cyrilzakka/clinical-trials huggingface dataset:
Seal Pressure With Classical Laryngeal Mask and Cookgas Mask in Adult Patients

The working hypothesis in this study is that the supraglottic device COOKGAS provides seal pressure as well or better than LMAc ™ when adult patients undergoing outpatient surgery, are sommeted to both interventions.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Patient ASA I, II and III
* Complete fast
* Ambulatory Surgery
* Time less than two hours surgically
* Supine Surgery
* Acceptance of informed consent

Exclusion Criteria:

* No acceptance of informed consent
* Pregnancy or breastfeeding
* Hemostatic alterations
* Abdominal surgery
* History of gastrointestinal reflux
* BMI over 35
* Mouth opening less than 1.5 cm
* Airway abnormalities
* Surgery in respiratory tract
A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis

The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis

The objectives of this study are to:

* Establish the safety and tolerability of once daily (QD) Aramchol meglumine in patients with PSC
* Examine whether once daily (QD) Aramchol meglumine has any effect on serum alkaline phosphatase
* Provide a comprehensive readout of clinical efficacy following once daily (QD) Aramchol meglumine administration

Eligibility Criteria:
Inclusion Criteria:

1. Male or female age 18 years and above (inclusive at first screening visit)
2. Established diagnosis of large duct PSC based on abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP) or Endoscopic retrograde cholangiopancreatography (ERCP)
3. Alkaline phosphatase \> 150 IU/l
4. Stable inflammatory bowel disease therapy \> 3months for IBD patients
5. If receiving treatment with Ursodeoxycholic acid (UDCA; ursodiol), therapy is at a dose of \<20 mg/kg/day, has been stable for at least 6 months before screening
6. Ability to understand the nature of the study and to sign a written informed consent form (ICF)

Exclusion Criteria:

1. Other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically
2. Active Crohn's disease (CDAI \> 40) or ulcerative colitis (Mayo IBD score \> 4) or active non-hemorrhoidal rectal bleeding
3. Small bowel resection \> 100 cm
4. Cirrhosis (clinically evident or by biopsy)
5. Prior hepatic decompensation event
6. Recent (\< 6 weeks) acute cholangitis or hospitalization for PSC or IBD
7. Bleeding diathesis or other contraindication for liver biopsy
8. Known GI or hepatobiliary malignancy
9. Prior liver transplantation
10. Prior exposure to study drug
11. Active untreated viral hepatitis or other concomitant liver disease
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors

This is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 for Phase 2 studies


Eligibility Criteria:
Inclusion Criteria:

* Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
* ECOG performance status 0-1
* at least 4 weeks between surgery or last dose prior anti-cancer therapy

Exclusion Criteria:

* symptomatic brain metastases
* any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
* uncontrolled or significant cardiovascular disease
* inadequate bone marrow, liver or kidney function
Machine leArning Based CT angiograpHy derIved FFR: a Multi-ceNtEr, Registry

Demonstrate in a large multicenter population the diagnostic performance of a pre-commercial on-site, local, CT angiography derived FFR algorithm in comparison to invasive FFR.

To retrospectively evaluate the diagnostic accuracy of FFRCT, in patients with known or suspected CAD. the investigators propose to do technical assessment of the software and evaluate how different parameters effect the outcome. Validate the FFTCT outcome by comparing the FFRCT values with invasive FFR values from retrospective patient data. To analyze the potential of FFRCT on decision making and prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Know or suspect coronary artery disease followed within 6 months by an invasive FFR measurement.

Exclusion Criteria:

* Cardiac event between coronary CT angiography and the invasive FFR procedure, noninterpretable coronary CT angiography image quality, or incomplete coronary CT angiography coverage.
Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Volunteers

DA-9701 is a new prokinetic agent formulated with Pharbitis Seed and Corydalis Tuber. These plants have been used in oriental traditional medicine for the treatment of gastrointestinal maladies. In a stage 3 trial, its' efficacy has been compared to that of itopride in functional dyspepsia patients and proved to have comparable safety and efficacy. However, its' exact effect on the gastrointestinal motility has not been completely elucidated. This study will study the effects of DA-9701 on the healthy adult gastrointestinal tract.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults of either sex, at least 20 years of age
* Having no abdominal discomfort or pain
* No diseases diagnosed by screening gastroduodenoscopy
* Having given voluntary written consent

Exclusion Criteria:

* Currently participating or having participated in another drug trial within four weeks of trial start.
* Women of childbearing age who are either pregnant, breast-feeding or not under proper contraceptive methods.
* A history of surgery which may affect gastrointestinal motility.
* Subjects with gastrointestinal bleeding, mechanical obstruction or perforation.
* Subjects with irritable bowel syndrome or inflammatory bowel disease.
* Subjects with serious conditions involving the liver, kidneys, heart, lung or endocrinology system.
* Psychiatric disease patients, substance abuse subjects such as alcohol or drugs.
* Subjects who have taken drugs that may affect the study outcome such as antibiotics, corticosteroids or NSAIDS within 1 month or motility agents, H2 receptor blockers, proton pump inhibitors, anticholinergics, erythromycin or antipsychotics within 2 weeks.
* Other reasons that the investigator considers valid.
An Exploratory Phase 1 Microdose Study of PRX-105

Exploratory phase 1, first in human, open label, non-randomized, single-dose study of PRX-105, administered intravenously by slow bolus injection to 10 healthy volunteers. The objective is to evaluate the pharmacokinetic profile of PRX-105 without any significant physiological effect in healthy volunteers after a single, intravenous microdose administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18-45 (inclusive) years.
* Body Mass Index (BMI) 19 to 29 kg/m2 (inclusive) and weighing at least 60 Kg and up to 90 kg.
* Non-smoking (by declaration) for a period of at least 6 months prior to screening visit.
* Blood pressure and heart rate within normal limits.
* Electrocardiogram (ECG) with no clinically significant abnormalities.

Exclusion Criteria:

* History of significant neurological (including history of seizures or EEG abnormalities), renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety, tension or agitation) or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medication.
* Current / previous occupational exposure to organophosphates or pesticides.
* Previous receipt of any investigational butyrylcholinesterase product.
Early Switch from Controlled to Assisted Ventilation

The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg).

The intervention is that participants will be switched from controlled to assisted ventilation when PaO2/FiO2 ratio \> 200 mmHg.

The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.

A crucial milestone in the trajectory of the mechanically ventilated patient is the switch from fully controlled mechanical ventilation to assisted ventilation. This switch should be made as early as feasible and safe, to limit the detrimental effects from prolonged controlled ventilation and sedation. However, there is also indirect evidence that excessive breathing effort during assisted ventilation may worsen lung injury (P-SILI). There are no guidelines that address this important switch moment.

Therefore, the overall aim of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg).

Participants will be switched from controlled to assisted ventilation switch when PaO2/FiO2 ratio \> 200 mmHg and will be monitored continuously using electrical impedance tomography, and oesophageal and gastric pressure until 4 hours post-switch and twice daily for 72 hours or until switch failure (switch back to controlled ventilation within 72 hours).

The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* Written informed consent from a legal representative
* Mechanical ventilation via an endotracheal tube
* Acute hypoxemic respiratory failure with PaO2/FiO2 ratio \< 200 mmHg
* Under continuous sedation with or without paralysis

Exclusion Criteria:

* Expected mechanical ventilation duration of \<48 hours
* Pure chronic obstructive pulmonary disease exacerbation
* Pre-existent respiratory muscle disease
* Contraindication to EIT monitoring (as per clinical protocol, e.g. pacemaker, burns or thoracic wounds limiting electrode placement)
* Contra-indications to oesophageal manometry (as per clinical protocol, e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders)
* Known pregnancy
* Anticipating withdrawal of life support and/or shift to palliation as the goal of care
Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis

This non-interventional study aims to identify key factors that are driving treatment decisions by rheumatologists in the treatment of rheumatoid arthritis (RA) patients starting treatment with Tofacitinib in a real world setting.


Eligibility Criteria:
Inclusion Criteria:

Patients aged ≥ 18 years

Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist

Patient is eligible for Tofacitinib treatment according to Summary of Product Characteristics (SmPC)

Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Contraindications according to Xeljanz® SmPC

Receipt of any investigational drug within 3 months before study inclusion

Patients who have received any previous treatment with Tofacitinib or other JAK inhibitors

Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the study.
Effect of Haemodialysis on the Efficacy of Antiplatelet Agents

The main purpose of our study is to investigate whether haemodialysis itself affects the efficacy of antiplatelet drugs and the effects of two different types of dialysis membranes (polysulfone membranes and polyamide membranes) on antiplatelet efficacy. A total of 60 patients with ESRD and under dual-antiplatelet treatmen for at least 5 days will be enrolled and divided into the Clopidogrel group (clopidogrel 75mg qd;aspirin 100mg qd, n=30) and the Ticagrelor group (ticagrelor 90mg bid; aspirin 100mg qd, n=30). All included patients will receive haemodialysis by two different types of dialysis membrane.Platelet aggregation of venous blood from all patients will be detected by LTA and VerifyNow immediately before and after two times of haemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of coronary heart disease including stable angina, unstable angina, acute myocardial infarction
* taking dual antiplatelet drugs (clopidogrel 75mg qd + aspirin 100mg qd or ticagrelor 90 mg,bid + aspirin 100 mg,qd) at least 5 days
* haemodialysis patients
* sign informed consent

Exclusion Criteria:

* platelet count\>450 × 10 9 /L or \<100 × 10 9 /L
* using IIb / IIIa inhibitor drugs within 10days
* taking nonsteroidal anti-inflammatory drugs other than aspirin
* hemorrhagic disease
* allergic to aspirin, ticagrelor or clopidogrel
* other factors may affect the results of this study
Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure

The primary objective of this study is to evaluation the success of endoscopic treatment of Zenker's diverticulum using a LigaSure device (thermal fusion of vessels) via a measure of swallowing function at 12 months post-surgery.

Our secondary objectives are:

A. To evaluate short-term (pain, fever, time to start of eating) and medium-term (weight, swallowing) post-operative parameters.

B. To evaluate the prevalence of post-operative complications.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up
* The patient has a Zenkers diverticulum as confirmed by a pharyngo-oesophagean transit test, regardless of van Overbeek classification

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient (or his/her person-of-trust) refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient does not read french
* The patient is pregnant
* The patient is breastfeeding
* The patients has a contraindication for a treatment necessary for this study, or for general anesthesia
* The patent has a history of complications related to hemostasis
* The preoperative checkup indicates potential for hemostasis related problems
Effects of Smoking and Vitamin D3 on the Levels of Human Cathelicidin Peptide LL-37

The aims of our study were 1) to evaluate levels of gingival crevicular fluid( GCF) human cathelicidin peptide LL-37 and serum vitamin D3 in smoker and non-smoker patients with chronic periodontitis(CP) 2) to determine whether any correlation between GCF LL-37 and vitamin D3 serum levels exist and 3) to asses the correlation between clinical parameters and biochemical markers

Background: Cathelicidin LL-37, an antimicrobial peptide, is part of the host innate immune response in the oral cavity. The aims of this study are to evaluate; gingival crevicular fluid (GCF) levels of LL-37, serum vitamin D3 levels and periodontal clinical recordings in smoker and nonsmoker patients with chronic periodontitis (CP).

Methods:

This study consisted a total of 60 volunteers including 20 smoker patients with CP (CP-1 group), 20 non-smoker patients with CP (CP-2 group) and 20 periodontally healthy subjects (CTRL group). Prior to participation, the design and purpose of the research were explained to each subjects, and written informed consent form was obtained from 60 individuals before the study.

The periodontal status of the patients were determined by measuring the probing depth (PD), clinical attachment level (CAL), gingival index (GI), plaque index (PI) All clinical parameters were measured on six sites per tooth from the full-mouth teeth (mesiobuccal, distobuccal,midbuccal, mesiolingual, distolingual and midlingual) using a William's periodontal probe calibrated in millimeters by the same examiner. All samples were obtained on the day following clinical examinations of the individuals. The deepest six pockets site per individual were chosen for collection of GCF across both of the periodontitis groups. Six pocket locations showing a lack of clinical inflammation were also tested to guarantee collection of a sufficient volume of GCF across the CTRL groups.

GCF levels of LL-37 were measured by ELISA and serum levels of vitamin D3 were analysed by High-performance liquid chromatography (HPLC). Statistical analysis were performed.

Eligibility Criteria:
Inclusion Criteria for chronic periodontitis groups:

* Clinical attachment loss ≥ 5mm
* Probing depth ≥5mm
* Bone loss affecting \>30% of the existing teeth on clinical and radiographic examination
* gingival index (GI) score\> 1

Inclusion criteria for control group:

* full-mouth PD was≤ 3mm,
* Gingival index \<1
* there was no indication of Attachment Loss or no radiographic evidence of alveolar bone loss in control group.
* Non-smokers.

Smoking criteria for groups:

* patients smoked more than 10 cigarettes in a day
* smoking for 3 or more years,

Exclusion Criteria:

* systemic condition (diabetes, cardiovascular disease, immunologic disorders, hepatitis, e.g.)
* pregnancy, lactation or menopause term,
* antibiotic treatment or non-steroidal anti-inflammatory medications within the last 3 months before the study,
* non-surgical periodontal treatment during the last 6 months before the study,
* treatment with Vitamin D supplementation before the study
A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers

This study is determines if metered dose inhalers are as effective as breath actuated nebulizers for the treatment of mild to moderate asthma exacerbations in pediatric patients presenting to the emergency department. Half of the participating patients received albuterol via the metered dose inhaler whereas the other half received albuterol via the breath actuated nebulizer.

Albuterol administered via metered dose inhalers with spacers are more effective than small volume nebulizers in the treatment of acute pediatric asthma exacerbations. There is also supporting data that the breath actuated nebulizers are also more effective than small volume nebulizers. The effectiveness of breath actuated nebulization compared to MDI for treating asthma exacerbations is less well defined.

Metered dose inhalers with spacers are more readily available to the general population, are easily transportable and do not require a power source. Demonstrating equal effectiveness of albuterol delivery systems for treatment of acute pediatric asthma exacerbations would enable physicians to confidently utilize clinical encounters as opportunities to educate families on management of asthma exacerbations using their home appliance.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting either with a first time wheeze or with an asthma exacerbation of a mild to moderate severity, both defined by a pediatric asthma score (PAS)11 of 5 to 11.

Exclusion Criteria:

* Subjects were excluded if they had initiated therapy at an outlying medical facility or had a history of any chronic lung disease
* Congenital heart disease, tracheostomy, or were receiving diuretic therapy.
* Patients diagnosed by the treating physician with bronchiolitis or pneumonia were excluded along with children who were wards of the state or whose parents did not speak English.
Computerized Eye-tracking Attention Training for Children With Special Needs

Children with special needs (e.g. autistic spectrum disorder, attention deficit hyperactivity disorder) are found to have sustained attention problems. Several behavioral interventions have been carried out in the past to improve this situation. However, these interventions are often involved a high administration cost. Recently, researchers have been focusing on training the eye gaze fixation using the eye-tracking training games, as some of the research studies reported a correlation between atypical eye gaze patterns with poor sustained attention. The objective of the present study is to evaluate the effectiveness of a computerized eye-tracking attention training. Two batches of 48 primary school students will be recruited from email and the subject pool of the Department of Psychology of The Chinese University of Hong Kong. Participants are dividedly randomly and equally into either intervention or control group. Participants in both groups will undergo pre- and post-assessments measuring the executive function and attention before and after the intervention, respectively. However, there will be eight eye-tracking training sessions for the intervention group, but only the assessments are received in the control group. It is hypothesized that after the training, the performance of the training games and assessments will improve, indicated by increasing accuracy rates, as well as the reaction time of the tasks. The results would provide important information on the value of computerized eye gaze training and would guide the direction of interventions that target on improving the sustained attention and impulse control of children with special needs.


Eligibility Criteria:
Inclusion Criteria:

* a total of 96 primary school children (aged between 6 to 12 years) with special needs, defined by psychological disorders such as ASD, ADHD, ADD, and Dyslexia

Exclusion Criteria:

* Children with mental retardation will be excluded