cyrilzakka/clinical-trials huggingface dataset:
Anesthesia and Critical Care Registry

In recent decades, knowledge in the anesthesiology field has increasingly expanded, allowing for the refinement of monitoring techniques, therapies, and local-regional anesthesia maneuvers, and for the extension of care to a larger number of patients, including those previously excluded due to advanced age or comorbidities. Similarly, Intensive care management has continuously evolved, following innovations in the field of drugs and with the great diffusion of extracorporeal supports. The fundamental importance of registry studies has been recognized in this context to rapidly generate reliable data and improve the quality of care.

This prospective observational study is aimed at collecting data of all patients (expected 300,000) undergoing anesthesia or intensive care maneuvers at our institution. This registry aims to assist in carrying out registry-based clinical studies focused on improving current therapeutic and patient management standards.

The study aims to collect data on 300,000 patients who undergo anesthesia and/or resuscitation procedures at the IRCCS San Raffaele Scientific Institute over a 10 years period. The information collected will include demographic data, anthropometric data, past and/or current clinical history of the patient, anamnestic clinical-instrumental data related to the anesthetic activity, data on therapeutic measures taken during stay in intensive care units, laboratory parameters, diagnostic tests, therapeutic procedures carried out during hospitalization, patient satisfaction, and evaluation scales. All this data will be anonymized prior insertion in the database, with the aim of creating a registry that can be used for scientific research. This registry aims to assist in carrying out registry-based clinical studies focused on improving current therapeutic and patient management standards. The duration of observation of each patient will be variable, depending on the length of hospital stay and/or the duration of the diagnostic-therapeutic process. The analysis will follow the clinical course of patients from admission to hospital discharge, with the possibility of conducting telephone follow-ups for certain categories of patients after 1 year. Statistical analyses will be performed by grouping or describing patients based on their characteristics or in relation to the type of anesthetic and resuscitation procedures they undergo.

This study will follow the ethical principles outlined in the Helsinki Declaration and the current regulations for Observational Studies. All patients will be fully informed about the aspects of the study and their written informed consent will be required before participation.

Participation in the study is voluntary and free. No additional costs are expected for data collection and analysis: given the observational nature of the study, insurance coverage is not required.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Anesthesia or Critical care
* Signed informed consent.

Exclusion Criteria:

Refused informed consent
Comparison of Ticagrelor vs. Prasugrel on Inflammation, Arterial Stiffness, Endothelial Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Coronary Stenting

To investigate pleiotropic effects of ticagrelor in addition to its antiplatelet effects in type 2 diabetic patients with non-ST elevation acute coronary syndrome by measuring inflammatory markers, circulating number of endothelial progenitor cells, brachial artery endothelial function, and arterial stiffness.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Newly diagnosed type 2 diabetic patients or type 2 diabetic patients on hypoglycemic agents between the age of 30 to 70
3. Non-ST elevation Acute coronary syndrome with successful coronary stent implantation (with TIMI flow grade 3 after the procedure)

Exclusion Criteria:

1. Hypersensitivity to ticagrelor, prasugrel or any of the excipients
2. No prior use of either ticagrelor or prasugrel within a month prior to randomization.
3. History of intracranial bleeding at any time
4. Active pathologic bleeding
5. Hemoglobin A1c \>9%
6. Type 1 diabetes
7. Decreased serum platelet level (\< 100,000/uL)
8. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
9. Gastrointestinal bleed within the past 6 months, or major surgery within 30 days
10. Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
11. Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study
12. Involvement in the planning and/or conduct of the study
13. Left ventricular ejection fraction \< 40%
14. Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase \> twice the upper limit)
15. Gastrointestinal disorder such as Crohn's disease
16. Alcohol abuse
17. Steroid or hormone replacement therapy
18. Serum creatinine \> 2.0 mg/dL.
19. Prior history of CVA or stroke
20. Body weight \< 60 kg
21. Life expectancy less than a year
22. Known pregnancy, breast-feeding, or intend to become pregnant during the study period
Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Advanced Malignant Melanoma

PRIMARY OBJECTIVES: Determination of safety and toxicity of vaccination with patients' tumour mRNA transfected DCs .

SECONDARY OBJECTIVES:Determine immunological response to the vaccine (induction of specific T-cell response) and assessment of tumour response


Eligibility Criteria:
Inclusion Criteria:

* Accessible tumour tissue for vaccine production (extraction of tumour mRNA) i.e.subcutaneous or lymph node metastases.
* Must be at least 18 years of age.
* Must have histologically confirmed advanced, metastatic cutaneous melanoma no longer amenable for surgery.
* Must have evidence of disease progression and measurable or evaluable metastases
* Must be ambulatory with a ECOG performance score of \<2
* Must have lab.values as following :

ANC \> 1.5 x 109/L; platelets \> 100 x 109/L, Hb \> 9g/dL (\> 5.6 mmol/L). Creatinine \< 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance \> 40 mL/min, Bilirubin \< 20% above the upper limit of normal, ASAT and ALAT \< 2.5 the upper limit of normal. Albumin \> 2.5 g/L.

* Prior radiotherapy: A minimum of 4 weeks (8 weeks in case of extensive radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol.
* Prior chemotherapy: A minimum 4 weeks must have elapsed between the end of the prior chemotherapy and entry into the protocol.
* Signed informed consent of the patients for the treatment and follow up must be obtained and documented according to the ICH-GCP Guidelines.

Exclusion Criteria:

* History of prior malignancy other than melanoma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervix stage 1B.
* Active infection requiring antibiotic therapy.
* Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
* Autoimmune disease currently treated with steroids.
* Adverse reactions to vaccines such as anaphylaxis or other serious reactions.
* History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
* Chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination.
* Pregnancy or lactation.
* Any reason why, in the opinion of the investigator, the patient should not participate.
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib

The rationale of the ROSY-O study is to continue to provide study treatment for patients who have participated in a parent study with olaparib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

ROSY-O is an open label, non-randomised, multicentre,international trial for patients who have completed a parent study using olaparib and who are deriving clinical benefit from continued treatment as judged by the Investigator. Patients will be rolled-over from the parent study and will continue the study indefinitely, until they meet one of the treatment discontinuation criteria

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated, written ICF.
2. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AstraZeneca (AZ) compound that has met its endpoints or has otherwise stopped.
3. Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close.

Exclusion Criteria:

1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
2. Currently receiving treatment with any prohibited medication(s).
3. Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
4. Permanent discontinuation from the parent study due to toxicity or disease progression.
5. Local access to commercially-available drug at no cost to the patient is permitted by local regulation.
Nighttime Feeding and Morning Endurance Performance

The purpose of this study is to investigate the influence of a nighttime feeding on next morning running performance, hydration status, and exercise metabolism in female endurance athletes. Specifically, the effect of a chocolate milk beverage will be examined versus a non-nutritive, flavor-matched placebo. The investigators hypothesize that the nighttime consumption of chocolate milk, a whole food complex, will result in improved next morning running performance versus placebo. Secondarily, the investigators hypothesize that any potential positive performance outcomes from the chocolate milk treatment may be due to an enhanced pre-exercise hydration status or improved exercise metabolism.

This study will be interventional in nature and employ a crossover, randomized, double-blinded approach. This study will include a maximal oxygen uptake test and three trials: one familiarization trial, and two experimental trials. The familiarization will serve as a practice test to minimize any training effects between experimental trials. The experimental trials will be completed within a 2-week period determined by the luteal phase of the menstrual cycle (days 15-28 of the menstrual cycle, with day 1 being the first day of menstruation). A minimum of 48-72 hours will be provided between testing days.

Experimental trials will consist of baseline testing (height, weight, urinalysis, resting metabolic rate), followed by a treadmill performance protocol. Participants will complete a 3-stage incremental exercise test (at 55%, 65%, and 75% of maximal oxygen uptake respectively). Metabolic data will be collected during this time. Participants will then complete a 10-kilometer running time trial in which markers of intensity are monitored at various time points (blood glucose, blood lactate, heart rate, rating of perceived exertion). Participants and primary researchers will be blinded to all time and speed data. Distance will be the only known measure of progress. Additional blood, urine, and body weight measures will be taken immediately post exercise.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Between the ages of 18 and 40 years old
* Consistently use oral contraceptives (greater than 2 months) or be considered eumenorrheic without oral contraceptive use
* 'Moderately trained,' defined as a weekly mileage ≥ 25 miles for at least 6 months, and a VO2max ≥ 45 ml/kg/min

Exclusion Criteria:

* Lactose intolerant
* Smokers
* Uncontrolled thyroid conditions
* Uses anti-inflammatory drugs or any dietary supplements intended to improve performance
* Have musculoskeletal injury that could limit performance
Trial of Proton Versus Carbon Ion Radiation Therapy in Patients With Chordoma of the Skull Base

This study is a prospective randomised clinical phase III trial. The primary objective of this study is to evaluate, if the innovative therapy (carbon ion irradiation) in chordomas is superior to the standard proton treatment with respect to the local-progression free survival (LPFS).

The study is a prospective randomised clinical phase III trial. The trial will be carried out at Heidelberger Ionenstrahl-Therapie (HIT) centre as monocentric trial.

Proton therapy is the gold standard in the treatment of skull base chordomas. However, high-LET beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. Up until now it was impossible to compare two different particle therapies, i.e. proton and carbon ion therapy directly with each other. The aim of this study is to find out, whether the biological advantages of carbon ion therapy mentioned above can also be clinically confirmed.

Patients with skull base chordoma will be randomised to either proton or carbon ion radiation therapy. As a standard, patients will undergo non-invasive, rigid immobilization and target volume delineation will be carried out based on CT and MRI data. The biologically isoeffective target dose to the PTV in carbon ion treatment (accelerated dose) will be 63 Gy E ± 5% and 72 Gy E ± 5% (standard dose) in proton therapy respectively. Local-progression free survival (LPFS) will be analysed as primary end point. Toxicity and survival are the secondary end points. Also matters of interest are patterns of recurrence, prognostic factors and plan quality.

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky Performance Score ≥60%
* Age \>18 years and \<80 years
* Informed consent signed by the patient
* Histological confirmation of chordoma with infiltration of the skull base.

Exclusion Criteria:

* Inability to understand the aims of the study, no informed consent
* Prior RT of skull base region
* Other malignancies with disease-free interval \< 5 years (excepting pre- cancerous lesions)
* Participation in another trial
* Pregnancy
* Simultaneous CHT or Immunotherapy.
Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders

In a double-blind, placebo-controlled 16-week trial investigators administered daily doses of either youths with autism spectrum disorders.ARA and DHA supplementation significantly improved communication as well as social withdrawal symptoms. This pilot study provides the first evidence that supplementation with larger ARA doses added to DHA improve impaired social interaction in youths with Autism Spectrum Disorders (ASD).

We recruited 13 individuals who met the DSM-IV criteria for a diagnosis of high functioning autistic disorder (n=1) or Asperger's Disorder (n=12),corroborated by the Autism Diagnostic Interview-Revised. Participants were free of any medical or comorbid psychiatric disorders. Other inclusion criteria included weigh of at least 16 kg, either a verbal or performance intelligence quotient (IQ) above 80, and a score greater than 10 on the social withdrawal subscale of the Aberrant Behavior Checklist-Community.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of high functioning autistic disorder or Asperger's Disorder. Free of any medical or comorbid psychiatric disorders.

Exclusion Criteria:

* Any medical treatment for other psychiatric disorders
EFFECTS OF OLEUROPEIN ON BLOOD PARAMETERS AND INFLAMMATORY MARKERS IN ADULTS WITH METABOLIC SYNDROME

The aim of this study is to determine the effect of 6 weeks supplementation of oleuropein on individuals diagnosed with metabolic syndrome. The baseline and end biochemical parameters and anthropometric measurements will be compared with control subjects.

This study was conducted to investigate the effect of adding oleuropein to the medical nutrition therapy of individuals with metabolic syndrome on their anthropometric measurements and biochemical parameters.

Sub-objectives of the study;

Determining the presence of inflammation in patiens with metabolic syndrome Determination of the effect of diet and diet combined with oleuropein on both fasting blood glucose, insulin and blood lipid profile.

Determination of both anti-inflammatory and antidiabetic effects of oleuropein. Determination of the effect of diet and diet combined with oleuropein on anthropometric measurements.

The aim of this study is to compare the anthropometric measurements and biomarkers of patients with metabolic syndrome as a result of the medical nutrition therpy with consumption of olive leaf extract (2 times a day) that has been contain 100 mg oleuropein for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who volunteer to participate in the study by signing the voluntary consent form
* Diagnosed with Metabolic Syndrome
* Individuals who did not have any infection at the time the study started
* Not consuming any medication
* Not pregnant or lactating
* Women aged 18-49 who have not entered menopause and men in the same age group
* Willing to consume the given extract
* Not allergic or intolerant to olive leaves
* No history of drug use
* People with a BMI below 40 kg/m2

Exclusion Criteria:

* The patient included in the study leaves the study
* Any health issues that may affect the results of the research during the research.
* Occurrence of the problem and/or infection
* Becoming pregnant during the research
* Being in the experimental group and not consuming extract regularly
* Failure to comply with the regulated medical nutrition treatment
* Failure to participate in routine meetings and failure to complete necessary measurements
* Starting to use any medication or nutritional supplement during the study
* Leaving study voluntarily
Study Evaluating EKB-569 in Advanced Colorectal Cancer

This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced colorectal cancer. Patients must have been previously treated with a fluoropyrimidine (5-FU or capecitabine) and either oxaliplatin or irinotecan (given concurrently or as separate regimens).

The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced colorectal cancer.

Secondary objectives include:

* To further evaluate the safety of EKB-569
* To explore additional clinical activity parameters
* To explore subject survival
* To evaluate the pharmacokinetics of EKB-569
* To assess subject reported outcomes

EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures
* Previous histologic diagnosis of adenocarcinoma of the colon or rectum
* EGFR expression by immunohistochemical analysis (must be \> or = 20% positive tumor cells in prior tumor biopsy specimens)

Exclusion Criteria:

* Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas).
* Prior epidermal growth factor receptor-targeting therapy
* Known central nervous system (CNS) metastases
Performance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial (SBT) in the Prediction of Extubation Failure

Extubation failure (EF) is independently associated with excess mortality of critically ill patients. To avoid EF, critically ill patients being weaned from invasive mechanical ventilation (IMV) perform spontaneous breathing trial (SBT), which is the litmus test for determining the ability to breathe without a ventilator.

Thus, the performance of the SBT during weaning from IMV to predict successful extubation is crucial. The investigators hypothesize that patients with EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia.

The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients.

Extubation failure (EF) is defined as the need for reintubation within 48-72 hour. This complication is independently associated with a seven-fold increased risk of death in critically ill patients.

To avoid EF, critically ill patients being weaned from invasive mechanical ventilation (IMV) perform spontaneous breathing trial (SBT), which is the litmus test for determining the ability to breathe without a ventilator. However, EF occurs in 10 to 20% of patients despite having successful SBT.

Thus, the performance of the SBT during weaning from IMV to predict successful extubation is crucial.

Previous studies of predictive markers of EF have been performed primarily to assess weaning failure from cardiac origin.

The investigators hypothesize that critically ill patients who are going to have EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia, regardless of the cause of failure.

The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years old
* Intubation and ventilation \> 24 hours

Exclusion Criteria:

* Patients under guardianship or curators
* Opposition to participation in the study by the patient or family member
* Patients with tracheotomy
* Pregnant or breast-feeding women
Circadian Variation of Cardiac Troponin

Acute myocardial infarction (AMI) is defined by an increase and/or decrease in the concentration of cardiac troponin, with at least one value above the 99th percentile value of the reference population together with evidence of ischemia. An objective tool to determine the magnitude of the cardiac troponin change is the use of reference change values (RCV). The basis for this tool is that, for a change to be significant, the difference in serial results must be greater than the inherent variation in two test results. The inherent variation of a laboratory test result is composed of analytical and within-subject biological variation. An important requirement to use RCVs is that the concentrations of cardiac troponins fluctuate randomly around a homeostatic set point in cardio-healthy individuals. Verification of this important condition has never been performed, and violation of this condition would preclude the use of RCV's in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with no evidence of active cardiovascular disease

Exclusion Criteria:

* History of acute myocardial infarction in the last year
Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.


Eligibility Criteria:
Inclusion Criteria:

* erythema migrans

Exclusion Criteria:

* pregnancy
* extracutaneous manifestations of Lyme borreliosis
* immunocompromising state
* serious adverse event to beta lactam antibiotic
* receiving antibiotic with antiborrelial activity within 10 days