cyrilzakka/clinical-trials huggingface dataset:
Acute Kidney Injury in Children After Cardiopulmonary Bypass

Acute kidney injury (AKI) is a common complication in patients with congenital heart defects after cardiopulmonary bypass. The death rate from AKI in critically ill children remains high and reaches 60%.

The basic criteria for diagnosing and assessing the severity of kidney injury until recently were the level of serum creatinine and the amount of urine released. However, it should be noted that the level of serum creatinine, traditionally used to assess renal function, does not significantly increase until a decrease of more than 50% of the glomerular filtration rate, in addition, its level depends also on some extrarenal causes. Artificial blood circulation and hemodilution leads to the preservation of the level of creatinine at sufficiently low levels up to 1-3 days postoperative period. The level of diuresis as well as the level of creatinine is a nonspecific criterion after cardiac surgery and depends on several factors.

Currently, in the field of acute renal injury studies, progress has been made in the emergence of new biomarkers such as the tissue inhibitor metalloproteinase-2 (TIMP-2) and insulin-like growth factor binding globulin-7 (IGFBP7), which are early markers of acute renal damage. In a study in adult patients, it was shown that the levels of TIMP-2 and IGFBP7 increased In the first 24-48 before the diagnosis of IR-associated renal damage.

Among pediatric patients with congenital heart defects, such studies are single and only present for the age group 3 and older, which also demonstrated the high specificity and prognostic significance of these biomarkers in the early diagnosis of acute renal damage.

It should also be noted that, in spite of the high specificity of the markers described, it is also necessary to note their considerable cost.

Thus, taking into account the above, it is planned to compare and identify the relationship of these indicators with such parameter as the index of renal vascular resistance, the increase of which in the pre- and postoperative period may serve as a sign of the beginning acute renal injury.


Eligibility Criteria:
Inclusion Criteria:

Age from 1 month to 1 year Presence of congenital heart disease Radical correction of the defect in conditions of cardiopulmonary bypass

Exclusion Criteria:

Inconsistency with age criteria Cardiotonic support before surgery Acute renal, acute liver failure before surgery
Evaluation of QoL, Tolerability and Use of Zoladex 10,8 SafeSystem for Advanced PCa - German IPEP Trial

Purpose of this study is the evaluation of QoL, tolerability and use of Zoladex 10,8 SafeSystem for advanced PCa under naturalistic conditions


Eligibility Criteria:
Inclusion Criteria:

* Patients with PCa, who will be treated with Zoladex 10,8 SafeSystem based on the current SPC
A Livelihood Intervention for Impoverished Women and Children in Rural Uganda

The objective of the study is to determine whether a livelihood intervention can improve health and schooling outcomes of the children of woman participating in a livelihood intervention in rural Uganda.


Eligibility Criteria:
Inclusion Criteria:

* All children under 18 years

Exclusion Criteria:

* Adults older than 18 years
Stress and Sugar Synergy

The main objectives of this study are to test the hypotheses that: 1) consumption of beverages sweetened with sucrose will increase risk factors for cardiovascular disease to a greater extent than a naturally-sweetened fruit juice such as orange juice, and 2) chronic psychological stress may augment the adverse metabolic effects of sugar intake. The study intervention consists of 2-week's consumption of 25% of energy as sugar provided either as a sucrose-sweetened beverage or naturally-sweetened orange juice.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 28-35
* Self report of stable body weight during the past six months
* High stress participants: Perceived Stress Scores (PSS) ≥ 24, and the presence of a predefined chronically stressful event as assessed by the Telephone screening questions. (IDS scores are not an inclusion criteria in this group, merely a rule-out for the low stress participants).
* Low stress participants: PSS scores ≤ 8, Inventory for Depressive Symptom (IDS) scores ≤ 14, and the absence of any predefined chronically stressful events as assessed by the telephone screening questions.

Exclusion Criteria:

* glucose intolerance
* Evidence of liver disorder
* Evidence of kidney disorder
* Evidence of thyroid disorder
* Systolic blood pressure consistently over 140mmHg or diastolic blood pressure over 90mmHg
* Triglycerides \> 200mg/dl
* LDL-C \> 130mg/dl
* Hemoglobin \< 8.5 g/dl
* pregnant or lactating women
* Current, prior (within 12 months), or anticipated use of any hypolipidemic or anti-diabetic agents
* Use of Selective Serotonin Reuptake Inhibitors and anti-hypertensive medications
* Any other condition that, in the opinion of the investigators, would put subject at risk
* Strenuous exerciser
* surgery for weight loss
* Diet exclusions: food allergies, special dietary restrictions, habitual ingest of \>2 alcoholic beverages/day
Effect of Genetic Variation in Starch-digesting Enzymes on Digestibility and Glycemic Index of Cold and Hot Rice

This study evaluates the effect of different methods of preparation (cooked and consumed hot vs cooked, cooled overnight and consumed cold) and variation in the activity of salivary amylase on the glycemic index and carbohydrate digestibility in healthy human subjects. The effect of genetic variation in small intestinal starch digesting enzymes on glycemic index and starch digestibility will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females aged 18-75 years and in good health
* Eligible to receive income in Canada
* Have Ontario Health Insurance Plan or equivalent medical coverage.
* Previous donor of saliva using protocol reference number # 31093 or GIL-1670 (in which subject consents to measurement of salivary amylase activity and genetic variation in AMY1, SI and MGAM genes).
* Salivary amylase activity in the lowest tertile (\<50 U/ml) or highest tertile (\>105 U/ml) of salivary amylase activity of 40 subjects previously measured.

Exclusion Criteria:

* known history of AIDS, hepatitis, diabetes or a heart condition
* Allergy to rice, canola oil or sesame oil.
* use of medications (including, but not limited to, insulin or other antidiabetic drugs, systemic steroids, antipsychotics, protease inhibitors, antivirals, immunosuppressive agents and drugs affecting gut motility or digestion) or with any condition which might, in the opinion of Dr. Wolever, the Medical Director or GI Labs, either: 1) make participation dangerous to the participant himself (or herself) or to others, or 2) affect the results.
* individuals who cannot or will not comply with the experimental procedures or do not follow the instructions of GI Labs staff related to the safe performance of the experimental procedures
Evaluation of Fosmidomycin and Piperaquine in the Treatment of Acute Falciparum Malaria

The objective of this study is to explore the role of fosmidomycin and piperaquine as non-artemisinin-based combination therapy for acute uncomplicated Plasmodium falciparum when administered over three days.

Together, fosmidomycin and piperaquine fulfil the WHO criteria for combination therapy by meeting the three key parameters of having different modes of action and different biochemical targets while exhibiting independent blood schizonticidal activity. Like the artemisinins, fosmidomycin is fast-acting, has an excellent safety record and is active against existing drug-resistant parasites. Piperaquine has a long half life protecting fosmidomycin as a much shorter lived molecule against selection of resistant parasites and will provide post-treatment prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 1 to 60 years inclusive
* Body weight between 5kg and 90kg inclusive
* Acute manifestations of a mono-infection with Plasmodium falciparum as determined by either a rapid diagnostic test for adults or microscopically confirmed by an asexual parasitaemia of 1,000 to 150,000/uL and fever with an axillary temperature of \> 37.5 degress C or oral/rectal/tympanic temperature of \> 38.0 degrees C or history of fever during the previous 72 hours
* Compliance with contraceptive measures throughout the study period of 63 days in females of child bearing potential

Exclusion Criteria:

To be eligible for inclusion in the study, subjects must NOT meet any of the following criteria:

* Signs of severe/complicated malaria according to WHO criteria
* Pregnancy as excluded by negative serum human chorionic gonadotrophin (hCG) test
* Lactation
* Mixed Plasmodium infection
* Severe vomiting on three or more occasions in the previous 24 hours
* Severe diarrhoea on four or more occasions in the previous 24 hours
* Concomitant disease masking assessment of response including

  * abnormal liver function tests with bilirubin \> 40 µmol/L, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) levels \> x 2 upper limit of normal
  * impaired renal function with creatinine level \> x 2 upper limit of normal
  * haemoglobin level \< 7.5g/dl
  * white cell count \> 12000/µL
* History of cardiovascular disease including arrhythmia with QTc interval ≥ 450msec, respiratory disease including active tuberculosis, hepatic disease including jaundice, renal failure, malignancy, neurological disorders including convulsions and psychiatric disturbances
* History of immunological disease including Hepatitis A, B and C and HIV-AIDS
* Severe malnutrition
* History of hypersensitivity or adverse reactions to fosmidomycin, piperaquine, artesunate and mefloquine
* Treatment with antimalarial and antibacterial agents within the previous 28 days
A Prototype Tri-modal Imaging Device for Breast Cancer

Breast conservation surgery (BCS) is performed on patients with breast cancer with the intent to resect and completely remove the tumour while conserving as much of the surrounding normal tissue as possible. Currently, there is no way for surgeons to determine the adequacy of surgical resection in real-time during surgery; the assessment of surgical margins requires histological examination that is not available in real-time and is impractical in most clinical cases. This results in a re-excision rate of 23% among Canadian women in order to achieve optimal surgical margins. In addition, the presence or absence of cancer in tumor draining lymph nodes is recognized as a key element for breast cancer staging; however, lymph node dissection can be associated with overtreatment and morbidity (nerve damage and post surgical lymphedema) and histological analysis of nodes can be time consuming and thus delay subsequent procedures. In an effort to address these issues, we have designed and constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel imaging system that performs three complementary imaging modalities (tri-modal): ultrasound (US), photoacoustic (PA) and fluorescence (FL).

This first-in-human pilot study will recruit 10 breast cancer patients undergoing breast conserving surgery at Princess Margaret Hospital (Toronto, Canada). The study is designed to test our tri-modal (US, PA, FL) imaging technology in breast cancer patients. The overall goal is to obtain initial information on the technical feasibility of the tri-modal system in a peri-operative setting and to confirm the anticipated safety of the procedures. Additionally, it will provide initial data on the ability of this system to detect/localize primary breast cancer lesions and cancer-involved lymph nodes prior to surgery.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with biopsy-confirmed first primary invasive unilateral breast cancer
* 18 years of age or older
* Have consented to standard of care surgery (lumpectomy, mastectomy) for primary invasive breast cancer, with or without auxiliary lymph node dissection
* Have had pre-surgical imaging of the affected breast and (where applicable) lymph notes (Note: additional imaging may also be done day of scheduled surgery i.e. mammography, nuclear medicine)
* Have existing biopsies banked at the hospital
* Surgery scheduled at Princess Margaret Hospital
* Tumor size of 1 cm or larger

Exclusion Criteria:

* Inability to provide informed consent
* Pre-operative therapy for current breast cancer (including chemotherapy, endocrine therapy and radiotherapy)
* history of other previous cancer requiring therapy (including chemotherapy, endocrine therapy and radiotherapy) within the past 12 months
* History of photosensitivity, skin disease or recurrent disease
* Pregnancy
* Absence of in-house biopsy in tissue bank
* Bilateral breast cancer
Role of [18F]-FDG Brain PET in Newly Diagnosed Primary Cerebral Lymphoma, in Immunocompetent Patient Older Than 60 Years

Patients older than 60 years account for half of cases of Primary Central Nervous System Lymphoma (PCNSL) and have a poorer outcome. No prognostic or predictive factors exist for survival after initial remission. 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose - Positron Emission Tomography (\[18F\]FDG-PET) plays a key role in grading and therapy monitoring of systemic diffuse large B-cell type.

LOCALYZE is an ancillary Positron Emission Tomography / Magnetic Resonance (PET/MR) clinical study from BLOCAGE 01 (Pr Hoang-Xuan). The aim is to evaluate the usefulness of \[18F\]FDG-PET to monitor treatment response in PCNSL older than 60 years (n=56), in complement to multiparametric Magnetic Resonance Imaging (MRI).

Hypothesis The investigators assume that the development of new imaging biomarker extracted from PET imaging and multiparametric MRI, could improve the assessment of treatment response in PCNSL.

\[18F\]-FDG PET/MR will be performed in the Department of Nuclear Medicine - Pitié-Salpêtrière Hospital:

* prior to initiation of chemotherapy (rituximab, methotrexate, procarbazine, vincristine and cytarabine) (PET#1),
* after two chemotherapy cycles (PET#2),
* at the end of the first-line chemotherapy regimens (PET#3).

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed primary cerebral lymphoma
* Age ≥60 years
* Pathology proven diagnosis or positive cytology of the Cerebrospinal Fluid (CSF) or vitreous
* Karnofsky Performance Status ≥40
* No evidence of systemic Non-Hodgkin lymphomas (NHL) (body CT scan, bone marrow biopsy)
* Adequate haematological, renal and hepatic function
* Calculated creatinine clearance \> 40 ml/min

Exclusion Criteria:

* Uncontrolled diabetes with fasting glycaemia \> 200 mg/dL
* Sensitivity to active substance in \[18F\]-FDG
* Calculated creatinine clearance \< 40 ml/min
* No contraindication to MRI (magnetic resonance imaging)
18F-FluorThanatrace (PET/CT) in Glioblastoma

The subject will be a candidate for this imaging study because they have agreed to participate in a treatment study involving TTFields (Optune device), a device that uses low intensity, wave like electrical fields, and a PARP inhibitor drug (niraparib). The research study is being conducted to test how a new radioactive imaging drug called 18F-Fluorthanatrace (18F-FTT) can be used to image sites of recurrent brain cancer before or after new treatment or surgery. 18F-FTT is a drug used with an imaging test called Positron Emission Tomography/Computed Tomography (PET/CT).

Participants will undergo up to three \[18F\]FTT PET/CT scans at the following time points:

* Baseline: Subjects from either cohort may agree to undergo a baseline \[18F\]FTT PET/CT prior to the start of TTFields therapy to measure baseline FTT uptake. This scan is not required and may be omitted at the discretion of the investigator or based on subject availability.
* Post-TTFields: Subjects from both cohorts will undergo an \[18F\]FTT PET/CT scan 3-7 days after initiation of TTFields therapy and before surgical resection or initiation of niraparib. This scan will measure the FTT uptake after TTFields therapy is initiated. This scan is required.
* Post-PARPi: Subjects from Cohort A may agree to undergo an post-therapy \[18F\]FTT PET/CT scan 1- 21 days after the initiation of niraparib to collect pilot data on the changes in FTT uptake after TTFields and niraparib combination therapy. This scan is not required and may be omitted at the discretion of the investigator or based on subject availability.

For each \[18F\]FTT PET/CT imaging session, participants will undergo approximately 60 minutes of dynamic brain scanning starting nearly simultaneously with the injection of \[18F\]FTT. A second optional brain scan will be done at approximately 90 minutes post-injection. Each imaging session will include an injection of up to 12 mCi (approximate range for most studies is anticipated to be 8-12 mCi) of \[18F\]FTT.

Eligibility Criteria:
Inclusion Criteria:

1. Participants will be ≥ 22 years of age
2. Participants will have a diagnosis of glioblastoma and be enrolled in the companion treatment trial, IRB 832694.
3. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of childbearing potential at screening.
2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.

Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Relationship Between the Clinical Pharmacist & Antibiotic Use by Using the Electronic Program

A retrospective cohort study to explore the association between clinical pharmacists' interventions and antibiotic consumption through the use of the medical electronic reports and to identify mortality and cost savings in hospital infectious disease.

The role of clinical pharmacist includes :

1. a check of suitable selection and dosing of antimicrobials according to the diagnosis, type of infection, antimicrobial cultures as possible, comorbidities of patients (renal or hepatic function, etc), adverse effect, and drug interaction with other drugs.
2. Documentation of the clinical intervention, cost-saving, adverse effect,, antimicrobial culture and antimicrobial consumption on the electronic program (CPC "clinical patient care").
3. The clinical pharmacist inspector reviews the data recorded on CPC.

Eligibility Criteria:
Inclusion Criteria:

* All inpatient with infectious disease (disorders caused by organisms as (bacteria, viruses, fungi, or parasites).

Exclusion Criteria:

* Any other cause of hospital admission other than infectious disease.
Carotid Web Associated With Cerebral Infarctions

Carotid Web located at the bulb level is a rare condition and is often associated with severe cerebral infarction in the carotid territory. This condition has been described predominantly in the black population. However, limited data are available for the epidemiology of carotid web and often result from selected population studies. It has been shown that the carotid web is a focal intimal dysplasia. Rate of ischemic stroke recurrence is high, even in patients treated with antiplatelet therapy. This subtle lesion is often unknown and misdiagnosed including in stroke unit. We assume that the implementation of a multicentric cohort would allow a comprehensive analysis of the carotid web condition.

Carotid web lesions associated with cerebral infarctions are a relatively rare and largely unknown disease. However, carotid web lesions are associated with severe infarction involving the functional and vital prognosis of patients. The high rate of recurrence should lead to an identification of the lesion at the first event in order to propose a suitable preventive treatment. We believe that only a multicenter cohort will be able to analyze the characteristics of the pathology and propose studies on critical size samples. A national cohort would lead quickly to a consequent collection of cases. By including overseas departments and communities, notions of prevalence and characteristics within different populations could finally be studied. Participation to the cohort constitution will probably lead to sensitizing the various actors of the course of stroke care to the diagnosis and appropriate care of the carotid web.

Patients will be selected by the Stroke Units which take part in the cohort constitution. Stroke Unit investigator will fill the WEPI online entry database. Clinical, imaging and outcome characteristics will be informed.

In order to guarantee the quality of the cases collected, the validation of the carotid web lesion will be carried out by a pair of expert Neurologist - Neuroradiologist appointed within an expert committee. In case of no consensus, a third expert will resolve the disagreement.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Available imaging revealing the presence of a carotid web
* Cerebral infarction or transient ischemic attack in the carotid area downstream of a carotid web lesion.
* Validation of the carotid web by a pair of experts Neurologist and Neuroradiologist
* Agreement of the patient or the support person given after reading the information and non-opposition form

Exclusion Criteria:

* Age \<18 years
* Patient expressing opposition to be enrolled in the CAROWEB cohort
The Early Coagulopathy for the Prognosis in Sepsis

In this cohort study, the parameters (TM, TAT, PIC, tPAIC, et al.) associated with the hemostatic system will be collected in sepsis patients when admitted to the Intensive Critical Unit. Parameters will be evaluated for their prognostic function of 28 days mortality.

The object of this study is to find the early mortality prognostic biomarkers within the hemostatic system in sepsis patients. Blood samples will be collected from sepsis patients at admission. Parameters reflect endothelial injury, such as thrombomodulin (TM), tissue type plasminogen activator inhibitor complex (tPAIC), parameters reflect procoagulation condition, such as thrombin-antithrombin complex (TAT), and parameters reflect hyperfibrinolysis, such as plasmin-plasmin inhibitor complex (PIC) will be tested. Based on the results of these parameters, sepsis patients will be divided into coagulation parameter normal or abnormal groups. Twenty-eight days of mortality will be determined by patient follow-up. Regression analysis will be used to evaluate the relationship between these parameters and the mortality of sepsis patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology from August 2020 to July 2022.
* Patients diagnosed with sepsis. The criteria for diagnosis is: 1. Infection or suspected infection; 2. SOFA score ≥ 2.
* Age interval: 18 years -- 80 years.
* Gender: unlimited.
* Signed informed consent form received.
* Results of the coagulation parameters tested within 24 hours after admission are available.

Exclusion Criteria:

* Pregnant and lactating women.
* With primary diseases that can cause thrombocytopenia or prolong prothrombin time, such as leukemia.
* Patients with severe liver dysfunction.
* Patients with anticoagulation or fibrinolysis medications within 72 hours before admission.
* Patients are in a procoagulation condition, such as VTE patients, protein C or protein S deficient individuals.
* Patients with chronic renal failure.
* Patients need ECMO therapy.
* Patients with severe cardiopulmonary diseases or nervous system diseases.
* Patients at the end-stage of disease.
* Patients without signed informed consent forms.