cyrilzakka/clinical-trials huggingface dataset:
Duration of Infusion Set Function: Quick-Set Teflon Catheter Versus Sure-T Steel Infusion Set Catheter

This is an open-label cross over study looking to compare the length of infusion set wear between a teflon catheter (Quick-Set) or a steel (Sure-T) catheter.

Currently infusion sets are approved for 2-3 days of wear. In this study subjects will wear each infusion set for up to 7 days or until the infusion set fails. Subjects will alternate between wearing the Quick-Set Teflon catheter and the Sure-T steel catheter each week. They will wear each infusion set twice.

For the study, subjects will be provided with an investigational Medtronic Real-Time Continuous Glucose Monitor (CGM) Enlite Sensor/Serter to help identify, serious hyperglycemia or hypoglycemia during the study. This sensor is not yet FDA approved, but is similar to commercially available sensors. If the sensor detects a high or low glucose, subject must obtain a fingerstick glucose to confirm the result. In the study, all insulin dose and other treatment decisions will be made using glucose meter results, and will not be based on sensor results. Subjects will be instructed on how to identify infusion set failures.

Infusion set failure are defined as: 1) Blood ketones greater than 0.6 mmol/L, 2) Evidence of infection at the infusion site (such as redness of more than 4 mm), or 3) Blood glucose that does not decrease by at least 50 mg/dL within 1 hour of a correction bolus to treat a blood glucose greater than 300 mg/dL.

Subjects will follow-up weekly in one of our test centers for a total of five visits.

At home subjects will be asked to keep a log recording measurements of redness and induration at the infusion site when it is changed prior to the study visit.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 3 months
* The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
* Age 12 to 45 years
* For females, not currently known to be pregnant
* An understanding of and willingness to follow the protocol and sign the informed consent
* Hemoglobin A1c level less than or equal to 10%
* Medtronic Continuous subcutaneous insulin infusion pump
* Must be able to understand spoken or written English

Exclusion Criteria:

* Diabetic ketoacidosis in the past 6 months
* Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
* Current treatment for a seizure disorder
* Cystic fibrosis
* Active infection
* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
* Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
* Presence of a known adrenal disorder
* If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
* Abuse of alcohol
Evaluation of Cognitive Dysfunction and Psychiatric Comorbidities

Primary objective

* Collection of patients with wilson disease either presented with neurological or hepatic symptoms
* Assessment of psychiatric and cognitive disorders in both groups by using specific scales Secondary objective
* correlation of MRI brain findings with cognitive \& psychiatric symptoms found in the patients ,if possible.

Wilson's disease is an autosomal recessive disorder of copper metabolism caused by ATP7B mutations. Originally described as hepatolenticular degeneration, it classically presents with the combination of liver disease and a movement disorder during adolescence or early adulthood, albeit with a highly variable phenotype. Up to 60% of patients have neurological or psychiatric symptoms at onset, and are referred to as having neurological presentations (1). Chelating agents are used to 'de-copper' patients but neurological outcomes are unpredictable; symptoms usually improve however, a minority have persistent or progressive neurological disability (2, 3).

It is clinically relevant that the severity of neurologic symptoms commonly fluctuates, sometimes during the same day. Symptoms may be exacerbated by stress, concurrent illnesses, or medications (4). WD has been associated with multiple cognitive, emotional, or psychiatric disorders, which may occur at any stage of disease (5 ). The first psychiatric manifestation of WD could occur in childhood and appear as a decline in school performance, inappropriate behavior or impulsiveness(6). It is common to observe classic psychiatric syndromes in later early adulthood, including behavioral and personality changes, anxiety, depression, manic and hypomanic syndrome, cognitive deficits (7-10). personality and behavioral disorder due to brain disease, damage and dysfunction' (11).The BG are a structure capable of generating diverse psychiatric syndromes under dysfunctional conditions. Cognitive impairment in WD patients with neuropsychiatric presentation is well described (12) and probably related to the cerebral lesions detected by MRI (13). WD patients will firstly experience prospective memory related to the planning or goal-making of daily activities (14), which is associated with gray matter loss in the basal ganglia and structural changes in frontal and occipital whiter matter (15).

Eligibility Criteria:
Inclusion Criteria:

* age 8-70, both sexes, diagnosed as Wilson disease.

Exclusion Criteria:

* • Patients with neurological symptoms due to neurological disease other than Wilson disease such as patients with cerebrovascular stroke or Parkinson disease, ......

  * Patients with hepatic encephalopathy or severe neurological impairments (disabling dysarthria, tremor or dystonia) or severe psychiatric disorders incompatible with neuropsychological examination
  * Patients with liver transplant
Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration

The purpose of this study is to evaluate clinical outcomes of Photobiomodulation treatment on patients with dry Age Related Macular Degeneration (AMD).

Photobiomodulation is the use of non thermal, non laser light of specific wavelengths and energy directly on the eye to improve retinal function and delay AMD progression.

This is a prospective 2 center phase 2 clinical pilot study with no placebo group.

Dry AMD is a progressive sight threatening disease affecting central acute vision. Dry AMD may progress to the wet form where leaking and bleeding in the retina can cause sudden severe visual loss.

There are no proven active treatments for Dry AMD. Dry AMD accounts for over 80% of AMD cases.

There are estimated to be 30 million people afflicted with AMD by the year 2020 in North America.

Photobiomodulation in this study is utilised by using two devices that are already approved for other indications by the FDA and Health Canada.

Photobiomodulation is a novel clinical application for treating dry AMD. As this is a pilot study there is no placebo or control group.

Eligibility Criteria:
Inclusion Criteria:

* patients of both genders aged 50 years inclusive and over
* patients must have DRY macular degeneration in the study eye
* best corrected visual acuity between 20/40 and 20/200
* patients must be competent to sign and have signed a consent form before study entry

Exclusion Criteria:

* visually significant cataracts
* presence of a visually significant posterior capsule if prior cataract has been performed
* any visually significant disease process in any ocular structure that would affect vision unrelated to macular degeneration
* a patient can be enrolled if only one of their eyes meets the criteria
* patients with severe clinically significant medical disease or unstable medical conditions including cardiovascular, hepatic, renal, neurological, endocrine, gastrointestinal, CNS or life threatening disease or current malignancy at the discretion of the investigators
* patients who are non-ambulatory or bed ridden
* female patients who are pregnant or of childbearing potential as the effects of PBM on the developing fetus are unknown
* patients with a history of epilepsy
* patients with a history of alcohol, drug or substance abuse in the past 6 months
* patients deemed uncooperative or non compliant with the requirements of the protocol
* patients who have received any investigational drug or treatment within 30 days prior to study entry
* patients who are not competent to understand and sign consent form
Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH4808 After Oral Administration in Healthy Male Subjects

First in human study

Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of YH4808 in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers in the age between 20 to 45 years old
* Subjects who were determined to be appropriate through screening
* Weight: over 50kg, within ±20% of ideal body weight
* Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug

Exclusion Criteria:

* Clinically significant disorder in liver, kidney, cardiovascular, respiratory system, endocrine system and CNS in the physical examination and clinical laboratory tests or a medical history of malignant tumor or psychological disease
* Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery)
* A history of hypersensitivity to drugs or clinically significant allergic disease
* Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT)
* Subjects who were unable to be applicable for pH meter catheter
* Subjects who had a history of drug abuse or who had a positive results on urine drug screening
* Subjects who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment(cf, be able to be enrolled in this study according to an investigatory consideration)
* Subjects who participated in another clinical trial within 3 months before enrolling in this study
* Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
* Subjects who drank Over 21 units/week of alcohol or subjects who weren't able to stop drinking alcohol during the hospitalization
* Subjects who stopped smoking within 3 months before the treatment
* Subjects who had a beverage containing grapefruits within 24hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
* Subjects who had a beverage containing caffeine during the hospitalization
* H.pylori positive results on the Urease breath test(Only repeat doses)
* Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators
Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

The study aims to compare between two bolus doses of dexmedetomidine in preventing PONV in highly susceptible patients.

Being A challenging complaint, many studies tried to find an effective preventive strategies for PONV. In this study protocol the investigators aim to compare between 0.5 mic/kg and 0.75 mic/kg bolus doses of dexmedetomidine when given toward the end of head and neck surgeries in highly susceptible patients with a controlled group receiving ondansetron.

The primary outcome is the 1st 24 hours incidence of PONV

Other outcomes include:

* Time to 1st call for rescue antiemetic and the total amount of antiemetics
* Number of PONV attacks
* Post operative pain score with visual analogous scale (VAS) and time to 1st call for rescue analgesia
* Sedation Score using Observer's Assessment of Alertness and sedation (OAA/S)
* Patient satisfaction
* Vital signs in the 1st 24 hours

Eligibility Criteria:
Inclusion Criteria:

* Two risk factors or more for PONV ( female, non-smoking, postoperative opioids, history of motion sickness or PONV )
* Head and neck surgeries in adults
* ASA ( I , II )

Exclusion Criteria:

* Patients on ( steroids , antiemetics or any drug caude emesis )
* Any active cardiac condition at the time of the surgery
* Pregnancy
Prospective and Monocentric Study of the Incidence of Venous Thromboembolic Disease (VTE) in Spinal Cord Injury (SCI) Patient Between 3 and 12 Months After SCI

Venous Thromboembolic Disease (VTE) in SCI patients is very common, its prevalence is 60 to 80% against 10-20% in the general population.

The risk of VTE is very important in the first weeks after spinal cord injury, and then declines with a prevalence of VTE slightly higher than the general population after 12 weeks. However there is no prospective study of incidence of VTE in SCI patients after 3 months. The investigators wish to conduct such a study during the year following spinal cord injury with performing venous Doppler ultrasound of the lower limbs 6, 9 and 12 months of the initial injuryassociated with a standardized clinical assessment, to know the incidence of VTE and determine prognostic factors for VTE.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years.
* Patients having paraplegia or tetraplegia from C2 levels and above S1
* Paraplegia and tetraplegia of traumatic or non progressive SCI from traumatic or medical origin (ischemic, post-surgical, myelitis, benign tumor)
* Informed consent signed.
* stabilized respiratory situation with absence of chronic hypoxemia (hypoxemia being characterized by PaO2 steady state \<7.33 kPa)
* Patient not amputated.
* Absence of heart failure with ejection fraction below 30%
* Lack of solid neoplasia or progressive lymphoid haemopathy for 5 years, or myeloproliferative disorders (including polycythemia and thrombocythemia).
* No personal history of VTE and / or thrombophilia before the injury.

Exclusion Criteria:

* Unstabilized respiratory situation with presence of chronic hypoxemia (hypoxemia being characterized by PaO2 steady state \<7.33 kPa)
* Amputated Patient.
* Patients with heart failure with ejection fraction below 30%
* Solid neoplasia or progressive lymphoid haemopathy for 5 years, or myeloproliferative disorders (including polycythemia and thrombocythemia).
* Personal history of VTE and / or thrombophilia before the injury.
* Can not to follow during the study period
* Pregnant women
* Patient Refusal
The Potential Benefit of Xiao-Yao-San Treatment in Patients With Insomnia

The investigators recruited patients ages 20-65 from 2 groups in Tainan Hospital. One was from a weight loss class, also called WLC, one was from our regular clinic. These patients have no history of schizophrenia, narcolepsy, neurological disease, alcohol and drug addiction but had Pittsburgh Sleep Quality Index (PSQI) scores for psychometric properties ≥ 5 between January 1 to November 30 of 2019. The study group were the patients who received XYS for 28 days and the control group were those who didn't receive any Chinese medicine but attended the WLC. Age, gender, personal biodata, polysomnography findings, and these subjective sleep questionnaires were collected. The Wilcoxon test was used to compare the difference in pre and post evaluation in two groups. After comparing the objective and subjective assessment between the better and poorer performance in the XYS group, we would find more suitable criteria for XYS in traditional Chinese medicine.


Eligibility Criteria:
Inclusion Criteria:

* 20- to 65-year-old patients.
* Pittsburgh Sleep Quality Index (PSQI) scores ≥ 5.

Exclusion Criteria:

* Schizophrenia.
* Narcolepsy.
* Neurological diseases (history of stroke, neurodegenerative diseases, etc.).
* Alcohol addiction.
* Drug addiction.
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. In addition to its direct inhibitory action against these kinase targets, masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this prospective, multicenter, randomized, open-label, active-controlled study is to compare the efficacy and safety of masitinib with respect to imatinib in the first line treatment of gastro-intestinal stromal tumor (GIST). Treatment will be given until disease progression, limiting toxicity or patient consent withdrawal.

Eligibility Criteria:
Main inclusion criteria include:

* Histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery GIST
* Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
* c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-Kit negative

Main exclusion criteria include:

* Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria
* Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
* Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
On-Q Catheter Caregiver Education

The present study aims to compare caregiver satisfaction and efficacy between two modes of patient education materials (PEMs): media based and print based. The caregivers of patient's who undergo ACL (anterior cruciate ligament) reconstruction surgery and receive an On-Q Catheter pain block receive both a hand-out (print based PEM) and watch a short video (media-based PEM) describing how to care for their child's On-Q Catheter at home. Upon enrollment into the study, caregivers are randomly assigned to either first view the hand-out or the video, then complete a 10 questions standardized assessment of information that was presented in the PEMs. Caregivers are called the next day to assess caregiver satisfaction with the PEMs, which mode of PEM was more helpful to them, and how comfortable they felt managing their child's pain pump at home.

The present study aims to compare the efficacy and caregiver satisfaction between two modes of patient education materials (PEMs): media based and print based. The PEMs are designed to education caregivers on how to manage their child's On-Q catheter pain block at home. After caregivers have enrolled in the study and have been randomized to an education group, study interventions take place in the private family waiting room. Immediately after viewing their assigned PEM, the caregiver completes a 10 question standardized assessment, formatted as a multiple-choice quiz, of their understanding and knowledge of the information conveyed in both modes of PEM. The following day, caregivers are contacted by phone call to answer a number of questions to assess their satisfaction with the PEMs they received, the mode of PEM they preferred, and how comfortable they felt managing their child's pain pump at home.

All information is stored in a secure database (REDCap).

Eligibility Criteria:
Inclusion Criteria:

* Caregivers of patients undergoing ACL repair/reconstruction. These caregivers are registered in the Children's Hospital of Colorado medical record.

Exclusion Criteria:

* Illiterate or blind individuals
Contribution of Genetics, Non-invasive Methods and Neuropsychology in Focal Cryptogenic Epilepsies

Patients with cryptogenic focal epilepsy (unknown cause) represent about the 30% of the entire population of epilepsy patients. Among them, about 30% are drug-resistant. The implementation of of high-field magnetic resonance imaging resolution, the new Next Generation Sequencing techniques,and innovative non-invasive neurophysiological methods (Electroencephalogram-Functional magnetic resonance imaging and High Density-Electroencephalogram) could provide a superior identification of the epileptogenic zone and therefore an increased access to epilepsy surgery.

Despite this, patients with cryptogenic epilepsy require more frequently invasive methods of presurgical study and they have more unfavorable results than patients with lesions detectable on magnetic resonance imaging. Within this context, the study is aimed at integrating the neurophysiological, radiological, neuropsychological and genetic aspects of patients with focal cryptogenic epilepsy in order to evaluate their surgical eligibility,sparing invasive methods.

The investigators foresee study duration of 36 months and the enrollment of about 20-25 patients, affected by cryptogenic epilepsy with onset during pediatric age (0-18 years), not only to identify the cause of epilepsy and the epileptogenic zone, but also to define in a non-invasive manner, the patient's possible eligibility for surgical therapy.

Innovative neurophysiological methods, such as combined Electroencephalogram-Functional magnetic resonance imaging recording and high resolution electroencephalogram, in addition to 7 Tesla brain magnetic resonance imaging (available through the Imago7 non-profit foundation), neuropsychological studies and genetic tests through Next generation sequencing allow an advanced pre-surgical study free from the risks and discomforts caused by invasive methods. The systematic use of these diagnostic approaches will implement the knowledge and skills of the teams and it will stimulate their use in the clinical daily practise, especially for pediatric patients.

In addition to that, the investigators would like to analyse descriptive indications relating to the diagnostic sensitivity of the combined Electroencephalogram-Functional magnetic resonance imaging recording, High Density-electroencephalogram and 7 Tesla magnetic resonance imaging in the identification of the epileptogenic zone, in patients with cryptogenic focal epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* focal epilepsy, onset during pediatric age (\<18 y)
* drug resistance
* unknown cause
* Brain magnetic resonance imaging negative

Exclusion Criteria:

* epilepsy with good therapeutic control
* focal symptomatic epilepsy
* age limits onset (\> 18 y)