cyrilzakka/clinical-trials huggingface dataset:
Clinical Application of Fibroblast Activation Protein PET/MRI in Liver Fibrosis

Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and staging of liver fibrosis. Activation of hepatic stellate cell (HSC) is a key link in the pathophysiological development of liver fibrosis. In human liver tissue, fibroblast activation protein (FAP) was only expressed in active HSCs and fibroblasts, but not in static HSCs. Therefore, FAP has become an excellent target for diagnosis and treatment of liver fibrosis. Recently, radionuclide-labeled fibroblast activation protein inhibitors (FAPI) as a new novel positron tracer has shown to be effective to detect various cancers. In this prospective study, the investigators will use the most advanced imaging equipments, integrated PET/MR, and PET/CT with gallium-68 (68Ga) -FAPI to image patients with or suspected of liver fibrosis, the aim is to explore the value of 68Ga-FAPI hybrid PET/MR and PET/CT in liver fibrosis.

Liver fibrosis is a key step in the development of various chronic liver diseases (viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, autoimmune liver disease, etc.) to cirrhosis and an important link that affects the prognosis of chronic liver disease. Fibrosis is histologically reversible, and early liver fibrosis can still be reversed to restore liver tissue to normal. However, due to the lack of specific initial symptoms and accurate non-invasive diagnostic methods, the onset of liver fibrosis is insidious. Most patients have developed liver cirrhosis and/or hepatocellular carcinoma when they are diagnosed, and some even require liver transplantation. If liver fibrosis can be diagnosed accurately and treated early, the prognosis of chronic liver disease can be improved.

Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and staging of liver fibrosis. Activation of hepatic stellate cell (HSC) is a key link in the pathophysiological development of liver fibrosis. In human liver tissue, fibroblast activation protein (FAP) was only expressed in active HSCs and fibroblasts, but not in static HSCs. Therefore, FAP has become an excellent target for diagnosis and treatment of liver fibrosis. Recently, radionuclide-labeled fibroblast activation protein inhibitors (FAPI) as a new novel positron tracer has shown to be effective to detect various cancers. In this prospective study, the investigators will use the most advanced imaging equipments, integrated PET/MR, and PET/CT with gallium-68 (68Ga) -FAPI to image patients with or suspected of liver fibrosis, the aim is to explore the value of 68Ga-FAPI hybrid PET/MR and PET/CT in liver fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected or diagnosed or treated liver fibrosis.
* Subjects are able to understand and sign the informed consent voluntarily, with good compliance.

Exclusion Criteria:

* Acute systemic diseases and electrolyte disorders.
* Pregnant or lactating women.
* Patients refuse to sign the informed consent.
O-GlcNac Modified Proteomics Study of the Maturation of Hemodialysis Arteriovenous

We divided into three parts to carry out. Firstly, evidence the pre-existing fibrosis in vein of AVF failure patients. investigation of expression, the role, and the mechanism by which the identified O-GlcNAac proteins promote, maturation of AV fistula. Finally, ddress and compare the proteomics differentiation between failure and maturation of AVF patients.

End stage renal disease (ESRD) patients requires hemodialysis to maintain bloodstream functions. Before the hemodialysis, the patients requires a long-term vascular access, which best choice is Arteriovenous fistulas (AVF). However, 1/3 of patients were failure in AVF maturation, and it is still unknown. Our preliminary data have shown that pre-exisiting fibrosis in vein of AVF failure. Here, we will investigate whether pre-existing fibrosis of vein is asssociated with circulating fibrocytes in AVF failure, and further to address molecular mechanism of fibrocytes differentiation. We will divide into three parts to carry out. Firstly, evidence the pre-existing fibrosis in vein of AVF failure patients. Secondary, investigation of expression, the role, and the mechanism by which the identified O-GlcNAac proteins promote, maturation of AV fistula. Finally, address and compare the proteomics differentiation between failure and maturation of AVF patients. We hope that through this project, we can obtain signifiture molecules for precision detection and solve the current clinical unmet need.

Eligibility Criteria:
Inclusion Criteria:

* Age of 20 and older adult patients, and preoperatively clinical and ultrasound assessment of the arm vessels are fisible for the creation of a native HDAVF that include:the augmented diameters of the veins is \> 2.0 mm and the diameter of the radial artery is\> 2.0 mm. Besides, there is no obvious stenosis of vessels in the forearm.

Exclusion Criteria:

* The patient refused to join the study
* Too weak
* Serious heart failure
* Unconsciousness
* Bedridden for long time
* systemic lupus erythematosus(SLE), or other known autoimmune diseases
* The physician excludes the possibility of creating a wrist HDAVF before surgery
* Surgeon preoperatively identifies vessel inadequacy for the creation of a wrist HDAVF
* Choose a site other than the wrist for surgery
* Unexpected negative complications happen during surgery that prevent the completion of a wirst HDAVF
Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Requiring Cardiopulmonary Bypass

Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and mortality. Clot formation and clot stability are important factors in coagulation and hemostasis. As such platelet dysfunction and impaired thrombin generation play a central role in bleeding after cardiac surgery. The primary objective of this study is to evaluate the relationship between point-of-care determined platelet function and thrombin generation and postoperative bleeding in infants and young children undergoing cardiac surgery with cardiopulmonary bypass adjusting for clinically important confounding factors.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≤5 years
2. Undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

1. Non-english speaking parents/care-givers
2. Refusal to consent
3. Extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
4. Therapeutic heparin use (unfractionated or low molecular weight) in the immediate preoperative period (\<12 hr)
5. Weight \<3 kg
Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome

The purpose of this study is to determine whether Mepolizumab (a monoclonal antibody against interleukin-5) is a safe and well-tolerated therapy that will allow for steroid tapering in patients with steroid-dependent Churg-Strauss Syndrome (CSS).

Specific Aims:

1. Document the safety of mepolizumab therapy in patients with CSS.
2. Demonstrate the steroid sparing effect of mepolizumab therapy by decreasing corticosteroid dosage while using this anti-IL5 therapy.
3. Demonstrate the efficacy of anti-IL5 therapy in improving the signs and symptoms of CSS by:

   1. Measuring serum markers of CSS disease activity, including: peripheral eosinophilia, erythrocyte sedimentation rate, anti- neutrophil cytoplasmic antigen, C-reactive protein and IgE levels.
   2. Assessing the activity level of vasculitis via the Birmingham Vasculitis Activity Score
   3. Evaluating asthmatic response via serial peak flow and FEV1 measurements as well as asthma symptom scores using the Juniper scale.
   4. Assessing changes in novel parameters such as fractional excretion of nitric oxide and IL-5 levels.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Diagnosis of Churg Strauss Syndrome
* Maintained on stable corticosteroid dose of at least prednisone 10mg daily (or equivalent) prior to enrollment in study
* If on cyclophosphamide, azathioprine or methotrexate, must be on a stable dose and be able to maintain that dose for the duration of the study

Exclusion Criteria:

* Hypereosinophilic Syndrome
* Wegener's Granulomatosis
* Malignancy
* Parasitic Disease
* Pregnant or nursing
* If female and of child-bearing potential, must have negative pregnancy test prior to each infusion of study medication and must adhere to acceptable method of contraception (with \<1% failure rate)
* Any other medical illness that precludes study involvement
The Relationship Between Single Nucleotide Polymorphisms of Chitinase 3-like 1 Gene,YKL-40 Serum Levels and Adult Asthma

The objective of this study was to investigate the relationship between single nucleotide polymorphism of chitinase 3-like 1 and human asthma.

Chitinase 3-like 1 (CHI3L1) is a member of human chitinases family. According to previous studies in literatures, increased expression of CHI3L1 has been proven to be correlated with the presence of different diseases, including cancers, autoimmune diseases, and chronic inflammatory conditions. Elevated serum levels of YKL-40 are associated with increased disease severity, poorer prognosis and shorter survival for many other diseases. When monitored over time, increases in serum YKL-40 parallel with disease progression. It can serve as an measurable marker of changes in disease status.

There were indicated that chitinase 3-like 1 might be associated with some clinical diseases. The C-allele of the -131 C→G (rs4950928) polymorphism of CHI3L1 has been shown to associate with bronchial hyperresponsiveness and reduced lung function. It is suggesting that variations in CHI3L1 may influence risk of asthma.

The objective of this study was to investigate the relationship between single nucleotide polymorphism of chitinase 3-like 1 and human asthma. The association between CHI3L1 SNPs and the continuous outcomes were examined by real time PCR and gene sequencing analysis.

In Korean reports there was no significant associations between CHI3L1 SNPs and asthma were observed. On the other hand, there were association between CHI3L1 and asthma observed in the majority of Caucasian populations. However, similar research has not been conducted in Taiwan. In contrast to preliminary studies, the investigators predict the rs4950928 G allele, and not the C allele, was found to be associated with asthma. The g.-247C/T polymorphism in the CHI3L1 promoter region is associated with the risk of atopy.

Eligibility Criteria:
Inclusion Criteria:

* ages 20 to 60 years
* asthma patients
* atopy patients
* control (non-asthma and non-atopy)
Corticosteroids to Treat Pancreatitis

This research is being done to determine if the administration of a short course of intravenous hydrocortisone, an anti-inflammatory medication, to patients with severe acute pancreatitis will improve their clinical outcomes and decrease the length of hospitalization. We think that because inflammation in the body drives the progression of pancreatitis, giving a short course of intravenous hydrocortisone may mitigate disease progression and improve clinical outcomes in patients with severe acute pancreatitis.

This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous hydrocortisone on clinical outcomes in patients with severe acute pancreatitis. The interventional drug is Hydrocortisone (100 mg of hydrocortisone in 50 milliliters of saline solution). The placebo is saline and is identical in appearance and volume to the interventional drug. Study drug will be administered intravenously every 8 hours for 72 hours as per standard clinical procedures by nursing staff. The patient's sequential organ failure assessment score (SOFA) will be assessed for changes over time. Blood will be drawn at several time points to assess biomarkers over time.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥18 years)
2. Acute pancreatitis as defined by a clinical diagnosis of pancreatitis and a lipase level ≥3x the upper limit of normal.
3. Admission or planned admission to an intensive care unit
4. SOFA disease severity score ≥3 (or at least 3 points above a known baseline)

Exclusion Criteria:

1. Known diagnosis of autoimmune pancreatitis
2. Existing clinical indication for corticosteroids at a dose \>5mg of oral prednisone daily (or equivalent)
3. Contraindication to receiving corticosteroids
4. Protected populations (prisoners)
5. Pregnancy
J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer

The objective of this study was to compare the functional and surgical results of the J-pouch with those of the side-to-end anastomosis and their impact on quality of life.

Invalidating anorectal dysfunctions are common after restorative rectal surgery. Improvement of functional results by the technically more demanding J-pouch has been demonstrated in comparison with the straight coloanal anastomosis. In the present multicenter randomized trial we assessed whether the J-pouch is also superior to the side-to-end coloanal anastomosis.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria comprised a histologically proven rectal cancer located in the middle or distal part of the rectum (≤ 10cm from the anal verge), and a WHO performance status ≤ 2.

Exclusion Criteria:

* Patients with a T1 or T4 tumor were excluded
* Patients diagnosed with distant metastases
* A medical history of colonic resection
* Anorectal surgery or chemo- radiotherapy
* Pre-existing fecal incontinence grade III or IV according to Parks10
* Life expectancy of less than one year.
Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children

Sodium bicarbonate injected into a blood vessel transforms to carbon dioxide and water. The increase in carbon dioxide production can be detected by measuring the exhaled carbon dioxide in the lungs.

This study is conducted to access the clinical application of measuring exhaled carbon dioxide to verify the correct position of intravenous catheters.Once the catheter is in the correct position the injected bicarbonate will be detected as a distinct elevation of exhaled carbon dioxide. A similar study was already performed in adults and was found useful. The investigators now extend the clinical application to children.

Extravasation is the unintentional injection or leakage of fluids into the perivascular or subcutaneous space resulting in potential tissue injury. This prospective controlled study, will assesse the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of intravenous (IV) catheters in ventilated children. Diluted sodium bicarbonate will be created using undiluted standard 8.4% (1 meq/mL) sodium bicarbonate mixed in a 1:3 ratio with sterile water to achieve a final diluted concentration of 2.1% (0.25 mEq/mL). In 20 ASA I-II mechanically ventilated children age 2-8 years, the effects of 1 ml/kg of diluted 2.1% sodium bicarbonate or 0.9% normal saline,injected in a randomized order, will be analyzed. All children will have venous blood samples taken prior to injection and 10 minutes after injection for analysis of venous blood pH and electrolytes.

Eligibility Criteria:
Inclusion Criteria:

* ASA I,II
* age 2-8 years

Exclusion Criteria:

* ASA III or higher
A Phase 1 Mass Balance Study of Varegacestat

This clinical study is designed to study the mass balance of a single dose of varegacestat in healthy male participants.

This is a single-center, open-label, Phase 1, mass balance study of varegacestat administered as a single oral dose (containing \~100 µCi) \[14C\]varegacestat in 6 healthy male participants.

Following completion of Screening and Day -1 assessments and an overnight fast of at least 10 hours, eligible participants will be administered a single dose (containing \~100 µCi) \[14C\]varegacestat as 2 oral capsules followed by approximately 240 mL room temperature filtered water on the morning of Day 1. Whole blood, plasma, urine, feces, and vomitus (if any, up to 24 hours post-dose) will be collected over at least 168 hours post-dose.

Eligibility Criteria:
Inclusion Criteria:

* Be a male participant between 18 and 55 years of age, inclusive, at Screening.
* Medically healthy based on the absence of clinically significant abnormal vital sign measurements, clinical laboratory test results (especially tests for renal and hepatic function), resting 12-lead Electrocardiogram (ECG) evaluation, and physical examination, as determined by the Investigator at Screening and the Check-In visit.

Exclusion Criteria:

* Have taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer.
* Have participated in a radiolabeled drug study or have been otherwise exposed to significant diagnostic (excluding dental X-rays), therapeutic, or occupational radiation, where exposure is made known to the Investigator, within one year prior to admission to the clinic for this study. The total estimated 12-month exposure to radio material or ionizing radiation should be below the CFR recommended levels considered safe (per US Title 21 CFR 361.1) or below 3000 mrem.
* Any condition which, in the opinion of the Investigator and/or Sponsor, would jeopardize participant safety or compliance with the Protocol.
Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice

TO FAst is a non-interventional study in France with primary objective to describe the clinical benefit of tofacitinib 1 year after its initiation for the treatment of moderate to severe UC in routine clinical practice. The study will also make it possible to report the clinical benefit 2 years after its initiation, to search for predictors of clinical benefit, improve our understanding of the efficacy of treatment in a real-life setting (in terms of response and speed of response), describe the characteristics of patients starting a treatment by tofacitinib, its real-life patterns of use as well as patient adherence to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 years old or above
* Patients with confirmed diagnosis of moderate to severe ulcerative colitis
* Patients for whom gastroenterologist decides to initiate treatment with tofacitinib as per the French SmPC
* Patients informed about the study procedures and receiving an information letter signed by the investigator

Exclusion Criteria:

* Patients who have already received tofacitinib treatment before baseline
* Patients that fulfill any of the contrindications according to the latest version of the SmPC
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.
* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
* Measurable disease according to RECIST v1.1.
* Subjects over 18 years old.
* Subjects' ECOG Performance Status Scale is \< 2.
* Subjects' life expectancy is more than 6 months.
* Platelet count ≥100,000/mm3.
* International normalized ratio of prothrombin time ≤1.8.
* Creatinine ≤1.9 mg/dL.
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
* Subjects are willing to sign an informed consent form.

Exclusion Criteria:

* Subject has a tumor of Keratoacanthoma histology.
* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
* High probability of protocol non-compliance (in opinion of investigator).
* Subjects not willing to sign an informed consent.
* Women who are pregnant or breastfeeding.
The Study is About the inﬂuence of the Combination of Music and Noise Cancelling as a Non-pharmacological Aid in Reducing Anxiety and Discomfort During Wisdom Tooth Removal. The Level of Fear is Measured by a Questionnaire Which the Patients Answer Twice and a Measurement of the Heartbeat

The goal of this clinical trial is to learn if the reduction of the noises (through head phones with music and noise cancelling) that occur during wisdom teeth removal, leads to a significant reduction in fear levels in patients compared to patients who do not have any noise reduction. The main questions it aims to answer are:

Do music and noise cancelling help patients to have less fear during wisdom teeth removal surgery by reducing the sounds of the surgery? Is there a difference between just the noise cancelling function or is it better to combine noise cancelling and music together?

Participants will:

Just come to their regular appointment (wisdom teeth removal) to our clinic, no follow ups needed. All participants will answer one questionnaire before and one after the surgery. All of them will have their rate of heartbeat measured for three times (before, during and after surgery, measured by a puls oximeter on the finger). They will be allocated to one of the three study groups (no headphones, headphones with noise cancelling or headphones with noise cancelling and music).

The headphones that will be used are Sennheiser Overear Headphones with modern noise cancelling function.

Pulse Oximeter is by BRAUN and CE-certified.

Observational Study Model: Randomised controlled, unblinded clinical trial, parallel group design

Sampling method: randomisation by a online randomizer tool

Eligibility Criteria:
Inclusion Criteria:

* willing to participate in the clinical trial, understood and signed the information sheet

Exclusion Criteria:

* younger than 18 years old
* hearing impairment