cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Status in Inflammatory Bowel Disease

Inflammatory bowel disease (IBD), comprising crohn's disease (CD) and ulcerative colitis (UC), is a a chronic, relapsing-remitting systemic disease. Vitamin D is a secosteroid hormone that possesses immunomodulatory properties and has been demonstrated to potentially influence inflammatory bowel disease (IBD) pathogenesis and activity.

Inflammatory bowel disease (IBD), comprising crohn's disease (CD) and ulcerative colitis (UC), is a a chronic, relapsing-remitting systemic disease and it is increasing sharply with rapidly increasing proportion in developing countries., and the common medications are not effective for most patients.The key underlying pathogenic mechanisms for both diseases is a dysregulated host immune response to commensal intestinal flora in genetically susceptible individuals.Vitamin D is a fat-soluble vitamin, a secosteroid hormone whose active form, calcitriol or 1,25-dihydroxyvitaminD3 (1,25(OH)2D3) plays important roles in immune regulation, particularly involving the innate immune system, cell differentiation and intercellular adhesion, promotes the production of anti-microbial peptides, including β-defensins and cathelicidins, the shift towards Th2 immune responses, and regulates autophagy and epithelial barrier integrity.The relationship between vitamin D deficiency and IBD is bidirectional that vit D with its immunomodulatory effects influence IBD pathogenesis and activity and IBD itself can lead to vitamin D deficiency.Vitamin D deficiency has associated with increased IBD activity scores, lower quality-of-life, an increased risk of IBD-related surgery and increased hospitalizations.\[4\]. Vitamin D downregulate powerful proinflammatory cytokines, such as TNF, which enhance the durability of anti-TNF therapy in IBD and its deficency has been found to be associated with earlier cessation of anti-TNFα therapy( loss of response to biologic therapy.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with Inflammatory Bowel Disease (either ulcerative colitis or crohns disease ) patients diagnosed through clinical evaluation ,laboratory ,colonoscopic and histopathological studies.

Exclusion Criteria:

* patients known to have malignancy, or metabolic disease associated with vitamin D and calcium abnormalities e.g. hyperparathyroidism and history of vitamin D supplementations.
* patients with known biliary disease, chronic liver and kidney diseases.
* Patients with a mal-absorption syndrome other than IBD.
* Pregnant or lactating patients.
Hybrid Procedure in Patients With Persistent Atrial Fibrillation

In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram, 24 hour Holter monitoring, and 2 week long-term electrocardiogram of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.

Atrial fibrillation is highly associated with sudden death and stroke, requiring definitive treatment. In Korea, atrial fibrillation is a common disease predicted to affect more than 5% of the population over 65 years of age and more than 10% over 80 years.

Totally thoracoscopic ablation has been adopted and performed successfully on February 2012 at Samsung Medical Center for the first time in Korea. More than 120 operations have been performed up to date.

In Korea, treatment for atrial fibrillation is still dependent on percutaneous RFCA, and life-long medication and anticoagulation is needed when recurrent atrial fibrillation occurs. The investigators expected thoracoscopic ablation to be an alternative to overcome this limitation. Also, thoracoscopic ablation and RFCA are recently being performed simultaneously or stage by stage as a hybrid procedure, and the results are being reported.

In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram and 24 hour Holter monitoring of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Long-lasting persistent atrial fibrillation
2. Persistent atrial fibrillation refractory to antiarrhythmic drug therapy
3. over 18 years

Exclusion Criteria:

1. Valvular heart disease of more than moderate degree
2. Unresponsive ischemic cardiomyopathy
3. Follow-up of over 1 year was not possible
4. Warfarin was unable to be used
5. Refusal of informed consent
6. Left atrial thrombus
Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma

The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.


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

Key Inclusion Criteria:

* Histologic diagnosis of unresectable stage III or IV metastatic melanoma
* Prior ipilimumab induction treatment (3 mg/kg)
* Documented disease control \[Stable Disease ≥3 months or Partial Response/Complete Response\] after ipilimumab induction
* Documented progressive disease following disease control

Key Exclusion Criteria:

* Patients with brain metastasis are excluded, unless they are free of neurologic symptoms related to metastatic brain lesions and do not receive systemic corticosteroid therapy for the purpose of reducing intracranial inflammation in the 10 days prior to beginning retreatment with ipilimumab
* Any intervening anticancer therapy between last dose of ipilimumab induction and ipilimumab retreatment on study
* Patients who experienced any grade 3 immune-related adverse event (irAE) (except for endocrinopathies where clinical symptoms were controlled with appropriate hormone replacement therapy) or any grade 4 toxicity during prior treatment with ipilimumab
* Patients with a prior irAE that has not improved to grade 1 or better at randomization
Identification and Validation of Clinical Phenotypes in Staphylococcus Aureus Bacteremia and Their Association With Mortality and Development of Complicated Bacteremia

The goal of this observational study is to determine retrospectively whether different patient clinical phenotypes (adults and children) develop Staphylococcus aureus bacteremia.The main questions it aims to answer qre:

1. Evaluate its reproducibility and correlation with mortality
2. Derive and validate a simplified probabilistic model for phenotype assignment
3. External validation of the simplified probabilistic phenotype assignment model found and its association with mortality and development of complicated bacteremia in a prospective cohort
4. Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes.


Eligibility Criteria:
FOR STANDARD STUDY:

Inclusion Criteria:

* Adults and children with clinically significant Staphylococcus aureus bacteremia (at least two classic systemic inflammatory response criteria: fever, tachycardia, tachypnea, lowered awareness, low blood pressure, leucocytosis/leucopenia, organ failure)

Exclusion Criteria:

* Patients with non-clinically significant bacteremia.
* Death within 48 hours after detection of bacteremia for the inclusion of retrospective cases, life expectancy less than 48 hours for the inclusion of retrospective cases, life expectancy less than 48 hours for the inclusion of retrospective cases.
* Patients under palliative sedation at the time of bacteremia report.
* Polymicrobial bacteremia.

FOR EXTENDED STUDY:

Inclusion Criteria:

* Adults with clinically significant Staphylococcus aureus bacteremia included in the Standard Study
* Selected at random as one of the model phenotypes until completing recruitment (only HUVM and HUVV)

Exclusion Criteria:

* Patients with non-clinically significant bacteremia.
* Death within 48 hours after detection of bacteremia for the inclusion of retrospective cases, life expectancy less than 48 hours for the inclusion of retrospective cases, life expectancy less than 48 hours for the inclusion of retrospective cases.
* Patients under palliative sedation at the time of bacteremia report.
* Polymicrobial bacteremia.
The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants with Peanut Allergy

Early and regular ingestion of the common allergens, peanut and egg has been shown to be an effective allergy prevention strategy. It is not clear whether this is also true of tree nut allergy. Current practice in many Australian allergy clinics for children with peanut allergy (high risk of tree nut allergy), is to advise families to introduce each individual tree nut into their child's diet via a cautious home introduction protocol without prior allergy testing (screening). The safety and effectiveness of an early and regular ingestion strategy for the prevention of tree nut allergy has not been formally evaluated and it is known that around a third of children with peanut allergy develop one or more other nut allergies. This trial is a 2-armed, open-label, randomized, controlled trial (RCT) to assess the safety and efficacy of a supervised hospital based multi-tree nut (almond, cashew, hazelnut and walnut) oral food challenge (OFC) + then home introduction of the remaining tree nuts versus standard care (home introduction of all 8 tree nuts) in infants with peanut allergy to reduce the risk of developing tree nut allergy.


Eligibility Criteria:
Inclusion Criteria:

Infants aged greater than 4 months and less than 11 months of age diagnosed with IgE-mediated peanut allergy in conjunction with a positive SPT (≥3mm) or sIgE (specific immunoglobulin E) (\>0.35 kU/L)

Exclusion Criteria:

* Any history of severe food induced anaphylaxis. Defined as reaction requiring 2 doses of intramuscular (IM) adrenaline.
* Pre-existing tree nut allergy (parent-reported).
* Any tree nut already tolerated (ingestion on \>3 occasions without reaction of around 1 teaspoon)
* SPT or sIgE performed to any tree nuts
* Not commenced or unable to eat solid food
* Prescribed beta-blocker medication
Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children

The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.

A study of safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years, inclusive, who require continuous opioid analgesia for moderate to severe pain.

Eligibility Criteria:
Inclusion Criteria include:

* Male and female patients, 7 to 16 years of age, inclusive, with malignant and/or nonmalignant moderate to severe pain requiring or anticipated to require continuous, around-the-clock, opioid treatment for at least 2 weeks (based on the investigator's judgment);
* Patients must have written informed consent provided by the parent or legal guardian and assent provided by the patient, when appropriate;
* Patients on incoming opioids must be taking ≤ 80 mg/day morphine or equivalent if aged 12 to 16 years or ≤ 40 mg/day morphine or equivalent if aged 7 to 11 years prior to the screening visit;
* Patients and patient's parent/caregiver must be compliant with the protocol, ie, must be able to perform study assessments and understand and complete the age-appropriate scale to rate pain intensity. Patients must not have a cognitive developmental delay or any other condition that would preclude them from completing the age-appropriate pain scale.

Exclusion Criteria include:

* Patients who are allergic to buprenorphine or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects \[eg, nausea, constipation\]) or who have allergies or other contraindications to transdermal delivery systems or patch adhesives;
* Patients with a dermatological disorder, including burn and skin graft sites, at any relevant patch application site that would preclude proper placement and/or rotation of BTDS patches;
* Patients with evidence of impaired renal function;
* Patients with hepatic impairment;
* Patients with history of seizures;
* Patients with intracranial pressure;
* Patients who have a history of sleep apnea within the past year;
* Patients who require mechanical ventilation during study treatment period, are cyanotic, or who have unstable respiratory disease;
* Patients with clinically significant structural heart disease or a pacemaker;
* Patients with clinically unstable cardiac disease;
* Patients who receive or anticipate to receive investigational medication/therapy during study drug treatment period.

Other protocol-specific inclusion/exclusion criteria may apply.
Neoadjuvant Vs Adjuvant in Locally Advanced Recurrent NPC

A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy

Eligible patients are randomized into the control group and the experimental group.

Patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy.

Patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
2. Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;
3. Cervical lymph node metastasis can be controlled locally;
4. Aged 18 to 75 years;
5. Informed consent forms signed to participate in the trial;
6. Without distant metastasis;
7. ≥6months from the accomplishment of radical radiation to recurrence
8. previously only 1 course of radiotherapy;
9. Sufficient organ function;
10. ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.

Exclusion Criteria:

1. Participate in other interventional clinical trials;
2. Uncontrolled illnesses that interfere with the therapy;
3. Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);
4. Any contradiction to surgery;
5. With serious autoimmune disease;
6. The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration;
7. Severe allergic reactions to other monoclonal antibodies;
8. History of radioactive particle planting;
9. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
10. Female patients who are at pregnancy or lactation;
11. Other situations that the researchers believe not suitable for enrollment
Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients

Within clinical settings observation of hemodynamic changes (e.g. mean systemic filling pressure, cardiac output) in critically ill patients with a clinical indication for deresuscitation with intravenous diuretic therapy.

Rationale: The assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (MAP) and cardiac output (CO) supply insufficient information about the circulating volume and cardiac performance. There is a clinical need for adequate determination of intravascular volume status. However, in determining the intravascular fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. The importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce CO many times more than a similar increase in arterial resistance. Mean systemic filling pressure (Pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment.

Positive fluid balance and /or substantial weight gain in critically ill patients is a common problem in the intensive care unit (ICU), potentially associated with a poor outcome. This problem, in association with hemodynamic instability and increase of creatinin, ureum and sodium, may lead to peripheral edema. Furosemide, a loop diuretic, is frequently administered to critically ill patients to increase urine output and to relieve edema.

Objective: Observing changes in Pms during continuous furosemide administration.

Study design: Prospective, observational study Study population: Patients with a PICCO® system with a positive fluid balance and / or substantial weight gain and therefore with a clinical indication for diuretic therapy.

Intervention: Continuous furosemide administration. Main study parameters/endpoints: Pms measured at baseline, changes in Pms during continuous furosemide administration.

Adverse events: No risks involved.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years
* PiCCO in situ (cardiac output device applied in light of clinical treatment)
* CVL in situ
* Clinical indication for continuous furosemide administration

Exclusion Criteria:

* Patients younger then 18 years
* Patients without PiCCO
* Pregnant women
Testicular Tissue Viability After Cryopreservation

we will use testicular tissue from patient who underwent orchidectomy due to medical reasons and test the viability of the tissue after cryopreservation and de-freezing.


Eligibility Criteria:
Inclusion Criteria: male patient undergo orchidectomy -

Exclusion Criteria: non viable testicular tissue

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Online Psychosocial Support for Young People With a Visible Difference: A Randomised Control Study

A visible difference can have a profound impact in a society with a massive emphasis on appearance and "looks". A vulnerable group is adolescents with a condition affecting their appearance as a result of injuries (burns, accidents), treatment (cancer), skin conditions or congenital anomalies (birthmarks, craniofacial conditions). Research has identified potential psychological difficulties, which, if not addressed, can lead to anxiety, depression, and eating disorders.

In addition to medical treatment options, aiming at diminishing a difference that may be visible to others, young people with appearance concerns also need self-management skills. However, evidence-based interventions are scarce and specialised psychological treatment is difficult to reach.

The Centre for Appearance Research (Bristol, UK) has developed an online intervention for adolescents, now translated into Norwegian (www.ungfaceit.no). UNG Face IT provides easy access to specialist advice and support via a home computer, using information, videos, and interactive activities. It provides advice, teaches coping and social skills, strengthening psychological adjustment to a visible difference.

A systematic evaluation of the Norwegian version is needed. UNG Face IT could potentially address unmet needs, provide a cost-effective tool to reduce the need for "face-to-face" psychological and surgical/medical services, and contribute to make online health care available for young people with a visible difference.


Eligibility Criteria:
Inclusion Criteria:

* Age 12-17 with an appearance-altering condition, and experiencing appearance-related distress, teasing, or bullying
* Access to a home computer/tablet and internet
* Reading level \> 12 years of age. Audio recordings for all written text available on the website for those who may struggle with reading
* Normal/corrected-to-normal vision

Exclusion Criteria:

* Clinical depression, psychosis, eating disorder (alternative support necessary)
* Post-traumatic stress disorder (PTSD) or within 12 months of traumatic injury (alternative support necessary)
* Learning disability that would impede understanding of the programme's content
* Currently receiving psychological intervention
Immunohistochemical Algorithm for the Diagnosis and Classification of Hepatocellular Carcinomas With TERT, TP53 and CTNNB1 Mutation

The presence of certain mutations in HCC, such as TERT and TP53, have a suspected or proven prognostic role in resected patients, but lack a morphological or immunophenotypic counterpart, which would allow us to define which tumours are rationally candidate for molecular biology analysis. The identification of a histological and immunohistochemical algorithm to determine which HCCs to take to NGS for prognostic purposes will save time and economic costs in the laboratory by rationalising available resources. In the future, the application of the immunohistochemical and molecular algorithm on biopsy could allow better prognosis and predictivity even before surgery/therapy.

The primary aim is the identification of possible associations between the biomarkers p53 and beta-Catenin and the presence of the genetic mutations TERT, TP53 and CTNNB1 identified by clinical practice, in patients undergoing hepatic resection of HCC.

The secondary objective is the identification of possible associations between the presence of biomarkers Glutamin Synthetase, Glypican-3 and HSP70 and genetic mutations identified by clinical practice, in patients undergoing hepatic resection of HCC.

STUDY DESIGN: exploratory study. It is planned to recruit approximately 100 patients, who underwent liver resection for HCC and already underwent NGS analysis (for which the mutational profile is already known). All clinical and histological data will be collected, immunohistochemistry investigations will be performed on formalin-fixed and paraffin-embedded material corresponding to that used for molecular analysis.

STUDY POPULATION: The study envisages the enrolment of 100 patients, already undergoing liver resection for HCC at the IRCCS AOU of Bologna, in the period 2020-2022, who will be retrospectively re-evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients resected for HCC
* Availability of NGS data
* Availability of paraffin material for immunohistochemistry investigations

Exclusion Criteria:

* None