cyrilzakka/clinical-trials huggingface dataset:
Prospective Evaluation of Changes in Tissue Oxygen Saturation in Brain and Kidney in Children Admitted to Intensive Care in the Postoperative Period of Cardiac Surgery

It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of live births, 5,000 new cases per year currently in France These are serious diseases that can be life-threatening to more or less short term.

The advances in surgical techniques in recent years has improved the prognosis of these patients in the first months of life.

The success of surgery is, among other things, conditioned by a support per complex operation, involving a multimodal intensive monitoring, and respiratory and hemodynamic support techniques.

These elements of surveillance, NIRS (Near-infrared spectroscopy) allows measurement of non-invasive tissue saturation (rSO2) in cerebral and renal oxygen.

The fundamental principle of NIRS based on an estimate of the percentage proportion of cerebral oxy-hemoglobin.

A light source is emitted by NIRS and through body tissues to the brain where the light will be absorbed and refracted depending on the tissue composition in oxy-hemoglobin.

Refracted light will be analyzed by NIRS which in turn using software will help to determine a percentage of oxyhemoglobin.

Normal values of cerebral NIRS are between 50 and 80%.NIRS can be used according to this principle to estimate cerebral tissue oxygenation but also for other tissues such as the kidney.

More than the figure, those are changes NIRS compared to a baseline that will alert us to the conditions of tissue oxygenation and allow us to identify hypoxia times.

Changes in the value of the NIRS depends on 3 criteria: the tissue blood flow, the percentage of oxyhemoglobin and deoxyhemoglobin percentage.


Eligibility Criteria:
Inclusion criteria

* Children under 5 years
* Allowed in pediatric intensive care unit
* Having received heart surgery for management of congenital heart disease

Exclusion criteria

* Patients aged over 5 years
* Violations preexisting brain to the intervention (brain malformation)
* Patients with congenital heart disease and admitted to intensive care for reasons other than the surgical treatment of heart disease
Effect of Core Engagement Exercises and Routine Exercise Therapy on Low Back Pain in Middle School Children

Low back pain is defined as the region of pain between the lower ribs and hips. Low back pain with respect to middle school children corresponds to the age where children and adolescents go to school for longer periods of time, having heavy bags, assuming poor postures while sitting for prolonged hours. Poor posture, prolonged sitting and lack of physical activity results in back pain that leads to poor performance in school as well as attendance.

Middle school children are the children of the age where they spend most of their hours sitting in school. Low back pain often goes undiagnosed and unreported in children which persists and if left untreated, causes problems in later stages in life.

Low back pain is the region of pain from lower ribs to hips. Children and teenagers often have lower back discomfort, which may be brought on by several conditions, including poor lifting skills, bad posture, and overuse injuries from sports or other physical activity. According to estimates, up to 50% of school-aged children may sometimes have lower back discomfort. The muscles that surround our spine are considered the "core" of our body. It is composed of the abdominal muscles on your front and sides, the erector muscles and gluteus. Each and every one of these muscles must work together in order to enhance the stability of the spine. When muscles contract they create force and stiffness. It is the stiffness part that is important for stability. When the core fails to meet the stability demands placed on the body during a certain lift, parts of the spine will be overloaded with forces that increase injury risk and performance will suffer. For that, various warm up exercises, stretches and mobility exercises are performed so that the body can work as stable linked system that works efficiently as well.

Eligibility Criteria:
Inclusion Criteria:

* Middle aged school children between age 9 and 14.
* Both male and female.
* Back pain of 2 or greater on NPRS

Exclusion Criteria:

* Structural observational deformity (kyposis, lordosis, scoliosis)
* History of post spinal surgery
* Acute low back pain flare up
* Pain or any other injury of lower limbs
The Effects of Ashwagandha in Endurance Exercise Performance

Ashwagandha (Withania Somnifera) is a widely used herb in Ayurvedic medicine for vitality and rejuvenation. This study investigates the effects of both acute and short-term oral supplementation of Shoden (Ashwagandha extract) intake on performance and rate of perceived exertion in high-intensity aerobic and anaerobic exercise.

Only a few clinical trials have looked at the effects of Ashwagandha in exercise and training. The studies had a dosage of 2 x 300 mg \& 2 x 500 mg per day for 8 weeks and found to stimulate effects of strength training on muscle strength and muscle mass (Wankhede et al., 2015) and small increments in time to exhaustion and VO2max (Shenoy et al., 2012). However, the training intervention in both the studies were not adequately controlled and did not make a distinction between the acute and short-term effects of Ashwagandha intake.

Moreover, a lot of herbal supplements are commercially available containing majority of alkaloids and small amount of withaferine. European Food Safety Authority (EFSA) has categorized anaferine, anahygrine, withanine, sominiferine, somnine, tropine etc as toxic and harmful. Apart from alkaloids, withaferine A has also been categorized as cytotoxic lactones by EFSA. The Ashwagandha extract developed by Arjuna Natural Ltd is free from these alkaloids and is standardized to contain about 35% glycowithanolides.

This study will be a randomized, double blinded, placebo controlled, two treatment, crossover study and will be conducted in 2 phases ( acute \& short term) with a total of 5 identical test sessions. Each test session involves a maximal incremental cycling test followed by a 90-sec maximal cycling performance test (day 1), and a 30-min simulated time-triaI on a cycling ergometer (day 2). Day 1 and day 2 are separated by a 24hr rest interval and for each subject it will be consistently scheduled on the same time of the day in order to eliminate a potential impact of diurnal variation in the results.

Eligibility Criteria:
Inclusion Criteria:

* Males between 18 and 35 years old
* Physically fit and involved in physical fitness training, or in individual or team sport activity for 2-4hours per week, or 3-6 hours per week for cycling
* Body mass index between 18 and 25
* Good health status confirmed by a medical screening

Exclusion Criteria:

* Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise.
* Intake of any medication or nutritional supplement that is proven to affect exercise performance
* Intake of analgetics, anti-oxidants, or anti-inflammatory agents from 2 weeks prior to the start of the study
* More than 3 alcoholic beverages per day, including a maximum of one glass of wine per day
* Blood donation within 3 months prior to the start of the study
* Smoking
* Involvement in elite athletic training at a semi-professional or professional level
* Current participation in another research trial
* Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study

Egg allergy is common in early childhood, affecting at least one in 50 preschool children. Influenza ("'flu") vaccines contain egg protein, as the vaccine is cultured in hen's eggs. There is robust data to support the safety of influenza vaccines (containing low or negligible amounts of egg protein) in patients with egg allergy.

A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been approved by a number of licensing boards and is given by a spray into the nose. This new vaccine has been available in the United States for several years and is highly effective and against influenza infection, with an excellent safety profile in children without egg allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and there are NO published data on the safety of LAIV in egg-allergic children. In SNIFFLE 1 Study, 433 doses were given to 282 egg-allergic children; data is currently being analysed.

The objective of this multicentre study is to further assess the safety of intranasal LAIV in egg-allergic children, in order to demonstrate that these children can safely be given the new LAIV within a primary care health environment.


Eligibility Criteria:
Inclusion Criteria:

* Aged 2 - 17 years old
* Physician-diagnosis of egg allergy

Exclusion Criteria:

1. Clinical resolution of egg allergy
2. Contraindications to LAIV (notwithstanding allergy to egg protein):

   * Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
   * Previous systemic allergic reaction to LAIV
   * Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the site PI to confirm patient suitability
   * Children/adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids. NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
   * Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
3. Contraindication to vaccination on that occasion, due to child being acutely unwell:

   * Febrile ≥38.0oC in last 72 hours
   * Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional
   * Recent admission to hospital in last 2 weeks for acute asthma
   * Current oral steroid for asthma exacerbation or course completed within last 2 weeks
Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy

The purpose of this study is to determine whether ciliary body thickness increased in the presence of diabetic macular edema and whether it changed after pars plana vitrectomy.

A diabetic macular edema group consisted of diabetic patients who underwent PPV for diffuse diabetic macular edema. A epiretinal membrane group, a surgical control group, consisted of non-diabetic patients with epiretinal membrane who underwent pars plana vitrectomy. A healthy control was also included for the comparison of preoperative ciliary body thickness. Ciliary body thickness was measured using ultrasound biomicroscopy, and central macular thickness was determined using optical coherence tomography. The visual outcome, ciliary body thickness, and central macular thickness were compared between groups before and 1, 2, and 4 months after pars plana vitrectomy and the correlations between the central macular thickness and ciliary body thickness and best corrected visual acuity were determined.

Eligibility Criteria:
Inclusion Criteria for diabetic macular edema group:

* Diabetic macular edema with preoperative central macular thickness \> 300 μm on optical coherence tomography
* Macular edema that was not associated with an epiretinal membrane or traction membrane
* No combined traction retinal detachment or vitreous hemorrhage
* No signs of ocular inflammatory disease on preoperative examination
* Phakic eye
* An axial length between 22.0 mm and 25.0 mm

Exclusion Criteria for diabetic macular edema group:

* Patients with uveitis, inflammatory connective tissue disorders or a history of previous ocular surgery
* Long-term application of topical medication, a history of intravitreal steroid or anti-VEGF injection within 3 months before vitrectomy

Inclusion Criteria for epiretinal membrane group:

* Non-diabetic patients with an epiretinal membrane who were scheduled for vitrectomy
* No ocular or systemic disease other than epiretinal membrane

Inclusion Criteria for healthy group:

* No diabetes
* No ocular disease other than cataract
Blood Glucose Response to Meals of Varying Glycemic Index in Youth With Type 1 & 2 Diabetes

Research to date suggests that the selection of lower glycemic index foods, that is, foods provoking a slower, more sustained blood sugar response, may result in improved glycemic control in youth with diabetes. However, there is currently insufficient data to support practice recommendations. The purpose of this pilot study is to test the blood glucose response to low and high glycemic index meals in youth with diabetes using continuous blood glucose monitoring, and to determine whether the effect of glycemic index differs by regimen or diagnosis. In this pilot study up to 42 youth with type 1 diabetes or impaired glucose metabolism (elevated fasting glucose, insulin resistance, or type 2 diabetes) will participate in 5 days of continuous blood glucose monitoring during which they will receive both low and high glycemic index meals. Children will be provided with 1 full day of low glycemic index meals and 1 full day of high glycemic index meals in a supervised setting in randomized order. Each of these test days will be preceded by a standard evening meal and snack. Continuous blood glucose monitoring will also be conducted during regular food intake ad libidum away from the clinic, as well as during one day of instructed low glycemic meals at home. All food intake, insulin, and blood glucose self-monitoring will be recorded. While in the clinic, measures of satiety and acceptability of the food will also be obtained. Data analysis will include indices of blood glucose levels and variability.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with type 1 diabetes for a minimum of 1 year with insulin dose greater than or equal to 0.5 u/kg/day, or diagnosed with elevated fasting glucose, insulin resistance, or type 2 diabetes
* age 7 to 16

Exclusion Criteria:

* dietary restrictions that would preclude eating the study diet
* comorbid chronic illness requiring daily medical management
* comorbid major psychiatric diagnosis
* non-English speaking/writing
The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family

The purpose of this pilot study is to determine the feasibility of conducting a study of out-of-pocket costs and the long-term financial impact of allogeneic stem cell transplant.

Allogeneic hematopoietic stem cell transplantation (HSCT) is the indicated treatment for many life-threatening illnesses affecting both adults and children. Transplant recovery and late effects require long-term medical care. At the same time that the family faces a medical crisis, a resulting financial crisis may also be pending, but is often pushed to the background due to the necessity of first preserving life. A large proportion of patients undergoing HSCT incur significant financial burden from out-of-pocket costs and a decrease in household income. Predetermined variables, both medical and demographic, gathered at the pre-transplant clinical consultation have the potential to predict the patients at greatest financial risk. This study will describe both the out-of-pocket costs and the income changes that may result from HSCT to help patients and their caregivers have a clearer picture of these costs and develop a financial plan. Health care providers can utilize this information to better inform patients and connect them to resources.

Eligibility Criteria:
Inclusion Criteria:

1. Adult recipients and parents/guardians of pediatric (age 0-17 years) recipients of allogeneic HSCT
2. Recipient has a primary caregiver, who is a member of the recipient's household
3. Allogeneic HSCT using any donor cell source (related, unrelated, or cord blood)
4. Any age at HSCT
5. Diagnosis of primary disease for which HSCT is being performed must have been made within two years prior to transplantation
6. Adult recipients, parents/guardians of pediatric recipients, and primary caregivers should be able to read, write, and understand the English language
7. Signed informed consent from adult patient, caregiver and/or parent/guardian for study participation
8. Signed consent to participate in the Center for International Blood and Marrow Transplant Research (CIBMTR) research database.

Exclusion Criteria:

1. Recipients who have had a previous HSCT (autologous or allogeneic)
2. Households with more than one transplant recipient
An Exploratory Study Investigating Human Skin Reaction to Output

The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.

Six types of patches are tested:

Patch 1: Standard adhesive with own feces

Patch 2: Standard adhesive with own feces mixture

Patch 3: Standard adhesive with simulated feces

Patch 4: Standard adhesive with simulated feces mixture

Patch 5: Standard adhesive with buffer (control)

Patch 6: Standard adhesive with buffer feces mixture (control)

Each subject is randomized to one of two arms testing three patches on the peristomal skin (patch 1, 3 and 5 or patch 2, 4 and 6). Furthermore, within each arm an attempt will be made to randomize each of the three patches on the peristomal skin to one of three locations surrounding the stoma (upper left, upper right, lower). On the healthy contralateral abdominal skin the subjects test all six patches.

A run in period with 2 subjects (healthy volunteers) was conducted to clarify the length of the test period. They were exposed to 4 patches (patch 3-6) on healthy abdominal skin which was removed at 2 different time slots. Based on the results the test period was established

Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Have had an ileostomy for more than one year
* Have normal to slightly red skin on the area used in the evaluation
* Has an ileostomy with a diameter up to (≤) 35 mm
* Have a peristomal area accessible for applied patches (assessed by investigator)

Exclusion Criteria:

* Currently receiving or have within the past 2 months received radio- and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
* Are pregnant or breastfeeding
* Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
* Participating in other interventional clinical investigations or have previously participated in this investigation
Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?

Emergency medicine is notorious for its high rate of burnout and mental health issues. The emergency department (ED) is a high paced work environment dealing with life and death issues. Employees in the ED work shift times that are not conducive to a natural circadian rhythm. All of these factors lead to high rates of burnout and overall dissatisfaction with their career choice. These are known downsides of a career in emergency medicine, but little effort is put into addressing this issue in everyday EDs.

Cell phones offer an easy and convenient means to participate in meditation. There are multiple evidence-based meditation apps available to cell phone users free of charge. Meditation has been shown to decrease burnout, rates of depression, and rates of anxiety. We hypothesize that weekly use of a meditation-based cell phone application will improve the mental health of emergency department employees as measured on various wellness inventories.


Eligibility Criteria:
Inclusion Criteria:

* Employment in the Emergency Department (with at least 8 shifts a month at Dell Seton Medical Center or Seton Medical Center) as either an attending physician, resident physician, or nurse
* Age greater than/equal to 18 years old and younger than 75 years old
* Must own a mobile phone operating on the iOS system

Exclusion Criteria:

* Already use a phone-based meditation app on a weekly basis
* Currently undergoing psychological treatment in the form of weekly therapy or psychotropic medications
Cryotherapy and Body Slimming

The purpose of this study is to evaluate the efficacy of cryotherapy on the slimming of subcutaneous fat mass in the abdomen and saddlebags. Cryotherapy is a completely non-invasive method that induces a selective reduction of fat cells by localized and controlled cooling in areas such as the abdomen, flanks, inner knees, inner thighs, back and arms.

Adipose tissue is composed of two types of tissue: white and brown adipose tissue. Studies have shown that exposure to cold induces an increase in the number of brown adipocytes (detected by PET/CT-scan) under the effect of the hormone irisin produced by the muscles. In addition, another study has shown that prolonged exposure to cold reduces the size of brown adipocytes leading to thermogenesis, suggesting that cold exposure may contribute to the control of obesity.

The freezing technology of this cryotherapy unit allows the temperature of the subcutaneous adipose tissue to move almost instantaneously from -6°C to -10°C, gradually causing the reduction of subcutaneous adipose tissue.

Prospective, monocentric pilot and comparative (before and after) study in simple blind (assessor different from the operator).

* The effectiveness of cryotherapy will be evaluated by the metric measurement of the treated areas: waist circumference, from the hips to the level of the saddlebags.
* Measurement of subcutaneous fat mass with iDXA scanner on treated areas
* Metabolic parameters from a blood test: Liver function (AST, ALT, gamma GT), inflammatory markers, plasmatic fatty acids, glycerol, total cholesterol, triglycerides, lipids, blood sugar, insulin, lactate.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old and non-menopausal with a BMI between 20 and 30 (20≥IMC≤30), with an overload of abdominal subcutaneous fat tissue and at the saddlebags

Exclusion Criteria:

* - \< 18 years old.
* Pregnancy
* Breastfeeding
* Cold allergy: 2-minute ice cube test positive
* A waist/hip ratio indicative of a pathological fat distribution (\>0.8 for women, \>0.9 for men)
* Endocrine pathologies (Cushing's disease, endocrine tumours, unbalanced frank or labile hypothyroidism, hirsutism and hyper-androgenism, insulin resistance and/or unbalanced type 2 diabetes...)
* Neoplasia
* Psychiatric pathologies with or without treatment (Antidepressants, Neuroleptics, Anxiolytics...), well characterized anorexia-bulimia syndromes.
* Established alcoholism. Daily alcohol consumption should not exceed 2 glasses of wine per day.
* Digestive pathologies (especially hepatic) and functional digestive disorders (chronic constipation, alternating constipation-diarrhoea, chronic abdominal pain).
* Weaknesses of the abdominal wall (umbilical, inguinal, crural hernias)
* HIV in therapy
* Genetic deformities and diseases
* Vegetarian/vegetarian diet, macrobiotic diet
* Spasmophilia
* Surgery less than 3 months old
* Unbalanced coronary artery disease, untreated angina