cyrilzakka/clinical-trials huggingface dataset:
Effects of Anesthetic Infusion on the Amplitude of Motor Evoked Potential in Pediatrics Undergoing Tethered Spinal Cord Surgeries

The tethered spinal cord is a common pathology in pediatric neurosurgery. Intraoperative neurophysiologic monitoring (IOM) has gained popularity over the past two decades as a clinical discipline that uses neurophysiologic techniques to detect and prevent iatrogenic neurologic injuries. IOM techniques are extensively used in adult neurosurgery and, in their principles, can be applied to the pediatric population. Inhalational agents cause a dose-dependent reduction in MEPs and are arguably considered incompatible with effective neurophysiological monitoring(5) For this reason, total intravenous anesthesia (TIVA), using IV anesthetics (propofol or ketamine) and opioids (fentanyl or remifentanil), is commonly used in spinal surgeries under MEPs monitoring

A combination of ketamine and dexmeditomidine has several benefits in terms of hemodynamic stability, absence of respiratory depression, postoperative analgesia, and recovery. (11) ketamine could prevent the decrease of blood pressure and heart rate which had been observed with dexmedetomidine. In addition, dexmedetomidine could prevent the increase of blood pressure and heart rate, salivation, and physiological emergence reaction from ketamine. This combination was not previously used in this type of procedure except in a case report performed by Rozzana Penny who had used dexmedetomidine and ketamine infusion during scoliosis repair surgery with somatosensory and motor evoked potential monitoring in 15 years old female.(10) Evoked potentials are highly sensitive to fluctuations in physiological parameters such as peripheral and core body temperature, arterial blood pressure, hematocrit, etc. Keeping in view all the above factors we plan this study to compare the effect of the combinations of propofol and fentanyl versus the combination of ketamine and dexmedetomidine and fentanyl in producing a minimum effect on MEP amplitude and on hemodynamic stability during the surgery.

Eligibility Criteria:
Inclusion Criteria:

* children with ASA I and II presented to Abu elreesh hospital for untethered spinal cord surgery.

Exclusion Criteria:

* Children with neuromuscular diseases or congenital scoliosis.
* Children with growing rod distraction surgery.
* Children with American Society of Anaesthesiologists (ASA) physical status III, IV
* Children with preoperative use of antidepressant or anticonvulsant medications.
* Children with a known history of drug allergies.
The Effectiveness of Smoking Cessation Guidelines in the Emergency Department

Although 78% of smokers report that a health professional has previously advised them to quit smoking, most smokers are not advised to stop smoking or offered assistance with smoking cessation during a given ED visit. There are multiple barriers to routine implementation of smoking cessation guidelines by emergency clinicians, however, and rigorously performed clinical trials are needed to demonstrate that routine screening and counseling of ED patients results in increased quit rates. To determine the feasibility of implementing the Agency for Healthcare Research and Quality (AHRQ) Smoking Cessation Guideline in the ED, we will conduct a clinical trial in 974 ambulatory adult smokers who present to 2 emergency departments, using a pre-post design. During the 3-month baseline period, clinicians will perform their usual duties but will not receive training in use of the AHRQ Guideline. Based on the Chronic Care Model, the 3-month intervention period will include: 1) a tutorial on brief cessation counseling for ED nurses and physicians, 2) use of an ED algorithm that includes recommended tobacco counseling items, 3) fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy, and 4) group and individual feedback to ED staff. We will conduct exit interviews of ED patients to assess performance of guideline-recommended actions by ED staff and 3- and 6-month telephone follow-up to determine 7-day point-prevalence abstinence (with biochemical confirmation of self-reported quitters at 6 months). Our main analyses will examine the contrast between the intervention and control periods in the performance of guideline-recommended actions and in 6-month quit rates, using hierarchical logistic regression to adjust for baseline differences in potentially confounding patient variables. In secondary analyses, we will assess the change in attitudes of ED nurses and physicians toward smoking cessation counseling. This feasibility study will determine the receptivity of patients and ED staff to the guideline-based intervention and will provide estimates of effect size in planning a full scale multi-site clinical trial of the study intervention in community hospital EDs.


Eligibility Criteria:
Inclusion Criteria:

* Presentation to the Emergency Department by private vehicle or on a walk-in basis
* Current cigarette smoker (5 or more cigarettes per day)

Exclusion Criteria:

* Acute medical decompensation (e.g., acute respiratory failure requiring intubation, cardiac arrest, cardiogenic or septic shock)
* Life-threatening trauma
* Altered mental status
* Dementia
* Language barrier
* Incarceration
* Transfer to another ED
* Departure from the ED prior to evaluation
* Inability to be contacted by telephone
* ED presentation for sexual assault
* ED presentation for acute psychiatric crisis (e.g., suicidal ideation)
* Participation in a smoking cessation program in the past 3 months
Epidemiological and Molecular Colorectal Cancer Registry

This is a Registry that invites patients undergoing colorectal surgery for colorectal cancer. Epidemiological data is collected. The Registry includes tumor tissue and blood banks for analyzing different genetic mutations and disease-specific biomarkers.

This is a Registry that invites patients undergoing colorectal surgery for colorectal cancer. Epidemiological data is collected. The Registry includes tumor tissue and blood samples banks used to studied different genetic variants and disease-specific biomarkers present in patients with Lynch syndrome and others hereditary cancers.

The aim of this registry is to set up the necessary resources to help basic and clinical research projects on colorectal cancer (CRC) within the Hospital Italiano de Buenos Aires (HIBA) and promote scientific collaborations between the HIBA and other institutions within and outside the country.

To make this project, the following specific goals are proposed:

Objective 1: Establishment of an efficient algorithm to enroll patients diagnosed with CRC from HIBA, through collaboration between the services of Surgery, Gastroenterology, Pathology, Oncology, Institute of Translational Medicine and Biomedical Engineering (IMTIB), Medical Clinic and Medical Informatics.

Objective 2: Development of logistics for the connection and expansion of the bank of biological samples (DNA, serum) and tumor samples (tissue fixed in formalin, frozen tissue) to the CRC.

Objective 3: Development of computer software to record data about patient enrolled in a dynamic way.

Objective 4: Development of pipelines and create a supervisory committee to regulate the future of samples and data obtained through the registry, accord the current standards of ethical code, and improve the current collaborations with foreign researchers.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing colorectal surgery for colorectal cancer.

Exclusion Criteria:

* Unwillingness to participate.
Reduction or Extension of COnduction Time With Ventricular Electromechanical Remodeling (RECOVER)

This prospective multicenter registry study aims to detect the serial changes in ventriculo-ventricular conduction times according to cardiac-resynchronization therapy response.


Eligibility Criteria:
Inclusion Criteria:

* meeting the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for cardiac-resynchronization (CRT) implant

Exclusion Criteria:

* Myocardial infarction, unstable angina within 40 days prior the enrollment
* Recent cardiac revascularization in the 4 weeks prior to the enrollment or planned for the 3 months following
* Cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months prior to the enrollment
* Primary valvular disease requiring surgical correction
* Pregnant or are planning during the duration of the investigation
* Status 1 candidate for cardiac transplantation or consideration for transplantation over the next 12 months
* Post-cardiac transplantation
* Life expectancy \< 12 months
* Currently participating in any other clinical investigation except for observational registry
Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage

This multicenter open-label trial is designed to evaluate if the implementation of an enhanced peri-operative care protocol results in an optimal intraoperative condition of the patient and in a decrease in incidence of anastomotic leakage after colorectal resection as compared to current practice.

Rationale Colorectal anastomotic leakage (CAL) remains a severe complication following surgery with a reported incidence of 3-19% worldwide. Recent research has identified several modifiable peri-operative CAL risk factors, suggesting that the intraoperative condition of the patient plays an important role in CAL development.

Objective To successfully implement an enhanced perioperative care protocol, focusing on optimizing the intraoperative condition of the patient to minimalize exposure to CAL risk factors. Secondly, to investigate whether implementation of this new guideline results in a better intraoperative condition and a decreased CAL rate as compared to current practice.

Study design An open-label multicenter design with historical cohort in nine participating hospitals.

Study population All adult patients that are scheduled for a colorectal resection with creation of a primary anastomosis.

Intervention An enhanced perioperative best practice protocol. The Double Check bundle exists out of interventions applicable without the introduction of new material to the operating room, on top of usual care. The protocol is based on the results of our previous large, multicenter, international observational cohort study (LekCheck study), systematic literature analyses, an inventory in current protocols on peri-operative care and expert opinion. Consensus is reached with colorectal surgeons from all participating centers. The final protocol was reviewed critically by experts in the field of colorectal surgery before implementation.

Comparison 1592 historical patients that were treated with standard practice (LekCheck study group). In addition the anastomotic leakage rates from the national registry of the period after the LekCheck study and before the start of the Double Check study will be used for comparison.

Endpoints Compliance to the study protocol, the patient's intraoperative condition and exposure to modifiable intraoperative risk factors, 30-day CAL and other postoperative complications according to Clavien-Dindo classification. Follow-up will be 90 days after colorectal resection.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Bowel (small intestine/colon/rectal) resection with creation of a primary anastomosis
* Ability to give informed consent

Exclusion Criteria:

* The need for emergency surgery
* Scheduled operation concerning a reoperation for complications from recent surgery (within 3 months after the initial procedure).
* The inability to read or understand informed consent material
A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Healthy Volunteers

The purpose of the study is to assess the tolerability and safety of a range of repeated inhaled doses of MDT-637. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.


Eligibility Criteria:
Inclusion Criteria:

* Males and/or surgically sterile or post-menopausal females (confirmed by FSH test); males must agree to practice barrier contraception until they are discharged from the study
* Willing to give written informed consent
* 18 to 50 years of age
* BMI of 19-30 kg/m2
* Non-smoker (for at least 90 days prior to screening) and willing to abstain from smoking during the course of the study
* Good general health as determined by medical history, physical examination, spirometry, ECG and clinical laboratory tests
* Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to and 24 hours after dosing

Exclusion Criteria:

* Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator and Sponsor (MDTx) would place the subject at risk through study participation or would confound the assessment of the safety of MDT-637
* Evidence of current or history of respiratory disease; for instance asthma, emphysema, chronic bronchitis or cystic fibrosis.
* Upper respiratory tract infection within 6 weeks of Visit 1
* Symptoms of rhinitis (stuffy nose, rhinorrhea, sneezing, nasal discharge) within 2 weeks of Visit 1
* Current symptoms of cough, dyspnea, wheezing or nocturnal awakenings due to respiratory symptoms
* History of significant nasal irritation from nasal inhalation of medication
* History of malignancy
* History of clinically significant alcohol or drug abuse
* Positive drug screen for drugs of abuse
* Positive test for HIV, Hepatitis B or Hepatitis C
* Allergy to lactose, or lactose intolerance
* Use of prescription medication within 14 days of Visit 2 or over-the-counter preparations, including dietary and herbal supplements, within 5 days of Visit 2
* Positive urine pregnancy test at Visit 1
* Inability to perform reproducible spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
* Abnormal QTc interval at Visit 1(\>450 msec in males or \> 470 msec in females)
* Significant blood donation (or testing) in previous 8 weeks
NAFLD in Diabetes Type 2 in Primary Care

The EPSONIP (Evaluating Prevalence and Severity Of NAFLD In Primary care) trial is a longitudinal cohort study of patients with T2DM recruited from primary health care centers in Östergötland, Sweden. The latest MRI techniques will be used to quantify the amount of hepatic fat, inflammation, liver fibrosis and body composition. Each patient will be investigated twice with three years apart to determine patients with progressive disease.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 2
* Age 35-75 year

Exclusion Criteria:

* Contraindication to MR
* Alcohol dependance
* Previously diagnosed liver cirrhosis
* Previously known liver disease (other than fatty liver)
Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate

Green tea extract contains ingredients that may prevent or slow the growth of prostate cancer. This phase I trial is studying how well green tea extract works in treating patients with prostate cancer undergoing surgery to remove the prostate

PRIMARY OBJECTIVES:

I. Determine the bioavailability of defined green tea catechin extract in prostate tissue after treatment with defined green tea extract in patients with prostate cancer.

SECONDARY OBJECTIVES:

I. Determine the effect of this treatment on changes in clusterin levels and matrix metalloproteinase (MMP)-2 and MMP-9 in prostate tissue from these patients.

II. Determine the effect of this treatment on changes in serum insulin-like growth factor (IGF)-1 and IGF binding protein-3 in these patients.

III. Determine the effect of this treatment on changes in oxidative DNA damage in peripheral blood leukocytes in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral defined green tea catechin extract daily for 4-7 weeks.

Arm II: Patients receive oral placebo daily for 4-7 weeks.

All patients undergo surgery one day after the last dose of study agent.

Biopsies are taken at the time of surgery. Plasma and tissue catechin levels are measured with high performance liquid chromatography (HPLC). 8OHdG levels in peripheral blood are measured with HPLC and mass spectometry. Immunohistochemistry is used to measure matrix metalloproteinase (MMP)-2, MMP-9, and clusterin. Insulin-like growth factor (IGF)-1 and IGF binding protein-3 are measured with immunoenzyme techniques.

Eligibility Criteria:
Criteria:

* Biopsy-proven adenocarcinoma of the prostate meeting the following criteria: organ-confined disease; treatable by prostatectomy
* PSA \< 50 ng/mL
* ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
* Bilirubin normal
* AST and ALT normal
* Creatinine normal
* Fertile patients must use effective contraception
* No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness or social situations that would limit study compliance
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extract
* No prior therapy for prostate cancer (i.e., hormone therapy, radiation therapy, or surgery)
* No systemic treatment (chemotherapy) and/or radiation therapy for any malignancy within the past 5 years (excluding nonmelanoma skin cancer or cancer confined to organs with surgical removal as the only treatment)
* No regular tea consumption (\> 6 servings of hot tea or 12 servings of iced tea or equivalent combination per week) within the past month
* No other concurrent investigational agents
* No other concurrent consumption of tea or tea-derived products from green, black, or oolong tea
Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

This study evaluated that strict control of perioperative blood glucose following pancreatic resection by using an artificial pancreas would improve postoperative surgical site infection.

This study recruited 50 patients undergoing elective pancreatic resection for pancreatic diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided into two groups: one for whom glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale and another that received programmed infusion of insulin determined by the control algorithm of the artificial pancreas.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective pancreatic resection for pancreatic diseases.

Exclusion Criteria:

* weight loss greater than 10% during the previous 6 months
* sign of distant metastasis
* respiratory, renal, or heart disease
Health Effects of Salmon Fishmeal in Humans

Diabetes contributes significantly to the burden of disease in Norway and cardiovascular disease is the main cause of mortality.

Both lean and fatty fish are shown to have beneficial health effects. In addition to omega-3 fatty acids, fish contain potential health-promoting components such as taurine, vitamin D, vitamin B12, iodine, selenium and more unspecified components such as bioactive peptides. With the expected growth in the aquaculture sector, more protein-rich by-products will become available.

The overall aim of this project is to investigate the health beneficial effects of fish protein in the form of salmon fishmeal in a human intervention study with regard to metabolic risk markers.

We will include subjects with impaired glucose tolerance to a randomized controlled parallel study. The subjects will receive capsules with fishmeal or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Fasting plasma glucose ≥ 5.6 mmol/l or
* Plasma glucose ≥ 6.5 mmol/l 2h after an OGTT or
* HbA1c ≥ 5.8 %

Exclusion criteria:

* Diabetes (defined as p-glucose ≥ 7.0 mmol/l p-glucose ≥11,1 mmol/l 2h after OGTT or HbA1c ≥ 6.5 %)
* High fish intake (\> 450 gram/week) or fish allergy
* Age-related elevated blood pressure (≥ 70 år: ≥ 180/110 mmHg, \> 40-70: ≥ 170/100 mmHg and ≤ 40 år: ≥ 160/100 mmHg)
* Use of prescription medicines related to diabetes, inflammation, systemic use of corticosteroids.
* Non-stable use of lipid lowering drugs, thyroxine, blood pressure lowering drugs, drugs affecting appetite, dietary supplements (including n-3)
* High intake of protein supplements powder
* Pregnancy
* Planning pregnancy or changes in body weight
An Evidence-based Approach for Bullying Prevention

This Phase II SBIR project is designed to address the critical public health problem of bullying and cyberbullying among middle school age youth. The project involves developing and testing bullying and cyberbullying prevention materials, including interactive classroom sessions and corresponding serious games, based on the evidence-based substance abuse prevention approach called Life Skills Training. The product has the potential to fill a gap in the intervention tools currently available to schools that can be widely disseminated throughout the country using existing marketing and dissemination channels and decrease the adverse consequences of bullying and cyberbullying as well as substance abuse.


Eligibility Criteria:
Inclusion Criteria:

* Middle school aged-youth

Exclusion Criteria:

* Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
UVA Light Device to Treat COVID-19

This pilot study will assess the safety and effectiveness of UV light treatment in hospitalized patients with COVID-19.

This is a single center, open label, pilot study. 5 adult patients, aged over 18, who are confirmed positive with SARS-CoV-2 and are newly intubed, will receive UV light treatment to reduce SARS-CoV-2 viral load.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed positive test result for SARS-CoV-2
* Mechanically ventilated
* Endotracheal tube inner diameter of at least 7.5 mm

Exclusion Criteria:

* Unable to provide informed consent (or surrogate)
* Enrolled in a therapeutic clinical trial for same condition that does not allow recruitment in other trials
* Pregnant women