cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetic Study of Dexmedetomine in Infants

Blind randomized trial of a single bolus dose of dexmedetomine followed by a continuous infusion (CIVI) for up to 24 hours in infants who immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus and infusion dose will be administered to a total of 36 patients.

This clinical trial of three dose rates of dexmedetomine will determine the pharmacokinetics of the drug in infants who remain tracheally intubated postoperatively. An exploratory pharmacodynamic study of a non-invasive device measuring sedation will be performed. Although the pharmacokinetics of dexmedetomine have been described for pediatric patients, the drug disposition in infants has not been well described. A range of doses has been studied, yet there are no reports describing the optimal dose for post-operative pediatric patients. This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 1 month, less than or equal to 24 months
* Post-operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-operative period
* Planned tracheal extubation within 24 hours post-operative period
* Renal function-serum creatine = 1.5 times the ULN for age
* Total bilirubin less than or equal to 1.5 X upper limit of normal (ULN) for age
* SGPT (ALT) ,less than+ 3x upper limit of normal (ULN) for age
* Signed written informed consent

Exclusion Criteria:

* Patients who have received another investigational drug within the past 30 days
* Receiving intermittent or continuous muscle relaxation during study period
* Patients who have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection.
* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
* Post-Operative hypotension
* Heart block
* Weight \< 5 kg
* Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study.
Evaluating Length and Depth Estimation Accuracy of Laypersons and Health-Care Providers

The objective of the study is to measure accurateness of length and depth estimation of laypersons and health-care providers.

The study hypothesis is that both laypersons and health-care providers will have difficulty estimating length and depth. The study will enroll 100 laypersons and 100 health-care providers. The participants will be asked to draw a 5cm line without assistance an estimate 5cm depth to measure accurateness of length and depth estimation.

Eligibility Criteria:
Inclusion criteria:

* Laypersons: adult laypersons without cardiopulmonary resuscitation training within 2 years
* Health-care providers: adult health-care providers (doctors, nurses and emergency medical technicians)

Exclusion criteria:

* Laypersons: laypersons with cardiopulmonary resuscitation training within 2 years.
* Health-care providers: health-care providers who are inactive (not currently working at medical facilities)
LRRK2 G2385R Leucocyte and Urine Biomarker Study

Given the emerging evidence on LRRK2-related biomarkers, this project will focus on identifying leucocyte and urine biomarkers that are altered by the LRRK2 G2385R variant, and investigating the effects of LRRK2 kinase inhibitor (MLi-2) on these biomarkers, using immunoblotting and mass spectrometry.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease assigned by a movement disorder specialist according to clinical diagnostic criteria
* Age above 18 year-old
* Provision of a written informed consent

Exclusion Criteria:

- Physical or mental incapacity to complete study protocol
Effect of RIPC on the Prevention of POD in Patients Undergoing Cardiac Surgery

Postoperative delirium (POD) is one of the most frequent neurological complications in elderly patients and is closely associated with longer ICU stay and hospitalization, deterioration of long-term neurocognitive function, and increased mortality. The incidence of POD is significantly higher in elderly patients undergoing cardiac surgery than in other populations. Therefore, the prevention of POD is an important clinical problem to be solved urgently. In this study, we intend to observe the effect of RIPC on the prevention and treatment of POD in patients undergoing cardiac surgery through a prospective randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective cardiac surgery;
* age ≥ 18 yr;
* any sex;
* American Society of Anesthesiologists (ASA) class ≥II class;
* New York Heart Association (NYHA) ≥II class.

Exclusion Criteria:

* emergency surgery;
* a history of cardiovascular surgery;
* peripheral vascular disease affecting the upper limbs;
* acute myocardial infarction (MI) up to 14 days before surgery;
* a history of severe injuries and operations within 3 months before cardiac surgery;
* a history of cancer and chronic autoimmune diseases.
Gait, cOgnitiOn & Decline (GOOD)

The main objective of the GOOD initiative was to determine which spatio-temporal gait parameters and/or combination(s) of spatio-temporal gait parameters best differentiate between cognitively healthy individuals (CHI), patients with mild cognitive impairment (MCI) and those with mild and moderate dementia.

Gait disorders are frequent in individuals with cognitive disorders. However, the profile of spatio-temporal gait parameters in the different cognitive status in aging (from normal cognition to dementia) has been poorly studied. Determining this profile associated with the severity of cognitive disorders may be helpful to understand the complex interplay between gait and cognitive disorders and, thus, may have important implication for the diagnosis process of patients with and without dementia. For instance, defining a motor phenotype of the severity of cognitive disorders by using quantitative gait measurements could be used to improve the prediction and the diagnosis of dementia.

The investigators hypothesized that, compared to CHI, people with MCI and mild dementia could be characterized by specific phenotypes of spatio-temporal gait parameters measured with the GAITRite® system, and that these profiles could be explained by declines in domain-specific cognitive performance.

Eligibility Criteria:
Inclusion Criteria:

* Being 60 years old and older
* Ability to answer questions

Exclusion Criteria:

* Opposition to the use of information collected for research purposes
Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness

This study is a trial looking at a drug to help prevent acute mountain sickness. The drug is prochlorperazine, a drug commonly used to treat nausea vomiting and headache. Participants will either take the drug or a placebo, and hike to and sleep at the summit of Mount Blue Sky located at 4,348 meters (14,265 feet).

This study will be a double-blind randomized controlled trial to investigate the utility of prochlorperazine maleate versus placebo for the chemoprophylaxis of acute mountain sickness on rapid ascent to 4,348 meters, specifically the summit of Mount Blue Sky in the Mount Blue Sky Wilderness. Participants will be evaluated for AMS utilizing the 2018 LLQ both the evening of and morning after ascent. The primary outcome will be the presence of AMS, defined by a 2018 LLQ score equal to or greater than 3, including the presence of a headache at any measured point during the study. Individuals will convene the morning of the study in Golden, Colorado where they will receive breakfast and either placebo or prochlorperazine. They will then be driven to Summit Lake where they will break for lunch and receive the second dose of placebo or prochlorperazine. They will then hike to the Mount Blue Sky summit where they will receive their third and final dose of either placebo or intervention, spend the night in the structures at the summit, and be assessed for AMS via LLQ. In the morning, they will be assessed for AMS again, receive breakfast, and then be driven back to the original meeting point. They will be monitored by Emergency Physicians at all points during the study.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years old.

Exclusion Criteria:

* Individuals \<18 years old or \>75 years old
* Pregnant women
* Individuals who reside at or have slept at elevations \>1,800 meters in the last two weeks
* Individuals having taken acetazolamide, steroids, ibuprofen, anti-emetics or additional analgesics within the last 24 hours prior to study initiation
* Individuals requiring supplemental baseline oxygen or with chronic disorders known to be significantly impacted by hypoxia
* Individuals with known allergies to prochlorperazine or phenothiazines
* Individuals taking medications with significant medication interactions with prochlorperazine: Dofetilide, potassium acid phosphate, potassium chloride, potassium citrate, potassium phosphate, Yohimbe.
* Individuals with a history of dementia
* Individuals who lack decision making capacity
Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)

The ASPIRE study is a Phase III randomized, single-center study designed to evaluate whether adaptive stereotactic body radiotherapy (SBRT) offers superior clinical benefits compared to standard image-guided SBRT for patients with localized prostate cancer. It aims to explore whether adaptive SBRT can improve urinary outcomes while maintaining effective cancer control.

This interventional study is randomized, single-institution, and includes 320 participants with localized prostate cancer. Patients will be stratified based on fractionation schedules (5 vs. 7 fractions), use of rectal spacers, androgen deprivation therapy (ADT), and baseline alpha receptor antagonist use. Participants will be randomized to receive either adaptive SBRT or standard image-guided SBRT, with both arms adhering to established dosing protocols.

Inclusion criteria includes an age greater than 18 years, diagnosed with localized prostate adenocarcinoma, and an ECOG performance status of 0-1, Eligible for prostate SBRT. The exclusion criteria includes patients who plan for elective nodal irradiation and contraindications to radiotherapy or MRI (for MR-Linac patients).


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. Histologic diagnosis of prostate adenocarcinoma
3. Localized prostate cancer
4. Low risk, intermediate risk, or high risk allowed
5. Patient planned for prostate SBRT

Exclusion Criteria:

1. Planned for elective nodal irradiation
2. Contraindications to radiotherapy
Biological Age Applied at Ubberup

In a previous study the investigators have developed a novel biological age model. Assessing biological age is the assessment of the present health status and functional capacity/physiological reserve of that person in comparison with people of the same age and sex.

The aim of this study is to investigate the utility and validity of this novel biological age model designed for health promotion in real world conditions.

Study design: This is a longitudinal study, where biological age assessment is conducted in the first and final week of an 11-14 week lifestyle intervention course. These courses take place at a Danish folk high school (Ubberup), which is specialized in performing intensive lifestyle interventions targeting a 10% weight loss. The intention is to include 80 adult men and women.

Data collection: This will take place at the facilities at Ubberup folk high school, participants being overnight fasted and without having exercised for the previous 24 hours. All analysis will be performed in investigators lab (Xlab) at the Department of Biomedical Sciences, Copenhagen University. When all samples are analysed Biological age will be calculated for each particpant.

Eligibility Criteria:
Inclusion Criteria:

* Participation in a long course at Ubberup folk high school (12-15 weeks)
* Age between 18-65 years

Exclusion Criteria:

* Previous or current cardiovascular disease
* Pregnancy
* Conditions that prevents from performing a cycle and/or strength tests
Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI

The purpose of this study is to investigate if MRI scans performed after neoadjuvant radiotherapy can predict the therapeutic response of rectal cancer following preoperative chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in the future.

We proposed to constructed multi-parameter predictive model for predicting therapeutic response and pathological complete response(pCR) of patients with rectal cancer who received neoadjuvant chemoradiation. MR radiomics,convolutional neural networks, morphological parameters and quantitative functional parameters derived from diffusion-weighted MR images will be integrated for model construction.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* T3/4 or node positive biopsy-proved primary rectal cancer
* Suitable for pre-operative chemoradiotherapy and surgical resection
* No contraindication to MRI
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* History or concurrent of other cancer
* Previous therapy to pelvis
* Unable/unwilling to have MRI
* Pacemaker or implanted defibrillator
* Pregnancy, lactation or inadequate contraception
* Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study
* Unwilling or unable to give informed consent
Appropriateness of Carpal Tunnel Syndrome Management Compared With the AAOS Appropriate Use Criteria

Purpose: Carpal tunnel syndrome (CTS) is a common peripheral nerve entrapment disorder among adults that causes upper-extremity disability. The American Academy of Orthopedic Surgeons (AAOS) developed an evidence-based appropriate use criteria (AUC) for the management of CTS. This study aims to assess the appropriateness of our practice and the usability of the AUC by comparing the actual management provided at our institution with that recommended by the AUC.

Methods: A retrospective review of the electronic medical records at our hospital will be performed between 1 Jan 2016 and 31 Dec 2019. Data will be collected by two authors independently. The collected data will be input into the AUC application to determine the rate of the appropriateness of the treatments. Afterwards, the agreement between the actual treatment provided and the AUC recommendation will be assessed. The primary outcome will be the appropriateness rate. Descriptive statistics such as the mean, range and percentage will be used to summarize the patients' demographics and treatment options.

Results: The appropriateness rating (appropriate, maybe, or rarely appropriate) for each treatment will be described with percentages. Similarly, the agreement of the treatments implemented at our institution with the AUC recommendations will be expressed as a proportion. A subgroup analysis within the same cohort compared the appropriateness rates of surgical release of patients across different surgical specialties using chi2 test.

Conclusion: This study will show if the management provided at our institution were appropriate and in agreement with the AUC recommendations. Additionally, it will test the usability of AUC for carpal tunnel syndrome as a valuable and practical tool that can be applied in clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years) who were diagnosed with CTS.

Exclusion Criteria as per the AUC:

* Acute carpal tunnel syndrome
* Untreated inflammatory arthritis
* Untreated diabetes
* Thyroid disease
* Pernicious Anemia
* Patients with a known space-occupying lesion in the carpal tunnel
* Failed treatment after surgery
* Pediatric and adolescent patients
Perioperative Immunonutrition in Colorectal Cancer Patients Undergoing Abdominal Surgery

The immune system plays an important role in helping to kill and prevent cancers. Cells of the immune system, such as natural killer (NK) cells and T cells, do not work as well following surgery. Arginine, an amino acid, is fundamental in metabolic processes of the body. Surgery has shown to cause a reduction of arginine in the body. In turn, this deficiency causes NK cell suppression. In this study, we want to look at the effects of arginine supplementation before and after surgery on NK cell function in surgery patients. In this study, we will be using a nutritional supplement containing arginine and a placebo drink (provided by Enhanced Medical Nutrition) that will be taken by colorectal cancer patients 5 days before surgery and 5 days after surgery. Using patient blood samples, we will measure NK cell levels, arginine levels and also arginase activity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of a primary colorectal cancer and eligible for surgical resection.
* Patients \> 18 years of age
* Eligible patients must have signed a consent for surgical resection of the malignancy.
* Ability to understand and provide a signed informed consent form (ICF) approved by the Research ethics board (REB).
* Adequate kidney function with Creatine clearance\>30mL/min
* Hemoglobin level \>90 mg/dL
* Ability to comply with protocol requirements.

Exclusion Criteria:

* Prior adjuvant chemotherapy or radiation within 8 weeks of planned surgery.
* Documented significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids, azathioprine, cyclosporin A). Subjects may be on physiologic doses of replacement prednisone or equivalent doses of corticosteroid (\<7.5 mg daily).
* Subjects with resting hypotension (Blood pressure \<90/50 at rest).
* History of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
* Serious intercurrent chronic or acute illness, or other illness considered by the investigator as an unwarranted high risk for an investigational product.
* Active infection of any site and/or active herpes requiring ongoing treatment
* Known pregnancy or nursing mothers
* Subjects with a fish allergy.
* Subjects with severe asthma defined as asthma not controlled with inhaled corticosteroids and additional controllers or by oral corticosteroid treatment (arginine can cause allergic response or make swelling in airways worse).
* Subjects with a known inherited guanidinoacetate methyltransferase deficiency (due to an inability to convert arginine to creatine)
* Subject with known history of liver cirrhosis
* Subjects who have who have suffered a myocardial infarction or life-threatening arrhythmia within the last 6 months
* Subjects with cardiac failure or coronary artery disease causing unstable angina
* Subjects with a medical or psychological impediment to probable compliance with the protocol should be excluded.
Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer

The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer.
* Gleason score 2-6 or 7.
* PSA ≤ 20 ng/ml.

Exclusion Criteria:

* Previous prostate cancer surgery or pelvic radiation.
* Prior/concurrent systemic chemotherapy for prostate cancer.
* Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
* History of hip replacement.
* Prior intrapelvic surgery.
* Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its uses during radiation.
* Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
Dry Needling Effectiveness and Post-punction Pain

The purpose of this estudy was to dertermine if the application of Transcutaneous Nerve Stimiulation (TENS) current have an hypoalgesic effect on pattientes suffering from miofascial neck pain, compared with a only dry needling treatment. Psicological varaibles were also mesured in order to determine how they change after each treatment.

All patients suffered from mechanical neck pain and were randomized into three groups of treatment. A doible blinded control was carryed out. The main outcome messures were Visual Analogue Scale (VAS). The scondary outcome messures were Pressure Pain hreshold (PPT) and Active Range of Movement (ROM). Also psicologicla messures were taken, like Neck Dissability Index, Level of stress and ansiety, Fear Pain and Pain Avoidance Strategies.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical Neck pain of at least 6 months.
* VAS 2 or greather.
* Existance of miofascial trigger point in trapezius muscle assesed by an expert PT.

Exclusion Criteria:

* Neck pain due secondary to ostheoporosis, metastasis, neoplasias, fractures, infections, cervical stenosis or infexious procces.
* Headache secondary to medular compression presenting one o the following signs: abnormal sensitivity, hiperreflexia, clonus, spread weakness, cervical hernia.
* Neck pain with radiculopathy.
* Whiplash.
* Vertebrobasilar syndrome.
* Dizzyness.
* Pregnancy.
* Having received dry needling treatment before.
Lay-user Trial of the iGlucose Blood Glucose Monitoring System

Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users

A non-randomized, prospective study of recruited subjects with diabetes. Subjects will include those with type I or type II diabetes of various duration and those who are naive to self-testing of blood glucose. Subjects will use provided instructions-for-use to undergo self-training on the use of the device and will then self-test their blood glucose level. Results will be compared to those obtained by a lab glucose analyzer.

Eligibility Criteria:
Inclusion Criteria:

* Be 12 years of age and older
* Have pre-existing diagnosis of diabetes
* Be able to read and understand English
* Agree to participate in the study
* Be able and willing to provide informed consent

Exclusion Criteria:

* Do not meet Inclusion Criteria
* With Hemophilia or any other bleeding disorder
* With any condition which in the opinion of the Investigator may place the subject or site staff at excessive risk
* With physical condition/limitation preventing the use of SMBG on their own