cyrilzakka/clinical-trials huggingface dataset:
Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

Study part 1 will consist of sensory evoked cortical potential (SEP) measurements of the lower urinary tract (LUT) in healthy subjects using different stimulation frequencies from 0.25 to 3Hz to find the most effective frequency in regard to acquisition time for reliable SEP response rates. Study part 2 will consist of a series of consecutive SEP measurements in patients with LUT symptoms during low bladder volume and maximum cystometric capacity to assess reliability of measurements and influence of potential concomitant LUTS treatments.


Eligibility Criteria:
Inclusion Criteria:

healthy volunteers:

* Written informed consent,
* good mental and physical health,
* age \>18y,

Patients with LUTS and Patients with LUTS and treatment:

* Written informed consent,
* age \>18y,
* prior urodynamic investigation,
* LUTS since \>6months with or without detrusor overactivity

Exclusion Criteria:

healthy volunteers:

* any neurological or urological pathology,
* current pregnancy or lactation,
* urinary tract infection,
* hematuria,
* any previous pelvic or spine or craniocerebral surgery,
* any anatomical anomaly of the LUT or genitalia,
* any metabolic disease,
* any LUT malignancy,
* bladder capacity \<150mL,
* SDV at 60mL;

Patients with LUTS and Patients with LUTS and treatment:

* current pregnancy or lactation,
* urinary tract infection,
* gross hematuria
Monitoring Obese Patients : Impact on the Frequency of Monitoring Weight

The literature data show that long-term monitoring has an effect on weight loss, comorbidity and on improving the quality of life. However, there are still no studies on monitoring obese patients after taking initial multidisciplinary approach. The recommendations of the HAS 2011 advocated "continuous monitoring needed to prevent weight regain, monitor the consequences of overweight and treat comorbidities. This requires a long-term support. "The frequency of follow-up consultations is not specified and "must be adapted to achieve a weight loss target and maintain." Having no specific recommendations on the frequency of monitoring, the investigators chose to experiment closer monitoring than our current monitoring to assess what is the best frequency monitoring, in terms of: weight loss, quality of life, feeding behavior, changes in physical abilities, evolution of comorbidities associated with obesity. The recommendations of the HAS 2011 advocate support of a multidisciplinary obesity for weight loss of 5% to 10 %, which, if maintained, can reduce comorbidities associated with obesity (type 2 diabetes, hypertension, pain associated with osteoarthritis).

2 groups of randomized patients will be followed:

* The control group will follow the current center: every four months for a year, combined with monitoring by email or regular mail during the year.
* The experimental group will be a follow-up every two months for one year HDJ more of the same followed by email or postal mail.

Follow by email or mail is identical to the control group, as well as HDJ 12 months.

Eligibility Criteria:
Inclusion Criteria:

* - Age ≥ 18 - ≤ 75 years
* Obesity with a BMI ≥ 35 or ≥ 30 if associated with at least one comorbidity whose support was commenced or continued during the initial hospitalization.
* Patients hospitalized for a period of at least 3 weeks in the Bernard Descottes center and were supported on dietary, psychological, psychomotor and physical education in a therapeutic approach.
* Patients who have signed consent form.
* Patients who never underwent bariatric surgery and bariatric surgery have not seen in the year following their hospitalization in Bernard Descottes Center.
* Patient accepting the constraints of the protocol in case of close monitoring.
* Patients able to travel with their own vehicle to Bernard Descottes Center.
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* - Patients who have hospitalized in Bernard Descottes Center.
* Failure to follow the protocol because of insufficient command of French or concomitant illness.
* Pregnant or breastfeeding.
* Patients under guardianship or under judicial protection.
* Participation to another trial which can impact on patient's experimental disease during all the study, and patients who are in an exclusion period of another trial.
Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure

The principal objective of this study is to qualify markers of oxidative stress in inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and patients with end-stage kidney failure (diabetic or not), who require dialysis. The evaluation of these markers will be done by the activation and localization of proteins implicated in vascular tone and oxidative stress in monocytes, correlated with the distribution of cholesterol sphingomyelin within planar rafts and caveolae. The aim is to describe their evolution under treatment, which could lead to interventional studies.


Eligibility Criteria:
Inclusion Criteria:

* Patient who have been informed about the research
* Patients with national health insurance cover
* Patients aged between 18 and 75 years
* Patients with stage 3 kidney failure (30 ml/min \< cl creat \< 59 ml/min) diabetic or not
* Patients with stage 5 kidney failure (cl creat \< 15 ml/mn) diabetic or not and requiring dialysis.

Exclusion Criteria:

* Patients under guardianship
* Pregnant or breast-feeding women
* Infection (including peritonitis in peritoneal dialysis, infection of the catheter insertion site),
* Neoplastic disease,
* Systemic diseases in flare,
* Patients positive for Human Immunodeficience Virus (HIV),
* Patients on immunosuppressants
* Patients taking antioxidants (selenium, vitamin C and/or E)
* Patient on statins
Programmed Death-Ligand1 Expression in Her-2 Positive and Triple Negative Breast Cancer

Patients with Her-2 positive and triple negative breast cancer who received neoadjuvant chemotherapy will be included in the study. Paraffin blocks of preoperative core or tru-cut biopsies of the participants will be collected and tested for programmed death-ligand 1 (PD-L1) expression. The variation of PD-L1 expression among different breast cancer subtypes will be evaluated and the investigator will correlate between PD-L1 expression and pathological complete response to neoadjuvant systemic therapy.

Files of breast cancer patients attending breast cancer clinic at Ain Shams University Clinical oncology and nuclear medicine department will be viewed by the investigator and those who fit the selection criteria will be included in the study. Tru-cut or core tissue biopsies obtained from the participants for initial diagnosis will be collected and PD-L1 testing will be done on the specimens. Scoring of PD-L1 will be done using Combined positive score (CPS) score. PD-L1 expression will be evaluated among Her-2 positive and triple negative subtypes and will be correlated with pathological complete response after reviewing the postoperative pathology results of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years old or more
* Histologically proven invasive breast cancer
* Any T stage, any N Stage with no distant metastasis M0 as evident by clinical examination and sonomammography.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.
* Patients with Her-2 positive Luminal B subtype, Her-2 enriched or triple negative breast cancer.
* Patients who completed their systemic neoadjuvant therapy.

Exclusion Criteria:

* Second malignancy
* Patients with early breast cancer clinicallyT1 (≤ 2 cm) N0
* Metastatic patients M1
* Patients with autoimmune diseases (Type I Diabetes mellitus, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Sjogren's syndrome and Behcet disease)
* Patients on systemic steroids or other immunomodulators (as Methotrexate, Tacrolimus and Cyclosporine)
* Patients who started but didn't complete neoadjuvant systemic therapy
* Patients who didn't undergo surgery after neoadjuvant systemic therapy
Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis

This trial is conducted in the United States of America (USA). The aim of this trial is to assess the efficacy of activated recombinant human factor VII in the treatment of refractory haemorrhagic cystitis (HC) following chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Severe haemorrhagic cystitis (HC)

Exclusion Criteria:

* Patients with overt DIC (disseminated intravascular coagulation)
* Patients with known active atherosclerotic disease, such as active coronary artery disease or recent stroke in the past 3 months
* Central venous access device related thrombus in the last 3 months
* Patients with allergy to activated recombinant human factor VII or any component of its preparation
Caries Arresting in Primary Molar Teeth Using SDF VS ART

This study aimed to evaluate the oral health related quality of life ( OHRQoL), during caries management in children with vital carious primary teeth with no signs of irreversible pulpitis using SDF alone or SDF in combination with ART, using Early Childhood Oral Health Impact Scale (ECOHIS).

Early childhood caries (ECC) is a type of dental caries in the teeth of infants and children that is represented as one of the most prevalent dental problems in this period, which can lead to pain, infection, interference with eating.

According to the ADA, (ECC) is described as "the presence of one or more decayed ( cavitated or non cavitated lesions), missing (due to caries), or filled tooth surfaces in any primary tooth" in children.

Overall, 50% of children have one or more decayed primary teeth by the end of toddler age, but the importance of these teeth should not be neglected, because, healthy teeth in childhood have an important role in the eruption of healthy permanent teeth, healthy nutrition, and aesthetic appearance.

Conventional treatment methods (drill and fill) involve the use of rotary burs under local anesthesia which develops pain and needs cooperative child and highly trained dental health personnel and consider an invasive technique, on the other hand (ART) is an approach to increase accessibility to restorative treatment, inexpensive and can be employed in regions without electricity and running water. In addition, ART is a minimally invasive treatment that requires no rotary instruments or local anesthesia to remove decayed tissue before sealing the cavity with high viscosity glass ionomer cement (GIC).

(SDF), a low-cost cariostatic agent and a noninvasive method for caries management, treatment with SDF are easy, effective, and well accepted, it is also an alternative to traditional restorative treatment and may influence the reduction of untreated carious lesions in childhood

Eligibility Criteria:
Inclusion Criteria: • Age: 4-6 years old age.

* Both genders.
* Decayed vital primary molars (asymptomatic teeth with active single-surface lesions, vital pulp no signs of irreversible pulpitis) .

Exclusion Criteria:

* History of systemic conditions.
* Allergy to silver.
* Oral ulceration.
* Teeth with proximal or multi-surfaces caries, pulp pathology.
Pilot Study of Magnesium Infusions in Pediatric Asthma

This is a prospective randomized pilot study that seeks to address the research question: In children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard Pediatric intensive care unit (PICU)-level asthma care significantly decrease time from patient presentation until PICU discharge?

This study will be a double-blind, prospective randomized pilot study. Subjects will be randomized on a 1:1 basis to receive routine asthma care with or without a magnesium drip.

Eligibility Criteria:
Inclusion Criteria:

* Age 2 years 0 days up to 20 years 364 days
* Clinical diagnosis of asthma including both of the following:

  * Attending physician's primary working diagnosis is status asthmaticus
  * Results of a modified International Study of Asthma and Allergies in Children (ISAAC) diagnostic questionnaire consistent with an asthma diagnosis
* Planned PICU admission for moderate-to-severe asthma exacerbation persisting despite standard first-tier therapy (systemic corticosteroids and at least a one-hour treatment with nebulized albuterol/ipratroprium or equivalent) as evidenced by an asthma score of 7 or greater
* IV access or equivalent
* Ability to understand and give informed consent/assent in English

Exclusion Criteria:

* Prior enrollment in this study
* Prior adverse reactions to magnesium
* Use of systemic corticosteroids or magnesium in preceding 2 weeks, or administered at a transferring facility more than 3 hours prior to enrollment
* Admission for inpatient asthma care in preceding 2 weeks
* Hemodynamic instability, impending respiratory failure or intubation
* Inability in children age 7 years or older to give assent due to a developmental delay or altered mental status
* Significant renal or cardiac disease
* Sickle cell anemia
* Significant, active non-asthma pulmonary disease
Establishment of a Prospective Clinical-biological Database

A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Sarcoma

Liposarcomas (LPS) are soft tissue tumours of mesenchymal origin. The most common histological subtypes, represented by well differenciated Lipsarcomas (WD-LPS) and dedifferenciated (DD-LPS), are characterized by the quasi-systematic amplification of the q13-15 of chromosome 12 containing the Mdm2 gene.

The systematic amplification of the Mdm2 gene is such that it is used clinically to distinguish WD/DD-LPS from other types of sarcomas. These observations raise key questions about the high selection pressure that leads to the almost systematic amplification of Mdm2 during the development of these LPS.

Mdm2 is an oncoprotein whose roles in p53 tumour suppressor degradation are broadly described. However, the different inhibitors targeting this interaction were disappointing in clinical trials.

Recently a team from the U1194 INSERM unit of the IRCM which collaborates in this project showed by a pan-genomics analysis, that Mdm2 is recruited to chromatin within a multiproteic complex having as target a transcriptional program involved in the metabolism and in particular in the biosynthesis of the serin.

This clinical-biological basis will allow the continuation of this research project on liposarcomas and the development of new research projects on other histological types of sarcomas.

Eligibility Criteria:
Inclusion Criteria:

* men or women \> 18 years
* Patient treated by surgery for : a primitive sarcoma and/or local relapse sarcoma and/or metastatic localisation of sarcoma
* patient accepted blood sample
* patient treated by radiotherapy before or after the surgery
* Patient signed informed consent

Exclusion Criteria:

* Patient not affiliated to french Social Protection system
* Patient under guardianship
* Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
* Pregnancy and/or feeding
* Patient take care in an Emergency Situation
Impact of Pharmacists' Training on Oral Anticoagulant Counseling

This study evaluates the impact of community pharmacists' educational training on the nature and adequacy of counseling provided to patients on warfarin, an oral anticoagulant. Half of the community pharmacists participating in the study will receive a two-week educational training on how to adequately counsel patients on warfarin while the other half of community pharmacists will receive the same training after the study. A mystery patient model will be used in this intervention study where six different trained and standardized individuals will act as patients. Each of these mystery patients will supposedly have pulmonary embolism, deep vein thrombosis, or atrial fibrillation. The mystery patient will visit each pharmacy to buy warfarin or complain about adverse drug reaction been experienced. It is expected that pharmacists will provide relevant information and counseling to these patients on the use of the medication warfarin and how to handle the adverse drug reactions.

Although direct oral anticoagulants also have their limitations (such as the risk of gastrointestinal bleeding) they are not as prominent as that of warfarin but still important to consider before prescribing to patients. These limitations associated with the use of oral anticoagulants prove that there is need for special counseling of patients placed on oral anticoagulants. Counseling, as an important aspect of drug therapy management, is somewhat technical and requires a peculiar way of providing vital information on drug therapy within the shortest possible time. Pharmacists, who are key members of the healthcare team, are tasked with this role more than others and as such this area is of optimum importance.

Proper and adequate counseling on oral anticoagulants is essential for optimal use of the drug and to reduce the number of incidence of adverse drug reactions. Adequate counseling cannot be achieved without proper training. This aspect is seen to be lacking due to the suboptimal performance discovered in research among healthcare professionals including pharmacists with regards to counseling of patients on oral anticoagulant use Mystery patients in pharmacy practice research are a very reliable means of obtaining unbiased data on pharmacists with regards to counseling. This study, therefore, is aimed at providing counseling training to community pharmacists and evaluating the impact of the training on patients indirectly using the mystery patient model.

Eligibility Criteria:
Inclusion Criteria:

* Community Pharmacists with at least one-year practice experience
* Community pharmacies that stock and dispense warfarin

Exclusion Criteria:

* Community pharmacists working in order sectors
Caring Relationships Expression Study

This study will examine a heart rate variability biofeedback (HRVB) intervention versus a music listening control (MLC) for 30 family caregivers (FCGs) of Alzheimer's disease (AD) (and related dementias: ADRD) patients to examine feasibility (acceptability/adherence, satisfaction) and direction of change in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality over the course of 8-weeks.

This pilot study aims to examine feasibility of implementing a HRVB intervention and an MLC control with AD FCGs. The HRVB and MLC interventions will be evaluated for acceptability (operationalized as adherence to intervention) and satisfaction and to identify necessary intervention modifications. Feasibility benchmarks: 85% of participants will be at least 70% adherent to implementation goals (10-min use 5-7 days per week). Feasibility of randomization will be examined by comparing adherence/retention (expecting similar patterns across interventions). Acceptability/satisfaction with HRVB and MLC will be evaluated in semi-structured interviews post-intervention including detailed probing on feature preferences, barriers/facilitators, suggested improvements for retention.

The second aim of this study is to examine patterns of association of HRVB and MLC with outcomes. The investigators will examine pre- to post-intervention changes (and sustained outcomes at follow-up) in self-reported caregiver burden, stress and resilience. Change in relationship quality will additionally be assessed from pre- to post intervention. Change in ANS balance, a neurophysiological indicator of reduced emotional distress and improved resilience, will be assessed using HRV data at all four timepoints to examine trends and change over time. Significance tests will not be conducted, in alignment with goals for pilot feasibility studies. The investigators will observe the direction of change and outcomes to examine the value of MLC as an appropriate control condition showing minimal placebo effects compared to HRVB.

Eligibility Criteria:
Inclusion Criteria:

* In primary/unpaid FCG role \> 6 months
* Caring for mild-to-severe ADRD patient

  * 4 caregiver burden score Own/operate smartphone w data plan

Exclusion Criteria:

* Pacemakers or implanted cardioconverter defibrillator (ICD), or conditions/meds that interfere with HRV measurement/feedback
Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome

Post-thrombotic syndrome (PTS) is the most frequently observed chronic complication of deep vein thrombosis (DVT), with an estimated cumulative incidence of 20-50%. Endovascular venous recanalization with angioplasty and stenting of obstructive lesions is the recommended treatment option to reduce or correct the symptoms of DVT. However, its impact on the physical capacity and breathlessness of patients has not been fully demonstrated. The heterogeneous evidences of clinical improvement is probably related to the presence or absence of collateral veins developed in these patients with proximal venous obstruction (iliac or iliofemoral with or without inferior vena cava involvement), which ensure the cardiac venous return. The aim of this study is to compare changes in maximal oxygen uptake after endovascular venous recanalization in DVT patients and to evaluate the hemodynamic, respiratory and muscular improvement induced by the restoration of venous flow in the occluded segments.


Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for endovascular treatment for post-thrombotic syndrome in a chronic context (6 months after the occurrence of thrombosis, without time limit), after validation of the indication during a monthly medical-radiological PCR (St Eloi vascular medicine team and vascular radiologist performing the endovascular treatment)
* Age \>= 18 years

Exclusion Criteria:

* Contraindication to the performance of a maximal effort test on a cyclo-ergometer
* Refusal of consent after information
* Adult protected by law (guardianship, curatorship)
* Pregnant or breastfeeding woman
* Patient not affiliated to a social security system or not benefiting from such a system