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NCT ID: NCT04971226 Active, not recruiting - Clinical trials for Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Start date: October 6, 2021
Phase: Phase 3
Study type: Interventional

The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected TKI for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD.

NCT ID: NCT04968184 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe CKD

Clarion-CKD
Start date: November 5, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage 3b/4 chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula [eGFR {EPI}] ≥15 to ≤44 mL/min/1.73 m^2) and uncontrolled hypertension (systolic blood pressure (SBP) ≥140 and <180 mm Hg and taking 2 or more antihypertensive medications.

NCT ID: NCT04948333 Active, not recruiting - Clinical trials for Chronic Myelogenous Leukemia

Asciminib Treatment Optimization in ≥ 3rd Line CML-CP.

Start date: October 13, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs). Patients for this study will be identified based on warning criteria and resistance definition following European Leukemia Network (ELN) 2020 recommendations. In addition, the study will investigate the use of two different posologies. For this, patients will receive asciminib 40 mg (twice-daily) BID or of 80 mg (once daily) once daily (QD).

NCT ID: NCT04940052 Active, not recruiting - Clinical trials for Differentiated Thyroid Cancer

Study of Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer

Start date: November 15, 2021
Phase: Phase 3
Study type: Interventional

150 adults patients with locally advanced or metastatic BRAFV600E mutation-positive, differentiated thyroid carcinoma who are refractory to radioactive iodine and have progressed following prior VEGFR targeted therapy will enter in the trial. Patients will be randomized in a 2:1 ratio to either dabrafenib plus trametinib or placebo. Patients will be stratified by number of prior VEGFR targeted therapy (1versus2) and prior lenvatinib treatment (yes versus no)

NCT ID: NCT04938830 Active, not recruiting - RSV Infection Clinical Trials

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

Start date: November 30, 2021
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).

NCT ID: NCT04923035 Active, not recruiting - Clinical trials for Pneumonia, Pneumococcal

Paediatric Pneumococcal Pneumonia in Malaysia Prior to and During Pneumococcal Conjugate Vaccine (PCV) Implementation

MSIP PCV
Start date: October 13, 2021
Phase:
Study type: Observational

The purpose of this research is to provide baseline surveillance of pneumonia in young children in Malaysia before and during the implementation of the pneumococcal conjugate vaccine (PCV). Pneumonia is a respiratory infection that can cause mild to life-threatening disease among all age groups but is the leading infectious cause of death among children globally. The most common cause of pneumonia is infection with a bacteria called Streptococcus pneumoniae, also known as pneumococcus. Hence, immunisation with a pneumococcal vaccine is an effective way to prevent pneumonia. In Malaysia, pneumococcal vaccination under the National Immunisation Programme (NIP) for children has since commenced in December 2020, comprising of 3 doses at four, six and 15 months. The routine use of PCV in children will contribute to reducing the burden of pneumococcal infections in the country, especially severe infections. The ongoing COVID-19 pandemic may also have implications on the pneumococcal serotype and clinical presentation of infections in the community.

NCT ID: NCT04895358 Active, not recruiting - Breast Neoplasms Clinical Trials

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)

Start date: June 18, 2021
Phase: Phase 3
Study type: Interventional

The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.

NCT ID: NCT04870385 Active, not recruiting - Clinical trials for Psychological Distress

An Islamic Psychospiritual-Acceptance and Commitment-based Prevention Program for At-risk Young Adults in the COVID-19 Pandemic

Start date: April 11, 2021
Phase: N/A
Study type: Interventional

The COVID-19 pandemic has increased mental health concerns worldwide, and young adults are at higher risk of experiencing increased psychological distress due to the pandemic. University students face compounding stressors during the pandemic, such as online and remote learning, economic insecurity, and uncertain career prospects. This study aims to evaluate the effectiveness of an online modular prevention program featuring integrated elements of Acceptance and Commitment Therapy (ACT) and Islamic spirituality in reducing the psychological distress and increasing the psychological flexibility, self-compassion, and resilience of Muslim university students in Malaysia.

NCT ID: NCT04846881 Active, not recruiting - Schizophrenia Clinical Trials

Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)

Start date: June 7, 2021
Phase: Phase 3
Study type: Interventional

This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia. Participants are put into two groups randomly, which means by chance. One group takes Iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like Iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia. During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups. Participants are in the study for about 8 months. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT04832984 Active, not recruiting - PreDiabetes Clinical Trials

Prevention and Treatment of Diabetes in Adults

Start date: March 23, 2022
Phase: N/A
Study type: Interventional

Currently, an estimated 3.9 million Malaysians continue to live with diabetes with many more who live with prediabetes. Diabetes was the one of the leading causes of death in the Malaysia and the leading cause for kidney failure, lower-limb amputations, and adult-onset blindness. Heart disease and stroke are two to four times more likely for individuals with diabetes. The use of mHealth or mobile health application can reduce blood sugar among individuals with prediabetes but also prevent a later occurrence of diabetes. In this study, the investigators aim to develop and evaluate the effectiveness of a digital health supported pre-diabetes management program based in an urban community pharmacy setting