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NCT ID: NCT06277973 Not yet recruiting - Clinical trials for Post-traumatic Stress Disorder

Feasibility Study of the Self-Care Immediate Stabilization Procedure (ISP) ® After a Traumatic Experience

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

The study aims to assess the feasibility of an online intervention platform based on the Immediate Stabilization Procedure (ISP®). This intervention targets early trauma reactions, aiming to reduce the risk of future PTSD.

NCT ID: NCT06274437 Not yet recruiting - Cancer Clinical Trials

A Study of BND-35 in Participants With Advanced Solid Tumors

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

This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization (Part 2). Part 1 is comprised of three sub-parts: BND-35 administered alone (Sub-Part 1A), BND-35 administered in combination with nivolumab (Sub-Part 1B), and BND-35 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of BND-35 per indication are administered in combination with nivolumab or with cetuximab.

NCT ID: NCT06240585 Not yet recruiting - Clinical trials for Gastroparesis and Sepsis

Gastroparesis as an Early Sign of Sepsis

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

Upper gastrointestinal tract disorders, such as gastroparesis, are common in critically ill patients in the ICU, estimated at 60%. Gastroparesis symptoms include nausea, vomiting and abdominal pain. Risk factors for the development of gastroparesis include diabetes, surgical injury to the vagus nerve (such as certain types of bariatric surgery, and in the past - surgeries for patients who suffered from peptic ulcer), use of drugs that inhibit the activity of the digestive system such as opiates, anticholinergic drugs, sepsis, as well as being bedridden and inactive - are all common conditions in critically ill patients. There are different definitions for gastroparesis. One of the accepted definitions refers to gastric residual volume (GRV) over 200 ml at one measurement. Gastroparesis is found in some studies to be associated with increased morbidity and mortality in critically ill patients. As mentioned above, it is known that sepsis is a risk factor for gastroparesis. According to our experience based on treatment of a large number of septic patients, we have the impression that often gastroparesis is an early sign for the development of sepsis. We did not find any studies that tested this hypothesis. In this study we would like to investigate whether the development of gastroparesis in critical patients in intensive care can be a predictive sign for the development of sepsis.

NCT ID: NCT06224088 Not yet recruiting - Clinical trials for Neurocognitive Dysfunction

Neuro-cognitive Function 1 Year Post ICU Discharge Among VV ECMO Survivors

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

In the past three years, in the general intensive care unit in Meir medical center, 25 patients were treated with ECMO, of which two patients were treated with VA ECMO and the rest with VV ECMO. 70% of the patients survived to hospital discharge. ECMO is indicated as a rescue therapy for patients in critical condition suffering from severe cardiac and/or respiratory failure that does not respond to conservative treatment. It can be used as a bridge to recovery or to heart/lung transplantation. ECMO was introduced in the late seventies of the pervious century. Between the years 2006-2011, partly due to the outbreak of the flu epidemic (H1N1), a 433% increase was observed in the use of ECMO worldwide in adults. In light of the outbreak of the Covid-19 epidemic in recent years, another significant increase has been observed. There are short-term and long-term complications of ECMO. Short-term complications include bleeding, thrombosis, hemolysis, HIT, renal and neurological injuries, associated infections, and technical-mechanical problems. Long-term complications include significant physical and psychological consequences that may adversely affect the patient's daily function, especially executive function.

NCT ID: NCT06212830 Not yet recruiting - Clinical trials for Provide Evidence-based Recommendations for Clinicians to Optimize Pain Control After CXL

Pain Relief After Corneal Collagen Cross-Linking

Start date: February 2024
Phase: Early Phase 1
Study type: Interventional

Keratoconus is a progressive corneal ectasia that can lead to significant visual impairment and decreased quality of life. The introduction of corneal cross-linking (CXL) with riboflavin and ultraviolet-A (UVA) light has revolutionized the treatment of keratoconus by increasing corneal rigidity and arresting disease progression. The epithelium-off protocol, which induces heightened post-surgical discomfort, is the prevailing approach. Despite the success of CXL, postoperative pain is a common side effect that can negatively impact patients' quality of life and impede recovery. Pain management after CXL is essential for optimizing patient outcomes and satisfaction. Systemic painkillers, though not researched enough, may potentially aid in healing and recovery, minimizing complications and discomfort for the patient. In this study we will provide evidence-based recommendations for clinicians to optimize pain control after CXL in collaboration with pain specialists.

NCT ID: NCT06206759 Not yet recruiting - Clinical trials for Hypertriglyceridemia

Vitamin C Administration and Triglycerides Level in Critical Care Patients

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

Vitamin C (ascorbic acid) is a water-soluble vitamin with antioxidant properties. Previous studies showed that the administration of vitamin C was associated with decreased triglyceride (TG) levels in ambulatory patients, especially in patients with type 2 diabetes. The decrease in TG level was more significant the younger the patient's age (less than 52.8 years), the longer the administration of vitamin C lasted (over 12 weeks) and the higher the daily dose was (over 1 gram per day) (2). However, we did not find any studies that examined the relationship between administration of vitamin C and lowering of TG level in critical patients in intensive care. High TG levels are often found in these patients, secondary to sepsis, administration of propofol by continuous infusion, administration of TPN, pancreatitis, liver failure and chronic dyslipidemia, diabetes and chronic renal failure. High TG levels in these patients may cause pancreatitis secondary to elevated TG, and we take several actions to lower TG levels in the unit when they exceed 500 mg per dL in order to avoid these complications. The actions taken include starting treatment with fibrates and/or statins, giving high-dose insulin, stopping the propofol drip and changing it to another hypnotic drug (usually midazolam), and giving fat-free TPN instead of fat-containing TPN. There are of course disadvantages to these interventions, such as drug interactions, longer clearance time and higher incidence of delirium when giving midazolam compared to propofol, hypoglycemia when giving a continuous insulin drip in high doses and giving a lower amount of calories to a patient who will receive TPN without lipids. There are many studies that examined the administration of vitamin C to patients in intensive care, especially patients with sepsis, with varied but inconclusive results. A recently published meta-analysis found a reduction in mortality among critical intensive care patients treated with intravenous vitamin C, especially in the subgroup of critically ill patients with a high risk of in-hospital mortality. The drug was found to be safe for use among patients in intensive care. In these patients in the various studies, vitamin C treatment was given intravenously in different doses, with most patients receiving a dose of 6 grams per day for 3-5 days. In light of a trend about five years ago that showed an improvement in survival among septic patients in intensive care who were treated with intravenous vitamin C as monotherapy, or in combination with steroids and/or intravenous thiamine, also in the intensive care unit at our institution (as well as in other hospitals) we started giving this treatment, at the recommended dose of 6 grams per day for 3-5 days. Over time, new studies did not find clear benefits for this treatment, so we gradually stopped giving it. However, if indeed vitamin C can contribute to a significant decrease in TG levels in patients in intensive care, there may be a point in administering it to a group of patients with high TG levels, in order to reduce complications associated with a high TG level and/or treatment to reduce it.

NCT ID: NCT06192537 Not yet recruiting - Obesity Clinical Trials

Examining the Effect of Role-playing Exercise by Utilizing an Obesity Suit in a Simulation Scenario on Weight Bias and Empathy Levels Among Nutrition Sciences Students

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

A quasi-experimental design (i.e., "One-Group Pretest-Posttest Design") will be applied among 40 convenient samples of undergraduate students in their first year of nutrition sciences program at Ariel University and Tel-Hai College. The intervention will take place at the simulation centers of the institutions. All participants will be asked to wear an obesity simulation suit (Unisex obesity Simulation suit, Erler-Zimmer, Germany) and to participate in a standardized scenario that simulates meetings between a person with obesity and a 'registered dietitian'. The 'registered dietitian' will be presented by a professional role-player and the scenario will encompass different levels of weight bias. At baseline, 1- and 3-week post-intervention both groups will be asked to fill in a survey using "Qualtrics" software. The survey will include the Anti-Fat Attitudes questionnaire (AFA), the Short-Form of Fat-Phobia scale (F-scale), the Weight-Implicit Association-Test (weight-IAT), and the Jefferson Scale of Empathy. Data on demographics, weight history, and perception, measurement of actual weight and height, and the beliefs about the causes of obesity questionnaire will be collected at baseline.

NCT ID: NCT06168669 Not yet recruiting - Colorectal Surgery Clinical Trials

A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection

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

Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis. The clinical team is blinded to the leak detection of the xBar system.

NCT ID: NCT06154382 Not yet recruiting - Clinical trials for Thyroid; Functional Disturbance

Eltroxin Administration to Patients With Extremely Low T4 Values in the Intensive Care Unit

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

Nonthyroidal illness (formerly called sick euthyroid syndrome) is a common condition in patients hospitalized in the intensive care unit, and it is caused by changes in the levels of thyroid hormones in the blood . These changes are correlated to the severity of the critical illness, morbidity and mortality. This condition is characterized by low serum T3 levels, high rT3 levels, normal or low T4 levels, and normal or low TSH levels. Previous studies have shown a relationship between NTIS (nonthyroidal illness) and poor therapeutic outcomes in patients admitted with sepsis, multi trauma, ARDS, acute respiratory failure, septic shock and mechanically ventilated patients in intensive care . In general, the recommendation is not to routinely take blood tests to evaluate thyroid function in critical patients in the intensive care unit, unless they were previously known to have a thyroid disease or there is a clinical suspicion that such a disorder developed during hospitalization in the intensive care unit. Also, studies so far have not shown an advantage for eltroxin administration to intensive care patients with low T3 and/or T4 levels when the laboratory tests indicate NTIS. However, there is a specific group of patients, with NTIS and extremely low T4 levels (less than 50% of the lower limit of the normal range) who have a particularly high mortality rate in intensive care (over 85%) and in whom it has not been investigated whether the administration of eltroxin will improve the therapeutic outcomes ( , i.e. was such a low T4 level in them considered a marker for the severity of their general critical illness, or is it another disorder in itself, the treatment of which would benefit the patient) . We would like to examine whether the administration of eltroxin in this specific group of patients, which has not been studied so far, will be beneficial in improving the therapeutic outcomes

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.