Clinical Investigation Centre

Clinical Investigation Centre

Clinical Investigation Centre

Clinical Investigation Centre

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PERISTIWA & BERITA
BOOTH OPENING IN CONJUCTION WITH THE CRC AWARENESS MONTH 2023

On 24th March 2023 – Booth opening by CIC in conjunction with the CRC Awareness Month 2023 at Menara Utama Ground Floor.#BeAHero#CIC#UMMC#LeaderinClinicalResearch#ClinicalResearchinMalaysia#ClinicalInvestigationCentre#MedicalDevice#Phase1#phaseoneB#medicineumalaya#colorectalcancer#colorectalcancerawareness

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No. Study Title Specialty Study Status
1. A phase 4 Double-blinded, randomized, active comparator-controlled clinical trial to study the eficacy, safety, and pharmacokinetics of sugammadex (MK-8616) for reversal of neuromuscular blockade in Pediatric participants aged birth to <2 years. Anesthesiology Open
2. A Post Market Registry of Abluminus® Sirolimus Eluting Coronary Stent System for Percutaneous Intervention in Patients With Diabetes Mellitus Cardiology Open
3. INTERSPIRE- a survey of cardiovascular disease prevention, diabetes and chronic kidney disease in partnership with the world heart federation, European society of cardiology, the Euro observational research programme and the euroaspire survey
4. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction >/= 40% (LVEF >/= 40%)
5. Effects of Semaglutide on functional capacity in patients with type 2 diabetes and peripheral arterial disease
6. Diabetes and Cardiometabolic research
7. A Phase 3b, open-label treatment extension study of upadacitinib for the treatment of adult subjects with moderate to severe atopic dermatitis who completed treatment in study M16-046 Dermatology Open
8. A prospective, multicentric, single-arm study to evaluate the safety and efficacy of the UNITY-B Biodegradable Balloon Expandable Biliary Stent System in subjects with biliary strictures Gastroenterology Open
9. Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment with GSK3228836 in Participants with Chronic Hepatitis B Virus (B-Clear)
10. A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218 Alone or in Combination with Pegylated Interferon Alpha-2a
11. A phase 2b/3, randomized, double-blind, placebo-controlled, parallel-group, multicenter protocol to evaluate the efficacy and safety of Guselkumab in participants with moderately to severely active Ulcerative Colitis.
12. An open-label, non-randomized, multi-center extension study to evaluate the long-term safety and efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) Haematology Open
13. A randomized, double-blind, placebo-controlled phase III multi-center study of azacitidine with or without MBG453 for the treatment of patients with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
14. Implementation of the National Antimicrobial Prescribing Survey (NAPS) And Identification of Targets to Improve Judicious Use of Antimicrobials and Evaluation of Interventions to Address these Targets in Two Malaysia Teaching Hospitals, University of Malaya Medical Centre (UMMC) and the Malaysia National University Medical Centre (UKMMC) Infectious Disease Open
15. A Prospective, Randomized, Open-Label, Comparative Study to Assess The Efficacy, Safety And Tolerability of Aztreonam-Avibactam (ATM-AVI) And Best Available Therapy For The Treatment Of Serious Infections Due To Multi-Drug Resistant Gram-Negative Bacteria Producing Metallo-Β-Lactamase (MBL)
16. Open-Label Randomised Controlled Trial of Efepoetin Alfa for Treatment of Anemia Associated with Chronic Kidney Disease Patients not on Dialysis (ND-CKD). A Non-Inferiority Trial Compared to Methoxy Polyethylene Nephrology Open
17. ACHIEVE – Adolsterone blockade for Health Improvement Evaluation in End-stage renal disease
18. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A (IgA) Nephropathy
19. High risk screening for late onset prompe disease in Malaysia patients with Limb -Girdle Muscular weakness and/or Hyperchemia.
20. Understanding the impact of Migraine on work productivity and healthcare cost using self-reported data from the Migraine-Buddy application in Malaysia
21. A two-part randomized, Phase 3 Study of combinantions of cemiplimab (Anti-PD-1) Antibody and Platinum- based Doublet Chemotheraphy in First-line treatment of patients with advanced or Metastatic non-small cell lung cancer Oncology Open
22. Hyperthermia in treating patients with painful unresectable abdominal or pelvic malignancy.
23. Immune modulatory effect of hyperthemia during treatment of recurrent or metastatic solid organ malignancies
24. A Phase III, Randomized, Double-blind, Clinical Trial of Pembrolizumab (MK-3475) plus Chemotherapy (XP or FP) versus Placebo plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)
25. A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)
26. A Phase 1b/2 Open-Label Study to Evaluate Pharmacokinetics, Safety, Efficacy and Pharmacodynamics of PF-06801591 (PD-1 inhibitor) in Paticipants with Advanced Malignancies
27. EPIK-B3: A Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab-paclitaxel in patients with advanced triple negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation.
28. A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
29. A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPS)
30. Biomarker study to determine frequency of DNA-repair defects in men with metastatic prostate cancer.
31. A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
32. A Phase III, randomized, double-blind, placebo-controlled, multicenter, international study of osimertinib as maintenance therapy in patients with locally advanced, unresectable EGFR mutation-positive Non-Small Cell Lung Cancer (Stage III) whose disease has not progressed following definitive platinum-based chemoradiation therapy (LAURA)
33. A Phase 3 Study to Evaluate Zimberelimab (AB122) Monotherapy Compared to Standard Chemotherapy or Zimberelimab Combined with AB154 in Front-Line, PD-L1-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
34. Reference range establishment for high sensitivity troponin i (hstrop i) in a multi- ethnic population Ophtalmology Open
35. A double-blinded, randomized, placebo-controlled study to evaluate the efficacy and safety of odevixibat (A4250) in children with Biliary Atresia who have undergone a kasai hepatoportoenterostomy (BOLD) Paediatrics Open
36. 1/2 PROSpect: Prone and Oscillation Pediatric Clinical Trial (CCC)
37. Efficacy and safety of oral semaglutide versus placebo both in combination with metformin and/or basal insulin in children and adolescents with type 2 diabetes
38. A Double-Blind Placebo-Controlled, Randomized Withdrawal Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-Redcution Paradigm in the Prevention of Relapse in Patients with Schizophrenia Psychological Medicine Open
39. A Randomized, Open-Label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor
40. A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1, 50% Respiratory Disease Open
41. Incidence of E-Cigarette or Vaping Product Use Associated Lung Injury (EVALI) among Severe Acute Respiratory Infections (SARI) Patients in University Malaya Medical Center (UMMC)
42. A Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Lazertinib versus Gefitinib as the First-line Treatment in Patients with Epiderman Growth Factor Receptor Sensitizing Mutation Positive, Locally Advanced or Metatastic Non-Small Cell Lung Cancer
43. A 52-week, phase 3, multicenter, randomized, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. Rheumatology Open
44. A randomized, double-blind, placebo-controlled, parallel group, phase III multicenter study of intravenous secukinumab to compare efficacy at 16 weeks with pla-cebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis or non-radiographic axial SpondyloArthritis
45. Bioengineered collagen scaffold as an alternative to conventional buccal mucosa for substitution urethroplasty of distal urethral strictures-A pilot study Surgery Open
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