cyrilzakka/clinical-trials huggingface dataset:
Corneal Epithelial Autograft for LSCD

The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial autograft is more effective than limbal conjunctival autograft for ocular surface reconstruction in patients with limbal stem cell deficiency (LSCD).


Eligibility Criteria:
Inclusion Criteria:

1. Unilateral LSCD secondary to ocular burns, with the duration of disease of at least 24 months at the time of screening visit;
2. Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea;
3. Informed consent signed by patient or legal guardian. Having the ability to comply with study assessments for the full duration of the study.

Exclusion Criteria:

1. LSCD of mild degree, with less than 2 quadrants of neo-vessel invasion and without central cornea involvement;
2. LSCD by ocular surface disorders other than pterygium;
3. Eyelids malposition;
4. The center corneal thickness\<450µm, the depth of corneal opacity \> 150µm;
5. High myopia with a spherical equivalent of -15.0 D or less;
6. Corneal or ocular surface infection within 30 days prior to study entry;
7. Ocular surface malignancy;
8. Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
9. Renal failure with creatinine clearance\< 25ml/min;
10. Alanine aminotransferase \> 40IU/L, or aspartate aminotransferase \> 40IU/L;
11. Platelet levels \< 150,000 or \> 450,000 per microliter;
12. Hemoglobin \< 12.0 g/dL (male) or \< 11.0 g/dL (female);
13. Prothrombin time \> 16s and activated partial thrombin time \> 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy;
14. Pregnancy (positive test) or lactation;
15. Participation in another simultaneous medical investigation or clinical trial;
16. Severe cicatricial eye disease; Conjunctival scarring with fornix shortening;
17. Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases;
18. Severe dry eye disease as determined by Schirmer's test \< 2mm at least in one eye;
19. Any medical or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent;
20. Signs of current infection, including fever and treatment with antibiotics;
21. Active immunological diseases;
22. History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately

The purpose of the study is to assess whether there is any pharmacokinetic interactions between CAZ-AVI and metronidazole.

A Phase I, Open-Label, 3-way Crossover, Pharmacokinetic and Drug-Drug Interaction Study of ceftazidime avibactam (CAZ-AVI) and Metronidazole when Administered Alone and in Combination in Healthy Subjects

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study-specific procedures.
* Healthy male and female subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture; female subjects must be post menopausal or surgically sterile.
* Male subjects should be willing to use barrier contraception ie, condoms, from the first day of the investigational product administration until 3 months after the last administration of the investigational product.
* Have a body mass index (BMI) between 19 and 30 kg/m2
* Be able to understand and willing to comply with study procedures, restrictions, and requirements, as judged by the Investigator

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Known history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to carbapenem or cephalosporin antibiotics or other beta-actam antibiotics or any other investigational product to be administered as part of the study
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks prior to the first administration of investigational product Any clinically significant abnormalities in physical examination, ECG, clinical chemistry, haematology, or urinalysis results, as judged by the Investigator
C-protein Reactive for the Detection of Anastomotic Leakage After Surgery for Digestive Cancer

The aim of this study is to investigate the diagnostic accuracy of the C Protein Reactive (CRP) for the detection of Anastomotic leakage after surgery for digestive cancer. The standard protocol in our unit is to measure the CRP on the second and fourth postoperative day.

The main aim of the study is to investigate the diagnostic accuracy of the ratio CRP on the fourth postoperative day on CRP on the second postoperative day (CRP_D4/CRP_D2). Secondary outcomes are the diagnosis accuracy of the CRP_D4 and CRP_D2.

The occurrence of anastomotic fistula (AF) is the most feared complication after digestive cancer surgery. It is responsible for high morbidity and accounts for more than a third of the deaths observed. The rate of anastomotic fistula reported in the literature varies between 1 and 40% according to the definition chosen by the authors. In the literature, the occurrence of the anastomotic fistula is responsible for a mortality rate of 4% and an overall morbidity of 35%. In the short term, the anastomotic fistula can put the patient's vital prognosis at risk by its septic consequences. Also, it is responsible for increasing the length of stay and costs. In the longer term, anastomotic fistula affects the functional prognosis of the patient as well as oncology in patients operated for cancer.

Early rehabilitation becomes a standard in colorectal surgery, with exits around the 5th postoperative day. Anastomotic fistulas and their complications may appear well beyond. The diagnosis is made on average around 6-7 postoperative days. At an early stage, clinical signs are inconsistent and not very specific. Anastomotic fistula can manifest itself in a variety of clinical presentations, ranging from no symptoms to life-threatening septic shock. Routine imaging is neither reliable nor cost-effective for the detection of anastomotic fistulas and has the disadvantage of radiation.

It is necessary to find an intraperitoneal infection marker with a high negative predictive value. This is particularly important in the era of early rehabilitation, allowing for safe patient discharge with a low risk of readmission. C-reactive protein (CRP) has already shown its utility in the early detection of infections after digestive surgery, however, because of conflicting results, no clear recommendations are established in the literature.

Our study aims are to investigate the diagnostic accuracy of the postoperative CRP trajectory as an approach to eliminate the diagnosis of anastomotic fistula and to try to establish an optimal threshold with high sensitivity and negative predictive value.

Eligibility Criteria:
Inclusion Criteria:

* Surgical resection for digestive cancer
* Creation of anastomosis.
* at least one measurement of CRP at the second and/or fourth postoperative day.

Exclusion Criteria:

* Surgical resection without anastomosis creation
* No measurement of CRP on the second or the fourth postoperative day.
Transcutaneous Diaphragm Stimulation in ICU Patients

The aim of this study is to compare the effects of transcutaneous electrical diaphragm stimulation (TEDS) on diaphragm thickness, duration of mechanical ventilation, length of ICU stay, and right/left heart functions between patient groups with low and high ejection fraction (EF) levels.

This randomized controlled trial will record demographic data, diaphragm ultrasound measurements, and echocardiographic findings of patients who receive or do not receive TEDS for five consecutive days.

Participants will be divided into four groups according to their EF levels and whether or not they receive diaphragm stimulation:

Group 1: Patients with low EF who receive TEDS Group 2: Patients with high EF who receive TEDS Group 3: Patients with low EF who do not receive TEDS Group 4: Patients with high EF who do not receive TEDS

Diaphragm thickness and echocardiographic assessments will be performed at baseline and at the end of the five-day TEDS intervention.

TEDS Application Protocol

In the ICU, TEDS is administered by a physiotherapist once daily for 20 minutes, five days a week, as part of the routine treatment protocol. The stimulation is delivered using the LGT-231 model device from the LONGEST brand.

A transcutaneous current with a frequency of 30-50 Hz and a pulse width of 300-400 microseconds is applied to the diaphragm. The stimulation intensity is increased until visible muscle contraction is achieved.

Electrode placement involves:

The first pair of electrodes placed bilaterally between the 8th and 10th anterior intercostal spaces, lateral to the xiphoid process.

The second pair placed along the mid-axillary line of the thorax, also between the 8th and 10th intercostal spaces.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 80 years
* Patients expected to require mechanical ventilation for at least 72 hours

Exclusion Criteria:

* Presence of known neuromuscular diseases that contraindicate the use of transcutaneous diaphragm stimulation
* Phrenic nerve injury
* History of abdominal or thoracic surgery that prevents the application of diaphragm stimulation
Intervention Effect of TP and AOB-w on Acrylamide Exposure in Chinese Adolescents

A double-blind randomized controlled trial (RCT) was conducted in current human study. This study aims to investigate the intervention effect of AOB-w on the short-term exposure and toxicokinetics of acrylamide, a dietary hazardous substance generated during heat processing, in Chinese adolescents.

In the morning of test day, participants were served with a meal of potato chips, corresponding to a single oral dose of 12.6 μg/kg b.w. exposure to acrylamide, and an edible capsule, which contains 350 mg AOB-w or the placebo with the same dose. Urine were collected within 48 hours thereafter. The diet was rigorously controlled within 24 hours prior to study till entire study finished. Four mercapturic acid metabolites have been investigated as urinary biomarkers for short-term internal exposure of acrylamide in human

Eligibility Criteria:
Inclusion Criteria:

* Subject has no smoking or drinking hobby

Exclusion Criteria:

* Having any drugs within 7days
* Smoking or drinking
* Pregnant, trying to become pregnant or breast feeding
* Allergic frying foods
GSK618334 Repeat Dose Study

The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.

GSK618334 strongly binds to dopamine type 3 receptors in the human brain and is being developed as an innovative treatment for substance dependence. This study will evaluate the safety, tolerability, blood concentrations and effect following repeated oral doses of GSK618334 in healthy male and female volunteers. The effect of food on a single oral dose of GSK618334 will also be evaluated. Another portion of this study will investigate dopamine type 3 receptor binding in the human brain by PET scan before and after repeated doses of GSK618334.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Males and Females between the ages of 18-50 years old
* Male and Female subjects must agree to use protocol specified contraceptive methods.
* Male subjects only in PET parts of the study.
* Capable of providing written informed consent.

Exclusion Criteria:

* A positive test for Hepatitis B or Hepatitis C within 3 months of screening.
* Current or chronic history of liver disease, or known liver/bile/gallbladder abnormalities.
* Personal or family history of heart disease (such as irregular heart beats, a history of sudden unexplained death in a first degree relative, or unexplained fainting).
* Screening ECG parameters outside the protocol specified parameters.
* Pulse rate \<50 or \>100 bpm OR a systolic blood pressure \>140 or \<95 mmHg OR a diastolic blood pressure \>90 or \<50 mmHg at screening and/or baseline.
* Pregnant or lactating females.
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden.
* Significant suicidal risk.
Efficacy of Patient Centred Information for Vascular Disease

This study aims to determine the usefulness of providing patients with web-based electronically accessed patient information when compared to the provision of written information leaflets.

Hospitals and health care institutions attempt to provide information to patients through a variety of media including; written information, web-site based information and more recently through the use of smart phone based applications. Such educational campaigns have financial implications for hospitals and institutions.

The level of knowledge among patients with vascular disease of their pathology and its associated risk factors has been shown to be poor (Lovell et al 2009, Hirsch et al 2007). The optimum tool with which to provide information to patients with vascular disease has not been determined to date.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed abdominal aortic aneurysm, peripheral vascular disease or varicose veins
* Capacity to and willingness to consent to participation in the study
* Adult patients
* In-patient or out-patient status

Exclusion Criteria:

* Previously diagnosed with vascular disease
* Limited capacity or unwilling to consent
* Information already provided by hospital doctor
* Cognitive/intellectual impairment/acquired brain injury/visual impairment
* Qualified medical professionals
Evaluation of 11C-acetate PET Imaging as a Novel Approach to Detecting Pathology in Pulmonary TB

Imaging using 11C-acetate PET (positron emission tomography) in patients with tuberculosis (TB) may be able to detect non-replicating persister bacilli. This may permit identification of those patients at risk of relapse following completion of TB treatment. The main aim of this pilot study is to assess the ability of 11C-acetate PET to detect pulmonary lesions in individuals with active pulmonary TB.

Novel biomarkers for detecting pulmonary TB and response to treatment are sorely needed. PET in conjunction with either CT (computed tomography) or MRI (magnetic resonance imaging) scanning allows assessment of the metabolic activity of lesions as well as the structural anatomy of the lung. The standard radiolabelled tracer for PET is 18F-fluorodeoxyglucose (FDG) which labels metabolically active cells. However, one of the main limitations of FDG is the non-specific uptake leading to difficulty differentiating between tumours, infection and inflammatory pathologies.

11C-acetate is a PET ligand used currently to image various conditions but has not been used to identify TB lesions previously. 11C-acetate may be taken up by the lipid bodies in the dormant bacteria in TB, enabling visualization of this sub-population of bacteria. Using the 11C-acetate ligand for imaging pulmonary TB may add to the utility of PET scanning, potentially allowing monitoring of drug activity against the persister population and identification of those patients who may be at risk of relapse following drug therapy.

This pilot study will compare 11C-acetate to the standard ligand, FDG, using PET/CT and PET/MRI. The target population for this study is those individuals with confirmed pulmonary TB who have a high chance of demonstrable bacillary burden who are therefore likely to have populations of persister bacteria in the lungs.

Eligibility Criteria:
Inclusion Criteria:

1. Age 21 years and above
2. Willing to comply with the study visits and procedures
3. Willing and able to provide written informed consent
4. Clinical diagnosis of pulmonary TB with characteristic symptoms and compatible X-ray findings plus microbiological confirmation with one or more of (i) Acid-fast bacilli (AFB) smear-positive or (ii) molecular test positive or (iii) TB culture positive. Tests done at any time during the current episode of TB are acceptable for diagnostic purposes
5. Not on TB treatment or have completed less than 8 weeks of TB treatment

Exclusion Criteria:

1. Diabetes that is, in the judgment of the investigator, so poorly controlled that it would prevent adequate PET scanning
2. Cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for MRI
3. Known chronic kidney disease
4. Occupation involving substantial exposure to radiation
5. History of medical procedures in the last year involving substantial exposure to radiation (\>2mSv)
6. Malignancy requiring chemotherapy or radiation
7. Women who are currently pregnant or breastfeeding
Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE)

This French national, multicenter, prospective, longitudinal, observational study will describe the treatment modalities of a cohort of patients with relapsed or refractory follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the presence or not of MabThera® (rituximab) maintenance therapy. Actively participating physicians will enroll patients and collect therapeutic management data in a real-life setting up to 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age \>/= 18 years)
* Presenting with WHO grade 1-3, CD20-positive follicular non-Hodgkin's lymphoma, histologically confirmed at initial diagnosis
* In relapse (or refractory) after at least one line of treatment, regardless of the nature of previous treatments (chemotherapy and/or immunotherapy and/or radioimmunoconjugate therapy and/or radiation+chemotherapy) and for whom a decision was made to give salvage therapy
* Having received oral and written information about the study and having raised no objections to electronic capture and processing of his/her personal data

Exclusion Criteria:

* Patient participating in a clinical trial evaluating a new, non-commercialized cancer treatment at the time of inclusion
* Follicular lymphoma presenting with a transformation to diffuse large cell non-Hodgkin's lymphoma
* First line treatment with radiotherapy alone
* Initial abstention from treatment (decision to not treat the progression at the time of inclusion in the OLYMPE study)
Correlation of Genetic Susceptibility Genes to Inflammatory Bowel Disease in Chinese Han Population

The pathogenesis of IBD is still unclear, and the disease characteristics of IBD patients are affected by genetic susceptibility genes. Therefore, this study aims to explore the relationship between genetic susceptibility genes of IBD and the pathogenesis of IBD in Chinese Han population, in order to clarify the pathogenesis of IBD and provide basis for individualized treatment of IBD.

The pathogenesis of IBD is still unclear, and the disease characteristics of IBD patients are affected by genetic susceptibility genes. Therefore, this study aims to explore the relationship between genetic susceptibility genes of IBD and the pathogenesis of IBD in Han Chinese, in order to clarify the pathogenesis of IBD and provide basis for individualized treatment of IBD.In this study, 5ml peripheral venous blood was drawn from IBD patients and normal controls for gene testing.To investigate the relationship between polymorphisms of TRAIL, ITGA4, ICAM1, ITGA4, ICAM1, LTA, FCGR3A, TRAP1, TNFRSF1B, CDKN2B-AS1 and susceptibility to IBD in Chinese Han population.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed IBD patients were collected from the Department of Gastroenterology, The Second Affiliated Hospital of Wenzhou Medical University.According to the consensus of "Diagnosis and treatment of inflammatory bowel disease" formulated by Chinese Society of Gastroenterology, the diagnosis of IBD was established by clinical, laboratory, radiographic, digestive endoscopy and histopathological examination.During the same period, 476 healthy subjects were collected from the physical examination center of our hospital as the normal control group

Exclusion Criteria:

* Active infection, malignant tumor, congestive heart failure, demyelination of nervous system, allergy to rat derived protein components, etc All subjects were excluded from infectious diarrhea, ischemic enteropathy, radiation enteritis, gastrointestinal tumor, diabetes, systemic lupus erythematosus, rheumatoid arthritis and autoimmune thyroiditis by clinical examination before inclusion.
Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis

To collect data on actual-use to assess technical performance and user injections of dupilumab auto-injection device by patients with atopic dermatitis (AD).

Study is conducted in 2 parts: part A and part B.

Part A - Patients with moderate-to-severe AD will be randomized to receive dupilumab (dose 1) by auto-injector (AI) device or prefilled syringe.

Once part A is completely enrolled, part B will randomize patients with moderate-to-severe AD to receive dupilumab (dose 2) by auto-injector (AI) device or prefilled syringe.

Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosis of chronic atopic dermatitis for at least 3 years with inadequate response to topical medications within 6 months before screening
2. Willing and able to comply with all clinic visits and study-related procedures
3. Provide signed informed consent

Key Exclusion Criteria:

1. Patient \< 30.0 kilograms (Kg) in weight
2. Patient who has previously participated in a dupilumab clinical study
3. Patient who has been treated with the following:

   * An investigational drug within 8 weeks or within 5 half-lives (if known),whichever is longer, before the baseline visit
   * Immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mufti, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.) or Phototherapy for AD within 4 weeks before the baseline visit
   * An experimental monoclonal antibody within 5 half-lives or within 6◦months prior to visit 1 if the half-life is unknown
   * Biologic agents within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer
   * Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to visit 1
   * A live (attenuated) vaccine within 4 weeks before the baseline visit
4. Patient who has initiated treatment with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
5. Patient who has skin comorbidities that may interfere with study assessments
6. Patient with a planned or anticipated major surgical procedure during the patient's participation in this study
7. Women of childbearing potential unwilling to use adequate birth control measures during the study
8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply