cyrilzakka/clinical-trials huggingface dataset:
ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children

There are several recommended doses of dexmedetomidine for prevention of emergence agitation in children. In this study, the investigators examine ED50 in prevention of emergence agitation after tonsillectomy or adenoidectomy in children.

To investigate ED50, Dixon's up and down method will be used.

Eligibility Criteria:
Inclusion Criteria:

* tonsillectomy or adenoidectomy

Exclusion Criteria:

* recent URI
An Advanced Digital Phenotype System Among People Suffering From Post-traumatic Stress Disorder

Psychiatric diagnosis is based mainly on questioning the patient and subjective impression rather than a quantitative assessment. The assessment is usually done with long time intervals between assessments and arbitrary in relation to the clinical course of the disorder. Post-traumatic stress disorder has physiological, physical, and behavioral manifestations. These changes appear as a response to different situations during the day and can be measured directly and indirectly in order to obtain an objective, quantitative and fuller picture of the severity and changes in the disorder. This is a non-interventional pilot study, using a system that collects data through wearable sensors and smartphone over a long period of time for patients suffering from PTSD and enables data analysis and characterization of a personal digital phenotype using a dedicated algorithm. Based on this pattern, the investigators will attempt to support the establishment of the PTSD diagnosis. During the course of the study, the therapeutic procedure will not be affected by the study and will be independent of the research.


Eligibility Criteria:
Inclusion Criteria for study group:

* Current PTSD diagnosis based on DSM-5. We will aim to recruit patients with Clinically Administered PTSD Scale (CAPS)- 5, medium severity and up.
* A person who is being monitored by the Ministry of Defense PTSD clinic at the Sheba Medical Center.
* Proper ability to give informed consent.
* A person with a smartphone that is not hacked with an Android version 2.3 or higher (relevant to smartphones manufactured since 2011).

Inclusion Criteria for control group:

* Proper ability to give informed consent.
* A person with a smartphone that is not hacked with an Android version 2.3 or higher (relevant to smartphones manufactured since 2011).

Exclusion Criteria for study group:

* A person defined as a violent or suicidal person (significant events of physical violence or suicidal behavior in the past year, according to the treating psychiatrist professional opinion).
* An active or terminal oncology disease or a dialysis patient.
* A person who is not independent or reports that he/she will not meet the requirement to wear the watch, recharge it or any other requirement arising from the use of the watch.
* A person without a smartphone that is not hacked or without Android version 2.3 or higher (relevant to smartphones manufactured since 2011).

Exclusion Criteria for control group:

* Current mental health diagnosis.
* A person defined as a violent or suicidal person (significant events of physical violence or suicidal behavior in the past year, according to the treating psychiatrist professional opinion).
* An active or terminal oncology disease or a dialysis patient.
* A person who is not independent or reports that he/she will not meet the requirement to wear the watch, recharge it or any other requirement arising from the use of the watch.
* A person without a smartphone that is not hacked or without Android version 2.3 or higher (relevant to smartphones manufactured since 2011).
Mechanisms and Treatment of Intradialytic Hypertension

1. To determine in a cross sectional case-controlled cohort study of 50 hemodialysis patients if blood pressure elevations with hemodialysis are associated with decreased endothelial cell function (measured by brachial artery flow mediated dilation and endothelial progenitor cell number), both of which are novel mechanistic markers in the causal pathway for detrimental cardiovascular outcomes; and
2. To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood pressure elevations with hemodialysis can improve endothelial cell dysfunction as a surrogate mechanistic marker for improving cardiovascular outcomes.


Eligibility Criteria:
Inclusion Criteria:

* on hemodialysis \> 30 days
* aged 18 to 80 years old
* ability to provide informed consent
* Primary nephrologist deems patient is at target dry weight
* Predialysis SBP \>140 or postdialysis SBP\>130

Exclusion Criteria:

* Patients with active wounds
* Blood pressure unable to be measured by routine mechanisms in the upper extremity
* Change in blood pressure medications in the previous 2 weeks
* Intolerance of beta or alpha-blockers
* pregnancy
* Resting heart rate \<50
* Life expectancy \< 6 months
* Current therapy with carvedilol or contraindication to carvedilol (ONLY in the intervention arm)
Mulligan Ankle Taping on Volleyball Players

34 volunteer professional volleyball players with (n=12) and without (n=22) CAI will include in the study. Mulligan ankle taping will apply. Measurements will take before and after the intervention. Muscle tone, stiffness, and elasticity will measure with MyotonPRO hand-held device. The static balance will measure with single leg stance test(SLST) while the eyes-closed, dynamic balance will measure with the Y balance test(YBT). Single leg hopping test(SLHT) will evaluate performance and an active position sense test will use for JPS. During the static and dynamic balance and performance tests, the ankle's confidence will be evaluated with the Visual Analog Scale (VAS). The study aimed to determine the effect of Mulligan fibular taping over the Tibialis Anterior(TA), Peroneus Longus(PL), Gastrocnemius Lateralis(GCL), and Medialis(GCM) muscles on muscle tone, stiffness, elasticity, as well as the performance, joint position sense(JPS), static and dynamic balance in female volleyball players with and without chronic ankle instability(CAI).


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 15-24,
* Being a professional volleyball player,
* Training for 90 minutes at least 3 days a week,
* Turkish native speakers,
* For participants with chronic ankle instability, those with a Foot and Ankle Disability Index score below 90% and a Foot and Ankle Disability Index-Sport survey score below 75% were included.

Exclusion Criteria:

* An ankle sprain history in the last 6 weeks,
* Having a previous history of fracture in the lower extremity,
* Having bilateral chronic ankle instability,
* Pregnant athletes were excluded from the study.
Dietary Control of Type 2 Diabetes: Low-Carbohydrate Mediterranean Diet Versus Low-Fat Diet

The major environmental factors that increase the risk of type 2 diabetes, presumably in the setting of genetic risk, are overnutrition and a sedentary lifestyle, with consequent overweight and obesity. The high rate of weight regain has limited the role of lifestyle interventions as an effective means of controlling glycemia long term. The aims of the present study were: 1) To compare the effectiveness and safety of two nutritional protocols - namely low-carbohydrate Mediterranean diet or low-fat diet - in newly-diagnosed, drug-naive overweight patients with type 2 diabetes mellitus. The primary aim of the study was the effect on hemoglobin A1c levels; secondary aims were time to introduction of the first hypoglycemic agent, prevalence of the metabolic syndrome, percentage of patients meeting ADA goals for risk factors (HbA1c, blood pressure, LDL-cholesterol, percentage of patients with HbA1c \< 7%.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (ADA criteria)
* BMI (body mass index) \> 25 kg/M2
* Hemoglobin A1c (HbA1c) \< 11%; Blood pressure \< 160 (systolic) and 100 (diastolic) mm Hg
* Triglyceride levels \< 500 mg/dl.

Exclusion Criteria:

* Pregnancy or breast-feeding
* Previous use of insulin or oral antidiabetic drugs
* Investigational drug within the previous 3 months
* Use of agents affecting glycemic control (systemic steroids and weight loss drugs)
* Patients with history of alcohol or illicit drug abuse
* Patients with liver enzymes higher than three times the upper limit of normal
* Serum creatinine \> 1.4 mg/dl.
Most Total Pancreatectomies for Ductal Adenocarcinoma Can Be Replaced by Whipple Over the Splenic Artery: A Before and After Study

Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during Whipple (WOTSA). In that case, TP can be replaced by WOTSA. This uncontrolled before and after study assesses the safety and efficacy of a new technique "Whipple over the splenic artery (WOTSA)" as a treatment for PDAC which traditionally requires total pancreatectomy (TP).

Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during Whipple (WOTSA). In that case, TP can be replaced by WOTSA. This uncontrolled before and after study assesses the safety and efficacy of a new technique "Whipple over the splenic artery (WOTSA)" as a treatment for PDAC which traditionally requires total pancreatectomy (TP).

Methods: The study group comprised 40 consecutive patients who underwent WOTSA for PDAC. Their clinicopathological characteristics and survival were compared with those of a historical control group comprising 30 consecutive patients who underwent TP between.

Eligibility Criteria:
Inclusion Criteria:

* pancreatic ductal cell adenocarcinoma (PDCA) patients

Exclusion Criteria:

* Patient undergoing palliative pancreatectomy, other malignancies with distant metastases
* Vulnerable groups
GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology

Male self catherterisng observational study.

This is a multicentre, prospective international observational study. Male patients in the UK, USA and France performing self-catheterisation will be asked to participate in this study. The subjects will be asked to use the GentleCath™ Intermittent Catheter with FeelClean™ Technology as per their normal routine. They will be asked to record when and where they catheterise. At the baseline, during and on completion of the study, the subjects will be asked to complete Difficulty in Catheterisation plus Intermittent Catheter related Quality of Life Questionnaires.

Difficulty during catheterisation and quality of life will be assessed using the ICDQ and ISC-Q validated questionnaires during catheterisation at the start of the study before use of GentleCath™ Air has commenced (D0) and on day 1 (D1), day 15 (D15), day 30 (D30), day 45 (D45) and day 60 (D60) transcribed in a collecting record provided for this purpose. Compliance and catheter use will also be assessed.

Patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* • Adult male (aged 18 years and over)

  * Diagnosed with a neurological lower urinary tract dysfunction due to either spinal cord injury, Multiple Sclerosis, Parkinson's Syndrome, Cauda equina syndrome Or Diagnosed with bladder outflow obstruction secondary to benign prostate enlargement Or Diagnosed with detrusor underactivity
  * Performing single use clean intermittent self-catheterisation (ISC) at least twice a day
  * Willing to undergo training with GC Trainer video prior to use of catheter
  * Provided fully informed consent and has sufficient understanding of English or French
  * Sufficient dexterity to use GentleCath™ Air for Men intermittent including ability to open packaging
  * Intact urethral sensation of catheterisation
  * Willing to use only the GentleCath™ Air intermittent catheter for the full duration of the study (60-days)
  * Subject has a valid email address so the Investigator can send links to study questionnaires and the subject has access to a web enabled device

Exclusion Criteria:

* • Participation in another related urological study

  * Unable to perform ISC unaided
  * Already prescribed the GentleCath™ Air Intermittent Catheter
  * Absent urethral or perineal sensation
  * Unwilling to undergo training with GC Trainer prior to use of catheter
  * Insufficient dexterity to use GentleCath™ Air Intermittent Catheter and or packaging
  * Suffering from a symptomatic UTI (Urinary Tract Infections) at the time of inclusion or in the preceding 6-weeks
  * Undergoing surgical treatment during the period of the study
  * Performing catheterisation for urethral stricture
Phase III Study to Evaluate the Immunogenicity and Safety of MG1109 in Healthy Adult Volunteers

The purpose of this study is to evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study.

MG1109 is purified, inactivated influenza viral antigen.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults who are available for follow-up during the study

Exclusion Criteria:

* Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine
* Subjects with immune system disorder including immune deficiency disease
Emotional Awareness and Expression Therapy for Prediabetes

This feasibility study seeks to develop and pilot test Emotional Awareness and Expression Therapy as a possible treatment for people with prediabetes.

Prediabetes is a clinical condition in which hemoglobin A1C is between 5.6 and 6.4, and is usually associated with being overweight, poor diet, limited exercise, and psychological stress. This condition develops in to Type II diabetes in many people, and interventions to prevent such progression are needed. Because stress can directly negative impact blood glucose metabolism and can indirectly affect it through unhealthy behaviors (e.g., diet, exercise), it may be possible to reduce stress and improve clinical outcomes. Although most stress management approaches help people to calm their physiology and reduce their negative emotions, another approach to stress treatment is to help people disclose emotionally difficult experiences, become aware of and express their emotions, and change interpersonal relationships by becoming more assertive as well as more open/connected.

Emotional Awareness and Expression Therapy (EAET) is an approach to stress reduction that uses these principles and it has been shown to be effective for somatic symptom disorders like chronic pain. In this study, we will adapt EAET to the prediabetes context and test its feasibility, acceptability and initial efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Affiliated with Wayne State University (faculty, staff, student, or family member/friend thereof)
* HbA1C value of 5.7% to 6.4%
* overweight or obese (≥25 kg/m2) Also, if over ≥ 18 and \< 45 years of age must have at least one of the following: a) physical inactivity, b) close family history of diabetes, c) history of hyperlipidemia, d) history of hypertension, e) history of gestational diabetes, and/or f) from high risk race groups (e.g., African American, Latino, Native American, and pacific Islander).

Exclusion Criteria:

* Confirmed history of Type 2 Diabetes
* have prediabetes being treated pharmacologically
* pregnant
* taking medications that affect blood glucose (e.g., corticosteroids)
* chronic depression or major psychotic disorder
* any comorbidities that limit survival or ability to tolerate the intervention (Cushing's, cancer treatment, asthma with inhaled corticosteroids, unstable CAD or MI in last 6 months, CHF, COPD requiring oxygen, chronic kidney disease)
Efficacy of Simvastatin for the Treatment of COPD

To evaluate in patients with stable Chronic Obstructive Pulmonary Disease (COPD) the efficacy of statins (simvastatin) on: (1) endothelial function; (2) systemic inflammation; (3)BODE (B: body mass , O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index; (4) Uric acid; and, (5)vascular growth factors. Design: a 12 weeks randomized (1:1), double-blind, placebo control study. Population: 18 males with stable COPD between 40-80 years of age, exsmokers, with Forced expiratory volume in one second (FEV1) between 30 and 80% predicted post-bronchodilation.


Eligibility Criteria:
Inclusion Criteria:

* Stable COPD between 40-80 years of age, exsmokers, with FEV1 lower that 80% predicted post-bronchodilation.

Exclusion Criteria:

* Severe co-morbidity (advanced-stage cancer, tuberculosis affecting more than a third of the total lung parenchyma, pneumonectomy, pneumoconiosis, left cardiac failure previously reported, known cardiopathy with ventricular dysfunction (ejection fraction \< 45%) or any cardiovascular disease, Diabetes Mellitus treated with insulin, Hypercholesterolemia, Chronic inflammatory diseases (asthma, rheumatoid arthritis, lung fibrosis, autoimmune diseases), Treatment with systemic steroid, non steroidal anti-inflammatory drugs or stains within 3 months prior to inclusion.
Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes

The aim of this study is to assess the post-prandial response of four breakfast with different content of dietary fiber and glycemic index on glycemic response and satiety in patients with type 2 diabetes.

Design study:

Single-blind crossover randomized clinical trial

Hypothesis:

A meal with high GI and high fiber content determines a lower glycemic response compared to a meal with high GI and low fiber content (fiber beneficial effect on glycemic response independent of glycemic index.

Test meals:

Four test meals isocaloric and with the same proportion of macronutrients will be evaluated (5 kcal/kg, 17% of energy provided by protein, 58% of energy provided by carbohydrates, and 25% of energy provided by fat):

Test Meal A:high glycemic index (GI= 60.3%) and high fiber content(5.88g) Test Meal B:high glycemic index (GI= 62.8%) and LOW fiber content(2.05g) Test Meal C:low glycemic index (GI= 37.0%) and high fiber content(5.75g) Test Meal D:low glycemic index (GI= 38.4%) and high fiber content(1.91g)

Outcomes:

Glycemic response: serum glucose and insulin Satiety response: serum ghrelin and subjective assessment of satiety by a specific scale for measurement of appetite in single test meal studies.

Logistic:

Patients will undergo a clinical, nutritional and laboratory evaluation for confirm the inclusion criteria and will be request to give their written informed consent.

All participants will test each meal with a mean of seven days separating the individual test days.A 12h fast will precede all the study visits.Pre-and postprandial blood samples will be draw to determine the concentrations of serum insulin and plasma glucose, and ghrelin through an antecubital cannula before and 15, 30, 45, 60, 90, 120 and 180 min after the test meals. The VAS scale will be applied in these times.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes,
* HbA1c \< 9%,
* BMI \< 35kg/m²,
* Metformin and/or diet as treatment for diabetes

Exclusion Criteria:

* Use of insulin as diabetes treatment
* digestive disease with malabsorption
* diabetes neuropathy with gastroparesis
Dietary Treatment for IBS Within Primary Health Care

Irritable bowel syndrome (IBS) is a multifaceted disorder where diet plays a pivotal role in symptom generation and management. The traditional dietary advice given to patients in clinical settings are based on the NICE guidelines. Some of the advice included in these guidelines have limited scientific evidence. The aim of this study is to investigate the effectiveness of the traditional dietary advice in IBS, according to the NICE guidelines, within a primary health care setting, where treatment is delivered digitally and in groups of 8-12 individuals. As a sham comparator, one group will receive dietary advice according to the Swedish dietary guidelines regarding healthy eating habits.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with IBS (ROME IV) by physician
* Age 18-50
* Ability to read and understand Swedish
* Signed informed consent

Exclusion Criteria:

* Received dietary treatment for IBS previously
* Manifestations of other conditions that may explain gastrointestinal symptoms
Evaluation of PCD-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease

The goal of this observational study is to learn about a new type of computed tomography (Photon-Counting Detector CT) in patients with coronary artery disease.

The main questions it aims to answer are:

* How good is the image quality for the new CT
* How accurate are measurements in the images of the new CT
* Is there a relationship between measurements in the images and the management of the disease (e.g. new medication or additional investigations)
* Is there a relationship between measurements in the images and the results of follow-up investigations
* Is there a relationship between measurements in the images and the patient outcome

Participants will undergo normal clinical assessment of coronary artery disease and all data from the CT scan and additional investigations will be collected. There will be no additional investigations for the purpose of the study. After 1, 2 and 5 years, participants will be asked to answer a health questionaire.


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for a coronary computed tomography angiography (CCTA) for the suspicion of coronary artery disease or the progression thereof
* Written informed consent

Exclusion Criteria:

* Contraindications preventing the execution of the CCTA (e.g., pregnancy)
Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients

The objective is to evaluate whether the medication in polymedicated metabolic syndrome patients could determine the effects of a pomegranate extract on i) metabolic markers, ii) inflammatory markers, and iii) the modulation of the gut microbiota.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index \>30 kg/m2 or waist circumference \>94/80 cm (males/females) in European-Caucasians subjects, plus two of the following:
* Triglycerides \>150 mg/dL or under treatment against hypertrigliceridemia.
* Fasting glucose ≥100 mg/dL
* Diagnosed type 2 diabetes mellitus
* HDL-cholesterol (mg/dl) \<40/50 (males/females) or under treatment against low HDLc values.
* Systolic blood pressure \>130 mmHg o diastolic blood pressure \>85 mmHg, or under anti-hypertensive drug treatment.

Exclusion Criteria:

* Age under 18 years
* Pregnancy or breastfeeding
* Antibiotic treatment within one month before inclusion in the trial
* Pomegranate allergy or intolerance (known or suspected)
* Chronic intestinal inflammatory diseases (ulcerative colitis, Crohn's disease, etc.)
* Malignancies
* Consumption of botanicals or dietary supplements within one month before the inclusion and during the trial.
* Consumption of ellagitannin-rich sources within one week before the inclusion and during the trial (pomegranate, walnuts, strawberries, raspberries, tea, blackberries and oak-aged wine).