cyrilzakka/clinical-trials huggingface dataset:
Constructing a Risk Prediction Model for Intraoperative Hypothermia in Children Under General Anesthesia

Intraoperative hypothermia refers to a core body temperature below 36.0°C during surgery, which is common in surgical patients. Due to the fact that children's body temperature regulation function is not yet fully developed, they are light in weight, and their blood vessels are superficial, children are very susceptible to the influence of environmental temperature. With the effects of anesthetic drugs, exposure of the surgical field, and disinfection of the surgical area, children face a higher risk of intraoperative hypothermia than adult patients. Studies have shown that the incidence of intraoperative hypothermia can be as high as 80%. Intraoperative hypothermia can lead to increased adverse cardiovascular events, poor coagulation, slower healing of surgical incisions, or wound infection, threatening the health of children, resulting in prolonged postoperative hospitalization and increased hospitalization costs. Therefore, there is an urgent need to develop a tool for predicting intraoperative hypothermia suitable for children, identify high-risk groups early, and take preventive measures as soon as possible, thereby reducing a series of complications caused by hypothermia. The purpose of this study is to clarify the current status and risk factors affecting intraoperative hypothermia in children, to provide a theoretical basis for clinical medical staff to provide intraoperative thermal insulation care for children, and on this basis to construct an intraoperative hypothermia risk prediction model to identify the probability of hypothermia in children at an early stage, so as to take targeted thermal insulation measures.

The study first clarified the overall incidence and influencing factors of IOH in children through meta-analysis, combined with expert consultation to determine potential predictive variables, and developed a data questionnaire for this study. The second part of the study will collect data prospectively, use four algorithms in machine learning, including logistic regression, decision tree, random forest, and support vector machine, to build an excellent intraoperative hypothermia risk prediction model, and conduct internal verification of the model. The third part of the study prospectively collects sample data to complete external verification of time period and space. The constructed model still has good predictive ability in the new data set. Finally, some models are visualized to form intuitive and easy-to-understand charts or interfaces.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 16 years old;
* Anesthesia includes general anesthesia;
* Anesthesia duration \> 30 minutes.

Exclusion Criteria:

* Cardiac surgery or other procedures that require lowering the child's body temperature;
* Refusing to participate in this study;
* ASA grade \>Ⅳ;
* Abnormal basal body temperature, preoperative core body temperature \<36.0℃ or \>38.0℃;
* Hyperthyroidism or hypothyroidism and other diseases that affect body temperature;
* The core body temperature cannot be measured due to surgery or ear canal disease.
Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion

Propofol is a commonly used agent for sedation and anaesthesia in the intensive care unit and the operating room. The pharmacokinetics of propofol are difficult to predict in patients not conforming to the norms in which the original pharmacokinetic research was based. Such patients, including the critically ill, and morbidly obese, are increasingly being encountered. The investigators group have been involved in the development of a device which can measure blood propofol concentrations, and hope for this to be available to use in the operating room in a clinically useful timeframe in the future. Data will be collected on patients undergoing propofol based general anaesthesia. The Marsh target controlled algorithm in effect site mode (commonly used by anaesthetists) will be assessed for accuracy using the propofol monitor. A new proportional correction method will be developed using this data, designed to enable recalibration of the TCI algorithm in near real time in order to achieve a more accurate estimated propofol concentration in these identified patient groups. The research will investigate the effectiveness of a correction of estimated propofol levels based on a one off measurement early on in the anaesthetic, and will take subsequent samples to measure propofol levels without modifying the TCI algorithm. Additionally, data on anaesthetist choice of TCI model, and method of administration in this relatively unselected group of patients will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* Only patients undergoing major surgery where blood sampling through arterial or central venous catheters is part of their routine clinical care will be recruited.
* Only patients undergoing total intravenous anaesthesia using propofol will be recruited.

Exclusion Criteria:

* Anaemic patients will not be recruited into the study.
* Patients unable to consent will not be recruited into the study.
An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed MTC with signs of residual/persistent disease based on tumor marker levels and/or radiographic imaging. Pathologic diagnosis must be confirmed at UWCCC. Grading must be confirmed by pathologic review performed at UWCCC.
* Elevated neuroendocrine markers at least 1 month post -op. In MTC, persistently elevated neuroendocrine markers such as calcitonin and CEA are indicative of persistent disease.
* Disease progression is not required for this trial

  * 4 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration. Subjects will have had standard of care prior to enrollment. Subjects will have had standard of care prior to enrollment (for example it could include total thyroidectomy, central lymph node dissection, and when necessary ipsilateral radical neck dissection but is tailored to the patient).
  * 3 weeks from the completion of radiation therapy to study registration
* The following laboratory values obtained within 14 days prior to registration:

  * Absolute neutrophils count (ANC) ≥ 1000/mm3
  * Platelets ≥ 75,000/mm3
  * Hemoglobin ≥ 8.0 g/dL
  * Total bilirubin greater than or equal to 2.0 X the upper limit of normal (ULN)
  * AST greater than or equal to 3 X ULN or greater than or equal to 5 X ULN if liver metastases are present
  * Creatinine greater than or equal to ULN
  * Serum sodium within normal limits
* ECOG performance status of 2
* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
* Availability of tissue specimens to be analyzed for pathologic confirmation.
* Age ≥ 18 years.
* Women must not be pregnant or lactating due to the deleterious effects of Lithium carbonate on a fetus or small child. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
* Women of childbearing potential and sexually active males are required to use an accepted and effective method of contraception.
* Patients must not have known history of allergic reactions or adverse reactions to Lithium or its derivatives.
* Patients are not allowed to be on concurrent chemotherapy or radiation therapy.

Exclusion Criteria:

* Gastrointestinal tract disease resulting in an inability to take oral medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, bowel obstruction, or inability to swallow the tablets).
* Significant, active cardiac disease
* Patients must not be taking the following medications: diuretics, ACE inhibitors, NSAIDs (except aspirin or sulindac), neuroleptics, tetracycline, and COX2 inhibitors.
* Patients with radiographic evidence of disease will be presented the option to undergo a tumor biopsy although this is not mandatory.
* Patients already taking Lithium for any reason are not allowed on study
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 75 years old
* Any prior documented intracerebral bleed
* Any documented stroke in the last 12 months
* Hospital admission for bleeding during the prior 12 months
* Non-skin cancer diagnosed or treated ≤3 years
* Planned surgery within the next 12 months
* Renal failure defined as: Creatinine clearance \<40 ml/min
* Thrombocytopenia (PLT \<100,000/mm3)
* Severe chronic liver disease defined as: subjects who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice

Exclusion Criteria:

* Pregnant and breastfeeding women
* Subjects requiring a planned PCI procedure after 1 month of index procedure
* Active bleeding at the time of inclusion
* Cardiogenic shock
* A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (eg, BioLinx™), stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
* PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
* Participation in another clinical study within 12 months after index procedure
* Subjects with life expectancy of less than 2 years
Clinical Characteristics of Lymphatic Malformations

The primary purpose of this study is to retrospectively identify the clinical characteristics of abdominal lymphatic malformations (ALMs) in our single center in China. The second objective of this study is to retrospectively compare the epidemiological features, clinical presentations, cyst properties, surgical treatments, and risk factors for preoperative complications of ALMs between paediatric participants and adult participants.

Lymphatic malformations (LMs) are vascular anomalies that arise from abnormal embryonic development of the lymphatic system and can present as dilated lymphatic channels or cysts lined by lymphatic endothelial cells. Abdominal lymphatic malformations (ALMs) are rare entities that account for fewer than 10% of LMs and may occur not only in the tissues or organs in the abdominal cavity, such as the mesentery, spleen and pancreas but also in the retroperitoneal space. ALMs can manifest as an infection, chronic abdominal discomfort, acute abdomen, or fatal disease.

Eligibility Criteria:
Inclusion Criteria:

* The investigators enrolled participants who were pathologically diagnosed with lymphangioma or lymphatic malformations in the abdominal cavity (i.e., abdominal lymphatic malformations) from January 2009 to December 2022 at our institution.

Exclusion Criteria:

* The investigators excluded participants without a pathological diagnosis of abdominal lymphatic malformations through resection specimens and those with pathological confirmation of other diseases, as well as patients with complex lymphatic anomalies.
Handheld Ultrasound-assisted Versus Palpation-guided Labor Combined Spinal-epidural Analgesia

Parturients who need combined spinal-epidural analgesia for labour analgesia are randomly assigned to two groups. For the handheld ultrasound-assisted technique group, ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle. For the conventional palpation-guided technique group, the interspinous space is detected by palpation. Procedure time, the number of needle passes, the number of needle insertion attempts, success rate, and complications are compared.

This study aims to determine whether handheld ultrasound-guidance can reduce procedural time for labor combined spinal-epidural analgesia compared with conventional surface landmark-guided technique.

Eligibility Criteria:
Inclusion Criteria:

- Adult parturients with ASA physical status classification I, II or III requiring a combined spinal-epidural for labor analgesia

Exclusion Criteria:

* Contraindication to neuraxial anesthesia (local anesthetics hypersensitivity, coagulopathy, needle insertion site infection, etc.)
* Difficulty in communication
* Severe cardiac disease
* History of spine surgery
* Anatomical abnormality of the lumbar spine
* Age under 18
The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE

The purpose of this study is to investigate the effect of using the McMurray Enhanced Airway (MEA) which is a flexible extended-length distal pharyngeal airway on improving oxygen delivery compared to standard nasal cannula.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years old
* Patients willing to participate and provide an informed consent
* Patients scheduled to undergo an elective TEE procedure.

Exclusion Criteria:

* Patients with history of uncontrolled gastroesophageal reflux disease
* Patients with anatomical airway obstruction
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements
Use of Lung Ultrasound to Diagnose the Etiology of Respiratory Failure in a PICU.

The purpose of this study is to determine the utility of point-of-care lung ultrasound (POC-LUS) in identifying the etiology of acute respiratory failure in pediatric patients admitted to the pediatric intensive care unit.

Respiratory failure is one of the most common conditions requiring admission to the pediatric intensive care unit (PICU). As such, chest radiography has emerged as the most commonly utilized tool in the assessment of lung pathology despite evidence that it may not be the most accurate. Since the seminal article by Lichtenstein in 2008, lung ultrasound has emerged as an alternative to chest radiography in the assessment of critically ill adults. Likewise, pediatric lung ultrasound has a growing body of research to support its use in commonly encountered lung pathology including pneumonia, asthma, bronchiolitis, acute chest syndrome, pleural effusions, and pneumothorax. Despite the rapidly growing body evidence, there remains little literature to support its use the diagnosis and management of acute respiratory failure in the PICU.

The proposed study will evaluate whether point-of-care lung ultrasound is accurate in determining the etiology of acute respiratory failure on admission to the PICU.

Specific aims include:

* Aim 1: To determine the sensitivity and specificity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU.
* Aim 2: To determine the inter-observer reliability of point-of-care lung ultrasound examination findings in acute pediatric respiratory failure among trainee and expert sonographers.
* Aim 3: Compare point-of-care lung ultrasound with chest radiography in the rate of detection of consolidation, interstitial edema, pneumothorax, and pleural effusion.
* Aim 4: Describe the POC-LUS findings in patients admitted to the PICU with acute respiratory failure

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 37 weeks gestational age and less than 18 years
* Admitted to PICU
* Clinical diagnosis of acute respiratory failure
* Requirement of non-invasive or invasive respiratory support (as defined by a clinical need for high flow nasal cannula \>1L/kg/min; RAM cannula, nasal or full face mask delivered continuous positive airway pressure ventilation; RAM cannula, nasal or full face mask delivered bi-level positive airway pressure ventilation; or invasive mechanical ventilation); requirement of supplemental oxygen with FiO2 \> 0.35 while on high flow nasal cannula \<1L/kg/min to maintain saturations \> 90%; continuous nebulized therapy; or chronic use of home oxygen or ventilator support AND any increase in home settings

Exclusion Criteria:

* Hemodynamically unstable as defined by the initiation of or the need for increased vasopressor support within the previous 30 minutes
* Known chronic respiratory disease such as primary ciliary dyskinesia, cystic fibrosis, or congenital pulmonary malformations.
Study of Prophylactic Vs Preemptive Valganciclovir

This is a study of prophylactic Vs preemptive oral valganciclovir for management of cytomegalovirus infection in adult renal transplant recipients looking at clinical and pharmacoeconomic outcomes

This is a study of prophylactic Vs preemptive oral valganciclovir for management of cytomegalovirus infection in adult renal transplant recipients looking at clinical and pharmacoeconomic outcomes. Patients at risk for CMV (D+/R-, D+/R+, D-/R+) were randomized to prophylaxis (valganciclovir 900 mg qd for 100 days, n=49) or preemptive therapy (900 mg bid for 21 days, n=49) for CMV DNAemia (CMV DNA level \>2000 copies/ml in ≥ 1 whole blood specimens by quantitative PCR done weekly for 16 weeks then at months 5, 6, 9, and 12. Clinical and virologic outcomes were measured and pharmacoeconomic outcomes will be analyzed

Eligibility Criteria:
Inclusion Criteria:

* All patients who received a kidney transplant at Washington University Medical Center between March 2003 and June 2004.

Exclusion Criteria:

* Age younger than 18
* Refusal to consent for the study
* Allergy to ganciclovir and severe illness too serious to justify randomization
Kinematics of Silastic Joint Replacements in the Hand

To assess in vivo the kinematics of single piece silastic joint replacements in the hand with magnetic resonance imaging

Proximal inter phalangeal joint (PIPJ) replacement is performed for pain relief in the end stage of arthritis. Rheumatoid arthritis is the commonest indication in the metacarpophalangeal joint (MCPJ). In the PIPJ there is a more even spilt between degenerative and rheumatoid arthritis.

There are several options for PIPJ replacement currently licensed for use in the United Kingdom although data is not entered in to the National Joint Registry so the exact numbers and failure rates are unknown. Data from the Norwegian joint registry indicates that 99% of implanted MCPJ and PIPJ replacements are single piece silastic implants.

Three main prostheses represent the majority of implants used in the United Kingdom, Swanson, Sutter and Neuflex. All these implants have been shown in the literature to fracture either at the hinge or the distal stem - hinge interface. This is true of explants and in vitro simulator testing.

Long term survivorship in MCPJ and PIPJ replacement is below that of hip and knee replacement. One of the largest single series shows 63% survivorship at 17 year follow up but with radiological evidence of failure in at least two thirds. This compares poorly to the 82.9% survivorship for Exeter cemented hip replacements at 22 years. The long term aim of this project is to understand how the implants move. This will help explain failure in particular the newly observe hinge failure in Neuflex implants and provide ideas to improve these implants. Any modifications can be tested on the in vitro finger joint testing rig The method of MRI acquisition will be similar to that described in. This will require optimising. In order to limit movement to a sagittal displacement, a thermoplastic splint will support the wrist and hand up to the level of the proximal palmer crease. A rig will also be made to hold the MCP / PIP joints in extension and positions of flexion increasing by 200 to maximum flexion. These will depend upon the patient's range of motion. The Investigators will define the centre of rotation of the hinge then points on the shoulder and stem of the implant from which to measure displacement. Points on the metacarpal and proximal phalanx will also be defined to allow measurement of the displacement of the implant relative to the bone during the range of movement.

Eligibility Criteria:
Inclusion Criteria:

- Single piece silastic joint replacement with an adequate range of movement (ROM), i.e.

an arc of movement of ≥ 50

* Age over 18
* Able to give informed consent

Exclusion Criteria:

* Any contraindication to MRI scanning
* Fractured implant
* Fixed flexion deformity \>30 degrees in the replaced joint
* Total range of motion \<50 degrees in the replaced joint
* Awaiting further surgery
* Abnormal joint instability
* Previous surgery on the same digit (other than the joint replacement)
* Replacement of the joint of the opposite hand
Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients

People with kidney transplants often develop bone disease. One reason for bone disease may be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been discovered that many patients with kidney transplants have low Vitamin D levels. The investigators are examining the effects of doxercalciferol on parathyroid hormone levels, proteinuria and bone turnover markers in people who have had a kidney transplant.

People with kidney transplants often develop bone disease. One reason for bone disease may be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been discovered that many patients with kidney transplants have low Vitamin D levels.

25-OH Vitamin D3 is now recommended to treat kidney transplant patients with low vitamin D levels but it may not be enough to treat the parathyroid problems and bone disease. Doxercalciferol is a form of Vitamin D that has been used to treat bone disease and parathyroid problems in dialysis patients but has not yet been studied in patients with kidney transplants. We are interested in seeing whether doxercalciferol given together with 25-OH Vitamin D3 will be a better treatment for the overactive parathyroid gland and bone disease than 25-OH Vitamin D3 alone in patients with kidney transplants.

Eligibility Criteria:
Inclusion Criteria:

* Adults of both genders between the ages of 18 and 65.
* Kidney transplant at least 1 year prior to enrollment
* Creatinine value of \<2.5 mg/dl with no excursion \>0.5 within the past 3 months
* Proteinuria of 500 mg/24 hours or a protein/creatinine ratio of 0.5 or greater
* Hypovitaminosis D, as defined by a 25-OH Vitamin D value of \<25 ng/ml
* Intact PTH value between 150 and 600 pg/ml

Exclusion Criteria:

* History of parathyroidectomy
* History of prior intolerance to vitamin D therapy (not including hypercalcemia)
* History of biopsy proven acute rejection over the 3 months preceding enrollment
* Recent (over the past month) addition of an ACE inhibitor or Angiotensin -
* Receptor Blocking agent - patients who have been on a stable dose are acceptable
* Current use of active Vitamin D supplement (patients in whom therapy has been discontinued more than 1 month prior to enrollment are acceptable)
* Postmenopausal woman or women receiving hormone replacement therapy