cyrilzakka/clinical-trials huggingface dataset:
Tacrolimus During the Implantation and the Effect on Ischemia-reperfusion Injury in Liver Transplantation

The evaluation of the efficacy of an intraportal infusion with Tacrolimus, at the time of liver graft implantation, compared to a control group without immunosuppressive intraportal infusion (Placebo: Saline solution 0.9%) with respect to the initial liver function measured by the parameters of the liver function (LFP): AST (U/L), ALT (U/L), total Bilirubin (mg/dL) and the coagulation factors: NT (%), PTT (s), INR.


Eligibility Criteria:
Inclusion Criteria:

* Multi organ transplantation or retransplantation
* ABO incompatible donor organ recipients- Patients, who are listed on the liver transplant-waiting list at the Vienna General Hospital and who fulfill the clinical requirements (local allocation)
* Written informed consent
* Age \> 18
* First transplantation

Exclusion Criteria:

* Fulminant failure of the liver
* Liver-Living donor recipients
* pregnant or nursing women
* Allergy/Intolerance to antimetabolites, HCO-60, EL Cremophor or similar compounds,Steroids or macrolide antibiotics
* HIV-positive donors or recipients
* Participants of another clinical study
* Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
Role of Thymus-And Activation-Regulated Chemokine (TARC) In Diagnosis Of Allergic Bronchopulmonary Aspergillosis

This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary Aspergillosis.

Allergic bronchopulmonary Aspergillosis (ABPA) is a pulmonary hypersensitivity disease mediated by an allergic response to Aspergillus fumigates. ABPA occurs in, 10% of cystic fibrosis (CF) patients and may lead to acute worsening of respiratory status and ongoing decline in lung function, ultimately progressing to a chronic state and lung fibrosis without adequate treatment. Despite the existence of the gold-standard Nelson criteria, diagnosis of ABPA in CF patients remains difficult. The wide variation in diagnostic practices between clinics, different estimates of prevalence and a delay in recognition lead to under treatment (Virnig and Bush 2007).

The main reason for the difficulties in diagnosis of ABPA and ABPA exacerbations in CF patients is the overlap of diagnostic criteria for ABPA with common manifestations of CF. Pulmonary infiltrates, obstructive lung disease and bronchiectasis occur regularly in CF patients, due to the underlying disease with bacterial colonisation, and thus are not specific to ABPA. Furthermore lung colonisation with A. fumigatus occurs in 20-25% of CF patients. Therefore, as stated in the most recent consensus document on diagnosis and therapy of ABPA in CF patients, serological findings should contribute strongly to the confirmation or exclusion of clinically suspected ABPA (Stevens, Moss et al. 2003).

The diagnosis of allergic bronchopulmonary Aspergillosis (ABPA) in cystic fibrosis (CF) is a challenge. Thymus- and activation-regulated chemokine (TARC) has recently been reported to play a role in ABPA (Latzin, Hartl et al. 2008).

TARC levels (analyzed by sandwich ELISA) increased early in the course of ABPA, before total IgE elevation, with an inverse correlation between TARC levels and spirometric parameters (FEV 1) identified in CF patient with ABPA. Elevated TARC level was strongly correlated with the level of rAsp f4 in ABPA patients, while no association was found with the other recombinants (rAsp f1, f2, f3 and f6). This biomarker showed a greater test accuracy for ABPA diagnosis than all other biological markers tested (total IgE, specific c IgG and antibodies against recombinants allergens rAsp f1, rAsp f3, rAsp f4 and rAsp f6). It seems to be able to differentiate CF patients with ABPA from those colonized or sensitized to A. fumigatus. Furthermore, corticotherapy decreases the TARC secretion, producing a rapid decrease of serum TARC level that can be used to follow patient evolution as well as the effect of corticosteroid therapy in ABPA (Delhaes, Frealle et al. 2010).

Eligibility Criteria:
Inclusion Criteria:

* • In this study patients referred from chest department for diagnosis of allergic pulmonary Aspergillosis will be included.

Exclusion Criteria:

* • Pregnancy

  * Lactating women
Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement

This is a randomized, double blind, vehicle controlled Phase 2 study with a 4-week open label extension in adolescent and adult participants with atopic dermatitis and head and/or neck involvement. It is intended to compare the efficacy and safety of ruxolitinib cream 1.5% BID versus vehicle cream, then further evaluate ruxolitinib cream as maintenance during the open label extension period.


Eligibility Criteria:
Inclusion Criteria:

* Participants with diagnosis of AD for at least 6 months.
* Participants with an overall and a face and/or neck IGA score of 2 or 3 at screening and baseline.
* Participants with AD affecting the following at screening and baseline:

  1. ≥ 0.5% of the total BSA on the face and/or neck
  2. Up to a total of 20% BSA (face and/or neck plus other body areas)
* Willingness to avoid pregnancy or fathering children based on the criteria outlined in the protocol.
* Further inclusion criteria apply.

Exclusion Criteria:

* Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline.
* Participants with concurrent conditions and history of other diseases such as immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with the evaluation of AD or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids.
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Previous treatment with systemic or topical JAK inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
* Participants who are pregnant (or who are considering pregnancy) or lactating.
* Laboratory values outside of the protocol -defined criteria
* Further exclusion criteria apply.
Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

The purpose of this Phase 3 study is to evaluate the efficacy and safety of iptacopan upon switching from anti-C5 antibody to iptacopan treatment in study participants with aHUS.

The study is designed as a multicenter, single-arm, open label study to evaluate the efficacy and safety of iptacopan upon switching from anti-C5 antibody to iptacopan treatment in participants with aHUS. It consists of a screening period of up to 8 weeks followed by a 12-Month Core Treatment period and 12-Month Extension Treatment period.

The study will assess the effects of iptacopan on a range of efficacy assessments relevant to aHUS.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adult participants ≥ 18 years of age with diagnosis of aHUS for whom etiologies of other types of TMA and non-aHUS kidney disease have been excluded.
* Currently on the recommended weight-based dosage regimen of anti-C5 antibody treatment for at least 3 months prior to the screening visit.
* Clinical evidence of response to anti-C5 antibody treatment (in absence of PE/PI) for at least 3 months prior to entering the screening period as defined by:

  1. Hematological normalization in platelet count ≥150 x 109/L and LDH below upper limit of normal \[ULN\], and
  2. Stable or improving kidney function as defined by ≤15% increase in serum creatinine.
* Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections is required prior to the start of treatment with iptacopan.
* If not received previously or if a booster is required, vaccination against Haemophilus influenzae infection, should be given, if available and according to local regulations.

Exclusion Criteria:

* History of aHUS disease relapse while on anti-C5 antibody treatment.
* eGFR \< 30 ml/min/1.73m\^2
* Active infection or history of recurrent invasive infections caused by encapsulated bacteria, i.e., meningococcus, pneumococcus (eg., N. meningitidis, S. pneumoniae) or H. influenzae.
* Participants with sepsis or active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study treatment administration.
* Kidney, bone marrow transplant (BMT)/hematopoietic stem cell transplant (HSCT), heart, lung, small bowel, pancreas, liver transplantation or any other cell or solid organ transplantation
* Female patients who are pregnant or breastfeeding, or intending to conceive during the course of the study
* Any medical condition deemed likely to interfere with the patient's participation in the study
REThink for Mental Health of the Youths in Romania

In order to test the effect of the intervention, a multi-center randomized control trial (RCT) will be conducted to test the efficacy of the REThink interventions on improving bullying (both victimization and aggression) and mental health compared with a care as usual group. A minimum of 1000 students from the participating institutions (schools will be able to join based on a recruitment call), will be recruited and randomly assigned to either the experimental or control group.


Eligibility Criteria:
Inclusion Criteria:

* internet and PC access to complete the scales and game

Exclusion Criteria:

* no internet or PC access
Role of Flexible Cystoscopy in Laparoscopic Stone Surgery

Authors want to investigate the usefulness of flexible cystoscopy in performing laparoscopic pyelolithotomies and ureterolithotomies by comparing operative results of a single surgeon's experience.

Previous trials to increase stone clearance rates have been recently reached using flexible equipment in laparoscopic surgery, however, it is not clear whether using flexible equipment is really helpful in performing pyelolithotomies and the clearance rates using flexible equipment varies 71% to 100%. Therefore, authors plan to investigate the usefulness of flexible cystoscopy in performing laparoscopic pyelolithotomies and ureterolithotomies by comparing operative results of a single surgeon's experience.

Eligibility Criteria:
Inclusion Criteria:

* patients with complex renal stones and large or impacted ureter stones
* patients who underwent laparoscopic pyelolithotomies with concomitant calyceal stone removal or ureterolithotomy using a flexible cystoscopy or not

Exclusion Criteria:

* active infection, uncontrolled bleeding tendency, previous abdominal surgery
Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis

Nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in Japan, and in May 2015 the use of nalfurafine hydrochloride was officially approved in Japan for pruritus in patients with chronic liver diseases including PBC. In the current study, the investigators aimed to assess pruritus and overall QOL before and after administration of nalfurafine hydrochloride in patients with PBC. Furthermore, the investigators took serum sample from the enrolled patients and examine the association of pruritus with possible biomarkers.

Primary biliary cholangitis (PBC, formally known as primary biliary cirrhosis) is a chronic cholestatic liver disease. Taking advantage of ursodeoxycholic acid (UDCA), the outcome of patients with PBC has been improved, comparable to those in general population. However, pruritus, which is often a persisting and annoying symptom, may decrease the quality of life (QOL) of patients with PBC. Although anti-histamines are administered for this the efficacy is limited, and no drugs which was clearly proved to be effective for suppressing pruritus have been developed worldwide.

Nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in Japan, and in January 2009 approved for pruritus in patients with renal failure and under hemodialysis. A phase 3 trial of nalfurafine hydrochloride for pruritus in patients with chronic liver diseases was completed, indicating the efficacy as well as safety was confirmed. Therefore, in May 2015 the use of nalfurafine hydrochloride was officially approved in Japan for pruritus in patients with chronic liver diseases including PBC. However, only 59 patients with PBC were included and therefore it is still unclear whether nalfurafine chloride is effective in all PBC patients or a part of them, whether the effect of this drug depends on coadministered drugs or other complications, or whether this drug may improve QOL overall in patients with PBC.

In the current study, the investigators aimed to assess pruritus and overall QOL before and after administration of nalfurafine hydrochloride in patients with PBC, to answer the clinical questions described above. Furthermore, the investigators took serum sample from the enrolled patients and examine the association of pruritus with possible biomarkers.

Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of PBC
* Complain of moderate or severe pruritus
* Decided by physician to be administered nalfurafine hydrochloride

Exclusion criteria

* Severe liver damage (Child-Pugh grade C)
* Allergic to nalfurafine hydrochloride
* With no or mild pruritus
Psychiatric and Cognitive Assessment of Adult Patients With Hearing Impairment

1. Assess the impact of hearing impairment on cognition
2. Evaluate the impact of hearing impairment on mental health
3. Evaluate the impact of hearing impairment on quality of life
4. Assess the relation between hearing loss and psychiatric disorder

Hearing impairment is described as the partial or total loss of hearing ability. On the basis of the severity of the problem hearing impairment can be classified as mild, moderate, severe and profound. Age related hearing impairment is a very common disorder in older adulthood. It is considered as third most prevalent chronic health condition in people over 65 years of age. Hearing impairment in old age typically stems from some pathological changes inside the ear which are related to aging, it may lead to the impairment of low to high frequency hearing. This problem comes up with greater difficulty in listening process that significantly impairs person's ability to communicate with others, which in turn is a serious concern related to the mental health of individual.

It has been reported that adults with hearing loss tend to exhibit more symptoms of depression, anxiety, psychological distress, and emotional sensitivity as compared to people with normal hearing.

Hearing loss poses a serious risk to the mental well-being and overall quality of life in older adults. People may experience diminished self-esteem that in effect leads to the poor mental health and decline in psychological well-being.

Also, recent studies have demonstrated independent associations of hearing loss with incident dementia.

In Egypt such studies are lacking so investigators try to assess the impact of hearing loss on Psychiatry, Cognition and Quality of life by psychiatric interview, psychometric assessment , cognition assessment and quality of life assessment.

the aim is to evaluate the impact of hearing impairment on the above domains in Egypt

Eligibility Criteria:
Inclusion Criteria:

1. All patients diagnosed with hearing impairment
2. Age : 18 years and above
3. Gender: both sexes are included
4. willing to participate in the study
5. willing and able to provide informed consent

Exclusion Criteria:

1. Patients with intellectual disabilities
2. Patient with previous psychiatric and cognitive disorders
3. Patients with neurological diseases that affect hearing
4. Patients with history of chronic/ significant medical condition
Relationship of Noninvasive Assessment of Central BP With 10 Years Atherosclerotic CVD in Subclinical Hypothyroidism

verify Relationship of noninvasive assessment of central arterial blood pressure with 10 years Atherosclerotic Cardiovascular disease (ASCVD) in Subclinical hypothyroidism

Subclinical hypothyroidism (SCH), characterized by elevated thyrotropin (TSH) levels with normal free thyroxine (T3,T4) concentrations, is a prevalent disorder affecting approximately 10% of the adult population. It has been increasingly recognized for its potential impact on cardiovascular health. A 10-year follow-up study highlighted a significant association between elevated serum TSH levels and increased cardiovascular (CV) risk, independent of conventional risk factors. And it demonstrated its association with hypercholesterolemia and atherosclerosis as the leading risk of CVD. Moreover, in a recent meta-analysis, subclinical hypothyroidism was shown actually be correlated with an increased risk of CVD and mortality.

Monitoring thyroid function underscores the potential importance of cardiovascular (CV) risk assessment, for patients with subclinical hypothyroidism (SCH). Incorporating thyroid function tests, such as TSH and free thyroxine (FT4) levels, alongside non-invasive central arterial blood pressure monitoring, provides a comprehensive understanding of a patient\&amp;#39;s CV risk. This integrated approach enables early identification and targeted interventions, ultimately improving patient outcomes and reducing the incidence of CVD among those with SCH.

One of the earliest functional changes underlying ASCVD is Arterial stiffening it reflects a variety of pathologies, including atherosclerosis. As an important determinant of cardiovascular health, arterial stiffness can contribute to increased blood pressure and reduces vessels\&amp;#39; capacity to buffer the pulsatile flow when the heart contracts, which are significant risk factors for predicting ASCVD.

For continuous non-invasive central arterial blood pressure monitoring, the auscultatory method or The Oscillometric technique can be used. These methods provide valuable insights into the health of the central arteries, which are crucial in understanding the cardiovascular risk profile of patients with SCH.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70
* Both sex

Exclusion Criteria:

* Patients had thyroidectomy operation
* Patients with a history of encompassing acute coronary syndrome (ACS).
* Myocardial infarction (MI).
* Coronary heart disease (CHD).
* Cerebrovascular diseases or other arterial revascularization
Adapting Food Culture to the Mediterranean Pattern for International Students in Italy

The goal of this clinical trial is to describe the adherence to the Mediterranean diet, the nutritional status, the level of physical activity, and possible eating disorders in international students attending the University of Pavia before and after a food education intervention. The main questions it aims to answer are:

Does the intervention of food education change the nutritional status of the international students of the University of Pavia? Does the intervention of food education change the level of physical activity of international students of the University of Pavia? Does the intervention of food education change the possible risk of eating disorders related to the possible change of diet from the country of origin of international students? Researchers will compare the measurements done at the first meeting to the measurements made at the last meeting (6 months) to see if the food educational intervention helped the students.

Participants will:

* have the body composition analysed by anthropometric measurements (weight, height, electric bio impedance)
* Receive personalized guidance and support from our team of experts for 6 months.

Visit the clinic 3 times (beginning, 3 months, and by the end of 6 months) for check-ups and tests, and participate in online meetings the other 3 months (second, fourth, and fifth).

Answer online questionnaires and perform a 3-day food diary (beginning, 3 months, and by the end of 6 months).


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Able to understand English or Italian
* Nationality diverse than Italian
* Absence of major morbidities that interfere with food choices, such as diabetes, hypertension, renal dysfunction, etc.

Exclusion Criteria:

* ≤18 years old;
* Italian nationality;
* Presence of major morbidities that interfere with food choices, such as diabetes, hypertension, renal dysfunction, etc.
Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients

The goal of this clinical trial is to investigate whether gastroscopies with single-use gastroscopes used bedside can reduce the time from indication to procedure compared with gastroscopies with reusable gastroscopes used in the endoscopy unit in patients referred to a subacute gastroscopy. The main question it aims to answer is:

- Is the time from indication to procedure reduced when performing the gastroscopy bedside compared with performing the gastroscopy in the endoscopy unit.

Researchers will compare bedside gastroscopies with gastrosopies in the endoscopy unit to see if the time from indication to procedure is reduced.

Participants will in the first period have gastroscopy with a reusable gastroscope in the endoscopy unit. In the second period participants will have gastroscopy with a single-use gastroscope bedside.


Eligibility Criteria:
Inclusion Criteria:

* Patients of any gender, 18 years of age or older admitted to surgical department 2 (the acute section of the surgical department) at Zealand University Hospital referred to early EGD without general anesthesia.

Exclusion Criteria:

* ASA-score of 4 or higher
* Unstable patient
* Suspicion of ventricular retention
* Suspicion of active bleeders
* Need for expert endoscopist to perform the procedure, e.g. stenting
* Patients \< 18 years of age
Accuracy of Linear Measurements of Ultra-low Dose Cone Beam Computed Tomography and Digital Panoramic Radiography

measurements performed directly on dry mandibles will be compared with measurements obtained from CBCT( ultra-low dose) scans and Digital panoramic radiography.

Mandibular anaesthetic landmarks will be identified on each dry mandible and will be marked using gutta percha.

The ten human dry mandibles will be submitted for:

1. Digital Panoramic Radiography. Panoramic radiographs will be obtained using the SOREDEX CRANEX™ 3Dx unit. The exposure parameters will be 8Ma, 63kVp and 16.4 sec exposure time.
2. Cone Beam Computed Tomography (CBCT). SOREDEX CRANEX™ 3Dx unit will be used in this study. Images will be acquired at a single rotation. SOREDEX® MiniDose parameters will be used. The exposure parameters will be 3.2 Ma, 90kVp and 2.3 sec exposure time to take the advantage of 3D data in dose sensitive cases like children, or reduce the radiation dose for the patient.

The real linear measurements will be measured in millimeter on dry mandibles using digital caliper and will be compared with measurements obtained from both techniques.

Images will be evaluated by two experienced radiologists of ten years of experience. Each one will evaluate the images separately twice with a period of two weeks in-between the two reading sessions. The researcher will measure out the real linear measurements on the dry mandibles using digital caliper.

Eligibility Criteria:
Inclusion Criteria:

* age 10 to 70 years
* no gender nor race predilection
* Either dentulous or edentulous are acceptable.

Exclusion Criteria:

* fractures
* pathology