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NCT ID: NCT05118737 Recruiting - COVID-19 Pneumonia Clinical Trials

Adding Colchicine to Tocilizumab in Patients With Severe COVID-19 Pneumonia.

Start date: October 1, 2021
Phase: Early Phase 1
Study type: Interventional

Colchicine acts upstream in the cytokines cascade by inhibiting the NLRP3 inflammasome while IL-6 receptor antagonists (tocilizumab) block the end result of the cytokines cascade. Hence, adding colchicine to tocilizumab with the aim of blocking the early and end products of the cytokines cascade, might reduce the risk of developing cytokine storm and hence the need for invasive mechanical ventilation and eventually death. Therefore, investigators aim to conduct an open-label randomized controlled trial to evaluate the efficacy and safety of adding colchicine to tocilizumab among patients with severe COVID-19 pneumonia in an attempt to reduce the rate of invasive mechanical ventilation and mortality. Investigators will include patients with severe COVID-19 pneumonia and already received tocilizumab according to local protocol. Enrolled patient will be then randomized in 1:1 to colchicine versus no colchicine. Patients will be followed up until discharge or for 30 days, whichever comes first. Data will be collected from electronic medical profiles. The primary efficacy outcome will be rate of invasive mechanical ventilation and will be determined using Cox proportional hazard model.

NCT ID: NCT05069727 Not yet recruiting - Diabetes type1 Clinical Trials

Simple Initiation of Advanced Hybrid Closed Loop System

780GGS
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Background and Aim. The new and advanced hybrid closed loop (AHCL) system MiniMed 780G automatically adjusts basal insulin delivery in addition to automated bolus corrections, based on continuous glucose monitoring (CGM) readings, to offer protection against both hyperglycemia and hypoglycemia. The objective of this study is to evaluate whether a simplified approach for patients' follow up using preset of pump settings and a simplified meal announcement, followed by minimal interaction can achieve similar glycemic control of AHCL system MiniMed 780G with Guardian Sensor 4 than a regular protocol that is currently used in adolescents with Type 1 Diabetes (T1D). Methods. This study is Randomized Clinical Trial, two arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months. A total of 34 individuals (age 12-18 years) will be enrolled to reach 30 individuals who will complete the 3 months study. Participants will be randomized in two groups: Group 1, Regular Clinical Protocol, 17 participants and Group 2, Simplified Clinical Protocol, 17 participants. All patients will be recruited during the regular clinic visits to the outpatient Endocrine Clinics at Sidra Medicine in Doha. Patients will be chosen on a first-come first-served basis. Inclusion criteria: Clinical diagnosis of type 1 diabetes, , Age 12-18 years, Basal Bolus therapy >8.0 units per day. Exclusion criteria: Diabetic Ketoacidosis (DKA) in the 6 months prior to screening visit. The initiation protocol consists of four stages: HCL system compatibility assessment, HCL system training, Manual Mode Start and Auto Mode start. Patients will have 7 visits in a period of 3 months after initiation of insulin pump therapy. Pump initiation: Group 1, Finetune ICR, Target 100 or 110 mg/dl and AIT: 2-3 hour and Group 2, Carb Ratio by formula 360 / TDD, ICR 8-10 (TDD 40-60), ICR 5-7 (TDD >60), Target 100 mg/dl, AIT: 2 hours with fixed meals Results. No group difference in Time in Range (TIR) (70-180mg/dl) > 70% and HbA1c < 7.5% in a period of 3 months after initiation of AHCL. Conclusion. Conclusions will be drawn on completion of the study and evaluation of the results.

NCT ID: NCT05061654 Not yet recruiting - Hematologic Cancer Clinical Trials

CEFtolozane-Tazobactam for the Empiric Anti-bacterial Treatment of Neutropenic Fever in Hematology Patients

CEF-10
Start date: February 2022
Phase: Phase 4
Study type: Interventional

Patients with blood cancers and those who received a bone marrow transplant frequently have low circulating white blood cell countS. Fever in patients with low white blood cell count requires early appropriate antibiotic treatment to prevent complications including death. Bacteria have increasingly become more resistant to existing antibiotic options. Ceftolozane-tazobactam is a newer type of antibiotic that has been shown to be safe and effective in infections caused by several types of resistant bacteria that can cause serious infections in individuals with low blood count. This study aims to examine the effectiveness of this antibiotic in these types of patients. Patients with blood cancer and those who have received a bone transplant will be offered the option to join this study if they develop unexplained fever. If informed consent is granted, they will receive ceftolozane-tazobactam on top of the usual care that such patients receive. The patients will then be followed very closely to check their response to the treatment and if they develop any untoward events. The study will include 164 patients over an estimated 2 year period. The study is funded by Merck & Co, the company that manufactures the study antibiotic. However, Merck & Co. will not be involved in the actual running of the study, the collection of the study results or their analysis and interpretation. The study protocol has been reviewed and approved by an independent research oversight committee.

NCT ID: NCT05045885 Completed - Respiratory Failure Clinical Trials

Safety and Feasibility of Percutaneous Dilatational Tracheostomy in Patients With Severe COVID-19 Supported by ECMO

Start date: March 1, 2020
Phase:
Study type: Observational [Patient Registry]

COVID-19 pandemic has presented the global health care systems with unprecedented and unexpected challenges. The clinical spectrum of COVID-19 disease varies from mild, at times asymptomatic, to severe life-threatening multiple organ dysfunction and shock. The latter group, albeit represent less than 10% of all SARS-CoV-2 infections will require ICU admission, multi-modal organ support including Extracorporeal Membrane Oxygenation (ECMO) for severe refractory cardiac and/or pulmonary failure. Prolonged mechanical ventilation is a typical indication for tracheostomy. Percutaneous tracheostomy at the bedside has several advantages over surgical tracheostomy. However, with the emerging pandemic, there is a lack of literature regarding the safety of percutaneous bedside tracheostomy for patients with COVID-19 supported by ECMO. Our study aims to describe the safety of bedside percutaneous dilatational tracheostomy of confirmed COVID-19 positive patients supported on ECMO.

NCT ID: NCT05043779 Recruiting - Obesity, Morbid Clinical Trials

Evaluation of Preoperative Nasoendoscopy to Predict Difficult Intubation

Start date: August 12, 2020
Phase: N/A
Study type: Interventional

Despite the availability of different methods for airway assessment, unexpectedly difficult intubations occur at a frequency of up to 15%. A variety of pre-intubation clinical screening tests have been advocated to predict difficult laryngoscopy and airway but their usefulness is limited in obese patients. Could awake invasive airway assessment be more predictive for difficult airways in obese patients? The use of nasendoscopy assessment for the airway could be a useful additional invasive tool to predict the difficult airway in obese

NCT ID: NCT05033730 Recruiting - Clinical trials for Ventilation Therapy; Complications

Comparison Between VCV and FCV Through Ultra-thin Tube in Upper Airway Surgery

Start date: October 15, 2020
Phase: N/A
Study type: Interventional

Ventilation through the small endotracheal tube is not an uncommon situation. The indications for it differ from elective upper airway surgery to emergency ventilation through needle cricothyrotomy. Conventionally, ventilation through small endotracheal tubes has been challenging by jet ventilation with subsequent risk of barotrauma and inadequate gas exchange. Expiration during jet ventilation occurs passively.

NCT ID: NCT05033704 Recruiting - Clinical trials for Coagulation; Intravascular

Effect of Human Plasma Protein Transfusion With and Without Crystalloids During Major Liver Resection Surgeries

Start date: September 9, 2019
Phase: N/A
Study type: Interventional

Evaluation of acid-base and electrolyte changes after administration of commonly used colloid solutions (plasma protein fraction contains 5% albumin), and crystalloids (saline 0.9% and lactated ringers solutions) is the primary endpoint of this study. The secondary endpoints are to study dilution acidosis and changes in plasma volume induced by albumin versus crystalloids and their effect on tissue perfusion by randomizing patients into two groups where each group receives intraoperatively one type of the two fluids. Changes in acid-base, electrolytes, and dilution acidosis

NCT ID: NCT05021523 Completed - Clinical trials for Immobilization, Tonic

Heat Therapy to Prevent Deconditioning During Immobilization

Start date: November 26, 2020
Phase: N/A
Study type: Interventional

Animal models suggest that heat stress increases protein content and facilitates the recovery of atrophied muscle after an immobilization period, or following a chemically induced muscle injury in rats. Thus, a recent study in human have reported that daily heat treatments, applied during 10 days of immobilization, reduced the loss of muscle mass. In addition of protecting muscle mass, repeated heat stress may also help to maintain cardiovascular fitness from the onset of injury through passive exposures in the condition that they sufficiently trigger an increase in body temperature, circulation and sweating. This study will investigate the benefits of using heat therapy to prevent deconditioning during immobilization in human.

NCT ID: NCT05020873 Recruiting - Sickle Cell Disease Clinical Trials

Prospective, Observational Study in Sickle Cell Disease Patients on Crizanlizumab Treatment in Middle East Countries and India

SPOTLIGHT
Start date: November 4, 2021
Phase:
Study type: Observational

This is a multicenter, prospective, single-arm observational non-interventional study (NIS), which will be conducted in various countries in the Middle East and India.

NCT ID: NCT04992221 Recruiting - Arterial Monitoring Clinical Trials

Arterial Line Patency in ICU Bound COVID-19 Patients

Start date: February 1, 2021
Phase:
Study type: Observational

Severe acute respiratory syndrome coronavirus-2 (SARS-Cov-2) overwhelmed the health care system and ICU admission was maximized with increased work load of ICU physicians. Invasive line procedures are inserted with a dedicated team to ensure safe and perfect performance. Frequent requests for arterial line insertion were observed during the second wave follow up of COVID-19 bound patients. High rates of thrombosis were found in those critically ill patients which was associated with thrombotic complications. Many factors are contributed for reduction of arterial line patency, including morbidities of patients, technique of insertion, and criteria of the operating health care skilled personnel. In response of our ICU management committee to increase incidence of thrombosis and pulmonary embolic events in patients with COVID-19 admitted to ICU in the second wave of the epidemic, they recommended the use of systemic anti coagulation of ICU admitted patients since 21 March 2021.