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Results 81 - 90 of 635

Solidarity Trial Vaccines

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This large, simple, international, randomized controlled clinical trial to test vaccines is consistent with the collaborative spirit underlying COVID-19 vaccine development and will foster international deployment with equity of access. The goal of the Solidarity Trial Vaccines is to coordinate . . .
Primary Sponsor
Department of Health
Secondary Sponsor
University of the Philippines - Philippine General Hospital
Lung Center of the Philippines
Quirino Memorial Medical Center
St. Luke's Medcal Center Quezon City
Manila Doctors Hospital
Medical Center Manila
Makati Medical Center
The Medical City
San Lazaro Hospital
San Juan de Dios Hospital
Ospital ng Sta. Ana
Study Type
Interventional
Date of Registration
01 October 2021
Date of FIrst Enrollment
30 September 2021
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0627
Sources of Monetary or Material Support
World Health Organization
Department of Science and Technology
Department of Health
Primary Outcomes

virologically confirmed COVID-19 disease, regardless of severity (Vaccine Efficacy)

Key Inclusion and Exclusion Criteria
Inclusion Criteria Male or female participants between the ages of 16 and above at randomization Living in the area and planning to reside in the area for at least 6 months. Capable of giving personal signed informed consent/have parent . . .
Health Condition(s) or Problem(s) Studied

COVID-19


Glucoacetobacter Xylinus-derived Cellulose Gel in the Prevention of Radiation Therapy-Induced High-Grade Acute Dermatitis among Filipino Patients with Breast Cancer: A Pilot Randomized Controlled Trial

Recruitment Status
Pending
Project Status
Ongoing
Project Description
We are implementing the research study entitled “GLUCOACETOBACTER XYLINUS- DERIVED CELLULOSE GEL IN THE PREVENTION OF RADIATION THERAPY- INDUCED HIGH-GRADE ACUTE DERMATITIS AMONG FILIPINO PATIENTS WITH BREAST CAN . . .
Primary Sponsor
Philippine General Hospital
Study Type
Interventional
Date of Registration
08 February 2022
Date of FIrst Enrollment
30 November -0001
Region
Philippines
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II
Sources of Monetary or Material Support
Philippine General Hospital
Department of Science and Technology
Department of Health
Primary Outcomes
The general aim of this study is to determine the efficacy of a suspension from Gluconacetobacter xylinus in reducing the incidence of high grade radiation dermatitis in adult breast cancer patients receiving postmastectomy treatment. The specific objectives of the study are to: To compare the in . . .
Key Inclusion and Exclusion Criteria
Adult (≥ 18yo) Filipino female patients whose ECOG Performance Status is 0 or 1, with a histopathologic diagnosis of unilateral breast cancer and have already underwent mastectomy and chemotherapy, neoadjuvant or adjuvantly. Such patients about to receive conventionally-fractionated, postmastec . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied

Acute radiation dermatitis is a consequence of a number of factors, including endothelial cell changes, inflammation, epidermal cell apoptosis and necrosis, as well as reduced number and impairment of stem cells (Hymes et al., 2006). It has a profound effect on patients and the course of their therapy, as cutaneous discomfort leads to treatment interruptions and patient non-compliance to treatment protocols (Becker-Schiebe et al., 2011). Management differs across institutions and individual practitioners. Apart from topical corticosteroid use, there is a lack of evidence based recommendations for radiation dermatitis despite the multitude of studies on therapeutic approaches (Bolderston et al., 2006). Topical corticosteroids, however, have several adverse effects such as atrophy, hypopigmentation, hypertrichosis, exacerbation of skin infections and delayed wound healing (Hengge et al., 2006). Given this, further research on new therapies is warranted.


Linezolid Dosing Strategies in Drug-Resistant TB

Recruitment Status
Pending
Project Status
Ongoing
Project Description
The purpose of the study is to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug or treatment) of an anti-TB treatment regimen that compares two doses of linezolid (LZD), combined with bedaquiline (BDQ), d . . .
Primary Sponsor
De La Salle Medical and Health Sciences Institute
Study Type
Interventional
Date of Registration
11 September 2021
Date of FIrst Enrollment
30 November -0001
Region
Region IV-A
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2021-CT0620
Sources of Monetary or Material Support
National Institute of Allergy and Infectious Diseases (NIAID)
Department of Science and Technology
Department of Health
Primary Outcomes
  1. Cumulative probability of sputum culture conversion [ Time Frame: Up to 26 weeks ]
  2. Cumulative probability of permanent discontinuation of at least one anti-TB drug due to adverse events, intolerance, or death [ Time Frame: Up to 26 weeks ]
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Aged greater than or equal to 18 years at screening. Newly diagnosed pulmonary drug-resistant tuberculosis (DR-TB), with resistance to at least rifampicin or rifampin (which is a drug used in the therapy of tuberculosis) confirmed from a sputum specime . . .
Countries of Recruitment
Botswana, Brazil, Haiti, India, Kenya, Peru, Philippines, South Africa, Thailand, Zimbabwe
Health Condition(s) or Problem(s) Studied

Tuberculosis, Multidrug-Resistant

Tuberculosis

Tuberculosis, Pulmonary


A Phase Ib Multicenter, Open-label Dose-escalation Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan(T-DXd) and Durvalumab in Combination with Cisplatin, Carboplatin or Pemetrexed in First-line Treatment of Patients with Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth FactorReceptor 2 Overexpression (HER2+) (DESTINY-Lung03)

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This is an open-label, multi-center, dose-escalation Phase Ib study to evaluate the safety, tolerability and RP2D of T-DXd with durvalumab plus cisplatin, carboplatin or pemetrexed in patients with non-squamous HER2+ (IHC 3+/2+) mNSCLC. Patients must have RECIST v1.1 evaluable disease and ECOG PS . . .
Primary Sponsor
AstraZeneca AB
Study Type
Observational
Date of Registration
12 June 2021
Date of FIrst Enrollment
01 September 2021
Region
Sweden
Method of Allocation
Non-Randomized
Masking
Open Label
Assignment
Single
Phase
Phase I
FDA Clinical Trial Reference (CTR) Number
2021-CT0591
Sources of Monetary or Material Support
AstraZeneca Pharmaceuticals (Philippines) Inc.
Department of Science and Technology
Department of Health
Primary Outcomes

To assess the safety and tolerability (and to determine the RP2D) of T-DXd plus durvalumab in combination with cisplatin, carboplatin, or pemetrexed.

Key Inclusion and Exclusion Criteria
For inclusion in the study, patients should fulfil the following criteria and must not enter thestudy if any of the criteria are not fulfilled: Informed Consent1 Capable of giving signed informed consent as described in Appendix A, which includes compliance with the requiremen . . .
Countries of Recruitment
Belgium, Canada, France, Italy, Netherlands, Philippines, Singapore, South Korea, Spain, Taiwan, Thailand, United States
Health Condition(s) or Problem(s) Studied

Patients with Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 Overexpression 


A Multi-national, Multi-center, Randomized, Double-Blind, Active-Controlled, Phase III Study to Investigate the Efficacy and Safety of 'GC3107 (BCG Vaccine)' after Intradermal Administration in Healthy Infants

Recruitment Status
Pending
Project Status
Ongoing
Project Description

This is a Phase III randomized, multi-center, double-blind, active-controlled clinical trial to assess the efficacy and safety of the lyophilized Bacillus Calmette-Guerin (BCG) vaccine in healthy infants. 

Primary Sponsor
Green Cross Corp.
Study Type
Interventional
Date of Registration
24 June 2021
Date of FIrst Enrollment
01 September 2021
Region
South Korea
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0597
Sources of Monetary or Material Support
Green Cross Corp.
Department of Science and Technology
Department of Health
Primary Outcomes

Proportion of subjects with maximum diameter of induration ≥5 mm in the tuberculin skin test performed 84 days after administration of the investigational product (PPD response rate)

Key Inclusion and Exclusion Criteria
Inclusion Criteria 1) Subject's legally acceptable representatives had this clinical trial information explained to them and understood it, voluntarily decided participation, and provided informed consent 2) Healthy infants aged ≤ 4 weeks 3) Body w . . .
Countries of Recruitment
Philippines, Canada, France, Italy, Netherlands, Philippines, Singapore, South Korea, Spain, Taiwan, Thailand, United States
Health Condition(s) or Problem(s) Studied

Tuberculosis prevention


A Phase 3 Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
There is a large unmet medical need that could be addressed by an effective RSV prophylaxis in infancy. Given the global burden of disease, maternal immunization offers an attractive strategy for infant disease prevention.  Both preclinical studies in animals and interim data from a Phase 1/2 st . . .
Primary Sponsor
Pfizer Inc.
Study Type
Interventional
Date of Registration
07 October 2021
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2021-CT0623
Sources of Monetary or Material Support
Pfizer Inc.
Department of Science and Technology
Department of Health
Primary Outcomes
  1. Prevention of RSV-associated LRTI in infants by active immunization of pregnant
    women.
  2.  Prevention of RSV-associated moderate to severe lower respiratory tract disease in adults
    60 years of age and older by active immunization.
Key Inclusion and Exclusion Criteria
Inclusion Criteria – Maternal Participants Healthy women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications Willing a . . .
Countries of Recruitment
Argentina, Australia, Brazil, Canada, Chile, Denmark, Finland, Japan, Mexico, Netherlands, New Zealand, Philippines, South Africa, South Korea, Spain, Taiwan, The Gambia, United States
Health Condition(s) or Problem(s) Studied

RSV is a major cause of respiratory infection in both infants and older adults. Like influenza, RSV infection follows a seasonal pattern, causing illness primarily in the cooler months of the year in temperate regions and during the wet season in tropical countries with seasonal rainfall. RSV has 2 subgroups, A and B, which cocirculate. Either can cause severe disease.


A Study of Guselkumab in Participants with Active Psoriatic Arthritis

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This is a Phase 3b, multicenter, randomized, double-blind, placebo-controlled, 3-arm study in participants with active psoriatic arthritis (PsA) who are biologic naive and have had inadequate response to current standard therapies (eg, disease-modifying antirheumatic drugs [DMARDs]/apremilast, co . . .
Primary Sponsor
Janssen Research and Development LLC
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Lung Center of the Philippines
Quirino Memorial Medical Center
St. Luke's Medcal Center Quezon City
Manila Doctors Hospital
Medical Center Manila
Makati Medical Center
The Medical City
San Lazaro Hospital
San Juan de Dios Hospital
Ospital ng Sta. Ana
Study Type
Interventional
Date of Registration
08 July 2021
Date of FIrst Enrollment
01 September 2021
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0619
Sources of Monetary or Material Support
Janssen Research and Development LLC
Department of Science and Technology
Department of Health
Primary Outcomes

Outcome Measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

Timeframe: Week 24

Key Inclusion and Exclusion Criteria
Inclusion Criteria: - Have active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy - Have a diagnosis of PsA for at least 6 months before th . . .
Countries of Recruitment
Australia, Belarus, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, Estonia, Georgia, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Philippines, Poland, Russia, Serbia, Slovenia, Spain, Taiwan, Ukraine, United States
Health Condition(s) or Problem(s) Studied

Active Psoriatic Arthritis


Phase III clinical study of SARS-CoV-2 Vaccine (Vero Cells), Inactivated

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This Phase III clinical study is a global multi-national, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety and immunogenicity of the SARS-CoV-2 Vaccine (Vero Cells), Inactivated, manufactured by Shenzhen Kangtai Biologica . . .
Primary Sponsor
Shenzhen Kangtai Biological Products Co., Ltd. and Beijing Minhai Biotechnology Co., Ltd
Study Type
Interventional
Date of Registration
03 September 2021
Date of FIrst Enrollment
30 November -0001
Region
China
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0622
Sources of Monetary or Material Support
Shenzhen Kangtai Biological Products Co., Ltd.
Beijing Minhai Biotechnology Co., Ltd
Department of Health
Primary Outcomes

Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination.

Key Inclusion and Exclusion Criteria
Inclusion Criteria Healthy residents ≥ 18 years at the time of consent, be voluntary and capable of signing the informed consent forms.  Be able to understand and comply with study requirements/ procedur . . .
Countries of Recruitment
Malaysia, Philippines, Ukraine, Bulgaria, Canada, Croatia, Czech Republic, Estonia, Georgia, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Philippines, Poland, Russia, Serbia, Slovenia, Spain, Taiwan, Ukraine, United States
Health Condition(s) or Problem(s) Studied

To prevent COVID-19 caused by the SARS-CoV-2 Virus


A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician’s Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer 

Recruitment Status
Pending
Project Status
Ongoing
Project Description
Endocrine therapy with tamoxifen or aromatase inhibitors (AIs [with or without ovarian function suppression]) are currently the main endocrine treatment options for estrogen receptor-positive (ER+) early breast cancer (EBC). Despite the effectiveness of available therapies, many patients ultimate . . .
Primary Sponsor
F. Hoffmann-La Roche Ltd.
Secondary Sponsor
PPD Pharmaceutical Development Philippines Corporation
Lung Center of the Philippines
Quirino Memorial Medical Center
St. Luke's Medcal Center Quezon City
Manila Doctors Hospital
Medical Center Manila
Makati Medical Center
The Medical City
San Lazaro Hospital
San Juan de Dios Hospital
Ospital ng Sta. Ana
Study Type
Interventional
Date of Registration
01 October 2021
Date of FIrst Enrollment
30 November -0001
Region
Switzerland
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0621
Sources of Monetary or Material Support
F. Hoffmann-La Roche Ltd.
Beijing Minhai Biotechnology Co., Ltd
Department of Health
Primary Outcomes
The primary objective is to demonstrate superiority of the giredestrant over the control treatment. The primary estimand per the estimand framework introduced in the ICH-E9 addendum (2020) is defined as follows:-Population: Participants with ER+ HER2- EBC who have completed (neo)adj . . .
Key Inclusion and Exclusion Criteria
Inclusion: -Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and in this protocol -Participants (females, regardless of menopausal status, and males) who are age 18 . . .
Countries of Recruitment
Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Israel, Italy, Japan, Kenya, Latvia, Malaysia, Mexico, Netherlands, Peru, Philippines, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United States
Health Condition(s) or Problem(s) Studied

Breast Cancer


A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description

Phase 3 neoadjuvant study of T-DXd or T-DXd followed by THP versus ddAC-THP in participants with early-stage high-risk HER2+ breast cancer.

Primary Sponsor
AstraZeneca AB
Study Type
Interventional
Date of Registration
13 December 2021
Date of FIrst Enrollment
25 October 2021
Region
Sweden
Method of Allocation
Randomized
Masking
Open Label
Assignment
Single
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0638
Sources of Monetary or Material Support
AstraZeneca AB
Beijing Minhai Biotechnology Co., Ltd
Department of Health
Primary Outcomes
pCR (ypT0 ypN0): Rate of pCR is defined as the proportion of participants who have no evidence by H&E staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by central evaluation following completion of neoad . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria Age Male or female participants ≥ 18 years of age.  Type of Participant and Disease Characteristics Histologically documented HER2-positive EBC participants with: Locally assessed HER2 . . .
Countries of Recruitment
Austria, Brazil, Bulgaria, Canada, China, Germany, India, Italy, Japan, Peru, Philippines, Poland, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Thailand, United States, Hong Kong, India, Israel, Italy, Japan, Kenya, Latvia, Malaysia, Mexico, Netherlands, Peru, Philippines, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United States
Health Condition(s) or Problem(s) Studied

Early-stage Breast Cancer


Results 81 - 90 of 635
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