cyrilzakka/clinical-trials huggingface dataset:
METabolomic and Immune PROfiling in the Development of Pancreatic Fistulas After cepHalic duodEnopancreatectomy

Pancreatoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology.

The aim of this prospective monocentric and observational study is to identify predictive biomarkers and/or risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications.

Participants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling).


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo elective pancreaticoduodenectomy
* Non-opposition of the subject to participate in the study.
* Affiliated to the French social security system (CMU included).

Exclusion Criteria:

* Emergent surgery.
* Pregnant patients.
* Refusal to participate or inability to provide informed consent.
* Patient under legal protection (individuals under guardianship by court order).
Investigating the Acute Effects of THC on Functional Brain Systems

The purpose of this study is to determine whether THC, the main psychoactive ingredient in cannabis, affects functional brain systems underlying memory and reward.

Cannabis is by far the most frequently used illicit drug worldwide and has significant effects on memory. Further, cannabis has an addictive potential. These effects are mediated by an action of THC, the main psychoactive ingredient of cannabis, on cannabinoid CB1 receptors. These receptors are particularly highly expressed in brain regions involved in memory and reward. Therefore, in this study we will investigate the acute effects of THC on functional brain systems underlying memory and reward. We will visualize these effects using the latest non-invasive imaging technique: pharmacological MRI (phMRI).

Eligibility Criteria:
Inclusion Criteria:

* History of mild cannabis use for at least one year (\<1/week and ≥ 4/year)
* History without psychotic experiences after cannabis use
* Age between 18 and 45 years
* Right-handedness, assessed with the Edinburgh Handedness Inventory
* Written informed consent of the subject

Exclusion Criteria:

* Any clinical significant abnormality of any clinical laboratory test, including urinary drug screening
* Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests
* History of clinically significant psychiatric or neurological illness
* History of clinically significant psychiatric or neurological illness in first- or second-degree relatives
* History of alcohol and/or drug abuse (DSM-IV criteria)
* Body Mass Index (B.M.I.) \<18 kg/m2 or \>28 kg/m2
* Paranoid ideation or psychoticism on SCL-90
* Any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug
* The use of any medication within three weeks prior to the start of the study, except for paracetamol
* Positive HIV or Hepatitis B/C test
* Blood donation within 3 months before the start of the study
* Claustrophobia
* Metal objects in or around the body (braces, pacemaker, metal fragments)
Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study

This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and to compare if these effects are similar to those observed in adults.

Phase 1, open-label, multiple-center study in pediatric patients from 0 to \< 18 years of age. Patients will receive a single dose of edoxaban to match either the 30 mg (low dose) or the 60 mg (high dose) exposure in adults. Exact doses will be selected during the study on the basis of PK modeling of emerging data. If unanticipated exposures are observed, the target doses may be modified to best match expected exposure response relationships observed in adults.

Enrollment in the study will start with the low dose, highest age group (adolescents) and will continue from low to high dose in each age group and from higher to lower age groups. Enrollment in the next dose/age cohort will begin after 50% of the subjects have completed the previous dose/age cohort.

Age cohorts and dose groups: (6 participants each in low and high dose groups, for a total of 12 participants per age cohort)

* 12 to \< 18 years of age
* 6 to \<12 years of age
* 2 to \<6 years of age
* 6 months to \<2 years of age
* 0 to \<6 months of age

Eligibility Criteria:
Inclusion Criteria:

* Is a pediatric subject requiring anticoagulant therapy
* Will abstain from the use of nonsteroidal anti-inflammatory drugs (such as ibuprofen), and other antiplatelet and anticoagulant agents (except for aspirin) from 24 hours prior to edoxaban dose until after the last PK sample is collected
* Will follow food and concomitant medication restrictions

Exclusion Criteria:

* Any major or clinically relevant unexplained bleeding during prior anticoagulant therapy
* History of abnormal bleeding or coagulation within last 6 months prior to study drug administration
* Renal function with glomerular filtration rate (GFR) less than 50% of normal for age and size
* Malabsorption disorders (e.g., cystic fibrosis or short bowel syndrome)
* Hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk, alanine transaminase (ALT) \> 5 times the upper limit of normal (ULN) or total bilirubin \> 2 times the ULN with direct bilirubin \> 20% of the total
The Analgesia Effect of Electroacupuncture Battlefield Acupuncture Versus Sham Electroakupuncture Post Surgery

The goal of this clinical trial is to learn the effect of ear electroacupuncture BFA therapy in reducing pain, analgesic dose, and improving patient quality of live post percutaneous nephrolithotomy surgery. The main questions it aims to answer are:

* Does BFA ear electroacupuncture reduce postoperative pain of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?
* Does BFA ear electroacupuncture reduce postoperative analgesic dose of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?
* Does BFA ear electroacupuncture improve postoperative quality of life of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?

Researchers will compare ear electroacupuncture BFA to sham electroacupuncture to see the different analgesia effect between these groups.

Participants will:

* Get ear electroacupuncture BFA or sham electroacupuncture therapy, 2 hours before surgery for 30 minutes
* Take drug paracetamol 1000 mg intravenous after surgery according to the needs of the patient's pain complaints after surgery in both groups


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18-65 years
* Patients who have been diagnosed with kidney stones measuring \> 2 cm and will undergo PCNL surgery
* VAS score \<7, assessed 2 hours before PCNL surgery
* Receive standard analgesic therapy
* Willing to participate in this study until completion and sign an informed consent.

Exclusion Criteria:

* Kidney anatomical abnormalities
* Ear deformities (microtia)
* Patients with cognitive impairment, uncooperative (receiving antidepressants or strong opioid or narcotic analgesics)
* Tumors, wounds or skin infections in the needling area.
* Heart rhythm disorder, unstable hemodynamics that require intensive care including extremely high body temperature and using a pacemaker.
* Allergy to acupuncture needles or certain metals
* Patients who have had a DJ stent or nephrostomy before PCNL
* History of metal implants in the body except amalgam
Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients

In patients with Helicobacter pylori-positive functional dyspepsia, long-term follow-up for 6 months after standard triple therapy first-line eradication treatment, the rate of symptom disappearance and degree of improvement of functional dyspepsia were confirmed through changes in symptom scores and changes in drug usage, and eradication treatment The purpose of this study is to confirm the rate of symptom disappearance according to the results.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients between the ages of 19 and 75
* Who have symptoms of functional dyspepsia (early fullness, postprandial discomfort, epigastric pain, epigastric soreness) that correspond to Rome criteria 4 (diagnostic criteria questionnaire)

Exclusion Criteria:

* Small intestine and large intestine disease within 6 months of the screening visit (Visit 1)
* liver, pancreatobiliary disease within 6 months of the screening visit (Visit 1)
* peptic ulcer within 6 months of the screening visit (Visit 1)
UEMR for Medium-sized Pedunculated Colon Polyps

Underwater EMR (UEMR) is an emerging technique for endoscopic resection. The purpose of this research is to observ wether the UEMR for medium-sized pedunculated polyps is safe and effective.


Eligibility Criteria:
Inclusion Criteria:

Patients age between 18-75 years old with pedunculated colonic polyps (measuring between 10 and 20mm), who willing to participate in this study.

Exclusion Criteria:

1. pregnancy,
2. inflammatory bowel disease,
3. familial polyposis
4. the use of anticoagulant therapy or antiplatelet therapy
5. the absence of informed patient consent.
6. Polyps showing signs of deep submucosal invasion
Dedicated Lactation Support in Infants With Tongue - Tie; a Randomised Control Trial

The investigators are registering a randomised controlled trial to assess whether dedicated, intensified lactation support is as good as frenotomy on the incidence of breastfeeding among term infants with ankyloglossia.

The investigators plan to include a total 316 infants. The study will be carried out in level III hospital in Warsaw, Poland. The primary outcome will be exclusive breastfeeding at 12 weeks of age. Secondary outcomes include breastfeeding \> 50% of feedings, improved breastfeeding comfort as assessed by the mother, weight gain, head circumference and length gain, the need to use a breast pump or lactation accessories, time of breastfeeding cessation, the type of lactation, neurological and rehabilitation assistance received, the frequency of obtained lactation, neurological and rehabilitation assistance.

Eligibility Criteria:
Inclusion criteria:

1. full - term infants born with an Apgar score of 8-10 points
2. no visual causes of lactation difficulties (malocclusion, posterior and small jaw, cervical torticollis, significant positional asymmetry)
3. parental consent

Exclusion criteria:

1. hypotrophy
2. low birth weight
3. perinatal complications
4. congenital craniofacial defects
5. neurological diseases
6. visible genetic syndromes
7. mother' unwilling to breastfeed
8. no consent for vaccination against hepatitis B
9. neonates born to HIV seropositive mothers
Adipose Tissue Blood Flow in Aging Humans

The goal of this basic science clinical trial is to understand whether adipose tissue blood flow changes between younger and older healthy adults.

The main question\[s\] it aims to answer are:

* Is basal and nutrient responsive adipose tissue blood flow (ATBF) different between younger and older adults
* What molecular and systemic signatures related to adipose tissue blood flow are altered between these two groups.

Participants will undergo measurements of adipose tissue blood flow using the xenon washout technique, undergo 2 abdominal subcutaneous adipose tissue biopsies, and drink a sugary drink.

On Visit 1, volunteers will provide written informed consent (and urine pregnancy test for women of childbearing age), complete a Dual x-ray absorptiometry scan, baseline labs (comprehensive metabolic panel) and a cardiopulmonary exercise test. Participants will arrive fasted at 08:00, and urine pregnancy test for women of childbearing age administered and an intravenous catheter will be placed. Following 30min of supine rest, baseline venous blood samples will be collected. ATBF will be assessed on participants' left abdomen first by measurement of blood flow using 133Xenon washout method. Immediately thereafter, an abdominal adipose tissue biopsy of the left side will be performed but ≥6 cm distant from location of 133Xenon injections. Subjects will them consume 75 gm glucose; because ATBF peaks 30-60 minutes following ingestion of glucose, ATBF measures will start 30 minutes after ingestion on the contralateral side followed immediately by plasma measures and another adipose tissue biopsy. During ATBF measurements, brachial blood pressure will be assessed in two-minute intervals.

Eligibility Criteria:
Inclusion criteria

* Within the ages of 18-35 years or 65-80 years at time of study visit
* BMI between 20-25.0 kg/m2.

Exclusion criteria:

* Presence of diagnosed cardiometabolic diseases (e.g., Type 2 diabetes, hypertension, Heart Failure)
* Taking prescription anticoagulants
* Taking prescriptions or supplements that effect adipose tissue metabolism (i.e., statins, Thiazolidinediones, niacin, atypical antipsychotics, or fish oil)
* Pregnant or nursing
* Inability to provide written informed consent
* Smokers
Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)

Accidental vaccine injection into adjunct shoulder structures can cause tissue damage, termed Shoulder injury related to vaccine administration (SIRVA). The immunopathological mechanisms and consequences of SIRVA are unknown.

The study assesses the clinical and immunological consequences of an influenza vaccine if accidentally administered in periarticular space.


Eligibility Criteria:
Inclusion Criteria:

* participation at a local vaccination campaign
* Shoulder pain \>3 days after vaccination

Exclusion Criteria:

* no vaccine received
* preexisting shoulder pathology
Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)

This study is designed to assess the safety, tolerability, and immunogenicity of 5 different formulations of V114 in healthy adults and infants. Adults only will be enrolled in Period 1 and infants only will be enrolled in Period 2; Period 1 will complete prior to the start of Period 2.


Eligibility Criteria:
Inclusion Criteria

Infants:

- Healthy and able to attend all scheduled visits.

Adults:

- Highly unlikely to conceive from vaccination to 6 weeks after administration of the vaccine.

Exclusion Criteria

Infants and Adults:

* Prior administration of any pneumococcal vaccine, any non-live vaccine within 14 days, or any live vaccine within 30 days.
* History of invasive pneumococcal disease.
* Known hypersensitivity to any vaccine component.
* Received systemic corticosteroids within 14 days of first vaccination.
* Known or suspected impairment of immune function.
* Febrile illness within 72 hours before vaccination.
* Received blood transfusion or blood products within 30 days. Infants
* Mother has documented human immunodeficiency virus or is hepatitis B surface antigen positive.
* Has asplenia or failure to thrive.

Adults:

- Is breastfeeding.
PMS of Trazenta on the Long-term Use as Add-on Therapy

Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion criteria:

Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.

Exclusion criteria:

None
Prognostic Value of the Urinary Nerve Growth Factor in the Patients With Benign Prostatic Hyperplasia

Persistent detrusor overactivity (DO) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. Storage symptoms are major complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate (HoLEP). Levels of the urinary nerve growth factor (NGF), produced by bladder urothelium and smooth muscle, are increased in the patients with overactive bladder (OAB), and decreased after the OAB symptoms were improved. Also, urinary NGF levels are increased in patients with benign prostatic obstruction (BPO), but the changes of the NGF levels after relief of the BPO by the medical or surgical treatment have not been fully investigated. If the elevated urinary NGF levels are reduced after successful surgical treatment of BPO, measurement of urinary NGF could be a useful objective tool to assess the therapeutic outcomes of the operation.

The aims of this study are to measure the urinary NGF levels in patients with BPO and to compare the results between the patients with detrusor overactivity (DO) and without detrusor overactivity (Non-DO), average 2 weeks before Holmium Laser Enucleation of the Prostate (HoLEP) procedure. After HoLEP, urinary NGF levels are rechecked at the periods of postoperative 3 months and 6 months, and compare changes between the two groups.

* Investigators are going to enroll age-matched control group and measure the urinary NGF levels as a baseline value (30 males).
* Investigators are going to enroll BPO patients group (DO group 50 and Non-DO group 50 patients).
* Administration of the anti-cholinergic agents was reported to decrease urinary NGF levels. Investigators are going to try to avoid the effect of anti-muscarinic drugs.

Eligibility Criteria:
Inclusion Criteria:

* Male aged 50 yrs or greater
* International prostatic symptom score \>= 12
* Bladder outlet obstruction confirmed by pressure-flow study (BOOI \> 20)
* Ability and willingness to correctly complete the micturition diary and questionnaire
* Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

* Patients with urologic malignancies such as prostate cancer and bladder cancer
* Patients underwent urethral, prostate surgery
* Patients with urethral stricture or bladder diverticulum or bladder neck contracture
* Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Esketamine Anesthesia in Thoracic Surgery

Esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium bromide 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h. Anesthesia induction in the opioid group Sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium bromide 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and remifentanil 1 ug/kg/h.

Before anesthesia induction, radial artery puncture and catheterization under local anesthesia for manometry, and intravenous pentethylquine hydrochloride 1 mg and dexamethasone 5 mg were given. Anesthesia-induced opioid group (group A) received intravenous sufentanil 0.5 ug/kg, and esketamine group (group E) received intravenous esketamine 0.5 mg/kg. Subsequently, both groups were sequentially injected with intravenous propofol 2 mg/kg and rocuronium bromide 0.9 mg/kg. After the onset of rocuronium bromide, the left double-lumen bronchial intubation was guided by a video laryngoscope, the correct position of the catheter was confirmed by bronchoscope, and the anesthesia machine was connected to the anesthesia machine for mechanical ventilation after fixation, with a tidal volume of 6 mL/kg (ideal body weight), a respiratory rate of 12\~18 breaths/min, and end-expiratory carbon dioxide partial pressure at 35\~40 mmHg.

Intraoperative anesthesia maintenance opioid group was injected with intravenous injection of propofol (5 mg/kg/h) and remifentanil (1 ug/kg/h), and esketamine group was pumped with propofol (5 mg/kg/h) and esketamine (0.5 mg/kg/h). After the lateral decubitus position is set up and the lateral paravertebral nerve block (T4, T6 levels 0.5% ropivacaine 10 ml each) is performed under ultrasound guidance, and the anesthesiologist is responsible for the complications and accidents that occur during the routine management of anesthesia. After the operation, they were given 200 mg of sugammadex sodium as an antagonistic residual muscle relaxant, and after being extubated awakely, they were sent to PACU for continued PCIA treatment and observation, and returned to the thoracic surgery ward for further treatment after reaching the discharge criteria.

Eligibility Criteria:
Inclusion Criteria:

1. ASA scores 1 \~ 2
2. Age \> 18 years and \< 70 years
3. Thoracoscopic segmentectomy or lobectomy is proposed under general anesthesia
4. Patient controlled intravenous analgesia was planned
5. Sign informed consent.

Exclusion Criteria:

1. BMI\>30 kg/m2 or \< 19 kg/m2;
2. preoperative use of opioids, acute and chronic pain or hyperalgesia;
3. Preoperative coronary atherosclerotic heart disease, significant ischemic heart disease, severe angina, heart failure, valvular disease or other heart disease;
4. severe hepatic and renal insufficiency before operation;
5. A history of mental illness or alcoholism;
6. A history of alcohol or drug abuse;
7. cranial pressure, intraocular pressure or suffering from glaucoma;
8. Poorly controlled or untreated hypertension;
9. Preeclampsia or eclampsia;
10. untreated and undertreated hyperthyroidism;
11. The Numerical Rating Scale (NRS) cannot be used.
Repeat Nasal Allergen Challenge

This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.

This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects with a history of seasonal (intermittent) atopic rhinitis, aged 18-40 years.
2. Otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies.

Exclusion Criteria:

1. Smokers (use of tobacco products in the previous 3 months).
2. Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (FEV1 \> 80% predicted at screening).