, Open-label, Single Arm Study to Assess the Effect of ConcoR (bisoprolol) on Glycaemic Levels in Type II Diabetic Patients with Hypertension

40-     Duration and Adherence to International Guidelines of VTE prophylaxis in Oncology Patients Undergoing a Major Abdominal  or Pelvic  Surgery

41-     A phase III randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg, 25 mg) administered orally, once daily over 12 weeks in hypertensive patients with type 2 diabetes mellitus

42-     A phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of once daily oral administration of BI 10773 25 mg/linagliptin 5 mg and BI 10773 10 mg/linagliptin 5 mg Fixed Dose Combination tablets compared with the individual components (BI 10773 25 mg, BI 10773 10 mg, and linagliptin 5 mg) for 52 weeks in treatment naÔve and metforrnin treated patients with type 2 diabetes mellitus with insufficient glycaemic control

43-     International Diabetes Management Practices Study, DIREG_R_05941 (Wave 5) / IDM PS

44-     Use of the Plavicx Loading Dose In Clinical Practice in Lebanon STEMI

45-     A Randomized, double-blind, double-dummy, Active-comparator Controlled Study Investigating the Efficacy and Safety of Linagliptin Co-Administered with Metformin QD at Bedtime versus Metformin BID  Over 14 Weeks in Treatment Naive Patients with Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

46-     Assessment of Venous Thromboembolism Management in the Near-East Hospitals-2

47-     LUX-Breast  1: An open label, randomized phase III  trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine  in patients with metastatic HER2-overexpressing  breast cancer  failing one prior trastuzumab treatment

48-     A Multinational, open label, randomized, active-controlled, 3-arm parallel group, 24-week study comparing the combination of glimepiride and metformin versus glimepiride and metformin alone in patients with type 2 diabetes

49-     Efficacy and Safety of Long-Term (6 Months) Innohep Æ  Treatment Versus Anticoagulation with a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT

50-     Evaluation of the Safety and EFFICACY OF Short-term A-002 Treatment in Subjects with Acute Coronary Syndromes

51-     A Randomized, Placebo-Controlled, Phase 2 Study of HQK-1001 in Sickle Cell Disease

52-     An open-Label Phase 2 Study of HQK-1001 in Subjects with Beta Thalassemia Intermedia

53-     A multinational, open label, non comparative, 24-week study to evaluate the blood glucose Lowering Efficacy and safety of  a fixed dose combination of Glimepiride and mEtformiN in patients with inadequately controlled type 2 Diabetes

54-     A Multicenter, Prospective , Observational Cohort Study to Assess the Effects of Vildagliptin  Relative to Sulphonylurea as Dual Therapy with Metformin ( or as monotherapy*) in Muslim Patients with Type 2 Diabetes Fasting During Ramadan

55-     A Multi-center, Randomized, double blind, dose escalation safety study of MP4CO in clinically stable Adult sickle Cell patients

56-     A Double Blind, Double Dummy, Randomized, Multi-Center Study to Assess the Tolerability and Efficacy Profile of Vildaglptin Compared to Gliclazide as Dual Therapy with Metformin in Muslim Patients with Type 2 Diabetes Fasting During Ramadan

57-     A 24-week phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of twice daily oral administration of empaglifozin + metformin compared with the individual components of empaglifozin or metformin in drug naÔull •ve patients with type 2 diabetes mellitus

58-     A Cluster Randomized Trial on Cardiovascular Risk Factor Mnagement: CADUETÆ Versus Usual Care in Subjects with Hypertension and Additional Cardiovascular Risk Factors in Clinical Practice

59-     A Randomized, Open-Label, Multi-Dose Study of HQP-1001 in Subjects with Sickle Cell Disease

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List of the Closed Clinical Studies at Rafik Hariri University Hospital