cyrilzakka/clinical-trials huggingface dataset:
Supraglottic Airway Devices in Pediatric Difficult Airway Situations

The purpose of the study is to compare three supraglottic airway devices (Combitube, Easytube, laryngeal mask airway) to endotracheal intubation in a simulated difficult airway scenario in a pediatric manikin.

Supraglottic airway devices (SAD) have been designed for the "cannot intubate, cannot ventilate" scenario in prehospital as well as intrahospital settings and are utilized in medical emergency services and emergency departments all over the world, not only for anticipated and unanticipated difficult airway situations but also as an airway device used by non-anesthesiologists or in situations where only limited practice is possible. Securing an airway in a pediatric emergency situation is crucial. Unfortunately, pediatricians usually lack the required skills and regular practice to perform endotracheal intubation (ETI, which is the gold standard for securing an airway) quickly and safely. SADs would pose a safe and feasible alternative to ETI. However, no studies on this topic are available. The investigators therefore wanted to evaluate three different SADs (Combitube, Easytube, laryngeal mask airway) in simulated difficult airway situations in a pediatric manikin in comparison to ETI.

Eligibility Criteria:
Inclusion Criteria:

* pediatricians
* residents
* interns
* written informed consent form

Exclusion Criteria:

* none
Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction

The goal of this clinical randomized controlled trial is to perform primary percutaneous stenting (PPS) in patients with malignant hilar biliary obstruction (MHBO). The main question it aims to answer is:

To compare the efficacy of PPS above the ampulla to standard endoscopic biliary drainage (EBD) in patients with a MHBO who are ineligible for surgical resection.

Researchers will compare PPS with EBD to see if major complications within 90 days after randomisation occur.

Participants will undergo either primary percutaneous stenting or endoscopic biliary drainage, depending on randomization.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be given according to ICH/GCP and national/local regulations.
* MHBO on imaging with histopathological confirmation or high clinical suspicion.
* Ineligible for surgical resection.
* Hyperbilirubinemia (a combination of a total bilirubin level \>50 mmol/l.

Exclusion Criteria:

* Fluctuation or spontaneous decrease of a total bilirubin level before start of any treatment suggesting a potential non-malignant diagnosis.
* Patients who underwent previous biliary drainage procedures endoscopically or percutaneously. Patients who underwent an attempted but failed ERCP are eligible only when no papillotomy or cannulation was performed.
* Clinical signs of cholangitis. Cholangitis is defined as the presence of both fever (i.e. body temperature \>38.5°C) and leucocytosis (i.e. ≥10 \*109/L) without clinical or radiological evidence of acute cholecystitis (22).
* Uncorrectable coagulation disorder.
* Uncorrectable contrast allergy.
Genetics of Charcot-Marie-Tooth Dystrophy and Related Diseases

This is a cross-sectional study to clarify the gene lineage distribution of CMT genes in CMT patients in my country, draw a frequency map of CMT gene distribution, and assist in determining the genetic diagnosis strategy of CMT diseases. All patients will be collected for clinical and electrophysiological data. Patients and families who meet the enrollment criteria will be tested for blood tests.

\[Background\] Peroneal muscular atrophy (Charcot-Marie-Tooth, CMT) is a group of the most common hereditary peripheral neuropathy, with a prevalence of about 1/2500-4000. The inheritance mode can be autosomal dominant inheritance, autosomal recessive inheritance, X-linked dominant inheritance and X-linked recessive inheritance. The typical clinical manifestations are progressive, length-dependent weakness and atrophy of the distal limbs, accompanied by hypoesthesia and weakened tendon reflexes. But the generalized peroneal muscular atrophy also includes hereditary motor neuropathy and hereditary sensory neuropathy, which represents the evolution of a disease spectrum from motor nerve to motor sensory nerve and sensory nerve, collectively referred to as CMT and its related diseases. CMT can be divided into demyelinating type (CMT1), axonal type (CMT2) and intermediate type. There are more than 80 kinds of genes discovered so far, and genetic diagnosis plays a vital role in the treatment of peroneal muscular atrophy and genetic counseling.

\[Purpose\]

1. To clarify the gene lineage distribution of CMT genes in CMT patients in my country, draw a frequency map of CMT gene distribution, and assist in determining the genetic diagnosis strategy of CMT diseases;
2. Discover new mutations and newly published types of known genes, and perform gene-phenotype correlation analysis
3. Perform whole-exome sequencing on some families that have not been clearly diagnosed to find new pathogenic genes or related genes of CMT, so as to enrich the genetic and clinical types of CMT.

\[Design\] This is a cross-sectional study. All patients will be collected for clinical and electrophysiological data. Patients and families who meet the enrollment criteria will be tested for blood tests. The inspection strategies are as follows: (1) Use MLPA method for PMP22 gene Duplicate or deletion mutation check (charge); (2)) Use high-throughput sequencing method to detect the currently known gene panel (gene panel) (charge); (3) Check the process (1) and (2) Some patients and families whose disease-causing genes have not been detected by the inspection methods are tested by whole-exome sequencing (scientific research, free of charge).

Eligibility Criteria:
Inclusion Criteria:

* Meet the clinical diagnostic criteria of peroneal muscular atrophy; Sign informed consent

Exclusion Criteria:

* Those who have recently received blood transfusion treatment will not be able to collect blood samples.
Bougie Use in Emergency Airway Management

This prospective, open-label trial randomizes adult patients intubated in the ED with a Macintosh blade to use or not use a bougie for the first intubation attempt. The primary outcome is first pass success.

The primary analysis for all outcomes will be for those with a difficult airway characteristic (defined as any of: cervical immobility, obesity, large tongue, short neck, small mandible, facial or neck trauma, airway edema, blood in the airway, or vomit in the airway).

We will also analyze all outcomes for all patients enrolled, regardless of whether they have a difficult airway characteristic.

We plan to enroll 374 patients with a difficult airway characteristic (DAC). The total enrollment for the trial will be higher, depending on the proportion of patients that have a DAC.

Based on observational data, we aim to detect a 9% absolute difference in first pass success (95% with bougie compared to 86% without the bougie), which requires enrollment of 374 patients with a DAC.

To help achieve balanced randomization for patients with a DAC, patients are stratified into two groups: 1) obese or cervical immobilization present and 2) not obese and no cervical immobilization.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must be undergoing orotracheal intubation in the ED with a Macintosh blade (using either video or direct laryngoscopy)
2. The patient must be presumed to be 18 years of age or older at the time of enrollment.

Exclusion Criteria:

1. Known anatomic distortion of the upper airway or perilaryngeal structures.
2. Prisoner or under arrest
3. Known or suspected to be pregnant, based on the opinion of the treating physician.
Study to Evaluate Performance, Usability, Safety of Microwave Technology When Collecting Data From Patients With Stroke

This is a prospective, open, multicenter study that will enroll patients admitted to and hospitalized at the Stroke Unit due to diagnosed stroke and healthy volunteers.

The main purpose of the study is to evaluate the ability of the Microwave Technology to deliver adequate measurement data.

After written informed consent has been acquired a physical examination will be performed followed by confirmation of the inclusion/exclusion criteria. After subject enrollment the microwave measurement will be performed. The procedure will take approximately 15 minutes (the duration of the actual measurements is \< 1 minute) and will not interfere with the patient's standard of care at the Stroke Unit.

The measurement data will be evaluated for the presence of signal artifacts. The diagnostic ability of the device will be evaluated using a leave-one-out cross validation method with the CT diagnosis as ground truth. Microwave signals are sensitive to the dielectric parameters of the investigated object. In biological matter this is often related to amount of water. Brain tissue has different dielectric properties from blood. The physiological changes inside the brain that occurs as a result of a stroke will change the dielectric parameters.

Eligibility Criteria:
Inclusion Criteria:

(Group A)

* Signed Informed Consent Form
* Patient diagnosed (by CT) with ischemic stroke, within 24 hours of stroke onset
* Patient should be ≥ 18 years of age

(Group B)

* Signed Informed Consent Form
* Patient diagnosed (by CT) with hemorrhagic stroke, within 48 hours of stroke onset
* Patient should be ≥ 18 years of age

(Group C)

* Signed Informed Consent Form
* Subject should be ≥ 18 years of age

Exclusion Criteria:

(Group A+B)

* Pregnant or nursing woman
* Woman of child bearing potential and not taking adequate contraceptive precautions
* Patient that has already received thrombolytic treatment
* Patient participating in any other clinical study that could interfere with the result in the present study
* Patient diagnosed with a condition associated with risk of poor protocol compliance
* Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgment
* Any patient that according to the Declaration of Helsinki is deemed unsuitable for study enrollment

(Group C)

* Pregnant or nursing woman
* Woman of child bearing potential and not taking adequate contraceptive precautions
* Subject participating in any other clinical study that could interfere with the result in the present study
* Any other condition or symptoms preventing the subject from entering the study, according to the investigator´s judgment
* Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment
An Extension Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in dry eye patients with Sjögren's syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Dry eye patients with Sjögren's syndrome finished KCT1301 study

Exclusion Criteria:

* Patients with poor adherence to medication of study drug in KCT1301 study
Effect of Leg Elevation on Prevention of Intraoperative Hypotension During Beach Chair Position

The aim of this study is to evaluate the effect of leg elevation on the prevention of intraoperative hypotension during shoulder surgery in the Beach-chair position. patients undergoing shoulder surgery in the Beach-chair position will be randomly assigned to Group L (with leg elevation) or Group C (no intervention). The primary outcome is the incidence of intraoperative hypotension (mean blood pressure \< 60mmHg or systolic blood pressure \< 80% of baseline). Secondary outcomes are the incidence of intraoperative cerebral desaturation (cerebral oxygen saturation \< 80% of baseline, longer than 30 seconds), total amounts of administered inotropic agents, and systolic blood pressure, heart rate, and cerebral oxygen saturation at various time points.


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing shoulder surgery in the beach chair position

Exclusion Criteria:

* Patients with myocardial infarction
* Patients with pacemaker
* Patients with cerebrovascular disease
* patients with arteriovenous fistula at the opposite arm
* Patients with autonomic nerve disorders
* Patients with hip or knee joint disorder limiting hip or knee flexion
* BMI \> 30 kg/m2
Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease

Pulmonary arterial hypertension (PAH), or high blood pressure in the lungs, is common in patients with congenital heart disease. Historically these patients suffered significant morbidity and mortality due to a lack of effective therapies. More recently, advanced therapies which target the mechanisms underlying the development and progression of PAH have been introduced into clinical care. Oral, intravenous, subcutaneous, and inhaled therapies are all available for the treatment of PAH. Patients with PAH are first treated with oral agents (including sildenafil and bosentan). However, if these agents fail to achieve the desired effect for the patient, intravenous or inhaled therapies may be initiated. Combination therapy with multiple agents is common in routine clinical care. However, the most efficacious therapeutic regimen has yet to be delineated. The present study seeks to evaluate the efficacy of one specific regimen: iloprost, an inhaled prostacyclin derivative, used in combination with oral therapy (sildenafil and/or bosentan). Iloprost has been approved by the FDA for use in this patient population. Adults with PAH already receiving oral therapy will be invited to participate in this study. Iloprost will be added to their current therapeutic regimen for a period of three months, with pre- and post-treatment assessments. These will include a cardiopulmonary exercise test, BNP (a blood test), six minute walking distance, and a quality of life questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old
* Congenital heart disease with pulmonary arterial hypertension and cyanosis (resting oxygen saturation \< 90% on room air)
* Stable on oral therapy (PDE5 inhibitor and/or endothelin blockade) for at least three months

Exclusion Criteria:

* Age \< 18 years old
* Current intravenous or subcutaneous prostacyclin therapy
* Resting Systemic Hypotension (Systolic blood pressure \< 85 mmHg)
* Women who are pregnant or may become pregnant (unwilling to utilize effective contraception), as well as nursing mothers
* Inability to ambulate
* Planned surgical procedure during the study period
Cohort Study of the Clinical Course of Macular Diseases in Japanese

Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic macular edema (DME), and so forth.

Patients with such macular diseases are registered and and are followed up for 5 years with appropriate treatment for each patient. By the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.


Eligibility Criteria:
Inclusion Criteria:

* Patients who visit Department of Ophthalmology Kyoto University Hospital with macular diseases.
* Patients who are agreed with the participation of this study.

Exclusion Criteria:

* None
Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment

Aims: To identify the predictors associated with smoking cessation in smokers under treatment for alcohol and/or cannabis treated in drug treatment centers (DTC). Methodology: Mixed methods project with qualitative and quantitative designs (three studies). Study I discussion groups: of clinical professionals of DTC to explore the barriers/facilitators of these smokers in quitting and the interventions carried out. Study II Prospective cohort of smokers in alcohol and/or cannabis treatment that will be followed-up for 12 months. Sample size: difference in incidence (exposed to cessation interventions versus non-exposed = 12 per 100 years), α = 0.05, β = 0.10, losses = 20% (n = 726). Dependent variables: self-reported and verified tobacco consumption abstinence, quit attempts, motivation, and self-efficacy. Independent variables: age, sex, the substance under treatment. Analysis: incidence, relative risk and simple and multiple logistic regression models (odds ratio and confidence interval, CI, 95%) of quitting. Study III discussion groups: with smokers under alcohol and/or cannabis treatment selected according to their typology. Analysis: of thematic content and triangulation qualitative and quantitative results. Expected results: Characterization of variables that influence tobacco cessation, to improve the design of interventions.


Eligibility Criteria:
Inclusion Criteria:

* Smokers (at least 1cig./week)
* Undertreatment for Cannabis and/or Alcohol Abuse for the first time
* \>=18 years-old
* Under clinical follow-up
* Informed consent

Exclusion Criteria:

* Severe cognitive impairment
* 12-month follow-up not guaranteed
Effects of HypnoBirthing Training and Oxytocin Massage in Primiparous Pregnants

This study was conducted to determine the effects of hypnobirthing training and oxytocin massage on birth and postpartum period in primiparous pregnant women.

Hypnobirthing is a birth philosophy and method that prepares women physically and psychologically for giving birth. It is important to break the fear-tension-pain cycle in HypnoBirthing training. Because the continuity of the cycle increases the pain related to birth, and as the pain increases, the fear increases. In this case, the duration of labor is prolonged, birth success, shape, preference, course and satisfaction are negatively affected. Therefore, this training helps to reduce pain and fear related to labor and increase labor satisfaction. Similarly, it has been determined in the literature that oxytocin (back massage) massage during pregnancy increases uterine contractions, reduces labor pain and duration of labor, accelerates postpartum uterine involution, significantly increases the amount of breast milk, and increases mother-baby attachment. The pregnant education role of the health professional is an effective factor that shapes the birth experience of pregnant women. For this purpose, health professionals in the world and in our country are actively involved in pregnancy education programs in which different methods are applied. The most common ones are Lamaze, Bradly and HypnoBirthing. These trainings also serve to reduce pain and fear related to childbirth, increase labor and postpartum satisfaction, and meet the need for professional support and education of pregnant women. When the studies on HypnoBirthing training and oxytocin massage are examined in the literature, it is noteworthy that there is a very limited number of studies. Therefore, there is a need for well-designed randomized controlled trials that can create a level of evidence for HypnoBirthing training and oxytocin massage.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the ages of 18 and 45,
* Able to communicate verbally,
* Being in the 36th week of pregnancy,
* Having a single fetus,
* Being nulliparous

Exclusion Criteria:

* Pregnant women at risk
* Multiparous pregnant women
The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy

Each year a large number of patients undergo ileostomy surgery, a procedure in which a portion of the small intestine is attached to a hole in the abdominal wall, allowing for digested material to pass into a disposable bag worn attached to the skin. Ileostomies are performed for the treatment of a variety of diseases of the intestinal tract, such as inflammatory bowel disease, intestinal trauma, and gastrointestinal malignancy. Of the patients that undergo ileostomy surgery, 36% will require urgent medical care within the first 30 days of surgery. Most frequently, this is a result of dehydration due to excessive ostomy output. Thus, there is potential for significant improvement of the post-operative outcomes of ileostomy patients. Implementation of an automated text messaging system, EpxOstomy, can provide a way of monitoring patient's daily ostomy output and allow for timely intervention if output is outside normal limits, providing an effective way of improving patient outcomes while simultaneously reducing healthcare costs.

Each year thousands of patients undergo ostomy surgery in the treatment of diseases such as colorectal cancer, Crohn's disease, diverticulitis, and ulcerative colitis. During the 30-day post-operative period, patients that undergo ileostomy have a 36.1% rate of acute healthcare encounter compared to 16.2% of patients undergoing similar surgery but with primary anastomosis. The 30-day hospital readmission rate for ileostomy patients due to dehydration and renal failure is 17%, with the median cost per colorectal surgery readmission being $8,885. Thus, there is substantial room for post-operative improvement in the care of ileostomy patients, both to reduce healthcare costs and improve patient quality of life. An automated text messaging system can provide a way to consistently monitor patients' ileostomy output, ensuring that patients are measuring their daily output as instructed and allowing for timely preemptive intervention should output be outside normal limits.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-90 years of age with phone or text receiving device access.
* English speaking
* Patients undergoing ileostomy surgery

Exclusion Criteria:

* Patients who do not have phone or text receiving device access
* Patients mentally unable to provide consent for the study
* Patients who do not speak English
Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes

Based on previous promising results, the next step for the validation of a multimodal MRI method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to test whether the multimodal neuroimaging is able to discriminate at the individual level, patients with multiple system atrophy parkinsonism (MSA) and patients with idiopathic Parkinson's disease (PD) (ii) to determine whether the method is sensitive to measure changes over time for the two diseases, according to imaging, neuropsychological and other clinical data. Patients will be compared with healthy controls.

30 patients with PD, 30 patients with MSA and 30 healthy controls will be examined in a 3Tesla MRI.

The aim of our project is to demonstrate that our multimodal MRI method can discriminate both diseases with a similar clinical presentation and monitor the progress of the disease. CIC's expertise in recruitment and assessment of patients, and the powers of the INSERM U825 in terms of development and processing in neuroimaging guarantee the feasibility of the project and its successful completion.

Eligibility Criteria:
Inclusion Criteria:

* informed consent signed
* right handed patients
* Mini Mental Score \> 22
* no other neurological disease than Parkinson's Disease (PD) or Multiple System Atrophy (MSA)
* non-demented patients reached by PD or MSA (according to diagnosis criteria from UK PD Brain Bank and from Gilman and colleagues, 1998, for PD and MSA respectively)
* for PD patients only : Hoehn and Yahr score from 2 to 3

Exclusion Criteria:

* claustrophobia
* contraindications to MRI (cardiac or auditive prothesis, pacemakers, cerebral clip, stimulating electrodes)
* pregnant women
* major neuropsychiatric disease
* refusal to be informed in case of cerebral anomaly detected during MRI acquisition
* uncompensated thyroid deficit