cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms.

The aim of our study is to provide data on the efficacy and safety of endoscopic papillectomy, by including consecutive patients treated after 2015, when first guidelines on endoscopic management of ampullary neoplasms were available.

Ampullary neoplasm (AN) is a rare disease, but its incidence is increasing. In the last 20 years, endoscopic papillectomy (EP) has become the gold standard treatment for ampullary adenomas and early stage adenocarcinomas, thereby replacing surgical resection, which is burdened by higher rates of morbidity and mortality. However, the data supporting safety and efficacy of EP derive from multiple retrospective studies, that included procedures mostly performed before 2015, when first guidelines on endoscopic management of AN were available. This had an impact on large variability in patient selection criteria and endoscopic techniques, resulting in heterogenous outcomes. Therefore, the aim of our study is to provide data on the efficacy and safety of this technique, by including consecutive patients treated after the standardization of this technique.

All patients who underwent EP at 19 Italian centers between January 2016 and December 2021 were included. Clinical success was defined by the complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period. EP-related adverse events and recurrences were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Ampullary neoplasm, confirmed by histological examination of the endoscopically resected specimen

Exclusion Criteria:

* Absence of dysplasia on the resected specimen;
* Locally advanced or metastatic disease (Clinical TNM stage \>T1 or N+ or M+);
* Neoplasm Intra-Ductal Extension (IDE) \> 20 mm;
* Previously treated ampullary neoplasm.
Endocardial Mapping with the CoreMap EP Mapping System

This is a global, multi-site, prospective, feasibility study.

The INvENI Study consists of three phases. For Phase 1, the goal is to collect and analyze high fidelity endocardial electrograms (EGMs) in patients with persistent and long-standing persistent AF. For Phase 2, the goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System. For Phase 3, the goal is the evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate both chronic safety and effectiveness in de novo PerAF patients.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has persistent or long-standing persistent AF, at the discretion of the investigator
2. Subject is 18 to 80 years of age
3. Patient scheduled for standard of care AF ablation
4. Subject is able to provide written informed consent
5. Subject is able and willing to complete all study procedures

Exclusion Criteria:

1. Any of the following within three months of enrollment:

   1. Myocardial infarction (MI)
   2. Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
   3. Confirmed thrombus on imaging
2. Any of the following within six months of enrollment: a) Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy b) Thromboembolic event (stroke)
3. Any of the following cardiac conditions:

   1. New York Heart Association (NYHA) IV
   2. Left ventricular ejection fraction (LVEF) \< 30%
   3. Carotid stenting or endarterectomy
   4. Atrial or ventricular septal closure or left atrial appendage closure
   5. Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator
   6. Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
   7. Unstable angina
   8. Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
   9. Moderate to severe mitral valve stenosis or other severe valvular disease
   10. Any blood clotting or bleeding abnormalities
4. Contraindication to systemic anticoagulation
5. AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
6. Body mass index (BMI) \> 40 kg/m2
7. Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition
8. Renal failure requiring dialysis or transplant
9. Acute illness, active systemic infection, or sepsis
10. Active drug or alcohol dependency
11. Any contra-indication that may extend procedure time, at the discretion of the operator
12. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
13. Subject considered part of vulnerable population
14. Life expectancy less than one year
15. Employee of the study site or Sponsor
16. Subjects who are currently enrolled in another study that would directly interfere with this study
A Pilot Study Using Laser Speckle Imaging of Neonate Cerebral Vasculature

The researcher want to know whether reflections of light can be used to provide real-time pictures of blood vessel formation around infants' heads. This approach is called laser speckle imaging

This study involves imaging of superficial blood vessels in the infant's head. Analysis of reflected light images provides the type of data necessary to see the blood vessels.

The researcher want to assess only feasibility of our instrument. If we determine that our instrument has sufficient spatial resolution to image directly large vessels, then we will proceed with plans for a larger study with statistical power.

Eligibility Criteria:
Inclusion Criteria:

* newborn

Exclusion Criteria:

* non-new bron
A Study Comparing the Supraglottic Airway Devices and Endotracheal Tube During Controlled Ventilation for Laparoscopic Surgery

In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery.

The lungs were ventilated at tidal volumes (8mL/kg) using volume controlled. After that, we wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal volume, peak airway pressure and mean airway pressure.

In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during volume controlled ventilation in laparoscopic surgeries.

In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery.

Our patient receive i-gel or endotracheal tube by draw. These patients were Included by the criteria:1.ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent.

The excluding criteria was: 1.presence of any significant lung, heart, brain disease 2. pathology of the neck or upper respiratory tract 3.Potential difficult intubation 4.an increased risk of aspiration, ex:gastroesophageal reflux, full stomach,Obese (BMI\>30), and pregnant woman, who were confirmed by patient history and medical chart.

Preoxygenation was maintained for three minutes to avoid bag and mask ventilation. Anesthesia was induced with the routine medication, such as lidocaine、 propofol, fentanyl and cisatracurium. The i-gel or endotracheal tubes were inserted. The lungs were ventilated at the tidal volume (8mL/kg) using volume controlled. After that, we wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal volume, peak airway pressure and mean airway pressure.

In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during volume controlled ventilation in laparoscopic surgeries.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent.

Exclusion Criteria:

* presence of any significant lung, heart, brain disease
* pathology of the neck or upper respiratory tract
* Potential difficult intubation
* an increased risk of aspiration, ex:gastroesophageal reflux, full stomach,
* Obese (BMI\>30),
* pregnant woman, who were confirmed by patient history and medical chart
Assessing Dietary Requirements in Relation to Resting Metabolic Rate in Spinal Cord Injury

Assess the relationship between body composition, metabolism, and dietary needs in people with spinal cord injury compared to their healthy controls that are age and sex matched.

This study will quantify body composition and resting metabolic rate and then compare these parameters to results from a nutritional analysis. Participants will have two study visits that include physical exam, blood draws, resting metabolic rate, Dual Energy X-ray Absorptiometry (DXA) scan, and dietary assessments.

Eligibility Criteria:
Inclusion Criteria:

1. C4-L2 motor complete (AIS A \& B) Spinal Cord injury for duration greater than 12 months.

4. \<5% change in body in body weight over the past 12 months 5. Fluent in written and spoken English

Exclusion Criteria:

1. \<22% body fat
2. Coronary artery disease
3. Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus (fasting glucose\>126 or HgbA1c\>7.0)
4. Hypothyroidism, and/or renal disease
5. Decisional impairment
6. Prisoner
Amoxicillin Challenge for Penicillin Allergy Diagnosis

False diagnosis of penicillin allergy are frequently reported, and have been proven detrimental to patients. Current guidelines for the assessment of drug allergies recommend that penicillin allergy be evaluated first with prick and intradermal skin tests, and then completed with a graded oral challenge, spread over at least two doses. However, it has been shown that these skin tests, in addition to consuming resources and time, are of limited, or even doubtful validity, given the poor predictive values that have been reported in the modern penicillins era. It now seems unreasonable to continue their use without addressing other, more efficient diagnostic stategies. Several groups have now demonstrated the safety, validity, and efficiency of a direct, two-step amoxicillin oral challenge (starting with 10% of the standard therapeutic dose, followed by 90 % of the dose), without prior skin tests, first for any type of reaction in the pediatric population, then for any non-immediate reaction in the adult population. The objective of this study is to demonstrate the safety, efficiency, and validity of direct, two-step graded oral challenge with amoxicillin for the evaluation of any reported penicillin allergy in the adult population, excluding high-risk patients (documented anaphylaxis to a penicillin in the last 5 years). Skin tests will first be performed according to the protocol currently in use at the CHUL, then consented patients will proceed with the graded oral challenge still according to the protocol currently in use at the CHUL, but regardless of the skin tests results. The results of the two tests will be compared to determine the safety, efficiency and validity of proceeding directly to the graded oral challenge.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older at the time of the test
* Being referred by a health professional for the evaluation of any allergic reaction to a penicillin, including natural penicillins, anti-staphylococcal penicillins, aminopenicillins, penicillins combined with a beta-lactamase inhibitor, and carboxypenicillins ; or an antibiotic of the beta-lactam family, whose assessment requires testing for penicillins, according to the treating allergist

Exclusion Criteria:

* Pregnancy
* Poorly controlled asthma, chronic lung disease or heart disease
* Failure to stop beta-blockers prior to the test
* Occurrence of the reaction in the 4 weeks preceding the test (possibility of false negatives)
* History of severe delayed hypersensitivity reaction, reaction requiring hospitalization of more than 24 hours, or bullous, pustular, exfoliative or mucosal reaction (excluding angioedema)
* Recent anaphylaxis (\<5 years), defined as concomitant involvement of at least two systems (respiratory, digestive, mucocutaneous or cardiovascular) within one hour of administration of the drug
Immediate Pain Relieving Effects of Sinbaro-3 for Low Back Pain

The purpose of this study is to investigate the immediate pain relieving effects of sinbaro-3 pharmaco-acupuncture in patients with low back pain admitted for inpatient care

60 patients with LBP with moderate to severe pain(NRS\>6) were randomly allocated to 2 groups. The experimental group was treated with sinbaro-3 pharmacoacupuncture and the control group was treated with Hwangryun pharmacoacupuncture. All administrations were limited to 1 session, and comparisons of measurements were made before and after treatment. Primary outcomes were measured using the VAS scale. Post-treatment follow-up will be performed to measure primary outcomes at 30 minutes, 2hours, 4hours, and 6 hours after treatment. Before and after each measurement, the patients are asked to stand up and rotate their torso. At termination of the study, satisfaction levels of the patient's current status will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to a Korean Medicine hospital for low back pain with or without radiculopathy
* Age between 18 and 69
* NRS score of \>6 on the day of the intervention
* Voluntary participation with written consent given to study consent form

Exclusion Criteria:

* Diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc.
* Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.
* Progressive neurologic deficit(s) or concurrent severe neurological symptoms
* Unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc.
* Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher
* Experience of gastroenteric complications after taking NSAIDs or currently undergoing treatment for digestive disorders
* During pregnancy or suspected pregnancy
* Subjects considered unsuitable for clinical trial by the researcher
EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions

Solitary pulmonary nodule are a diagnostic dilemma. Nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. Therefore more tissue is necessary. With a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy.

Until now, the use of the cryoprobe ism´t show in peripheral lung tissue.

Eligibility Criteria:
Inclusion Criteria:

* solitary pulmonary nodule \< 4 cm
* no endobronchial lesion
* indication for bronchoscopy

Exclusion Criteria:

* coagulopathy
* pulmonary hypertension
* pregnancy
Perspectives on CPPD Outcome Domains

The purpose of this study is to obtain patient and stakeholder perspectives on what outcome measures should be included in future trials on CPPD (Calcium PyroPhosphate Deposition), a common form of inflammatory arthritis. This will form part of a wider OMERACT (Outcome Measures in Rheumatology) study, involving multiple international sites, to determine a core domain set (an agreed set of outcome measures) for this disease.

In the UK, up to 10 patients with CPPD and their caregivers, healthcare professionals who care for patients with CPPD, and other stakeholders, which may include government organisations, non-government organisations, pharmaceutical representatives and health advocacy groups, will be invited to participate in a single, semi-structured interview.

Interviews will be face-to-face or telephone, last up to one hour and digitally audio-recorded. For patients and their caregivers, interviews will explore their lived experience of CPPD, its impact on their daily lives, and the perceived relevance of outcome measures used in previous studies. For healthcare professionals and other stakeholders, interviews will explore their experience dealing with patients with CPPD, how they perceive CPPD impacts patient lives, and the perceived relevance of the outcome measures used in previous studies.

Following analysis of the data, participants will be sent a short report with the researchers' findings, and asked to check the accuracy of these and provide brief written feedback.

Interviews will also take place with patients, caregivers, healthcare practitioners and stakeholders at the other international sites where ethics committee approval will be sought locally. It is anticipated that around 30 participants will be recruited across all sites. Analysis of all interviews will be primarily conducted and managed at the UK site.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* People with a diagnosis of CPPD of any form and/or their caregiver (includes acute CPP crystal arthritis (pseudogout), chronic CPP crystal arthritis, crowned dens syndrome, and osteoarthritis with CPPD)
* Ability to give informed consent
* Age over 18 years

Healthcare professionals:

* A healthcare professional (nurse, GP or hospital doctor) who cares or has cared for patients with CPPD

Other stakeholders:

* Government organisations, non-government organisations, pharmaceutical representatives and health advocacy groups

Exclusion Criteria:

* Dementia
* Terminal illness
* Unable to give informed consent
* Stroke with receptive or expressive dysphasia
* Severe enduring mental illness
* Autoimmune rheumatic disease such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout
* Total joint replacement in the previous 3 months
Evaluation of the BRAINDEX Brain Monitor in Cardiac Surgery, Interventional Comparative Study

The main objective of this study is to show the concordance of the SctO2 values of the ARGOS platform with the standard SctO2 values (comparative study with platform INVOS, Medtronic).

SctO2 values from ARGOS and INVOS will be resampled every 30 seconds. The two signals will then be resynchronized and compared on a sample-by-sample basis using a Pearson correlation test. Bias and agreement limits will be assessed using Bland \&amp; Altmann graphs. This test will be carried out for the entire duration of the recording.

Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, over 18 years of age
* Patient scheduled for cardiac surgery with programmed extracorporeal circulation (ECC)
* Patient with no history of scalp injury or or skin diseases
* Patient with an Euroscore 2 of less than 7%.
* Patient affiliated or entitled to a social assurance

Exclusion Criteria:

* Weight under 40 kg
* Frontal surface too small to allow application of SctO2, BIS electrodes on the same hemifront
* Patient with severe, unbalanced hypertension
* Measurement of systolic blood pressure (SBP) \&gt; 180 mm Hg and/or diastolic blood pressure (DBP) \&gt; 110 mm Hg
* Patients undergoing emergency surgery
* Patient with chronic renal failure, with glomerular filtration \&lt; 30 ml/min/1.73m², or requiring renal transplantation or requiring renal transplantation
* Patient with left ventricular ejection fraction \&lt; 40%
* Patient with a history of ischemic stroke
* Patients with preoperative sepsis
* Patient requiring noradrenaline infusion noradrenaline infusion in the 24 hours prior to surgery
* Patient with preoperative uni or bilateral carotid stenosis bilateral carotid stenosis \&gt; 50%.
* Protected patient: adult under guardianship, curatorship or legal protection, deprived of liberty by judicial or administrative decision.
* Pregnant, parturient or breast-feeding women.
* Patients hospitalized without consent.
The Median Effective Dose (ED50) of Paracetamol and Morphine : A Study of Interaction Study

The aim of our study is to define the median effective analgesic doses (ED50) of paracetamol, morphine, and their combination and determination the nature of their interaction administered IV for postoperative pain after moderate painful surgery using up-and-down and isobolographic methods.

Ninety patients scheduled to undergo moderately painful surgery were included in one of three groups. Determination of median effective (ED50) doses was performed by the Dixon and Mood up-and-down method. Initial doses were 1.5g and 5mg, with dose adjustment intervals of 0.5g and 1 mg, in the paracetamol and morphine groups, respectively. The initial doses of paracetamol and morphine were 1.5g and 3mg, respectively in the paracetamol-morphine combination group with dose adjustment intervals of 0.25g for paracetamol and 0.5mg for morphine. Analgesic efficacy was defined as a decrease to less than 3 on a 0-10 numeric pain scale, 45 min after the beginning of drug administration. Isobolographic analysis was used to define the nature of their interaction.

Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status І or ІІ
2. Moderately painful surgery patients
3. postoperative pain more than 3 on a numerical pain score (NPS) -

Exclusion Criteria:

1. contraindication to the use of paracetamol and morphine
2. Pregnancy
3. age younger than 18 yr
4. patient weight less 65kg
5. intra-operative regional anesthesia,
6. intra-operative administration of analgesics other than fentanyl,
7. postoperative pain less than 3 on a numerical pain score (NPS)
Gut Microbiota and Stool Frequency

We hypothesized that some difference in the composition and distribution of gut microbiota in people with a large number of defecation (two or three times a day or more), people with normal defecation (one time a day or two days), and people with a small number of defecation (two times a week or less).

And we investigate the association between gut microbiota and stool frequency.

We divided three groups. (total number = 60 subjects)

1. a large number of defecation group (≥ 2-3 times/day) - 20 subjects
2. normal defecation group (1 time/day or 1 time/2 days) - 20 subjects
3. a small number of defecation group (≤ 2 times/week) - 20 subjects

After collection of stools, we will analyze the composition and distribution of gut microbiota, and compared the results of three groups.

Eligibility Criteria:
Inclusion Criteria:

* adults between the age of 20 and 50

Exclusion Criteria:

* subjects with cancer or IBD (inflammatory bowel disease)
* subjects with history of abdominal surgery
* subjects who take medication related to gastrointestinal motility within 3 months
* subjects who take antibiotics within 3 months