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NCT ID: NCT05624554 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)

Start date: March 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of nemtabrutinib compared to investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) or bendamustine plus rituximab (BR) in participants with previously untreated CLL/SLL without 17p deletion and/or tumor protein (TP) 53 mutation. The primary hypothesis is that nemtabrutinib is superior to FCR/BR with respect to progression-free survival (PFS).

NCT ID: NCT05624450 Recruiting - Clinical trials for Viral Lung Infection and Acute Respiratory Failure

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

TILIA
Start date: December 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

NCT ID: NCT05623137 Recruiting - Stroke Clinical Trials

Acu-TENS to Improve the Sleep Quality in People With Stroke

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

Post-stroke sleep disorder and motor/cognitive dysfunction are common complications that affect the quality of life of older patients. The proposed study investigates the effects of an acupuncture-like method applied to six bilateral acupoints on sleep quality, motor function and cognition in older adults with chronic stroke. The study will be a single-blind (i.e., only patients will be blinded about the research purpose) randomized controlled trial (i.e., patients receiving the treatment is chosen at random) with a pre-mid-post follow-up design and involve two parallel groups of post-stroke survivors (aged > 55 years) diagnosed with insomnia. Participants will be randomly allocated in a 1:1 radio to two independent groups, i.e., a treatment group or placebo group, namely a transcutaneous electrical nerve stimulation placed on acupoints (Acu-TENS) or a placebo group. The Acu-TENS group will receive a 6-week treatment that includes a 30-minute Acu-TENS + sleep hygiene program (SHP) twice a week. The placebo group will receive sham Acu-TENS (i.e., devices with the electrical circuit disconnected) + SHP with the same frequency as the Acu-TENS group. The selected acupoints will be bilateral Hegu (LI4), Quchi (LI11), Neiguan (PC6), Shenmen (HT7) on the arm and Sanyinjiao (SP6) and Zusanli (ST36) on the lower limb. The study's primary outcomes will be sleep quality measured by the device of ActiGraph and the self-report survey. The secondary outcomes will be motor function, measured by physical performance tests, cognition, measured by computer battery, and quality of life, measured by the self-report survey. All outcomes will be measured at the baseline assessment (before the treatment), mid-term assessment (after the three weeks treatment), post-treatment assessment (after the six-week treatment), and follow-up assessment (two weeks after the treatment ended). It is hypothesized that the Acu-TENS + SHP treatment will better alleviate insomnia, improve cognition and motor function in participants than the sham Acu-TENS + SHP treatment.

NCT ID: NCT05621720 Recruiting - Healthy Aging Clinical Trials

Adopting a Health-social Partnership Program to Promote Health and Self-care Management Among Older Adults in the Community

Start date: June 6, 2022
Phase: N/A
Study type: Interventional

Hong Kong has notably the longest life expectancy in the world. Ever-increasing demand and challenges are posing to the healthcare, social welfare, and elderly care service system. As a global public health strategy to address the increasing burdens, there is a strong urge for an effective approach to enhance the health and self-care ability among the older adults dwelling in the community. Literature suggested that the effectiveness of community-based self-care management programs is inconclusive. In addition, though the concept of the health-social partnership has been widely promoted to improve primary care, literature addressed that the multiple barriers existed throughout the collaboration. More evidence should be sought in the local context to evaluate the effectiveness of self-care complex interventions program among older adults.

NCT ID: NCT05617677 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

POETYK SLE-1
Start date: January 12, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

NCT ID: NCT05615610 Recruiting - Chronic Stroke Clinical Trials

Effects of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

Upper limb impairment is present in more than 85% of people with stroke, which greatly affect the quality of life, social participation, and performance of daily activities of people with stroke. Previous study also revealed that 53.4% of people after stroke experienced cognitive impairment. Different cognitive domains might be affected following stroke, such as attention, memory, language, and orientation, and the problems with memory are often prominent. Yet, there is no effective treatment for the post-stroke cognitive impairment. Transcutaneous electrical nerve stimulation (TENS) applied on thoracic region and transcutaneous vagus nerve stimulation (tVNS) are simple and non-invasive treatment to improve upper limb motor function and cognitive function. However, no existing studies have explored on the effects of TENS and tVNS on cognitive function in people with stroke. Therefore, the purpose of this study is to evaluate the effectiveness of TENS on improving upper limb function and cognitive function in people with chronic stroke. Also, this study will investigate the cortical response of people with stroke during TENS by using EEG power spectrum analysis.

NCT ID: NCT05613062 Recruiting - Atopic Dermatitis Clinical Trials

Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children

Start date: April 11, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The study aims to evaluate the clinical efficacy of Chinese medicine (CM) for the treatment of subacute and chronic Atopic Dermatitis (AD) patients when compared to the placebo control by examining the clinical symptoms.

NCT ID: NCT05613049 Recruiting - IVF Clinical Trials

Confounding Factors of Chronic Endometritis in Women With Reproductive Failure

Start date: January 26, 2023
Phase:
Study type: Observational

The aim of the study is to investigate the confounding factors of chronic endometritis and therapeutic benefits of antibodies targeting plasma cells in women with reproductive failure.

NCT ID: NCT05611840 Recruiting - Choledocholithiasis Clinical Trials

RCT on Robotic vs. Endo-laparoscopic Approach for Difficult Choledocholithiasis

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Gallstone disease is a very common disease identity in the world. Migration of stones from gallbladder to common bile duct (CBD), causing CBD stones (choledocholithiasis), occurs in up to 22% of cases. Traditionally, choledocholithiasis can be managed by therapeutic endoscopic retrograde cholangiopancreatography (ERCP) with interval cholecystectomy in 85% of patients. In around 15% of the patients, the clearance of choledocholithiasis cannot be effectively achieved with standard ERCP (difficult choledocholithiasis). As recommended by European Society of Gastrointestinal Endoscopy guideline, difficult choledocholithiasis can be managed by either endoscopic or surgical approaches. Clinical evidences by meta-analyses comparing endoscopic with surgical approaches are conflicting. Considering the timing of cholecystectomy to eliminate the pathological source of CBD stone, one-stage laparoscopic CBD exploration LCBDE plus laparoscopic cholecystectomy LC is an attractive approach. Although one-stage laparoscopic approach is associated with higher stone clearance rate (up to 96%) than traditional two-stage endo-laparoscopic approach (preoperative ERCP and LC), postoperative complication rate is substantial (up to 17%). Among those complications, postoperative bile leak is likely related to laparoscopic instrumental limitations in LCBDE. With advancement of da Vinci robotic system, there are 3-dimensional dual cameras providing high-quality intraoperative view and 7-degree of freedom of robotic instruments. The system is able to cope with complex hepatobiliary surgical procedure, including robotic CBD exploration (RCBDE). Theoretically, postoperative bile leak following RCBDE is lower than that of LCBDE. Hence, one-stage RCBDE plus robotic cholecystectomy RC could become a new standard of treatment for difficult choledocholithiasis. Up till now, only case series have reported the safety and efficacy of RCBDE. There is, however, no prospective randomized trial comparing one-stage RCBDE and RC with traditional two-stage endo-laparoscopic approach (preoperative ERCP and interval LC) for difficult choledocholithiasis, in terms of stone clearance rate and procedure-related complications. The investigators thus propose a single-center randomized trial on this issue. 90 patients (45 patients in each arm) with difficult choledocholithiasis will be randomized to definitive treatment by either one-stage robotic approach or two-stage endo-laparoscopic approach. The primary outcome is the stone clearance rate. The secondary outcomes include treatment related morbidity, hospital mortality, and hospital stay. This will be the first randomized trial in the world evaluating the efficacy of the novel one-stage robotic approach for difficult choledocholithiasis, and it will certainly add level 1 evidence to change the management algorithm for choledochothiliasis.

NCT ID: NCT05609500 Recruiting - Warfarin Clinical Trials

Warfarin Dosage Adjustment Model Analysis Study

Start date: September 6, 2022
Phase:
Study type: Observational [Patient Registry]

Despite the wide availability of Direct oral anticoagulation (DOAC), warfarin remains an important oral anticoagulant1 especially in patients with mechanical valve replacement or chronic renal failure where the evidence of DOAC is limited. However, the dosing of warfarin is challenging as it has a narrow therapeutic index and is highly influenced by dietary vitamin K intake and drugs that interacts with cytochrome (CYP) P4501. The time outside therapeutic range will carry the risk of adverse events such as thrombosis and bleeding. Numerous algorithms have been proposed that utilized either clinical or pharmacogenetics factors. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has recommended the use of 4 dosing algorithms. However, these algorithms require the input of genetic information such as CYP2C9 and VKORC1 type which are not widely available locally and are less relevant in maintenance phase. Furthermore, these algorithms target mainly at predicting the initiation and the maintenance dose of warfarin. This has provided us with the opportunities to explore the Prediction model for on-treatment warfarin dose titration for outside therapeutic range.