cyrilzakka/clinical-trials huggingface dataset:
Study Assessing the Contribution of Telemedicine Monitoring in Addition to Standard Follow-up of an Obesity Program

STROBERRY Study is a Prospective, monocentric, randomized, open-label study assessing the contribution of telemedicine, in addition to standard follow-up, strengthening an Obesity program in Berry (France). The principal objective is to study the effectiveness of a follow-up reinforced with telemedicine in addition to the standard multidisciplinary annual follow-up on the rate of patients lost to follow-up after initial or second line management in a multidisciplinary bariatric medical program

Obesity became a major public health issue in France. In 2019, obesity represented 5% of annual costs in health and was responsible of a 2.7% lost in France's Gross Domestic Product. In the scop of french health ministry's recommendations for obese patients'care and the territorial healthcare program; Saint-François' hospital set up 3 healthcare programs: "medical obesity"," interventional" and "post surgery". A very few number of studies aim to asse the efficacity of a long-term telemedicine follow-up after a bariatric medical care program. STROBERRY Study is a Prospective, monocentric, randomized, open-label study assessing the contribution of a long term, telemedical, personalized, educative quarterly, follow-up (4 years follow up), in addition to standard follow-up, strengthening an Obesity program in Berry (FRANCE). The principal objective is to study the effectiveness of a follow-up reinforced with telemedicine in addition to the standard multidisciplinary annual follow-up on the rate of patients lost to follow-up after initial or second line management in a multidisciplinary bariatric medical program

Eligibility Criteria:
Inclusion Criteria:

* Woman or Male aged from 18 to 60 years old included
* Patient in obesity (BMI\> or = 30)
* Patient who has completed a multidisciplinary medical program for obesity management, as a first- or second-line intention (after initial obesity management) at the investigating center
* Affiliation to a social security scheme
* Patient informed of the study and who had signed the informed consent form

Non Inclusion Criteria:

* Management of obesity within the framework of an exclusively interventional program, without redirection to a medical program
* Managing obesity as part of a post-operative program
* Pregnant or breastfeeding women
* Patients deprived of liberty
* Patients under legal protection
Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France

The purpose of this study is to respond to The French Health Authority which has requested BMS France and Astra Zeneca (AZ) France to set-up a long-term cohort study in a representative sample of French Type 2 Diabetes mellitus (T2D) patients treated with Saxagliptin to generate real world data on drug utilization, joint population, non comparative effectiveness and safety

Time Perspective: Ambispective cohort follow by a 18 to 24 month follow up period, Retrospective follow by Prospective.

Eligibility Criteria:
Inclusion Criteria:

* Registry

  * Patient ≥ 18 years old
  * Patient with T2D
* Ambispective Cohort

  * Patient ≥ 18 years old
  * Patient with T2D
  * Patient initiated with Saxagliptin in the last 6 months before the inclusion or day of inclusion visit (whatever his/her ongoing hypoglycaemic treatment)
  * Patient agreeing to participate, and not yet enrolled by another physician

Exclusion Criteria:

* Patient participating in a clinical trial
Surgery Plus Intraoperative Radiotherapy as Treatment for Squamous Cell Carcinoma Over Pilonidal Disease.

Background: Pilonidal sinus is a very common disease. Malignant transformation occurs in 0,1% of patients. The investigators present a case of squamous cell carcinoma arised from recurrent pilonidal disease, managed by multimodal treatment.

Case presentation: The investigators present a 70-year-old man with chronic pilonidal sinus. Inflammation had worsened in previous months and exploration revealed a large ulcerative mass which biopsy showed a squamous cell carcinoma. CT scan and MRI imaging showed tumoral invasion of the coccyx and both gluteus major muscles. Neoadjuvant radiotherapy, chemotherapy as radiosensitizer and surgery with intraoperative radiotherapy was decided in the multidisciplinary tumor committee. Post neoadjuvant therapy MRI showed partial response with a decrease of the mass but persistence of the coccyx infiltration.

Surgery consisted in en-bloc resection of the tumor with presacral tissues, coccyx and partial gluteal resection. Intraoperative radiotherapy was administered over the sacrum and in the bed of the coccyx resection. One week later, reconstructive surgery was practiced using a latissimus dorsi free flap, advancement of gluteal flaps and skin graft. Histological examination showed no residual tumor. The patient is currently asymptomatic and he has a satisfactory quality of life.

Conclusions: Although squamous cell carcinoma is rare, it must be suspected in patients with recurrent pilonidal disease. Diagnosis is done by histological examination of biopsies. This type of tumors have a high local recurrence rate. The investigators propose a multimodal treatment that includes neoadjuvant radiotherapy and chemotherapy as radiosensitizer and surgery plus intraoperative radiotherapy with the aim to decrease local recurrence rate.


Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinoma over pilonidal disease

Exclusion Criteria:

* Distant Metastases
Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"

The purpose of this study is to evaluate both short and long term clinical performance and safety of the commercially available U2 Knee™ System.

This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total knee arthroplasty (TKA) with the U2 Knee™ System. The study will enroll up to 200 subjects with scheduled pre-discharge, 6-week, 3- and 6-month and up to 5-year annual follow-up visits. Study outcomes will be analyzed and published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.) all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study.

The study will follow GCP guidelines and will be registered on clinicaltrials.gov.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is between 18 and 75 years of age
2. Subject is indicated for a unilateral total knee arthroplasty (TKA) based on the approved labeling of the device
3. Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative knee
4. Subject is willing and able to provide informed consent to participate in the study;
5. Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits;

Exclusion Criteria:

* Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
Heated Circuit for One-lung Ventilation

One-lung ventilation interrupts oxygenation. The effect of heated humidifed breathing circuit on arterial oxygenation during one-lung ventilation has not been investigated. The investigators will investigate the effect of the heated humidifed breathing circuit on oxygenation during one-lung ventilation in patients undergoing thoracoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist class I-II
* Patients scheduled for one-lung ventilation for thoracoscopic surgery

Exclusion Criteria:

* Obesity
* Severe obstructive or restrictive lung disease
* Preoperative oxygen supply
* Preoperative intubated state or under mechanical ventilatory support
* Baseline arterial partial pressure of oxygen (PaO2) \< 70 mmHg
* Symptomatic coronary or peripheral arterial disease
* Renal failure
* Preoperative continuous infusion of inotropes or vasopressor
* Pregnancy
PROBE Investigation of the Safety & Efficacy of Telmisartan (Micardis®) vs Ramipril (Altace®) Using ABPM in HTN

Demonstrate that telmisartan 80mg was at least as effective and possibly superior to ramipril 5mg \& 10mg in lowering mean ambulatory DBP and SBP during the last 6 hrs of the 24-hr dosing interval in mild-to-moderate hypertensives at the end of 8 and 14 week treatment phases.


Eligibility Criteria:
Inclusion criteria:

* Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
* Mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥95 mmHg and ≤109 mmHg, measured by manual cuff sphygmomanometer at Visit 2.
* Age 18 years or older (or 19 years if dictated by local State/Province policies).
* Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
* 24-hour mean DBP of ≥85 mmHg at Visit 3 as measured by Ambulatory Blood Pressure Monitoring (ABPM).

Exclusion criteria:

* Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who:

  * were not surgically sterile; or
  * were nursing, or
  * were of childbearing potential and were NOT practicing acceptable methods of birth control, or did NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control included IUD, oral, implantable or injectable contraceptives. No exceptions were made.
* Night shift workers who routinely slept during the daytime and whose work hours included midnight to 4:00 a.m.
* Mean seated SBP ≥180 mmHg or mean seated DBP ≥110 mmHg during any visit of the placebo run-in period.
* Known or suspected secondary hypertension (e.g., phaeochromocytoma).
* Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
* Serum Glutamate-Oxaloacetate-Transaminase (Aspartate Aminotransferase) (SGOT (AST)) or Serum Glutamate-Pyruvate-Transaminase (Alanine Aminotransferase) (SGPT (ALT)) \>2 times the upper limit of normal range, or
* Serum creatinine \>2.3 mg/dL (or \>203 μmol/l).
* Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
* Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
* Uncorrected volume depletion.
* Further exclusion criteria apply
A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* female patients 18-70 years of age;
* adenocarcinoma of the breast;
* previous invasive breast cancer if diagnosed \>5 years before entering study;
* no evidence of metastatic disease.

Exclusion Criteria:

* history of severe hypersensitivity reaction to Taxotere;
* previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;
* treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.
BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator

Phototherapy is routinely used in neonatal intensive care units for the treatment of jaundice. Guidelines focus mainly on bilirubin serum levels to start the phototherapy. Only few data are available about clinical management of phototherapy devices and subsequently the impact on bilirubin serum decrease. Especially there are no strong recommendations about phototherapy duration, irradiance measurements, incubator temperature and humidity settings. Various factors can influence irradiance and thus the preterm infant bilirubin serum decrease. This study aims at evaluating the impact of an educational program on the use and efficacy of phototherapy in a neonatal intensive care unit.

Only few data are available about clinical management of phototherapy devices for the treatment of jaundice in the preterm infant.

This study is a prospective, monocentric, observational study. Preterm infant \< 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.

The decrease in bilirubin serum level before and after phototherapy treatment will be measured.

This decrease in bilirubin serum level will be assessed for two consecutive periods before and after an educational program on jaundice management of the preterm infant.

The investigators aim at demonstrating that an educational program could improve phototherapy management and result in a higher decrease in bilirubin serum during treatment of the preterm infant with jaundice.

Eligibility Criteria:
Inclusion Criteria:

* preterm infant less than 35 weeks gestation
* preterm infant hospitalized in the neonatal intensive care unit of CHU Amiens-Picardie
* preterm infant placed in an incubator
* preterm infant with a jaundice requiring treatment according to NICE guidelines
* preterm infant with a no hemolytic disease
* preterm infant with informed written consent from the parents

Exclusion Criteria:

* preterm infant more than 35 weeks of gestation
* preterm infant with hemolytic disease
* preterm infant with Jaundice related to a cholestasis
* Jaundice requiring exchange transfusion
Safety and Bioefficacy of Vitamin D2 and Vitamin D3

The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.

Study design: Human volunteers will receive supplements containing either vitamin D2 or D3 for a period of 8 weeks. At baseline, after 4 weeks and after 8 weeks, 25(OH)D2, 25(OH)D3 and total 25(OH)D will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum, ambulatory blood pressure and heart rate, and renin expression in peripheral mononuclear cells.

Groups/Cohorts Assigned Interventions

1. Placebo group
2. Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per capsule)
3. Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per capsule)

Eligibility Criteria:
Inclusion Criteria:

* 18 years
* healthy

Exclusion Criteria:

* supplementation of vitamin d and calcium
* hypercalcemia
* hypercalciuria
* chronical illness (diabetes, kidney diseases, cardiovascular diseases)
* serum-creatinine above 115 mmol/l
* pregnancy or breastfeeding women
Reducing PTSD in Hospitalized Burn Patients

The investigators propose to develop and pilot-test a short-term cognitive-behavioral treatment (CBT) for hospitalized survivors of acute burns, in order to reduce posttraumatic symptoms before they consolidate into long-term posttraumatic stress disorder (PTSD). This is important because approximately one third of burn survivors develop PTSD after discharge. PTSD is associated with extended psychological suffering and a greater need for medical services in the future. Although there are treatments for chronic PTSD, there are far fewer interventions available to treat acute posttraumatic symptoms before they develop into this disorder, and none to date has focused on adult burn survivors. The little research available on other forms of trauma suggests that interventions developed to treat PTSD may be helpful in preventing PTSD when used in the first weeks following a trauma.

The investigators will develop a six-session intervention package for use with patients at the Los Angeles County + University of Southern California Burn Center. The intervention will translate CBT principles that have been validated with trauma survivors, but will be adapted to hospitalized burn patients. After manual development, we will pilot-test this treatment on 15 patients who are medically stable, and not critically ill, intubated, or delirious. Treatment will consist of three 50-minute CBT sessions per week, involving mindfulness-focused relaxation training, graduated exposure to memories of the burn, psychoeducation, and cognitive restructuring. Assessment will include standardized tests of posttraumatic stress, anxiety, and depression, administered at the initiation and termination of treatment, and at one-month follow-up. Also assessed will be number of hospital days to discharge and participant satisfaction with treatment. We will evaluate the overall feasibility of conducting a study on PTSD prevention in burn survivors, as measured by initial recruitment success, subsequent dropout rates at the end of treatment and at the one-month follow-up, and participant satisfaction. These data will then be used to support a subsequent application for funding of a larger-scale randomized clinical trial (RCT) study.


Eligibility Criteria:
Inclusion Criteria:

* Male \& female patients at the LAC+USC Medical Center Burn Center
* 18 years of age or older
* English-speaking, able to read \& write English
* Expected by the treatment team to require at least 2 weeks of hospitalization
* Willing to participate

Exclusion Criteria:

* Patients who are critically ill; intubated; unable to converse; or delirious
* Cognitively impaired or mentally retarded
* Severely depressed or suicidal
* Psychotic; manic or hypomanic due to a bipolar affective disorder
* Currently demonstrating withdrawal from alcohol or other substances
* Patients whose physical pain level requires medications that would cognitive impair him or her to the point of diminished or impaired functioning
Study of Brain Anatomo-functional Substrates Related to the Use of Human Tool by Means of Simultaneous Acquisition of Magnetic Resonance Imaging and Electroencephalogram

This is an observational study, conducted on subjects with neurological disorders primarily involving the frontal and parietal lobes of the brain. Throughout the indicated period, the study will aim to enroll 100 subjects divided into 30 units per year. Specifically, the study will be carried out on patients with fronto-parietal dysfunction for whom a prescribed a clinical investigation of electroencephalogram and MRI


Eligibility Criteria:
Inclusion Criteria:

* subjects of either sex with fronto-parietal dysfunction, who are able to able to provide voluntary consent, who have been asked for clinical purposes for an EEG and an MRI

Exclusion Criteria:

* pregnant or presumed pregnant subjects and subjects with claustrophobia or with contraindications to the examination.
Phenotypic and Functional Study of 4BL B Cells in Multiple Sclerosis (MS)

Recent works highlight the B cells involvement in multiple sclerosis (MS) pathology but their role remains poorly understood. It was previously described that activated memory B cells called 4BL due to the increased expression of 4-1BBL, an activation marker, induce pro-inflammatory response by activating T CD8+ lymphocytes. Those 4BL cells are also described in systemic inflammation in 80 years old people explaining the poor efficiency of vaccination in that sub population. Those 4BL cells can also induce anti-tumoral T cell response.

The hypothesize is that 4BL may induce a pathogenic inflammatory response in MS.

the aim to compare the proportion of peripheral (blood) 4 BL cells but also 4-BL cells in cerebro spinal fluid (CSF) in MS compared to healthy controls and to other inflammatory neurological disease but also non inflammatory neurological disease.

For all groups of patients and controls it will collect blood and CSF only once (at diagnosis time for patients).

Blood collect from healthy controls will come from transfusion volunteers and we won't have CSF from them.

For patients from the MS group, the blood collect will be sequential at diagnosis, 3, 6, 12 and 24 months after during the follow up.

In the blood and CSF we will evaluate:

* percentage of 4 BL cells. 4 BL cells are found using cytometric parameters
* capacity of 4 BL cells to induce inflammatory response in vitro: percentage of induced activated TCD8 proliferation after cell culture using extracellular and intracellular cytometric parameters

Eligibility Criteria:
Inclusion Criteria for MS group:

* MS defined by McDonald 2017 criteria with a disease duration of less than 1 year
* between 18 and 60 years old patients
* naïve of any immune therapy or steroid intake
* patients who signed consent to the study

Inclusion Criteria for controls with inflammatory of non inflammatory neurological disease:

* patients who signed consent to the study
* between 18 and 60 years old patients
* naïve of any steroid intake or immune therapy

Inclusion criteria for healthy controls:

* control who signed consent at transfusion center for their blood collect to be used for study
* between 18 and 60 years old patients
* naïve of any steroid intake or immune therapy

Exclusion Criteria:

* pregnancy or breast-feeding
* patients or controls unable to sign the consent or to consent
Prognostic Value of Plasma DPP4 Activity in ST-elevation Myocardial Infarction Patients

Increased plasma DPP4 activity (DPP4a) could predict both subclinical and new-onset atherosclerosis, and our previous study has found that the DPP4a was significantly lower in MI patients compared with patients having chest pain or unstable angina alone, and DPP4a is associated with no-reflow and major bleeding events in STEMI patients during hospital stay. As no-reflow phenomenon and major bleeding events independently associates with a worse in-hospital and long-term prognosis. One may speculate that the DPP4a is associated with long-term follow-up adverse cardiovascular events in these patients.The hypothesis was tested in this study.


Eligibility Criteria:
Inclusion Criteria:

* consecutive patients of acute STEMI come to our department,absent of cardiogenic shock, and survival for at least 24 h after PCI treatment.

Exclusion Criteria:

* patients with cancer, and patients who were taking a DPP4 inhibitoror a glucagon-like peptide-1 (GLP-1) analogue
Endoscopic Scoring System Utilization in Inflammatory Bowel Disease

Inflammatory bowel diseases comprise two distinctive entities: Crohn's disease and ulcerative colitis. During the last decade, endoscopic assessment of inflammation has become relevant since it is a prognostic factor. As a consequence, therapeutic targets now contemplate mucosal healing as part of the goals to be achieved. Endoscopic scores for Crohn's disease and ulcerative colitis have been developed to objectively assess the mucosal inflammatory activity. Although they may have some limitations, these scores have been widely accepted in referral centers, especially since they have been adopted as standard evaluation in inflammatory bowel disease clinical trials . However, their use in the setting of endoscopic practice outside centers with a high volume or with less experience in clinical trials is not known.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who underwent colonoscopy for the evaluation of mucosal inflammatory activity
* Patients with an established diagnosis of either Crohn's disease or ulcerative colitis

Exclusion Criteria:

* Sigmoidoscopies performed in ulcerative colitis for the assessment of mucosal inflammatory activity