cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer

The aim of this pilot study is to assess the efficacy and toxicity of immediate pre-operative instillation of mitomycin C compared to the standard early post-operative .


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years,
* Primary or recurrent bladder tumor with endoscopic papillary aspect,
* One or two bladder tumors,
* Cytology before TURB showing no high-grade cells,
* Patients without tutorship or subordination (ou curatorship),
* Patients under the general social security system or qualifying through a third party,
* Informed consent signed by the patient after clear and fair information.

Exclusion Criteria:

* Age \< 18 years,
* Allergy to mitomycin C,
* Traumatic stenting,
* Upper tract urothelial cancer,
* Urethral invasion,
* History of muscle invasive bladder cancer,
* Extensive tumor (3 cm or more),
* Any contraindication to TURB,
* Simultaneous participation in another clinical research study,
* Patients not insured by the social security or not qualifying through a third party,
* Patients with enhanced protection, namely pregnant or lactating women, persons deprived of their liberty by a judicial or administrative decision, people staying in a health or social institution, adults under legal protection, and finally patients in emergency situations,
* Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study (i.e. hormonal / mechanical contraceptive : oral, injectable, transdermal, implantable, intrauterine or surgical device: tubal ligation, hysterectomy, total oophorectomy).
A Prospective Study to Evaluate the Implementation of Shared Decision Making Strategy for Renal Cell Cancer (RCC)

The aim of this study is to evaluate the effect of two decision aids for renal cell carcinoma (RCC) on the decision-making process and the quality of the decision.

Background: Treatment options for patients diagnosed with RCC depend on the stage of the disease, histopathology and patient's preferences and values regarding outcomes. For local (non-metastatic) disease, gold standard for treatment is surgical resection of the tumour. Besides this, ablative therapies or active surveillance could also be an option. For metastatic disease, targeted therapy and/or immunotherapy can be offered and new treatment options are being tested in clinical trials. The number of available treatment options for patients with RCC is increasing, but the availability of these options differs per hospital and the transparency about treatment options is limited, resulting in practice variation between hospitals.

Decision aids help patients to make decisions regarding treatment, particularly when there is not one medically superior treatment option. In this tools treatment options are explained, including outcome information such as possible side effects and benefits of therapy. Decision aids have proven to lead to increased patient knowledge, less anxiety in patients, improved health outcomes such as physical en mental health, reductions in unwarranted variation in care and costs, greater alignment of care with patients' values.

For patients with RCC, two decision aids are in development right now: one decision aid focussed on local disease and one decision aid focussed on metastatic disease. Using these decision aids, patients are encouraged to make a well-informed decision together with the healthcare professional.

Objective: To assess how the decision aids for RCC influence the quality of the decision-making processes for RCC, defined as the extent to which elements of shared decision-making (SDM) are observed.

Design, setting and participants: This study includes patients clinically diagnosed with RCC, facing a decision which is addressed in the decision aids. Study design will be a prospective multicenter pre-test post-test study.

Outcome measurements and statistical analysis: The primary endpoint of this study is the mean change in OPTION-5 score between pre-test and post-test groups. Secondary outcome measures include perceived quality of the decision-making process, quality of the decision and implementation of the decision aids.

Eligibility Criteria:
Inclusion Criteria:

* Patients clinically diagnosed with RCC
* Patients facing a decision which is addressed in the decision aids (T1 tumor or metastatic disease)
* Written informed consent

Exclusion Criteria:

* Patients who are not able to fill in a questionnaire or undergo an interview individually
ETNA-MS Device Validation Study

The overarching goal of this research protocol is to validate the effectiveness of Innodem's ETNA-MS device in informing clinicians on the disability status of Multiple Sclerosis (MS) patients. Effectiveness of the device will be assessed by the level of agreement between the EDSS estimated by the device and the actual scores measured by the neurologist in-person assessments.

This study will use a multi-site cross-sectional design in a single cohort of Multiple Sclerosis (MS) patients. Eligible patients with MS will be selected and categorized based on their Expanded Disability Status Scale (EDSS) score. Patients eye movements will be captured using the patented eye-tracking technology at one single time point. In addition to the eye-tracking tests, patient phenotypes will be further detailed via brief functional and cognitive assessments using the EDSS, Brief International Cognitive Assessment for MS (BICAMS) and Multiple Sclerosis Functional Composite (MSFC). All patients will be required to participate in a single session.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Aged 18 years or older at the time of enrolment
* Able to read in either English, Spanish or French
* Able to read the oculomotor task on-screen instructions at the testing distance (45 cm) with or without corrective lenses
* Confirmed diagnosis of MS as per the Macdonald criteria, irrespective of MS subtype (relapsing-remitting (RRMS), secondary-progressive (SPMS), primary-progressive (PPMS), and progressive-relapsing (PRMS))
* Neurologist-determined EDSS score between 1.0-4.5

Exclusion Criteria:

* Evidence or medical history of a neuropsychiatric disorder such as schizophrenia and autism, which are known to impair eye movements and oculomotor control.
* Presence of comorbid neurological conditions causing significant eye movement anomalies (such as strabismus, cranial nerve palsy, stroke-causing hemianopsia).
* Diagnosis of macular edema or other pre-existing ocular conditions that would prevent a participant from performing the eye movement assessments.
* Having started a new prescription medication or having changed the dose of a medication known to influence ocular motor visual function (e.g. benzodiazepines, antipsychotics, and anticonvulsants) within the past three months.
* Participants with non-disease related physical impairments to a leg, hand, or arm (e.g., broken bone or severe sprain) that would not allow completion of the assessments.
* Having an EDSS score for which the desired sample size has been reached.
A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients

This is an open, multicenter Phase II clinical study of SSGJ-707 combined with chemotherapy in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer. The objective is to evaluate the safety, tolerability and antitumor activity of SSGJ-707 in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age:18-75 years old
2. Advanced endometrial cancer and platinum-resistant ovarian cancer
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>=12 weeks.
5. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sleeping Healthy/Living Healthy Development

This pilot study will: (1) develop Sleeping Healthy/Living Healthy, a school-based health center (SBHC) intervention that combines MBIH and sleep hygiene strategies to improve sleep quality in urban adolescents with poor sleep quality; (2) evaluate the feasibility and acceptability of intervention procedures; and (3) assess the preliminary intervention effects on sleep quality in urban adolescents.

This study includes a development phase and a pilot individually-randomized group treatment (IRGT) phase. In Year 1, the investigators will develop the novel integrated intervention using an iterative participatory design process. In Year 2, the investigators will conduct an IRGT trial with 60 adolescents with insufficient sleep recruited from two SBHCs in New York City. Adolescents will be randomized 1:1 to receive the intervention or an attention control of equal intensity and duration. Process evaluation interviews guided by a rigorous fidelity framework with adolescents and with SBHC providers and personnel will be conducted to obtain feedback regarding intervention procedures.

Poor sleep quality, which contributes to impaired functioning, is elevated in urban, ethnic/racial minority adolescents due, in part, to poor sleep hygiene. Despite successful sleep hygiene interventions in younger children, none focus on adolescents, a group with unique developmental needs. Urban adolescents face unique contextual stressors, which may contribute to ineffective use of sleep hygiene behaviors. Mind-body integrative (MBIH) approaches (e.g. yoga, meditation) improve sleep quality in adults, but are rarely applied to adolescents. MBIH has been shown to reduce stress among adolescents. Taken together, this suggests that integrating MBIH with sleep hygiene strategies has the potential for a synergistic effect on improving sleep quality, yet no interventions concurrently use MBIH and sleep hygiene with adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Age 13.0 -17.9;
* Grade 9 - 11;
* Currently enrolled as a patient in one of the participating SBHCs; and
* Report sleep duration \< 8 hours (below the minimally recommended number of hours of sleep for this age group through the following questions: What time do you: a) usually fall asleep on weekdays and b) usually wake up on weekdays?).

Exclusion Criteria:

* Report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, or periodic limb movement;
* Significant developmental delay and/or severe psychiatric or medical conditions that preclude completion of study procedures or confound analyses; or
* Not capable of communicating (reading, speaking, writing) in English.
Levels of Contaminants in Human Milk

Recent international data have shown that the levels of chemical substances found in human milk could be at risk for breastfed infants. New data are necessary to assess this risk among French newborns.

The objective of this study is to assess levels of certain contaminants in breastmilk. Measurements will be made on breastmilk samples collected in Milk Bank but not suitable for infants due to bacteriological reasons. 6 Milk Banks well distributed on the French territory will be contacted to participate. 180 women will be included. Women who gave their milk and correspond to the inclusion criteria (in particular breastfeeding a child under 6 months at the time of the donation) will be contacted by the investigator by phone. They will be asked to fill in a written consent as well as a questionnaire on socio-demographic data, pregnancy related information and potential environmental exposures.

2 breastmilk samples of 50 mL will be sendsending to the lab for analysis and 2 samples of 50 mL will be collected.

Eligibility Criteria:
Inclusion Criteria:

For the samples:

* Not allowed to use for bacteriological reasons
* Breastmilk samples from lactating women between delivery and 6 months (+/- 1 month) of the infant

For the mothers:

* Age \> or = 18 years
* Lived on the French territory
* Well french writer and speaker
* Mother child couple in good health
* Non opposability
Regulatory T Cell With Related Interleukins in Periodontal Disease Progression

T Regulatory cells which suppressor subset of T cells and related cytokines remain in blood and infiltrates into the tissue under need. The role of Treg and related cytokines in succession of periodontal inflammation is recently a subject of research interest. Chronic gingivitis and periodontitis being chronic inflammatory diseases can upregulate various cytokines in the systemic circulation and gingival crevicular fluid. This study aimed to compare levels of Tregs with Interleukin-21, 22, 33, 35 and vitamin D-binding protein in blood and GCF of periodontally healthy persons, chronic gingivitis patients, and severe chronic periodontitis patients.

T regs infiltration might reveal a trial to control tissue damage, however it also might be suggestive of a destructive effect of Tregs in periodontitis . Tregs can actually play a damaging role as this cells can annoyingly weaken the immune reaction towards infectious agents that could be possibly harmful in a periodontal environment . Immunopathology of Treg cell mediated via its pro-inflammatory cytokines during inflammatory conditions. IL-33 "recent member of pro-inflammatory IL-1 category" was recognized as placard in the stability of Foxp3+ Treg cell at mucosal sites. IL-33 has either pro- or anti-inflammatory property according to the disease and the model. It was speculated that IL-33 could improve the propagation from suppressive to dysregulated Treg cells in a dose-dependent manner . Interleukin (IL)-21 which member of the type I (ℽ chain) cytokine family has the ability to minimize FoxP3 expression and restraining Treg suppressor function and homeostasis . The purpose from this study was to assess the role of circulating and localized Treg with their related cytokines in patients with inflammation of periodontal tissues and to correlate their levels with disease progression.

Eligibility Criteria:
Inclusion Criteria:

* periodontally healthy persons without any signs of periodontal disease. This was determined by the absence of attachment loss and bleeding upon probing either ˂ 10% or probing depth ˂3 mm.
* persons exhibiting generalized chronic gingivitis exhibiting signs of erythema, bleeding on probing up to 20%, edema, probing pocket depth less than 3 mm and no periodontal attachment loss.
* persons having severe generalized form of chronic periodontitis exhibiting PPD ≥ 6 mm, CAL ≥ 5mm and bone loss affecting at least six teeth as observed in dental periapical radiograph.

Exclusion Criteria:

* Patients with systemic diseases according to Modified Cornell Medical Index criteria
* Patients receiving either antibiotics or non-steroidal anti- inflammatory at least 3 months prior to samples collection.
* Patients subjected to previous periodontal therapy 6 months before sampling.
* Patients with systemic or local inflammatory conditions other than periodontal disease.
* The smokers.
* Neither lactating nor pregnant.
Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation

Thymoglobulin is widely applied as serotherapy in order to prevent acute graft-versus-host disease (GvHD) and graft rejection in patients undergoing non-Human Leukocyte Antigen (HLA)-identical hematopoietic stem cell transplantations (HSCT), with a delicate balance between prevention of GvHD and the promotion of immune reconstitution. Thymoglobulin is known as a drug with high pharmacokinetic (PK) variability. This variability influences drug exposure, which in turn determines the drug response of pharmacodynamics (PD). In order to maintain efficacy while reducing adverse effects of drugs across the entire age range, identification of the PK/PD relationships and the effect of growth and maturation on the different PK and PD parameters involved are crucial.

The investigators hypothesise that a better knowledge of Thymoglobulin PK and its covariates would help to individualise dosage regimen and would improve clinical outcomes, such as GvHD and immune reconstitution.

The investigators aim to build a population PK model of Thymoglobulin in order to study PK variability and its covariates. This model will help in optimizing dosage regimen in an individually way.


Eligibility Criteria:
Inclusion Criteria:

* Patient receiving Thymoglobulin therapy as part of a first HSCT
* Age ≥ 2 years
* Lansky or karnofsky score ≥ 50%.
* Enrolled in a social security plan
* Patient 18 years of age or older who is informed and has consented to participate in the study or minor patient whose parents/guardians have been informed and have given consent for the minor patient to participate in the study
* Female patients of childbearing potential must have an effective method of contraception (a pregnancy test will also be performed at inclusion).

Exclusion Criteria:

* Patient having received serotherapy (Thymoglobulin® or other) within 3 months before this HSCT
* Patient receiving another serotherapy during conditioning (Campath®)
* Patients with uncontrolled acute or chronic infections for which any form of immunosuppression would be contraindicated
* Known hypersensitivity to Thymoglobulin®.
* Pregnant or lactating women
* Patient participating simultaneously in another study of an investigational drug (no exclusion period)
* Patient under legal protection or deprived of liberty
Optimization of Quality in Cardiopulmonary Resuscitation Through Monitor-defibrillator With Feedback System

AIM: To verify the effect of a feedback system on optimizing quality during CPR on mannequins.

Hypothesis: The quality of CPR performed by healthcare professionals through a defibrillator monitor with a feedback system is higher than those that do not use a feedback system on a manikin.

METHOD Type of study: Pre-experimental with pretest-postest design. Sample: Health professionals of the General Emergency Service of the Virgen de la Arrixaca University Hospital (HCUVA).

Sampling type: Non-probabilistic for convenience. Variables: sex, age, profession, years of experience, last CPR training received, last time performing CPR, depth, frequency, quality CPR, perception of the quality of CPR.

Statistical analysis: Student's t for related samples and McNemar.


Eligibility Criteria:
Inclusion Criteria:

* Health professionals working in the General Emergency Service of the Virgen de la Arrixaca University Clinical Hospital during the study period. They include doctors, resident doctors, and nurses.
* Health professionals from the General Emergency Service of the Virgen de la Arrixaca University Hospital who receive the training session on CPR quality and use of the defibrillator monitor with feedback system.

Exclusion Criteria:

* Health professionals who do not work in the General Emergency Service of the Virgen de la Arrixaca University Clinical Hospital during the study period.
* Health professionals who work in the General Emergency Service of the Virgen de la Arrixaca University Hospital and refuse to carry out the training and demonstration session.
Fascia Iliaca Compartment Block for Proximal-end Femur Fractures

Fracture femur is a common injury which is associated with excruciating pain. Positioning for neuraxial blocks is always challenging because even slight overriding of the fracture ends is intensely painful .It can causing major patient distress which accompanied by well-known physiological sequelae such as sympathetic activation causing tachycardia, hypotension, and increased cardiac work that may compromise high-risk cardiac patients.

Fascia iliaca compartment block is highly effective in blocking lateral cutaneous nerve of the thigh and femoral nerve. Fascia iliaca compartment block is not only easy to perform but it is also associated with minimal risk as the local anesthetic is injected at a safe distance from the femoral artery and femoral nerve. It is always safe to perform the fascia iliaca compartment block prior to spinal anesthesia as the patient can respond during administration of the local anesthetic and can prevent intra-neuronal injections

On arrival to the pre-operative holding area half hour before the scheduled surgery. Patient will be connected to basal monitoring devices; pulse oximetry and non- invasive blood pressure. Fascia iliaca compartment block will be performed with the aid of ultrasound device in all cases.The injected local anesthetic solution will be prepared by a staff member who was not involved in the study) according to the randomization. After 20 minutes from the injection the investigators will assessed nerves that had been blocked.

On arrival to the operative theater, under complete aseptic technique spinal anesthesia will be carried out in the sitting position (if there is severe pain at positioning we will use lateral position) at space between L3-4 or L4-5 using a 25-gauge spinal quincke needle. After feeling the desired space, the needle will be advanced (paramedian approach) till free flow of cerebrospinal fluid dropped from the needle then 15 mg hyperbaric bupivacaine+20mic fentanyl will be injected.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist physical status I to III
* Patients scheduled for fixation for proximal end femur fracture

Exclusion Criteria:

* Patients refusal
* Morbid obese patients (BMI\>40)
* Bleeding diathesis
* Previous femoral bypass surgery
* Inguinal hernia
* Inflammation/infection over injection site
* Peripheral neuropathy
* Allergy to local anesthetics agents used.
* Severely altered consciousness level
* Psychiatric disorders
* Polytrauma