Monastir

This research aims to compare intravenous magnesium sulfate with a placebo to treat non-traumatic acute headaches in adults visiting the Emergency Department. The study focuses on patients experiencing acute headaches that are not caused by trauma and evaluates the effectiveness of these treatments in relieving headache pain. It is a Phase 3 clinical trial designed to assess treatment outcomes in this specific patient group. Participants in the study receive either 1 gram of paracetamol combined with a 20-minute infusion of 2 grams of magnesium sulfate dissolved in 150 ml of saline solution, or 1 gram of paracetamol with a 20-minute infusion of 150 ml of saline solution alone as a placebo. Both treatments are administered intravenously while patients are in the Emergency Department. During the study, researchers monitor participants on the day of treatment to assess headache relief and other outcomes. The main measure is the rate of response to the magnesium sulfate compared to placebo for treating acute headaches. Participants are assessed for safety and effectiveness during their stay in the Emergency Department, with data collected on headache improvement and any side effects.

Researchers are evaluating whether a small fluid challenge of 50 ml can predict fluid responsiveness in adults with acute circulatory failure who are breathing on their own. This early phase 1 study focuses on critically ill patients in an emergency setting, aiming to avoid unnecessary fluid overload, which can increase complications and mortality. The study tests the hypothesis that this mini-bolus can accurately assess heart function response before administering larger fluid volumes. Participants receive a mini-bolus of 50 ml crystalloid solution infused over 30 seconds. The study also uses a passive leg raising test, where the patient is repositioned to raise their legs for 2 minutes to simulate fluid changes and observe heart output. Cardiac output and stroke volume are measured multiple times using EsCCO and FloTrac-Vigileo monitors before and after the mini-bolus and leg raising to compare responses. During the study, researchers record patient characteristics, vital signs, and heart function measurements at specific time points to track changes in response to the interventions. The primary outcome is the measurement of cardiac flow changes three minutes after the fluid load. Patients treated with vasopressors like norepinephrine have their doses kept stable during measurements. This thorough monitoring aims to identify those who will benefit from fluid therapy while minimizing risks.

Researchers are evaluating the effects of olive leaf extract treatment in adults diagnosed with type 2 diabetes. This Phase 2 and Phase 3 study is conducted in two emergency departments and two external consultation settings including endocrinology and diabetology clinics. The purpose is to assess how olive leaf extract may influence blood sugar control and glycemic variability over a 3-month period. Participants with diabetes will be randomly assigned to receive either the study drug, Atherolive, or a placebo. Both treatments are given as a 400 mg dose once daily for three months. Continuous blood glucose monitoring using an iPro device will be done at the start of the study to measure glycemic variability. Biological assessments such as lipid profiles, blood sugar, creatinine levels, HbA1c if diabetic, and inflammatory markers like C-reactive protein will be performed. During the study, participants will undergo laboratory tests and continuous glucose monitoring at baseline and throughout the 90-day treatment period. The main outcome measured is the rate of continuous glycemic monitoring and levels of Hemoglobin A1C after 90 days. The study includes careful monitoring and data collection to evaluate the impact of the olive leaf extract treatment on diabetes control.

Researchers are evaluating the effectiveness of a treatment based on olive leaf extracts in controlling hypertension, a condition characterized by high blood pressure. This Phase 2 and Phase 3 study is conducted in two emergency departments and two outpatient clinics, including endocrinology and diabetology consultations. The study focuses on adult patients aged 18 to 95 with arterial hypertension to assess cardiovascular risk factors. Participants will be randomly assigned to receive either the study drug, atherolive, or a placebo. Both treatments will be given as a 400 mg dose once daily for three months. The assignment is done through a computer-generated randomization list, and the investigator with the randomization code does not participate in other study activities or interact with participants. Patients will undergo a 24-hour blood pressure monitoring using a holter device. During the study, all participants will have biological assessments including a complete lipid profile, blood sugar, and creatinine tests. Researchers will monitor the rate of blood pressure reduction over 90 days as the primary outcome. This comprehensive monitoring aims to evaluate how the olive leaf extract treatment affects blood pressure and cardiovascular risk over the treatment period.

Renal colic is a common cause of severe sudden abdominal pain leading many patients to visit emergency departments. Researchers are evaluating the effectiveness and safety of oral non-steroidal anti-inflammatory drugs (NSAI), specifically piroxicam, as a second line treatment for patients discharged after initial emergency care for uncomplicated renal colics. This Phase 2 study aims to compare oral NSAI treatment with acetaminophen or placebo to determine benefits in reducing pain recurrence, reconsultation rates, and hospital admissions. Participants are randomly assigned to receive one of three treatments: 20 mg of piroxicam daily, 1000 mg of acetaminophen daily, or a placebo. Each treatment lasts five days following discharge from the emergency department. On the seventh day, patients receive a telephone call to assess how well the treatment worked and to check for any side effects. During the study, participants will be monitored for the effectiveness of the oral NSAI treatment over a 7-day period after starting the medication. Researchers will collect information via phone calls about pain recurrence, need for additional medical visits, and any adverse effects. The main outcome measured is the efficacy of the oral NSAI after one week of treatment.

Researchers are studying adults with renal colic, a type of sudden, severe pain in the kidney area, to compare the effects of different oral medications after emergency treatment. This Phase 2, prospective, randomized, single-blind study aims to evaluate and compare paracetamol combined with tramadol, paracetamol combined with caffeine, and a placebo in managing pain after discharge from the Emergency Department. Participants are assigned to one of three groups: one group takes 1 tablet twice daily of a combined paracetamol (325 mg) and tramadol (37.5 mg) medication for 7 days; another group takes 1 tablet three times daily of a paracetamol (500 mg) and caffeine (65 mg) combination for 7 days; the third group receives a placebo tablet three times daily for 7 days. Patients are enrolled after successful treatment of their acute pain episode and randomized at discharge. Throughout the study, researchers collect various health data including body temperature, blood pressure, heart rate, pain levels using a visual analog scale, and abdominal tenderness. Additional tests like urine analysis, kidney ultrasound, and blood tests may be performed based on clinical need. The main outcome is to monitor the recurrence of renal colic and any readmission to the Emergency Department within 7 days after inclusion in the study.

Heart failure (HF) is a major cause of hospitalization, rehospitalization, and death among adults over 65 years old. This research aims to compare the rates of death and hospital readmission at 30 days and one year after discharge between patients with heart failure with reduced ejection fraction (HFrEF) and those with preserved ejection fraction (HFpEF). The focus is on individuals admitted to the emergency department with acute heart failure. The study includes patients admitted to the emergency department of Monastir with a main diagnosis of heart failure. Participants are observed after hospital discharge to assess their health outcomes over short and long-term periods. No specific treatments or interventions are detailed in the trial information. Participants will be monitored for death or hospital readmission within 365 days after discharge. The study collects and evaluates data to understand the prognosis of different types of heart failure. The total participation duration includes follow-up assessments up to one year after discharge to track these outcomes.

Heart failure is a major cause of death and hospital visits in Canada, and access to specialized care varies across regions. This research aims to create and test a virtual heart failure care program that allows patients to receive outpatient treatment and medication adjustments remotely. The study compares this virtual care to usual care to see if it improves health and treatment outcomes. A pilot phase was done to test the feasibility and acceptability of the virtual care approach and to finalize study procedures. Participants will receive virtual clinic visits for three months after a hospital or emergency visit for heart failure. During this time, their physiological data will be monitored remotely, and treatments will be adjusted as needed. The trial compares this virtual care to routine heart failure care provided by the treating physician. The virtual care period represents the main follow-up for medication and health status outcomes. Throughout the study, participants will be monitored for up to 180 days to assess clinical outcomes, with primary results collected at 30, 90, and 180 days. Researchers will evaluate a combination of health and treatment measures to understand how virtual care impacts recovery after heart failure hospitalization. The study includes assessments of patient health status and ongoing monitoring of their condition during the follow-up period.