cyrilzakka/clinical-trials huggingface dataset:
Does LMA Instead of ET Tube Affect Incidence of Postoperative Vomiting in Children Undergoing Strabismus Correction?

The effect of airway management on vomiting after strabismus surgery is unknown. The purpose of this study is to find out whether the use of different airway devices, such as LMA, which is a special mask placed in the throat or Endotracheal tube (ET tube), which is a soft tube placed in the wind pipe, affects the incidence of vomiting after surgery. Two hundred six children between the ages of 2 and 12 years are expected to take part in this study.

The child will be checked by the study doctor to determine if he/she qualifies to be part of the study. The study doctor may not want the child to take part in this study if he/she is currently in another research study; or if the child has been in any other research study within the last 30 days, or if the child is extremely obese, or has reflux or another GI problem.

If the child qualifies for the study, he/she will receive routine general anesthesia. For airway management, the child will have either a LMA or ET tube. The child has an equal chance of receiving either one of these airways devices, much like the coin flip.

After surgery, the child will be transferred to the recovery room (PACU). If the child vomits in PACU, he/she will receive rescue medication, which can be repeated if the need arises.

A research coordinator will call the parents the following day to find out whether the child vomited after leaving the hospital, in the car or at home, for any complications and receiving any medications.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Elective Uni- or Bilateral Strabismus repair

Exclusion Criteria:

* ASA \>2
* History of Prematurity
* History of Reflux
* History of Neurological Disease
* Difficult Airway
* Obesity
Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant

To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants, so far limited to clinical cases, we will perform an observational retrospective pharmacovigilance study, using two databases. First, disproportionality analysis in Vigibase®, the World Health Organization global database, will be perform between antidepressant drugs and neonatal hypotonia . Second, narratives from the French National Pharmacovigilance Database will be extracted.


Eligibility Criteria:
Inclusion Criteria:

* neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs

Exclusion Criteria:

* Reports with maternal suicide, congenital malformation and hypotonia occurring only during breastfeeding
A Personalised Percutaneous External 3D Guide for Scaphoid Fixation

The investigators want to analyse the advantages of using a 3D constructed prototype from a previous CT Scan to model an external customised guide por percutaneous Scaphoid fixation.

The investigators hypothesise that the usage of this device will shorten surgery time, radiation for the surgery team and optimise the percutaneous screw trajectory inside of the scaphoid bone.

To carry out this analysis the investigators will recruit 10 patients who present with an acute fracture of the Scaphoid bone type B1 and B2 (Herbert Classification).

A CT Scan will be performed and a 3D exoesqueleton model printed, previously deciding the position of the fixation screw inside of the bone and adding a cannulated sleeve in the volar aspect of the exoesqueleton to insert the initial positional guide wire for surgery.

Surgery time, surgery radiation exposure and screw positioning will be recorded and compared to 10 control patients operated following standard procedure.

Eligibility Criteria:
Inclusion Criteria:

* Acute scaphoid fracture (Herbert B1 B2)

Exclusion Criteria:

* Concomitant fractures
Effect of a Probiotic, Lactobacillus Gasseri BNR17, on Body Composition and Weight Management in Overweight Adults

Lactobacillus gasseri BNR17™ has shown promise in several pre-clinical and randomized controlled clinical trials for weight management outcomes. The current randomized, double-blind, placebo-controlled, parallel-arm trial will further assess L. gasseri BNR17™ on body composition and weight management, and in a study population that is distinct to prior randomized controlled trials on the strain. The study will recruit 126 overweight adult participants who will be randomly assigned to consume L. gasseri BNR17™ or placebo once daily for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent;
* Aged between 25 and 65 years inclusive;
* Body mass index between 25.0 to 29.9 Kg/m2, inclusive;
* Waist-hip ratio of ≥0.91 for males and ≥0.81 for females;
* Sedentary lifestyle, exercising ≤2 times/week;
* Good general health, as determined by the investigator;
* Willing to consume the investigational product daily for the duration of the study;
* Outside the healthy parameters of visceral adipose tissue, defined as 762 cm3 for males and 256 cm3 for females.

Exclusion Criteria:

* Females who are pregnant, lactating or wish to become pregnant during the study;
* Participant regularly takes probiotic supplements, or has within the 4-weeks prior to randomisation or plans to during the study;
* Participant is hypersensitive to any of the components of the investigational product;
* Participant is severely immuno-compromised (HIV positive, transplant patient, on antirejection medications, on a steroid for \>30 days, or has underwent chemotherapy or radiotherapy within the last year);
* Participant has Type 1 or Type 2 Diabetes Mellitus;
* Participant has a history of bariatric surgery;
* Participant has taken anti-obesity medication or supplements in the 12-weeks prior to randomisation or plans to during the study;
* Participant is actively or has recently (3 months prior to randomisation) participated in a weight loss program or weight change of 3 kg during the past 3 months;
* Participant has a life-threatening illness;
* Participant is on a glucose lowering medication, anti-psychotic drugs or any medication that the investigator determines could impact the results of the study; participant has commenced use, within 3-months of randomisation, anti-hypertensive drugs, anti-depressive drugs, statin or any other medication that the investigator determines could impact the results of the study;
* Participant has a history of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology (e.g. colon cancer, colitis, Crohn's Disease, Celiac, Endometriosis, prostate cancer) or lactose intolerance;
* Participant has a recent history of drug and/or alcohol abuse at the time of enrolment;
* Participant is currently, or planning to participate in another study during the study period;
* Participant has a history of non-compliance;
* Participant has taken antibiotics in the 12-weeks prior to randomisation.
Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis

Several studies have shown that bone mineral density (BMD) at the femoral neck decreases with increasing physical handicap (EDSS-score) in MS patients. Possible explanations are less weightbearing exercise or less UV-exposure resulting in reduced vitamin D generation in the skin. Prevention of osteoporosis is a high priority, because treatment of the established disease remains sub-optimal.

We have designed a double-blind randomised controlled trial of two years' duration including 90-100 persons with MS age 18-50 to assess whether supplementation with vitamin D, given as a weekly dose of 20,000 IU cholecalciferol, can prevent bone loss.

The primary objective of this study is to determine changes in BMD over the 2 year study period comparing treatment and placebo groups.

The most important secondary objective is to determine cytokine profiles in blood samples. We will also assess parameters related to vitamin D status and physical performance.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 50 years
* EDSS \< 4.0 (able to walk without rest some 500 m)
* Women have to be premenopausal
* MS according to the McDonald criteria; prepared and considered able to follow the protocol; using appropriate contraceptive methods (women of childbearing potential)
* Having given written informed consent.

Exclusion Criteria:

* Pregnancy or unwillingness to use contraception; alcohol or drug abuse
* Use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses
* Known allergy to cholecalciferol or arachis oil (peanuts)
* Therapy with digitalis, calcitonin, active vitamin D3 analogues, fluoride, or bisphosphonates during the previous 12 months
* Any condition predisposing to hypercalcaemia
* Nephrolithiasis or renal insufficiency
* Presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the year before the study began; a history of nephrolithiasis during the previous five years.
Oral Surgery Virtual Reality Glasses Study

The goal of this randomized trial is to investigate if using virtual reality (VR) glasses for patients who require non-emergent oral surgery procedures under intravenous (IV) sedation improves their overall experience compared to using standard of care safety glasses.

This study has two primary objectives.

1. To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure.
2. To investigate whether the use of VR glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure.

80 subjects will be randomly assigned 1:1 to either wear VR glasses playing a relaxing video and audio or VR glasses that will only serve as eye protection (control group).


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring IV sedation for oral surgery procedure
* Patients able to understand the use of virtual reality glasses and provide informed consent/assent
* Patients classified as American Society of Anesthesiologists (ASA) I or II
* No reported substance use within the previous 24 hours
* No reported excessive alcohol consumption
* Willingness to wear eye protection
* Willingness to use certified interpreters if required
* A legal guardian must accompany minors

Exclusion Criteria:

* Patient with hearing aids or severe hearing impairment
* Patient with blindness or significant visual impairment that is not corrected by contact lenses
* Patients with cognitive impairments determined and assessed by the researchers
* Pregnant women or women who could be pregnant based on self reporting
* Patients unable to tolerate virtual reality glasses due to motion sickness or other issues
* Patients with history of seizures or epilepsy per self report
* Patients who cannot tolerate VR glasses due to discomfort or a medical emergency that arises during the procedure
Health Promotion and Management for Hepatitis B Carriers

The investigators propose a project of preventive medicine with concern of local context in Taiwan. The target population includes all staff and faculty members, students, and alumni of a university in Northern Taiwan, with chronic hepatitis B infection. The intervention of this project includes standardized lectures, sports courses, nutrition courses, and an information platform. The investigators will evaluate the efficacy after the intervention, like the reduction of hepatitis B viral load and the associated anthropometric parameters. The results of this project will be initially served as a pilot study for this cohort, and applicated as a promising basis for health promotion.


Eligibility Criteria:
Inclusion Criteria:

* Participants were recruited from students, alumni, faculty and staff members with chronic HBV infection (positive HBsAg serostatus ≥6 months) in a university of northern Taiwan from August 1, 2009 to July 01, 2010. Only participants aged 18 and older were included.

Exclusion Criteria:

* Excluded were:

  * (a) those who had been diagnosed as chronic liver diseases like chronic hepatitis C infection (Anti-HCV (+)), autoimmune hepatitis, Wilson disease, alcoholic liver diseases, drug-related hepatitis, decompensated liver diseases, cirrhosis, or malignant hepatic tumors;
* (b) those who had undergone liver transplantation or major operations for liver except cholecystectomy;
* (c) men who consumed more than 30 gram of alcohol per week or women who consumed more than 20 gram of alcohol per week;
* (d) women who were pregnant;
* (e) those who had current medications for any types of chronic diseases except for hyperglycemia, elevated blood pressure, or dyslipidemia within six months.
Bihemispheric Modulation of the Motor Cortex by Transcranial Direct Current Stimulation in Subacute Stroke Patients

Post-stroke sensorimotor recovery largely depends on ipsilesional and interhemispheric motor circuit reorganization. Transcranial direct current stimulation (tDCS) may be used to enhance after-effects of rehabilitation through membrane polarization modulation. In this double-blind, crossover randomized controlled trial, we aim to investigate whether single-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper extremity rehabilitation therapy modulates ipsilesional motor circuit excitability using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.

We will consecutively enroll subacute (2-4 weeks after stroke onset) patients with first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory with mild to moderate hand weakness. All subjects will be assessed for baseline upper extremity motor function (Fugl-Meyer test and Action Research Arm test), structural and functional magnetic resonance imaging (fMRI). A single session of bihemispheric tDCS (anodal tDCS to ipsilesional M1 and cathodal tDCS to contralesional M1 with 2 mA stimulation for 20 min) or sham tDCS (same but stimulation for only 2 min) with simultaneous physical/occupational therapy will be tested in each subject with a randomized sequence on different days (at least two days apart from each other). All stroke patients will receive standard medical and rehabilitation treatments during the study period. Changes in corticospinal excitability and transcallosal inhibition from the TMS study, as well as sensorimotor oscillations, MEG source projection, and functional connectivity from the task-related MEG will be assessed immediately before and after intervention.

Eligibility Criteria:
Inclusion Criteria:

* subacute (2-4 weeks after stroke onset) patients
* first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory
* mild to moderate hand weakness (MRC 2-4/5)

Exclusion Criteria:

* cerebral cortex lesions
* containing metal implants (such as implanted electrodes, pacemakers)
* sensitive or fear of electromagnetic waves
* pregnant women
* history of alcohol or drug abuse
* history of seizures or epilepsy EEG recording
* other significant disease or neuropsychiatric disorders
* claustrophobia
* fixed dentures over two or more (enough to interfere with MEG signals)
Medical Review: Hand Surgery After Local Block Versus Non-block

In this study, the effects of local block vs non block will be assessed with respect to postoperative outcomes (such as pain score, and recovery profiles) in outpatients after hand surgery.

Analyzing medical records and through a telephone questionnaire, in a retrospective and prospective review respectively.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Outpatients who underwent hand surgery under peripheral nerve block or local infiltration alone

Exclusion Criteria:

* Patients who do not meet inclusion criteria
Validation of Scales in Reconstructive Breast Surgery

The main purpose of the project is to validate patient reported outcomes measures (PROMs) in reconstructive breast surgery. BREAST-Q will be evaluated for Swedish and Sweden.Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ5D), and SF-36 will be validated for reconstructive breast surgery. In addition, the complication classification system according to Clavien-Dindo will be validated for reconstructive breast surgery.


Eligibility Criteria:
Inclusion Criteria:

* Women who have had or will have reconstructive breast surgery in Sahlgrenska university hospital.

Exclusion Criteria:

* Do not understand Swedish.
Endothelin Receptor Function and Acute Stress

Our bodies respond differently to stress. Animal studies by the investigators have found that endothelin-1 plays a role in regulating blood pressure in response to stress. This study is an extension of the investigators previous animal work to evaluate the role of endothelin-1 during stress in humans.

Using a salt sensitive animal model of prehypertension, the Dahl S rat,the investigators have previously published that acute stress elicits a pressor response that is accompanied by an increase in 8 isoprostane and endothelin-1. However, the pressor response is suppressed by endothelin A/B receptor antagonism. Moreover, the investigators have identified that the increase in 8-isoprostane occurs downstream of endothelin receptor activation. These data indicate that endothelin receptor activation is a main player In the pressor response to acute stress in pre-hypertensive animals; however, this phenomenon has yet to be elucidated in humans.

Eligibility Criteria:
Inclusion Criteria:

* Men and premenopausal women (Ages 18-50 years old)
* Self-reported Black and White adults
* Lean adults (BMl \<25 kg/m\^)
* Obese adults (BMl \> 30 kg/m\^)

Exclusion Criteria:

* Having a BMI less than 16 kg/m2 (severely and very severely underweight) or that is greater than 40 kg/m2 (Class III obesity)
* Having evidence of cardiovascular, pulmonary, renal, hepatic, cerebral, or metabolic disease
* Having evidence of pregnancy
* Using medications that affect vascular tone (i.e., nitrates, etc.)
* Postmenopausal women
* Uncontrolled hypertension
* Individuals who are on a restricted salt diet
* Having a history of chronic pain
* Having a history of rheumatoid arthritis
* Using medications that are contraindicated with bosentan (i.e. glyburide, cyclosporine)
* Liver dysfunction (which may be identified with the blood sample we take)
HEROIC (Heparin Requirement in Counterpulsation)

Patients with intra-aortic balloon pumps (catheters placed in the groin connected to a pump which assists the heart by opening and closing a balloon in the aorta, thereby decreasing the work of the heart and improving blood flow to the coronary arteries) often receive intravenous (IV) heparin (a "blood thinner") to prevent circulation problems in the leg (where they are inserted). When intra-aortic balloon pumps were initially developed, the catheters were larger than the catheters used today. Due to the large size of the catheter and the material used to make the catheter, it was thought that intravenous heparin would prevent poor blood flow to the leg that contained the temporary catheter. Intravenous heparin, however, has never been proven to maintain good blood flow in these patients. The catheters used with intra-aortic balloon pumps are now smaller in size and made of a material that is less likely to produce blood clots. It is not clear that heparin is needed with intra-aortic balloon pumps. Bleeding complications associated with intra-aortic balloon pumps may be decreased if heparin is not used. In 2004, 99 patients received intra-aortic balloon pumps in the cardiac catheterization labs at William Beaumont Hospital. These patients received intravenous heparin and experienced a large number of bleeding complications (27 patients required a blood transfusion). This study will help the investigators to clarify if heparin should or should not be routinely used in patients with intra-aortic balloon pumps.

Potential patients will be identified in the cardiac catheterization lab when an intra-aortic balloon pump is placed. Patients who agree to participate in this study will be randomized (they will be selected to receive heparin or not to receive heparin with their intra-aortic balloon pump) by a process that is similar to flipping a coin. Patients will have a 50% chance of receiving heparin and a 50% chance of not receiving heparin. If a patient does not want to participate in the study, his/her cardiologist will decide if the patient will receive or not receive heparin. Intra-aortic balloon pumps have been used with and without intravenous heparin and there is no known increase in complications in patients who do not receive heparin. Risks include bleeding and possible blood clots/decreased blood flow to the leg with the catheter in both groups (due to different medical reasons). The patients in both groups will be monitored closely in the cardiac care unit while the intra-aortic balloon pump is in place to prevent and/or minimize complications.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Able to provide consent
* Insertion of Intra-aortic Balloon Pump (IABP) in William Beaumont Hospital (WBH) cath lab
* Anticipated duration of IABP \>/= 18 hours

Exclusion Criteria:

* Contraindications to heparin
* Pre-existing condition requiring heparin administration (other than IABP)
* IABP placed outside of the WBH cardiac catheterization lab prophylactically for high-risk percutaneous coronary intervention (PCI), without complications)
* Pregnant women
Effect Of Aspirin Preoperative on Postoperative Cognitive Dysfunction In Elderly Patients Undergoing Knee Arthroplasty

Studies have shown that the lifetime risk of developing symptomatic knee osteoarthritis is 40% in men and 47% in women; and the risk can be increased to 60% when the patient's BMI reaches 30 kg/m2. In this population, knee replacement is the most common, effective, and cost-effective method in all treatments with reducing pain, improving joint function and quality of life. Postoperative cognitive dysfunction (POCD) is a common complication in the elderly, and its incidence can reach 25-40% in major non-cardiac surgery. As for POCD can prolong hospital stay, increase mortality and morbidity, and increase social and economic burden, it is especially important for the prevention and treatment of POCD. However, The mechanism of POCD is still unclear. Studies suggest that it may involve inflammation and oxidative stress in the central nervous system. But for the elderly, they are in a state of low inflammatory response. At the same time, surgery and tourniquets also can trigger or aggravate inflammatory response. Once the inflammatory factors released into the blood circulation, they can act on the central nervous system in a variety of ways. As a result,elderly patients are more likely to develop POCD. In addition, some studies have shown that pain can also increase cognitive burden. Aspirin, its pharmacodynamic effects includes anti-inflammatory and analgesic effects which may have a certain effect on the prevention of POCD.

Elderly patients undergoing knee replacement are more likely to develop POCD. The aim of this study is to determine the incidence of short-term POCD and long-term cognitive status in the elderly patients who use Aspirin atleast three months before knee replacement.And then, the study evaluates the effect of Aspirin on the incidence of postoperative delirium. In addition, it also shows the risk factors for POCD such as postoperative delirium, pain, C reactive protein and so on in the elderly patients who undergo knee replacement.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 60 years old undergoing elective knee replacement with general anesthesia
* ASA score grade I-III
* Sign that informed consent is willing to participate in the study
* Can communicate in verbal
* The time of using aspirin is at least 3 months

Exclusion Criteria:

* Central nervous system disease;
* Mental illness before or now;
* With using Antipsychotic treatment such as sedatives or antidepressants;
* With drug dependence;
* Severe visual, auditory, or motor impairment;
* Acute infection;
* Emergency surgery;
* Serious systemic diseases;
* Preoperative delirium and/ or cognitive dysfunction preoperative;
* History of hospitalization 3 months before surgery.
* Participating in other research