cyrilzakka/clinical-trials huggingface dataset:
Does the Preoperative Midazolam Dose Affect Postoperative Pain?

To investigate whether midazolam has any effect on postoperative pain in outpatient surgery, the investigators will assess the impact of different midazolam doses on pain scores 24h, 7 days and 3 months after ambulatory surgery.

The investigators hypothesize that patients being administered higher midazolam doses will refer more pain.

Systemic midazolam prescribed perioperatively might have impact on pain, with studies suggesting antinociceptive and hyperalgesic effects. Anxiety might be a confounder in this association. In order to investigate the effect of midazolam on postoperative pain, a clinical trial will be conducted in Portuguese ambulatory surgery units. A convenience sample with consecutive design will include patients admitted for open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery under spinal anesthesia. Patients will be randomized into 3 premedication groups, and this randomization will be stratified for each centre and each type of surgery. Postoperative pain will be blindly assessed by telephone interviews at 24h, 7 days, and 3 months.

The investigators will use multiple regression models to explore the interaction of midazolam dose with preoperative anxiety, gender and chronic benzodiazepine use, as they hypothesize there might be a differential effect of midazolam on postoperative pain amongst these subgroups.

Eligibility Criteria:
Inclusion Criteria:

* adult patients submitted to open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery in Portuguese ambulatory surgery units

Exclusion Criteria:

* psychiatric disorders
* alcoholism
* illiteracy or poor understanding of Portuguese language
* history of chronic pain under opioids
* recurrent surgery
* contraindication for midazolam or deep sedation
* contraindication for spinal anesthesia
Dual Energy X-ray Absorptiometry (DXA) Comparison Hip Resurfacing Versus Total Hip Arthroplasty (THA)

This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement.

This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement. The goal is to evaluate the bone loss in the proximal femur resulting from hip resurfacing surgery and to compare this to the bone loss in the proximal femur resulting from total hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 20 years
* Osteoarthritis
* Elective Total Hip Arthroplasty / Resurfacing
* Signed Informed Consent

Exclusion Criteria:

* Osteoporosis
* Revisions
* Femoral dysplasia
* Trochanteric osteotomy
* Inflammatory arthritis
* Breast-feeding, pregnancy, or women of child-bearing potential without documentation of a negative pregnancy test and not utilizing contraception
* Patients with a history of having taken or currently taking PTH, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the Investigator's opinion are known to affect bone mineral density in a substantial way
* Patients with severe medical condition(s) that in the view of the Investigator prohibits participation in the study
* Use of any other investigational agent in the last 30 days
Study of Effects of Electroacupuncture on Balance in Subjects With Chronic Functional Ankle Instability

Introduction: Ankle sprains, the most common sports-related musculoskeletal injury, account for approximately 25% of sports injuries. An estimated 40% of these individuals will progress to develop chronic functional ankle instability (CFAI), which can significantly affect athletic performance and activities of daily life. Stresses from the injury can damage the ligaments, muscles, nerves and mechanoreceptors. It is widely accepted that ankle proprioception is critical for balance and that individuals with CFAI demonstrate decreased proprioception and altered muscular function, which impairs postural stability. The goal of this study is to determine if a single application of electroacupuncture can have an immediate positive outcome related to balance in individuals with CFAI.

Methods: This single blinded randomized trial will include 12 subjects receiving a single application of electroacupuncture and 12 subjects in the placebo group receiving sham electroacupuncture. Subjects aged 18-50 with a history of unilateral inversion ankle sprain(s) and chronic symptoms of instability will be selected. Balance will be assessed pre- and post-treatment using force plate data during a single-leg stance and via the Star Excursion Balance Test (SEBT). GB-34 and GB-40 will be used for the experimental group and non-traditional points on the medial aspect of the leg will be used for the sham electroacupuncture group. Both will be connected to the electrical stimulation unit for 10 minutes. Results from this study may inform future research investigating the ability of EA at decreasing the risk of ankle sprains, improving perceived stability, and reducing the risk of subsequent degenerative changes.

A single application of electroacupuncture improves balance greater than placebo control in subjects with chronic functional ankle instability

Specific Aim #1:

Evaluate the effect of a single application of electroacupuncture on center of pressure mean total velocity in individuals with chronic functional ankle instability during single-leg stance compared to placebo control.

H0: EA will not improve postural sway during single-leg stance compared to placebo control.

Specific Aim #2:

Describe the effects of a single application of EA compared to placebo on mean total displacement, as well as the mediolateral and anterioposterior components during single-leg stance for possible trends to inform hypothesis generation.

Specific Aim #3:

Correlate the results from the Star Excursion Balance Test with results of the single-leg stance measures to inform hypothesis generation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years old
* History of inversion ankle sprains
* Chronic symptoms of instability

Exclusion Criteria:

* Please see inclusion criteria
Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation

The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.

To the best of the authors' knowledge, there have been no clinical trials using an appropriate regimen for pupillary dilation up until now. Therefore, the authors were interested to find out the most appropriate regimen for complete ocular examination, based on the finding that a pupil diameter of 6 mm or greater is adequate for indirect ophthalmoscopy. The authors hypothesize that a single dose of 1% tropicamide and 10% phenylephrine is adequate to complete the job and are conducting this prospective randomized clinical controlled trial to prove the hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* aged between 20 and 80 years old
* dark iris
* require binocular indirect ophthalmoscopy for complete ocular examination
* signed written consent forms

Exclusion Criteria:

* history of ocular trauma
* history of intraocular surgery
* history of laser treatment
* previous eye drop instillation that may affect pupillary dilation
* ocular diseases that may affect pupil size such as Horner's syndrome, Adies' pupil, glaucoma and uveitis
* history of diabetes mellitus, severe hypertension and cardiovascular diseases
Validation of Lower Body Negative Pressure (LBNP) Model of Human Hemorrhage in Trauma Patients

Lower body negative pressure (LBNP) is a laboratory model used to study hemorrhage in humans. The investigators hypothesize that the physiologic changes that occur with application of LBNP mimic those observed in bleeding and hemodynamically unstable trauma patients, and that LBNP is a truly valid model of human hemorrhage.

Specific aims:

1. Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects.
2. Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.

Eligibility Criteria:
Inclusion Criteria:

* age: 31 days - 89 years
* patients cared for in the Emergency Department (ED), Operating Room (OR), or the Intensive Care Unit (ICU) at Denver Health Medical Center, Children's Hospital Colorado and San Antonio Military Medical Center
* Patients with report of physical trauma within 24 hours of presentation at the hospital.

Exclusion Criteria:

* pregnant patients
* incarcerated patients
* patients who object at any time to participating in the study
Percutaneous Intradiscal Radiofrequency as A Treatment for Radicular Pain From Lumbar Disc Herniation

The goal of this clinical trial is to demonstrate the efficacy of percutaneous intradiscal radiofrequency as a treatment for radicular pain from lumbar disc herniation.

The main question it aims to answer is:

• Can percutaneous intradiscal radiofrequency lower the severity of radicular pain from lumbar disc herniation Participants will be treated with percutaneous intradiscal radiofrequency and evaluated for radicular pain severity before and 3 months after the procedure.

There is no comparison group.


Eligibility Criteria:
Inclusion Criteria:

1. 18-85 year-old patients with radicular pain from lumbar disc herniation for ≥ 3 months
2. Lumbar disc herniation ≤ 2 locations evidenced by MRI, with ≥ 50% remaining disc height, without disc sequestration
3. Previously treated with epidural steroid injection (ESI) and achieved ≥ 50 % pain relief from local anesthetic effect, confirming radicular pain from lumbar disc herniation, but did not respond to ESI (\< 50 % Pain relief or pain relief \< 3 months)

Exclusion Criteria:

* Patient refusal
* Discitis
* Previous lumbar spine surgery
* Progressive neurological deficit and/or cauda equina syndrome
* Coagulopathy
* Allergic to any medication in study protocols
* Unable to rate the pain
* Pain in any area worse than the radicular pain
Effect of Intermittent Hepatic Inflow Occlusion During Donor Hepatectomy In Living Donor Liver Transplantation

Intermittent hepatic inflow occlusion (IHIO), also called Pringle maneuver, is a safe and effective procedure for major hepatectomy in patients with liver disease. In addition, ischemic preconditioning with IHIO has been reported to have protective effects in patients undergoing liver resection. The role of IHIO, however, has not been fully elucidated in donors and recipients during living donor liver transplantation.

Intermittent hepatic inflow occlusion (IHIO) by clamping of the portal triad, also called Pringle maneuver, is a safe and effective procedure in major hepatectomy in patients with liver disease. IHIO minimizes blood loss and operation time during liver resection. In addition, ischemic preconditioning with IHIO has been reported to have protective effects in patients undergoing liver resection. In the setting of living donor liver transplantation (LDLT), one of the most important concerns is liver donor safety. Several studies have shown the safety of IHIO in donors for liver transplantation (LT). However, the effect of preconditioning with IHIO during donor hepatectomy on LDLT recipients remains unclear. Several small series have assessed the effects on recipients of ischemic preconditioning during whole liver transplantation from deceased donors. The role of IHIO, however, has not been fully elucidated in liver donors and recipients during LDLT. In this randomized, prospective study, we'll evaluate the efficacy of IHIO in the recipients and donors.

Eligibility Criteria:
Inclusion Criteria:

* Donors and recipient of LDLT, saged ≥18 years, who will undergo LDLT with donors undergoing right hemihepatectomy and recipients receiving right hemiliver grafts
* Informed consent agreement

Exclusion Criteria:

* if the recipients has fulminant hepatic failure
* if the graft to recipient body weight ratio (GRWR) is \<0.9
* if a frozen biopsy of the donor liver taken prior to donor hemihepatectomy shows \>30% macrovesicular steatosis
* if liver transplantation is ABO incompatible
* if recipients has received previous organ transplants
* if recipients has received or were scheduled to receive multi-organ transplants
Post Operative Delirium Study

Post-operative delirium happens when patients wake up from anesthesia. Patients experiencing post-operative delirium are very confused, not being able to think or function "normally". These patients are hard to take care of and they tend to have more dementia as they age compared to patients who don't experience post-operative delirium. Intranasal insulin has been shown to reverse confusion associated with Alzheimer's disease (humans) and AIDS (mice).

Intranasal insulin has been safely administered to 1092 patients in 38 different studies. There were no cases of clinically low blood sugar and a few cases of mild nasal irritation that happened also with salt water when the subjects received multiple intranasal doses.

No one has tried to reverse post-operative delirium with intranasal insulin. The delirium associated with Alzheimer's Disease and AIDS have very similar symptoms and what happens in the brain is very similar also.

The investigators intent is to administer intranasal insulin to patients exhibiting post-operative delirium in order to reverse the symptoms because the investigators think that the three disease states are closely related and intranasal insulin has had some success in reversing the delirium in the other two disease states.


Eligibility Criteria:
Inclusion Criteria:

* All patients (\>65 years of age) undergoing elective surgery using vapor anesthesia displaying post-operative delirium as defined by a CAM evaluation within time to PACU discharge post-surgery are eligible.
* Those patients 65 and older undergoing surgery using vapor anesthesia, who are consented but do not exhibit delirium and are not part of the study are still considered recruited subjects, but are not in the active study.

Exclusion Criteria:

* Patients with a history of severe dementia, anoxic brain injury, or neuromuscular disorders
* Non-English-speaking patients
* Planned use of drugs that effect plasma glucose concentration during the first four hours of surgery
* thiazolidinediones
* hormones which may affect plasma glucose or insulin
* contraceptive, diphenylhydantoin
* patients with allergy to insulin
* acromegaly
* Cushing's syndrome
* hyperthyroidism and pheochromocytoma
* renal impairment
* pregnant and lactating women
* base line blood glucose \< 3.9 mmol/L
An Open Label, Safety and Tolerability Continuation Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis

This is an open label safety and tolerability continuation study of intracerebroventricular administration of sNN0029, containing the growth factor VEGF165, in patients with amyotrophic lateral sclerosis that have previously participated in study sNN0029-001. The intention of the study is to investigate safety and tolerability of intracerebroventricular administration of sNN0029 and whether it can improve motor function and prolong survival in patients with ALS.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of ALS classified as definite, or probable with or without additional laboratory evidence, according to the revised WFN El Escorial criteria (Appendix B).
2. Previous participation in study sNN0029-001 with completion of 12 weeks study drug administration.
3. To have completed the investigations associated with safety in study sNN0029-001 without development of clinically significant safety concerns.
4. Patient has been given written and verbal information about the continuation study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments.
5. Patient has given oral and / or signed consent (written) to participate in the study. In the event that a patient who gives oral informed consent is not physically able to sign the informed consent form (ICF) due to disease progression, a witness may sign the ICF on the patient's behalf.

Exclusion Criteria:

1. Hypertension defined as blood pressure \>160 mmHg systolic or \>90 mmHg diastolic.
2. Proliferative retinopathy.
3. Non-proliferative retinopathy of moderate severity or higher.
4. Concurrent clinically significant dementia as determined by the investigator.
5. Concurrent clinically significant depression as determined by the investigator.
6. Need for administration of any antiplatelet or anticoagulant medication (e.g. aspirin, Plavix, non-steroidal anti-inflammatory drugs \[NSAIDs\]). Low dose aspirin or occasional use of NSAIDs is allowed (See Appendix E).
7. Clinically significant abnormalities in haematology or clinical chemistry parameters as assessed by the investigator.
8. For female patients, ongoing pregnancy or planned pregnancy
9. Breast feeding
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase

This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis (MS)
* Patients with a relapsing-remitting disease course
* Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5

Exclusion Criteria:

* Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc
* Pregnant or nursing women
* Patients who cannot tolerate treatment with an interferon

Other protocol-defined inclusion/exclusion criteria applied to the study.
Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)

The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* History of persistent bronchial asthma for at least 6 months
* Good health with the exception of asthma

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Smoking history with ≥10 cigarette pack years
* Pregnancy
* Intention to become pregnant
* Breast feeding
* Lack of safe contraception
* Previous enrolment into the current study
Dual Diagnosis Training Trial

This is a clinical trial, with participants undergoing the 16 hour SPECTROM training, and completing 2 assessments before and after training (the Psychotropic Knowledge Questionnaire-Revised and the Management of Aggression and Violence Attitude Scale-Revised-ID).


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are individuals who work in the 3 ARCA group homes or in the UNM psychiatric center and who are fluent in English and 18 years and older

Exclusion Criteria:

* All participants must be fluent in English because for this pilot study we do not have funds to translate study materials.
Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil

Nicorandil is potentially effective to prevent cardiovascular events in patients with coronary artery disease (CAD) receiving hemodialysis. The purpose of this study is to prospectively investigate whether nicorandil is effective in reducing the incidence of cardiovascular events in patients with CAD on hemodialysis.

Patients on hemodialysis for end-stage renal disease are at high risk for death from ischemic heart disease. It was reported that nicorandil, a hybrid compound on adenosine triphosphate-sensitive potassium channel opener and nitric oxide door, was potentially effective to prevent cardiovascular events in patients with CAD receiving hemodialysis. Therefore, investigators prospectively examine whether nicorandil is effective in reducing the incidence of cardiovascular events in patients with CAD on hemodialysis.

The primary endpoint is a composite of cardiovascular death, sudden cardiac death, nonfatal myocardial infarction, hospitalization for recurrent symptomatic myocardial ischemia and stroke. The secondary endpoints are total mortality, revascularization therapy, hospitalization for heart failure, hospitalization for peripheral artery disease and newly onset of atrial fibrillation.

Patient population that needs to prove the hypothesis is estimate to be 300 cases in total (150 cases in each group). Investigators set the parameters which are need to calculate the number of study patients as follows; drop out rate 10%, an event rate of the primary end point for two years 50%, a risk reduction rate brought by nicorandil 60%, a statistical power 80% and two-sided significant level 0.05. Investigators referred the event rate and the risk reduction rate from the previous study by Ishi H et al. In this study, event rate of the primary end point for two years was 50% and the risk reduction brought by nicorandil was 60%. Event rate of the present study will be lower, because drug-eluting stents are widely used to prevent restenosis in the present era. Moreover, investigators include the patients underwent coronary bypass graft in the present study. In addition, non-cardiovascular mortality is high in the patients on hemodialysis. Considering all the various factors together, investigators estimated the study sample size.

Eligibility Criteria:
Inclusion Criteria:

Eligible patients are who meet the following criteria:

* Patient with previously diagnosed coronary artery disease (significant coronary artery stenosis is defined as \> 75% narrowing of the artery lumen)
* Patients who continued hemodialysis for more than one month

Exclusion Criteria:

* Within one month after acute myocardial infarction
* Within 3 months after coronary artery bypass graft (CABG)
* Treatment with phosphodiesterase type 5 inhibitor
* Candidates for carotid artery stenting
* Severe disease requiring active medical treatment