cyrilzakka/clinical-trials huggingface dataset:
Chyle Leak After Pancreatic Surgery

Currently it is unclear whether postoperative chyle leak (CL) after pancreatic surgery requires treatment. Thus, the present study aims to compare dietary treatment of CL with drain removal despite of persistent CL.

With an incidence of up to 11%, postoperative chyle leak (CL) is a frequent phenomenon after pancreatic surgery, where extensive lymph node dissections are indispensable. Postoperative CL is frequently treated with either medium-chain triglyceride diet (MCT-diet) or total parenteral nutrition (TPN). Ignoring CL and removing the surgical drains irrespective of CL may also be discussed. While dietary restrictions are known to hinder postoperative convalescence and prolong the length of stay at the hospital, recent retrospective data show that leaving CL untreated is not associated with an increased morbidity rate. More precisely, removing the surgical drains irrespective of CL does not result in an increased incidence of CT-guided drainages. However, prospective data on CL after pancreatic surgery do not exist in the literature. Accordingly, the present trial aims to compare treatment of CL with dietary restrictions to removing the surgical drains irrespective of CL.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Pancreatic surgery of any kind

Exclusion Criteria:

* Liver cirrhosis \> Child-Pugh grade A
* History of portal vein thrombosis
* Portal Hypertension

Dropout Criteria:

* Irresectable Tumor (no surgical resection)
* Biochemical leak or postoperative pancreatic fistula (POPF)5
* Serous drainage on POD 5
* Peritoneal carcinomatosis
* Portal vein thrombosis
* Postoperative bile leak
* Drain volume \>1000ml on POD5
Respreeza® Self-administration and Learning Program (AmAREtTI Study)

According to the Respreeza® Summary of Product Characteristics, the initial infusions must be administered under the supervision of a health professional experienced in the treatment of alpha-1 antitrypsin deficiency, although subsequent infusions may be administered at home by the person responsible for care or by the patient.

Clinical data on self-administration of Respreeza® are however limited and the grounds for self-administration are left to the assessment of the attending physician, who needs to ensure that appropriate training is delivered.

In this context, CSL Behring would like to run a clinical study in order to assess the effectiveness of a home self-administration learning program in terms of switching to self-administration, and the long term maintenance of this administration.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥18 years old).
* Patients suffering from AATD treated by Respreeza® through a peripheral vein at home for at least 3 month (consecutives or not). The 3-month period of treatment with Respreeza® does not necessarily correspond to the 3 months prior to inclusion.
* Patient accompanied by a third person at home
* Patients deemed to be suitable by the investigator for self-administration.
* Patients with a life expectancy of over 3 years.
* Patients who have been informed verbally and in writing via the information leaflet and who have signed the informed consent form.

Exclusion Criteria:

- In order to reflect the reality of everyday practice, no non-inclusion criteria are intended except for patient refusal to take part in the study.
Comparison of Silk Suture and Tissue Adhesive for Wound Closure After Impacted Tooth

This study was administered to 21 female and 9 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After extraction of the impacted teeth, silk sutures were used on one side and cyanoacrylate tissue adhesive on the other side for wound closure. The effects of these two materials on patient comfort were investigated.

The aim of this study was to compare the effectiveness of tissue adhesive (Periacryl 90) and silk suture in bilateral mandibular impacted wisdom tooth surgery. In the study of 30 patients, 21 females and 9 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilaretal teeth of the patients was randomly selected and tissue adhesive (Periacryl 90) was applied for wound closure as the experimental group, while the other tooth was selected as the control group and the wound was closed with silk suture. The selected side was determined by a closed envelope procedure. After the first impacted tooth extraction, the patient waited until the wound healed and the symptoms disappeared completely, and then the other tooth was extracted. Both extractions were evaluated on days 3 and 7 for wound healing, edema and trismus. Wound healing was evaluated as good, acceptable and poor. VAS (Visual Analog Scale) was used for pain assessment

Eligibility Criteria:
Inclusion Criteria:

* Volunteers with bilateral fully impacted mandibular wisdom teeth

Exclusion Criteria:

* Patients were excluded from the study if they did not understand the clinical procedures of the study,
* Had allergies or intolerance to any of the substances used in the study,
* Patients on anticoagulant or psychiatric treatment,
* Pregnant or breastfeeding,
* Patients using oral contraceptiveswere,
* Diabetic,
* Patients with periodontal disease or active infection,
* Poor oral hygiene
Long Term Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

This study will evaluate the long term safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant


Eligibility Criteria:
Inclusion Criteria

* Patients who completed the 12 month core study
* Patients who gave written informed consent to participate in the study Exclusion Criteria
* Not applicable Other protocol-defined exclusion criteria may apply
Evaluation of the Sub Epidermal Moisture a Device for the Screening of Pressure Ulcer (RELIASEM)

The device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. The Sub Epidermal Moister(SEM) Scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician

The device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. The Sub Epidermal Moister(SEM) Scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician.

The study "RELIASEM" will study hospitalized patients with high risk of Pressure Injurieswith the next conditions:

For each patient 14 mesures: 6 on the sacrum, 4 on the right heel and 4 on the left heel. This set of measure will be realized 2 timesby 4 different evaluator. To will have been trained in the use of the SEM Scanner where as the other will be novice.

The main objective of this study is to determine on a risk population the intra- and inter-examiner reliability of the SEM Scanner

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18
* Taken the full-hospital care in physical and rehabilitation Medicine
* Patient affiliated with a social security scheme
* In the case of curatorship, patient have read the patient information document and given his consent free and informed, in the presence of his/her curator
* In the case of guardianship, legal representative have to had read the legal representative information document for major placed under legal protection (under guardianship) and given his consent free and informed for the person for whom he is responsible (if the patient is agree),

Exclusion Criteria:

* Patient who objected his opposition during the exam
* Patient who have one or more presure ulcer on at list one of the measuring area
* Patient who has had a lower limb amputation
* Pregnant, post natal period or breastfeeding women,
* Person deprived of liberty by judicial or administrative decision
The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant

This study examined patients on taking oral anticoagulants (OACs) are often prescribed for Atrial fibrillation (AFib) to determine the effectiveness of a multiple interactive health education program, which was developed based on the health belief model (HBM) and incorporated information technologies.

A randomized controlled study was conducted on the cardiology outpatients. The patients were recruited through purposive sampling. The participants had been diagnosed with AFib and were receiving OACs. The participants were divided according to the blocks of clinic hours and assigned randomly to the experimental group or control group. The control variables involved demographic characteristics and medical history. The dependent variables and corresponding research instruments were medication knowledge and health beliefs, medication satisfaction and quality of life (QoL). Other than the medication knowledge questionnaire, which was assessed monthly, all the measurement instruments were applied twice: first in a pretest, and again in a posttest administered at the third month. The interventions administered to the experimental group were one-on-one instruction and HBM-driven strategies, health information technology system, monthly telephone follow-ups, and providing medication cards. The participants in the control group only received brochure and medication cards.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Atrial Fibration by a physician and taking oral anticoagulant as treatment
* 20years old or older
* clear consciousness for communication
* willingness to participate in research.

Exclusion Criteria:

* can not communicate clearly
* without willingness to participate in research
Reverse Trigger Phenotypification and Response to Ventilatory Adjustments

The goal of this prospective observational study is to describe the incidence of reverse trigger (RT) in mechanically ventilated patients with diagnosis of acute respiratory distress syndrome (ARDS).

The main questions it aims to answer are:

* Real incidence of RT based on continuous monitoring
* The response to mechanical ventilatiory adjustments Participants will be included as soon as neuromuscular blockers (NMB)/sedation is stopped or in case of spontaneous respiratory efforts detection, whatever happens first. Continuous monitoring will be performed by esophageal manometry until switch to a pressure support (spontaneous) mode, restart of deep sedation/neuromuscular blockers by medical indication, or death.

In order to allow detection of possible RT in patients with ongoing sedation/NMB, mechanical ventilator waveforms will be screened every 1-2 hours by investigators and critical care physicians with at least 1 year of specific training in detection of dyssynchronies.

Measurements:

An esophageal catheter for manometry will be placed as usual practice with confirmation of adequate position with the Baydur's occlusion test before recordings. An independent flow sensor and pressure transducer will be placed and connected to a laptop computer to obtain real-time monitoring along with continuous recordings, which then will be off-line analyzed by two experts, for confirmation of RT and characterization.

Data collection:

Main cause of the acute respiratory failure and days on mechanical ventilation until enrollment will be collected as well as demographic characteristics, including APACHE II, SOFA and the previous requirement of prone positioning therapy.

At identification of the RT, drugs for sedation and analgesia, time from initiation of mechanical ventilation to RT identification and blood gas analysis will be recorded. Ventilatory settings will also be collected, including the control variable of the ventilatory mode (volume or pressure), respiratory rate, received tidal volume in ml/kg of predicted body weight, maximum inspiratory flow, ratio of partial arterial oxygen pressure (pO2) to fraction of inspired oxygen (FiO2), driving pressure and (positive end-expiratory pressure (PEEP). Data about esophageal pressure related to RT will also be recorded, including the magnitude of pressure swing, phase angle, coefficient of variation, RT phenotype, entrainment ratio and the presence of breath stacking.

Patient-centered outcomes including length of mechanical ventilation, intensive care and hospital length of stay, and mortality will be followed-up until 60 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ARDS according to the Berlin criteria and added New Global Definition 2023
* Mechanical ventilation

Exclusion Criteria:

* \<18 years
* Tracheostomy status
* Pneumothorax
* Tube thoracostomy with air leaks
Re-licensing Study to Assess Virosomal Influenza Vaccine Formulated With WHO Recommended Influenza Strains

The study is to assess whether the virosomal influenza vaccine for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male adults aged ≥18 on Day 1
* Written informed consent
* Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years

Exclusion Criteria:

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine in the past 330 days
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
* Investigational medicinal product received in the past 3 months (90 days) starting from the first day of the month following the last visit in a previous study
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Pregnancy or lactation
* Participation in another clinical trial
* Employee at the investigational site, or relative of the investigator
* Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol
Study on Early Genetic Screening and Precise Strategy of Neonatal Critical Illness

The researchers hope to establish an overall program of early genetic screening for neonatal critical illness in China, and to develop precise intervention strategies to assist clinical diagnosis and treatment of hereditary critical illness.

Reducing the rate of neonatal death and disability is an important part of health education in China, and genetic diseases are an important cause of neonatal death. At present, with the development of life support platform technology, the treatment level of critically ill newborns has been rapidly improved. How to quickly diagnose and early precise intervention is the key to further break through the diagnosis and treatment of genetic diseases. Based on the "neonatal genome project" carried out in the early stage, the research group based on the genetic diagnosis results of over 10000 cases of neonatal critical illness cohort, studied the genetic disease spectrum of neonatal critical illness in line with the actual situation in China. In terms of detection technology, based on the second-generation sequencing technology, we established a critical illness screening gene sequencing combination including 300 genes; In the aspect of data analysis, an intelligent analysis process integrating clinical phenotype and gene sequencing data was established; In terms of clinical diagnosis and treatment, we cooperated with 5 maternity and children's hospitals in Shanghai to carry out multi center clinical verification, and formed the implementation plan of early universal genetic screening for neonatal critical illness. Through this project, we will carry out genetic disease screening research on neonatal critical diseases, focus on typical clinical manifestations such as encephalopathy, immunodeficiency, metabolic diseases, and carry out molecular autopsy on neonatal death cases to identify potential genetic causes, so as to provide basis for the research of corresponding early precise intervention strategies, and achieve the purpose of reducing neonatal death and disability rate.

Eligibility Criteria:
Inclusion Criteria:

* Postnatal age less than 100 days;
* Perinatal death after 20 weeks of gestation (more than 500 g)
* Can be retained biological samples for genetic screening;
* Biological parent or guardian's informed consent.

Exclusion Criteria:

* Reluctance of parents to use genetic sequencing data for subsequent research;
* Parents under 18 years of age or incapacitated for decision-making;
* subjects older than 100 days;
* Perinatal death less than 20 weeks of gestation or weight less than 500 g;
* Inherited metabolic diseases with chromosomal abnormalities;
* Multiple pregnancies;
* Lack of access to biological samples from which DNA can be extracted;
* Failure to sign informed consent.
Alkaline Diet for Insulin Sensitivity

The purpose of this study is to test the effect of increasing the body pH acutely with an alkaline medication (sodium bicarbonate, NaHCO3, sodibic) on glucose metabolism post meal in non diabetic subjects with normal renal function.

The investigators aim to determine whether there is an acute reduction in venous blood pH following a typical Western-style (high acid load) breakfast in healthy men and women, and whether this effect is attenuated by the concurrent administration of an alkaline medication. The effect on glucose metabolism, hunger/satiety and arterial stiffness post meal will be assessed.

The aim of the study is to test the effect of increasing the body pH acutely with an alkali (NaHCO3) prior to a high acid load meal on glucose metabolism in non-diabetic men and women.

This is a double-blind placebo-controlled randomised study with a crossover design.

Study Procedures:

Two (2) meal studies will be performed 1 to 2 weeks apart. Studies will include collecting fasting blood to assess circulating glucose, insulin, C-peptide, free fatty acids, glucagon-like peptide-1, acid/base markers, including electrolytes (EUC) and venous blood pH. Participants will then be either administered sodibic (1680 mg) or matching placebo and a standardised Western style/high acid load meal. Investigators and participants will be blinded to the intervention. Blood will be drawn every 15 min in the first hour and then every 30 min for 3 hours in total. Arterial stiffness and appetite score will be evaluated at ½ h intervals.

Sample size: 30

sample size calculation: To detect a difference in area under the curve (AUC) of venous blood pH with a paired crossover design, 32 individuals will be required with statistical power 1-β\>0.8 (allowing for drop-out).

statistical considerations: Differences between AUC of outcome measures post sodium bicarbonate vs. placebo will be tested using paired t-tests. Two-way repeated measure ANOVA tests will be conducted to assess differences in the response to the meal with sodium bicarbonate vs. placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age range: 22-65
* Disease status: Healthy.
* Laboratory parameters: Fasting plasma glucose \<7 mmol/L, HbA1c \<6.5% (48 mmol/mol).
* Willingness to give written informed consent and willingness to participate and comply with the study.

Exclusion Criteria:

* Individuals with a personal history of diabetes, hypertension, cardiovascular disease, kidney disease, respiratory disease or inflammatory disease.
* Individuals treated with medications known to affect insulin sensitivity.
* Individuals with fasting plasma glucose ≥7 mmol/L, HbA1c ≥6.5% (48 mmol/mol).
* Individuals with an unstable body weight in the past 3 months (+/- 2 kg or more).
* Individuals with a history of a psychological illness or condition that may interfere with the participant's ability to understand the requirements of the study.
* Individuals who smoke.
* Individuals who consume more than 40 g of alcohol daily.
A Study of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis

Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice daily oral LNK01001 dose A or LNK01001 dose B or matching placebo for 12 weeks.

The study was to include a 12-week double-blind treatment period. Participants who met eligibility criteria were to be randomized in a 1:1:1 ratio to one of the three treatment groups.

Group 1:LNK01001 dose A (Day 1 to Week 12) Group 2:LNK01001 dose B (Day 1 to Week 12) Group 3: Matching placebo (Day 1 to Week 12)

Eligibility Criteria:
Inclusion Criteria:

* participants between ≥ 18 and ≤75 years of age.
* subjects meet Hanifin and Rajka criteria.
* subjects meet moderate to severe AD criteria.
* inadequate response to topical treatment or systemic treatment for AD within 6 months before screening.

Exclusion Criteria:

* current use of topical treatment for AD within 2 weeks before baseline visit.
* prior exposure to Janus Kinase (JAK) inhibitor.
* prior exposure to phototherapy, tanning bed, or any other light emitting device treatment within 4 weeks before baseline visit.
* Prior exposure to any Biologic treatment including Dupilumab, Omalizumab within 3 months before baseline visit.
* Any significant clinical and laboratory abnormalities, as determined by the Investigator, may affect the safety of the subjects, including but not limited to:WBC\<3×10e9/L, neutrophil\<1.2×10e9/L, platelet\<100×10e9/L, hemoglobin\<85 g/L; Aspartate aminotransferase or alanine aminotransferase\>1.5×ULN, or total bilirubin\>1.5×ULN; Serum creatinine\>1.2×ULN.