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NCT ID: NCT04109391 Completed - Breast Cancer Clinical Trials

Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

Start date: August 20, 2019
Phase: Phase 3
Study type: Interventional

This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03.

NCT ID: NCT04085601 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH

Start date: August 27, 2019
Phase: Phase 3
Study type: Interventional

Evaluation of the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria .

NCT ID: NCT04077216 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus Patients

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Extra virgin olive oil (EVOO) is known for its cardiovascular effects and its effect on glucose lowering. However, the effects of EVOO on the blood glucose of Type 2 Diabetes Mellitus Filipino patients has not been studied. The investigators aimed to determine whether a significant difference exists in meals containing EVOO versus meals without EVOO among Type 2 Diabetes Mellitus patients. Thirteen patients were included in this randomized controlled cross-over trial. They were randomized to receive a meal with or without EVOO followed by a one week wash out period, where they were given the other intervention. The primary outcome is the trans-meal blood glucose, which is calculated as the percent change in 2-hour postprandial blood glucose.

NCT ID: NCT04072887 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients

Start date: September 12, 2019
Phase: Phase 2
Study type: Interventional

This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.

NCT ID: NCT04042441 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study, Looking at How Ryzodeg® (Insulin Degludec/Insulin Aspart) Works in People With Type 2 Diabetes in Local Clinical Practice

ARISE
Start date: July 29, 2019
Phase:
Study type: Observational

The purpose of the study is to collect information on how Ryzodeg® works in real world patients and to see if Ryzodeg® can lower blood sugar levels. Participants will get Ryzodeg® as prescribed to them by their doctor. The study will last for about 6 to 9 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.

NCT ID: NCT03989284 Completed - Depressive Symptoms Clinical Trials

Efficacy of Peer Counseling, Social Engagement, and Combination Interventions in Improving Depressive Symptoms of Filipino Senior Citizens

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

Poor mental health is getting more common in low- and middle-income countries than in high-income countries due to lack of available resources and access to health services. In these countries, there is a large treatment gap for mental health care, with the majority of people with mental disorders receiving no or inadequate care. Depression, for instance, is one of the most common mental disorders and it affects physical health, social activities, and quality of life of senior citizens. Despite being a commonly studied mental disorder, very little is known about depression interventions conducted in low resource settings. Recently, Filipinos' mental illness has been increasing and it affects around 10-15% of children and 17-20% of adults. Their major symptoms include excessive sadness, delusion, confusion, and forgetfulness. Additionally, more Filipino senior citizens are committing suicide due to depression. This is associated with their inability to adapt to rapid social and economic developments. In this study, the investigators aimed to assess the efficacy of 3-month-duration interventions with peer counseling, social engagement, and combined intervention vs. control in improving depressive symptoms among community-dwelling Filipino senior citizens.

NCT ID: NCT03969901 Completed - Clinical trials for Suspected or Documented Gram-negative Bacterial Infection

Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)

Start date: October 8, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial infection. Participants are expected to require hospitalization through completion of intravenous (IV) study intervention, and have at least one of the following primary infection types: hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP); complicated intra-abdominal infection (cIAI); or complicated urinary tract infection (cUTI). Participants will be randomized in a 3:1 ratio to receive IMI/REL or active control. This study will also evaluate the efficacy of IMI/REL by assessing all-cause mortality at Day 28 post-randomization, as well as clinical and microbiological response to treatment. It will also evaluate the pharmacokinetics of IMI/REL.

NCT ID: NCT03961555 Completed - Rabies Clinical Trials

Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies

ARPEP
Start date: September 3, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2b, double blinded, randomized study of SYN023 compared to HyperRab® (a licensed Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis (PEP). The trial will enroll sequentially two different risk substrata of WHO Category 3 rabies exposure which are Low Risk Group (LRG) and Normal Risk Group (NRG). The enrollment will be stepwise while subject's data will be reviewed by DSMB to confirm the safety and permit for next enrollment. Besides, rabies vaccine would be administered within 75 minutes after Study Drug in each group. This trial is proposed to further the licensure of SYN023 to provide an effective PEP alternative available to those exposed persons who need such a product. A placebo-controlled rabies trial is unethical thus HRIG is selected as the control group. Rabies immune globulin from equine and human sources (HRIG) have been evaluated in many trials and HRIG is the standard of care in the United States.

NCT ID: NCT03956524 Completed - Typhoid Fever Clinical Trials

Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults

Start date: March 16, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.

NCT ID: NCT03941886 Completed - Pre-Eclampsia Clinical Trials

Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)

FORECAST
Start date: July 31, 2019
Phase: N/A
Study type: Interventional

This implementation study aims to evaluate the efficacy, acceptability, and safety of first-trimester screening and prevention for preterm-preeclampsia. It is a multicenter stepped wedge cluster randomized trial including maternity / diagnostic units from ten regions in Asia. The study involves a period where no intervention will take place at all recruiting units, and then at regular intervals, one cluster will be randomized to transit from non-intervention group to intervention group in which first-trimester screening for preterm-preeclampsia by the Bayes based method followed by the commencement of low-dose aspirin in high-risk women.