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NCT ID: NCT06054555 Recruiting - Melanoma Clinical Trials

A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

Start date: November 2, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

NCT ID: NCT06049771 Recruiting - Clinical trials for Carbapenem-resistant Enterobacteriaceae

The Population Pharmacokinetics Study of Tigecycline and Pharmacokinetics- Pharmacodynamics Index in Patients With Carbapenem Resistant Enterobacteriaceae Bloodstream Infection

Start date: September 17, 2023
Phase: N/A
Study type: Interventional

Carbapenem-resistant Enterobacteriaceae (CRE) are an urgent global public health problem. Patients who were infected caused by CRE bloodstream infection were high mortality up to 40%. The National Antimicrobial Resistance Surveillance Center, Thailand (NARST) reported CRE increased from 1.1% to 17.9%. For carbapenemase producing CRE in Thailand was reported blaNDM 47.33%, blaOXA-48 43.33% and blaNDM+blaOXA-48 6.67%. Tigecycline (TGC) was a glycylcyclines antibiotics. High dose tigecycline (HD-TGC) loading dose 200 mg then TGC 100 mg q 12 h via intravenous improve clinical cure in critically ill patients and reduce mortality in carbapenem resistance Klebsiella pneumoniae bloodstream infection compared with standard dose therapy. TGC has susceptibility to CR-KP 79.6% and has an activity to blaNDM, blaKPC and blaOXA-48 carbapenemase producing CRE. However, TGC has clearance (CL) 0.2-0.3 L/h/kg, and high volume of distribution (vd) 2.8-13 L/kg resulted in low levels of TGC in plasma. Moreover, the pharmacokinetics of TGC in critically ill was limited and inconsistent with the previous study. Now pharmacokinetics-pharmacodynamics index (PK/PD index) of TGC for CRE bloodstream infection was not reported. This study aims to study the population pharmacokinetic and PK-PD index of TGC in patients who were CRE bloodstream infection to increase the success rate of treatment.

NCT ID: NCT06042478 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients.

Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH).

NCT ID: NCT06040086 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

MIRANDA
Start date: September 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.

NCT ID: NCT06039904 Completed - Knee Injuries Clinical Trials

Protection of Knee Joints in Bleeding Disorder Patients

Start date: April 8, 2021
Phase: N/A
Study type: Interventional

INTRODUCTION Knee supports, usually made with sponge cushion, are used to protect knee joint and prevent its injury. Sponge has less elasticity and durability compared with natural rubber. To our knowledge, there has been no study regarding effectiveness of natural rubber and sponge for knee joint protection and injury prevention in children with bleeding disorders. AIMS The study aimed to compare the effectiveness and satisfaction between natural rubber and sponge knee supports for knee joint protection among children with bleeding disorders METHODS The study had three phases: 1) measurement of compression force, 2) fabrication of knee supports, and 3) a randomized crossover trial. The supports were fabricated in 4 sizes, S, M, L, and XL. They comprised two parts: body, made from stretchable cotton; and cushion (protection part), made from either natural rubber or sponge. The trial included 8 weeks of alternatively wearing natural rubber knee support and sponge knee support with a 4-week wash-out period. Numbers of knee bleeds and satisfied users were recorded.

NCT ID: NCT06035510 Recruiting - Clinical trials for Postoperative Outcomes

Effect of Whey Protein Supplementation on Postoperative Outcomes After Gynecological Cancer Surgery

Start date: August 21, 2023
Phase: N/A
Study type: Interventional

Major surgeries including gynecological cancer surgery can make surgical stress that leads to increased burden of postoperative complications, delayed length of hospital stay and increased mortality rate. Protein is one of the essential factors that contribute to the recovery of patients following surgery, as the surgical process increases protein breakdown in the body. Providing patients with an adequate amount of protein helps enhance muscle building, aids in muscle repair, and reduces postoperative inflammation. One study administered a fluid containing a combination of whey protein and carbohydrates to cancer patients in preoperative and postoperative periods. The result of the study shows that intervention group can reduce the length of hospital stay and postoperative complications. However, studies focusing on the use of only-protein supplement to improve surgical complications in gynecological cancer patients are limited. This study aims to investigate the administration of protein supplement before and after surgery in gynecological cancer patients its contribution to the reduction of length of hospital stay and postoperative complications at Rajavithi Hospital.

NCT ID: NCT06035328 Recruiting - Immunotherapy Clinical Trials

Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

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

Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not standardized, and a wide heterogeneity exists in the literature . So the purpose of our study is to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT

NCT ID: NCT06034990 Recruiting - Critical Illness Clinical Trials

ICU Fluid Utilization Survey in Southeast Asia

Fluid-SEA
Start date: January 31, 2024
Phase:
Study type: Observational

The objective of this study is to examine the use of different types of fluids for resuscitation in different phases of fluid management in 3 types of critically ill patients including (1) not bleeding, not septic but need volume resuscitation (representing normal condition), (2) bleeding but not septic (representing normal vascular integrity but with a loss of intravascular colloids), (3) septic (representing the condition with increase vascular permeability and endothelium damage) in the ICU within Southeast Asia. The data are collected by a 10-min online survey administered to included physicians which will be distributed via multiple online channels through representatives of each countries.

NCT ID: NCT06034743 Recruiting - Clinical trials for Resistant Hypertension

A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

BaxHTN
Start date: November 22, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

NCT ID: NCT06034041 Not yet recruiting - Clinical trials for Failed Back Surgery Syndrome

The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study

Start date: October 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare efficacy and safety of Mediclore as anti-adhesion agent in patient who undergo endoscopic lumbar discectomy. The main question[s] it aims to answer are: - efficacy (patient-reported outcomes, epidural fibrosis) - safety (complications) Participants will received Mediclore at surgical site after finish the operation in experimental group and normal saline in control group. Researchers will compare to see if experimental group have better patient-reported outcomes (PROs) after surgery with no different in complications rate.