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Results 11 - 20 of 635

A Phase 3 Multi-Center International, Randomized, Active-Controlled Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost with UB-612 Vaccine

Recruitment Status
Pending
Project Status
Pending
Project Description
This is a multicenter, international, randomized, active-controlled platform study with each sub-study designed to randomize subjects to receive a single injection with UB-612 or a comparator COVID-19 vaccines in 1:1 ratio. A double-blinded or an open label sub-studies were designed for BNT162b2 . . .
Primary Sponsor
Vaxxinity Inc.
Secondary Sponsor
Syneos Health Philippines Inc.
Study Type
Interventional
Date of Registration
25 July 2022
Date of FIrst Enrollment
30 November -0001
Region
United States of America
Method of Allocation
Randomized
Masking
Open Label
Assignment
Single
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2022-CT0683
Sources of Monetary or Material Support
Vaxxinity Inc.
Primary Outcomes
The primary safety endpoints in this study will be: Solicited adverse events (AEs): Day 1-8 after immunization Unsolicited AEs: Day 1- 29 days after immunization Serious adverse events, and medically attended adverse events, and adverse events of special interest: througho . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria Males or females of childbearing potential, 16 years or older, willing to adhere to practice abstinence or use acceptable methods of contraception. Females subject of non-childbearing potential may be enrolled. Documented completed primary series with a . . .
Health Condition(s) or Problem(s) Studied

COVID 19

 


Global Study on the Clinical Detection Performance and Usefulness of Novel Coronavirus Rapid Diagnostic Kit

Recruitment Status
Completed
Project Status
Ongoing
Project Description
This study aims to examine the usability of a novel Rapid Antigen Test kit in diagnosing SARS-CoV-2. The accuracy of the test kit result will be evaluated and compared with plate-based polymerase chain reaction result in swab specimens collected. This study will also examine whether the test ki . . .
Primary Sponsor
National Center for Global Health and Medicine
Secondary Sponsor
University of the Philippines - Philippine General Hospital, Department of Laboratories
Study Type
Observational
Date of Registration
23 September 2022
Date of FIrst Enrollment
30 November -0001
Region
Japan
Method of Allocation
Non-Randomized
Masking
N/A
Assignment
Not Applicable
Phase
Not Applicable
Sources of Monetary or Material Support
National Center for Global Health and Medicine
Primary Outcomes

The agreement rate between the test results of RT-PCR test and the Rapid Antigen Test.

Key Inclusion and Exclusion Criteria
Inclusion criteria:(1) Participants who willingly participate and sign a voluntary written consent after being informed with full comprehension of the objectives, methods, significance, and entire contents relevant to the study. Minors from whom an assent can be obtained from their represen . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied

To verify that the ESPLINE SARS-CoV-2 (Fuji Rebio, Co. Ltd, Japan) has comparable clinical detection performance to that of RT-PCR, an existing nucleic acid detection test. The following concerns with consideration of the usefulness of the kit as a routine test due to its versatility will be addressed by testing nasopharyngeal swab specimens from participants suspected of the novel coronavirus, SARS-CoV-2 infection.


A Randomized, Observer-blind, Phase 2/3 Adaptive Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two-dose Regimen in Healthy Adolescents From 12 to 17 Years Inclusive

Recruitment Status
Pending
Project Status
Terminated
Project Description
Available safety, immunogenicity and efficacy data from the Ad26.COV2.S vaccine development program supports initiating evaluation of Ad26.COV2.S in the pediatric population. Ad26.COV2.S will be evaluated in the pediatric population through a dose-confirmation approach. Ad26.COV2.S (also known as . . .
Primary Sponsor
Janssen Research & Development, LLC
Secondary Sponsor
IQVIA RDS Philippines, Inc.
Study Type
Interventional
Date of Registration
05 April 2022
Date of FIrst Enrollment
30 November -0001
Region
United States of America
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Parallel
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2022-CT0661
Sources of Monetary or Material Support
Janssen Research & Development, LLC
Primary Outcomes
• To assess the safety and reactogenicity of Ad26.COV2.S administered IM as a 1-dose regimen (at 2.5×1010 vp per 0.5 mL or 2.5×1010 vp per 0.25 mL, 1.25×1010 vp, and 0.625×1010 vp dose levels) or as a 2-dose (56-day interval) regimen (1.25×1010 vp, 0.625×1010 vp dose levels and at a lower . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria 1 Criterion modified per Amendment 1:1.1 Each participant and/or participant’s parent(s)/legal guardian(s) must sign anICF according to local regulations, indicating that they understand the purpose . . .
Countries of Recruitment
Argentina, Brazil, Colombia, India, Mexico, Philippines, South Africa, Thailand
Health Condition(s) or Problem(s) Studied

Coronavirus Disease-2019 (COVID-19) Prevention


The Prevalence of Renal Hyperparathyroidism among Dialysis-Requiring Patients

Recruitment Status
Pending
Project Status
Ongoing
Project Description
Renal hyperparathyroidism is a known complication of Chronic Kidney Disease (CKD). It is associated with increased parathyroid hormone (PTH) levels brought about by imbalances between serum calcium, phosphate and Vitamin D levels. Its world-wide prevalence is reported between 12-54% but local dat . . .
Primary Sponsor
Southern Phiippines Medical Center
Secondary Sponsor
Southern Philiipines Medical Center
Study Type
Observational
Date of Registration
23 May 2022
Date of FIrst Enrollment
30 November -0001
Region
Region XI
Method of Allocation
Non-Randomized
Masking
Open Label
Assignment
Not Applicable
Phase
Phase 0
Sources of Monetary or Material Support
Southern Philippines Medical Center, Department of Internal Medicine
Primary Outcomes

The primary outcome in this study is the prevalence of Renal hyperparathyroidism.

Key Inclusion and Exclusion Criteria
The following are the inclusion criteria: Any chart of ESRD patient (on renal replacement therapy as an outpatient basis) with the following criteria will be included in this study: age 19-75 years old on renal replacement therapy (either hemodialysis or peritonea . . .
Health Condition(s) or Problem(s) Studied

Local prevalence of Renal hyperparathyroidism and correlation of intact Parathyroid hormone (iPTH) levels, Vitamin D, serum Calcium and serum Phosphorus with the risk factors identified among dialysis-requiring patients.


A Randomized, Double-Blind, International Multi-Center Clinical Study to Investigate Efficacy and Safety of Lianhua Qingwen Capsules Compared to Placebo and Combined with Standard of Care (SOC) in Adult Patients with Mild to Moderate COVID-19

Recruitment Status
Pending
Project Status
Ongoing
Project Description
The presented research is a Randomized, double-blind, placebo-controlled, international multicenter clinical study to Investigate Efficacy and Safety of Lianhua Qingwen Capsules Compared to Placebo and Combined with Standard of Care (SOC) in Adult Patients with Mild to Moderate COVID-19. . . .
Primary Sponsor
Shijiazhuang Yiling Pharmaceutical Co. Ltd.
Secondary Sponsor
Novotech (Australia) Pty. Ltd. - Philippine Branch
Study Type
Interventional
Date of Registration
01 July 2022
Date of FIrst Enrollment
30 November -0001
Region
China
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2022-CT0684
Sources of Monetary or Material Support
Shijiazhuang Yiling Pharmaceutical Co. Ltd.
Primary Outcomes
Primary Efficacy Endpoints Median time to sustained improvement or resolution of 9 major symptoms. (14d observation period) Median time to sustained improvement or resol . . .
Key Inclusion and Exclusion Criteria
INCLUSION CRITERIA Each participant must meet all the following criteria to be enrolled in this study: Adult patients with mild or moderate COVID-19 (WHO criterion), who received positive results on SARS-CoV-2 rapid antigen test or RT-PCR for confirmation o . . .
Countries of Recruitment
Cambodia, China, Philippines, Singapore, Thailand, Vietnam, South Africa, Thailand
Health Condition(s) or Problem(s) Studied

The study aims to evaluate the clinical efficacy, safety, and economy of LHQW in the treatment of adult patients with mild to moderate COVID-19.


A phase III, randomized, observer-blind, active-controlled, parallel-group, multi-center study to evaluate immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 in healthy adults aged 18 years and older

Recruitment Status
Pending
Project Status
Pending
Project Description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen of Coronavirus Disease-19 (COVID-19) that may result in acute respiratory distress syndrome in children and adults. SARS-CoV-2 is associated with a variety of signs and symptoms ranging from asymptomatic to mild symptoms . . .
Primary Sponsor
Eubiologics Co. Ltd
Secondary Sponsor
Novotech (Australia) Pty. Ltd. - Philippine Branch
Study Type
Interventional
Date of Registration
07 July 2022
Date of FIrst Enrollment
30 November -0001
Region
South Korea
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2022-CT0672
Sources of Monetary or Material Support
Eubiologics Co. Ltd
Primary Outcomes
Primary Endpoints (Immunogenicity) -The proportion of GMT of neutralizing antibody of EuCorVac-19 and AZD1222 on Day 14 after the 2nd dose (Visit 6) (GMT of EuCorVac-19 / GMT of AZD1222). -The difference in neutralizing antibody SRR* of EuCorVac-19 and AZD1222 on Day 14 after the . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria  To be eligible for enrollment, individuals must meet all of the criteria described below. 1) Individuals who voluntarily decide to participate in this study and provide written informed consent 2) Male and female of childbearing potential who agree to . . .
Countries of Recruitment
Philippines, China, Philippines, Singapore, Thailand, Vietnam, South Africa, Thailand
Health Condition(s) or Problem(s) Studied

Preventive intervention (vaccine) for COVID-19 infection


Social media intervention in patients with psoriasis

Recruitment Status
Pending
Project Status
Ongoing
Project Description
Thru this study, the researcher aims to utilize and maximize the popularity and wide reach of social media to help patients manage their disease better by providing an evidence-based study. The virtual experience will supplement and extend the traditional physical encounter between patients an . . .
Primary Sponsor
Rizal Medical Center
Study Type
Interventional
Date of Registration
06 July 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Parallel
Phase
Phase II/III
Sources of Monetary or Material Support
Self-funded
Primary Outcomes
  1. Treatment adherence
  2. Disease knowledge
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Age between 18 and 65 years Diagnosed with psoriasis Psoriasis Area and Severity Index (PASI) between 5 and 15 Currently receiving systemic, and/or phototherapy and/or topical treatment Has the ability to . . .
Health Condition(s) or Problem(s) Studied

Psoriasis


EFFECTS ON POST-OPERATIVE PAIN REDUCTION IN CESAREAN SECTIONS (LOW MIDLINE INCISION) WITH THE USE OF CRYOTHERAPY: A RANDOMIZED CONTROL TRIAL

Recruitment Status
Pending
Project Status
Ongoing
Project Description

This study aims to determine the post-operative pain reduction by adding cryotherapy to the standard postoperative pain management in cesarean sections (low midline incision) among patients in Corazon Locsin Montelibano Memorial Regional Hospital.

Primary Sponsor
Corazon Locsin Montelibano Memorial Regional Hospital
Secondary Sponsor
Corazon Locsin Montelibano Memorial Regional Hospital
Study Type
Interventional
Date of Registration
12 July 2022
Date of FIrst Enrollment
30 November -0001
Region
Region VI
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Not Applicable
Phase
Phase 0
Sources of Monetary or Material Support
Corazon Locsin Montelibano Memorial Regional Hospital
Primary Outcomes
The primary outcome in this study is the postoperative pain reduction by cryotherapy together with the standard post-operative pain management versus without among patients who underwent obstetric low midline incision surgeries in CLMMRH. Any observable result pattern . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria All admitted patients who underwent cesarean section (low midline incision) without any complications Patients who have given consent to participate in this study. . . .
Health Condition(s) or Problem(s) Studied

The information derived from this research shall form part of an integral data base that could help guide future researches with the use of adding a non-pharmacologic treatment and it’s benefits in obstetric postoperative pain management.

 


EVALUATION OF FINE NEEDLE BIOPSY (FNB) FOR EUS GUIDED TISSUE ACQUISITION OF PANCREATIC MASSES TO NEGATE THE NEED FOR RAPID ON-SITE EVALUATION: A RANDOMIZED CONTROL TRIAL

Recruitment Status
Pending
Project Status
Ongoing
Project Description
Endoscopic ultrasound guided fine needle aspiration (EUS FNA) is a key component for the investigation and diagnosis of solid pancreatic masses.  It has a proven track record for being safe with complications and tumour seeding being a rare occurrence.  The sensitivity, specificity and diagnost . . .
Primary Sponsor
University of the Philippines - Philippine General Hospital, Department of Medicine
Secondary Sponsor
None
Study Type
Interventional
Date of Registration
14 July 2022
Date of FIrst Enrollment
01 August 2018
Region
NCR
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Not Applicable
Sources of Monetary or Material Support
Self-funded
Primary Outcomes

Diagnostic yield of EUS FNA with ROSE versus EUS FNB without ROSE for solid pancreatic masses.

Key Inclusion and Exclusion Criteria

Inclusion Criteria
• Age more than 18 years old
• Patients requiring endoscopic ultrasound and tissue sampling of solid lesions greater than 1cm diameter in the pancreas that are visualized and within the reach of EUS FNA

Countries of Recruitment
Philippines, China, Philippines, Singapore, Thailand, Vietnam, South Africa, Thailand
Health Condition(s) or Problem(s) Studied

Pancreatic tumors

Pancreatic cancer

Endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) or biopsy  (FNB) of pancreatic tumors.

Rapid onsite evaluation (ROSE) of biopsy/aspiration samples

 


A Phase 2, Randomized, Double-blind, Placebo-controlled, Double-dummy, Multicenter Trial Assessing the Efficacy and Safety of Two Dose Regimens
of JNJ-64281802 for the Prevention of Dengue Infection

Recruitment Status
Pending
Project Status
Pending
Project Description

The purpose of this study is to evaluate the prophylactic effect of JNJ-64281802 with respect to the prevention of laboratory-confirmed dengue virus (DENV) infection up to last day of dosing among participants who have no evidence of current DENV infection at baseline.

Primary Sponsor
Janssen Research & Development, LLC
Secondary Sponsor
IQVIA RDS Philippines, Inc.
Study Type
Interventional
Date of Registration
19 May 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
FDA Clinical Trial Reference (CTR) Number
CTA 2022-20-04-17
Sources of Monetary or Material Support
Janssen Research & Development LLC
Primary Outcomes
Primary outcome measure Number of Participants with Laboratory-confirmed Dengue Virus (DENV) Infection Between Baseline and the Last Day of Dosing Among Participants Who Have No Evidence of Current DENV Infection at Baseline.   TIMEFRAME: Baseline up to Day 28 De . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria:- Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically relevant. This determination must b . . .
Countries of Recruitment
Brazil, Colombia, Malaysia, Mexico, Panama, Peru, Puerto Rico, Thailand, Vietnam
Health Condition(s) or Problem(s) Studied

Dengue


Results 11 - 20 of 635
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