cyrilzakka/clinical-trials huggingface dataset:
Respiratory and Hemodynamics Parameters Response to Positive End-Expiratory Pressure

In this study, the sixty mechanically ventilated class I obese patients were divided into two equal groups A and B. group A received RTP position + PEEP protocol, while group B underwent RTP position protocol only. The results showed that the group A protocol has positive effects on the improvement of respiratory mechanics by significant increase the arterial oxygen partial pressure (PaO2) in mmHg to fractional inspired oxygen (FiO2), (PaO2/FiO2 ratio), partial pressure of carbon dioxide (PaCO2), and static compliance (Cstat) parameters. Moreover, a significant decrease in hemodynamics of BP\& MAP was measured. While the results of the group B protocol demonstrated a non-significant increase in the PaO2/FiO2 ratio, PaCO2, and Cstat. Besides, non-significant decreases in hemodynamics of blood pressure (BP) \& mean arterial blood pressure (MAP) were recorded.

Objective To investigate the effect of the positive end-expiratory pressure (PEEP) titration maneuver with Reverse Trendelenburg Position (RTP) on the respiratory and hemodynamic parameters of mechanically ventilated obese patients.

Design Randomized, control trial. Participants Thirty mechanically ventilated obese patients were randomized equally as a group A to receive Reverse Trendelenburg Position (RTP) + Positive End Expiratory Pressure (PEEP) titration, and group (B): receive Reverse Trendelenburg Position (RTP).

Intervention After post-operative bariatric surgeries, the sixty mechanically ventilated obese patients immediately receive a PEEP and RTP once before the weaning through the ventilator of the operation to evaluate the response of arterial blood gases before admission to the intensive care unit ICU room.

Outcomes The primary outcomes included the respiratory parameters (PaO2/FiO2 ratio, PaCO2, Cstat), and the secondary outcomes included the hemodynamics parameters (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP)).

Eligibility Criteria:
Inclusion Criteria:

* Subjects included in this study had the following criteria:

  1. Mechanically ventilated obese patients in operation room undergoing upper abdominal surgeries (bariatric) and under general anesthesia.
  2. Obese patients with BMI (30-34.9).
  3. Age 40-50 years old.
  4. Both sexes.
  5. Non-smoker.
  6. No history of disease affecting the heart \& lungs.

Exclusion Criteria:

* Subjects with any of the following were excluded from the study:

  1. Severe head injury.
  2. Increase intracranial pressure and who are potentially liable to develop pathologically raised intracranial pressure.
  3. Acute pulmonary edema.
  4. Barotrauma/volutrauma.
  5. Un-drained Pneumothorax/Hemothorax.
  6. Flail chest.
  7. Low blood pressure (systolic less than 80 mmHg).
  8. Oxygen saturation is less than 90%.
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.

The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study (AC-055H301, NCT03153137). This OL trial studies the long-term effect of macitentan in Fontan-palliated patients as it is not known if the effect of macitentan is sustained beyond 52 weeks (end of the parent RUBATO DB study). In addition, the trial also studies the long-term safety of macitentan as this is also unknown. Furthermore, the opportunity will be given to patients who were on placebo in the parent RUBATO DB study to receive macitentan 10 mg and benefit from a potentially active treatment.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent from the subject and/or a legal representative prior to initiation of any study-mandated procedures.
* Subjects who have completed Week 52 of the parent AC-055H301/RUBATO DB study (NCT03153137)
* Women of childbearing potential must:

  1. have a negative serum pregnancy test prior to first intake of OL study drug, and,
  2. agree to perform monthly pregnancy tests up to the end of the safety follow up (S-FU) period, and,
  3. use reliable methods of contraception from enrollment up to at least 30 days after study treatment discontinuation.

Exclusion Criteria:

* Clinical worsening leading to medical interventions including reoperation of Fontan circulation (Fontan take-down) during the enrollment period
* Systolic blood pressure \< 90 mmHg (\< 85 mmHg for subjects \< 18 years old and \< 150 cm of height) at rest
* Criteria related to macitentan use
* Any known factor or disease that may interfere with treatment compliance or full participation in the study
Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome

Continuous Positive Airway Pressure (CPAP) is the standard treatment in patients with Obstructive Sleep Apnea Syndrome (OSAS).

The goal of the study is to evaluate CPAP treatment duration recorded by the AL539 during attended in-hospital polysomnography in patients with Obstructive Sleep Apnea Syndrome.

Patients are patients with sleep apnea predominantly obstructive, with CPAP for at least 2 months, and requiring in-hospital night polygraphic record control.

The medical device was developed to determine:

* the duration of use of CPAP by the patient,
* the persistence of any respiratory abnormalities during treatment.

These two parameters are used to ensure that treatment is done correctly.

The use of the AL539 is expected to improve the home-monitoring of ventilation with CPAP.

Eligibility Criteria:
Inclusion Criteria:

* Sleep apnea predominantly obstructive
* CPAP for at least 2 months and requiring in-hospital night polygraphic record
* Written informed consent form
* Able to read and write in French

Exclusion Criteria:

* Ventilator with two levels of pressure
* CPAP breathing circuit non-compatible with the AL539
* Chronic respiratory disease
* Psychotropic treatment which may influence the respiratory parameters
* Acute rhinitis or acute nasopharyngitis
* Moderate or severe chronic heart failure
* CHEYNE-STOKES respiration
* Body mass index (BMI) \> 40
* Pregnant woman or woman of childbearing potential with a positive urinary pregnancy test
* Uncontrolled progressive disease
* Psychiatric disorders or regular user of drugs
* Participation in any interventional clinical trial within 30 days prior to selection
Effect of Psychological Intervention on Drop-out Rates in IVF

The most common reason why insured In Vitro Fertilization (IVF) patients drop out of treatment is the distress caused by the treatment.

The objective of this study is to determine the efficacy of a combined Cognitive Coping and Relaxation Intervention (CCRI) in reducing drop out behavior in IVF patients.

Intervention participants will be given a packet containing the CCRI, which consists of two intervention components tailored to the Stimulation Phase and Waiting Phases of IVF. The cognitive component of the CCRI is the PRCI intervention (Boivin \& Lancastle, 2008) tailored to the stimulation/waiting phases of an IVF cycle. The PRCI intervention consists of a series of ten statements that facilitate the use of cognitive reappraisal coping, a form of coping that helps people think more about the positive aspects of a difficult situation and dwell less on problems or uncertainties of the future.

The relaxation components of the CCRI consists of techniques that have been used for two decades in the mind/body infertility program as well as in randomized controlled research trials. For the Stimulation phase, participants will receive instructions on how to do "mini relaxation" techniques which are specifically designed to reduce anxiety in the moment, for example feelings of tension, worry, and nervousness that might occur prior to and during Stimulation phase procedures (e.g. injections, blood tests, and ultrasounds). For the Waiting Phase the relaxation intervention will include a relaxation CD. The CD contains narrated instruction on how to elicit the relaxation response through several techniques

This is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes women ages 44 and below scheduled to undergo their first IVF cycle. Subjects are randomized to a CCRI or a control group. The primary outcome measure is dropout rates.

Eligibility Criteria:
Inclusion Criteria:

* First fresh IVF cycle
* Using own eggs
* Able to read, understand, and sign the informed consent in English
* Must have insurance coverage for IVF cycle

Exclusion Criteria:

* \>1 previous IVF cycle
* Donor egg cycle
Effect of Mentoring on Endotracheal Tube Exchange Using a New Device

The purpose of this pilot study is to compare the time it takes to change a breathing tube with a new device, performed by two different groups of anesthesiologists; one group will study on their own how to change the tube, while the second group will also receive expert training, before either group performs the procedure for the very first time. The Investigators predict the group who gets expert training will change the tube faster, and those investigators also need to learn how much faster, before moving to a larger study.

After informed consent is obtained, two groups of randomized anesthesiologists will receive detailed instructional materials including a brochure to introduce the new device, a videotape showing how the device is used, a detailed slide show explaining each of the steps, and a checklist of the steps to perform during the exchange (E) in simulation. The Mentored group (M) will also receive expert instruction just before the procedure, while the Control group (C) will have the same amount of time to review the steps themselves. Next, they will perform the first exchange procedure (E1) while the pair of experts observe and measure the simulated patients' apnea time. The experts will then conduct a debriefing with the M group, while the C group will debrief themselves before both groups perform the exchange a second time (E2). Both groups will then receive debriefing by the experts. The apnea times and a performance assessment will be compared between M and C to determine the effects of expert training, and will also be compared within each group from E1 to E2, to determine the effect of experience on apnea time and performance. Finally, surveys conducted after E1 and E2, and before debriefing, will determine the participants' satisfaction with the new device. Data on apnea times will be used for a statistical power analysis to determine the size of a larger group necessary to show significant differences in outcomes.

Eligibility Criteria:
Inclusion Criteria:

* physician airway management experts
* training in the skill of fiber-optic endoscopic intubation

Exclusion Criteria:

* non-physicians
* physicians without airway management expertise
* physicians without skill in fiber-optic endoscopic intubation
Effects of Metformin on Hepatic FFA Metabolism

Background: Metformin treatment has beneficial effects on both glucose and lipid metabolism. Whereas there is general agreement that the blood glucose lowering effect of metformin results from inhibition of hepatic gluconeogenesis, it is less clear exactly how the drug lowers blood triglyceride concentration. There are indications that it enhances hepatic free fatty acid (FFA) oxidation thus diminishing substrate for reesterification and resecretion as very-low-density-lipoprotein (VLDL) triglycerides (TG). However, the liver is not easily accessible for sampling in humans and data on the clinical effects of metformin in the liver are therefore lacking. This may change due to the increasing use of the positron emission tomography (PET) technique. Using PET isotopes (11C or 18F) coupled to either palmitate or a fatty acid analogue, it is possible to non-invasively measure hepatic fatty acid handling.

Aim: To determine how 3 months metformin treatment (1000 mg twice daily) affects hepatic lipid and glucose metabolism in patients with newly diagnosed type 2 diabetes.

Design: Randomized, placebo controlled, double-blind parallel study with patients receiving either metformin or placebo. A control group of BMI and age-matched non-diabetic individuals will receive metformin for 3 months.

Hypothesis: Metformin lowers VLDL-TG secretion and circulating triglycerides by increasing hepatic fatty acid oxidation


Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed type 2 diabetes
* Age 50-70 years
* BMI\<40

Exclusion Criteria:

* Insulin treatment
* NASH (non alcoholic steatohepatitis)
* Cancer
* Anemia
* HbA1C\>8.5 %
* Chronic or acute pancreatitis
* Alcohol or medicine abuse
* Allergy towards metformin
* Claustrophobia
* Severe obesity (weight \>130 kilogram)
Short-term Prehabilitation Program : Interest of on Resumption of Function at 2 Months

This study aimed to evaluated the interest of a short-term (2 weeks) prehabilitation program compared to no prehabilitation before thoracic or urological surgery

Prehabilitation is a form of global strength training, aims to improve functional capacity before surgery.This preparation compensate for its decrease due to the intervention. This process includes physical training, nutritional and psychological care.

Previous studies consider 4 weeks to be the ideal duration time for such program. However, extended program duration may reduce subject compliance and may not be possible for patient who can not or do not want to postponed their surgery.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 55 or over
* Requiring major surgery (thoracic or urological surgery: kidney or bladder) within 15 days after the completion of the inclusion assessment
* Having signed a consent form after a reflection period
* Being affiliated to a Health Insurance plan.

Exclusion Criteria:

* Pregnant, parturient or lactating women
* Persons deprived of their liberty: minors or adults subject to legal protection measures or out of state to express their consent
* Patients (men or women) aged \<55 years;
* Inability to walk or initial physical assessment
* Inability to complete questionnaires
* Walk\> 450 meters in the 6 minute test
* Patients under guardianship or curators.
Shop For Success: Experimental Grocery Store Study

The purpose of this research is to study how the price of foods affects food buying choices at the grocery store. The researchers are interested in this topic because the price of foods can have a big impact on what people choose to buy and prices change over time. The researchers are doing this study to see how changes in food prices affect what foods mothers choose for their families.

It is well known that the price of a given food affects the amount of that food an individual purchases. However, little is known about how specific groups, such as overweight/obese and those with lower incomes, change their food purchasing decisions depending on food price changes. Evidence has shown that these groups have lower quality diets and worse health outcomes than their normal weight and higher income counterparts. Therefore, it is important to gain a better understanding of how food price changes affect purchasing decisions among these populations in order to develop targeted nutrition interventions to improve their diet quality. To investigate this, the researchers will create a laboratory-based grocery store, in which pictures of foods will be used to substitute actual food. Food prices will be indicated on each picture. Participants will be given play money and a budget, and ask them to "purchase" foods in the mock grocery store. The price of food will be changed throughout the study to investigate how participants change their purchasing decisions based on these price changes.

Eligibility Criteria:
Inclusion Criteria:

* Have at least one child up to 18 years of age residing in the household
* Primary grocery shopper for the household
* No health conditions or food practices that substantially limit food choice
* Not currently pregnant
* Consent to the study design

Exclusion Criteria:

* Male
* \< 18 years of age
* Not a mother, or children not living with subject in their household
* No children below the age of 18 years of age
* Not the primary grocery shopper for their household
* Health conditions or food practices that substantially limit food choice
* Currently pregnant
The Effect of Foot Massage and Bed Bath on Individuals With Cancer

Foot massage or bed bath will be applied to improve sleep quality and reduce fatigue levels of individuals with cancer.

Foot massage provides relaxation of the body with rubbing movements applied to the feet. The bathroom was an important part of the individual's general hygienic care In addition, it also ensures the physical and psychological comfort, safety and well-being of the individual.Massage and bed bath are among the independent interventions of the nurse that help the individual to relax within the scope of the Nursing Regulation. This study was planned to determine the effect of foot massage and bed bath on fatigue and sleep level in individuals with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years,
* illiterate,
* diagnosed with cancer
* volunteer to participate in the study

Exclusion Criteria:

* unable to communicate verbally
* Patients who do not meet the inclusion criteria.
Utilizing Gaze Training to Enhance Laparoscopic Skills Training

The purpose of this study is to test the influences of gaze training (GT) on the acquisition of laparoscopic surgical skills. For this purpose, the investigator will compare variants of GT in the second of 2 experiments. These questions will be evaluated using the validated Fundamentals of Laparoscopic Surgery (FLS) module 1, with the overall goal of developing a surgical training curriculum that achieves expert level skill in an expedited timeframe. This research provides a novel approach to general surgery training that has the potential to reduce the amount of time and repetitions required to achieve expert laparoscopic skills.

Developing expert performance requires assessment of the thought processes underlying performance and continued refinement of skills in order to obtain automaticity and intuition. Therefore, developing expert surgical skill is a process likely to take longer than the length of residency, thereby diminishing the quality of care delivered to patients.

The proposed study will implement novel neuroscience technique of gaze training to determine if it has the capacity to accelerate technical surgical skill learning in order to achieve competency and expertise in an earlier timeframe. Studies of skill performance have demonstrated that eye movement patterns can be optimized to improve subsequent motor movements. Therefore, gaze training encourages novices to adopt the more efficient gaze patterns of experts while performing a specific task such as laparoscopic surgery. This technique has been applied in the training of surgical residents in a limited capacity making this project an innovative approach to enhance skill development.

Experiment 2: Determine if gaze training can accelerate the learning of laparoscopic skills.

In this experiment the investigators will first establish expert gaze patterns in the Fundamentals of Laparoscopic Surgery modules 1 and 5 by testing a total of 9 participants, including attending surgeons, senior residents, and novices trained to proficiency. The investigators will then compare behavioral learning curves from non-expert participants without gaze training against those trained using both explicit (by reviewing the expert gaze pattern) and implicit gaze (by using a visual mask during the training, leading the participant to follow the expert gaze) derived from the expert gaze patterns. This will be tested in 3 groups of 20 participants, who train for 40-minutes in each of 6 sessions that occur within 3 weeks.

The investigators hypothesize that both explicit and implicit gaze training will lead to faster skill acquisition, with implicit greater than explicit and measured by trials required to gain proficient module completion scores, relative to the group of participants who practice without any gaze training.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Healthy male and female
* Willing and able to provide informed consent
* Able to follow study procedures
Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor

This investigation is looking at a currently available technology to see if it could have another use i.e. in helping to diagnose patients with sleep apnoea.

With 2-4% of the population suffering from this disease, and the current wait time for a test at approximately 20 weeks, it is hoped that a simple screening method could help speed up the process of finding these patients and getting them on treatment faster.

The current standard of care test involves a sleep study in the patients own home with a device with multiple parts and wires. The RespiraSense Sleep Screener is completely cableless and consists of one small, discrete unit attached to the patients side and a mobile device plugged in by the bed.

Patients at Queen Alexandra Hospital who are prescribed sleep studies will be invited to participate. The RespiraSense Sleep Screener data is only for comparison purposes and will have no effect on their clinical care.

If patients agree to participate they will undergo the sleep study with both devices in the same night and may be followed up with over the phone on their experiences with the test.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 Years
* Patients due to undergo home monitoring to investigate presence of sleep apnoeic events
* Patients able to provide informed consent to participate in this investigation

Exclusion Criteria:

* Patients with known respiratory disorders that are uncontrolled at the time of the sleep study
* Patients allergic to medical grade skin adhesive
* Patients on long term, oral steroid use
* Pregnant women during second and third trimester
* Patients presently on any sleep disorder therapy
* Patients with any history of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
* Patients with any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent
Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults

This study is being done to understand the effects of calorie restriction and weight loss on muscle protein metabolism in adult men and women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI will be between 30 kg/m2 - 38 kg/m2 and waist circumference for women ≥ 88 cm and men ≥ 104 cm
* Age 45 to 65 years.
* Male and Female

Exclusion Criteria:

* Active coronary artery disease
* BMI \< 30 kg/m2 Participation in structured exercise (\>2 times per week for 30 minutes or longer)
* Smoking
* Medications known to affect muscle metabolism (beta blockers)
* Renal failure (serum creatinine \> 1.5mg/dl)
* Chronic active liver disease (AST and ALT \> 3 times normal)
* Fasting blood glucose \> 126 mg/dl
* Anti-coagulant therapy (warfarin/heparin)