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Results 51 - 60 of 635

EFFICACY OF DRY HYDROGEN PEROXIDE TECHNOLOGY IN REDUCING MICROBIAL COLONIZATION IN THE AIR AND HIGH TOUCH AREAS IN A TERTIARY HOSPITAL IN THE PHILIPPINES

 

Recruitment Status
Pending
Project Status
Pending
Project Description
Isolation rooms in the hospital that have no proper ventilation may increase the possibility of more pathogenic microbes circulating in the air and hospital equipment that may transmit and be the cause of hospital acquired infections. Droplet nuclei that transmit TB infection have remained a conc . . .
Primary Sponsor
Philippine General Hospital
Study Type
Interventional
Date of Registration
02 December 2021
Date of FIrst Enrollment
30 November -0001
Region
Philippines
Method of Allocation
Non-Randomized
Masking
Open Label
Assignment
Crossover
Phase
Phase II/III
Sources of Monetary or Material Support
Pediatric Infectious Disease Society of the Philippines
Primary Outcomes
The primary objective of this study is to assess the efficacy of a DHP microbial reduction system (Synexis TM) as an adjunct to routine environmental cleaning and disinfection in reducing the degree of air and surface microbial contami . . .
Key Inclusion and Exclusion Criteria
The principal investigators will obtain verbal and written consent from each patient and/or one or both parents or legal guardian upon admission to the isolation rooms of the identified units in the hospital. All . . .
Health Condition(s) or Problem(s) Studied

A better understanding of what organisms are circulating in the Isolation Rooms while the patients are admitted would be able to evaluate the risk of the patients and their caregivers to these infectious agents. A devise such as DHP (Synexis TM) as an adjunct to regular cleaning of the rooms may be able to attempt to reduce exposure and control the disease.

 


A Phase 2/3 Randomized, Controlled, Open-Label Study of KRT-232 in Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post-ET-MF) who are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This global, multicenter, Phase 2 (Part A)/3 (Part B) randomized, controlled, open-label study will evaluate the safety and efficacy of KRT-232 versus BAT for the treatment of Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV-MF), or Post-Essential Thrombocythemia MF (post-ET-MF) in . . .
Primary Sponsor
Kartos Therapeutics, Inc.
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
13 December 2021
Date of FIrst Enrollment
07 June 2022
Region
United States of America
Method of Allocation
Randomized
Masking
Open Label
Assignment
Not Applicable
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2021-CT0641
Sources of Monetary or Material Support
Kartos Therapeutics, Inc.
Primary Outcomes

The proportion of subjects in each arm achieving SVR of ≥ 35% at Week 24 by MRI/CT scan (central review)

Key Inclusion and Exclusion Criteria
Inclusion Criteria: 1. Adults >18 years of age2. Confirmed diagnosis of PMF, post–PV-MF, or post-ET-MF, as assessed by treating physician according to the World Health Organization (WHO) criteria. 3. High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynam . . .
Countries of Recruitment
Australia, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Philippines, Poland, Spain, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV-MF), or Post-Essential Thrombocythemia MF (post-ET-MF) 


Etonogestrel subdermal implant for the management of endometriosis-associated pain after ovarian-sparing surgery

Recruitment Status
Pending
Project Status
Pending
Project Description
This study aims to determine efficacy of ENG subdermal implant as management for endometriosis-associated pain after ovarian-sparing surgery compared to the GnRH agonist. At optimal dosing, GnRH agonist has been proven to be the most effective in reducing endometriosis-associated pain. However, . . .
Primary Sponsor
UP Manila
Study Type
Interventional
Date of Registration
31 December 2021
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Not Applicable
FDA Clinical Trial Reference (CTR) Number
NA
Sources of Monetary or Material Support
Merck Sharp & Dohme Corporation
Primary Outcomes
Outcome : Pain control Method of measurement: VAS Scores for endometriosis-related pain (worst pain) Timepoint: Baseline then 1 month, 3 months, 6 months, 12 months after surgery   Outcome: Health-related Quality of Life Method of . . .
Key Inclusion and Exclusion Criteria
The study population will include premenopausal women aged 18-49 years old who are diagnosed with endometriosis and are scheduled to undergo ovarian-sparing surgery.   Inclusion criteria: Women aged 18-49 years old With symptomatic painful dysme . . .
Health Condition(s) or Problem(s) Studied

Postoperative medical management of pelvic endometriosis


A study to test whether different doses of BI 690517 alone or in combination with empagliflozin improve kidney function in people with chronic kidney disease

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This trial is a multicentre, randomised, double-blind, parallel dose group, placebo-controlled clinical trial to investigate the effect of three doses of BI 690517 alone, and in combination with empagliflozin, in patients with diabetic and non-diabetic chronic kidney disease (CKD) who are on back . . .
Primary Sponsor
Boehringer Ingelheim (Philippines), Inc.
Study Type
Interventional
Date of Registration
14 January 2022
Date of FIrst Enrollment
30 March 2022
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2021-CT0651
Sources of Monetary or Material Support
Boehringer Ingelheim Singapore, Pte. Ltd.
Primary Outcomes
Primary objective: to demonstrate the efficacy of BI 690517, alone and in combination with empagliflozin, and to characterise the BI 690517 dose-response relationship in patients with diabetic and non-diabetic chronic kidney disease by assessing 3 doses and placebo Primary endpoint: Chang . . .
Key Inclusion and Exclusion Criteria
Main Inclusion: Male or female patients of legal adult age (according to local legislation) and aged ≥18 years at time of consent estimated Glomerular Filtration Rate (eGFR) ≥ 30 and <90mL/min/1.73m2 Urine Albumin Creatinine Ratio (UACR) ≥200 . . .
Countries of Recruitment
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Portugal, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, Ukraine, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Treatment of Diabetic or Non-Diabetic Chronic Kidney Disease


A multicenter, randomized, double-blind, placebo-controlled Phase II/III trial to evaluate the efficacy, safety and immunogenicity of the recombinant two-component COVID-19 vaccine (CHO cell) in adults aged 18 years and
older.

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This study is a global multicenter, randomized, double-blind, placebo-controlled, operationally seamless adaptive designed Phase II/III clinical trial. The objectives of Phase II stage are to evaluate the safety and immunogenicity of ReCOV in adults aged 18 years and older, to support the initiat . . .
Primary Sponsor
Jiangsu Recbio Technology Co., Ltd.
Secondary Sponsor
Tigermed Services Philippines Inc.
Jiangsu Recbio Technology Co., Ltd.
Study Type
Interventional
Date of Registration
08 February 2022
Date of FIrst Enrollment
28 January 2022
Region
China
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2021-CT0653
Sources of Monetary or Material Support
Jiangsu Recbio Technology Co., Ltd.
Primary Outcomes
Phase II Primary Outcome: Safety: To evaluate the safety and reactogenicity of the recombinant two-component COVID-19 vaccine (CHO cell) (ReCOV for short) in adults aged 18 years and older. Endpoints: The occurren . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: 1. Aged 18 years and older.2. Able and willing to comply with all study requirements.3. Willing to allow investigators to discuss the medical history with his/her general practitioner/personal doctors and access all medical records which a . . .
Countries of Recruitment
Philippines, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Portugal, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, Ukraine, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Prevention of Coronavirus Disease 2019 (COVID-19) caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).


A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ANX005 in Subjects with Guillain Barré Syndrome (GBS)

Recruitment Status
Pending
Project Status
Ongoing
Project Description

This study is intended to evaluate the efficacy and safety of ANX005 administered by intravenous (IV) infusion to participants recently diagnosed with Guillain-Barré Syndrome (GBS). The total duration of study participation is approximately 6 months.

Primary Sponsor
Annexon, Inc.
Secondary Sponsor
Ascent Therapeutics Corp. (Ascent Development Services)
Jiangsu Recbio Technology Co., Ltd.
Study Type
Interventional
Date of Registration
18 March 2022
Date of FIrst Enrollment
30 November -0001
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2021-CT0633
Sources of Monetary or Material Support
Annexon, Inc.
Primary Outcomes
GBS Disability Score (GBS-DS) [ Time Frame: Baseline to Day 56 ] Change in GBS-DS in participants recently diagnosed with GBS; scoring is based on a modified functional grading scale administered by a physician as follows: 0 = healthy, 1 = minor symptoms and ca . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain-Barré Syndrome. Onset of GBS-related weakness ≤10 days prior to start of infusion. GBS-DS score of 3,4, or 5 at scre . . .
Countries of Recruitment
Philippines, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Portugal, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, Ukraine, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Guillain-Barré Syndrome (GBS)


The clinical efficacy and safety of midpoint transverse process to pleura block versus thoracic paravertebral block for postoperative analgesia among patients undergoing modified radical mastectomy: A non-inferiority double blind randomized controlled trial

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This is a research proposal in developing a new alternative technique to the thoracic paravertebral block. The midpoint transverse process to pleura block (MTP) is promising in terms of safety and efficacy which is classified as a novel paraspinal technique. This study aims to determine the clini . . .
Primary Sponsor
Philippine General Hospital
Secondary Sponsor
Philippine General Hospital
Jiangsu Recbio Technology Co., Ltd.
Study Type
Interventional
Date of Registration
23 May 2022
Date of FIrst Enrollment
07 February 2022
Region
Philippines
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Not Applicable
FDA Clinical Trial Reference (CTR) Number
None
Sources of Monetary or Material Support
National Institutes of Health - University of the Philippines - Manila
Primary Outcomes
General objectives: To determine the clinical efficacy and safety of midpoint transverse to pleura block versus thoracic paravertebral block in alleviating postoperative pain among patients who underwent modified radical mastectomy. Primary objectives: (1) To determine different pain scor . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: female with natural breasts, diagnosed with breast cancer, ages 18-64.9year old, BMI of < 29.99 kg/m2, elective modified radical mastectomy with or without axillary dissection, for General Endotracheal Anesthesia, ASA 1-2. Exclusion Criteria: BMI of > 30kg/m2, pa . . .
Countries of Recruitment
Philippines, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Portugal, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, Ukraine, United States, Vietnam
Health Condition(s) or Problem(s) Studied

This is a research proposal in developing a new alternative technique to the thoracic paravertebral block. The midpoint transverse process to pleura block (MTP) is promising in terms of safety and efficacy which is classified as a novel paraspinal technique. This study aims to determine the clinical efficacy of MTP, being a non-inferior alternative to paravertebral block. Cadaveric studies and case reports have been published about MTP. This will be the first double blinded non inferior randomized controlled trial that will take effect in a 14th month duration in the national university hospital, University of the Philippines-Philippine General Hospital. This new intervention will deliver good immediate post-operative analgesia, which is associated with lower risk of developing chronic pain, which can lead to a significant reduction of hospital stay and facilitate early discharge. The use of narcotics for pain relief will be reduced leading to reduced incidence of nausea and vomiting. It will lead to a better quality of life, physically and mentally.


A 24-week, multicenter, randomized, double-blind, parallel-arm, placebo-controlled extension study to assess the safety of CSJ117, when added to existing standard of care asthma therapy in patients ≥18 years of age who completed study CCSJ117A12201C 

Recruitment Status
Pending
Project Status
Pending
Project Description
This study is a Phase llb, multicenter, multi-national, double-blind, randomized, parallel-arm, placebo-controlled extension study to evaluate the safety and tolerability, pharmacokinetics and immunogenicity of 5 dose levels of CSJ117 in adult asthma participants treated with medium or high dose . . .
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
22 November 2021
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2021-CT0642
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
Primary Objective The primary objective of this study is to evaluate the safety and tolerability of multiple doses of CSJ117 (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared to placebo in participants with moderate to severe asthma receiving SoC asthma therapy a . . .
Key Inclusion and Exclusion Criteria
Written informed consent and any locally required authorization obtained from the participant/legal representative prior to performing any protocol related procedures, including screening evaluations. Able to safely continue into the study as judged by the investigator. All participants must have . . .
Health Condition(s) or Problem(s) Studied

TSLP (Thymic Stromal Lymphopoietin)


A 12-week randomized, participant-and investigator-blinded, placebo-controlled, parallel group study to explore the efficacy, pharmacodynamics, safety, and pharmacokinetics of two doses of inhaled CSJ117 in adults with Chronic Obstructive Pulmonary Disease (COPD)

Recruitment Status
Pending
Project Status
Pending
Project Description
This is a non-confirmatory Phase 2 study in patients with COPD to assess the efficacy, PD, PK. and safety of two dose levels of CSJ117 in comparison to placebo. For this, the impact of CSJ117 on disease symptom burden, lung function, lung structure, and biomarkers indicative of disease and target . . .
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
02 December 2021
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2021-CT0639
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes

The primary objective of this study is to assess the effect of CSJ117 on disease/symptom burden after 12 weeks of treatment in patients with COPD. The primary clinical question of interest is whether CSJ117 in comparison to placebo provides symptom relief to COPD.

 

Key Inclusion and Exclusion Criteria
Inclusion Criteria Able to provide written informed consent Male and female adult patients aged ≥> 40 years at screening visit Able to perform acceptable and reproducible spirometry with post-bronchodilator . . .
Health Condition(s) or Problem(s) Studied

Chronic Obstructive Pulmonary Disease (COPD)


EPIK-B4: A Phase II, multicenter, randomized, open-label, active-controlled study to assess the safety and efficacy of dapagliflozin + metformin XR versus metformin XR during treatment with alpelisib (BYL719) in combination with fulvestrant in participants with HR+, HER2-, advanced Breast Cancer with a PIK3CA mutation following progression on/after endocrine-based therapy

Recruitment Status
Pending
Project Status
Pending
Project Description

Treatment of HR+, HER2-, advanced Breast Cancer with a PIK3CA mutation following progression on/after endocrine-based therapy

Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
03 February 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Open Label
Assignment
Single
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2021-CT0647
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
Study CBYL719C2202 (EPIK-B4) will assess the safety and efficacy of the combination of dapagliflozin plus metformin extended release (XR) compared with metformin XR, duringtreatment with alpelisib plus fulvestrant in participants with Hormone Receptor (HR) positive, Human Epidermal growth factor . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria ● Participant has a histologically and/or cytologically confirmed diagnosis of estrogenreceptor positive (ER+) and/or progesterone receptor positive (PgR+) breast cancer bylocal laboratory● Participant has a PIK3CA mutation(s) pres . . .
Health Condition(s) or Problem(s) Studied

Treatment of HR+, HER2-, advanced Breast Cancer with a PIK3CA mutation following progression on/after endocrine-based therapy


Results 51 - 60 of 635
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