cyrilzakka/clinical-trials huggingface dataset:
Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.

Remifentanil (RMFNT) is a very short active opioid, used for analgesia during general anaesthesia and for analgesic and sedative effect in intensive care units (ICU) patients. Registration for anesthesia includes bolus dose and continuous infusion, in ICU only infusion regimen is allowed. Pharmacokinetic/pharmacodynamic parameters of RMFNT results in rapid onset and offset of clinical effect, which makes this drug almost ideal in many situations. Unfortunately, its vagomimetic influence on cardiac activity may result in decrease of heart rate. It may be hypothesized that patients with parasympathetic predominance may be prone to more intense parasympathomimetic effect of this opioid. An optimal method for assessment of autonomic nervous system activity and assessment of influence of RMFNT on that activity is Heart Rate Variability (HRV) analysis. Parasympathetic predominance is expressed as high frequency (HF) power and HF/(LF+HF) (LF-low frequency) ratio in frequency domain and Root Mean Square of the Successive Difference (RMSSD), the number of pairs of successive NNs that differ by more than 50 ms (NN50), the proportion of NN50 divided by total number of NNs (pNN50) in time domain. The aim of this study is to verify the hypothesis that patients with predominance of parasympathetic activity are more subject to vagomimetic effect of RMFNT. HRV based on 5 minutes electrocardiogram (ECG) recorded before and after bolus dose of RMFNT will be analyzed. The occurrence of heart rate decrease will be than compared between patients with sympathetic and parasympathetic predominance measured prior to drug injection.


Eligibility Criteria:
Inclusion Criteria:

* patients assessed with American Society of Anesthesiologists' Physical Status Classification System as 1-2 status
* planned surgery under general anaesthesia

Exclusion Criteria:

* known sensitivity to remifentanil
* anticipated problems with tracheal intubation
* increased risk of aspiration
* diabetic patients
* patients taking medications with known influence on autonomic nervous system
Community and Physician Perspectives Regarding Male Youth Human Papillomavirus (HPV) Disease and Vaccination

This is a minimal risk, anonymous, convenience sample, social behavioral study using qualitative descriptive survey methods. It is to ascertain community member, physician, resident and medical student perspectives regarding Human Papillomavirus (HPV) infection, associated diseases and to identify barriers which prevent these groups from ensuring that males 9-26 receive the three-shot vaccine series to prevent HPV infection.

The research is focused on these questions:

Do community members understand the ease of transmission of the HPV virus in males 9-26? Do community members, physicians, residents and medical students have knowledge of the associated diseases that may occur with the HPV virus infection in males age 9-26? Do community members, physicians, residents and medical students know the ages in which males should receive the HPV vaccine three-shot series? What barriers prevent community members and physicians, residents and medical students from ensuring that males 9-26 receive the three-shot vaccine series to prevent HPV infection?

This is a minimal risk, anonymous, convenience sample, social behavioral study using qualitative descriptive survey methods. It is to ascertain community member, physician, resident and medical student perspectives regarding Human Papillomavirus (HPV) infection, associated diseases and to identify barriers which prevent these groups from ensuring that males 9-26 receive the three-shot vaccine series to prevent HPV infection.

The research is focused on these questions:

Do community members understand the ease of transmission of the HPV virus in males 9-26? Do community members, physicians, residents and medical students have knowledge of the associated diseases that may occur with the HPV virus infection in males age 9-26? Do community members, physicians, residents and medical students know the ages in which males should receive the HPV vaccine three-shot series? What barriers prevent community members and physicians, residents and medical students from ensuring that males 9-26 receive the three-shot vaccine series to prevent HPV infection?

Eligibility Criteria:
Community Participants

Inclusion

All visitors to the Pediatric or Internal Medicine University Health Shreveport Clinics willing to complete a survey

Community Study Exclusion

Those do not wish to participate in the study

Those who English is not their first language

Clinical Faculty, Resident, and Medical Student Study

Inclusion

All Louisiana State University Shreveport Health Clinical Faculty, Resident, and Medical Student Inclusion willing to to complete the online survey.

Clinical Faculty, Resident, and Medical Student Study

Exclusion

Any LSU Health Shreveport Clinical Faculty, Resident, and Medical Student which declines to take the survey or do not attempt to complete it.
Transfer of Skills From VR-Trainer to Operation Room

The purpose is to determine if skills obtained by training in the laparoscopic virtual reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as improved score in a technical skills assessment.

The purpose is to determine if skills obtained by training in the laparoscopic virtual reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as improved score in a technical skills assessment. Design: prospective randomized double blinded intervention study.

Subjects:Younger gynaecologists (Postgraduate year 2-8) Half are having conventional training the other half is undergoing virtual reality simulator training before performing their first laparoscopic salpingectomy.

Outcome is measured by blinded video evaluation with criteria. The criteria is defined in the previous validated scoring system Objective Structured Assessment of Technical Skills (OSATS)

Eligibility Criteria:
Inclusion Criteria:

* Gyn/obs trainee 1.-2. year, with no experience from advanced laparoscopy

Exclusion Criteria:

* Advanced laparoscopic experience
* Previous training in simulator
Affixing Polypropylene Mesh Using Barbed Suture (Quill™ SRS) During Robotic Assisted Laparoscopic Sacrocolpopexy

1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).

1.2 SECONDARY OBJECTIVE - To compare robotic assisted laparoscopic sacrocolpopexy anatomic failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The investigators will also assess mesh erosion rates, costs, and surgeon satisfaction rates.

2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).

2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be less costly than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).

2.2.b. Failure rates and mesh erosion rates for each technique will be equally low.

2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique based on subjective surgeon satisfaction questionnaires.


Eligibility Criteria:
INCLUSION CRITERIA

* \>18 years old
* Undergoing RALSC with or without other procedures for pelvic organ prolapse or incontinence
* Willing to return for follow-up visits
* Written informed consent obtained from each subject
* Must be having a robotic assisted laparoscopic sacrocolpopexy

Exclusion Criteria:

* Decline to participate
* Pregnant or contemplating future pregnancy
* Unable to participate in the informed consent process
Doppler Ultrasonography in Assessment of Graft Hemodynamics After Living-Donor Liver Transplantation

Graft ischemia after liver transplantation is associated with a high incidence of morbidity and mortality . The overall incidence of vascular complications in adults varies widely among transplant centers worldwide, but remains around 7% in various series of deceased donor liver transplantation (DDLT), and around 13% involving living donor liver transplantation (LDLT) Vascular complications include; hepatic artery thrombosis and stenosis, portal vein thrombosis and stenosis, caval and hepatic veins obstruction, arterial pseudo aneurysm. Biliary complications include; biliary leakage, stricture and obstruction .

Hepatic artery thrombosis (HAT) is the most severe and frequent complication represents more than 50% of all arterial complications. Early HAT occurring within 1 month post-operation in 2.9%, and late HAT in 2.2%. The overall mortality rate for patients with early HAT is about 33% (13).

Hepatic arterial stenosis can occur immediately postoperative or later with an incidence of 1% to 2% and has been suggested to progress to HAT. This is due to surgical technique or fibrotic healing (14).

Hepatic artery aneurysm or pseudoaneurysm is rare and has an incidence of 0.27-3%. They occur in the second or third post-transplant week after infection caused by biliary sepsis, intestinal perforation, anastomotic leak, or intrahepatic stenting, or technical failure .

Portal vein thrombosis (partial or complete) or stenosis has an incidence of 2-3%, it can occur early postoperative within 1 month or more late. Early portal vein thrombosis can lead to liver insufficiency and failure. Late presentation, depending on the collateral circulation, can lead to portal hypertension with varices and ascites .

Currently, transplant outflow obstruction by kinking, stenosis or thrombosis of the inferior vena cava (IVC) or hepatic vein, especially in LDLT, are relatively uncommon complications following liver transplantation with an reported incidence of less than 3%. The main risk factor is a technical error in the creation of the anastomosis Despite all the advances in transplant patient care and surgical techniques, biliary complications remain high incidence in living donor or split liver transplant. There are early and late complications, and there are anastomotic, and nonanastomotic biliary complications, such as stones, sludge and casts .

Eligibility Criteria:
Inclusion Criteria:

* Adults more than 18 y with living donor liver transplantation in Al-Rajhi liver hospital, Assiut, Egypt

Exclusion Criteria:

* Pediatric liver transplantation
Effects of Exergaming Session Frequency on Work Performance, Cognition, and Mobility in Adults Age 55 to 65

Aim - determine the immediate and lasting effects of Exergaming frequency on work performance, health, motor, and cognitive function in clerical employees.

Hypothesis - In sedentary clerical workers the introduction of even 1 session / week exercise can cause lasting and correlated improvements in work, motor, and cognitive function, and effect which plateaus at 2 compared with 3 sessions / week. However, 6 months follow up would show residual effects only at the 3/week frequency in those who had become sedentary again.

Eligibility Criteria:
Inclusion Criteria:

* age
* active worker
* no detected neurological status

Exclusion Criteria:

* Sever heart problem
* Sever demeanor
* Alkoholism
* Drug problems
A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants

Dry Eye Disease (DED) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. This study will evaluate symptom relief and tolerability of ABBV-444 eye drops in adult participants.

ABBV-444 is being developed for the treatment of Dry Eye Disease (DED). This is a 30-day, open-label study to evaluate adult participant symptoms and tolerability of ABBV-444. Around 40 participants will be enrolled in 1 site in the United States.

Participants will receive 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Had used artificial tears for dry eyes within the past year
* OSDI score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at Screening and Baseline Visits Three consecutive tear breakup time (TBUT) tests ≤ 10 seconds in at least 1 eye at Day -7 (screening)
* Grade 1 to 4 (modified National Eye Institute \[NEI\] Grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that was related to dry eye in at least 1 eye at both at Screening and Baseline Visits

Exclusion Criteria:

* Have uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the participant at risk through participation, or which would prevent or confound protocol-specified assessments (e.g., hypertension and diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency disease, etc.)
* Known allergy or sensitivity to the study products or their components
* Schirmer Test (with anesthesia) ≤ 2 mm in either eye at Screening Visit
* Participant anticipated contact lens wear during the study, or the participant had worn contact lenses in the last 3 months prior to Screening Visit
Dynamic Vision Testing and Concussion Management

The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.

The subjects of interest are CSUN student-athletes who give consent to participate in the study. Dynamic vision will be assessed through the administration of the Dynamic Visual Acuity (DVA) test and the Gaze Stabilization Test (GST). Additionally, the 6-condition Balance Error Scoring System (BESS), which is currently a component of CSUN's established concussion protocol, will be administered to assess balance impairments. This cluster of tests will be administered three times per athlete: (1) during preseason to establish baseline measures, (2) acutely post-concussion once the athlete subject has been cleared by the team physician for return to exercise, and (3) when cleared to return to sport. The results will be used to evaluate whether or not dynamic vision results have returned to baseline by the time that CSUN Athletics clears the athlete to "Return to Play."

Eligibility Criteria:
Inclusion Criteria:

* California State University Northridge athletes
* Participants are able to give consent to participate in the study
* Completion of preseason testing for the 6-condition, BESS, DVA, GST with the research team
* Sustained a concussion as diagnosed by the medical staff during the 2020-2021 season of play.
* Sampling of convenience on a volunteer basis

Exclusion Criteria:

* Athletes with preseason baseline tests on BESS or DVA that are not within the normative value range for an unimpaired individual.
* The initial 6- condition BESS score is \>20 errors
* The subject is unable to attain a minimum of 85 degrees per second of horizontal head rotation when performing the DVA test.
A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain

This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the field of stereotactic neurosurgery.

AW frame is a stereotactic biopsy frame created by Dr. Albert Sii Hieng Wong. A phantom study had completed by Dr. Bik Liang Lau and Dr. Albert Sii Hieng Wong in year 2017 with good accuracy. The phantom study result is going to be submitted for publication by early 2019.

With the good accuracy of AW frame in the phantom study, the frame has been approved by the Medical Research \& ethic committee (MREC) for human use in a research setting.

In the study, patient with intracranial lesion which required biopsy, whom fulfilled the criteria will be recruited. All these patient will underwent standard biopsy procedure either under local or general anaesthesia with AW frame mounted.

A localisation CT scanning will be perform with localiser fixed onto the head frame. Target of the intracranial lesion is selected. The coordinates of the localizing points and the selected target inserted into the AW stereo-calculator to generate the AW frame setting up measurements.

Burr hole will be performed and biopsy taken by using Nashold® biopsy needle. An immediate post-biopsy CT imaging will be performed to confirm the site of the biopsy. Patient will be monitored in the neurosurgery ward for any complications.

Histopathologic analysis of the biopsies will be done using usual procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age \>17 years old
* Radiological diagnosis of intracranial space occupying lesion of any etiology

Exclusion Criteria:

* Patient involved in other study trial
* Any serious medical condition that according to the investigator could interfere with the conduct of the study
* Unwillingness or inability to comply with study requirements
Digital Patient Education Platform in Head and Neck Cancer

Head and neck cancer is a disease that has a particular propensity for treatment-related morbidity. It is hypothesized that patients who are more involved in their care in hospital and who are actively provided with more treatment-related education may report increased satisfaction and have improved overall outcomes. The investigators aim to determine whether delivery of patient-centred education in a multimedia format via a digital platform has an impact on overall satisfaction and perceived quality of medical care.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 years old or above
* Patients seen in outpatient clinic who are scheduled to undergo reconstructive head and neck surgeries for a confirmed oral or oropharyngeal cancer diagnosis.

Exclusion Criteria:

* Patients who are unable to use a digital tablet
* Patients who do not speak or read English
* Individuals unable to understand the purpose, methods and conduct of this study
* Patients unwilling to provide informed consent
Endoscopic Extirpation of Benign Breast Tumors Using a Lateral Chest Wall Incision

1. A new surgical method for breast surgery has been introduced, which involves the removal of benign breast tumors through endoscopic surgery, thereby avoiding noticeable scarring on the breast.
2. The feasibility of this surgery, key technical points, and potential complications have been analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Female breast benign tumor patients
2. Received endoscopic resection of benign breast tumors via a lateral chest wall approach.

Exclusion Criteria:

1. Patients who are unable to comply with follow-up requirements
2. Patients with a history of breast sugery
3. Breast cancer patients
Primary Hyperaldosteronism and Ischemia-reperfusion Injury

Patients with primary hyperaldosteronism experience more cardiovascular events compared to patients with primary hypertension, independent of the blood pressure level.

In this research we hypothesize that patients with primary hyperaldosteronism are more susceptible to ischemia-reperfusion injury.

Patients with PHA have an increased risk of cardiovascular events, independent of blood pressure level. Also in patients suffering a myocardial infarction, circulating aldosterone levels are associated with increased mortality. In animal models of myocardial infarction, the administration of exogenous aldosterone increased infarct size, although other studies did not report this effect. In similar models, antagonists of the mineralocorticoid receptor (MR) reduced infarct size, which was completely abolished in ecto-5'-nucleotidase (CD73, the enzyme that catalyses extracellular formation of the endogenous nucleoside adenosine) and adenosine receptor knock-out mice. Therefore, we hypothesize that patients with PHA have an increased susceptibility for ischemia-reperfusion (IR)-injury due to down-regulation of the enzyme CD73. We will use the reduction in brachial flow-mediated dilation (FMD) by forearm IR as a well-validated endpoint for (endothelial) IR-injury.

Eligibility Criteria:
Inclusion Criteria patients with primary hyperaldosteronism:

* Age 18-75 years
* Confirmed primary hyperaldosteronism (aldosterone \>0.28 nmol/l after salt loading)
* Serum potassium ≥ 3.5 mmol/L (with or without potassium supplementation)
* Written informed consent

Inclusion Criteria patients with primary hypertension:

* Age 18-75 years
* Primary hypertension
* Baseline aldosterone \<0.30 nmol/l and aldosterone-renin-ratio\<0.09
* Serum potassium ≥ 3.5 mmol/L
* Written informed consent

Exclusion Criteria for both arms (patients with primary hyperaldosteronism and patients with primary hypertension:

* Smoking
* History of atherosclerotic disease (myocardial infarction (MI), stroke, or peripheral vascular disease)
* Not possible to change the antihypertensive medication into only diltiazem with or without hydralazine, according to the treating physician.
* Not possible to temporarily interrupt statin treatment, if the patient use statins, according to the treating physician.
* Severe renal dysfunction (MDRD \< 30 ml/min)
* Second/third degree AV-block on electrocardiography
* Cardiac failure
* Diabetes Mellitus
* Use of acetylsalicylic acid and NSAID's theophylline, and dipyridamole