cyrilzakka/clinical-trials huggingface dataset:
The Cricoid Pressure in Pediatric Patients

Because the cricoid force in children has not been quantified, clinicians wrongly used the 'adult' force. it has been found that the use of the adult force can result in compression and distortion of the child's airway and can lead to airway obstruction and difficult intubation. Based on known measurements of the cricoid surface area in children, the theoretical forces necessary to occlude the esophageal entrance have been calculated . These forces were found to be much less than the recommended adult force and much less than the forces that distort the airway as reported previously. Based on these theoretical calculations, the current study was performed to determine the effective cricoid force for pediatric groups (group 1 and group 2).

120 children ASA I or II undergoing different surgeries scheduled to undergo procedures requiring general anesthesia and endotracheal intubation were enrolled in this protocol group1 (40 pts, age 3-5 ysr) group 2 (40 pts,6-8 yrs) and group 3 ( 40 pts, 9-13 yrs) .Following applying of ASA standard monitoring and placement of peripheral iv cannula maximal preoxygenation was achieved (end-tidal oxygen \> 90%), and anesthesia was induced with propofol 2 mg/kg, fentanyl 1-1.5 µg/kg and sevoflurane in oxygen/air mixture. Cisatracurium or rocuronuim was given to maintain muscle relaxation. Gentle mask ventilation was begun following an oropharyngeal airway placement. CP was applied by the same anesthesiologist in all patients with his back toward the video monitor. The cricoid cartilage was first identified and then held between the thumb and middle finger and the pressure was applied by the index finger with a force to facilitate the manual ventilation. After loss of consciousness, the force was increased to the predertmined force. The applied cricoid force in successive patients was determined by the response of the previous patient within the same group, using Biased coins up-and-down method in each group. The adjustment force interval was 1 N. Successful insertion of the GT with the adjusted force, was considered ineffective CP and the force was increased 1 N for next patient. Conversely, an unsuccessful GT insertion with the adjusted cricoid force was considered effective CP, and the force was decreased 1 N for the next patient. Tracheal intubation was performed with the appropriate size endotracheal tube while using the same cricoid force, initially tested, and the surgical procedure was begun.

Eligibility Criteria:
Inclusion Criteria:

Age : 3-14 years ASA 1,2 Easy Identification cricoid cartilage No contre indication of CP

Exclusion Criteria:

* ASA 3, 4
* Difficult intubation
* Obese patients
* Contre indication of CP
Mitigating ACEs in Pediatric Primary Care: Cohort #2 With 6-24 Month Old Children

The aim is to determine if a brief intervention can affect parents' attitudes about physical punishment and other parenting behaviors.

A public health problem that needs to be solved is how to educate more parents about healthy discipline options. The investigators aim to mitigate adverse childhood experiences (ACEs) by integrating evidence-based parent training into pediatric primary care. Some of the most modifiable ACEs are associated with parenting behaviors that can lead to child abuse. The investigators define unhealthy parenting behaviors such as spanking, threatening, yelling, and humiliation. For adults in the original ACEs study, it was exposure to these behaviors that led to the categorization of child abuse/neglect and that were associated with heart disease, obesity, depression, smoking, drug use, violence, and many other problems. This study may help change policy and practice related to mitigating ACEs in primary care. To accomplish this goal, randomized controlled trials are needed to test brief screening tools and evidence-based resources. A population-based approach is needed to reach all parents (i.e. primary prevention). In the study, parents in the intervention group will receive 3 minutes of education about healthy discipline strategies.

Eligibility Criteria:
Inclusion Criteria:

* Parents of 6 month to 2 year old children presenting to the Vanderbilt Pediatric Primary Care Clinic for a well visit or an acute care visit.

Exclusion Criteria:

* Parents who do not speak and read English, Spanish, or Arabic. The interventions are only available in English, Spanish, and Arabic.
Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis

The purpose of this study is to determine whether Magnetic Marker Monitoring is an appropriate opportunity to diagnose and to quantify a suspicious gastroparesis in subjects with diabetic polyneuropathy.


Eligibility Criteria:
Inclusion Criteria:

* age \> 50 years
* written informed consent
* Diabetes mellitus (only Diabetes mellitus group)
* Symptoms of diabetic gastroparesis with respect to nausea, postprandial fullness, abdominal pain, nausea, vomiting, abdominal bloating, early satiety, erratic blood glucose levels and weight loss evaluated by a standardized questionnaire (only Diabetes mellitus group)
* actually measured HbA1c (only Diabetes mellitus group)

Exclusion Criteria:

* Subject who is pregnant or breast feeding.
* Subject unwilling or unable to comply with study requirements.
* Any investigational agent or participation in another clinical trial within 28 days prior to randomization
* Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
* History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.
* Known allergy to the investigational product, to any of its excipients
* Active inflammatory bowel disease, serious gastric ulceration or other bowel diseases like e.g. coeliac disease
* Implanted cardiac cardioverter-defibrillator or cardiac pacemaker
* Stenosis or stricture of gastrointestinal tract or any surgery in this region except for cholecystectomy or appendectomy
* Long-term medication with drug, that influence gastrointestinal motility (opiate, opioids, erythromycin, metoclopramide, laxatives) \< 3 days before randomisation and before magnetic marker monitoring
Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure.

The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.

63 eligible subjects who are allocated for a diagnostic screening colonoscopy were enrolled in the study. The assignment of the level of the bowel preparation agent was according to the physician decision. Following preparation, enrolled subjects were intubated and cleansed using a standard colonoscope with the Motus GI CleanUp device attached to it. At the end of the procedure, subjects were followed through discharge and at 48 hours post procedure for occurrence of adverse events.

40 subjects were enrolled under protocol Rev 1.0 used Motus GI CleanUp System Rev 1.0 31 subjects were enrolled under protocol Rev 2 used Motus GI CleanUp System Rev 1.5, due to improvement made to the study device including the following:

1. One head that irrigates and evacuates instead of two heads
2. Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while keeping the same flow rate.
3. System adjustment to the above changes including updated software version.

Eligibility Criteria:
Inclusion Criteria:

* Subjects in the age range of 50-69 years
* Subjects who are considered for routine screening colonoscopy
* Subjects with BMI within the range of 18.5-30
* Subject is willing to sign informed consent form

Exclusion Criteria:

* History of G diseases or history of Colorectal cancer (personal or family)
* Previous major abdominal surgeries
* Medical status ASA grater or equal to 3
* Acute Gl symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (lBD).
* Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)
* Life-threatening condition
* Subjects who are unable or unwilling to cooperate with study procedures
* Severe Diverticula
Clinical Efficacy and Safety of Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis

This is a randomised, double-blind, placebo-controlled, international, multicentre, confirmatory Phase III study in patients with grass pollen-related allergic rhinoconjunctivitis. After having given written informed consent, the patients will be examined to establish eligibility according to inclusion/exclusion criteria. The eligible patients will be randomised to Placebo or gpASIT+™ treatment according to a 1:1 ratio. Study treatment will be administered before the start of the pollen season in 2019


Eligibility Criteria:
Inclusion Criteria:

* Allergy diagnosis:
* A clinical history of moderate to severe grass pollen-induced Seasonal Allergic Rhinoconjunctivitis (SARC) for at least 2 pollen seasons, requiring treatment with either antihistamines or nasal corticosteroids during the 2017 and 2018 grass pollen seasons and with symptoms interfering with usual daily activities or with sleep, as defined according to Allergic Rhinitis and its Impact on Asthma (ARIA) classification of rhinitis (Bousquet et al. 2001)
* A positive Skin Prick Test (SPT) (wheal diameter ≥3 mm) to grass pollen mixture, histamine wheal ≥3 mm, sodium chloride (NaCl) control reaction \<2 mm AND
* Specific IgE against grass pollen ≥0.7 kU/L. 6)
* For asthmatic patients, confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA; 2018)

Exclusion Criteria:

* Diagnosis of mastocytosis;
* Previous (within the last 5 years) immunotherapy with grass allergens;
* Ongoing immunotherapy with grass allergens or any other allergens;
* Patients with any history of anaphylaxis due to any cause;
* Patients with a history of hypersensitivity to the excipients of the investigational product;
* Patients with a forced expiratory volume in 1 second (FEV1) \<80% of the predicted value (European Community for Steel and Coal) or with a peak expiratory flow (PEF) \<70% of the individual optimum value at the Screening visit;
* History of being intubated with mechanical ventilator support or in intensive care unit for asthma at any point in the patient's life;
* History of emergency visit or hospital admission for asthma in the previous 12 months;
* Clinical history of moderate to severe allergic rhinitis, as defined according to the ARIA classification of rhinitis, due to tree pollen near or overlapping the grass pollen season;
* Clinical history of moderate to severe allergic rhinitis as defined according to the ARIA classification of rhinitis caused by an allergen to which the participant is regularly exposed;
Neuroimaging of Patients With Severe Knee Osteoarthrosis - Evaluation of Cerebral Volumetry

Due to scarce published articles about this subject, the researchers aim to study the volume measurements of the brain cortex of patients with primary severe knee osteoarthrosis and those with chronic knee pain compared to healthy and non-symptomatic volunteers, correlating the neuroimaging of cerebral volumetry with pain intensity, pain duration, knee function and pressure pain threshold.

The protocol was designed to include 31 patients in each observational arm, either patients with severe knee osteoarthrosis and chronic knee pain or healthy and non-symptomatic volunteers.

The researchers performed anamnesis to collect clinical and demographic information, the intensity of pain was assessed by the self-rated Visual Analogue Scale (VAS), the pressure pain threshold was evaluated with an algometer, the knee function was assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale and the images were collected with the use of the Magnetic Resonance.

Covariates, such as age, gender, Body Mass Index (BMI) and comorbidities as diabetes, cardiac diseases, pulmonary diseases, endocrine diseases and the practice of physical activities were also collected.

Eligibility Criteria:
Inclusion Criteria:

* Age above 60 years old;
* Both genders;
* Clinical diagnosis of knee osteoarthrosis;
* Self-rated VAS moderate to severe (VAS \> 4);
* Pain duration longer than 3 months prior to the evaluation;
* Signed Informed Consent;
* Light physical activity practice or sedentary (healthy volunteers only).

Exclusion Criteria:

* Presence of psychiatric disorders;
* Presence of fibromyalgia;
* Presence of rheumatologic diseases;
* Presence of previous knee surgery;
* Presence of clinical symptoms (healthy volunteers only);
* Presence of knee pain on the previous 6 months (healthy volunteers only);
* History of neoplasia.
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of the following for Acute Myeloid Leukemia (AML)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. ECOG 3 is allowed if participants are 18 to 74 years old with comorbidities
* Agree to serial bone marrow aspirate/biopsies

Exclusion Criteria:

* Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype
* Received prior hypomethylating agent (HMA) therapy for myelodysplastic syndromes/Chronic myelomonocytic leukemia then develop AML within 4 months of discontinuing the HMA therapy
* Prior history of malignancy unless the participant has been free of the disease for ≥ 1 year prior to the start of study treatment

Other protocol-defined inclusion/exclusion criteria apply
Premedication to Reduce Discomfort With Screening Mammography

This study will explore the effect of pre-medication with acetaminophen, ibuprofen, and topical lidocaine gel (Topicaine) on the perception of discomfort and overall satisfaction with the mammography experience.

The research questions are:

1. What is the relationship between the use of acetaminophen, ibuprofen, and Topicaine prior to screening mammography and the perception of discomfort during the procedure?
2. What is the relationship between perception of discomfort and overall satisfaction with the mammography experience?
3. What is the relationship between the perception of discomfort and plans for future mammograms?
4. What other factors are associated with the perception of discomfort and satisfaction?

Breast cancer is prevalent, deadly, costly, and has low cure rates unless detected in its early stages. Mammography is the key component to early detection, yet it remains underutilized due to cost, access, and factors such as fear of pain.

Multiple studies have shown that most women find mammography uncomfortable, even painful. Yet, little research has been done to find methods to reduce mammography-related discomfort. In an unpublished Master's thesis, this investigator found that women who expected discomfort \> 40 on a visual analog scale (VAS) who were pre-medicated with 1000 mg of acetaminophen reported lower discomfort scores than those pre-medicated with placebo, but the sample size was too small to reach statistical significance. Further study on the effects of pre-medication is needed.

Pain should not be associated with a potentially lifesaving procedure. A more comfortable and positive experience with mammography may increase the number of women who participate in regular mammography screening, and, thereby, increase early detection and reduce the mortality rate, costs, and emotional trauma associated with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Women scheduled for age-appropriate screening mammography at St. Luke's Breast Cancer Detection Center
* Expect discomfort of 40 or greater on a scale of 0-100
* Willing to arrive 1 hour early for appointment to enroll in study

Exclusion Criteria:

Women who:

* expect discomfort from their mammogram to be \< 40 on a scale of 0-100
* cannot understand or read English or who are unable to complete the consent process or questionnaire for reasons such as hearing impairment or other physical or mental disabilities
* have a sensitivity or allergy to acetaminophen, ibuprofen, or lidocaine
* have significant liver or kidney dysfunction
* are breast-feeding
* cannot arrive a minimum of 60 minutes earlier than their appointment time
* have taken any pain relief medications within 24 hours of their mammogram appointment, including over-the-counter medications.
The Effects Probiotic Has on Gastromicroecology and Combined With Quadruple Regimen for H Pylori Infection

This study assesses the efficacy and safety of treatment with two-week probiotics followed by a 10-day tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for H. pylori infection. Eradication was evaluated using the 13C-urea breath test at 4 weeks after the end of therapy, and side effects were recorded. Besides study gene-level changes in the gastric microbiota following use of probiotics.

Currently the infection rate of H. pylori is high. H. pylori infection has a close relationship with human diseases , Among the patients with H. pylori infection, 100% have active gastritis, \<10% show H. pylori related dyspepsia, 15%\~20% develop into peptic ulcer, \<1% ultimately evolve into gastric malignant tumor. H. pylori gastritis has been defined as an infective disease. Eradication of H. pylori plays an important role in the cure, reversal and delay of these diseases.

With the widespread eradication of H. pylori, antibiotics resistance rates are increasing seriously. The resistance of antibiotics results in the increase of H. pylori eradication failure rate. Choosing a safe and effective scheme for patients who have failed multiple times is a challenge for the clinicians.

Besides, both domestic and international consensuses point that the application of some probiotics can reduce adverse effects through regulating gastric microenvironment, and it is still controversial about whether probiotics can inhibit H. pylori to increase the eradication rate.

Investigators previously retrospectively analyzed 30 patients with H. pylori eradication failures at least two times given two-week compound Lactobacillus acidophilus followed with 10-day tetracycline- and furazolone- containing quadruple regimen, the ITT eradication rate was 92.1%, and 94.6% PP analysis. Side effects were mild mainly including dizziness, dry mouth and skin rash occurred in eight patients.

Eligibility Criteria:
Inclusion Criteria:

* All included patients were 18 to 70 years-old; negative for the urea breath test at least 4 weeks after last eradication treatment; and experienced at least 2 H. pylori eradication failures.

Exclusion Criteria:

* Patients were excluded if they presented with a severe comorbidity or a malignant tumor; had a known history of allergy to the drugs in the therapeutic regimen; used nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotic therapy, or bismuth salts up to 4 weeks before study inclusion; or were pregnant or breast-feeding.
PREMIER: PREvention of Metabolic Illness Through PrEcision NutRition

Dietary intake is a major driving force behind the escalating obesity and type 2 diabetes epidemics. Large, high-quality clinical trials have shown that close adherence to healthy dietary recommendations significantly reduce the incidence of obesity and type 2 diabetes, especially among people at increased risk. However, large inter-individual variability exists in response to dietary interventions. To inform more effective obesity and type 2 diabetes prevention strategies, it is crucial to better understand the biological, environmental, and social factors that influence how people interact and respond to specific foods.

In a recent large-scale genome-wide association study, our research team has identified 96 genomic regions associated with overall variation in dietary intake. This study provided evidence that inherited molecular differences are likely to impact on food intake (i.e., preference for certain foods) and metabolic homeostasis (i.e., glucose regulation). Connecting knowledge about human genetic variants with information from circulating metabolites can be particularly useful in understanding the mechanisms by which some people experience a detrimental response to specific foods.

The specific objective of the PREMIER study is to carry out an interventional dietary study to measure the response of blood glucose and other biomarkers to a standardized meal, and evaluate the extent to which food choices differ among individuals with distinct genetic susceptibility.


Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* 21-65 years of age.
* Body mass index (BMI) between 18.5 and 30.0 kg/m2.
* Healthy (free of diagnosed diseases listed in the exclusion criteria).
* Willing to comply with the study intervention.
* Able to provide informed consent

Exclusion Criteria:

* Refuse or are unable to give informed consent to participate in the study.
* Have type I or type II diabetes mellitus or are taking medications for type II diabetes mellitus. Those not on medications but having a capillary glucose level of \>126 mg/dL based on fingertip glucose measurements will be excluded.
* Are obese (BMI\>30.0kg/m2) or underweight (BMI\<18.5kg/m2).
* Have had a heart attack (myocardial infarction) or stroke
* Have had cancer in the last 3 years, excluding skin cancer.
* Have an ongoing inflammatory disease i.e. Rheumatoid arthritis, systemic lupus erythematosus, polymyalgia and other connective tissue diseases.
* History of cirrhosis and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times the upper limit of normal (ULN).
* Are currently suffering from acute clinically diagnosed depression.
* Currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids or fluoroquinolones.
* Are unable to fast from 9pm the night before the clinic visit until 9am on the clinic day
* Are pregnant or breastfeeding.
* Are participating in another clinical study.
* Are vegan, suffering from an eating disorder or unwilling to eat foods that are part of the study.