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Results 71 - 80 of 610

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
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
Health Condition(s) or Problem(s) Studied

Early-stage Breast Cancer

Effects of a 12-Week Virtual Arnis-based Exercise Program on Balance Control of Healthy Community-Dwelling Older Adults: A Pilot Randomized Study

Recruitment Status
Pending
Project Status
Ongoing
Project Description
Background: Aging causes impairment in balance, increasing prevalence of falls worldwide. Martial arts have been used as an intervention to improve balance. However, not many studies focused on Arnis, which is similar to Tai Chi, although it can possibly imp . . .
Primary Sponsor
University of Santo Tomas - College of Rehabilitation Sciences
Study Type
Interventional
Date of Registration
11 February 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Parallel
Phase
Not Applicable
Sources of Monetary or Material Support
University of Santo Tomas - College of Rehabilitation Sciences
Primary Outcomes

To investigate the effects of an Arnis-based exercise program on balance control of community-dwelling older adults using the Berg Balance Scale and Timed-up and Go test. 

Key Inclusion and Exclusion Criteria
Inclusion Criteria Filipino community-dwelling older adults aged 60 years or above from a UST Simbahayan partner community will be included in the study. They will be selected to participate based on the following inclusion criteria: 1) live with at least one adult companion, 2) with or w . . .
Countries of Recruitment
Philippines, Brazil, Bulgaria, Canada, China, Germany, India, Italy, Japan, Peru, Philippines, Poland, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Thailand, United States
Health Condition(s) or Problem(s) Studied

Balance problems in community-dwelling older adults

Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) - Phase III

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This is a Phase III study in a global, multicentre, randomized, double-blind, placebo-controlled, parallel-group, to evaluate the efficacy, safety, and immunogenicity of recombinant SARS-CoV-2 fusion protein vaccine (V01) produced by Livzon Mabpharm Inc. A 2:1 ration in the investigational vaccin . . .
Primary Sponsor
Livzon Mabpharm Inc.
Study Type
Interventional
Date of Registration
24 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-CT0624
Sources of Monetary or Material Support
Livzon Mabpharm Inc.
Primary Outcomes
Primary Efficacy Endpoint: The efficacy of V-01 for the prevention of symptomatic RT-PCR- positive COVID-19 (mild or above severity) starting from at least 14 days (≥15 days) after full-course immunization; The symptoms of COVID-19 meet an . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: The participants can be enrolled only all of the following criteria are met: Voluntarily participate in this study and sign the informed consent form; Adults aged 18 years and ol . . .
Countries of Recruitment
Philippines, Brazil, Bulgaria, Canada, China, Germany, India, Italy, Japan, Peru, Philippines, Poland, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Thailand, United States
Health Condition(s) or Problem(s) Studied

Prevention of coronavirus disease-2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)

Long Term Follow-up of Immunogenicity in Healthy Filipino Children who participated in IVI T002 (Phase II) study

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
The Phase II study (IVI T002) showed that both one and two doses of Vi-DT were safe, well tolerated, and elicited good immune response in infants and toddlers aged 6 months to 23 months. Four weeks following both single and two doses of Vi-DT in infants and toddlers i . . .
Primary Sponsor
International Vaccine Institute
Secondary Sponsor
Novotech (Australia) Pty. Ltd. - Philippine Branch
Study Type
Observational
Date of Registration
25 June 2021
Date of FIrst Enrollment
24 August 2021
Region
South Korea
Method of Allocation
Non-Randomized
Masking
N/A
Assignment
Not Applicable
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2021-CT0600
Sources of Monetary or Material Support
International Vaccine Institute
Primary Outcomes

To assess the long-term immunogenicity (GMT and Seroconversion) using anti-Vi IgG at different time points (i.e., at 3 years, 4 years and 5 years) of those who had received at least one dose of 25 μg of Vi-DT typhoid conjugate or comparator vaccine during the phase II study.

Key Inclusion and Exclusion Criteria
PARTICIPANT INCLUSION CRITERIA:In order to be eligible to participate in this study, individual must meet all the following criteria:1. Individuals who had participated in the Phase II (IVI-T002) study and had received at least one dose of Vi-DT typhoid conjugate or comparator vaccine . . .
Countries of Recruitment
Philippines, Brazil, Bulgaria, Canada, China, Germany, India, Italy, Japan, Peru, Philippines, Poland, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Thailand, United States
Health Condition(s) or Problem(s) Studied

Typhoid Fever

A global multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells), for the prevention of COVID-19 in adults aged 18 years and older

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This is a Phase III study in a global multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety and immunogenicity of the Recombinant COVID-19 Vaccine cells (Sf9 cells) produced by WestVac Biopharma Co., Ltd in the 5,000 participants/subject who wil . . .
Primary Sponsor
WestVac Biopharma Co., Ltd and West China Hospital of Sichuan University
Study Type
Interventional
Date of Registration
12 July 2021
Date of FIrst Enrollment
30 July 2021
Region
China
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0616
Sources of Monetary or Material Support
WestVac Biopharma Co., Ltd.
Primary Outcomes
1. Primary Efficacy Virologically confirmed (PCR positive) symptomatic COVID-19 cases first occurring ﹥28 days after completion of 3 doses vaccination, regardless of severity 2. Primary Safety SAEs from Day 0 through 6 months after completion of 3 d . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria Aged 18 years and older Able and willing (in the investigator’s opinion) to comply with all study requirements. Willing to allow the investigators to discuss the volunteer’s medical history with their general practitioner/ . . .
Countries of Recruitment
Philippines, Brazil, Bulgaria, Canada, China, Germany, India, Italy, Japan, Peru, Philippines, Poland, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Thailand, United States
Health Condition(s) or Problem(s) Studied

Prevention of COVID-19 caused by infection with the SARS-CoV-2.

Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This is a Phase III, randomised, three-arm, multi-centre, global study assessing the efficacy and safety of T-DXd with or without pertuzumab (blinded for pertuzumab in the T-DXd arms) compared with SoC THP (taxane, trastuzumab and pertuzumab) as first-line treatment in participants with HER2-posi . . .
Primary Sponsor
AstraZeneca AB
Study Type
Interventional
Date of Registration
06 July 2021
Date of FIrst Enrollment
08 September 2021
Region
Sweden
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0606
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes

To assess the efficacy of T-DXd ± pertuzumab compared with THP in terms of PFS according to BICR in participants with HER2-positive, first-line mBC.

Key Inclusion and Exclusion Criteria
Age 1 Participant must be ≥ 18 years at the time of screening (≥ 20 years for participants enrolled in Japan). Type of Participant and Disease Characteristics 2 Pathologically documented breast cancer that:   (a) Is advanced or metastatic (participants who can . . .
Countries of Recruitment
Argentina, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hungary, India, Italy, Japan, Mexico, Peru, Philippines, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Metastatic Breast Cancer

Randomized split-body double-blind trial on the effectiveness of glycolic acid 15% cream versus betamethasone valerate 0.1% cream in patients with chronic plaque psoriasis

Recruitment Status
Completed
Project Status
Ongoing
Project Description
An emerging treatment in psoriasis is alpha-hydroxy acids, particularly glycolic acid. Glycolic acid has a distinct mechanism of action from topical steroids, with the latter perceived as a more superior treatment for psoriasis due to its multiple actions on the disease pathogenesis. However, r . . .
Primary Sponsor
Rizal Medical Center Department of Dermatology
Study Type
Interventional
Date of Registration
03 September 2021
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase II
Sources of Monetary or Material Support
MCB Dermatological Products
Primary Outcomes
The primary outcomes are severity and improvement: On the baseline and follow-up visits, the severity of the erythema, scaling, and induration of the psoriatic plaques will be measured by the physician for each side of the body (left-right), using the 6-point Static Physician’s G . . .
Key Inclusion and Exclusion Criteria
The inclusion criteria include the following: Case of mild chronic plaque psoriasis (BSA < 10%), clinically diagnosed by a dermatologist (11) Age 19 years old and above   The exclusion criteria include the following: Had systemic . . .
Countries of Recruitment
Philippines, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hungary, India, Italy, Japan, Mexico, Peru, Philippines, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Chronic plaque psoriasis

A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients

Recruitment Status
Pending
Project Status
Pending
Project Description
This is a Phase 3, double-blind, placebo-controlled, multi-regional study to evaluate the safety and efficacy of GT0918 in male outpatients with mild to moderate COVID-19 disease. Eligible subjects are diagnosed as SARS-CoV-2 positive and exhibit mild to moderate symptoms according to FDA COVID-1 . . .
Primary Sponsor
Suzhou Kintor Pharmaceuticals, Inc.
Secondary Sponsor
INC Research
Study Type
Interventional
Date of Registration
11 August 2021
Date of FIrst Enrollment
31 August 2021
Region
China
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0610
Sources of Monetary or Material Support
Suzhou Kintor Pharmaceuticals, Inc.
Primary Outcomes
Primary study endpoint: Percentage of subjects requiring oxygen by day 28. Requiring oxygen is defined as: invasive mechanical ventilation or extracorporeal membrane oxygenation(ECMO) OR noninvasive ventilation or high flow oxyg . . .
Key Inclusion and Exclusion Criteria
Subjects are eligible to be included in the study only if all of the following criteria apply:  Adult males age ≥18 years of age at the time of randomization Are currently not hospitalized for acute respiratory symptoms (not applicable for subjects whose countries requir . . .
Countries of Recruitment
Brazil, China, Malaysia, Peru, Philippines, China, Denmark, France, Germany, Hungary, India, Italy, Japan, Mexico, Peru, Philippines, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Coronavirus disease 2019 (COVID-19)

DRAMATIC Trial

Recruitment Status
Pending
Project Status
Ongoing
Project Description
Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis (TB) that is resistant to at least isoniazid and rifampicin, the two most important anti-TB drugs. It occurs in 3.6% of newly diagnosed TB patients in the world and 17% of patients who have been previously treated. In 2017, approximately 6 . . .
Primary Sponsor
De La Salle Medical and Health Sciences Institute
Study Type
Interventional
Date of Registration
23 June 2021
Date of FIrst Enrollment
01 July 2021
Region
Region IV-A
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2021-CT0603
Sources of Monetary or Material Support
University of California, San Francisco
Primary Outcomes
Treatment Efficacy - Frequency of "successful treatment" outcomes [ Time Frame: Week 76 ] A participant's outcome will be classified as successful if, at 76 weeks after initiation of treatment, they have a "negative" sputum culture and were not previously . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Males and females age ≥12 years. Prior to study procedures, if ≥18 years of age, provides informed consent; if Has pulmonary TB based on investigator assessment of all available information (e.g., chest radiograph, sputum smear, culture, molecular . . .
Countries of Recruitment
Philippines, Vietnam, Malaysia, Peru, Philippines, China, Denmark, France, Germany, Hungary, India, Italy, Japan, Mexico, Peru, Philippines, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Tuberculosis, Multidrug-Resistant

A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed diffuse large B-cell lymphoma (DLBCL)

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This phase 3, multicenter, randomized, double-blind, placebo-controlled study is designed to investigate whether tafasitamab plus lenalidomide as add-on therapy to R-CHOP provides improved clinical benefit compared to R-CHOP in patients with newly-diagnosed high-intermediate and high-risk DLBCL. . . .
Primary Sponsor
Novotech (Australia) Pty. Ltd. - Philippine Branch
Study Type
Interventional
Date of Registration
03 May 2021
Date of FIrst Enrollment
30 June 2021
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0599
Primary Outcomes

PFS, defined as the time from randomization to the first occurrence of disease progression or relapse as assessed by the investigator, using the Lugano Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurs earlier.

 

 

Key Inclusion and Exclusion Criteria
Inclusion Criteria 1. Written informed consent.2. Age 18 to 80 years at time of signing of the ICF.3. Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) . . .
Countries of Recruitment
Philippines, Vietnam, Malaysia, Peru, Philippines, China, Denmark, France, Germany, Hungary, India, Italy, Japan, Mexico, Peru, Philippines, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

This phase 3, multicenter, randomized, double-blind, placebo-controlled study is designed to investigate whether tafasitamab plus lenalidomide as add-on therapy to R-CHOP provides improved clinical benefit compared to R-CHOP in patients with newly-diagnosed high-intermediate and high-risk DLBCL.

Results 71 - 80 of 610
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