cyrilzakka/clinical-trials huggingface dataset:
The Effect of Remimazolam on Opioid Induced Hyperalgesia

The goal of this prospective, randomized, controlled study is to investigate the effect of remimazolam on opioid-induced hyperalgesia (OIH) in patients undergoing single port-laparoscopically assisted urologic surgery.

The main question\[s\] it aims to answer are:

* \[The mechanical hyperalgesia threshold\]
* \[Area of hyperalgesia around the surgical incision 24 h after surgery (cm\^2)\]

In three groups: Group RHR (Remimazolam- High-dose Remifentanil), Group DHR (Desflurane-low-dose Remifentanil) or Group DLR (Control).

Ninety-three (n = 31 per group) American Society of Anesthesiologists I-II patients (age 20-65 years) will be scheduled for single port-laparoscopically assisted urologic surgery.

Group RHR (Remimazolam-Remifentanil): Administer remimazolam at a dose of 6 mg/kg/h initially, followed by 1 mg/kg/h, and remifentanil at 0.3 µg/kg/min.

Group DHR (Desflurane-Remifentanil): Administer desflurane at 1 minimum alveolar concentration (MAC), adjusting the dose by 1 vol% titration to maintain MAP and BIS levels, and remifentanil at 0.3 µg/kg/min.

Group DLR (Control): Administer desflurane at 1 MAC, adjust the dose by 1 vol% titration to maintain mean arterial pressure (MAP) and bispectral index (BIS) levels, and remifentanil at 0.3 µg/kg/min.

Mechanical hyperalgesia threshold, Time to first postoperative analgesic requirement (min), Injected PCA volume containing morphine for 12 h after surgery (ml), Pain intensity: VAS 1 h after surgery, VAS 6 h after surgery, VAS 12 h after surgery VAS 24 h after surgery. Area of hyperalgesia around the surgical incision 24 h after surgery (cm\^2) will be checked.

Eligibility Criteria:
1. Inclusion criteria will include as follows; ASA(American Society of Anesthesiologists)physical status 1-2 patients, Age with 20-65 years, and Single port-laparoscopically assisted urologic surgery.
2. Exclusion criteria will include as follows; a known allergy to remimazolam or remifentanil, a history of drug or alcohol abuse, psychiatric disorders, acute cardiovascular disorders, or unstable hypertension, and other respiratory or neuromuscular pathology, treated with opioid-containing any analgesic drug within 24 h before surgery and contraindications to the self-administration of opioids (i.e., were unable to understand the PCA device).
The Management of Complicated Colo-rectal Cancer in Older Patients in the Emergency Setting: the CO-OLDER Study

This is a multicenter observational study aimed to investigate the management of older patients aged 75 years old and over admitted to the emergency department with complicated colorectal cancer.

The final endpoint is to report morbidity and mortality in this group of frail individuals according to the shift of incidence of colorectal cancer in geriatric patients, over 2 periods: before the COVID pandemic outbreak (11th March 2020) and after the 11th March, during the ongoing pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 75 years old and over;
* Admission to the emergency department with acute abdominal pain;
* Diagnosis of obstructed and/or perforated colorectal cancer.

Exclusion Criteria:

* Patients aged\< 75 years old;
* Patients aged \>=75 years old admitted with acute abdomen, not due to complicated colorectal cancer.
Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications

To determine if a therapy regimen including treatment with The MetaNeb® System had a positive impact on the rate of pulmonary complications related to atelectasis and/or secretion retention that occur in high risk post-operative patients. This is a non-randomized facility (or hospital) level pre-post intervention study.

Post-operative pulmonary complications (PPC) are associated with significant excess morbidity, mortality and healthcare expenditure. Although PPCs are an incompletely understood multifactorial syndrome, atelectasis is recognized as a critical component. A variety of strategies have been shown to reduce the risk for development of post-operative atelectasis including lung expansion (LE) therapies. Well-designed studies are needed to distinguish which LE approach has the greatest potential to optimize patient care, clinical outcomes and cost savings.

Intrapulmonary percussive ventilation (IPV) devices have been in use for more than 25 years and are used widely in the acute care, post-surgical, and homecare setting. Such devices provide both LE and airway clearance therapy (ACT) for patients with obstructive and/or restrictive lung diseases and conditions. The MetaNeb® System is an LE expansion modality that incorporates all the physiological effects of IPV while providing additional therapeutic advantages intended primarily to more effectively treat or prevent pulmonary atelectasis.

The study was be conducted in two stages. In Stage I of the study, a retrospective review of medical records for post-surgical patients, who received STANDARD THERAPY as defined by current hospital and respiratory care department policies and procedures was performed. In Stage II, a CHANGE IN PRACTICE was made and patients received standard care with the addition of therapy with The MetaNeb® System. Demographic, clinical \& outcome data was collected for eligible patients during the two stages of the study. Study staff collected data from the medical records, following a protocol determined schedule.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years Post-thoracic, -upper abdominal or -aortic surgery Open surgical procedure Incision at or above the umbilicus

High risk defined by:

Documented ASA class ≥ 3 OR

Documented ASA class 2 AND One or more of the following:

Current smoker or smoking history within past 6 months History of COPD Documented obesity and/or BMI ≥ 30 kg/m2 Age ≥ 75

Exclusion Criteria:

Contraindication to Continuous High Frequency Oscillation (CHFO) therapy

Minimally invasive, or ". . . scopic" procedure.

Spinal surgery involving a posterior approach.

Surgery for organ transplant.

Chronic invasive positive pressure ventilation (PPV)
Fitt's Law MI Experiment

The aim of our study is to investigate the acute effects of real execution (RE) and motor imagery (MI) of Fitts law tasks on near and far transfer of learning.

Studies show changes in alpha (7.5 - 15 Hz) and beta (15 - 30 Hz) frequencies before and during motor tasks. However, researchers still disagree on the origin, timing, and direction of this. The neurophysiological mechanisms of motor learning are not yet fully understood. The authors note that event-related beta desynchronization is most commonly associated with motor learning. Reduced beta wave power can be observed in motor cortex, but it is still unclear whether this change is related to motor learning, performance, or movement repetition.

A comparative study of motor imagery and actual performance showed the occurrence of similar neurophysiological processes in the motor cortex. All the mentioned studies were conducted on adults and the results were mainly from the analysis of upper limb movements. In the present study, the investigators will comprehensively evaluate the upper and lower limb movements of children: from the recognition of visual stimuli to the generation of the motor program and the execution itself (behavioral data).

Forty-five children (year 2009) will be recruited from local primary schools. In a single-blinded design, children will be randomized into three groups (1st - real execution, 2nd - motor imagery, 3rd - control) and compared at baseline, immediately post-intervention and at follow-up 24 hours post-intervention. At pre-, post-, and follow-up assessments, participants will perform two different patterns of the Fitts Law task with the predefined difficulty: lower limbs/whole body and upper limbs/hands on an interactive whiteboard. The intervention period lasts approximately 10 minutes, during which participants perform the Fitts law task with different difficulty according to the intervention group to which they belong.

During the upper limb/hand tasks, brain activity will be recorded with electroencephalography (EEG).

Eligibility Criteria:
Inclusion Criteria:

* born in 2009
* no significant muscular, skeleton or nervous system damage
* the earlier-signed agreement to take part in the protocol.

Exclusion Criteria:

* Nervous system disorders
The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity

A randomized, controlled, double blind exploratory study to explore the effects of two different potassium nitrate concentrations and water on exposed dentine in reducing dentinal hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by visual analogue scale (VAS) scores following evaporative (air) stimulus.


Eligibility Criteria:
Inclusion Criteria:

* General Health and Oral Heath: Good general health and oral health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.
* Teeth: Presence of teeth in various locations in the mouth to determine stent success. Required teeth include: at least three first molars; a maxillary incisor, cuspid and bicuspid; and a mandibular incisor, cuspid and bicuspid.
* Dental Sensitivity: a) Self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth. b) A minimum of three accessible teeth that can be isolated that meet all of the following criteria at the screening visit: i. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. Study teeth must exhibit greater than or equal to 3mm recession at the facial surface midpoint. ii. Teeth must be visually stain and calculus free. iii. Teeth having a gingival index score less than or equal to 2. iv. Teeth with a clinical mobility of less than or equal to 1. v. Teeth that show signs of sensitivity, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm visual analogue scale (VAS). c) A minimum of three eligible teeth identified at the screening visit that continue to show signs of sensitivity at the baseline assessment at treatment visit 1, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm VAS.

Exclusion Criteria:

* Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the stent materials (or closely related compounds) or any of their stated ingredients.
* Condition of the Dentition: a) Sensitive teeth not expected to respond to treatment with an over-the-counter (OTC) dentifrice in the opinion of the investigator. b) Teeth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns, orthodontic bands, extensive caries or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine.
Recirculation, Oxygenator Blood Volume and Cardiac Output Measurements During Extracorporeal Membrane Oxygenation

This study is to test the usefulness of ultrasound dilution measurements in patients on extracorporeal membrane oxygenation. Measurements may include; efficiency of support (recirculation), amount of clotting in the oxygenator (oxygenator blood volume), and how well the heart is working (cardiac output). At the present time there are no devices available to perform these functions.

At the present time there are no devices available to measure recirculation, oxygenator blood volume and cardiac output in patients on extracorporeal membrane oxygenation. The study uses an external monitor, laptop computer, clamp on flowsensors and ultrasound dilution technology to measure blood flow. Measurements are made by injecting 0.5 - 1 ml/kg of sterile isotonic saline into the patient's extracorporeal circuit. The subject will be monitored throughout the measurements. The measurements will be coordinated with the regular care of the extracorporeal circuit.

Eligibility Criteria:
Inclusion Criteria:

* Neonatal, pediatric or adult patients receiving venoarterial or venovenous extracorporeal membrane oxygenation.

Exclusion Criteria:

* Patients not receiving venoarterial or venovenous extracorporeal membrane oxygenation.
Evaluation of a Cognitive Remediation Program for Mood Disorders

Psychotherapeutic management of cognitive disorders in patients suffering from a mood disorder


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years old
2. The patient's previous diagnosis of Bipolar-Related Disorder or Depressive Disorder according to the DSM-5 criteria.
3. Mood stabilized with respect to depressive symptomatology (absence or presence of residual mild depressive symptoms (HDRS-17 ≤ 18))
4. Mood stabilized with respect to manic symptomatology (absence or presence of residual mild manic symptoms (YMRS ≤ 8))
5. Stable and effective treatment at minimum dose for at least 2 months
6. Cognitive complaint expressed by the patient, and detected by the patient's referring psychiatrist
7. Free and Informed Consent Form read, initialled and signed
8. Patient affiliated to a social protection scheme or beneficiary of State Medical Aid
9. Patient knowing how to speak French -

Exclusion Criteria:

1. Presence of a DSM-5 disorder, other than a mood, anxiety or personality disorder
2. Substance addiction or abuse (Alcohol, psychoactive substances) in the past 12 months
3. Manic, hypomanic or major depressive episode in the last 2 months
4. Somatic or neurological disorder which may lead to cognitive impairment
5. Current or less than one month's commitment to another research protocol
6. A neuropsychological assessment prior to 6 months.
7. Patient under protective custody, guardianship or reinforced guardianship
Visual Feedback Monitoring During Exercise in Individuals With Obesity

Exercise has been shown to offer numerous health benefits and be particularly important in preventing weight gain or regain for people with obesity. Exercise guidelines can be difficult to interpret and apply independently and do not address specific exercise limitations in individuals with obesity. The exercise monitoring system proposed in this study might provide a new method to meet aerobic exercise guidelines independently with reduced risk of injury.

The exercise monitoring system controls, in real-time, the intensity of an exercise session consisting of treadmill walking. During treadmill walking, the exercise monitoring system will instruct participants to increase or decrease how much participants raise their knees and swing their arms while maintaining a smooth contact with the ground, based on real-time readings of the participants' heart rate.

In this clinical trial, each participant will perform a control and an experimental training session. Both training sessions will include four blocks of 7 minutes of treadmill walking alternated with three periods of rest (3 min). In the control session, participants will monitor the intensity of exercise independently using a standard heart rate monitor and control it by adjusting their walking speed. In the experimental session, each participant will follow the exercise monitoring system instructions displayed on a TV, and treadmill walking speed will be set at a comfortable walking speed. Target heart rates of 60% HRR will be used as the exercise intensities in both training sessions. The investigators will examine energy expenditure, heart rate, and kinematic measures under control and experimental conditions. The goals of this clinical trial are to determine the effect of exercising with the exercise monitoring system in individuals with obesity. The investigators hypothesized that the experimental session will result in higher total energy cost and efficiency than the control session; and in lower heart rate error, tibial positive peak accelerations and feedback errors than the control session.

The results of this study will inform proposals for larger interventions that will focus on 1) testing different types of obesity and osteoarthritis, 2) adding a resistance-training component, and 3) integrating a diet intervention.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2
* Age 20 to 45 years;
* Able to understand spoken English at the level needed to:
* understand and follow instructions for equipment setup, testing, and task performance
* answer questions related to effort and preference
* be able to understand consent document and provide informed assent

Exclusion Criteria:

* Any signs or symptoms suggestive of cardiovascular, pulmonary, metabolic, or renal disease.
* Any injury or health condition that affects the ability to walk on a treadmill.
Evaluation of a Boosting Regimen With Oral Cholera Vaccine

Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection over 3 years and data regarding the protective efficacy over five years is anticipated for 2012. Regardless at the end of five years, it may still be necessary to provide a booster dose or reimmunize with two doses to maintain protection in previously immunized populations. This study examines the immune protection and safety of providing a one and two dose boosting regimen of Shanchol™ given five years after the initial dose.


Eligibility Criteria:
Inclusion Criteria:

All subjects must be presently enrolled in the Phase 3 NICED RCT of Shanchol™ and satisfy the following criteria at study entry:

1. Male or female adults aged 6 years and above, who are available for follow-up visits and specimen collection.

   * The subject should be able to continue in the study for the next 6 weeks
   * The subject (or parent/guardian) should be willing to provide 3 blood samples
2. Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years.
3. Healthy subjects as determined by:

   * Medical history
   * Physical examination
   * Clinical judgment of the investigator

Exclusion Criteria:

1. individuals who are too weak to get out of bed to receive the vaccine
2. pregnant women (identified through verbal screening)
3. those less than 6 years of age
4. Receipt of cholera vaccine following 2009 (time of licensure and availability of Shanchol™ in India)
Canderel:Effects on Blood Glucose Concentration and Appetite Scores

This study investigates the effects of Canderel, an aspartame and acesulfame-k blend artificial sweetener powder, on post-postprandial blood glucose levels and appetite scores.

The study is separated into two parts: A) investigating the effects of artificial sweeteners in combination with complex carbohydrates; and B) investigating the effects of artificial sweeteners in combination with simple sugars.

A) Participants will be randomly given either the placebo drink (3g of maltodextrin dissolved in 250ml of water) or the Canderel drink (3g of Canderel dissolved in 250ml of water) alongside an isocaloric high carbohydrate breakfast. Blood glucose measurements will be obtained through finger pricking and appetite will be measured using self-reported visual analog scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after breakfast.

B)Participants will be randomly given either the placebo drink (3g of Lyle's Golden syrup and 3g of maltodextrin dissolved in 250ml of water) or the Canderel+sugars drink (3g of Canderel and 3g of Lyle's Golden syrup dissolved in 250ml of water) . Blood glucose measurements will be obtained through finger pricking and appetite will be measured using self-reported visual analog scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after drink

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults (18-64)

Exclusion Criteria:

-
AZD6765 for Treatment Resistant Depression

The purpose of this study is to determine whether treatment with AZD6765 will have an antidepressant effect with patients who have treatment resistant depression.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Depression
* Inadequate response to an adequate course of antidepressants

Exclusion Criteria:

* Psychiatric disorder other than depression
* Pregnancy or lactation
* Current diagnosis of cancer
Treatment of Latent Autoimmune Diabetes of the Adult

The purpose of the study is to clarify whether patients classified as Latent autoimmune diabetes of the adult (LADA) benefit from early treatment with insulin added to per oral treatment and lifestyle measures.

Latent autoimmune diabetes of the adult (LADA) is usually defined as a form of diabetes where the onset of diabetes takes place approximately after 30 years of age, where there is presence of beta-cell directed antibodies (mostly anti-GAD) and where there is no clinical need for insulin treatment during the first 6 months after the diagnosis of diabetes.

The aetiology and treatment of LADA patients is much less elucidated than is the case for type 1 diabetes (DM1) and type 2 diabetes (DM2). LADA constitutes about 10 % of the total diabetic population in many countries. LADA is therefore more common than insulin-requiring DM1.

LADA patients lose beta-cell function faster than patients with DM2. Residual beta-cell function in DM1 is coupled to better metabolic control with lesser degree of hyperglycemia, lesser frequency of hypoglycaemic events and lesser diabetic complications.

To retain beta-cell function in LADA patients is thus highly desirable.

There are several strategies to retain beta cell function. One therapeutic strategy is to induce some degree of "beta cell rest" by treatment with exogenous insulin. Several observations indicate that such a strategy can have beneficial effects.

This is a Scandinavian multicenter non-blinded clinical trial with 78 participants with newly diagnosed LADA. Participants will be randomized to either insulin- or per oral antidiabetic treatment. Participants will be followed up for 2 years after inclusion. Beta cell function and glycemic control will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes diagnosed during 0-3 years before entering the study.
* Age \> or equal to 30 years \< or equal to 75 years
* anti-GAD positivity
* fasting C-peptide \> or equal to 0,3 ng/ml
* no need for insulin treatment by clinical judgement for at least 3 months following the diagnosis of diabetes.
* HbA1c \> 15 % above the upper limit of normal

Exclusion Criteria:

* Renal insufficiency (plasma creatinine \> 150 mol/L)
* Severe retinopathy (proliferative or pre-proliferative)
* Severe cardiac disease (NYHA III-IV)
* Chronic severe illness judged by the investigator
* Females of reproductive age who wish to become pregnant during the study
Laser Therapy in the Treatment of Post Thoracotomy Pain; A Pilot Study

The purpose of this study is to demonstrate the safety of the AvicennaTM class IV laser for application over the skin of human subjects. In addition, we seek to measure the effectiveness and utility of this class 4 laser therapy in the treatment of post-thoracotomy pain syndrome.

This study was terminated prior to enrollment and closed.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 25-65 years old with chest wall pain after lung surgery lasting more than 2 months after surgery.
* Subjects shall have failed conservative treatment which may include rest, physical therapy, braces, and over the counter anti-inflammatory medications. All those enrolled will be native English speakers and have at least a high school degree

Exclusion Criteria:

* Subjects will be excluded if they are pregnant (which will be confirmed by a urine pregnancy test if they are of childbearing age)
* Have previous history of other pain syndromes or psychiatric disorders.
* We will exclude the morbidly obese (BMI \>30) because the laser may not be able to penetrate deep enough through adipose tissue. In addition, subjects who have had previous back surgery, or are on antidepressants for the treatment of depression in the preceding 6 weeks will be excluded as these may represent potential confounding factors.