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A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (MDI) Relative to Budesonide and Formoterol Fumarate MDI and Symbicort® Pressurized MDI in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS)

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This is a Phase III randomized, double-blind, double dummy, parallel group, multicenter variable length efficacy and safety study comparing two doses of BGF MDI (320/28.8/9.6 µg and 320/14.4/9.6 µg) to BDD MDI 320/9.6 µg (an ICS/LABA currently under development) and Symbicort pMDI 320/9 µ . . .
Primary Sponsor
AstraZeneca Pharmaceuticals (Philippines) Inc.
Study Type
Interventional
Date of Registration
06 February 2021
Date of FIrst Enrollment
01 April 2021
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2020-CT0581
Sources of Monetary or Material Support
AstraZeneca Pharmaceuticals (Philippines) Inc.
Primary Outcomes
  • Change from Baseline in FEV1 AUC0-3 (US Primary Endpoint)
  • Change from Baseline in Morning Pre-dose Trough FEV(EU and Japan Primary Endpoint)
Key Inclusion and Exclusion Criteria
Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: Age Participant must be at least 12 to 80 years of age inclusive, at the time of signing the ICF. . . .
Countries of Recruitment
Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Denmark, France, Hungary, India, Italy, Japan, Netherlands, Peru, Philippines, Poland, Romania, South Korea, Spain, Taiwan, Thailand, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Adult and Adolescent Participants with Inadequately Controlled Asthma


A prospective, randomized, open-label, comparative study to assess the efficacy, safety and tolerability of aztreonam-avibactam (ATM-AVI) and best availability therapy for the treatment of serious infections due to multi-drug resistant gram-negative bacteria producing metallo-β-lactamase (MBL)

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI), nosocomial pneumonia (NP) including hospital acquired pneumonia (HAP . . .
Primary Sponsor
Pfizer Inc.
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
13 March 2021
Date of FIrst Enrollment
01 April 2021
Region
NCR
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2020-CT0578
Sources of Monetary or Material Support
Pfizer Inc.
Primary Outcomes

Primary Outcome Measures:
1. Proportion of subjects with clinical cure in the microbiological Intent-To-Treat (micro-ITT) analysis set [Time Frame: Up to 31 day ]
Proportion of subjects with clinical cure at the TOC visit in the micro-ITT analysis set

Key Inclusion and Exclusion Criteria
Inclusion Criteria All Subjects1. Subject must be ≥18 years of age.2. Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study.3. Subjects must . . .
Countries of Recruitment
Greece, India, Malaysia, Philippines, Romania, Russia, Taiwan, United States, Hungary, India, Italy, Japan, Netherlands, Peru, Philippines, Poland, Romania, South Korea, Spain, Taiwan, Thailand, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Serious bacterial infection


Characteristics of musculoskeletal signs and symptoms during the recovery phase of moderate to severe COVID-19 patients at the Philippine General Hospital

Recruitment Status
Completed
Project Status
Ongoing
Project Description
We aim to characterize musculoskeletal signs and symptoms among adults in the recovery phase from moderate to severe COVID-19. To achieve this, we sought to explore and analyze patient musculoskeletal complaints, develop and validate a musculoskeletal monitoring and evaluation tool, and describe . . .
Primary Sponsor
University of the Philippines - Philippine General Hospital
Secondary Sponsor
University of the Philippines - Philippine General Hospital
Study Type
Observational
Date of Registration
22 August 2021
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Non-Randomized
Masking
Open Label
Assignment
Not Applicable
Phase
Phase II/III
Sources of Monetary or Material Support
University of the Philippines - Philippine General Hospital
Primary Outcomes
. The study describes the epidemiologic profile, the musculoskeletal signs and symptoms of the patients 2 weeks after moderate to severe Covid 19 infection and admitted in the UP-Philippine General Hospital. The study describes an appropriate tool for focused and thorough . . .
Key Inclusion and Exclusion Criteria
Inclusion criteria COVID-19 positive on RT- PCR-based test, admitted to PGH COVID ward Aged 18 years old and above Recovery phase, Glasgow Coma Scale 15, afebrile, with stable vital signs for at least 48 hours prior to recruitment, no cough, not v . . .
Countries of Recruitment
Philippines, India, Malaysia, Philippines, Romania, Russia, Taiwan, United States, Hungary, India, Italy, Japan, Netherlands, Peru, Philippines, Poland, Romania, South Korea, Spain, Taiwan, Thailand, United States, Vietnam
Health Condition(s) or Problem(s) Studied

This is a prospective observational descriptive study of moderate to severe COVID-19 aged 18 years old and above at UP PGH. It was done in phases: an exploratory phase to determine common signs and symptoms coming from patient reports. These signs and symptoms were then used to develop an appropriate structured questionnaire or assessment tool, which has undergone translation and validation. We implemented the tool over a cohort of 40 patients in their recovery phase from moderate to severe COVID-19, two weeks after clinical improvement or testing negative from Covid-19.


A 12-week, multicenter, randomized, double-blind, parallel-arm, placebo-controlled study to assess the efficacy and safety of CSJ117, when added to existing asthma therapy in patients ≥18 years of age with severe uncontrolled asthma

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV . . .
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
11 December 2020
Date of FIrst Enrollment
17 March 2021
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2020-CT0572
Sources of Monetary or Material Support
Novartis Pharma Services AG
Primary Outcomes

Average change from baseline in pre-dose FEV1 (L) at Week 8 and Week 12.

Key Inclusion and Exclusion Criteria
Key Inclusion criteria ·       Documented physician-diagnosed asthma (according to GINA 2019) for at least 12 months prior to screening. ·       Patients who hav . . .
Countries of Recruitment
Argentina, Belgium, Bulgaria, Canada, Czech Republic, Germany, Guatemala, Hungary, Italy, Japan, Latvia, Poland, South Korea, United States, Philippines, Poland, Romania, South Korea, Spain, Taiwan, Thailand, United States, Vietnam
Health Condition(s) or Problem(s) Studied

severe uncontrolled asthma


A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK119 in Healthy Subjects and Patients with Mild or Moderate Symptoms of COVID-19

Recruitment Status
Pending
Project Status
Terminated
Project Description
This is a Phase I randomized, double-blind, placebo-controlled, single dose escalation, first-in-human study evaluating the safety, PK profile, and immunogenicity of a single dose of AK119 in healthy subjects and patients with mild to moderate symptoms of COVID-19. This study consists of 2 parts: . . .
Primary Sponsor
Novotech (Australia) Pty. Ltd. - Philippine Branch
Secondary Sponsor
Novotech (Australia) Pty. Ltd. - Philippine Branch
Study Type
Observational
Date of Registration
11 March 2021
Date of FIrst Enrollment
11 March 2021
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase I
FDA Clinical Trial Reference (CTR) Number
2020-CT0587
Sources of Monetary or Material Support
Akesobio Australia Pty. Ltd.
Primary Outcomes
Part A: Healthy Subjects (single New Zealand site only)Primary Objectives• To evaluate the safety and tolerability of a single dose of AK119 in healthy subjects. Part B: Patients with Mild or Moderate Symptoms of COVID-19 (multiple sites in the Philippines and Malaysia) . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria (Part A and Part B) 1. Willing and able to understand and sign an ICF, which must be obtained prior to performing any protocol-related procedures, including Screening evaluations.2. Women or men between 18 and 55 years of age, inclusive, at Screening.3. Must . . .
Countries of Recruitment
Philippines, Belgium, Bulgaria, Canada, Czech Republic, Germany, Guatemala, Hungary, Italy, Japan, Latvia, Poland, South Korea, United States, Philippines, Poland, Romania, South Korea, Spain, Taiwan, Thailand, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Healthy Subjects and Patients with Mild or Moderate Symptoms of COVID-19


A Phase 1b Randomized, Double-blind, Placebo-controlled, Multiple Ascending-dose Study of EQ001 in Subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis

Recruitment Status
Pending
Project Status
Ongoing
Project Description
The study has 2 patient populations being studies in separate dose escalation cohorts: Type A (Systemic Lupus Erythematosus) patients and Type B patients (Lupus Nephritis). The Philippines will only take part in identifying and enrolling Type B patients for those cohorts of the study. To qualify . . .
Primary Sponsor
Equillium Inc.
Study Type
Interventional
Date of Registration
08 October 2020
Date of FIrst Enrollment
01 March 2021
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase I
FDA Clinical Trial Reference (CTR) Number
2020-CT0562
Sources of Monetary or Material Support
Equillium Inc.
Primary Outcomes

Safety and tolerability of EQ001, as assessed by treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), clinical laboratory values, vital signs, 12-lead electrocardiogram (ECG), and physical examinations 

Key Inclusion and Exclusion Criteria
Type B Cohort Inclusion Criteria. Subjects will be required to meet all of the following inclusion criteria in order to be eligible for study enrollment: Is male or female, age ≥ 18 and ≤ 75 years Has provided written informed consent prior to partici . . .
Health Condition(s) or Problem(s) Studied

Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis


Well-being and Exergaming

Recruitment Status
Completed
Project Status
Completed
Project Description
This is a randomized controlled trial study that aims to determine the effectiveness of exergaming in improving the well-being of older adults living in institutionalized centers. Well-being is defined by a person's feelings, positive functioning, and evalu . . .
Primary Sponsor
University of Santo Tomas, College of Rehabilitation Sciences
Study Type
Interventional
Date of Registration
23 March 2021
Date of FIrst Enrollment
01 March 2021
Region
Philippines
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Single
Phase
Phase 0
Sources of Monetary or Material Support
Self-funded
Primary Outcomes
The outcome of this study is well-being, and given the confusion regarding the definition of well-being and what it encompasses, it is challenging to accurately measure it. To assess the subjects well-being Short Form – 36 (SF-36) will be utilized as it consists of 36 items divided into ei . . .
Key Inclusion and Exclusion Criteria
  Inclusion Criteria Exclusion Criteria Older adu . . .
Countries of Recruitment
Philippines, Belgium, Bulgaria, Canada, Czech Republic, Germany, Guatemala, Hungary, Italy, Japan, Latvia, Poland, South Korea, United States, Philippines, Poland, Romania, South Korea, Spain, Taiwan, Thailand, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Well-being is defined by a person's feelings, positive functioning, and evaluation of self-fulfillment or satisfaction with life [1,2]. A person's feelings should involve positive emotions and moods (e.g., contentment, happiness) and fewer negative emotions (e.g., depression, anxiety) [2]. Well-being is primarily focused on six thematic dimensions: physical well-being, emotional well-being, psychological well-being, social well-being, spiritual well-being, and activities and functioning [3]. Age can substantially influence well-being; as people get older, they become more vulnerable to physical, psychological, and social factors, predisposing them to musculoskeletal disorders and other conditions [4]. In addition, older adults may lack interest in leisure activities due to physical limitations, leading to diminished social integration [5] and fostering loneliness and affecting their mental health [6]. Overall, the well-being of these individuals is often overlooked and not prioritized.

 

References:

1. Camitan DS, Bajin LN. The Importance of Well-Being on Resiliency of Filipino Adults During the COVID-19 Enhanced Community Quarantine: A Necessary Condition Analysis. Frontiers in Psychology 2021;12:1–13.

2. nef. Measuring Well-being A guide for practitioners Measuring Well-being 2.

3. Linton M, Dieppe P, Medina-Lara A. Review of 99 self-report measures for assessing well- being in adults: exploring dimensions of well-being and developments over time. BMJ Open 2016;6, DOI: 10.1136/BMJOPEN-2015-010641.

4. Briggs A, Cross M, Hoy D et al. Musculoskeletal Health Conditions Represent a Global Threat to Healthy Aging: A Report for the 2015 World Health Organization World Report on Ageing and Health. The Gerontologist 2016;56:S243–55.

5. Toepoel V. Ageing, Leisure, and Social Connectedness: How could Leisure Help Reduce Social Isolation of Older People? Social Indicators Research 2013;113:355.

6. Stephens C, Alpass F, Towers A et al. The Effects of Types of Social Networks, Perceived Social Support, and Loneliness on the Health of Older People: Accounting for the Social Context. Journal of Aging and Health 2011;23:887–911.


A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (EMERALD-2)

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy. This study will be conducted in patients with HCC who are at high . . .
Primary Sponsor
AstraZeneca AB
Study Type
Interventional
Date of Registration
11 March 2021
Date of FIrst Enrollment
01 March 2021
Region
Sweden
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2020-CT0582
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes

Recurrence-free survival (RFS) using Blinded independent central review (BICR) assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Key Inclusion and Exclusion Criteria
INCLUSION CRITERIA Informed consent1 Provision of signed and dated written informed consent form (ICF) and any locally required authorization (eg, Health Insurance Portability and Accountability Act i . . .
Countries of Recruitment
Australia, Austria, Bassas da India, Brazil, Canada, China, Egypt, France, Germany, Hong Kong, Italy, Japan, Peru, Philippines, Poland, Russia, Singapore, South Korea, Taiwan, Thailand, Thailand, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation


Prospective, Non-Randomized, Open-Label, Multi-Center, Single Arm Study of Exchange of Travoprost Intraocular Implant 

Recruitment Status
Completed
Project Status
Ongoing
Project Description
This prospective, non-randomized, open-label, multi-center, single arm, clinical trial intends to exchange the implant in approximately 45 male and female subjects who were previously implanted with the Travoprost Intraocular Implant in the GC-009 study (1st Cycle). All subjects are required to m . . .
Primary Sponsor
Asian Eye Institute
Secondary Sponsor
Asian Eye Institute
Study Type
Interventional
Date of Registration
25 June 2021
Date of FIrst Enrollment
01 March 2021
Region
NCR
Method of Allocation
Non-Randomized
Masking
Open Label
Assignment
Not Applicable
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2020-CT0577
Sources of Monetary or Material Support
Glaukos Corporation
Primary Outcomes

Primary outcome is to evaluate the safety of the surgical exchange procedure of Travoprost Intraocular Implant

 

 

 

 

Key Inclusion and Exclusion Criteria
INCLUSION CRITERIA1) Subject status as follows:a. able and willing to attend scheduled follow-up exams for theduration of the studyb. able and willing to provide written informed consent on the . . .
Countries of Recruitment
Philippines, United States, Bassas da India, Brazil, Canada, China, Egypt, France, Germany, Hong Kong, Italy, Japan, Peru, Philippines, Poland, Russia, Singapore, South Korea, Taiwan, Thailand, Thailand, United States, Vietnam
Health Condition(s) or Problem(s) Studied

This study is for the treatment of Open-Angle Glaucoma


A Phase 2, Randomized, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Several Doses of Antigen and MF59 Adjuvant Content in a Monovalent H5N1 Pandemic Influenza Vaccine in Healthy Pediatric Subjects 6 Months to < 9 Years of Age

Recruitment Status
Completed
Project Status
Ongoing
Project Description
This randomized, observer blind, multi-center clinical trial evaluates the immunogenicity in healthy children 6 months to < 9 years of age utilizing 6 different aH5N1 vaccine formulations, in order to describe the possible impact of decreasing the quantities of antigen and/or adjuvant dosage o . . .
Primary Sponsor
Seqirus UK Limited
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
29 April 2020
Date of FIrst Enrollment
18 February 2021
Region
United Kingdom
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Not Applicable
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2020-CT0528
Sources of Monetary or Material Support
Seqirus UK Limited
Primary Outcomes
Primary Safety Objective: To evaluate the safety in each study vaccine group from Day 1 through Day 387, by total population and by age cohort Primary Immunogenicity Objective: To assess by total population and by age cohort, the antibody responses to each of the study vaccine . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria 1. Healthy male and female subjects of 6 months through 2. Documented consent provided by the subject's parent(s)/LAR(s) have voluntarily given written informed consent/assent after the nature of the study has been explained according to local regulatory . . .
Countries of Recruitment
Estonia, Philippines, Bassas da India, Brazil, Canada, China, Egypt, France, Germany, Hong Kong, Italy, Japan, Peru, Philippines, Poland, Russia, Singapore, South Korea, Taiwan, Thailand, Thailand, United States, Vietnam
Health Condition(s) or Problem(s) Studied

H5N1 pandemic influenza


Results 91 - 100 of 601
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