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NCT ID: NCT05833048 Not yet recruiting - Postoperative Pain Clinical Trials

Rectus Sheath Block in Cardiac Surgery

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

This is a prospective, randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of a type of peripheral nerve block, Rectus Sheath Block. 1. Does the rectus sheath block decrease opioid consumption postoperatively after cardiac surgery? 2. Does the rectus sheath block decrease VAS pain scores postoperatively after cardiac surgery? Study participants will be assigned to receive either rectus sheath block or no block.

NCT ID: NCT05840406 Not yet recruiting - Postoperative Pain Clinical Trials

Effect of a Transversus Abdominis Plane Block on Wound Healing, Stress, and Immune Response After a Cesarean Delivery

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

The primary purpose of this study is to determine whether the addition of a TAP block to standard analgesia after the cesarean delivery will impact postoperative wound healing and attenuate postoperative stress and immune response. Random allocation of participants in 3 groups: group SA (standard analgesia), group L (TAP block with levobupivacaine), and group D (TAP block with levobupivacaine + dexmedetomidine). All participants will undergo elective cesarean section through Pfannestiel incision under spinal anesthesia. They will receive standard postoperative pain management with acetaminophen, nonsteroidal anti-inflammatory drugs, and tramadol. Groups L and D will additionally receive bilateral ultrasound-guided TAP block with 20 ml 0,25% levobupivacaine or with 20 ml 0,25% levobupivacaine with the addition of 0,5 μg/kg dexmedetomidine. TAP block will be performed in the theatre immediately after the cesarean delivery. Venous blood samples will be collected before the surgery and on the third postoperative day. Complete blood count and serum cortisol levels will be measured. REEDA scale will be used for assessing wound healing.

NCT ID: NCT05841758 Not yet recruiting - Clinical trials for Sarcoidosis, Pulmonary

Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis

CAESAR
Start date: April 1, 2024
Phase: Phase 4
Study type: Interventional

Sarcoidosis is a systemic granulomatous disease of unknown aetiology, mainly affecting the lungs and lymphatics. It affects people worldwide (incidence, 4.7-64/100000; prevalence, 1-36/100000/year). Although it is most often a benign acute or subacute condition, sarcoidosis may progress to a disabling chronic disease in 25% of the cases, with severe complications in about 5%, such as lung fibrosis, cardiac or neurosarcoidosis, defacing lupus pernio or blindness due to uveitis. When indicated, corticosteroids (CS) are the mainstay of treatment. Due to the kinetics of granuloma resolution, the usual and quite 'dogmatic' duration of treatment is said to be one year, following four classical steps. The long-term use of CS is hindered by cumulative toxicity and efforts have to be made to taper them, as quickly as possible, to the lowest effective dose. A recent report mentioned 39% of the CS-treated patients requiring a steroid-sparing agent. Chloroquine (CQ) and hydroxychloroquine (HCQ) are anti-malarial drugs that have been used since the 1960's as steroidsparing agents on the basis of a landmark study by Siltzbach reporting their efficacy in 43 patients with skin and intrathoracic sarcoidosis. Subsequently, two small randomized controlled trials have shown significant and prolonged improvement on pulmonary symptoms. Only small case series/reports have shown CQ/HCQ efficacy on extra-pulmonary sarcoidosis with response rates ranging from 67 to 100%. Nevertheless, CQ/HCQ are daily used for skin, bone, and joint sarcoidosis, as well as hypercalcemia. Nowadays, HCQ is preferred over CQ because of a lower incidence of gastrointestinal and ocular adverse reactions, which can be minimized by close attention to the dosage and regular retinal examination. Its profile of safety is well-known since it has long been employed to treat systemic lupus erythematous or rheumatoid arthritis. Its action is thought to rely on its ability to accumulate in lysosomes of phagocytic cells, to affect antigen presentation and reduce pro-inflammatory cytokines. The investigator hypothesize that HCQ may be an efficacious add-on therapy for extra-pulmonary sarcoidosis leading to a significant steroid-sparing effect.

NCT ID: NCT05850546 Not yet recruiting - Clinical trials for Steroid-Sensitive Nephrotic Syndrome

Rituximab in the First Episode of Paediatric Nephrotic Syndrome

Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

The study will be a randomized, open-label trial in children with the initial episode of SSNS and whose state of complete remission after received standard prednisolone, to determine whether rituximab (a single intravenous infusion of 375 mg/m2) would be noninferior to corticosteroid alone in maintaining complete disease remission during 12-month of follow-up.

NCT ID: NCT05858970 Not yet recruiting - Colonic Dysplasia Clinical Trials

Diagnostic Accuracy of Real-time Optical Biopsy

INSTASCOPE
Start date: April 1, 2024
Phase:
Study type: Observational

Differentiating neoplastic tissue from healthy tissue is fundamental for both early diagnosis during endoscopic examinations and radicality of the oncological interventions. Currently, histology is the gold standard for both diagnosis and evaluation of resection margins. However, it is time-consuming and can be performed only postoperatively. As such, the development of an ultra-sensitive method for real-time optical diagnosis may have a groundbreaking impact in this clinical setting. Recently, it has been developed a novel diagnostic methodology based on the evolution of non-linear optics systems that employs a multiphoton laser, is based on the complex propagation of light in multimodal optical fibers (MMFs - Multimodal Fibers). And allows multiplex Coherent Anti-Stokes Raman Spectroscopy (CARS) imaging to obtain a molecular fingerprint of the tissue. The molecular constitution and the structural alterations of the tissues can be detected by analyzing both the vibrational properties and the harmonic generation and the endogenous fluorescence of living matter, allowing to obtain an "optical diagnosis". The methodology uses a multiphoton laser (Femtosecond tunable laser system), is marker-free and safe for biological tissues, and allows extremely high-resolution imaging. The diagnostic methodology has been already evaluated on two-dimensional cell cultures. ESD is a well-established technique for the minimally invasive endoscopic resection of large and irregularly shaped superficial neoplastic lesions of the gastrointestinal tract with high en-bloc and margin-negative resection rates. The technique requires "safe margins" of resection of about 5 to 8 mm around the neoplastic tissue. As such, this resection specimen includes both neoplastic and normal tissue of "safe margins". On this background, this study is aimed at evaluating the methodology of imaging based on MMFs on normal and tumor tissues. The investigators plan to perform an in-vitro prospective diagnostic comparative pilot study between standard histology and optical biopsy with MMFs. The study will include 27 consecutive specimens of colorectal lesions resected with endoscopic submucosal dissection (ESD). Each ESD-resected lesion will be also the control group since it consists of surrounding safe margins (healthy tissue) and central tumor formation (tumoral tissue). The demonstration of in-vitro optical diagnosis with MMFs will include normal-to-normal and tumor-to-tumor comparisons. The laser system will be placed over a precise place with normal mucosa of the resected specimen and the characteristics of the mucosa will be registered. The same mucosa will then be indicated for histological analysis. The procedure will be repeated on tumoral tissue with the same methodology. The primary endpoint of this protocol is the diagnostic accuracy of the optical biopsy with MMFs. The results of optical biopsy will be expressed as the CARS signal difference between healthy and tumor tissues. The power to discriminate between healthy and cancer tissues will be determined using a ROC (Receiver Operating Characteristic) curve. The ROC curve will be obtained by determining the number of correct and incorrect classifications as a function of the threshold value to discriminate between the two groups.

NCT ID: NCT05867992 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury

MASTER-TBI
Start date: April 1, 2024
Phase:
Study type: Observational

The goal of this experimental observation study is to figure out differently expressed biomarkers in serum in traumatic brain injury patients, compared with bone fracture patients. The main questions it aims to answer are: 1. Which proteins and metabolites are differently expressed in TBI patients' serum? 2. Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? Participants will be treated by routine treatments, and their serum samples will be collected in the emergency room.

NCT ID: NCT05873842 Not yet recruiting - Clinical trials for Trans-femoral TAVI With Calcified Ilio-femoral Arteries

TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

TRAFIC-PTA
Start date: April 1, 2024
Phase:
Study type: Observational

To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.

NCT ID: NCT05875805 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

A Telehealth Advance Care Planning Intervention

TeleSICP
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The objective of this project is to conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program on healthcare communication, patient anxiety and distress, as well as completion of advance directives (specifically MOLST and healthcare proxy forms) for older patients with acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies.

NCT ID: NCT05878743 Not yet recruiting - Clinical trials for Risk Behavior, Health

A Qualitative Mixed Methods Realist Evaluation of Safety Planning

Start date: April 1, 2024
Phase:
Study type: Observational

Safety Planning is a recovery-orientated approach to risk management within mental health context. This study wants to answer the question 'how, why, for whom and it what circumstances does safety planning work? It will do this by carrying out a realist evaluation to identify programme theories by conducting a three phase study, reviewing materials of a Safety Planning training course, interviewing service users, carers and mental health professionals who have attended the training course, and/or use safety planning tools and techniques, adopting theory from existing literature and adding evaluator's insider knowledge. This data will be used to describe programme theory of safety planning that can be applied across diverse mental health settings, including NHS inpatient and community, and is designed to be adopted across different contexts. It will use a realist methodology to understand how safety planning works to develop the skills needed to manage risks associated with mental health difficulties in ways which increase an individual's quality of life.

NCT ID: NCT05885529 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries

GUEST
Start date: April 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to evaluate the performance of UCH-L1 and GFAP combined in patients with a mild traumatic brain injury. The main question : • Does the combination of UCH-L1 and GFAP can exclude brain injuries detected with CT scan in the first twelve hours after a mild traumatic brain injury? Participants will do the exams planed in routine care and : - during the expected blood sampling an additional blood sample will be done, - seven days after the discharge a call will be done by the investigator.