cyrilzakka/clinical-trials huggingface dataset:
Italian Registry of Allergen ImmunoTherapy

RIAIT (Italian Registry of Allergy Immunotherapy) is a multicenter observational study that aims to prospectively collect the most extensive data available on Italian patients using AIT for respiratory allergies (rhinoconjunctivitis and/or asthma) in a real-life context, through a network of allergy centers with specific interest and expertise in the management of allergic respiratory patients.

Objectives include:

* Evaluate short and long-term real-life effectiveness and safety of AIT overall, in specific patient groups' phenotypes and with specific AIT products.
* Evaluate the pertinence and differences in suggesting AIT to a patient comparing physician's evaluation in various settings with established international guidelines, describing the factors associated with treatment choices and changing over time, and promoting interoperability, data sharing, and cross-comparison among centers.
* Describe long-term respiratory allergic disease evolution in patients treated with AIT.
* Describe the natural history of the patient population with respiratory allergies and identify patient groups describing their illness burden, management patterns, and clinical progression.
* Promote the creation of accurate, standardized, and efficient processes for diagnosing and treating respiratory allergic diseases, especially with AIT.
* Assess biomarker data to predict diagnosis, treatment response and long-term disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 1 year
* Confirmed diagnosis of allergic rhinoconjunctivitis and/or allergic asthma according to EAACI 2019 guidelines.
* Having been followed by the recruiting center for at least one month: this is considered necessary to establish that the patients are truly affected by allergic respiratory disease and are eligible for allergen-specific immunotherapy; in this period, screening tests are carried out to exclude and/or confirm concomitant diseases (comorbidities). In fact, according to the aforementioned EAACI guidelines, a patient can be defined as truly eligible for allergen-specific immunotherapy only after a preliminary phase in which the patient is treated with symptomatic therapy; this observation period allows a correct evaluation of the real adherence and response to therapy, as well as the identification and appropriate treatment of any comorbidity and the possible elimination of aggravating factors.
* Having received the prescription of any of the available AIT products in Italy, irrespectively of the selected allergens and the administration route and schedule.

Exclusion Criteria:

There will no be exclusion criteria, in order to allow a real-life vision of the characteristics of these patients eligible for or treated with allergen-specific immunotherapy.
The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma

Studies have shown that combination therapy of TACE with Lenvatinib could achieve better survival outcomes than TACE alone for hepatocellular carcinoma (HCC) at BCLC B stage. However, whether patients could benefit from the ablation for intermediate recurrent HCC (RHCC) is still need high quality clinical evidence. This study is to evaluate the efficacy of ablation combined with TACE and Lenvatinib for the intermediate-stage RHCC.

The evidence of ablation combined transarterial chemoembolisation (TACE) and Lenvatinib for intermediate-stage recurrent hepatocellular carcinoma (RHCC) is limited. Patient responses to this treatment vary because of the heterogeneous nature of RHCC. Thus, it is important to identify patients who are most likely to benefit from this three regimes therapy. The aim of this study is to comparison of TACE-Lenvatinib with TACE-Lenvatinib-ablation for intermediate RHCC.

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years;
2. RHCC diagnosed by imaging;
3. intermediate-stage RHCC (two to three lesions which at least one was \>3 cm in size or more than three tumors);
4. the tumor number was no more than six, and the maximum tumor diameter was ≤5 cm;
5. absence of extrahepatic metastasis or macrovascular invasion;
6. Child-Pugh class A or B;
7. TACE as initial treatment after tumor recurrence and showed no tumor progression after TACE.
8. life expectance \>3 months;

Exclusion Criteria:

1. under 18 years or over 75 years of age;
2. primary intermediate-stage HCC;
3. RHCC with more than six tumors, or single RHCC

(5) RHCC \>5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;
Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study

This project tend to investigate the affection of ketone bodies on brain metabolism. This will be done by measuring human cerebral uptake of energy substrates, together with functional parameters, using PET imaging and appropriate radiotracers under hyperketonemia in healthy subjects by ketone infusion.

Hypotheses

1. Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake by brain cells contributing to hyperglycaemia.
2. Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood flow.
3. Altered oxygen consumption during hyperketonemia in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI 20-30 kg/m2

Exclusion Criteria:

* smoking
* alcohol abuse
* severe comorbidity
* blood donation 6 month prior
* claustrophobia
Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects

The main purpose of this study is to measure the amount of study drug (BMS-986189) in the blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after a single dose.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy, males and females, 18 to 55 years of age, inclusive
* Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive
* Women of childbearing potential (WOCBP) must have negative serum pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to start of study drug

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of diabetes mellitus, severe hypertriglyceridemia, acute or chronic pancreatitis, pancreatic exocrine disorder
* History of autoimmune disease
* Any known skin condition that would affect subcutaneous dosing
* Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV -1 and HIV -2 antibody

Other protocol defined inclusion/exclusion criteria could apply
Detachable Clip-assisted Endoscopic Cyanoacrylate Injection in the Treatment of Gastric Varices

A single-arm exploratory clinical study design was used to evaluate the safety and efficacy of a "modified sandwich injection" of tissue glue assisted by a detachable clip for the treatment of gastric varicose veins.


Eligibility Criteria:
Inclusion Criteria:

* The subject voluntarily signs the informed consent for this experiment; According to clinical manifestation, laboratory examination, imaging examination, or liver biopsy in the diagnosis of liver cirrhosis patients; The endoscopy diagnosed gastric varices (gastroesophageal varices, gastroesophageal varices type 2 or type 1 isolated gastric varices type 1); High risk of gastric varices or has a history of gastric varices bleeding. The initial fluid resuscitation patients before or after the recovery hemodynamic stability; The age of 18 years old or more.

Exclusion Criteria:

* \< 18 years old; Regional portal hypertension; Always have a liver transplant, via the jugular intrahepatic portal vein system bypass or splenectomy combined varices cut-out art history; A concurrent hepatorenal syndrome and/or multiple organ failure; Significant impact on survival of malignant tumor; Pregnancy or lactation; A known allergy to iodine.
Evaluation of the Anticaries Efficacy of Dentifrice Formulations Using an In-situ Model

The primary objective is to compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with six different aqueous slurries of toothpaste formulations.


Eligibility Criteria:
Inclusion Criteria:

* Be 18-75 years of age.
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form.
* Be in good general health based on medical/dental history and oral exam.
* Have no history of adverse or allergic reactions to tin or tin-containing products.
* Agree not to participate in any other oral study for the study duration.
* Have a reasonable functional dentition as determined by the oral examiner and sufficient teeth to support the fabricated dental appliance.
* Be willing to participate in the study, able to follow the study directions, successfully tolerate/perform all study procedures, and willing to return for all specified visits at their appointed time.
* Be willing to refrain from using non-study dentifrice, mouth rinse, chewing gum, and other non-study oral care products during the study.
* Be willing to postpone all elective dental procedures until the study has been completed.
* Be willing to refrain from using calcium chews while using the test products.
* Be willing and able to refrain from wearing a nightguard (occlusal splint) for the entire course of the study (for nightguard wearers only).
* Ability to understand, and ability to read and sign, the informed consent form.
* Have at least 22 natural teeth.
* Have a gum-stimulated whole salivary flow rate ≥ 1.0 ml/minute and unstimulated whole salivary flow rate ≥ 0.2 ml/minute.

Exclusion Criteria:

-
Tolvaptan add-on Therapy to Overcome Loop Diuretic Resistance in Acute Heart Failure With Renal Dysfunction

Renal dysfunction, which comprises 10%-40% of acute heart failure patients (AHF), plays an important role in diuretic resistance mechanism. DR-AHF was designed to demonstrate the effectiveness of early tolvaptan (a vasopressin-2 receptor antagonist) add-on therapy in acute heart failure patients with renal dysfunction and clinical evidence of loop diuretic resistance.

This is a single-center, open-label, randomized controlled trial, which will enroll 128 patients hospitalized due to AHF. These patients with wet-warm phenotype whose estimated glomerular filtration rates at admission are above 15 and below 60 mL/min/1.73 m2, and cumulative urine output \<300 mL in 2 hours after the first dose of intravenous furosemide will be randomly assigned 1:1 to receive a standard care with uptitrating intravenous furosemide alone or a combination therapy with tolvaptan 15mg once daily for 2 days. The standard furosemide treatment will follow the modified 2019 Position Statement from the ESC Heart Failure Association. The primary endpoint is the cumulative urine output at 48 hour. Key secondary endpoints include the improvement of fractional excretion of sodium at 6 hour, the total dose of furosemide, the changes in the body weights, the net fluid loss, the lessening of diastolic dysfunction parameters on echocardiography, and the incidence of clinically relevant worsening renal function at 48 hour.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to hospital with a primary diagnosis of acute heart failure with wet-warm phenotype
* Cumulative urine volume output \< 300ml within 2 hours after the first dose of intravenous furosemide
* eGFR at admission 15-60ml/min/1.73m2

Exclusion Criteria:

* Acute coronary syndrome
* Anuria
* Sepsis
* Consciousness impairment
* Pregnant or breastfeeding women
* Severe valvular heart diseases (severe valvular stenosis or regurgitation)
* Admission sodium level \> 140 mEq/L
* Serum total bilirubin \> 3 mg/dL
* Serum potassium \> 5.5 mmol/L
* Allergy or contraindication for tolvaptan
* Emergency indication for hemodialysis
* Cardiogenic shock or mechanical circulation support
SpO2 Hypoxia Accuracy Validation Study

The primary objective of this study is to evaluate the % oxygen saturation by pulse oximetry accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.

The primary objective of this study is to evaluate the %SpO2 accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.

Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female
* The subject is of any racial or ethnic group
* The subject is ≥ 30 kg (≥ 66 pounds) in weight (self-reported)
* The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement)
* The subject is between 18 years and 50 years of age (self-reported)
* The subject shows no evidence of medical problems as indicated by satisfactory completion of the health assessment form
* The subject has given written informed consent to participate in the study
* The subject is both willing and able to comply with study procedures.

Exclusion Criteria:

* The subject has a BMI greater than 31 (based on weight and height)
* The subject has had any relevant injury at the sensor location site (self-reported)
* The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination)
* The subject is current smoker (self-reported)
* The subject has a known respiratory condition (self-reported)
* The subject has a known heart or cardiovascular condition (self-reported)
* The subject is currently pregnant, is actively trying to get pregnant, or who has a positive urine pregnancy test on the day of the study
* The subject has a clotting disorder (self-reported)
* The subject has Raynaud's Disease (self-reported)
* The subject is known to have a hemoglobinopathy (self-reported)
* The subject is on blood thinners or medication with aspirin (self-reported)
* The subject has unacceptable collateral circulation from the ulnar artery (based on examination)
* The subject is unwilling or unable to provide written informed consent to participate in the study
* The subject is unwilling or unable to comply with the study procedures
* The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
SCM Muscle as a Marker for Frailty in Patients Undergoing ENT Surgery

This study focuses on evaluating the relationship between physical frailty and measurements of the muscles of the neck in patients undergoing non-cancer Head and Neck surgery.


Eligibility Criteria:
Inclusion Criteria:

• Non-oncologic patients presenting for head and neck surgery with available neck CT scans.

Exclusion Criteria:

* Patients undergoing cancer surgery
* Patients under18 years of age
* Patients without pre-surgical CT-scans of the head and neck
Women Underwent TRAM Surgery: Its Influence on Abdominal Muscle Function and the Effects of Therapeutic Exercises

The unilateral transverse rectus abdominis musculocutaneous (TRAM) flap is a major operation widely used for breast reconstruction. It is hypothesized that this surgery has the potential risk of weakening the abdominal wall because it disrupts the integrity of the rectus abdominis muscle (RA), therefore, alters the insertion of the oblique muscles and the biomechanical relationship between the RA muscle and adjacent structures. The purposes of this study were to examine the effects of the TRAM flap surgery on muscle size of abdominal muscles, strength and endurance of trunk muscles, strength and endurance of core stability, as well as the effects of therapeutic exercises on it in post-mastectomy women underwent TRAM surgery.

This first year of the proposed study was aimed to understand the impacts on abdominal muscle functions. We design a case-control, cross-sectional study. There were 46 women who have undergone TRAM flap and 36 age-matched healthy women. We recorded the biomechanic and electromyographic responses during voluntary limb movements and elicited by unexpected support surface translations and tilts in standing. A six-camera Qualisys motion system was used. Ground reaction forces and moments were acquired by one Kisler force plate. Surface electromyography electrodes were used to record the activity of selected trunk and limb muscles. The second year was aimed to evaluate the effects on abdominal muscle functions after 12 weeks abdominal muscle training in the TRAM women. Outcome measures were the clinical tests for trunk muscle strength, endurance and one-leg standing was also used to exam the abdominal muscle function.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults

   * Their age should be ranged between 30 - 60 years
2. TRAM flap surgery patients

   * at least 6 months after the MS pedicled TRAM flap surgery

Exclusion Criteria:

1. Healthy adults

   * a history of injury resulting in an inability to perform activities of daily living
   * scoliosis or spinal surgery
   * neurological, neuromuscular, rheumatological or systemic diseases
2. TRAM flap surgery patients

   * tumor distant metastasis
   * a history of injury resulting in an inability to perform activities of daily living
   * scoliosis or spinal surgery
   * neurological, neuromuscular, rheumatological or systemic diseases
Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)

The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions of routine clinical practice. The primary objective is to identify the current criteria/reasons to use sirolimus as base therapy in this selected population and define and understand the emerging patterns of immunosuppressive treatment with sirolimus.

pilot study

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older.
* Patients who received a renal transplant (primary, secondary, tertiary, etc.) without pancreas, from Expanded Criteria Donors (ECD), 3 months prior and no later than 1 year at the time of study enrollment.
* Patients who provided informed consent.
* Patients without sirolimus as base therapy.

Exclusion Criteria:

* Patients who are unwilling or unable to provide informed consent or who lack a legal guardian or designee able to provide consent on their behalf.
* Patients who are unable to complete the study.
* Patients who are participating in another clinical trial during the last 6 months.
* Pregnant or lactating patients.
A Multi-center Study on Human Microecology Assisted Diagnosis of Colorectal Cancer

As for this research，we want to find whether the intestinal microecology (flora, peptidoglycan fragments) have certain distribution characteristics in colorectal diseases; whether it can predict the development of disease/as a prognostic indicator.

We even want to find whether it can predict the development of disease/as a prognostic indicator.

Eligibility Criteria:
Inclusion Criteria:

* people who is going to get the colonoscopy examination

Exclusion Criteria:

* people who was diagnosed as one cancer，expect for CRC; who has had the antibiotics or the medicine that treats for colorectal disease, except for medical probiotics, in one month; who has had the laxative and the colonscopy in one week; who had a operation in three month.
EPO-4-Rhesus Study

Up to 80% of infants with hemolytic disease due to maternal alloimmunization, treated with IUT, require at least one top-up transfusion for late anemia during the first 3 months of life. Erythropoietin deficiency is also considered as a possible contributing factor to late anemia and therefore we will assess the role of EPO (darbepoetin alfa) in the treatment of these infants.

The mainstay of antenatal treatment of fetal anemia due to red cell alloimmunization is (serial) IUT. The mainstay of postnatal treatment in HDN is (1) intensive phototherapy and exchange transfusion to treat hyperbilirubinemia and prevent kernicterus, and (2) top-up transfusions to treat anemia. Up to 80% of infants with HDN treated with IUT require at least one top-up transfusion for late anemia during the first 3 months of life.

Several risk factors for late anemia have been reported, including serial IUT (due to bone marrow suppression), severity of HDN, reduced use of exchange transfusions during the neonatal period and reduced survival of transfused red blood cells. Finally, erythropoietin deficiency is also considered as a possible contributing factor to late anemia.

EPO has been increasingly used in neonates to prevent or reduce neonatal anemia without short or long-term adverse effects. Several small studies and casuistic reports suggest that neonates with HDN may benefit from treatment with EPO to reduce the risk of delayed anemia and subsequent top-up transfusions. However, other authors found that EPO may be less effective than expected. Due to the lack of evidence, routine use of EPO is currently not recommended. To determine a role for EPO in this group of patients, a well-designed randomized controlled clinical trial of sufficient sample size is required. Potentially, EPO stabilizes the hemoglobin levels of these infants and thus prevents top-up transfusions and extra admissions, creating a more stable and natural postnatal course for patients with HDN.

Eligibility Criteria:
Inclusion Criteria:

* all (near)-term neonates (gestational age ≥ 35 weeks) admitted to the Leiden University Medical Center (LUMC) with HDFN, treated with IUT.

Exclusion Criteria:

* none.
A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects

Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will be treated early with micafungin or placebo to determine the incidence and time to confirmation of fungal infection.

Subjects will be assessed at the following visits:

* Baseline (after surgery, prior to randomization)
* End of Treatment (EOT) visit (EOT is defined as: requires alternative antifungal, sufficient improvement of surgical condition, confirmed fungal infection or death)
* End of Study visit (28 days after the EOT visit)
* Long-term Follow up visit (90 days after the EOT visit)

Eligibility Criteria:
Inclusion Criteria:

* Intra-abdominal infection requiring surgery and Intensive Care Unit stay
* If Community Acquired Intra-Abdominal Infection, at least 72 hours (but not more than 120 hours) of Intensive Care Unit stay, counted from the end of surgery, and a further expected duration of Intensive Care Unit stay of ≥ 48 hours
* If Nosocomial Intra-Abdominal Infection, duration of Intensive Care Unit stay ≤ 48 hours, counted from the end of surgery, and a further expected duration of Intensive Care Unit stay of ≥ 48 hours
* Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain highly effective birth control during the study

Exclusion Criteria:

* Acute pancreatitis
* Neutropenia (ANC \<1,000/mm3) at the time of randomization
* Infected intra-peritoneal dialysis
* Patients undergoing solid organ transplantation
* Documented invasive candidiasis at the time of randomization
* Expected survival \< 48 hours
* Any systemically active anti-fungal within 14 days prior to administration of the study drug
* Allergy, hypersensitivity, or any serious reaction to an echinocandin anti-fungal or any of the study drug excipients
* Currently receiving and/or has taken an investigational drug within 28 days prior to randomization
* Pregnant woman or breast-feeding mother
* 'Do Not Resuscitate' order