cyrilzakka/clinical-trials huggingface dataset:
Epidemiology of Infections in Pediatric Cancer Patients

Infections are common causes of morbidity and mortality in pediatric cancer patients. Today, there are limited data on the incidence, distribution of specific infections, causative agents and risk factors for severe infections in this population. Moreover, little data exist on the epidemiology of infections among pediatric patients with solid tumors.

The objectives of the present study are to define the incidence, categories of infections by organ systems, etiologic agents and risk factors for infections in different pediatric malignancies. The results of this study will help the investigators to better understand the epidemiology of infections in the different types of pediatric malignancies, enable the investigators to identify high risk patients, and design a better approach to empiric treatment of these patients.

A prospective, multi-center study, conducted in 5 pediatric hematology-oncology units across Israel (Rambam Medical Center, Haemek Medical Center, Schneider Children's Medical Center, Hadassah Medical Center, Soroka Medical Center). All children aged 0-18 years of age, newly diagnosed with cancer and admitted to day care or inpatient departments with fever of \>38.0 C will be included in the study. Demographic, clinical and microbiological figures will be collected in each center by a research assistant supervised by the infectious disease specialist. Data will be collected according to a pre-defined Patient Data Form and entered into an electronic data base that will be analyzed accordingly. In each event of febrile episode during chemotherapy, the following data will be collected by a research assistant using a patient data form and computerized software:

* Demographic data: age, gender, ethnicity.
* Clinical data: Underlying disease, immunizations, prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy, duration of fever, duration and severity of neutropenia, diagnosis of present event.
* Imaging data
* Microbiological data
* Outcome

The statistical analysis will be performed by an epidemiologist and statistician using the SPSS 12.0 software.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric cancer patients admitted to hospital with fever
Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome

Combination therapy of ezetimibe with a low-dose statin is occasionally used to avoid statin-related side effects in clinical practice among patients with atherosclerotic cardiovascular disease. This approach is equivalent to high-dose statin therapy to decrease LDL cholesterol level by \>50%, allowing such patients to achieve LDL cholesterol target. However, it remains uncertain whether combination therapy with ezetimibe and low-dose statin verse high-dose statin monotherapy similarily suppress atherosclerotic plaque inflammation. This study is to compare high-dose rosuvastatin versus low-dose rosuvastatin plus ezetimibe on carotid plaque inflammation in patients with acute coronary syndrome using 18F-fluorodeoxyglucose (18FDG) positron emission tomography (PET) imaging.


Eligibility Criteria:
Inclusion Criteria:

1. aged ≥ 19 years
2. acute coronary syndrome, carotid artery disease (diameter stenosis 20-50%), and at least one 18FDG uptake lesion in the carotid artery (target to background ratio (TBR) ≥ 1.6) by 18FDG PET/CT imaging
3. written consent

Exclusion Criteria:

1. previous history of carotid endarterectomy or stenting
2. schedule for cardiac or major surgery within the next 6 months
3. statin or ezetimibe therapy in the past 4 weeks
4. chronic disease needed to be treated with oral, intravenous, or intraarticular steroid
5. end-stage renal disease
6. chronic liver disease
7. history of cancers within the past 3 years
8. pregnant, breast-feeding or child-bearing potential
9. expected life expectancy within 2 years
Effects of Mobile Application-based Lifestyle Counselling on Body Weight Loss in Obese Subjects

The aim of the trial is to study the effect of a mobile application-based lifestyle change program on body weight loss in adult subjects with obesity. The main focus is to motivate and support beneficial lifestyle changes targeting long-term weight management.

This study comprises two randomly assigned study arms: mobile application-based lifestyle change program and "waiting-list" control. The mobile application-based lifestyle change program consists of twice a week content for the first 6 months, continuing with less frequent contents for the following 6 months (the length of intervention 12 months). The "waiting-list" control group will receive mobile application-based lifestyle change program after 6 months followed by intervention for 12 months. The main aim is to demonstrate that the users of mobile application-based lifestyle change program lose more weight than controls at 6 month timepoint and weight loss is maintained for 18 months (6 months after the end of mobile application-based lifestyle change program use). Weight is measured and blood samples (lipids, glucose and metabolic syndrome measures) are collected at 0, 6, 12, and 18 months.

The mobile application-based counselling contains aspects of cognitive behavior therapy and persuasive system design and consists of twice a week reminders, tasks, self-monitoring, and reflection.

The main outcome is the decrease in body weight. Secondary outcomes are changes in eating behavior, psychological factors, components of metabolic syndrome (waist circumference, plasma lipid and glucose values, blood pressure), and calculated scores of metabolic condition and adiposity.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 30 to 40 kg/m2
* Ownership of a smartphone

Exclusion Criteria:

* Untreated hypothyroidism
* Oral glucocorticoid treatment
* Pregnancy or lactation
* No possibility to use mobile phone or tablet
* No knowledge of Finnish language
* Presumed lack of adherence to the study
* Participation in another ongoing weight management program
* Diagnosed or suspicion of cardiovascular disease causing restrictions to exercising
* Bariatric operation planned
* Usage of any anti-obesity drug
Maternal Serum Alpha-fetoprotein Level May Predict the Presence of Morbid Adherent Placenta

The aim of the study is to compare between alpha-fetoproteine as a biological marker and between ultrasound and Doppler in prediction of morbid adherent placenta.

in pregnant women withe previous cesarean section, placenta previa and ultrasonographic finding of an abnormally adherent placenta dose maternal serum alpha-fetoprotein predict prenataly the presence of morbid adherent placenta accurately?

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with history of scarred uterus

  * plcenta previa covering the scar of previous caesarean section as diagnosed by 2DU/S
  * Gestational age from 28wks to full term

Exclusion Criteria:

* pregnant women with fetus with congenital anomalies

  * pregnant women with ovarian swelling
  * pregnant women with medical disease
ABC Survey - do we Meet the Needs of Patients With Advanced Breast Cancer?

The study will follow a descriptive design involving a survey. Data collection will involve paper based questionnaires. The questionnaires have been developed in conjunction with breast cancer support groups associated with the Irish Cancer Society and patients.

The purpose of the study is to identify and categorise the need of Metastatic Breast Cancer (MBC) patients in Ireland with particular focus on; quality of life, symptom burden and access to and value of support available.

The study also aims to evaluate future service developments that will provide support to these patients.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Clinical diagnosis of MBC
* Female aged 18 years or older
* Able to complete the questionnaires independently

Exclusion Criteria:

* Any patient who does not meet the above mentioned inclusion criteria.
OsteoArticular Sepsis in Intensive Care unitS

This is an ambispective observational study of patients admitted to critical care with a diagnosis of osteoarticular infection on material device (mainly knee and hip prostheses). The main objective of the study is to describe the profile, care trajectories during the stay (before or after surgery) and prognosis of patients admitted to critical care with such an infection. We also aim to compare prognosis between different groups of patients sharing the same profile and care trajectory, and to assess independent risk factors associated with 2-year mortality among the study population. Finally, we will describe the microbiological and resistance profile of severe osteoarticular device infections requiring critical care admission in France.

This is a descriptive and analytical observational study open to all French public and private hospitals.

Patient data will be retrieved prospectively from patient source files. Only 2-year data (vital status, functional data) will be collected specifically for the study, by telephone contact with the patient or his or her support person.


Eligibility Criteria:
Inclusion Criteria:

* Patient at least 18 years old.
* No opposition from the patient (or surrogate in case of death)
* Stay in critical care (intensive care or continuing care) between 2018 and 2021 of at least 48 hours, with the principal or associated diagnosis of an osteoarticular

Exclusion Criteria:

* Patient under legal protection.
* Pregnant or breast-feeding patient.
* Patient deprived of liberty.
Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome

Burning mouth syndrome is an idiopathic condition characterized by symptoms burning and / or pain of the oral mucosa with an orderly clinical finding. So far not found a unique way of treatment. It is a diagnosis that impairs the quality of life of patients, and consequently it can affect the quality of sleep. Melatonin is a hormone secreted from pineal gland and regulates the day-night rhythm of man, and whose production in the body decreases aging. The level of melatonin in saliva correlates well with the level of melatonin in plasma, therefore they are advantages of determining from saliva painlessness and non-invasiveness of the procedure itself. The purpose of this study was to compare the level of melatonin in saliva and the quality of sleep with help of the Epworth Sleepiness Scale in patients with burning mouth syndrome and control groups of patients without subjective oral disorders and with an orderly clinical finding.


Eligibility Criteria:
Inclusion Criteria:

* female patients
* primary burning mouth syndrome
* without oral lesions

Exclusion Criteria:

* secondary burning mouth syndrome
* male gender
* patients with oral lesions
High Intensity Focused Ultrasound (HIFU) Ablation System Study

The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic drugs.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia affecting an estimated 2.2 million persons in the United States (US). In addition to being debilitating, AF has been identified as a leading risk factor for stroke. AF is often associated with structural heart disease, but a substantial number of AF patients have little or no detectable structural heart disease. A patient with AF is up to 5 times more likely to have a stroke than the general population.

Recently, it has been demonstrated that for a significant portion of AF patients (80% - 95 %) the arrhythmia originates in one of the four pulmonary veins (PV's). Furthermore, it has been shown that isolation of this arrhythmia by ablation can, in the majority of patients (50-70%), eliminate or markedly reduce episodes of AF. Currently, there are a number of modalities being investigated to treat AF. They include radiofrequency, laser, thermal, cryo, microwave, and ultrasound ablation of targeted areas in the atrium and/or PVs.

Comparison(s): Clinical success of High Intensity Focused Ultrasound (HIFU) Ablation for Pulmonary Vein Isolation in the treatment of Atrial Fibrillation, compared to medical therapy with anti-arrhythmic drugs (AADs).

Eligibility Criteria:
Inclusion Criteria:

* Documented atrial fibrillation
* Failed or intolerant to at least 1 anti-arrhythmic drug
* Able to take anti-coagulant therapy
* Able to complete screening tests required for inclusion/exclusion criteria
* Able to take at least 1 approved anti-arrhythmic drug
* Not pregnant
* Available for follow-up for at least 12 months

Exclusion Criteria:

* Persistent or permanent atrial fibrillation
* Mitral disease
* Prior surgical treatment for atrial fibrillation
* Ablation for treatment of atrial fibrillation within 6 months
* Severe left ventricular hypertrophy
* Known untreated coagulopathy
* Unstable angina
* Prior stroke
* Uncontrolled heart failure
* Secondary causes of atrial fibrillation
* Uncorrected hyperthyroidism within 12 months
* Pulmonary embolism within 6 months
* Pneumonia or acute pulmonary disease within 3 months
* Pacemaker/ICD
* High risk for esophageal disease
* Currently enrolled in investigational drug or device study
Trial of eRapa in Prostate Cancer Patients

This study is to determine the safety, pharmacokinetics/pharmacodynamics, and immunologic impact of encapsulated rapamycin in patients with low risk prostate cancer under active surveillance. There will be four groups of patients, each receiving a different dose of rapamycin.

This is a phase Ib trial of encapsulated rapamycin to determine safety, pharmacokinetics/pharmacodynamics, and immunologic impact in patients with low risk prostate cancer under active surveillance. This new formulation, encapsulated rapamycin (sirolimus), provides a more predictable bioavailability of this drug than \[the other formulation\]. The encapsulated and targeted rapamycin (eRapa) can be delivered at a consistent and lower dosage, not only improving the toxicity profile but also capitalizing on the newly appreciated mechanism of partial and/or intermittent mTOR inhibition, making eRapa an ideal immuno-oncologic and chemopreventative agent. Low dose rapamycin has been shown to prevent cancer formation, progression, and/or recurrence in the majority of cancer histologies including the most prevalent: lung, breast, prostate, and colon cancers.

Eligibility Criteria:
Inclusion Criteria:

-

The patient must:

* Have pathologically (histologically) proven diagnosis of prostate cancer with a Gleason score ≤7 (3+4) and already undergoing active surveillance
* Be able to give informed consent
* Be age 18 or older

Exclusion Criteria:

* Prostate cancer with a Gleason score \>7
* Unable to give informed consent
* Age \< 18
* Immunosuppressed state (e.g., HIV, use of chronic steroids)
* Active, uncontrolled infections
* On medications with strong inhibitors or inducers of CYP3A4 and or P-gp.
* On agents known to alter rapamycin metabolism significantly (Appendix H)
* Have another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
* Individuals with a reported history of liver disease (e.g., cirrhosis)
* Individuals who are not a good candidate for active surveillance in their treating physician's opinion
* Have a medical condition (e.g., anemia, anticoagulated) for which repeated phlebotomy may be problematic.
* Uncontrolled hypertension.
* Individuals that have abnormal screening vital organ function prior to enrollment

  * Liver Function Test

    * Bilirubin \>2.0
    * Alkaline phosphatase \>5x upper limit of normal (ULN)
    * ALT/AST \>2x ULN
  * Complete Blood Count:

    * WBC elevated above the normal standard per the testing laboratory
    * Hgb/Hct below the normal standards of the testing lab
    * Platelets below the normal standards of the testing lab
  * Total Cholesterol \>240 mg/dL
  * Triglycerides \> 200 mg/dL
  * Serum creatinine \>2 and BUN \>30
  * Urinary protein: proteinuria \>1+ on urinalysis or \>1 gm/24hr
Study of Visual-spatial Attention by Eye Tracking as a Function of Central or Peripheral Visual Impairment

The objective of this pilot work is to determine the role of central and peripheral visions in explicit attention processes (saccade planning) in the case of visual impairment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years;
* Patient with a central visual deficit (central scotoma on the visual field: DMLA, cones dystrophy ...) or peripheral (annular scotoma: chronic glaucoma, retinitis pigmentosa ...) or without visual deficit (corrected visual acuity and visual field)
* Patient agreeing to participate in the study and signing informed consent
* Patient affiliated to social security

Exclusion Criteria:

* Pregnant woman
* Patient with known epilepsy
* Major under judicial safeguard, or deprived of liberty
* Major under guardianship or curatorship or admitted to a health or social institution for purposes other than research.
LoveYourBrain Yoga for Multiple Sclerosis

The purpose of the study is to assess the feasibility of a 6-week yoga and meditation intervention for people with multiple sclerosis (MS). The study will evaluate the impact of the program on fatigue, anxiety, depression, positive affect, and other measures. A sub-study will collect brain images using MRI on 2 subjects before and after the intervention to identify potential biological markers of MS related-fatigue.

This study will recruit 20 subjects with multiple sclerosis (MS) to participate in a 6-week yoga/meditation program. Subjects will be randomly assigned to one of two groups. The first group will complete the yoga/meditation classes, followed by a waiting period. The second group will go through a waiting period, followed by yoga/meditation classes. Two subjects assigned to classes during the first session will be selected to participate in an MRI sub-study to look for biomarkers of MS-associated fatigue. All subjects will complete questionnaires and assessments during 3 clinic visits - at baseline, in between the class sessions, and at the end of the study. Questionnaires will also be mailed to subjects 6 weeks after the last study visit.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Multiple Sclerosis with EDSS score equal to or less than 6 (within last year)
2. 18 years of age or older
3. Ability to ambulate without assistance from a device or person
4. Subjects taking medications for depression, fatigue, or anxiety must be stable for 8 weeks prior to baseline
5. Able to read, write, and speak English
6. Willing to refrain from participating in yoga or meditation outside of the study for the duration of enrollment
7. Willing and able to give informed consent

Exclusion Criteria:

1. Participation in yoga and/or meditation more than twice within 8 weeks prior to baseline.
2. MS symptom exacerbation in the 8 weeks before baseline or other serious medical conditions that would impair ability to participate in the study.
3. Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study.
4. Contraindication to scanning, including but not limited to ferromagnetic metal in the body, claustrophobia, inability to lie still or otherwise tolerate being in the scanner.
5. Pregnant women must be excluded from the imaging component of the study due to unknown but possible risk of fetal exposure to the scanner. Women of child-bearing potential will take a confidential pregnancy test immediately prior to each scan session.
The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Pregnant Women at Risk for Gestational Diabetes

Gestational diabetes mellitus (GDM) is a condition in which high blood sugar levels occur during pregnancy. GDM increases the risk of medical complications during pregnancy which may harm the mother and her baby. Since treating GDM to reduce blood sugar reduces the risk of harm, all pregnant women are screened for GDM using a glucose challenge test (GCT). We think that a diet containing low glycemic index foods could help keep blood sugar levels normal during pregnancy and therefore prevent GDM. Thus, the purpose of this study is to see if a diet containing low glycemic index foods will reduced blood sugar after the GCT and reduce the prevalence of GDM in women at high risk for the development of GDM.


Eligibility Criteria:
Inclusion Criteria:

* Attending Mt. Sinai Maternal Fetal Medicine Unit
* Any ONE of: body mass index \>=25 kg/m\^2
* OR age \>=35 years
* OR high risk ethnicity (Asian, South Asian, Hispanic, African, Aboriginal)

Exclusion Criteria:

* Have pre-existing diabetes (type 1 or type 2) before becoming pregnant
* Acute or chronic illness which may affect carbohydrate metabolism
* Language/literacy barriers which cannot be overcome via available resources
* \>16 weeks gestation
Therapeutic Vaccine Trial of COVID-19 for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

GC004 is a Phase I trial to evaluate the safety and the immune responses of a therapeutic vaccine in SARS-CoV-2 infected patients. Covid-19 confirmed patients with mild or no symptoms will be enrolled sequentially into low dose and high dose groups. Following the vaccination subjects who received at least one vaccination will be followed for safety through week 26.


Eligibility Criteria:
Inclusion Criteria:

1. Documentation of Covid-19 infection based on laboratory evidence of positivity by RT- PCR.
2. Patients who have no clinical symptoms (fever, cough and dyspnea).
3. Patients who have mild clinical symptoms that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath (dyspnea).
4. Screening laboratory values within institutional normal range or judged to be not clinically significant by clinical investigator.
5. Ability and willingness of subject to give written informed consent.
6. Negative pregnancy test on the day prior to each vaccination.
7. Willingness to use adequate contraception by study participants.

Exclusion Criteria:

1. History of respiratory and cardiovascular diseases, hematologic disease (e.g., cryoglobulinemia, lymphoma), renal disease, dermatologic disease (e.g., lichen planus, porphyria cutanea tarda).
2. Autoimmune diseases or clinically serious cardiac, pulmonary, gastrointestinal, hepatic, renal or neurologic disease, which in the opinion of the investigator will compromise ability to participate in the study.
3. Pregnancy and breast-feeding.
4. Prior or current systemic cancer chemotherapy.
5. Investigational agents and immunomodulators (cyclosporine, hematological growth factors, systemic corticosteroids, interleukins or interferons) within 90 days prior to study entry.
6. Anaphylaxis or allergy to vaccine components.
7. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
8. Any other serious diseases other than Covid-19 infection including current or recent (within 5 years) cancers.
9. Subjects who are immunocompromised or immunosuppressed due to disease or medications.
10. Women who are lactating.