cyrilzakka/clinical-trials huggingface dataset:
Acute Pancreatitis : Comparison of Various Scores in Predicting Severity and Outcome

The study will make a comparison between Various severity scoring systems that has been designed to assess the severity and predict prognosis in acute pancreatitis

the study will evaluate the relationship between homeostatic model assessment of insulin resistance , bedside index of severity score and the harmless acute pancreatitis score and prognosis of acute pancreatitis ,will compare of these scores in predicting severity of acute pancreatitis and will compare of these scores in predicting outcome of acute pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with 18 years or above and met criteria for diagnosis of acute pancreatitis will be eligible for the study.

Exclusion Criteria:

-
Comparison of Outcomes During MRI Sedation With Midazolam-dexmedetomidine Versus Ketamine-dexmedetomidine

This study will compare 2 different sedation drugs (Ketamine and Midazolam) when they are used with another sedating medicine called Dexmedetomidine for MRI sedation. This study hopes to measure the impact each drug has on what happens during and after MRI sedation with Dexmedetomidine

The will be a randomized, double-blind, prospective study. All patients referred to UCSS for brain MRI and for whom dexmedetomidine would otherwise be the sedation regimen of choice will be eligible for enrollment. The investigators propose to limit the study to patients undergoing only brain MRI as these studies are of a predictable length (25-30 minutes); therefore the sedation regimen can be more easily standardized. Parents of eligible patients would be approached prior to or during the pre-sedation assessment and told about the study and, if they agree to enroll, informed consent would be obtained. Assent will be obtained from children 7 years of age and greater, if they are otherwise developmentally capable of giving assent. The goal is to enroll 50 subjects (25 per treatment group) which would be sufficient to detect a 25% or greater difference in the mean maximal heart rate or blood pressure decrease from baseline between the 2 groups.

Following consent, subjects would be randomized to be sedated with either midazolam-dexmedetomidine or ketamine-dexmedetomidine and, upon achieving an appropriate depth of sedation, undergo their MRI. Monitoring during the MRI and subsequent recovery would occur in compliance with the current Norton Children's Hospital Sedation policy. Recovery-related behavior would be assessed using the Pediatric Anesthesia Emergence Delirium Scale.

Eligibility Criteria:
Inclusion Criteria:

1. Inpatient at Kosair Children's Hospital.
2. Order placed by treating team for MRI of the brain with sedation.
3. Age less than or equal to 18 years.
4. Plan to sedate with dexmedetomidine, regardless of study participation.

Exclusion Criteria:

1. Previous adverse reaction to dexmedetomidine or clonidine
2. Current use of clonidine as a routine medication
3. Concurrent use of a heart-rate decreasing medication (digoxin, propranolol)
4. Contraindication to ketamine use

   * Intracranial hypertension or traumatic brain injury
   * Intraocular hypertension of eye trauma
   * Pulmonary hypertension requiring medical management
5. Planned additional procedure during the sedation encounter (non-brain MRI, lumbar puncture, EEG etc)
BIP ETT Clinical Tolerability, Safety and Performance Study

The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s tolerability, safety and performance and compare it to a standard un-coated Endotracheal tube.


Eligibility Criteria:
Inclusion Criteria:

* adult men and women \>=18 years of age
* are, in opinion of the investigator able to communicate with and understand the trial personnel and comply with the requirements of the trial (e.g. fill in questionnaire)
* requiring endotracheal intubation \>=3 h for elective surgery of upper gastrointestinal tract with a tube size of 7 or 8
* has signed informed consent

Exclusion Criteria:

* known transmissive blood disease
* known multiresistant bacterial colonization
* current and continuous treatment by immunomodulating therapies - e.g. systemic (or inhalation) use of cortisone or NSAIDS
* ongoing respiratory infection
Facial and Body Motion Technology and Stroke

The purpose of this study is to customize privacy protected facial expression and body motion tracking for use in the home environment by stroke survivor-informal caregiver dyads by investigating within a simulated home environment, background variability,possible occlusions, privacy considerations, and the motor weaknesses, gait impairments, and facial expressions of stroke survivors and to determine the acceptability of the customized facial expression and body motion technology in stroke survivors and their informal caregivers.

Stroke is a leading cause of disability. Most stroke survivors are discharged home after hospitalization and receive care from informal caregivers (e.g., unpaid spouses) who are often unprepared for the role. Stroke survivorship is an exemplar of a chronic condition that detracts from the affected individual and caregiver's capacity to live well within the home (e.g., psychosocial distress). Early identification of psychosocial distress is likely to lead to timely interventions and, subsequently, decreases in associated morbidity, mortality, and disability. Yet, only a minority of survivors are properly identified and treated for psychosocial distress, and caregivers are primarily forgotten. In-home, objective measures to identify psychosocial distress are lacking. Using facial expression and body motion technology by extracting facial characteristics and body joints (skeletal graph) known to be associated with psychosocial distress (e.g., frowning) provides new opportunities to support in-home telemonitoring. To accommodate real-world, post-stroke home environments, the technology needs to be customized to an in-home environment. Toward this end, the investigators must consider background variability, possible occlusions, privacy concerns, and stroke survivor motor weaknesses, gait impairments, and facial paralysis. Objectives: The primary objectives are to customize facial expression and body motion technology and examine the acceptability of the technology through a study of 6 stroke survivor-informal caregiver dyads within a simulated home environment. The project will serve as a necessary step to amass critical information to design future trials using facial expression and body motion technology. The ultimate goal is to improve psychosocial well-being for those aging at home.

Eligibility Criteria:
Inclusion Criteria:

* can read, write, and speak English
* are willing and able to provide informed consent
* Informal caregivers must live in the home with the stroke survivor and be unpaid for their role
* Stroke survivors must have some degree of facial and limb weakness and a Modified Rankin Scale (mRS)13 score between 1 and 3.

Exclusion Criteria:

- stroke survivors currently reside outside of the home and are wheelchair bound.
Evaluation of the Difference in the Acromion Humerus Gap at Sitting,Lying

The Objective is to evaluation the difference between the upper end of the Humerus head and the bottom end of the Acromion in sitting and lying, and to examine this difference to shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

* men and women with or without shoulder pain.

Exclusion Criteria:

* unwillingness to sign informed consent
Metformin for Treatment of Psoriasis Combined With Disorders of Glucose and Lipid Metabolism

Psoriasis and metabolic disorders are well-known mutual comorbidities. The investigators hypothesized metformin can ameliorate both psoriasis and metabolic disorders mainly via gut microbiota modulation. The investigators design a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of treatment of metformin for psoriasis combined with disorders of glucose and lipid metabolism and to explore the role of gut microbiota during the process.


Eligibility Criteria:
Inclusion Criteria:

criteria 1 and 2 are both needed for inclusion:

1. included if all of the following criteria are met

   * ≥18 years and ≤75 years
   * Diagnosed according to Classification criteria for Psoriasis Vulgaris
   * Understanding the whole process of the study, voluntary participation and signed the informed consent
2. included if at least one of the following criteria is met

   * Body Mass Index (BMI) over 24
   * impaired glucose or insulin resistance

Exclusion Criteria:

* Pregnant women, or women who ready for pregnancy or lactating;
* Have special primary endocrine system lesions that can influence glucose or lipid metabolism
* More than 20% change of their predrug body weight within a half year
* Severe diabetes which needs combined therapy
* Known major systemic diseases like cancer, liver or kidney malfunction, etc.
* Alcohol abuse
* Known severe or chronic infections like tuberculosis or HIV
* Use of other systemic medication that could influence the metabolic level
* Patients participated in any clinical trials within 3 months
* Other cases which researchers believe that can not enroll
Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer

The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 60 years or older.
* Invasive ductal carcinoma.
* Unifocal disease.
* Tumors less than 2cm.
* No clinical evidence of nodal disease.
* Estrogen receptor status (ER) positive.
* Her2 negative.

Exclusion Criteria:

* Age less than 60 years.
* BRCA 1 and/or BRCA 2 mutation.
* Tumour histology limited to lobular carcinoma only.
* Neoadjuvant hormonal manipulation or chemotherapy.
* More than one primary tumour in different quadrants of the same breast.
* Inability to view tumor on imaging.
Comparative Study of GlySure Continuous Intra-vascular Glucose Monitoring and Intermittent Monitoring in Medical ICU

It has been shown that close control of blood glucose levels in the intensive care unit patient has benefits for patient morbidity and mortality rates as well as an impact upon discharge times. GlySure has previously completed an evaluation of its intra-vascular glucose monitoring system in patients in a surgical ICU environment after cardiac surgery. This study seeks to evaluate the same equipment being used in a wider range of patients with a range of underlying conditions who require treatment in medical ICU's. The GlySure device consists of a sensor that is placed into the patient's blood through a central venous catheter. It measures blood glucose levels continuously which allows for more rapid control of blood glucose levels to be achieved as compared to existing methods where blood samples are taken repeatedly every 15 minutes or so.

The study is designed to show that the sensor can be used for a protracted period of time, giving accurate results when compared to a reference technique using the i-STAT device. The investigators intend to show that the device performs safely for the required time within the ICU.


Eligibility Criteria:
Inclusion Criteria:

1. Patient or legal representative MUST be willing to sign an informed consent document
2. Patient is male or female aged 18 years or above
3. Patient requires a CVC to be inserted as part of disease management and treatment
4. Patient is expected to remain in the intensive care unit for at least 36 hours post enrolment to the study

Exclusion Criteria:

1. Patient or legal representative is unable to provide written informed consent
2. Patient who is pregnant
3. Patient who is currently being administered Mannitol and/or may require the administration of Mannitol whilst in the ICU
4. Patient with history of pulmonary embolism (PE)
5. Patient with history of thrombosis
6. Patient with known hyper-coagulation
7. Patient with known history of heparin hypersensitivity
8. Patient with history of heparin induced thrombocytopenia
9. Participation in a clinical study involving an unlicensed pharmaceutical product or device within the 3 months prior to enrolment in this study
10. Patient with known hypersensitivity/allergy to adhesive I.V. dressings such as 3M Tegaderm film or StatLock® devices
Anesthesia for Vascular Access Devices

Our aim was to investigate whether remifentanil use in both infusion and bolus techniques could provide sufficient sedation and analgesia without serious adverse effects for central venous access device procedures under monitored anesthesia care.

The insertion and removal of implantable venous access devices (port-a-cath type) requires moderate level of sedation and monitored anesthesia care to prevent pain and anxiety of patients during the procedure. According to the American Society of Anesthesiologist Physical Status Score, monitored anesthesia care is a planned procedure where a patient undergoes local anesthetic infiltration together with sedation and analgesia. Remifentanil is a potent synthetic opioid with novel pharmacokinetic properties, including very rapid onset and an ultra short duration of action, making it effective for pain relief in short procedures. Remifentanil can be administered as either one of the techniques of intravenous continuous infusion (CI) or intravenous bolus patient-controlled sedation analgesia (PCSA).In previous studies, the insertion or removal of venous access procedures required either local anesthesia or low doses of orally administered anxiolytic medication. The infusion of remifentanil may cause respiratory depression and analgesic efficacy and safety of administration of remifentanil infusion and/or bolus doses of remifentanil during the administration of one of the techniques of either CI or PCSA in short term procedures has not been well studied. The prospective trials that compare analgesic efficacy and adverse events related to intravenous remifentanil consumption in sedation and analgesia of short procedures are very limited.

This study aims to compare level of pain and sedation, total amount of remifentanil consumption, bolus doses of remifentanil, patient and surgeon satisfaction, hemodynamic data and adverse events of two different techniques of intravenous remifentanil use such as; intravenous continuous infusion (CI) or intravenous bolus patient-controlled sedation analgesia (PCSA) in patients under moderate level of sedation for vascular access procedures.

Eligibility Criteria:
Inclusion Criteria:

1. 30-80 years old,
2. American Society of Anesthesiologists Physical Status I to III,
3. Referred for an venous access device implantation or removal procedure.

Exclusion Criteria:

1. morbid obesity (body mass index \> 40),
2. severe asthma, chronic obstructive lung disease, diabetes mellitus, hepatorenal disease,
3. a history of opioid allergy,
4. long-term opioid use or chronic pain,
5. ASA PS ≥ 4,
6. presence of epilepsy,
7. acute cerebrovascular event,
8. presence of hemodynamical instability such as peripheral oxygen saturation \< 90%, systolic blood pressure \< 60 mmHg and heart rate ≤ 40 bpm,
9. patients complaining about intense pain before the procedure.
Effects of an Adapted Physical Activity on the Postural Control of Residents in Nursing Home.

This study measures the effects of an Adapted Physical Activity on postural control of residents in nursing home. Half of participants will follow a program training 3 times a week during 8 weeks, while the other half will receive the usual accompaniment.


Eligibility Criteria:
Inclusion Criteria:

* Able to walk 20 meters with or without auxiliary help
* Able to stand 1 minute without help
* Health status considered stable
* Life expectancy greater than 6 months
* No major cognitive impairment preventing them from understanding a simple instruction
* No severe visual impairment
* No severe deafness
* Understanding french
* Able to discern

Exclusion Criteria:

* Unable to walk 20 meters with or without auxiliary help
* Unable to stand 1 minute without help
* Health status considered unstable
* Estimated life expectancy at less than 6 months
* Major cognitive impairment preventing them from understanding a simple instruction
* Severe visual impairment
* Severe deafness
* Not understanding french
* Inability to discern
SGA-induced Metabolic Syndrome in Bipolar Youth

The investigators tested the hypothesis that long-chain omega-3 (LCn-3) fatty acid supplementation will attenuate the adverse cardiometabolic effects of second-generation antipsychotics exposure in first-episode adolescent manic patients.

Following acute (6-week) open-label treatment with quetiapine, first-episode adolescent manic patients (ages 10-17 years) were randomized to double-blind adjunctive treatment with long-chain omega-3 (LCn-3) fatty acids or placebo for 24 weeks to investigate protective effects on the of adverse cardiometabolic events and weight gain during quetiapine maintenance therapy. They will have 6 visits over a 24-week period.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV-TR criteria for bipolar disorder, type I, manic or mixed episode
* Baseline YMRS score \> 20
* Ages 10-17 years
* Tanner scale stages III-V
* No prior exposure to SGA medications
* Fluent in English
* Provision of written informed consent by a legal guardian and written assent by the subject
* Manic or depressive symptoms do not result entirely from acute medical illness or acute intoxication or withdrawal from drugs or alcohol as determined by medical evaluation and rapid symptom resolution
* If female and of child bearing potential, agrees to use one of the following method of birth control: complete abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive. For Phase II, additional Inclusion criteria are
* Receiving a stable therapeutic dose of quetiapine for a minimum of 1 week (i.e., patients who achieved remission (YMRS total score 7 during Phase I)
* Not requiring concomitant use of antidepressant or mood-stabilizer medications (see Section C.4.c. Concomitant Medications).

Exclusion Criteria:

* IQ \< 70, as determined by The Wechsler Abbreviated Scale of Intelligence
* Positive pregnancy test (to avoid teratogenesis)
* A history of major cardiovascular or neurological illness
* Any lifetime DSM-IV-TR substance use disorder (nicotine dependence is permitted)
* A lifetime DSM-IV-TR diagnosis of any pervasive developmental disorder
* Any history of a hematological disorder in themselves or a first-degree relative will be excluded (since omega-3 fatty acids may be associated with anti-thrombotic effects). Similarly, concomitant use of medications with anticoagulant effects (e.g. aspirin) will be prohibited
* Allergy to fish/seafood; 8) Currently taking omega-3 fatty acid supplements
Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy

Patients who undergo chemotherapy for leukemia will receive study medication for prevention of fungal infections. The study investigates the safety and tolerability of two different dosages, the efficacy in prevention of fungal diseases.

Patients with Acute Myeloid Leukemia who undergo aggressive chemotherapy are due to immunosuppression susceptible to infections, including fungal infections. As the failure rate in the treatment of invasive fungal infections is high, prophylaxis is frequently recommended. This open label study investigates the safety and tolerability of two different dosages of a water soluble azole antifungal, as well as the efficacy in prevention of invasive fungal infections and pharmacokinetic data.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of acute myeloid leukemia
* patients entering first induction treatment; or subsequent chemotherapy if no prior invasive fungal infection was observed
* expected to be neutropenic for \>9 and \<28 days after enrollment
* women of childbearing potential must have a negative pregnancy test

Exclusion Criteria:

* patients who received any systemic antifungal therapy for more than 72 hours prior to first administration of study medication. Topical polyenes or nystatin are acceptable but should be discontinued during the study
* patients who received systemic antifungal therapy for proven or probable fungal infection in the last 12 months
* patients with fever defined as central body temperature of \> 38°C
* known hypersensitivity to azoles or any component of the study medication
* concomitant use of rifampicin, rifabutin, ergots alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine, and carbamazepine
* hepatic or severe renal dysfunction
* patients with a medical history of oliguria unresponsive to fluid challenge
* patients with a concomitant medical condition that may be an unacceptable additional risk to the patient should he/she participate in the study
* treatment with any investigational drug within 30 days prior to the first administration of study medication except open label chemotherapy protocols
* suspected other or additional cause for neutropenia or immunosuppression
Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer

The purpose of this study is to see whether or not the combination of cisplatin, irinotecan and radiation, followed by surgery, followed by oral Sutent, is effective and safe for patients with resectable esophageal cancer.

Survival outcomes for resectable esophageal cancer remain poor. Current data strongly support an adjuvant systemic strategy to improve time to progression and survival in this patient population. Adding a well-tolerated oral targeted therapy such as Sutent, after a combined chemo/radiation/surgery approach in this patient population has the potential to impact on the minimal residual disease left behind by relatively effective pre-operative chemoradiation and surgery. This has the potential to improve survival. The primary endpoint is to determine the feasibility and efficacy of adjuvant Sutent therapy (SU11248) after concurrent neoadjuvant therapy with irinotecan, cisplatin, external beam conformal radiotherapy plus surgery for potential resectable esophageal cancer. Preclinical and clinical data suggest that Sutent will have activity in esophageal cancer, as the results of Sutent activity in solid tumors appear to be superior to the results of other antiangiogenic compounds in development for esophageal cancer. Therefore, by extrapolation from promising phase I, II and III Sutent trials we propose to translate the target effects achieved with Sutent to reduce local and systemic therapy failure, and thus metastasis in esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous or adenocarcinoma or the esophagus \>20 cm from the incisors, including GE junction tumors (unless of gastric origin).
* Tumors must be technically resectable.
* Clinical T1N1M0, T2-3 N0-1 M0
* Performance status ECOG 0-1
* Medically fit for chemotherapy, radiation and esophagectomy

Exclusion Criteria:

* In situ or clinical T1N0M0, and stage IV (M1a orM1b)
* Cervical esophageal tumors (within 20 cm of the incisors)
* Age \<18 or \>70
* Participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy
* known or suspected drug or alcohol abuse
* Prior treatment for this malignancy except esophageal stenting