cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Blood Biomarkers and Postoperative Delirium in Elective Non-Cardiac Surgery.

More than 20% of patients over 60 years old develop postoperative delirium following non-cardiac surgery . Delirium increases morbidity and mortality , and may lead to long-term cognitive impairment . The underlying mechanisms behind delirium are not understood , endothelial dysfunction and disruption of the blood brain barrier (BBB ) caused by perioperative systemic inflammation may play a important role in the development of delirium . This study intends to evaluate the relationship between neuroinflammation and postoperative delirium in elderly non-cardiac surgery patients . The results of the study are to identify risk factors and explore the biomarkers most closely linked to each step of the proposed pathway .

The investigators do the neuropsychological tests , Mini-Mental score examination (MMSE ) , Charlson Comorbidity Index (CCI ) , Quality of Recovery Score - 40 (QoR-40 ) 1 day before the surgery（baseline ) . Serum of the patients was collected before operation and at POD1 , and then detect the concentration change of biomarkers of endothelial dysfunction , blood brain barrier disruption and neuronal injury . Also , the patients were interviewed once before discharge from PACU and twice on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups . Meanwhile , the severity of pain (Numerical Rating Scale（NRS )) was evaluated at the same time and QoR-40 at 1 day after surgery .

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing selective major noncardiac surgery and general anesthesia;
2. Age 60-90 yrs;
3. Anesthesia Society of American (ASA) Scale II\~III;
4. Anticipated surgery time 2-6 hrs
5. Written informed consent;

Exclusion Criteria:

1. decline to participate
2. Dementia patients（Mini-mental state examination\< 20）
3. Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction.
Development of an Adaptive Treatment for Weight Loss in People With Prediabetes

This 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. After 4 weeks, participants will be identified as Responders (greater than or equal to 2.5% weight loss) or Non-Responders (less than 2.5% weight loss). Responders will continue with their initial randomized group for the remainder of the trial. Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age
* BMI of 27 kg/m2 or greater
* at risk for developing type 2 diabetes (prediabetes)

Exclusion Criteria:

* Pregnant, planning to become pregnant, or breastfeeding
* uncontrolled hypo or hyperthyroidism
A Placebo-Controlled Phase 3 Trial of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis

The overall objective of this trial is to evaluate the efficacy and safety of repeated Lamazym i.v. treatment, compared with placebo, in subjects 5-35 years of age with alpha-Mannosidosis


Eligibility Criteria:
Inclusion Criteria:

* Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities
* The subject and his/her guardian(s) must have the ability to comply with the protocol
* The subject must have a confirmed diagnosis of alpha-Mannosidosis as defined by alpha-Mannosidase activity \< 10% of normal activity (historical data)
* The subject must have an age at the time of screening ≥ 5 years and ≤ 35 years
* The subject must have the ability to physically and mentally cooperate in the tests
* The subject must have an ECHO without abnormalities that, in the opinion of the Investigator, would preclude participation in the trial

Exclusion Criteria:

* The subjects diagnosis cannot be confirmed by alpha-Mannosidase activity \< 10% of normal activity
* The subject cannot walk without support
* Presence of known chromosomal abnormality and syndromes affecting psychomotor development, other than alpha-Mannosidosis
* History of BMT
* Presence of known clinically significant cardiovascular, hepatic, pulmonary, or renal disease or other medical conditions that, in the opinion of the Investigator, would preclude participation in the trial
* Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial
* Pregnancy: Pregnant woman is excluded. Before start of the treatment the investigators will for women of childbearing potential perform a pregnancy test and decide whether or not there is a need for contraception
* Psychosis; any psychotic disease, also in remission, is an exclusion criteria
* Planned major surgery that, in the opinion of the Investigator, would preclude participation in the trial
* Participation in other interventional trials testing IMP (including Lamazym) within the last 3 months
* Adult patients who, in the opinion of the Investigator, would be unable to give consent, and who does not have any legal protection or guardianship
* Total IgE \>800 IU/ml
* Known allergy to the IMP or any excipients (Sodium-Phosphate, Glycine, Mannitol)
Evaluation of the Venous Excess Ultrasound Score (VExUS) After Circulating Volume Modification in Children.

Venous overload has an impact on peripheral organ perfusion and on the short- and long-term prognosis of intensive care patients. The VExUS ultrasound score is a new tool whose parameters can be used to estimate this impact. This score was initially evaluated and validated on an adult population. ) In children, there is only one study looking at the use and applicability of this VExUS score, highlighting its feasibility in a paediatric population, as well as a possible correlation between elevated central venous pressure and altered renal Doppler (one of the score's components).


Eligibility Criteria:
Inclusion Criteria:

Children aged between 1 and 18 years, receiving extrarenal purification with UF \> 10 ml/kg, bleeding \> 10 ml/kg or vascular filling \> 10 ml/kg

Exclusion Criteria:

* Refusal of the patient or opposition of one or both holders of parental authority.
* Minors with parental authority.
* Ultrafiltration time \> 6h.
* Curarized patient, known abnormality of the hepatorenal venous network.
* Patient agitated or poor tolerance of the examination.
* Parents under court protection, guardianship or curatorship.
Correlation Between Optic Nerve Sheath Diameter and Neurological Deficit in Adult Patients with Suspected Ischemic Stroke

The ultrasound of the optic nerve sheath diameter (ONSD) is a non-invasive tool used in the detection of intracranial hypertension and other neurological conditions. The aim of this research is to evaluate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.

II. Hypothesis The ultrasound measurement of the optic nerve sheath diameter correlates with the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.

III. Objectives Estimate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.

Determine the sensitivity and specificity of the ultrasound measurement of the optic nerve sheath diameter for predicting the side of neurological focus.

IV. Methodology

Study design:

A observational study will be conducted in a secondary care hospital.

Population and sample:

Adult patients (≥18 years) presenting to the emergency department with neurological symptoms, such as headache, altered level of consciousness, motor or sensory deficit, among others, will be included. Patients with contraindications for ocular ultrasound or with a history of previous ocular surgery will be excluded.

Procedures:

1. Informed consent will be obtained from patients who meet the inclusion criteria.
2. A neurological physical examination will be performed to identify the side of neurological focus.
3. The optic nerve sheath diameter will be measured using ultrasound with a high-frequency linear transducer (7.5-12 MHz).
4. Demographic, clinical, and ultrasound data will be recorded for the patients.

Data analysis:

The correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus will be calculated using Pearson's or Spearman's correlation coefficient, depending on the distribution of the data. Additionally, sensitivity, specificity, positive and negative predictive values, and 95% confidence intervals will be calculated to determine the diagnostic utility of the ultrasound measurement of the optic nerve sheath diameter in identifying the side of neurological focus.

V. Ethical considerations The ethical guidelines established by the Declaration of Helsinki will be followed, and the privacy and confidentiality of patients will be protected. The protocol will be approved by the hospital's Research Ethics Committee before its implementation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected acute ischemic stroke
* CT scan negative to hemorrhagic stroke
* Informed consent

Exclusion Criteria:

* Contraindications to perform ocular ultrasound
* Patients with ocular surgery
Fixed-Free HTN Trial

Evaluation of the effect of FIXED triple anti-hypertensive therapy with losartan-amlodipin-HCTZ vs any free triple combination therapy chosen by the treating physician for patients with uncontrolled hypertension

Patients who have uncontrolled hypertension and who require triple therapy will be randomized to receive:

1. Fixed combination containing 3 anti-hypertensive drugs: losartan 100 mg + amlodipin 5 mg + hydrocholorothiazide 12.5 mg one tab/day
2. Or any other therapy decided by the treating physician containing three anti-hypertensive agents but supplied as "free" therapy, meaning supplied as 2 or 3 separate tablets Patients will have a baseline ambulatory blood pressure recording. The same recording will be repeated at 2 months of therapy.

We expect fixed triple combination to be more effective because the drugs used work synergistically together and the compliance will be higher

Eligibility Criteria:
Inclusion Criteria:

* Patients already on free triple anti-HTN therapy whether controlled or not Or patients on double anti-HTN therapy who are uncontrolled\* Or patients on monotherapy and who have a BP \> 160/100 mm Hg

  * BP is defined as UNCONTROLLED if \> 135/85 at home or \> 140/90 in clinic on at least 2 occasions

Exclusion Criteria:

* Contra-indication for the use of ARB or ACEI, CCB or hydrochlorothiazide History of angina pectoris or myocardial infarction \< 3 months old Permanent atrial fibrillation Ejection fraction \< 40% Patients with hypertension but who are not on any medication Patients with hypertension and who are treated with \> 3 drugs
Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC Through Liquid Biopsy Integration

Implementation of a new algorithm for HRR gene mutation testing in patients with mPC through liquid biopsy integration

Analysis of the current clinical landscape of mPC Italy to identify gaps and opportunities for improvement.

Patient identification and enrollment Blood sample collection and plasma purification ctDNA extraction and NGS analysis of homologous recombination repair (HRR) genes. Clinical Real-World Data (RWD) and molecular analysis data collection Testing algorithm development based on collected data Finalization and sharing of a best practice model for diagnostic procedures in mPC patients

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic prostate cancer whose tumor tissue is unavailable or inadequate for molecular testing. • Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.

Exclusion Criteria:

* Unable to provide written informed consent
Comparison of NOSE and Conventional Methods in Laparoscopic Right Colon Surgery

Laparoscopic right hemicolectomy (LRH) is an accepted surgical procedure for several right sided colonic pathologies. Recently the advantages of the intracorporeal ileotransversostomy over the extracorporeal anastomosis is appearing in the literature. Additionally, specimen extraction through the natural orifices is an emerging method when combined with the totally laparoscopic procedures. Our observations on natural orifice surgery was promising . In our daily surgical practice, investigators prefer the intracorporeal anastomosis and this study was conducted to compare the specimen extraction sites after LRH. Here investigators aimed to compare the results of conventional and natural orifice specimen extractions (NOSE) after totally LRHs.

compare the patient-selected NOSE method and conventional method in laparoscopic right colon cancer surgery

Eligibility Criteria:
Inclusion Criteria:

* laparoscopic right hemicolectomy patients

Exclusion Criteria:

* no
Biology of Young Lung Cancer Study: The YOUNG LUNG Study

The purpose of this research study is to learn more about lung cancer (NSCLC or SCLC) diagnosed in adults at ages 45 or younger.

This research study looks to enroll as many people diagnosed with lung cancer at 45 years old or younger in order to:

* Better understand causes of lung cancer in individuals 45 years old and younger, which is a rare disease
* Better estimate lung cancer risks and potential risk factors for lung cancer in individuals 45 years old and younger
* Examine tumor (somatic) or normal (germline) genetic changes that may be shared among young lung cancer patients
* Improve opportunities for screening and treatment of lung cancer in individuals 45 years old and younger

Study procedures will include:

* Collecting information from participants' medical record and two (2) short questionnaires
* Collecting blood and/or saliva samples
* Collecting tumor tissue samples (optional)

It is expected that about 500 people will take part in this research study. Participants will be in this study until it closes or the participant withdraws consent.

Eligibility Criteria:
Inclusion Criteria:

* Age 45 and under at lung cancer diagnosis
* Pathologically confirmed bronchogenic lung carcinoma (NSCLC or SCLC of any stage) at any treatment time point
* Provision of written informed consent
* Willingness to undergo no more than two (2) peripheral blood draws in a four (4) week period, with no more than 50 ml peripheral blood collected over eight (8) weeks
* Individuals under age 18 are eligible for study if they meet defined criteria; in addition, consent for participation must be given by a legal guardian or parent

Exclusion Criteria:

* Individuals who decline to sign consent
* Individuals who are unable to give consent or assent and are without a designated healthcare proxy
* Compromise of patient diagnosis or staging if tissue is used for research
Pre-Market Algorithm Validation Study

The study sponsor has developed a patented medical device called Seipher Wellness. This is a non-invasive medical device that assesses heart health based on established cardiac parameters; timing events of the cardiac cycle. These are specific parameters captured and analyzed by the device. A ratio of two specific timing parameters provides an assessment of the subject's overall heart health. The aim of this study is to validate the device algorithm across a range of subjects.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* able to understand the informed consent document
* willing to participate
* ambulatory volunteers

Exclusion Criteria:

* individuals with visible scar(s) or deformity in the test area of the chest
* non-ambulatory subjects
* enrolled in another concurrent study or trial
* exercised excessively within the last 4 hours
* unwilling to sign informed consent
* female subjects who are pregnant, suspected or planning to become pregnant or breast-feeding
Microcirculatory Guided Goal Directed Fluid Therapy in Septic Shock; a Feasibility Study

Prospective single centre study to assess the feasibility of fluid resuscitation guided by macrocirculatory and microcirculation parameters in patients in the early stages of septic shock. The investigators will utilise a novel point of care tool to assess microcirculatory sublingual perfusion in patients with septic shock. This, in combination with conventional haemodynamic monitoring will determine the timing and volume of resuscitative fluid administration. The feasibility of this technique will be determined prior to embarking on a pilot RCT.


Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years Within 6 hours of ICU admission Evidence of suspected or confirmed infection Serial Organ Failure Assessment (SOFA) score increase of 2 or more (assuming baseline 0 if no previous measures) Requiring vasopressor therapy to maintain a MAP \> 65mmHg Lactate \> 2 mmol/l despite initial fluid resuscitation Requirement for advanced haemodynamic monitoring (PiCCO system) in the opinion of the attending clinician

Exclusion Criteria:

Patients not expected to survive 24 h in whom the intent of treatment is palliative Patients in whom the primary cause of the shock state is cardiogenic

-
Psychological Aspects and Insulin Pump Therapy

The Continuous Subcutaneous Insulin Infusion (CSII) might have an impact on psychological distress and some psychological factors might be predictors of metabolic control; however, very few studies conducted so far were specifically focused on the psychological aspects of CSII therapy in adults affected by T1DM.

The aim of this project is to study the psychological effect of Continuous Subcutaneous Insulin Infusion (CSII) in a cohort of type 1 diabetic patients and to explore the influence of psychological factors (coping style, locus of control, self-efficacy) on glycaemic control. A sample of 36 type 1 diabetic patients will be recruited at Endocrinology, Diabetes and Metabolism Division of Verona City Hospital.

Among T1DM patients routinely followed by our Institution the study will be proposed to those starting the CSII therapy based on the inclusion and exclusion criteria.

Each study participants will provide a written informed consent and will undergo a set of 4 psychological evaluation assessing depression, anxiety, self-efficacy, perceived interference caused by diabetes, family support, locus of control and coping strategies on top of routine medical examination and laboratory testing for outcome measures at baseline and after 6, 12 and 24 months after study entry.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes
* Transition to CSII
* Age \>18 years

Exclusion Criteria:

* Current schizophrenia/ psychotic disorders, bipolar disorders, addictive disorders, personality disorders
* Pregnancy
Omegaven® as Parenteral Nutrition

The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids, Omegaven, would be beneficial in the management of steatotic liver injury in parenteral nutrition (PN) by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 14 days old.
* Have PN-associated cholestasis defined as at least 2 consecutive direct bilirubin \>2 mg/dL with anatomical or functional short gut (OR \>4 mg/dL if intact intestine) obtained at least 1 week apart with a ratio of direct: total bilirubin \> 0.4.
* Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least 4 more weeks.
* Patients must have failed standard therapies for Parenteral Nutrition Associated Liver Disease (PNALD) including: cycling of PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and use of ursodiol (i.e. Actigall).
* Signed patient informed consent.
* The patient is expected to have a reasonable possibility of survival.
* No other known etiology of cholestasis other than PNALD at time of Omegaven® initiation.

Exclusion Criteria:

* Causes of cholestasis other than PNALD including but not limited to Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency, prior to Omegaven® initiation.
* Known fish or egg allergy
* Any of the contraindications to use of Omegaven®:

  1. Active new infection at the time of initiation of Omegaven®
  2. Hemodynamic instability
  3. Use of medications with associated risk of bleeding, including nonsteroidal antiinflammatory drugs (NSAIDs)
  4. Active coagulopathy or bleeding
  5. Thrombocytopenia
  6. Unstable hyperglycemia
  7. Impaired lipid metabolism (triglycerides \>1000 mg/dL) while on 1 g/kg/day or less of Intralipid
  8. History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
  9. Unstable diabetes mellitus
  10. Collapse and shock
  11. Stroke/ Embolism
  12. Cardiac infarction within the last 3 months
  13. Undefined coma status
* Enrollment in a clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
* The parent or guardian of child is unwilling to provide consent or assent