cyrilzakka/clinical-trials huggingface dataset:
Leflunomide for Maintenance of Remission in IgG4 Related Disease

The study has been designed as a 12-month, open-label, randomized, controlled study comparing the use of prednisone mono-therapy and prednisone and leflunomide combination therapy in treating patients with IgG4-related disease.

The aim of this clinical trial is to determine the safety and efficacy of Leflunomide in treating patients with IgG4-related disease by comparing the outcomes of prednisone and leflunomide combination therapy with prednisone mono-therapy. The follow-up period will be 12 months. During the follow-up period, results of laboratory tests and image examinations, IgG4-RD RI and other parameters which can reflect treatment response as well as adverse effect events will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years.
2. Diagnosis of IgG4-RD according to either Consensus statement on the pathology of IgG4-related disease (for those who have undergone biopsies) or 2011 Comprehensive diagnostic criteria for IgG4-related disease. Both of the two criteria for diagnosis are specified below.

(1)Consensus statement on the pathology of IgG4-related disease

1. Histopathologic features consisting of dense lymphoplasmacytic infiltrate, fibrosis(usually storiform in character)and/or obliterative phlebitis within involved organs.
2. Either an elevated IgG4+/IgG+cell ratio of \>40% within the affected organs or elevated IgG4-bearing plasma cells per high-power field is necessary. The cut-off number of IgG4-bearing plasma cells per high-power field is different depending upon the types of affected organs and specimens(through surgery or needle puncture biopsy).

(2)2011 Comprehensive diagnostic criteria for IgG4-related disease

1. Clinical examination showing characteristic diffuse/localized swelling or masses in single or multiple organs.
2. Hematological examination shows elevated serum IgG4 concentrations(135 mg/dl).
3. Histopathologic examination shows marked lymphocyte and plasmacyte infiltration and fibrosis or Infiltration of IgG4+ plasma cells(ratio of IgG4+/IgG+ cells \> 40% and \>10 IgG4+ plasma cells/HPF).

   Definite: a + b + c,Probable: a + c,Possible: a + b
4. Excluded from malignant tumors of each organ (e.g. cancer, lymphoma) and similar diseases (e.g. Sjögren's syndrome, primary sclerosing cholangitis, Castleman's disease, secondary retroperitoneal fibrosis, Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome) by additional histopathological examination.
5. Even when patients cannot be diagnosed using the Comprehensive diagnostic criteria, they may be diagnosed using organ-specific diagnostic criteria for IgG4-RD, such as Diagnostic criteria for IgG4-Mikulicz's disease.

Exclusion Criteria:

1. Subjects having received steroids or immunosuppressants in recent 3 months will be excluded.
2. Subjects who were hypersensitive to leflunomide will be excluded.
3. ALT and/or AST is more than two folds of the upper limit of relevant reference value at baseline.
4. WBC is less than 3×10\*9/L at baseline.
5. Female patients who are pregnant or breastfeeding.
6. Known significant concurrent medical disease.
Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib

Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib.

Clinical trials for ibrutinib and idelalisib were performed with a small number of patients (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this study is to determine the association between clinically significant side effects occurrence during the first year of treatment and plasma mean concentration of the steady state of ibrutinib or idelalisib at 1 month.

Recently, European medicines agency approved ibrutinib and idelalisib in the treatment of Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib. Nevertheless, clinical trials for these two drugs were performed for only 300-350 patients and showed several side effects profiles, the most frequent were diarrhea, infection, cutaneous rash... For some patients, treatment had to be reduced or stopped temporary or definitely.

Pharmacokinetic properties of these two drugs highlight an interindividual pharmacokinetic considerable variability. The aim of this clinical research study is to determine the association between clinically significant side effects occurrence during the first year of treatment (serious adverse reaction and/or grade CTCAE ≥ 3 and/or leading a dosage concession) and plasma mean concentration of the steady state of ibrutinib or idelalisib performed at 1 month.

To determine plasma mean concentration of the steady state of ibrutinib or idelalisib, blood tests will be performed every scheduled monitoring at visit 1 month during a pharmacokinetic exploration and during scheduled medical consultation (2, 3, 6 and 12 months) and every unscheduled visit in case of side effect occurrence.

Every scheduled monitoring visit, blood tests will be performed to determine plasma concentration in drug. Complementary blood or salivary samples will be collected before the treatment, 24 months later and in case of relapse to determine genetic characteristics. In parallel, a logbook will be completed by the patient to collect side effects. Finally, an oncology certified nurse call patients every 2 weeks. In case of side effect occurrence a visit will be organized in the next 3 days and a blood test will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of Chronic Lymphocytic Leukaemia (CLL), or Follicular Lymphoma (FL) or Mantle cell lymphoma (MCL) and a first prescription of idelalisib or ibrutinib
* Patients must give written informed consent
* Patients with Health Insurance System

Exclusion Criteria:

* Patient who several blood tests can't be performed (poor venous access)
* Patients under legal guardian
* Pregnant or breastfeeding women
Medical and Surgical Treatment of Esophageal Reflux

The purpose of this project is to lay the groundwork for a proposed clinical trial to compare the effectiveness of two approaches to gastroesophageal reflux disease: treatment with medications and treatment with anti-reflux surgery. This project includes a non-interventional pilot study to test ways of measuring outcomes of treatment, and to gauge potential participants' willingness to enroll in the proposed clinical trial.


Eligibility Criteria:
Inclusion criteria:

* age 18-80
* diagnosis of gastroesophageal reflux disease
* have taken proton pump inhibitor medications

Exclusion criteria:

* prior esophageal surgery
* other serious medical conditions
Post-Activation Performance Enhancement in Single and Multi-Joint Exercises with BFR and EMS in Male Volleyball Players

Investigators used a randomized controlled crossover design to compare the effect of blood flow restriction (BFR) and electrical muscle stimulation (EMS) protocols on post-activation performance enhancement (PAPE) in multi-joint versus single-joint exercises. Participants took part in six test sessions 72 hours apart. In the BFR group, 50% of the arterial occlusion pressure (AOP) was used. In the EMS group, a 75 Hz current was applied. In the Low Resistance exercise group, only exercise was performed without any condition. Bench press (multi-joint) and triceps push-down (single-joint) exercises were used in the conditions.

Participants took part in six test sessions 72 hours apart. All tests were performed between 2 and 4 pm to reduce the influence of circadian rhythms or fatigue on performance. Anthropometric measurements, 1 RM test, and grip strength and serving speed tests were determined before the practice session on the first day as a control condition. On the other six experimental days, players were randomly assigned to protocols (BFR, EMS, and LOW-LOAD) using software (http://www.randomizer.org). In the BFR group, 50% of the arterial occlusion pressure (AOP) was used. In the EMS group, a 75 Hz current was applied. In the Low Resistance exercise group, only exercise was performed without any condition. Bench press (multi-joint) and triceps push-down (single-joint) exercises were used in the conditions. In all protocols, participants performed a standardized warm-up protocol consisting of a 5-minute run at 9 km/h on a treadmill and a general warm-up consisting of 3 minutes of whole-body light stretching exercises. Following the warm-up and pre-exercise protocols, grip strength and service speed tests were performed with rest periods.

Eligibility Criteria:
Inclusion Criteria:

* Being healthy
* Male volleyball athletes
* Willing to maintain the intervention for all sessions

Exclusion Criteria:

* Being under 18 years old
* Having a chronic disease
* Contraindication for Electromyostimulation (EMS)
* Contraindication for Blood Flow Restriction (BFR)
* Contraindications for exercise
Computational Medical Imaging and Prediction of Diffusion/FLAIR Mismatch in Stroke Patients

Stroke is a public health issue and a priority for our institution. MRI plays an essential role in the management of stroke. In this context, the contribution of MRI is diagnostic, etiological and prognostic.

Among the MRI parameters evaluated in the acute phase of the stroke, the evaluation of the mismatch between the DIFFUSION and FLAIR sequences is crucial as it will directly contribute to the therapeutic decision. A FLAIR-diffusion mismatch, i.e., a lesion with a diffusion but not a FLAIR hypersignal, identifies patients whose time of onset of symptoms is probably less than 4.5 hours. It is therefore understandable that the main arterial recanalization techniques performed in the acute phase are primarily reserved for patients with a positive mismatch.

In current practice, mismatch assessment is performed subjectively, by visually comparing the two sequences, which is known to be the cause of a lack of reproducibility and diagnostic performance.

Computational medical imaging techniques ("radiomics") have recently gained momentum and offer the prospect of automated and therefore more reproducible analysis of medical imaging data. In stroke patients, radiomics extracted from FLAIR imaging could thus contribute to describe the "diffusion flair" mismatch in a continuous and objective way.

For the time being, data analysis cannot be performed in real time due to technical constraints. If it is proven that radiomics can reliably analyze the mismatch on the FLAIR sequence alone, the next step will be to make the analysis feasible in clinical routine (i.e. in a time frame adapted to the therapeutic management).


Eligibility Criteria:
Inclusion Criteria:

* Patient with age ≥ 18 years
* Patient with supra-tentorial stroke treated by mechanical thrombectomy and who had MRI imaging on admission before endovascular treatment at Paris Saint-Joseph Hospital
* Complete MRI protocol including Diffusion and FLAIR sequences
* French-speaking patient

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his data for this research
A Study of the Combination of Anti-PD-1 AK105 and Anlotinib in First-line Hepatocellular Carcinoma (HCC)

This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody AK105 plus anlotinib hydrochloride in the first-line treatment of patients with unresectable hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent form voluntarily.
* Male or female，age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
* Expected life expectance ≥ 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
* Confirmation either by histology unresectable hepatocellular carcinoma..
* BCLC stage C, and non-resectable BCLC stage B .
* No prior systemic therapy for HCC.
* Child-Pugh class A and B (≤7 points).
* At least one measurable lesion according to RECIST criteria.
* Adequate hematologic and end-organ function.
* For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent.

Exclusion Criteria:

* Prior treatment with anti-PD1, anti-PD-L1 or anti-CTLA-4 antibody therapy.
* Active ongoing infection requiring therapy.
* History of severe hypersensitivity reaction to another monoclonal antibody.
* Received any live attenuated vaccine within the last 30 days.
* Other malignancy requiring treatment in the prior 5 years with the exception of locally treated squamous or basal cell carcinoma.
* Pregnant, breast feeding, or planning to become pregnant.
* Active or prior documented autoimmune or inflammatory disease with some exceptions.
* Central nervous system metastases and/or carcinomatous meningitis.
* Medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication.
* Co-infection of HBV and HCV.
* Inadequately controlled arterial hypertension.
A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)

The researchers are doing this study to see if giving people fluorescein sodium as an IV infusion before their vulvectomy for treating extramammary Paget's disease (EMPD) can help surgeons with performing the procedure. The researchers will look at whether fluorescein sodium helps surgeons identify disease cells that should be removed. Other purposes of this study include looking at the following: If there are any complications during or after vulvectomy involving the use of fluorescein sodium. If fluorescein sodium can reveal tissue that surgeons cannot operate on (unresectable tissue).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Noninvasive or microinvasive EMPD with a contiguous visible clinical lesion
* Newly diagnosed or recurrent lesion
* Scheduled to undergo wide local excision or vulvectomy not requiring resection of the clitoris, urethra, or anus and with the surgeon's judgment that primary closure is possible (V-Y advancement flap closure is allowed)

Exclusion Criteria:

* History of allergic reaction to fluorescein sodium
* Multifocal, noncontiguous clinical lesion
* Current or previous invasive EMPD
* History of invasive vulvar, vaginal, or anal cancer
* Lesion in which resection of the clitoris, urethra, and/or anus is deemed to be necessary
* Lesion in which a primary closure or V-Y advancement flap is believed not to be possible and a larger myocutaneous flap is needed for closure of the defect
* History of radiation therapy to the vulva and/or anus
The Prophylactic Effect of Garlic Tablets to Prevent Nosocomial Infections in Intensive Care Unit Patients.

The goal of this clinical trial is to learn if garlic tablets works to prevent nosocomial infections in hospitalized patients in ICU. The main questions it aims to answer are:

Does garlic tablets administration lower the occurence of nosocomial infections in hospitalized patients in ICU?


Eligibility Criteria:
Inclusion Criteria:

* All patients aged from 18 to 65 years old admitted to intensive care units without any type of infection.

Exclusion Criteria:

1. Patients with signs /symptoms of infection.
2. Patients with human immunodeficiency virus, malignancy and patients with a history of recent immunosuppressants or corticosteroids administration.
3. Patients with bleeding disorders or abnormal coagulation profile
4. Patients who will planned for surgery within 2 weeks.
A Study in Healthy People to Compare Two Different Sifrol® Tablets

The main objective of this trial is to establish the bioequivalence of Sifrol® tablets manufactured at two different sites.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical histo1y including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics

With CT-perfusion(CTP) it is possible to visualize the enhancement pattern of the tumor. The perfusion CT, interleaved with a routine contrast enhanced CT (CECT) will be performed at diagnosis in all patients (goal: n=125 patients) and at the first follow-up at 3 months in patients treated with systemic therapy (goal: n=50 patients). Also, the histopathology will be collected for resected tumors to perform histopathology analysis. CTP parameters will be correlated to immunohistological findings and clinical outcome.

The main goal of the study is to create an AI-assisted method to classify patients with a vascular phenotype of pancreatic ductal adenocarcinoma (PDAC). The investigators expect that this phenotype can be used to predict overall survival and chemotherapy response.


Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of pancreatic cancer
* 18 years and older
* written (signed and dated) informed consent

Exclusion Criteria:

* Contra-indications to undergo CT (due to untreatable contrast allergy or renal function impairment)
* Previous treatment for pancreatic cancer
* Concomitant malignancies. Subjects with prior malignancies must be disease-free for at least 5 years
* Insufficient command of the Dutch language to be able to understand the patient information
Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity

It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEP) is present in grossly obese subjects especially in the supine position. The investigators tried to investigate the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.

Impaired gas exchange is a common anesthetic problem in obese subjects. It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEPi) is present in grossly obese subjects especially in the supine position. It is known that there is a significant negative correlation between PEEPi present and PaO2. Therefore, the investigators postulated that if the reduce the PEEPi by reducing the respiratory rate in obese subjects, the impaired gas exchange might improve.

The investigators tried to research the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I or II obesity, Body-mass index \> 27.5 undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* patients with severe cardiopulmonary disease peak inspiratory pressure \> 40 in the study setting
One-step Application of Artificial Dermis

The goal of this observational study is to study the effectiveness of one-step application of Lando® artificial dermal regeneration matrix for burn and plastic wound repair.

The main question it aims to answer is: the effectiveness of one-step application of Lando® artificial dermal regeneration matrix, including the take rate of skin graft and the appearance recovery of the wound.

Participants will be treated with artificial dermis that perfomed with STSG simultaneously. According to the routine clinical practice, the take rate of split-thickness skin graft at about 2-3 weeks and the appearance recovery of the wound at 3 months and 6 months after the implantation were measured.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≤ 70 years old.
2. Patients with non-infectious wounds of deep burns, full-thickness traumatic skin defects or plastic surgery that need to be repaired and reconstructed by artificial dermis.
3. Patients who voluntarily participate in this clinical trial and sign the informed consent form. When the subjects are under 18 years old or they have no capacity or limited capacity, they should have the consent and signature of the guardian or legal representative.

Exclusion Criteria:

1. Patients who need to participate in other clinical researchers within 30 days before or during the period of joining the group.
2. Patients with poor control of diabetes (those with fasting blood glucose ≥ 7.0mmol/L or glycosylated hemoglobin HbA1c ≥ 12% after drug control, transaminase \> 1.5 times and other diabetic complications).
3. Other cases that researchers believe not suitable for the participants of the trial.