cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of the Effects of 4 vs 3 Hours of Preoperative Fasting in Breast-feeding Infants

In the new guideline from ESAIC breast-feeding should be encouraged until 3 hours before anesthesia. This recommendation was based mainly on gastric emptying studies in neonates with small sample sizes and single center experience.To address the lack of high quality evidence for this recommendation, the ESAIC task force for preoperative fasting plans perform a multicenter RCT omparing 4 vs 3 hours of preoperative fasting for breast milk.

The aim of the present pilot-study is to provide data for sample size calculation and feasibility for the multicenter trial.

Since the publication of several studies indicating that many children are subjected to unnecessarily long fasting waiting for surgery, there is great interest within the pediatric anesthesia community to understand gastric emptying to be able to revise existing guidelines. The new recommendation from ESAIC is that breast-feeding should be encouraged until 3 hours before anesthesia. This recommendation was based mainly on gastric emptying studies in neonates with small sample sizes and single center experience.To address the lack of high quality evidence for this recommendation, the task force plans to perform a multicenter RCT comparing 4 vs 3 hours of preoperative fasting for breast milk.

Twenty infants scheduled for elective surgery or procedures requiring general anesthesia or sedation will be recruited for this randomized controlled pilot study.

Based on the randomization, they are then asked to breast-feed (or bottle-feed with breast-milk) the child at 4 or 3 hours before the scheduled anesthesia induction.

On arrival to the operating room, the gastric ultrasound examination will be performed for analysis of the gastric antrum CSA. After i.v. or inhalational anesthesia, an oro-gastric catheter will be inserted and any residual gastric contents are aspirated when rotating the infant from supine to semi-prone right and left positions. The volume and color of the aspirate will be recorded.

The aim of the present pilot-study is to provide data for sample size calculation and feasibility for the multicenter trial.

Eligibility Criteria:
Inclusion Criteria:

- Breast-feeding infanta scheduled for elective procedure requiring general anesthesia

Exclusion Criteria:

* infant that does not breast-feed or is bottle-fed breast-milk
* Moderate to severe gastrointestinal motility disorder.
* Emergency surgery.
* Age \> 24 months or age \< 37 gestational weeks
* parents incapable of understanding the consent information due to language barrier
Mechanism and Dynamics of Bronchial Hyper-reactivity to Methacholine in Distal Airway on Obese Patients With Asthma

New insights of small airway contribution to asthma have been gained. Poor levels of control and recurrent exacerbations were shown to have the phenotypic counterpart of asthma with predominant small airway involvement. Very few pathological specificities were identified at this site: mast cells infiltration was suggested as the specific inflammatory change when compared to the proximal airways.Biomarkers in asthma are still complex to validate, especially in the blood, since compartmentalisation is intense in the lung and the airways, a property attributed to the filtering role of the lung to maintain homeostasis. Over the last few years, Fraction exhaled Nitric Oxide (FENO) was developed as a non-invasive and indirect reflection of airway eosinophilic inflammation\]. In the blood, peripheral eosinophil counts were shown as a correct T helper 2 (TH2)-phenotype identifier but not perfectly related to airway eosinophilic infiltration. Club cell secretory protein (SCGB1A1) levels have been shown to have some relevance in asthma, chronic obstructive pulmonary disease (COPD), BOS, sarcoidosis, and lung cancer.A biomarker for small airway disease in asthma may improve the management of the disease, identify areas of therapeutic resistance and constitute a therapeutic guidance tool. In this study, investigators aimed to assess small airway involvement in asthmatic women as far as they could. For this purpose, investigators analysed trends in air trapping by acquiring expiratory CT slices at each dose during a bronchoprovocation test with metacholine. Biomarkers were subsequently tested and confronted to clinical and demographical characteristics in their ability to predict the small airway involvement index obtained at CT.

Patients will be recruited in the respiratory department of University Hospital in Montpellier (France) from June 2012 to March 2014. All patients are asthmatics, in order to avoid any gender-related biases, investigators decided to include only women. All participants had normal range spirometry, specifically regarding forced expiratory volume. Each patient will undergo a bronchial provocation test coupled with a thoracic CT scan. Bronchial and alveolar Nitric Oxyde will also be measured, a blood sample will be obtained in order to measure biomarker concentrations, and the patients will be asked to answer the validated Asthma Control Questionnaire in order to quantify asthma control.

Eligibility Criteria:
Inclusion Criteria:

* Female \>= 18 yrs
* Asthma
* Treated with Inhaled Corticosteroid (ICS)
* normal range spirometry

Exclusion Criteria:

* Patients with other respiratory disease
* Patients with myocardial infarction (for 3 month before enrollment)
* Patients with cerebrovascular accident (for 3 month before enrollment)
* Patients with arterial aneurysm known
* Patients in pregnancy
* Patients nursing
Social & Contextual Impact on Children Undergoing Liver Transplantation

The social determinants of health have a large impact on health. For example, neighborhood socioeconomic deprivation is associated with increased risk of medication non-adherence, graft failure, and death in children after liver transplant. In order to address these socioeconomic inequities in outcomes, a more granular understanding of how the social determinants of health impact outcomes is needed. In this observational prospective cohort, caregivers of children undergoing liver transplantation will complete surveys and undergo in-depth, qualitative interviews. The survey will assess comprehensively for the social determinants of health (e.g. material economic hardship, health literacy, social connectedness, primary care quality, etc). The qualitative interviews will identify barriers and facilitators that socioeconomically deprived children/families have to obtaining the ideal outcome and identify health system opportunities to integrate social needs and medical care. Data will be linked to an existing prospective cohort study (The Society for Pediatric Liver Transplant registry) to assess the impact of social risk on outcomes after transplant.

Healthcare providers who take care of children undergoing liver transplant will also be included in the qualitative interviews. The goal of including this group in the study is to determine the health systems barriers and facilitators to social needs screening and intervention.


Eligibility Criteria:
Inclusion Criteria:

Caregivers/parents of children with the following criteria will be approached for inclusion in this study:

* Children \<18 years of age at the time of transplant
* Undergoing liver transplantation
* Guardian's consent, child assent (in accordance with each institution's IRB policies)
* Consents to enrollment in SPLIT

Exclusion Criteria:

Caregivers/parents of children undergoing liver transplantation will be excluded it:

* Caregiver unwilling or unable to complete the survey
* Child is a ward of the state (e.g., foster care) since present circumstances may not be reflective of child's past or future circumstances
* Non-English, non-Spanish speakers
* Non-US residents
* Declined participation in SPLIT

Inclusion Criteria for Interview Portion of the Study:

* Participants who have completed the questionnaire OR
* Medical team member involved in the care of children undergoing liver transplant (e.g., physician, nurse, social worker)
Novel Treatment for Port Wine Stain Birthmarks

Port wine stains Birthmark are congenital, progressive vascular malformations of the skin that occur in approximately 0.7% of newborns. Approximately 1.5 million individuals in the United States and 32 million people worldwide have Port wine stains birthmarks. Two-thirds of these malformations occur on the face. Personality development of virtually all patients is adversely affected as a result of the negative reaction of others to a "marked" person. Detailed studies have documented lower self-esteem and difficulties with interpersonal interactions in Port wine stains patients. Port wine stains are initially flat and red, but with time, they tend to darken to purple and become thickened as vascular nodules develop. This thickening occurs in approximately two-thirds of lesions and further disfigures the facial features of many patients.

Pulsed dye laser is currently the standard of care treatment for Port wine stains. Researchers at University of California Irvine at Beckman Laser Institute Medical Clinic can use Photodynamic therapy, another treatment option for Port wine stains. Photodynamic therapy involves light activation of a photosensitizer (a drug that is responsive to light or radiant energy). Because the photosensitizer can be localized to a desired portion of the Port wine stain, Photodynamic therapy creates an opportunity for targeted destruction of Port wine stains.

Researchers will use a photosensitizer medication called Talaporfin sodium, an intravenously administered investigational photosensitizer, being evaluated for multiple clinical indications. Photodynamic therapy with talaporfin sodium has been investigated for many different conditions, and can be used for treatment for Port wine stains. Photosensitivity precaution instructions will be provided, including appropriate photo protective clothing, protective hat and sunglasses that wrap around the temples to help minimize lateral sun light exposure when traveling home following discharge from the study site.

For efficacy, evaluated study variable will be Port wine stain blanching, and the researchers can use diffuse reflectance imaging chromametry, Laser Speckle Imaging and Spatial Frequency Domain Imaging to measure the change of Port wine stain blanching. The maximum power of the Laser Speckle Imaging and Spatial Frequency Domain Imaging light source is 10-50 mW, which is comparable to halogen-bulb household flashlights. Efficacy will be evaluated based on comparison of pre-treatment visit and post treatment day 1, week 1, week 4, and week 12 measurements.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female 18 years and older
* Have Port Wine Stain Birthmarks non-facial

Exclusion Criteria:

* Under 18 years of age
* No Port Wine Stain Birthmarks
* pregnant/breast feeding
Underwater Versus Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps

A prospective, randomized, controlled study to compare the efficacy and safety of underwater endoscopic mucosal resection and conventional endoscopic mucosal resection in removal of non-pedunculated colorectal polyps

* Patients are undergone colonoscopy at the Endoscopy department of Ho Chi Minh City University Medical Center.
* Randomize patients with non-pedunculated polyp of 10mm or larger in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Underwater endoscopic mucosal resection (UEMR) and (2) Group 2: Conventional endoscopic mucosal resection (CEMR).
* The time of local recurrence assessment depends on the histopathology of polyps. Polyps with low grade dysplasia are followed up at 6 months, while polyps with high grade dysplasia are followed at 3 months.
* Collecting variables which consist of primary and secodary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Non-pedunculated polyps of 10 mm or more in size
* Type 1 or 2 according to NBI International Colorectal Endoscopy (NICE) classification
* Patients must sign an informed consent form prior to registration in study

Exclusion Criteria:

* Lesions with signs of deep invasion (hard, friable tissue, poor mobility, positive "non-lifting" sign)
* Type 3 according to NICE classification
* Colorectal cancer
* Patients with unstable chronic disease (melitus diabetes, hypertension, heart failure, kidney failure, liver failure, chronic obstructive pulmonary disease)
* Hemostasis disorder (INR \> 1.5; platelets \< 100000/mm3)
Impact of Listening to Low Tones on Motor Function in Children With CP

The study aims to evaluate the impact of a possible new treatment for hypertonia, contributing to the motor disability in children with cerebral palsy (CP).

This study follows a 2005-2006 pilot study, that demonstrate a significant motor improvement in 4 children exposed to low tones via stereophonic Headphones.(A possible mechanism is a deep brain stimulation outspreading from the auditory pathways in certain tones) The goal of this study is to perform a double blind randomized placebo-controlled trial (RCT) on 30 children.

A three-arm study, with one group receiving the proposed treatment-music with low tones and the other two groups receiving a placebo (music without tones or stories) will be performed.

clinical and a non invasive laboratory measurements (surface EMG) related to spasticity, active and passive range of movement, isometric strength and upper and lower body function would be measured both before and after the treatment .the assessments will include also a Visual assessment , evaluation of gaze coordination and a quality of life and a caretaker burden questionnaires.

A pilot study we had done this year demonstrate a significant improvement in spasticity as measured clinically and by non invasive surface EMG, in four children with hypertonic CP, exposed to music combined with low frequency tones, via stereophonic headphones. Two children demonstrated a prompt motor improvement also.

The goal of this study is to perform a double blind randomized placebo-controlled trial (RCT) to assess these preliminary results.

participants: 30 children with moderate to severe hypertonic CP (GMFCS 3-5), aged 3-9 years, from the "Meshy" or "Ilanot" Early Childhood Development Centers - Jerusalem, Israel, will be recruited with parents informed consent. Children who refuse to put on the headphones will not be included.

A randomized controlled three-arm study, with one group receiving the proposed treatment-music with low tones and the other two groups receiving a placebo (music without tones or stories) will be performed.

The children will listen to the music / stories via stereophonic headphones for 10 minutes - 3 times a week for 4 weeks.

Before starting the treatment the children will undergo:

1. Neurological evaluation with their medical charts.
2. Physiotherapic evaluation using the GMFM assessment and a surface EMG
3. Fine motor assessment using the QUEST and visual assessments.
4. Parents will complete the PODCI and the Care and Comfort questionnaires.

We will repeat the EMG measurements immediately after the treatment.

3 months after completing the treatment we will repeat the measurements we had done before treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypertonic cerebral palsy
* ages 3-12 years

Exclusion Criteria:

* refusal to put on headphones
Analysis of Radiological Features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch Sign

Analysis of Radiological Features of Lateral Femoral Impaction Fracture (LFC-IF) / Lateral Femoral Notch Sign will be performed on MRIs of consecutive patients after anterior cruciate ligament (ACL) injuries and without ACL injuries.

Two independent measurers will twicely measure the radiological features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch Sign on MRIs of consecutive patients after anterior cruciate ligament (ACL) injuries and without ACL injuries. In cases without ACL injuries, radiological features of terminal sulcus (TS), a native sulcus located on the lateral femoral condyle, will be measured. Intra- and inter-rater agreements will be calculated.

The following radiological features will be assessed/ measured:

1. Presence of LFC-IF/ TS
2. LFC-IF/ TS depth
3. LFC-IF/ TS length
4. Distance from Blumensaat line to the front border of LFC-IF / TS
5. Distance from Blumensaat line to the deepest part of LFC-IF / TS
6. Distance from Blumensaat line to the rear border of LFC-IF / TS

Eligibility Criteria:
Inclusion Criteria:

* Performed knee MRI with or without ACL tear

Exclusion Criteria:

* Osteophytes hindering assessment of LFC-IF/ TS morphology
* Morphological disturbances hindering assessment of LFC-IF/ TS morphology
A Study to Evaluate Effectiveness and Safety of Ponatinib in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"

The purpose of this study is to evaluate the effectiveness and safety of ponatinib (Iclusig®) in patients with BCR-ABL positive acute lymphoblastic leukemia (ALL) in standard clinical practice in Europe.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with BCR-ABL (Ph+) positive ALL who are initiating Iclusig®, or for whom Iclusig® was initiated after January 2015.
* Patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures.

Exclusion Criteria:

* Patients previously treated with investigational ponatinib.
* Patients who are pregnant and/or breastfeeding.
* Concurrent treatment with another tyrosine kinase inhibitor for Ph+ALL.
Evaluation of EFficacy and SaFEty of Leukotac (Inolimomab) in Pediatric Patients With SR-aGvHD

A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)


Eligibility Criteria:
Inclusion Criteria:

* Patients who develop a first episode of aGvHD stage ≥ II (Przepiorka et al., 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose)
* Age 28 days to \< 18 years old
* Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
* Patients receiving Allo-HSCT for any indication (i.e. malignant or non-malignant disease)
* Signature of informed and written consent by the patient and/or by the patient's legally acceptable representative(s)

Exclusion Criteria:

* Isolated stage 1 skin SR-aGvHD
* Overlap chronic GvHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
* Acute GvHD after donor lymphocytes infusion (DLI)
* Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
* Other systemic drugs than corticosteroids for GvHD treatment (including extra-corporeal photopheresis). Drugs already being used for GvHD prevention (e.g. calcineurin inhibitors) are allowed.
* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
* Known allergy or intolerance to Leukotac of one of its ingredients
* Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female and male of childbearing potential
* Other ongoing interventional protocol that might interfere with
Examination of Potassium Levels in Saliva in ESRD Patients

Dialysis patients typically undergo 3 treatments a week every other day with an almost 3 day gap during the weekend. After this gap and before the first dialysis of the week the serum Potassium level is expected to be maximal.

Participants will be recruited from the dialysis clinic at Hadassah Ein Kerem Hospital. The research team would personally meet the patients who answer inclusion criteria f and ask whether they wish to participate.

Each willing participant will undergo Sialometry and blood will be drawn from the dialysis connections for CBC and Biochemistry to establish a baseline.

The study measurements namely Sialometry and collection of Saliva as well as blood test will be taken before the initiation of the dialysis.

Blood testing will be done via the laboratories of the Hadassah hospital. Saliva analysis will be done in the research lab of Prof. Doron Aframian.


Eligibility Criteria:
Inclusion Criteria:

* Present a predialysis serum potassium level over 5 mmol/L.

Exclusion Criteria:

* Pregnancy

Patients diagnosed with a pathology of the salivary glands such as Sjogren's syndrome, Sialosis, Sialadenitis.

Patients who have received previous radiation therapy to the head and neck region
Efficacy and Safety of Neosil on Chronic Effluvium

The purpose of this study is to evaluate the efficacy of Neosil in the treatment of chronic effluvium


Eligibility Criteria:
Inclusion Criteria:

* Participants who present hair loss for more than 6 months;
* Do not use other possible cosmetic or dermatological treatments, during the trial;
* Not change the diet during the trial and not be any restrictive diet during this period.

Exclusion Criteria:

* Pregnancy or risk of pregnancy and lactating patients;
* Use of any products to promote hair growth within the 6 months prior to the Baseline Visit;
* History of hair transplants;
* Current skin disease;
* History hypersensitivity to the active ingredients used in the study;
* Participation in clinical trial in the year prior to this study;
* Known history of non controled systemic disease (diabetes, hypertension, anemia, iron deficiency, and others);
* Gastric diseases;
* Smoker;
* History of systemic disease (HIV, non specify autoimmune disease, hepatitis, and others).
ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY (AMPORA)

This is a multi-institution, randomized, non-inferiority Phase II trial comparing external beam radiotherapy delivered as 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily with external beam radiotherapy delivered as 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Able to provide informed consent
3. Histologic diagnosis of prostate adenocarcinoma
4. ECOG performance status 0-1
5. Previous radical prostatectomy \> 6 months prior to radiotherapy start date
6. Planned to receive post-operative radiation

Exclusion Criteria:

1. Prior pelvic radiotherapy
2. Contraindications to radiotherapy
3. Mets confirmed as per (if scan has been done for clinical care)
4. Participants with visible disease in the prostate bed or pelvic lymph nodes on imaging are not eligible for treatment on study.