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Results 1 - 10 of 1326

A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 in Adult Participants with Active Systemic Lupus Erythematosus

Implementing Agency
Biogen Idec Research Limited
Project Description
This is a multicenter, randomized, parallel-group, dose-blind, Phase 3 LTE study designed to evaluate the continuous safety and efficacy of BIIB059 in adult participants with active SLE, despite the use of background nonbiologic lupus SOC therapy. This study will be conducted in participants who . . .
Cooperating Sponsor
IQVIA RDS Philippines, Inc.
Date of Registration
20 March 2023
Region
United Kingdom
Sources of Monetary or Material Support
Biogen Idec Research Limited
Primary Outcomes

1. Incidence of TEAEs
2. Incidence of SAEs

Health Condition(s) or Problem(s) Studied

Systemic Lupus Erythematosus: SLE is an autoimmune disease that affects multiple organ systems and is unpredictable in disease severity, with periods of illness or flares alternating with periods of remission.


A Phase 3 program evaluating the effect of filgotinib in subjects with active axial spondyloarthritis

Implementing Agency
Galapagos NV
Project Description
This is a Phase 3 program consisting of 2 randomized, placebo-controlled, double-blind, multi-center, parallel-group studies (Study A and Study B) to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered filgotinib for 16 weeks (doubl . . .
Cooperating Sponsor
IQVIA RDS Philippines, Inc.
Date of Registration
26 April 2023
Region
Belgium
Sources of Monetary or Material Support
Galapagos NV
Primary Outcomes

The primary objective is to :
To compare the efficacy of filgotinib 200 mg versus placebo on:
− Signs and symptoms

Health Condition(s) or Problem(s) Studied

Axial spondyloarthritis


Accuracy of Physical Examination Compared to Doppler Ultrasound in Detection of Early Arteriovenous Fistula Failure Among Hemodialysis Patients

 

Implementing Agency
Southern Philippines Medical Center, Davao City, Philippines
Project Description
            This is a multi-center analytical prospective cohort study designed to evaluate the outcome of the arteriovenous fistula of ESRD patients at 4-6 weeks after surgery. The general objective . . .
Cooperating Sponsor
Southern Philippines Medical Center, Davao City, Philippines
Date of Registration
05 June 2023
Region
Region XI
Primary Outcomes

Incidence of Early AVF Failure

Health Condition(s) or Problem(s) Studied

Patients with End-Stage Renal Disease on maintenance hemodialysis who underwent AVF creation.


RELATIONSHIP BETWEEN MENTAL DISORDERS AND SKIN DISEASES AMONG OUTPATIENTS AT SOUTHERN PHILIPPINES MEDICAL CENTER

Implementing Agency
Southern Philippines Medical Center, Department of Dermatology
Project Description

This is a prospective research study to determine the relationship between mental health disorders and skin diseases among patients seen at the outpatient department in Dermatology

Cooperating Sponsor
Southern Philippines Medical Center, Department of Dermatology
Date of Registration
02 June 2023
Region
Region XI
Sources of Monetary or Material Support
Southern Philippines Medical Center, Department of Dermatology
Primary Outcomes

TO determine the relationship between mental disorders and skin diseases

Health Condition(s) or Problem(s) Studied

Mental disorders

Skin diseases


Determining the Required Skill Mix to Deliver Primary Health Care Services: Phase 2 (Validation)

Implementing Agency
University of the Philippines - Manila, College of Nursing
Project Description
An adequate number and type of trained health workers is a key component of the health system in the delivery of health services. The Philippines is facing challenges in the human workforce/resource for health (HRH) such as shortages, inadequate skill mix and inequitable distribution of health wo . . .
Cooperating Sponsor
Department of Health, Health Policy Development and Planning Bureau
Date of Registration
23 January 2023
Region
NCR
Sources of Monetary or Material Support
DOST-PCHRD
Primary Outcomes

Initiatives that foster a positive work environment that does not demoralize health workers, with the potential to increase workload efficiency thus addressing the target of providing universal health care to every Filipino.

Health Condition(s) or Problem(s) Studied

This study will provide validation to the recommended HRH skill mix according to the different contexts in the Philippines according to the standards of WHO in HRH. The results will contribute to achieving UHC in the Philippines by providing evidence for ensuring equitable distribution of HRH through providing recommendations for adequate staffing patterns and appropriate skill mix in health facilities among healthcare provider networks (HCPNs). Furthermore, the study will advance the use of HRH data for health decision and policy making at the local, regional, and national levels.


Perceptions of Filipino Physical Therapists on Tele-Ergonomics: A Phenomenological Qualitative Study

Implementing Agency
University of Santo Tomas - College of Rehabilitation Sciences
Project Description
Background: Tele-ergonomics is a telehealth service that shows great potential use given the people’s growing reliance on the internet highlighted during the COVID-19 pandemic. Various studies have been conducted internationally regarding the implementatio . . .
Date of Registration
16 February 2023
Region
NCR
Sources of Monetary or Material Support
University of Santo Tomas - College of Rehabilitation Sciences
Primary Outcomes

Outcome Name: Perceptions of Filipino physical therapists on tele-ergonomics

Method of measurement: Key-informant interviews

Timepoint: N/A

Health Condition(s) or Problem(s) Studied

Perceptions of Filipino physical therapists on tele-ergonomics.


Skeletal Muscle Mass Among Postmenopausal Filipino Women and its Relationship with Bone Mineral Density and FRAX-based Fracture Risks

Implementing Agency
University of the Philippines - Philippine General Hospital
Project Description

The general objective of the study is to measure the skeletal muscle mass of postmenopausal Filipino women and its relationship with bone mineral density (BMD) and FRAX-based fracture risks.

Date of Registration
23 January 2023
Region
NCR
Sources of Monetary or Material Support
Self-funded
Primary Outcomes
Age, body mass index (BMI), total body skeletal muscle mass (SMM), height-adjusted appendicular skeletal muscle mass (ASM), lumbar spine BMD, femoral neck BMD (whichever is lower between right femur and left femur), total hip BMD (whichever is lower between right femur and left femur), FRAX with . . .
Health Condition(s) or Problem(s) Studied

Skeletal muscle mass, bone mineral density, and FRAX-based fracture risks


Level and Specificity of Cardiac Troponin I in Asymptomatic Long-term Hemodialysis Patients

Implementing Agency
Southern Phiippines Medical Center
Project Description
The study will make use of a prospective cross-sectional design. The study will recruit patients from the list of patients enrolled at the outpatient renal dialysis unit who are asymptomatic and ambulatory at the time of treatment and the level of troponin I will be measured before and after dial . . .
Cooperating Sponsor
Southern Phiippines Medical Center
Date of Registration
17 April 2023
Region
Region XI
Sources of Monetary or Material Support
Southern Phiippines Medical Center
Primary Outcomes

Level and Specificity of Cardiac Troponin I in Asymptomatic Long-term Hemodialysis Patients

Health Condition(s) or Problem(s) Studied

End stage kidney disease


Next generation T-cell vaccine against Coronavirus disease (COVID19)

Implementing Agency
Emergex Vaccines Holding Limited,
Project Description
A Phase I-II, double-blind, randomized, placebo-controlled study investigating the safety and immunogenicity of a T cell priming next-generation vaccine against Coronavirus disease in healthy adults. The clinical study will enroll 110 participants (88 vaccine vera and 22 placebo, [split 50:50 be . . .
Cooperating Sponsor
PPD Pharmaceutical Development Philippines Corporation
Date of Registration
26 April 2023
Region
England
Sources of Monetary or Material Support
Emergex Vaccines Holding Limited,
Primary Outcomes

To assess the safety, tolerability and reactogenicity of the vaccine.

Health Condition(s) or Problem(s) Studied

As this is an early phase trial with a focus on safety, participant numbers are limited to power the detection of adverse events with high incidence rates.


A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized,
Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the
Efficacy and Safety of BIIB059 in Participants with Active Subacute
Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus
Erythematosus with or without Systemic Manifestations and Refractory
and/or Intolerant to Antimalarial Therapy (AMETHYST)

Implementing Agency
Biogen Idec Research Limited
Project Description
This is a 2-part, seamless, randomized, double-blind, placebo-controlled, multicenter, Phase 2/3 study. Part A (Phase 2) is intended to confirm the adequacy of the performance of the CLA-IGA-R instrument to be implemented as a primary endpoint in the Phase 3 portion of the study in the US. Part B . . .
Cooperating Sponsor
IQVIA RDS Philippines, Inc.
Date of Registration
21 April 2023
Region
United Kingdom
Sources of Monetary or Material Support
Biogen Idec Research Limited
Primary Outcomes

Proportion of participants who achieve a CLA-IGA-R Erythema score of 0 or 1, defined as clear or almost clear skin disease activity at Week 16.

Health Condition(s) or Problem(s) Studied

Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus
Erythematosus with or without Systemic Manifestations and Refractory
and/or Intolerant to Antimalarial Therapy


Results 1 - 10 of 1326
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