cyrilzakka/clinical-trials huggingface dataset:
Early Childhood Prevention of Childhood Overweight

You are invited to participate in a research study to understand more about childhood obesity and how to prevent it. We hope to learn how families influence each others eating habits.

This study aims to understand more about childhood obesity and how to prevent it. Two different methods of prevention will be tested and participants will be allocated at random to one of these methods. The investigators hope to learn how families influence each others eating habits.

Participants in this study will attend a series of five classes, once a week for five weeks, on the topic of child feeding. The aim of the classes is to learn how to feed your child so as to prevent future eating and weight problems. The research component includes filling out some surveys before classes begin and at the end of the last class. Classes are small and interactive so that parents have a chance to voice concerns and get feedback.

Eligibility Criteria:
Inclusion Criteria:

* One or both parents with BMI \> or = to 27.5
* Healthy child ages 2-4 years

Exclusion criteria.

- Inadequate understanding of the English language
A Study of Hospital Healthcare Use and Cost in Patients in the Hospital With a Venous Thromboembolism (VTE) Treated With Apixaban or Warfarin in the US

A study involving real-world database analysis to evaluate the hospital healthcare utilization and costs, and all-cause, major bleeding-, clinically relevant bleeding-, any bleeding-, and venous thromboembolism (VTE)-related hospital readmissions among hospitalized VTE patients treated with apixaban or warfarin, with or without low molecular weight heparin (LMWH)


Eligibility Criteria:
Inclusion Criteria:

* Have a primary diagnosis of VTE identified by ICD-9-CM or ICD-10 codes from the Premier Hospital database between 01-Aug-2014 and 31-May-2016
* Age 18 years or older as of index hospitalization with VTE diagnosis
* Patients will be required to have received apixaban or warfarin with or without LMWH (index drugs) during the index hospitalizations

Exclusion Criteria:

* Received both apixaban and warfarin during the index hospitalization. This exclusion criterion will allow to cleanly group patients into the apixaban and warfarin usage cohorts.
* Received any other Direct oral anticoagulants (DOAC) including rivaroxaban, dabigatran, and edoxaban during the index hospitalization
* Have any primary or secondary diagnosis code for Atrial fibrillation/Atrial flutter (AF/AFL), or pregnancy, or records of inferior vena cava filter (IVCF) usage during the index hospitalizations or the baseline periods.
* Patients transferred from other facilities

Other protocol-defined inclusion/exclusion criteria could apply
Hyponatremia and Hypoalbuminemia is Morbimortality Predictors in Coronary Artery Bypass Graft Surgery

Coronary artery disease is a common medical disease in many populations. The pathogenesis of this disease is very complex. Surgery is one of the treatment choices. Assessing the risk factors will improve the surgical outcome. In this study some biochemical parameters were evaluated to find out the relationship between these parameters (electrolytes and albumin vs)


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent coronary artery bypass graft surgery
* Elective surgery

Exclusion Criteria:

* Pediatric patients
* Off-pump surgery
* Emergent surgery
Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite

The aim of this study is to evaluate the clinical feasibility of the angiographic Flat Detector CT perfusion imaging (6s PBV) technique. The investigators will examine the specific vessel distribution of patients with steno-occlusive disease, treated with a surgical extracranial-intracranial bypass and assess the cerebral perfusion during test occlusion upon a neurovascular treatment and in intracranial tumor patients referred for potential pre-operative embolization.

This study encompasses three scientific objectives:

1. What is the selective contribution of an individual bypass artery to the brain perfusion?
2. Is a selective intra-arterial angiographic perfusion examination useful in the decision-making of performing pre-operative embolization of intracranial tumors?
3. What is the usefulness of performing additive 6s PBV images compared to classical 2D angiography and/or clinical neurological evaluation in case of test occlusion in the evaluation of possible mother vessel occlusion in treatment of complex neurovascular diseases?


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for diagnostics and surgical (extracranial-intracranial bypass) treatment of steno-occlusive neurovascular disorders.
* Patients referred for hypervascular intracranial tumor resection
* Patients referred for angiographic test occlusion as part of treatment of complex neurovascular disorders.

Exclusion Criteria:

* Pregnant women or women trying to get pregnant
* People younger than 18 years old
* Patients with thyroid disorders and diabetes, especially those using medication with metformin.
Scoring Method for Describing the Position of a Tracheostomy Tube

Tracheostomies are artificial airway devices inserted into the neck. They can become displaced and lead to patient harm. Other than external visual inspection, there is no currently described system for describing the position of a tracheostomy tube within the airway. The investigators propose to undertake endoscopic inspection of the tracheostomy tube with a small fibre-optic camera from above and also through the tube to visualise its position within the airway. The investigators will take anonymised paired images and then score these using 6 different scoring systems. The investigators will determine which scoring system provides the simplest and most reproducible scores between 6 blinded assessors. A clinically useful scoring system could be used in future to predict problems with tracheostomy positioning.

Aims \& Outcomes

1. Develop an appropriate bedside scoring method for describing the position and orientation of a tracheostomy tube tip when viewed endoscopically from a standardised position
2. Secondary aims

   * Correlate the endoscopic views of the tracheostomy tube with the trans-laryngeal views.
   * Is it possible to predict the trans-laryngeal view from the endoscopic view.
   * Does the position of a tracheostomy tube tip change when the patient is repositioned following percutaneous tracheostomy (when viewed endoscopically)
   * Equipment training: Compare the number of supervised endoscopies required to consistently achieve the required standardised view
3. Primary outcome

   - Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
4. Secondary outcome

   - Assess correlation between the best scoring system (chosen by above) with the translaryngeal view
5. Tertiary aim - Assessment of training: Determine the number of attempts required to obtain adequate standardised views. This will be a manikin based assessment to demonstrate competence in performing the endoscopies for the study before any procedures are undertaken on patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>16 years old
* Presence of a percutaneous or surgical tracheostomy
* Patient being cared for in the AICU of UHSM

Exclusion Criteria:

* Endoscopy not clinically appropriate (in the opinion of the attending physician)
* Refusal by patient or their representative
Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease

Crohn disease is an inflammatory chronic disease of the bowel the complex physiopathology of which brings in immunological, genetic and environmental factors. At present, the appeal to biotherapics anti-TNFa (infliximab and adalimumab) or anti-IL-12/23 (ustekinumab) in MC represents a major therapeutic progress at the origin of a significant improvement of the symptoms, the healing of the intestinal hurts and the quality of life.

Considering the new immunological targets of these biotherapics, the investigators put the hypothesis that an immunological profile (impulsive person and\\or tissular) specific of the patients with one MC is associated with the answer to biotherapics. So, before beginning the treatment the patients expressing strongly the pro-inflammatory cytokine TNFa, would more may be answering machines in anti-TNFa and those with whom the immunological profile is very marked towards the way Th1/Th17 would more may answer favorably the ustekinumab. The identification of immunological profiles capable of predicting before treatment the answer under biotherapics could establish in MC but also in other inflammatory diseases a major step forward to guide the coverage.


Eligibility Criteria:
Inclusion Criteria:

* Patient of more than 18 years old
* Patient presenting a MC before diagnosed according to the usual criteria
* Patient in relapse (score CDAI \> 150) for at least 1 month
* requiring Patient a treatment by anti-TNF or ustekinumab according to the indications of the AMM
* Patient compatible with the realization of endoscopic digestive biopsies
* Patient having signed a consent of participation

Exclusion Criteria:

-· patient with Crohn disease with a CDAI score \< 150 ·

* contraindication to anti-TNF and\\or ustekinumab ·
* contraindication to the realization of an iléocoloscopie

  ·- Patient taking anti-inflammatory drugs or antibiotics ·
* Patient presenting complications of the type intestinal sub-occlusion, fistulas or abdominal abscesses ·
* Patient having a exclusive perianal disease or having
* pregnant Women ·
* Patients having been the object of a vast intestinal resection ·
* Patient with an ileostomy or a colostomy ·
* No consent of the patient ·
* patient under legal protection ·
* Subject participating in another research which need a period of exclusion
MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease

This is a prospective, multicentre randomised, phase II clinical trial, with randomisation 2:1 by minimisation and stratification by tumour stage, planned chemotherapy and institution.

This is a prospective, multicentre randomised, phase II clinical trial to evaluate safety and activity of stereotactic body radiotherapy (SBRT) in addition to chemotherapy in patients with high-risk and borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). High risk defined as any patient with tumour \>4cm, extrapancreatic extension or node positive disease.

Eligibility Criteria:
Inclusion Criteria:

* Adults, aged between 18-75 years, with histological confirmation of pancreatic adenocarcinoma
* Any of the following

  1. T3 (tumour \>4 cm)
  2. Extrapancreatic extension
  3. Node positive (stage IIB)
  4. Borderline resectable pancreatic cancer, locally advanced pancreatic cancer
* Measurable disease according to RECIST v1.1
* ECOG performance status 0-1
* Adequate renal and haematological function
* Adequate hepatic function. Defined as bilirubin \<1.5 X ULN (Upper Limit of Normal), AST + ALT \<3.0 X ULN. In patients who have had a recent biliary drainage and whose bilirubin is descending, a value of ≤ 3 X N is acceptable
* Study treatment planned to start within 14 days of registration
* Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
* Signed, written informed consent

Exclusion Criteria:

* Tumour size greater than 70mm
* Prior abdominal radiotherapy
* Evidence of metastatic disease on baseline radiologic investigations
* History of another malignancy within 2 years prior to randomisation, except adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial transitional cell carcinoma of the bladder, or any Stage 1 endometrial carcinoma. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 2 years after definitive primary treatment
* Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
* Neuroendocrine pancreatic carcinoma
* Life expectancy of less than 3 months
* Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must use a reliable means of contraception
* Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
Women's Assessed Cardiovascular Evaluation With MCG

Cardiovascular disease (CVD) is the number one cause of death for women over the age of 25, accounting for 1 of every 3 female deaths. Research has shown that while hypertension in women is less controlled, they are also less likely to be identified with ischemic heart disease and when diagnosed treated less aggressively than men. Moreover, women who are diagnosed with breast cancer have an increased risk for cardiovascular disease. The Women's Assessed Cardiovascular Evaluation with MCG (WACE-MCG) study is designed to collect CardioFlux scans on a select group of female volunteers who are Ms. Medicine patients. CardioFlux is used as a noninvasive MCG tool that analyzes and records the magnetic fields of the heart to detect various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 200 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.


Eligibility Criteria:
Inclusion Criteria:

≥ 18 years of age at the time of enrollment. Female Patients deemed at risk for cardiovascular disease (breast cancer survivors, patients referred to cardiologists, prior COVID-19 patients, etc.)

Exclusion Criteria:

\< 18 years of age Patients unable to fit into device Non-ambulatory patients Positive response on CardioFlux Pre-Screening Form Patients with claustrophobia or unable to lie supine for 5 minutes Pregnant women Poor candidate for follow-up (e.g. no access to phone) Prisoners
Diagnosis of Endocrine Dysfunctions in Covid-19

As observed with SARS-CoV responsible for SARS 2003, the new coronarovirus SARS-CoV-2 uses the angiotensin converting enzyme type 2 (ACE2) as cellular receptor to infect cells. The renin aldosterone angiostensin system (RAAS) has known effects in the lungs: some receptors are pro-inflammatory, others are anti-inflammatory. Thus the deregulation of the RAAS induced by the SARS-CoV-2 could explain the inflammatory response of Covid-19 infection and be a modulator of the severity of its course.

Furthermore, the SARS 2003 experience suggests that there may be others endocrine involvment, particularly an failure on the hypothalamus-pituitary and adrenal axis. Indeeed, cases of hypocorticism and hypothyroidism of central origin were described.

Altogether, the endocrine system might play a role both in the pathophysiology of Covid-19 infection and in the activity and severity of the disease.

In this study, the investigators proposed to explore endocrine functions on biological samples in a series of patients admitted for Covid-19 in our clinic.


Eligibility Criteria:
Inclusion criteria:

- Patients with Covid-19 diagnosis and hospitalized in our clinic

Exclusion criteria:

- Minor patient
Non-alcoholic Fatty Liver Disease Parametric PET (FLiPP) Study

The goal of this study is to evaluate non-invasive imaging techniques for determining liver steatosis (fat), inflammation (abnormal tissue swelling), and fibrosis (abnormal tissue scarring).In addition, the study group will be using other test measures including personal demographics, laboratory blood test results, and imaging measurements to determine the severity of NAFLD (non-alcoholic fatty liver disease), NASH (non-alcoholic steatohepatitis), inflammation, and fibrosis.

The study group proposes to evaluate the role of fluorodeoxyglucose (FDG) positron emission tomography (PET) in the determination of steatohepatitis and in combination with MRI for detection, differentiation and quantitation of liver steatosis, steatohepatitis and fibrosis in correlation to liver biopsy. Patient enrolled in this will already have had their liver biopsy or will be undergoing liver biopsy as a part of their clinical care as determined by their provider and will not be getting biopsies solely to be enrolled in the study. Current treatment options for patients that liver biopsy is being performed are limited to lifestyle changes and vitamin E for patients without diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Patients \>18 years age
2. Patients who had or will have a liver biopsy as standard of care for fatty liver disease and have risk factors for NASH. Liver biopsy needs to be within 6 months of planned imaging.
3. Patients undergoing bariatric surgery and will have a liver biopsy as standard of care.
4. Ability to provide informed consent.

Exclusion Criteria:

1. History of alcohol abuse, chronic hepatitis B or C, or other chronic liver disease other than non-alcoholic fatty liver disease.
2. Pregnant women
3. Prisoners
4. Claustrophobic to MRI
5. Allergic to FDG dye
6. Patients who are unable to lie in the scanner for one hour
Validation of a Psychological Fragility Questionnary in the Elderly in Isolation

Social isolation and loneliness of the elderly have become major public health problems, because of the deleterious consequences if not lethal they can generate.

Because of frequent resignation to these phenomena, support must be given to all means of prevention to prevent or at least mitigate their impacts. It appears from the literature that are isolated or living as they have adjustment difficulties which are linked to fragility. If geriatric frailty have been defined to date in somatic and cognitive criteria, psychological fragility criteria have been little discussed outside of psychiatric disorders (depression, anxiety disorders in particular).

This study aims to test in the elderly in isolation psychological fragility questionnaire and to study the statistical qualities and relations with socio-demographic variables, environmental and other known vulnerabilities.


Eligibility Criteria:
Inclusion Criteria:

* People over 65
* Living alone at home (rural and urban ) or institution ( nursing home , no family member or spouse in the same institution).
* No not refusing to participate in the survey

Exclusion Criteria:

* Overt or decompensated psychiatric pathology: major depressive disorder , bipolar disorder, psychotic disorder, severe personality disorder , primary addiction ( ICD-10 criteria)
* Alzheimer's disease or related illness probable or confirmed (ICD criteria 10)
* Sequel to severe neurological disease , unstabilized somatic pathology and / or may disrupt data collection
* Patients do not have the capacity to understand the objectives of the survey
Effect of Ultrasound and Laser in Chronic Low Back Pain: Randomized Double-blinded Controled Trial

The low level laser therapy has a better effect in decrease the pain than ultrasound therapeutic.

The laser will be applied with the dosimetry 3 J/cm², 2 minutes in 6 points around the back spine, during 4 weeks. Before the women will be evaluate again.

Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain
* 3,0 - 7,0 in the visual analogic scale

Exclusion Criteria:

* no use of medications
* no other treatment
* without fractures, pregnancy, psychiatric or neurologic disorders, diabetes, amputations
* with diagnostic of low back pain
Activity Breaks for Brain Health in Adolescents

The main aim for this study is to investigate to what extent physical activity of moderate or low intensity, relative to prolonged inactivity, may acutely alter neural activity-related prefrontal cortex oxygenated hemoglobin during a cognitive demanding task in 13- 15 year-old adolescents. The study is primarily focused on investigating these effects in ecologically valid conditions, i.e. activity patterns that closely resemble a typical day in school and using activity modes that are suitable in a school setting.

The study will be a controlled crossover experimental trial with three conditions. Each participant will complete each of the three experimental conditions, separated by a washout period of minimum four days. Physical activity behaviours and sleep will be monitored the day/night before each test day. The first visit will be a familiarization session for the collection of demographic data, fitness testing, and acquaintance with experimental procedures. On the second, third, and fourth visits, participants will undergo three different standardized 80-minutes interventions in a randomized order. Before and immediately after the 80-minutes interventions, blood pressure, augmentation index, and cerebral hemodynamic response of the prefrontal cortex during standardized cognitive tasks (nback test) will be measured. Additionally, saliva samples will be collected the morning of the test day, and before and after the interventions.

Eligibility Criteria:
Exclusion Criteria:

* Ongoing medication that can affect central circulation or brain circulation
* Ongoing infection
* Inability to apprehend information about the study or to perform the tests
A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors

This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.

This is a Phase 1 dose escalation study to assess the safety and tolerability of subcutaneously administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.

Once the MTD has been determined up to 12 patients will be treated at this dose level, to further characterize treatment emergent adverse events (TEAEs).

Eligibility Criteria:
Inclusion Criteria:

* Patients have at least one site of radiographically measurable disease.
* Eastern Cooperative Oncology Group (ECOG) status ≤1.
* Adequate renal and liver functions.
* Life expectancy ≥3 months.

Exclusion Criteria:

* Patients that have undergone organ transplant surgery.
* The patient has a known history of Hepatitis A, B, or C and is on active anti-viral therapy.
* History of gastric bypass surgery or banding procedure.
* Uncontrolled or refractory hypertension: systolic \>180 or diastolic \>110, or hypotension: systolic \<90 or diastolic \<50 despite medical treatment.
* Participation in any other trial of an investigational agent within 30 days prior to first dose of study drug.
* The resting 12-lead electrocardiogram obtained during screening shows QTc (Fridericia correction) ≥470 ms or has a congenital prolonged QT syndrome.