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NCT ID: NCT06123962 Not yet recruiting - Clinical trials for Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

ALI/ARDS Clinical Sub-phenotyping Study

Start date: December 20, 2023
Phase:
Study type: Observational

1. Construct a structured clinical data and biosample information platform for Chinese patients with acute lung injury/ acute respiratory distress syndrome. 2. By deciphering the heterogeneity of patients with acute lung injury/ acute respiratory distress syndrome, achieve clinical, longitudinal physiological, and biological sub-phenotyping to guide individualized precision treatment and improve prognosis.

NCT ID: NCT06123481 Not yet recruiting - Clinical trials for Avascular Necrosis of the Femoral Head

Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis

BATON
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Osteonecrosis of the femoral head (ONFH) is a debilitating musculoskeletal disease that is characterized by localized death of bone cells and associated cellular elements within the subchondral bone. If it progresses, it results in the collapse of the femoral head (ball part of the hip) giving rise to secondary arthritis. This condition is associated with marked pain and loss of function, often necessitating a joint replacement. Due to the relatively young age of onset of ONFH (often in 20s and 30s), there is great interest in utilizing joint-preserving procedures prior to the need for joint replacement. Joint-preserving procedures include core decompression (CD) with and without bone grafts or cells, vascularized and non-vascularized bone grafting, as well as osteotomies. Inconsistent results for each of these procedures have been reported and there are no Clinical Practice Guidelines or medical community consensus opinions regarding the treatment of early-stage ONFH. The hypothesis to be tested is "Participants who have early-stage ONFH undergoing CD augmented with autogenous bone marrow aspirate concentrate will have better clinical and radiological outcomes than CD alone." This multi-center randomized controlled trial for early-stage ONFH is prospective and controlled for participant stage (only early-stage pre-collapse individuals) and surgical technique. Participants will be evaluated as per routine surgical follow-up, and at 6 months (telemedicine), 1- and 2- years using radiographs, MRIs, and questionnaires. This project will also explore the scientific basis for success vs. failure in individuals who have osteonecrosis, and have different demographics and bone marrow aspirate cell profiles.

NCT ID: NCT06119139 Not yet recruiting - Clinical trials for Symptomatic Irreversible Pulpitis

Anesthetic Efficacy of 1.8 ml Versus 3.6 ml of 4% Articaine Buccal Infiltration

Start date: December 2023
Phase: N/A
Study type: Interventional

The aim of the study is to compare the anesthetic efficacy and need for supplemental anesthesia of 1.8 ml compared to 3.6 ml of 4% articaine buccal infiltration in mandibular molars with symptomatic irreversible pulpitis.

NCT ID: NCT06118515 Not yet recruiting - Clinical trials for Congenital Cytomegalovirus Infection

A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus

Start date: November 16, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1 single-arm open-label study of letermovir in neonates with symptomatic congenital Cytomegalovirus (CMV) disease. There will be two groups enrolled. Group 1 will be comprised of 4 subjects. Following documentation study inclusion and signing of informed consent, Group 1 subjects will receive one dose of oral letermovir (Study Day 0), using the dose bands. A full pharmacokinetics (PK) profile will then be obtained over the next 24 hours, and blood specimens will be shipped immediately to the University of Alabama at Birmingham (UAB) Pharmacokinetic Lab and processed in real time. Within = 7 days, pharmacokinetics (PK) results will be conveyed to the study site. If the Area Under the Curve (AUC24) is = 100,000 ngxhr/mL (see footnote a in Table 1), the subject will initiate a 14-day course of once-daily oral letermovir at the same dose as utilized on Study Day 0. This duration of letermovir therapy was selected based upon our earlier observation in this population that patients with symptomatic congenital Cytomegalovirus (CMV) disease who achieve viral suppression to = 2.5 log by day 14 of valganciclovir therapy and then maintain it over the next 4 months are statistically more likely to have improved hearing across the first two years of life (22). If the observed letermovir exposure of the subject is > 100,000 ngxhr/mL, the once-daily oral letermovir dose that will be used will be adjusted down in 2.5 mg increments. Oral valganciclovir (16 mg/kg/dose BID) will begin within the first month of life, as standard of care; initiation of valganciclovir can be concomitant with or prior to initiation of the 14-day course of letermovir (but will not start before obtaining the pharmacokinetics (PK) specimens following the single dose of letermovir on Study Day 0). This is similar to the intensification approach that has been evaluated in the management of patients infected with human immunodeficiency virus (23-25). The day that the 14-day course of letermovir begins for Group 1 subjects will be known as Study Day 1. Serial blood samples will be obtained on Study Days 1, 5, 10, and 14 for safety chemistry and hematology labs and for Cytomegalovirus (CMV) viral loads. Cytomegalovirus (CMV) viral load will be followed as well on Study Days 21 and 42 to assess for rebound in Cytomegalovirus (CMV) following cessation of letermovir treatment on Study Day 14. Saliva and urine viral loads will be followed at these timepoint as well. Full pharmacokinetics (PK) profiles for both letermovir and ganciclovir will be obtained on Study Day 10. In addition, sparse pharmacokinetics (PK) sampling will be obtained on Study Days 1, 5, and 14. Adverse events will be assessed at each study visit during treatment, and at Study Days 21 and 42 (4 weeks after the last study drug dose). Subjects then will continue on oral valganciclovir as routine clinical care to complete an anticipated 6 month duration of total therapy. The primary Objective is to determine the systemic exposure (AUC24) of letermovir following administration of oral letermovir granules in infants with symptomatic congenital CMV disease.

NCT ID: NCT06118281 Not yet recruiting - Cardiovascular Risk Clinical Trials

ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

ARTEMIS
Start date: June 25, 2024
Phase: Phase 3
Study type: Interventional

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

NCT ID: NCT06117839 Not yet recruiting - Clinical trials for Primary Osteoarthritis of Knee Nos

Rate of Infection After Using Antibiotic Loaded Cement and Regular Cement in Total Knee Arthroplasty

Start date: December 1, 2023
Phase:
Study type: Observational

Our study will be a prospective study To compare between the rate of infection after using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.this will be at assiut university trauma hospital .There are 2 groups ,first group is patients will be treated with regular bone cement ,the second one is patient will be treated with antibiotic loaded bone cement, commonly used antibiotics includeGentamycin powder.

NCT ID: NCT06117644 Not yet recruiting - Clinical trials for Non Small Cell Lung Cancer

The Efficacy of Double-dose Furmonertinib in the Treatment of Patients With Slow Osimertinib-resistant NSCLC

Start date: November 1, 2023
Phase:
Study type: Observational

This study is a single-center, prospective, single-arm study of the efficacy of double-dose Furmonertinib in the treatment of patients with slow Osimertinib-resistant non-small cell lung cancer, mainly in patients with advanced non-small cell lung cancer with EGFR-sensitive mutations in stage IIIB or IV, slow drug resistance after treatment with Osimertinib, and no therapeutic target was found by secondary biopsy after drug resistance.

NCT ID: NCT06117176 Not yet recruiting - Clinical trials for Airway Complication of Anesthesia

Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care PAPAYA III

PAPAYA-III
Start date: January 2025
Phase:
Study type: Observational [Patient Registry]

The overall objective of the study is to evaluate and analyze major and minor incidents during airway management in adults under anaesthesia care at all study sites. The patient characteristics, type of airway management is recorded and if airway management-related incidents occur, they are analyzed in more detail to improve patient safety in the future.

NCT ID: NCT06117059 Not yet recruiting - Clinical trials for Localized Prostate Cancer

The PRECISION Study: 3 Fractions of Prostate SBRT and RayPilot HypoCath Image Guidance

PRECISION
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The investigators want to investigate whether it is possible to reduce the number of curative radiotherapy doses from 5 to only 3 for men with localized early prostate cancer. The aim of the study is to ensure that the side effects of the 3-dose treatment are the same or potentially lower than those already published when using the 5-dose treatment as used in the UK PACE-B trial (NCT01584258). The name of this type of radiotherapy is Stereotactic Body Radiotherapy (SBRT) or participants may see it referred to as Stereotactic Ablative Radiotherapy (SABR). The study is a two-stage single arm Phase II study open to those Centres that use the RayPilot HypoCath tumour tracking system (Micropos Medical). This commercially available system was not available at the time of the original PACE-B study. The system acts like a Global Positioning Device (GPS) to continuously track the prostate position during radiotherapy. If the prostate moves more than 2mm (about 0.08 in) from its intended position during the treatment, then the radiotherapy team are alerted, and the treatment halted until the prostate moves back into the correct position. The ability to understand exactly where the prostate is throughout the treatment ensures the intended dose hits the cancer and does not accidentally increase the dose to the nearby bladder and rectum. The system is a modification of a standard urinary catheter which sits within the bladder with the GPS placed within the wall of the catheter as it passes through the prostate. The investigators are not testing the system as it is commercially available but using it to improve the accuracy of radiotherapy delivery, reducing the number of days of treatment, minimizing side effects and helping ease the burden on busy radiotherapy Departments.

NCT ID: NCT06116058 Not yet recruiting - Clinical trials for Chronic Non Specific Low Back Pain

Integrated Neuromuscular Inhibition Versus Instrument Assisted Soft Tissue Mobilization in Chronic Back Pain

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

this study will be conducted to identify the difference between the effect of integrated neuromuscular inhibition technique and instrument assisted soft tissue mobilization on back pain, pain threshold, back rang of motion ,back proprioception and back disability in chronic non specific low back pain