The participant will arrive fasted at Diex Recherche Sherbrooke. After installing a catheter and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive the omega-3 fatty acids as a unique dose of 3 g EPA + DHA in monoacylglycerol form + 45 mg vitamin K2. The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of omega-3 fatty acids in the plasma.

The participant will arrive fasted at Diex Recherche Sherbrooke. After installing a catheter and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive the omega-3 fatty acids as a unique dose of 3 g EPA + DHA in ethyl ester form + 45 mg vitamin K2. The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of omega-3 fatty acids in the plasma.

Healthy

The intervention is a randomized double bond cross over design testing the pharmacokinetics of a monoglyceride formulation compared to an ethyl ester form.
Treatments are randomly assigned on days 0 and 7 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform the two treatments, with a minimum of 6 days between treatments.

Omega-3 + vitamin K2 (monoacylglycerol form)

Omega-3 + vitamin K2 (ethyl ester)

Centre de Recherche sur le Vieillissement

Pharmacokinetics of Omega-3 Monoglycerides

Comparison of Pharmacokinetics of Omega-3 Fatty Acid Supplements in Monoacylglycerol or Ethyl Ester in Humans: a Randomized Controlled Trial.

Define by the area under the curve between 0-5h

Define by the area under the curve between 0-24h

Define by the highest concentration achieved by the participants

Mélanie Plourde

Associate professor, Department of medicine, Geriatric service

Université de Sherbrooke

Double-blind controlled-randomized pharmacokinetic (PK) pilot study with crossover design (10 men and 10 women), with a minimum of 6 days between treatments

Neither the participant nor the research nurse will know the administration order of the different treatments administered. All plasma samples collected during the research project will be anonymized i.e. it will not be possible to identify the participant by his name since a number will be assigned to him. The code key linking the participant's name to his number will be stored, with access restricted to those designated by the principal investigator. The data file is also protected by a password.

The participant will arrive fasted at he research center. After installing a cathether and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive the omega-3 fatty acidsesterified in a reconstitute triglyceride form as a unique dose of 1.5 g EPA + DHA in TG form + 45 mg vitamin K2.The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of omega-3 fatty acids in the plasma and a side effect questionnaire will be administered to monitor side effects.

The participant will arrive fasted at he research center. After installing a cathether and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive the omega-3 fatty acids in ethyl esters form as a unique dose of 1.5 g EPA + DHA in TG form + 45 mg vitamin K2.The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of omega-3 fatty acids in the plasma and a side effect questionnaire will be administered to monitor side effects.

The participant will arrive fasted at he research center. After installing a cathether and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive the omega-3 fatty acids in MaxSimil® form as a unique dose of 1.5 g EPA + DHA in TG form + 45 mg vitamin K2.The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of omega-3 fatty acids in the plasma and a side effect questionnaire will be administered to monitor side effects.

The intervention is a randomized double bond cross over design testing the pharmacokinetics of a monoglyceride formulation compared to a triglyceride and an ethyl ester form.
Treatments are randomly assigned on days 0, 7 and 14 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform all three treatments, with a minimum of 6 days between treatments. A questionnaire will document the side effects felt by participants during the omega-3 supplement taking day.

Omega-3 + vitamin K2 (TG form of omega-3)

Omega-3 + vitamin K2 (EE form of omega-3)

The intervention is a randomized double blind cross over design testing the pharmacokinetics of a monoglyceride formulation compared to a triglyceride and an ethyl ester form.
Treatments are randomly assigned on days 0, 7 and 14 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform all three treatments, with a minimum of 6 days between treatments. At each blood draw time points, a questionnaire will be administered to the particpant to monitor if they experiencec side effects with the dietary supplement they ingested in the morning.

Omega-3 + vitamin K2 [MaxSimil (MAG form of omega-3)]

Melanie Plourde

MaxSimil and Vitamin K2: Determining Their Bioavailability

Pharmacokinetics of a Combination of Omega-3 Fatty Acids and Vitamin K2 as a Natural Product

Plasma omega-3 (DHA and EPA) levels will be measured by gas phase chromatography while plasma vitamin K2 level will be measured by high-performance liquid chromatography (HPLC), each being performed randomly blindly. After GC and HPLC analyzes, area under the curve (AUC) 0-24 hours will be calculated, as the first parameter of the PK. Statistical analyzes will then be performed on this PK parameter.

Plasma Omega-3 (DHA and EPA) will be measured by gas phase chromatography while plasma vitamin K2 will be measured by high-performance liquid chromatography (HPLC), each being performed randomly blindly. After GC and HPLC analyzes, AUC 0-6 hours (absorption study) will be calculated, as the second parameter of the PK. Statistical analyzes will then be performed on this PK parameter.

Plasma Omega-3 (DHA and EPA) will be measured by gas phase chromatography while plasma vitamin K2 will be measured by high-performance liquid chromatography (HPLC), each being performed randomly blindly. After GC and HPLC analyzes, maximum concentration will be calculated, as the third parameter of the PK. Statistical analyzes will then be performed on this PK parameter.

Plasma Omega-3 (DHA and EPA) will be measured by gas phase chromatography while plasma vitamin K2 will be measured by high-performance liquid chromatography (HPLC), each being performed randomly blindly. After GC and HPLC analyzes, time when the maximum concentration is reached will be calculated, as the fourth parameter of the PK. Statistical analyzes will then be performed on this PK parameter.

The side effects of EPA + DHA type omega-3 supplements, all mild, belong to the category of gastrointestinal discomfort. These include dysgeusia (fishy taste or taste alteration), belching and nausea. A questionnaire will document the side effects felt by participants during the omega-3 supplement taking day. Statistical analyzes will then be performed on the evaluation of side effects (including gastrointestinal discomfort) by questionnaire.

We do not plan to share individual participant data to other researchers

Samuel Fortin, SFC pharma and associate professor UQAR

20 mls of Chloroprocaine Hcl 2% Inj (1 vial containing 400mg/20 mls of chloroprocaine) will be instilled into the abdomen prior to fascia closure.

20 mls of normal saline will be instilled into the abdomen prior to fascia closure.

Cesarean Section Complications

Pain

Chloroprocaine Hcl 2% Inj

Normal saline

Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control

An Evaluation of Intraabdominal Chloroprocaine During Cesarean Delivery and Its Effect on Postoperative Pain and Nausea; a Randomized Controlled Trial & Pharmacokinetic-pharmacodynamics (PKPD) Analysis.

Our primary outcome measure will be postoperative pain as measured by visual analogue scale (VAS) at 1 hours after skin closure (sitting in an upright position and movement of lower extremities) after cesarean section. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 being the best pain and 10 being the worst pain.

Visual analogue scale (VAS) at 2, 6, 24 and 48 hours at rest and during mobilization. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 being the best pain and 10 being the worst pain.

An adverse effect is an undesired harmful effect resulting from chloroprocaine use. Adverse effects of chloroprocaine include gastrointestinal (nausea, vomiting), dizziness, rash, itching, redness and anxiety.

The patients will be evaluated for increased analgesic requirement after use of chloroprocaine or placebo. The total amount of analgesia used will be recorded.

A hospital readmission for pain is an episode when a patient who had been adequately pain controlled is discharged from a hospital is admitted again within a specified time interval for poor pain control.

This is defined as the number of days the patient stays in the hospital after cesarean section.

No personal patient data will be shared with other researchers. The final de-identified manuscript will be published.

Johns Hopkins University

Patients admitted for cesarean section and meeting inclusion criteria will be approached for consent. Consented patients will then be randomized into two groups.
Group 1: (intraabdominal chloroprocaine administration): These participants will have intraabdominal chloroprocaine administration at the time of cesarean section before fascial closure.
Group 2: (Intraabdominal instillation of placebo (sterile water): These participants will have placebo (normal saline) administered at the time of cesarean section before fascial closure. Cesarean section will proceed traditionally, including fascial and skin closure.

The investigator and patients will be masked from the treatment options. The care providers will not be masked.

Crohn's Disease

Epanova™ (Omega-3 Free Fatty Acids)

Atlanta Gastroenterology Associates

Northwestern University Medical School

University of Chicago Medical Center

Carle Clinic Association

University of Louisville, Department of Surgery

Mayo Clinic

Gastroenterology Specialties, P.C.

Long Island Clinical Research Associates

University of North Carolina Chapel Hill

Cleveland Clinic Foundation

Health Sciences Centre

Royal Alexandra Hospital

University of Alberta

Vancouver General Hospital

St. Paul's Hospital

Victoria General Hospital

London Health Sciences Centre (South Street Campus)

London Health Sciences Centre (University Campus)

The Ottawa Hospital (Civic Campus)

Sunnybrook & Women's College HSC

St. Michael's Hospital

Mount Sinai Hospital

CHUQ - Pavillon St-François d'Assise

Hopital Maisonneuve-Rosemont

Hôpital Saint-Luc

Royal Victoria Hospital

Montreal General Hospital

Jewish General Hospital

CHUQ-Hôtel-Dieu de Québec

Hôpital St-Sacrement

An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease

A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Assess the Efficacy and Safety of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease

ethyl ester/náusea

Pharmacokinetics of Omega-3 Monoglycerides

MaxSimil and Vitamin K2: Determining Their Bioavailability

Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control

An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease

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