cyrilzakka/clinical-trials huggingface dataset:
Evaluation of CDSS in Detection of SIRS and Sepsis in Pediatric Patients

This trial aims to evaluate the accuracy of a Clinical Decision-Support System to support early recognition of SIRS in paediatric intensive care patients. This assessment will be rated by the primary goals, the sensitivity and specificity of the system. Two experienced paediatric intensivists, who are blinded for the CDSS results, will analyse the electronic patient file (EPF) for SIRS criteria and thus establish our Goldstandard. All SIRS events recognized by the CDSS during the patient's stay are taken into account and will be compared with the established Goldstandard.

The secondary goal of this trial is to evaluate the CDSS-results with the assessment of SIRS by paediatric doctors during their routine work on the PICU.

Clinical decision-support systems (CDSS) are designed to solve knowledge-intensive tasks for supporting decision-making processes. Although many approaches for designing CDSS have been proposed, due to high implementation costs, as well as the lack of interoperability features, current solutions are not wellestablished across different institutions. Recently, the use of standardized formalisms for knowledge representation as terminologies as well as the integration of semantically enriched clinical information models, as openEHR Archetypes, and their reuse within CDSS are theoretically considered as key factors for reusable CDSS. The investigators already successfully transferred their concept into a prototype and evaluated the practicability on clinical data sets and in close cooperation between the clinicians and the technical experts. To the author's knowledge, currently, there are no openEHR based CDSS approaches which have been implemented and evaluated with such complex and important clinical contexts. Hence, the first clinically evaluated CDSS based on openEHR was successfully designed. When enhancing the described approach and implementing a live system, it might support clinicians to identify the patient's course of disease at an early stage, which can lead to better outcome for the patient. Furthermore, the system can serve as a basis for integrating (cross-institutional) machine learning components that could facilitate dealing with other high-complex decision problems or revealing yet unknown disease patterns.

Eligibility Criteria:
Inclusion Criteria:

* all pediatric patients admitted to our PICU

Exclusion Criteria:

* patients that are supposed to stay for less than 12 hours on our PICU
Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS

The aim of this study is to evaluate the impact of Ultrasound-guided Erector Spinae plane block compared to Ultrasound-guided serratus anterior plane block on the emergence of post-thoracotomy pain syndrome in patients undergoing lobectomy for lung cancer.

Lung cancer has the highest incidence of all malignancies worldwide and accounts for approximately 13% of all cancer cases. Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the main therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing as is the incidence of post-thoracotomy pain. In addition to amputation and mastectomy, thoracotomy is considered the main etiology of severe and long-term acute and chronic post-surgical pain syndromes (CPSPs). The prevalence of post-thoracotomy pain syndrome (PTPS) is widely variable (30%-50%) and may range from 11% to 80%, according to other studies.

The International Association for the Study of Pain (IASP) has defined post-thoracotomy pain syndrome as "pain that recurs or persists along the thoracotomy scar at least 2 months after the procedure". In addition, post-thoracotomy pain syndrome is mostly described with neuropathic manifestations along the thoracotomy scar and in the mammary, inframammary, ipsilateral scapular and interscapular areas.

The ultrasound-guided erector spinae plane (ESP) block is a novel technique for thoracic analgesia that promises to be a relatively simple and safe alternative to more complex and invasive techniques of neural blockade.

Eligibility Criteria:
Inclusion Criteria:

* Age (18-65) Years
* Physical status American Society of Anesthesiologists Classification II, III
* Patients undergoing lobectomy through lateral thoracotomy
* Body mass index (BMI): (20-40) kg/m2

Exclusion Criteria:

* Patient refusal.
* Age \<18 years or \>65 years
* Body mass index (BMI) \<20 kg/m2 and \>40 kg/m2
* Known sensitivity or contraindication to drugs used in the study
* Contraindication to regional anesthesia e.g. local infection at site of introduction, pre-existing peripheral neuropathies and coagulopathy.
* Pregnancy.
* Physical status American Society of Anesthesiologists Classification IV
* patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
* patients with a history of drug abuse
* patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
* patients with a history of thoracic surgery through lateral thoracotomy; and patients with recurrent chest malignancies within 3 months.
* All patients who developed severe intra- or post-operative bleeding or required postoperative mechanical ventilation were also excluded from the study.
* Thoracic spine disorders or deformity.
PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study

The purpose of this study is to find out how an antibody called Hu3F8 travels through the body and to tumors. Antibodies, like Hu3F8, are proteins that help attack tumors or fight infections. Antibodies can be made by your own body or in a laboratory. The target of an antibody is called an antigen; antibodies fit their antigen like a lock fits a key.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of neuroblastoma must meet both of the following criteria:

  * Diagnosis confirmed by histological assessment by MSKCC Department of pathology or by the presence of BM metastases PLUS elevated urinary catecholamines
  * Relapsed or refractory stage 4 disease or relapsed or refractory stage MYCN-amplified 2B or 3 disease.
  * Patients with tumors other than neuroblastoma must meet both the following criteria:
  * Have one of the following diagnoses (these tumors are known to express GD2 on cell surface):
  * Melanoma
  * Osteogenic sarcoma
  * Leiomyosarcoma
  * Ewing sarcoma
  * Liposarcoma
  * Fibrosarcoma
  * Malignant fibrous histiocytoma
  * Spindle cell sarcoma
  * Small cell lung cancer
  * Medulloblastoma metastatic to extracranial sites
  * Paraganglioma
  * Have refractory or relapsed or metastatic disease
  * Patients with solid tumors with diagnoses OTHER than neuroblastoma or those listed above will be eligible if they meet both of the following criteria:
  * Immunohistochemical demonstration of GD2 expression on cell surface (Tumor assessment by immunohistochemistry is required for this group of patients)
  * Have refractory or relapsed disease or metastatic disease. All patients must have measurable or evaluable disease
  * Age 3-90 years
  * Prior treatment with anti-GD2 monoclonal antibody is permitted only if human anti-human antibody titer is ≤1300 assay developed by Dr. Nai-Kong Cheung.
  * Negative serum pregnancy test in women of childbearing potential
  * Women of child-bearing potential must be willing to practice an effective method of birth control while on study
  * Signed informed consent indicating awareness of the investigational nature of this study.

Exclusion Criteria:

* Existing major organ dysfunction \> grade 2, with the exception of myelosuppression (neutrophil count \> or = 500/μl and platelet count \> or = 25,000/μl are acceptable) and hearing loss.

  * Acute life threatening infection
  * Requirement for sedation for PET/CT scans
  * Pregnant women or women who are breast-feeding.
  * Inability to comply with protocol requirements.
  * Hypersensitivity to potassium iodide or Lugols products
  * Prior development of positive human antimouse antibody response (HAMA) or human antihuman antibody response (HAHA)
  * Positive human anti-hu3F8 antibody titer.
Determination of Analgesic Effect From One Transcranial Magnetic Stimulation(TMS)Treatment Following Vaginal Reconstructive Surgery.

To determine whether real TMS is more effective than sham TMS in reducing pain following surgery

To determine the amount of opiate and pain medication administered in the week following surgery. Subjects will receive an identical pain control regimen. Participants will undergo TMS motor threshold assessment at the ETSU Innovation Lab prior to the planned surgery. At this appointment a baseline Beck Depression Inventory (BDI), Center for Epidemiological Studies 10-item Depression scale (CES-D) and visual analog scale (VAS) ratings of pain and mood will be obtained.VAS ratings will also be done each evening over the following week. One day after surgery, the subject will return to the Innovation lab for TMS. A total of 22 subjects will be recruited for the study. At the return visit, 11 will receive 40 minutes of 10 Hz repetitive TMS at 120% of rMT (4-second stimulation trains with 26-second interstimulus intervals). The other 11 participants will receive sham treatment under identical settings. Participants, medical staff providing clinical care to patients and raters will not know whether participants receive real or sham TMS. Patients will keep a log of pain medications used over the following week in addition to the VAS ratings. Follow-up will occur one week after the TMS therapy. The subject will turn in logs and repeat BDI and CES-D scales.

Eligibility Criteria:
Inclusion Criteria: Dental fillings, implants, and bridge work are permitted. -

Exclusion Criteria: Metal objects within 30 cm of the brain. These include cochlear implants, stents, vagus nerve stimulators, heart devices, bullet fragments, or jewelry. Monitors, earrings, hearing aids, eyeglasses, jewelry, hair barrettes, cell phones, and digital sound recording device players will be removed. Actively suicidal. Older than 70 years. Seizures, strokes, dementia, or movement disorders. Pregnant or nursing. Permanent makeup with metal ink. Medication known to increase risk of seizures.

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Transpulmonary Pressure Under Stressing Conditions

Study aims to prospectively evaluate if the pressures normally applied during mechanical ventilation in laparoscopic surgery induce stress on the pulmonary wall. To do this is used measure the variation of esophageal pressure, as indirect index of the pleural pressure and therefore of the transpulmonary pressure, in response to changes in airway pressures in a group of patients undergoing robotic assisted radical prostatectomy or videolaparoscopy.


Eligibility Criteria:
Inclusion Criteria:

* ASA (american society of anesthesiologists) score ≤ III
* Patients underwent laparoscopic prostatectomy

Exclusion Criteria:

* BMI (body mass index) ≥ 30
* Impossibility to insert nasogastric tube
* Anatomic rib cage alterations
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants

To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants 11 and 17 weeks of age at the time of the first vaccination, born after a normal gestation period (between 36 and 42 weeks).
* Written informed consent obtained from the parents or guardians of the subject.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Previous vaccination against or history of or intercurrent diphtheria, tetanus, pertussis, polio and/or Hib.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
* Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
* GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
* Household contact with an immunosuppressed individual or pregnant woman.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
* Previous confirmed occurrence of RV GE.
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma

The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cholangiocarcinoma.

The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cholangiocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed cholangiocarcinoma
* Primary lesions (cholangiocarcinoma) are not resected
* Serum bilirubin level of 2.0 mg/dl or less.
* Performance status of 0 or 1.
* Expected survival of 1 year or more.
* Informed consent from the patient.

Exclusion Criteria:

* With extrahepatic metastases
* With other neoplastic disease that is measurable or being treated other than cholangiocarcinoma.
Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance

The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.


Eligibility Criteria:
Inclusion Criteria:

* Singleton, 14-35 days of age at baseline
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula-fed
* Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria:

* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
* Feeding difficulties or formula intolerance
* Maternal history of illicit drug use or psychiatric disease
Person-Centered Oncology Care and Choices (P-COCC): Piloting and Initial Randomized Testing of a Combined Values Narrative Interview and Video Education Advance Care Planning Program in Gastrointestinal Oncology Patients

This study is being done to get individuals' feedback on advanced care planning and decision making.

This study is divided into two parts (Part 1 and Part 2). The purpose of Part 1 is to survey people to find out what is important to people with advanced cancer (again, their values, such as their goals, concerns and sources of support). This has never been done before in the way the investigators are doing it, and that is why this is called a "pilot" study, which is where a new method or treatment is being created and evaluated.

The purpose of Part 2 is to see if combining a medical options video with a short interview about values helps people with how they feel about their medical situation, and what they know about their medical options for their medical situation.


Eligibility Criteria:
Inclusion Criteria:

* Able to speak, read and understand English well enough to complete study assessments and interviews in the judgement of the consenting professional
* 18 years of age and older
* Be seen regularly (at least monthly) at an MSKCC GI medical oncology clinic
* Has an exocrine GI cancer with MSKCC pathology confirmation at the primary or metastatic anatomic site
* Non-metastatic GI cancers are eligible only if the Eastern Cooperative Oncology Group (ECOG) performance status54 is 2,3, or 4 at the time of consent (although patients with locally advanced \[stage III\] and inoperable pancreatic cancers are eligible regardless of their performance status)
* Has a metastatic neuroendocrine histology with MSKCC pathology confirmation as moderately or poorly differentiated or intermediate or high grade
* A referring physician's estimate of patient life expectancy must be between 1-12 months. We use this life expectancy range in order to ensure some degree of subject homogeneity for the purpose of sample size and methodologic design. Also, these timeframes were chosen in order to test an intervention in patients with serious illness (under 1 year prognosis).
* Part 2 Only: Did not complete Part 1 of the study.

Exclusion Criteria:

* Short Portable Mental Status Questionnaire (SPMSQ) score of less than "intact mental functioning" (3 or more errors).
* Significant psychiatric or cognitive disturbance sufficient, in the consenting professional's or investigator's judgment, to preclude providing informed consent or participating in the interventions (i.e., acute psychiatric symptoms which require individual treatment).
Possible Epigenetic Changes in Offspring of Women With Pregestational and Gestational Diabetes

Pregestational diabetes (PGD) during pregnancy may be associated with an increased rate of spontaneous abortions, intrauterine death and congenital anomalies among the offspring. Although the prevalence of congenital anomalies among the offspring of diabetic mothers is reduced as a result of the improvement of the glycemic control in the early pregnancy, the rate of congenital anomalies is increased and there seems to be an increased rate of neurodevelopmental disorders including some fine and gross motor deficits as well as increased rate of inattention and/or hyperactivity. In gestational diabetes, that develops in the second half of pregnancy (past the period of major organogenesis), there seems to be no increase in the rate of major congenital anomalies but there are some developmental disorders in the offspring.

The exposure of the developing embryo and fetus to diabetic environment (i.e. hyperglycemia, hyperketonemia ext), is known to cause increased oxidative stress and significant changes in gene expression as observed in several experimental diabetic models. We hypothesize that diabetic environment may also cause long lasting epigenetic changes. It is therefore our purpose to evaluate these possible epigenetic changes and correlate their presence with the degree and time of onset of diabetes, (i.e. whether from the beginning as in PGD or in the second half of pregnancy as in GD), the degree of oxidative stress and with the neurodevelopmental outcome of the offspring. Diabetic pregnancies will be compared to a similar number of normal pregnancies in all parameters studied.


Eligibility Criteria:
Inclusion Criteria:

* Infants born to women suffering from pre-gestational or gestational diabetes.

Exclusion Criteria:

* Non Jewish population
* Triplets and up
* Premature infants under 32 weeks
* Infants suffering from major congenital anomalies
* Infants with chromosomal aberrations
Prognostic Value of a Multidimensional Assessment for Survival in Elderly Patients With CKD 4B/5

The aim of this study is to determine a multidimensional signature (integrating frailty and patient-reported outcomes measures (PROMs) at entry into stage 4B/5 CKD) to improve prediction of renal death (dialysis, transplantation, conservative management, death).

In 2019, 4,263 patients starting dialysis in France were aged 75 years or older. This elderly population, often with comorbidities, poses a number of challenges for nephrologists, both in terms of initiation and modalities of dialysis and access to transplantation. Dialysis may offer little benefit in terms of survival, often at the cost of a significant impact on quality of life and number of hospitalisations. There is a current trend to offer conservative treatment as an alternative to dialysis. However, there are no objective criteria to guide this decision and the uremic syndrome may distort certain clinical perceptions. The aim of this study is to determine whether an assessment that incorporates multiple dimensions, including those of frailty, can help the clinician determine the best course of treatment for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD stage 4B or 5 (first consultation with GFR \< 20 mL/min /1.73 m2 in CKD-EPI 2009).
* Fluency in French
* Membership of a French social security scheme
* Non-opposition from the subject to participate in the study

Exclusion Criteria:

* Subjects with limited legal capacity.
* Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.
* Subjects with no social security coverage.
* Subjects judged by the investigator to be unlikely to comply with study procedures
* Subjects unable to understand the reasons for the study; psychiatric disorders judged by the investigator to be incompatible with inclusion in the study.
Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation

The purpose of this study is to evaluate the role that the thalamus (the egg-shaped structure in the middle of your brain) plays in perception using a low-intensity ultrasound pulsation (LIFUP) device. The researchers expect to observe differential changes in the perceptual outcomes based on the LIFUP stimulation of different thalamic areas


Eligibility Criteria:
Inclusion Criteria:

* Must be right-handed.
* Must have normal or corrected-to-normal vision (while wearing contact lenses). Please note: persons who need eyeglasses to achieve 20/20 vision cannot be included in this study as eyeglasses cannot be worn during the study visit.
* Must not be on any medications for any neurological, psychological, or psychiatric conditions.
* Must be English speaking.
* Must be capable of giving written informed consent.

Exclusion Criteria:

• Vision that is not 20/20, or vision that is not corrected to 20/20 while wearing contact lenses.

Please note: persons needing eyeglasses to achieve 20/20 vision cannot be included in this study as eyeglasses cannot be worn during the study visit.

* History of significant head injury with loss of consciousness.
* Learning disability or other developmental disorder.
* Medication use for any neurological, psychological, or psychiatric conditions.
* Any impairment (sensory or motor loss), activity, or situation that in the judgment of the study coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.