cyrilzakka/clinical-trials huggingface dataset:
Accuracy of Venous Excess Ultrasound (VEXUS) Score Versus Central Venous Pressure in Patients With Severe Sepsis

assessing septic patients with a noninvasive ultrasound protocol, and earlier identification of fluid overload to help clinicians decide whether to administer supplemental fluid therapy or suspend its administration and to evaluate the possible relation between the different VExUS grades and the adverse effects of intensive fluid administration

Sepsis is a life-threatening organ dysfunction caused by a poorly regulated host response to infection. Septic shock is still a leading cause of death worldwide as it can induce multi-organ failure (1).

Septic shock is a subset of sepsis with manifest circulatory dysfunction .intravenous fluid therapy is an essential intervention to promote hemodynamic stabilization.. Similarly, septic patients are a very different and difficult subset in intensive care unit (ICU). They are vasodilated and require fluid resuscitation for optimization of venous volume and cardiac output (2).

Central venous pressure measurement which has been used for ages, is not the ideal monitoring technique as it does not correlate with blood volume and does not give a true representation of the response of fluid challenge (3).

a venous excess Doppler ultrasound (VExUS) grading system, are parameters for the assessment of the fluid status of the patient and organ congestion. This protocol evaluates the amount of venous congestion in the abdominal organs, specifically by scanning the portal, hepatic, and intrarenal veins. Doppler interrogation of these vessels yields a specific pattern corresponding to a level of venous congestion: normal, mild, or severe. (4).

Eligibility Criteria:
Inclusion Criteria:

* adult patients (≥ 18 years old) with the diagnosis of severe sepsis and clinical indication to be admitted in critical care units are recruited. Sepsis should be suspected to be the primary cause of their acute illness by the treating physician, consistent with the

Surviving Sepsis Campaign Guidelines (2021) :

* Life-threatening organ dysfunction
* Diagnosis of infection Some patients diagnosed with sepsis will not meet the criteria, but will be eligible for the study if the treating physician makes a clinical diagnosis of severe sepsis.

Exclusion Criteria:

* 1. Refusal to participate 2. Patients in hemodialysis program 3. Patients with previously known conditions that interfere with portal Doppler assessments, namely liver cirrhosis, or severe tricuspid regurgitation with structural heart disease. If any of these conditions are identified during the present episode, the patient would also be excluded.

  4. Age \< 18 years 5. Patients subjected to withdrawal of care 6. Hemodynamic instability due to active hemorrhage 7. Acute coronary syndrome 8. Indication for immediate surgery 9. Received CPR within 24 hours of enrollment 10. Pregnancy
ESP Block Versus Wound Infiltration for Laminectomy

Spinal surgery is often burdened by perioperative pain and its treatment presently represents a challenge for anesthetists. An inadequate intra and postoperative analgesic therapy leads to a delay in the mobilization of the patients, prolonged hospital stay and thromboembolic complications, as well as the onset of chronic pain syndromes . Effective pain treatment can help improve surgical outcome for patients undergoing spinal surgery. From the pathophysiological point of view pain in vertebral surgery can originate from different anatomical structures: vertebrae, discs, ligaments, dura mater, facet joints, muscles and skin-subcutis. The terminal innervation of these tissues originate from the dorsal branches of the spinal nerves, and this represents a target a multimodal approach to perioperative analgesia in vertebral surgery. Systemically administered drugs such as NSAIDs, opioids, ketamine, intravenous lidocaine could benefit from the addition of locoregional therapies such as neuraxial blocks (anesthesia peridural or subarachnoid) or as shown more recently by other anesthesia techniques locoregional ultrasound-guided In recent years the anesthesiological interest has focused on the Erector Spinae Plane Block (ESPB). First described by Forero et al, it is a paraspinal interfascial block targeting the dorsal and ventral branches of the spinal nerves just after their emergence from the spinal cord. In the ultrasound-guided technique the local anesthetic is injected between the deep fascia of the muscle itself and the transverse processes of the vertebrae at the level interested. The aim of this study is to evaluate the efficacy of ESPB when compared to wound infiltration in patients undergoing laminectomy


Eligibility Criteria:
Inclusion Criteria:

-Planned 1 or 2 level surgical laminectomy

Exclusion Criteria:

* Allergy to local anesthetics
* Refusal of consent
* Uncompensated cardiopathies, nephropathies, liver disease or peripheral neuropathies
* Hemopathies that predispose to bleeding
* Gastrointestinal ulcer or bleeding
* Local infection
* Psychiatric or neurological disorders (except those attributed to primary disease for which intervention is planned) History of abuse (or use in the 24 hours prior to surgery) Alcohol addiction ASA \> 3
Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.

To study the effects of liraglutide on neural responses to high fructose corn syrup (HFCS) in individuals with obesity.

Adolescents are the highest consumers of sugar sweetened beverages (SSB) potentially because their developing brains are most susceptible to the rewarding neural effects of sugar consumption. Thus, we specifically target this population (adolescents) to understand neural mechanisms involved in excess sugar consumption which predisposes to the development of obesity, prediabetes, and type 2 diabetes.

Upon results entry, the data elements in protocol section of this record were updated to reflect the appropriate study phase and primary purpose that was inadvertently mischaracterized at the time of registration. One of the secondary outcomes was removed because it was a duplicate of the second primary outcome.

Eligibility Criteria:
Inclusion Criteria:

1. 18-39 years old
2. Lean (BMI 18.5-24.9 kg/m2) with normoglycemia
3. Obese (BMI 30-45 kg/m2) with or without prediabetes
4. Weight stable
5. Right handed
6. Able to read and write in English
7. Able to provide written and verbal informed consent

Exclusion Criteria:

1. Current active participation in a weight loss program or weight loss of \>=10% of total body weight during the previous 6 months
2. Prior bariatric surgery or current gastric balloon
3. Weight \>440lbs or waist circumference \>142cm
4. Following a vegetarian/vegan diet or dieting/restricting food
5. Significant medical condition
6. Current use of weight-loss medications or supplements, psychiatric medications or anti- hyperglycemic medications
7. History of or family history of multiple endocrine neoplasia type 1 (MEN-I) or medullary thyroid cancer, alcoholism, or previous history of pancreatitis
8. Females who are pregnant or lactating, or who are unwilling to use proper contraception or remain abstinent,
9. Claustrophobia that would interfere with MRI or metal in their body that would pose a risk in the MRI.
A Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography

The goal of this clinical trial is to verify the safety and efficacy of Oral Contrast Agent for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD.

The goal of this clinical trial is to verify the safety and efficacy of Oral Contrast Agent for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD.

Participants will Ultrasound was administered with Oral Contrast Agent for Sonography and observed for 2 days.

The investigators will compare Oral Contrast Agent for Sonography produced by Huzhou East Asia Medical Supplies Co., LTD to see if the safety and efficacy of Oral Contrast Agent for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD

Eligibility Criteria:
Inclusion Criteria:

1. subjects whose physicians recommend oral gastrointestinal CEUS;
2. subjects aged 18-80 years;
3. The subject or guardian can understand the purpose of the study, voluntarily sign the informed consent, and agree to the clinical follow-up;

Exclusion Criteria:

1. Pregnant and lactating women;
2. Subjects with dysphagia;
3. Subjects suspected of gastric bleeding, gastrointestinal perforation, intestinal disorders or gastrointestinal obstruction;
4. Subjects who are expected to receive surgery within 60 hours;
5. Subjects who have received gastroscopy within 24 hours;
6. subjects deemed unsuitable for the study by the researcher;
7. Subjects who have participated in other drug or device clinical trials and have not completed the expected primary endpoint follow-up of the clinical trials in which they participated.
A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer

Adjuvant radiotherapy is the standard treatment for early breast cancer after breast conserving surgery. Molecular subtypes was significantly associated with the risk of local recurrence of breast cancer. Nguyen et al found that the overall 5-year cumulative incidence of local recurrence was 0.8% for luminal A, 1.5% for luminal B, 8.4% for HER2 positive, and 7.1% for triple negative breast cancer after lumpectomy and radiotherapy. Her2 positive and triple negative breast cancers may be inherently radioresistant.

Therefore, for HER2 positive and triple negative breast cancer with high local recurrence and radiation resistance, proton combined with carbon ion is proposed after breast conserving surgery.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed HER2 positive or Triple Negative invasive breast carcinoma.(HER2 positive: immunohistochemistry \[IHC\] 3+ and or fluorescence in situ hybridization \[FISH\] amplified; Triple Negative: estrogen receptor \[ER\] and progesterone receptor \[PR\] \< 1%, HER2 negative \[IHC 1+ or 2+ FISH non-amplified\])
* Age ≥ 18 years and ≤ 80 years.
* The primary tumor must be excised via breast conserving surgery.
* Stage p T1-2 N0 M0
* ECOG performance status ≤2.

Exclusion Criteria:

* Invasive breast cancer not confirmed by pathology.
* Distant metastasis
* Prior thoracic radiation.
* Pregnancy or lactating.
Primary Care iSBIRT to Reduce Serious Teen Health Risks

The goal of the project is to develop and test an internet/intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescents that targets a broad range of serious health-risks and problem behaviors.

We have previously developed and tested a computerized substance use screening and feedback program for adolescents. We will expand this program to include other serious health risks, enhance the feedback and health risk information adolescents will receive on the computer, develop Technological Extenders to extend the effect of the intervention, develop a training video and protocol for providers, and pilot test the system among adolescents coming for non-urgent care at a variety of primary care sites.

Eligibility Criteria:
Inclusion Criteria:

* 12-21 years old
* arriving for non-urgent care
* provide informed assent/consent

Exclusion Criteria:

* less than 6th grade reading level
* unavailable for follow-up questionnaires
A Study of the Safety and Pharmacokinetics of rhGAA in Siblings With Glycogen Storage Disease Type II

GSD-II (also known as Pompe disease) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with GSD-II, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. This study is being conducted to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme replacement therapy for a pair of siblings with GSD-II. To be eligible for this study, a patient must have a confirmed diagnosis of GSD-II and have a sister or brother who also has a confirmed diagnosis of GSD-II.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained from the parent or guardian prior to performing any study related procedures;
* Patient must have a clinical diagnosis of GSD-II confirmed by endogenous GAA activity below normal in at least one tissue;
* Patient must have a sibling with a clinical diagnosis of GSD-II confirmed by an endogenous GAA activity below normal in at least one tissue, who is eligible for participation in this study;
* Patient must have a sibling with identical GAA mutations who is eligible for participation in this study;
* Patient must have a sibling with evidence of different progression of GSD-II who is eligible for participation in this study;
* The patient or his/her guardian(s) must have the ability to comply with the clinical protocol.

Exclusion Criteria:

* Patient has significant organic disease (with the exception of symptoms relating to GSD-II), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, would preclude participation in the trial;
* Patient is participating in another investigational study.
Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial Ovarian Cancer

The purpose of this study is to evaluate the efficacy of paclitaxel and carboplatin followed by gemcitabine and carboplatin therapy for patients with epithelial ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified epithelial ovarian cancer
* FIGO stage III-IV
* Patients with measurable disease. RECIST criteria with GCIG modifications will be used for response and for progression assessment.
* Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal to 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal to 20 mm.

Exclusion Criteria:

* Ovarian tumors with low malignant potential (borderline tumors)
* Non-epithelial ovarian or mixed epithelial. non epithelial tumors (e.g. mixed Mullerian tumors)
* Time between definitive surgery and enrollment into the study is greater than 6 weeks
* Patients who have received previous chemotherapy or radiotherapy
Comparison of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer

The purpose of this study is to determine whether neo-adjuvant weekly paclitaxel with carboplatin is better than paclitaxel alone in efficiency and safety in early breast cancer, and to explore whether ultrasound and magnetic resonance imaging can predict the efficiency of neo-adjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* female patients between 18 and 65 years old
* pathological diagnosed invasive breast cancer; medium and high risk primary breast cancer according to St. Gallen 2007
* able and willing to give consent to participate in the study

Exclusion Criteria:

* pregnant or lactating females
* previous treatment for breast cancer
* other tumor history
* instable complication (e.g., myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection
* allergy history to similar drugs
* concurrent disease or condition that would make the patient inappropriate for study participation
* resist to participate in the study
Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease.

Congenital heart defects (CHDs) are heart malformations that occur before birth, and they represent one of the leading causes of neonatal morbidity and mortality. they occur in approximately 1% of newborns and are associated with high morbidity and mortality rates. The etiology of these cardiac anomalies is mostly unknown. around 70-80% of cases are generated by the involvement of multiple affected genes combined with an environmental trigger that, when acting on a susceptible individual, promotes the expression of the damaged genome. maternal diseases during pregnancy or exposure to teratogenic substances are also implicated in the etiology.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with a history of cardiac transplantation or acquired congenital heart disease who have undergone at least one interventional procedure or surgical intervention at least 6 months before the start of the program in a state of clinical stability, hemodynamic stability, and ECG stability. They should have residual hemodynamic defects of sufficient severity that potentially restrict participation, and their perception of fragility may be influenced by the social, family, school environment, or by the patient themselves.
* Children aged 6-15 years at the start of the study.
* Children with maximum predicted oxygen consumption (VO2 max) values \<80%, as measured in ergospirometry 6 months before the start of the intervention program.
* Patients for whom consultation with a pediatric cardiology specialist and pediatric rehabilitation specialist has not revealed contraindications for exercise.
* Children and their legal representatives should have provided informed consent and the ability to travel to the hospital center for in-person intervention.

Exclusion Criteria:

* Patients with acute, inflammatory, or infectious health conditions that could pose a risk to them during the course of the program.
* Patients who have undergone at least one interventional procedure or surgical intervention within a period of less than 6 months before the start of the study.
Anesthetic Blockades and Migraine

Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs) in different areas. We hypothesize that those patients receiving real GON anesthetic blockade will receive greater improvements in pain nociception. We will conduct a double-blind, randomized, parallel and placebo-controlled clinical trial where one group will be treated with bilateral GON blockade with bupivacaine 0,5% and the other group will be treated with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Chronic migraine

Exclusion Criteria:

* Other primary headaches
* Other secondary headaches
* Co-morbid medical diseases
Diabetic Cardiomyopathy

Diabetes represents one of the 10 leading causes of death in the world and concerns 5% of the French population (\> 3.3 million patients). About 30% of diabetic patients will develop heart failure. The specific and early identification of diabetic cardiomyopathy at a subclinical stage (asymptomatic patients with normal LVEF) will thus make it possible to predict the risk of the onset of heart failure and to strengthen their monitoring and further adapt their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years old)
* Type 2 diabetic and hypertensive subjects, cardiac asymptomatic, without myocardial ischemia documented by Dobutamine stress ultrasound (ESD), having at least 1 additional CV risk factor among: dyslipidemia, active or stopped smoking for less than 3 years, family history (1st degree relationship) of major CV accident before age 60, obliterating arteriopathy of the lower limbs and / or carotid atheroma, or proteinuria.
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Patient who expressed his opposition to participating in the study
* Valvular heart disease (moderate to severe valve disease), hypertrophic or dilated (MVGi\> 95 g / m2 in women and MVGi\> 115 g / m2 in men), chronic pulmonary;
* History of cardiotoxic chemotherapy;
* Subject under legal protection, under guardianship or under guardianship.
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. There have been efforts to lower the incidence of postoperative vitreous hemorrhage such as preoperative bevacizumab injection. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. Recently there have been reports showing that preoperative bevacizumab injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful. Our hypothesis is that intraoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery.

We started the prospective randomized comparative study to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without any adjuvant drug.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy

Exclusion Criteria:

* follow-up period of less than 3 months
* not first vitrectomy
* abnormal blood coagulation
* uncontrolled hypertension
Renal Resistive Index and Cardiac Output Changes During Resuscitation Predict the Occurrence of Acute Kidney Injury in Septic Shock Patients

Record the renal resistive index and hemodynamic parameters ( record the cardiac output and stroke volume if the patient's next to kin agree to undertake a PiCCO monitoring ) before and after resuscitation for severe sepsis or septic shock patients, to determine whether the changes of resistive index or hemodynamic parameters, especially the cardiac output can be a better parameter to predict AKI

* Purpose: To examine whether the resuscitation-induced changes of renal resistive index or hemodynamic parameters has the superiority as a valid tool to evaluate the renal perfusion improvement and whether the changes can better predict AKI occurrence in severe sepsis or septic shock patients.
* Methods: Measure the renal resistive index and take record of hemodynamic parameters (use a PiCCO monitoring to measure cardiac output if the patient's next to kin agree to undertake such a catheter ) before and after successful resuscitation for severe sepsis or septic shock patients, followup to determine the occurrence of AKI and mortality.
* Hypothesis: The changes of resistive index or cardiac output during shock resuscitation may be a better parameter to evaluate renal perfusion and predict AKI, and may have a better value to guide renal protective therapy in septic shock.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years, Sex unlimited
* Arriving ICU in 6 hours and diagnosed with severe sepsis or septic shock
* Physician in charge decide that an aggressive fluid resuscitation was in order

Exclusion Criteria:

* Pregnancy, Age \<18 years
* Ongoing recovery from AKI
* Known end-stage renal disease or chronic kidney disease(glomerular filtration rate \<30mL/min/1.73m2)
* Known other causes of shock morbidly
* conditions known to modify RRI, such as renal-artery stenosis, intra-abdominal hypertension(\>35cmH2O)