cyrilzakka/clinical-trials huggingface dataset:
Effects of Adjunct Antimicrobial Photodynamic Therapy in Periodontal Treatment of Patients with Obesity

The goal of this clinical trial is to compare the effects of adjuvant antimicrobial photodynamic therapy (aPDT) as an adjuvant of scaling and root planing with scaling and root planing alone for periodontal treatment in patients with periodontal disease and obesity. The main question it aims to answer are: Does adjuvant aPDT improves periodontal health? Are there differences in the proteomic profile of gingival fluid after both treatments? Participants will receive scaling and root planing complemented or not by aPDT. Results will be collected after 1, 3, and 6 months. Researchers will compare adjuvant aPDT treatment to regular treatment to see if it promotes reduction in inflammation and improvement in periodontal health.


Eligibility Criteria:
Inclusion Criteria:

* Obesity (grade II and III classified according to Body Mass Index)
* Periodontitis stage II to IV
* Presence of at least 20 teeth excluding 3rd molars.

Exclusion Criteria:

* Smokers
* Alcohol or drugs consumption
* Kidney disorders
* Pregnancy or lactation
* Use of antibiotics at the last 30 days
* Use of drugs that alter periodontal structures as phenytoin or ciclosporin
* Periodontal treatment at the last 6 months
Bacterial Colonization on Nails Covered With a Methacrylic Coating

In the research, the investigators will monitor the bacterial colonization of nails coated with a methacrylic coating

It is known that the hand hygiene of healthcare workers is extremely important in order to prevent health-related infections. The effectiveness of hand disinfection can be affected by aspects of hand hygiene such as long nails and fingernail applications. In order to determine whether and to what extent fingernails applied among healthcare workers pose a risk of transmission of potentially pathogenic bacteria, and until what day artificial fingernails are safe in healthcare workers, the investigators will monitor bacterial colonization on nails with UV-cured methacrylic fingernails lamp and compared it with a control group of natural nails without application.

Eligibility Criteria:
Inclusion Criteria:

* nurses, doctors and respiratory physiotherapists employed in high-risk wards for patients
* healthy nail surface and cuticle

Exclusion Criteria:

* subjects with damaged nails or cuticles
* operating room staff using surgical hand brushing and staff in general nursing wards.
Early Detection of Fabry Disease

The main aim of this study is early detection of FD using real-world data for the development of advanced natural language processing methods and to develop a predictive algorithm and to measure the performance of the algorithm in identifying participants with FD.

This study is about using data from hospital Electronic Health Record database from the last 10 years to describe the ranking of participants with FD using multilevel likelihood ratios and to validate the algorithm using positive controls. No investigational medicinal product or device will be tested in this study. Hospital electronic health record data will be analyzed for a period of up to 6 months.


Eligibility Criteria:
Inclusion criteria:

* In-patient or out-patient datasets of the participating hospital in the last 10 years
* Participants at any age Positive controls: a subset of all participant hospital records that includes the participants with confirmed FD.
Endometrial Cancer International Database

This project aims to determining prognostic factors and individualizing management decision per patient characteristics and endometrial cancer features. This study will include at least 10 centers from different countries that present at least Europe, South America, Asia, and Africa. Data will be retrospectively collected from January 2008 to December 2015 with a total follow-up of at least 5 years (December 2020).

Endometrial cancer (EC) or carcinoma of corpus uteri is a neoplastic change, mostly adenocarcinoma, arising from uterine columnar epithelial lining. Abnormal uterine bleeding is the main presenting symptom especially in postmenopausal women. EC is estimated to be the seventh most commonly diagnosed cancer in women. It is considered the 16th leading cause of death in women with cancer worldwide, with 382 000 estimated new cases and 89 900 deaths in 2018. Factors as obesity, parity, diabetes mellitus, unopposed estrogen exposure, genetics and hormonal therapies are recognizable risks for EC. Other factors as chronic comorbidities, tumor size and organ metastasis influence staging, prognosis, and management protocols.

FIGO staging has been adopted as the standard classification system in the management of endometrial cancer. However, this staging system does not consider all factors that affect treatment decision and prognosis including but not limited to patient demographics, tumor grade, and lymphovascular space invasion. In addition, some interventions are still debatable particularly in the presence of intermediate disease e.g, grade II early EC. Available evidence supports combined pelvic and para-aortic lymphadenectomy in management of patients with EC. However, combined pelvic and para-aortic lymphadenectomy carry the risk of long term morbidities as lymphedema. Thus, hysterectomy alone as management plan is suggested in patients with low risk EC. More comprehensive studies of the multiple confounders that determine patient's risk are essential to reach an individually adjusted management plans and to predict prognosis of each individual case. Therefore, availability of large multicenter studies will provide robust evidence regarding optimal management of EC and hence, improve treatment outcome and prognosis particularly in the era of machine learning and artificial intelligence.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with endometrial cancer, between 2008 and 2015.
* Women should be diagnosed and managed by the corresponding center.
* Patients with adequate clinical and pathological data.

Exclusion Criteria:

* Inadequate information and follow-up for at least 5 years.
* Authorization to use anonymous patient data for research purposes.
Towards an Early Integration of Palliative Care in Oncology

The primary objective of the study is to describe the nature and to estimate the prevalence the health needs of patients with metastatic cancer and their main caregivers, between the period from diagnosis to death.

As secondary objectives, the study aims:

* to determinate the proportion of patients with an indication for palliative care according to Hui et al., and to describe the adequation of health needs and the services for them;
* to study the association between clinical pathway and the indication of targeted palliative care;
* to study the association between the integration of palliative care service and the adequation of health needs service of patients;
* to study the factors such as the disease, the practice and the care, contribute to the patient's survivor of 1 year.

This is a descriptive, transversal, multicenter study, which will be performed in healthcare facilities in Ile de France area.

Each investigator center will be composed by oncologist / palliative care and support team. 10 centers will participate to the study, enrollement will be perfomed during 6 months targetting 400 patients with advanced cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years;
* Diagnosed metastatic cancer;
* Outpatient or inpatient care at a participating site to the study;
* Affiliation to the social security scheme;
* Patient informed and non-opposed to participate to the study.

Exclusion Criteria:

* Testicular or choriocarcinoma ovarian cancer;
* Hematology cancer;
* No understanding french language;
* Unable to express if needed his non-opposition opinion, according to physician investigator;
* Visually impaired, hearing impaired or aphasic.
Evaluation of a Power Assistance Device for Wheelchair-DUO

Power assisted wheelchairs have specific advantages compared to manual propelled or powered Wheelchair. Autonomad Mobility has developed a new device (DUO), the assistance being triggered by the motion of the wheelchair and not an push on the hand rim, people who use their foot to move or people pushing the wheelchair can be helped by the device as people propelling the wheelchair with their arms.

Furthermore DUO has an option with a longer assistance (AEP+) which can be preferred by some people.

To be referenced and reimbursed by the French health insurance, DUO has to be compared with an other power assistance device for wheelchairs, already referenced.

The study is a comparative study between DUO and the ALBER E Motion. Each patient is his own control and is assessed in 4 experimental conditions, with intervals of 3 or 4 days, manually propelled, with the E mtion device, with the DUO device and the single push configuration, with the DUO device and the AEP+ configuration.

The main outcome measure will be the user's satisfaction (using 8 items of the ESAT questionnaire)


Eligibility Criteria:
Inclusion Criteria:

* with a motor deficiency (of any origin) needing a manual wheelchair
* propelling his wheelchair with both arms or with one foot and one arm.
* covered by the French national health insurance.
* living at less than 30km form the investigation center

Exclusion Criteria:

* subject of a guardianship or tutelage measure
* owning already a power wheelchair or a powered assisted wheelchair
* with cognitive impairments that affect the steering capacity or the understanding of the instructions.
* Patient unable to use a manual wheelchair indoor without help,
* Contraindication in keeping a seating position especially the occurrence of ulcers.
A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients

This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* At least one draining enterocutaneous perianal fistula
* Diagnosis of Crohn's disease (CD) must have been established for at least 6 months
* At least one ineffective fistula treatment (but no previously failed anti-TNFα (tumour necrosis factor) antibody treatment)
* Patients should not suffer from any other health problems that may jeopardize their participation in the study.

Exclusion Criteria:

* Current or recent (within 30 days of enrollment, or 5 half-lives of the compound, whichever is longer) use of anti-TNFα antibody treatment
* Active Crohn's disease
* Recent or pending abdominal or ano-rectal surgery, particularly presence of stricture, or abscess, or retention for which surgery might be indicated
* Previously failed anti-TNFα antibody treatment
* Intercurrent bacterial or viral (intestinal) infection (serologically or microbiologically confirmed)

Other protocol-defined inclusion/exclusion criteria may apply
Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872) in combination with the HIV capsid inhibitor lenacapavir (LEN).


Eligibility Criteria:
Key Inclusion Criteria:

* On first-line antiretroviral therapy (ART) for ≥ 2 years prior to screening. A change in ART regimen ≥ 28 days prior to screening for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed
* No documented historical resistance to the current ART regimen
* Plasma HIV-1 RNA \< 50 copies/mL at screening
* Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 18 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable.
* Proviral phenotypic sensitivity to both teropavimab and zinlirvimab at screening by the PhenoSense mAb Assay (Monogram Biosciences) for inclusion in the Primary Cohort; sensitivity at screening by the PhenoSense mAb Assay (Monogram Biosciences) to 1 mAb, either teropavimab or zinlirvimab, within 18 months prior to enrollment for inclusion in the optional Pilot Cohort

  -- In both cohorts, teropavimab sensitivity is defined as 90% inhibitory concentration (IC90) ≤ 2 μg/mL; zinlirvimab sensitivity is defined as IC90 ≤ 2 μg/mL;
* Cluster determinant 4+ (CD4+) count nadir ≥ 350 cells/μL
* Screening CD4+ count ≥ 500 cells/μL
* Availability of a fully active alternative ART regimen, in the opinion of the investigator, in the event of discontinuation of the current ART regimen with development of resistance

Key Exclusion Criteria:

* Comorbid condition requiring ongoing immunosuppression
* Evidence of current hepatitis B virus (HBV) infection
* Evidence of current hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable)
* History of opportunistic infection or illness indicative of Stage 3 HIV disease

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Tracheal Intubation vs. Bag-valve-mask Ventilation in Patients With Out-of-Hospital Cardiac Arrest _ CAAM STUDY

The aim of this study is to improve the management of patients in cardiac arrest, and this by comparing two initial airway management methods: Tracheal intubation and bag-valve-mask ventilation.

The survival rate at 28-day with favorable neurological function will be compared in the tracheal intubation group versus the bag-valve-mask group

It is a multicenter prospective non-inferiority open randomized controlled trial in patients with out-of-hospital cardiac arrest carried out in physician-staffed emergency medical services.

The investigators hypothesis is that basic airway management (i.e. bag-valve-mask ventilation) is safe and may avoid the deleterious effects of tracheal intubation including interruption of chest compressions.

On medical team's arrival at the scene and after verification of participant's eligibility, patients will be enrolled in the study and randomly assigned to either initial bag-valve-mask ventilation or tracheal intubation. After the hospital admission, all patients will be intubated whatever the initial airway management.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* Patient with out-of-hospital cardiac arrest on medical team's arrival
* Resuscitation attempted
* Medical insurance

Exclusion Criteria:

* Massive suspected aspiration
* Presence of do-not-resuscitate order
* Pregnancy
* Prisoners
Life Experience of People Aged 60 and Over Living with HIV

The purpose of this study is to Assess the impact of HIV on the life course of patients aged 60 and over.

COREVIH IDF Nord and CERMES3 conducted a first qualitative survey of 32 HIV patients aged 60 and over. The study, in the form of an individual interview, aimed to identify the difficulties that PLWHIV may encounter in their life course, to question their future and the impact that HIV could have.

From this study, a questionnaire was drawn up covering the points raised by the qualitative study. The questionnaire was designed by doctors of the four hospitals that participated in the first study and a sociologist from CERMES3.

After patient's oral agreement obtained, the study questionnaire "Sociological study PVHIV ≥ 60 years" will be given to the patient for completion.

Eligibility Criteria:
Inclusion Criteria :

People aged 60 and over living with HIV and view in consultation

Patient participation agreement obtained

Exclusion criteria :

People living with HIV less than 60 years old
Cohort Biomonitoring Study to Evaluate the Biocompatibilty of Resin-based Dental Materials

Adult patients who require multiple dental restorations will be included in this study. Urine and saliva samples will be taken for determination of bisphenol A levels at several time points, and for analysis of the estrogenic activity using ERE-CALUX.

Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit. We will determine global alterations in DNA methylation and DNA hydroxymethylation levels using UPLC-MS/MS.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian, adults,

Exclusion Criteria:

* acute or chronic medical condition, presence of oral inflammatory conditions during the previous 2 weeks, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in the previous 2 months, smoking and consumption of alcohol
VoiceLove: An App-Based COMMunication Tool Designed to Address DeliriUm and Improve Family ENgagement and PatIent/Family SatisfaCtion in CriticAlly Ill PaTiEnts (COMMUNICATE)

VoiceLove is a phone application allowing family and patients to share information in a secure platform. This project will compare the VoiceLove app to usual care to learn about whether VoiceLove improves patient-family communication, family engagement, and ICU delirium.

VoiceLove is a novel, HIPAA compliant mobile phone application that enables families and patients to securely exchange and archive voice messages in real-time. For patients who are intubated or otherwise unable to communicate, VoiceLove allows family members to deliver real-time voice messages when they are away from the bedside without relying on the clinical team to coordinate calls. The investigator group has recently completed formative usability testing of the VoiceLove application with a variety of ICU stakeholders including family members, bedside ICU nurses, and ICU physicians to refine and optimize the app for clinical use in the ICU. During usability testing, stakeholders overall viewed the app favorably and expressed interest in tools to enhance communication in the ICU. As compared to traditional methods of communication, stakeholders identified the ability to customize messaging by unique family groups and to archive and replay messages as strengths. While promising as a tool to improve family engagement in the ICU, it has yet to undergo evaluation in the ICU to assess feasibility and acceptability of use.

The goal in this prospective, mixed method randomized control trial (RCT) is to compare VoiceLove implementation to usual care to investigate the effect of VoiceLove on optimizing patient-family communication, family engagement, and ICU delirium prevalence.

Eligibility Criteria:
Inclusion Criteria

Only patients who meet inclusion criteria, have no exclusion criteria, and consent for participation will advance to the Interventional Trial phase (i.e., the randomization phase) of the study. Patients will be eligible for inclusion in the Pre-Randomization Phase of the study (i.e., presented for study consent) if they are:

1. Adult patient ≥18 years old
2. Admitted to medical or coronary ICU
3. Intubated on mechanical ventilation with expected intubation of \> 24 hours

Exclusion Criteria

Patients will be excluded (i.e., not consented) for any of the following reasons:

1. Inability to obtain informed consent

   * Attending physician refusal
   * Patient and/or surrogate refusal
   * Patient unable to consent and no surrogate available
2. Acute or chronic neurologic deficit precluding CAM-ICU assessments
3. Inability to understand English
4. Current enrollment in a study that does not allow co-enrollment
5. Prisoners
6. Expected death or comfort measures within 24 hours of enrollment or lack of commitment to intervention by family or the medical team (e.g., likely to withdraw life support measures within 24 hours of enrollment).
7. Bilateral Deafness
Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS

The study will investigate whether cognitive behavioral psychotherapy (CBT) combined with prefrontal transcranial direct current stimulation (tDCS) is more efficacious with regard to symptom reduction in depressed patients than CBT combined with sham-tDCS or CBT alone.

Brain stimulation techniques are widely seen as promising treatment alternatives for patients not responding to or tolerating psychotropic medication. In particular, transcranial direct current stimulation (tDCS) is of special interest due to its potential to be used by a large number of patients because of its comparably ease of usage and good tolerability. Thus, a large number of studies investigating clinical effects of tDCS have been performed with statistically significant effects but that are of moderate clinical relevance. Clinical studies have mainly focused on the prefrontal cortex (PFC) as the main stimulation target based on findings of numerous studies indicating the lateral PFC to be a key dysfunctional node within brain networks involved in the pathophysiology of depression.

Studies in clinical and healthy participants indicate that tDCS is capable of positively augmenting prefrontal functions that are relevant for a successful cognitive behavioral therapy. More specifically, it has been shown that tDCS is capable of improving reappraisal strategies as well as the use of cognitive control techniques .

To date, previous studies have mainly addressed global antidepressant effects of tDCS and not effects on more circumscribed phenotypes mediated by top-down PFC processes such as impaired or biased emotional learning processes. All these trials have applied the stimulation to patients while being in a resting position. Nonetheless, recent neuropsychological studies indicate that tDCS effects appear to be "activity dependent", meaning that the stimulation effects are greater when the brain region being stimulated is simultaneously engaged in a cognitive task. Therefore, in the present study we will apply tDCS to patients with unipolar major depressive disorder during cognitive behavioral therapy (CBT), a well-established and highly effective psychotherapeutic treatment for depression.

Eligibility Criteria:
Inclusion Criteria:

- unipolar major depressive disorder

Exclusion Criteria:

* neurological diseases or relevant psychiatric diseases other than major depressive disorder
* current medication other than SSRI or Mirtazapine
* manic episodes (lifetime)
* psychotic symptoms (lifetime)
* treatment with psychotherapy within the past 2 years
* treatment with electroconvulsive therapy (lifetime)