cyrilzakka/clinical-trials huggingface dataset:
Study of the Impact of a Targeted Decolonization of S. Aureus Persistent Carriers

S. aureus nasal carriage is a well-known risk factor for S. aureus infections in hemodialysis (HD) patients. Strains of carriage and infections are the same in \>80% of cases We recently shown that persistent carriers of S. aureus, not intermittent ones are at increased risk of staphylococcal infections in HD. Thanks to a new algorithm developped based on one nasal sample the determination of carriage status (persistent, intermittent or non-carriers) among patients is easy. Mupirocin use in HD have been shown to reduce significantly S. aureus infections however, multiples schedules of decolonization have been proposed to all S. aureus carriers. To date, there is no national guideline for decolonization of S. aureus in HD. We showed that only 50% of HD centers in France propose screening and decolonization of S. aureus carriers. The aim of the study is therefore to evaluate the impact of a targeted decolonization of S. aureus persistent carriers using mupirocin nasal ointment and chlorhexidine baths during 5 days on the occurrence of S. aureus infections in HD patients compared to the absence of decolonization using a randomized open study methodology.

Hemodialysis patients will be randomized in 2 arms: one arm where persistent carriers will be decolonized. Decolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days. Screening of persistent carriers in this arm will be done every 3 months and a new decolonization will be proposed to patients found (again) persistent carriers. Determination of carriage status will be done using one nasal swab by following the algorithm previously described. Bacterial load will be determined by a quantitative S. aureus PCR (Polymerase Chain Reaction) : persistent carriers are the patient with a bacterial load \> 103 CFU/mL (Colony Forming Unit) .

The other arm is HD patients in which decolonization is not performed including impersistent carriers.

All infections that occurred in enrolled patients will be counted in both groups

Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥ 18 years-old)
* Patient under chronic hemodialysis
* Patent that accepted to participate in the study with a written consent form signed

Exclusion Criteria:

* Patients under peritoneal dialysis
* Patients with an active infection at the time of inclusion
* Patients previously treated by mupirocin and chlorhexidine for decolonization purpose
* Patients that received antimicrobials active on S. aureus during the month before the inclusion
* Patients with allergy to mupirocin or chlorhexidine
* Patients treated by hemodialysis transiently (non-terminal kidney failure)
* Pregnancy
PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY

This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).


Eligibility Criteria:
Inclusion Criteria:

* Women 18 years of age or older with histologically or cytologically proven locally advanced or metastatic breast cancer, not amenable to resection or radiation therapy with curative intent
* Documented diagnosis of HR+/HER2- breast cancer
* Any menopausal status
* Previously untreated with any endocrine therapy for their HR+/HER2- advanced breast cancer; or progressed while on or within 3 month from prior endocrine therapy other than tamoxifen for advanced breast cancer. If patients have adjuvant endocrine therapy, they must satisfy as follows: progressed 12 months or more since prior adjuvant endocrine therapy with tamoxifen; or progressed during or after adjuvant endocrine therapy with an aromatase inhibitor.
* Measurable disease or non-measurable disease as defined by RECIST ver.1.1
* Eastern Cooperative Oncology Group (ECOG) PS 0-1
* Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures

Exclusion Criteria:

* Prior treatment with any CDK inhibitor, tamoxifen, everolimus, or agent that inhibits the PI3K-mTOR pathway
* Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
* Use of strong or moderate CYP3A4 and/or CYP2D6 inhibitors or inducers
* Major surgery or any anti-cancer therapy within 2 weeks of randomization
* Prior stem cell or bone marrow transplantation
Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting

The frequency of neurological and psychiatric complaints for participants taking rilpivirine, elvitegravir, or dolutegravir reaches on average 20-30% during clinical trials. The inclusion and exclusion criteria for enrolling people living with HIV are at times so selective and the subsequent descriptions of minor or severe adverse events (AE's) so often imprecise and ambiguous that one cannot extrapolate these particular research results to practicing medicine. These adverse events negatively affect the patient's quality of life and ultimately his or her good adherence to treatments.

This study aims at assessing the prevalence and at describing the neurological and psychiatric adverse events related to these drugs.


Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* age \> 18
* treatment with rilpivirine, elvitegravir, or dolutegravir (for exposed patients)
* treatment with none of these drugs (for non exposed patients)
* capacity of reading French language

Exclusion Criteria:

* drugs addiction (except for amyl nitriles ("poppers") and cannabis)
* alcoholism
* co-infection with hepatitis C virus
* pregnant or breast feeding patient
New Families- Innovation and Development of the Child Health Services in Oslo

The New Families (NF) program will improve quality of existing services, secure personalised service and early intervention in Child Health Service (CHS) in Oslo. The study will measure the effects of a primary prevention family-centered healthcare intervention in Norwegian CHS.

The New Families (NF) program will improve quality of existing services, secure personalised service and early intervention in Child Health Service (CHS) in Oslo. The study will: 1) Measure the effects of a primary prevention family-centered healthcare intervention in Norwegian CHS, 2) Create case studies from CHS praxis advancing Public Health Nurse (PHN) training and education in Oslo and Norway, 3) Establish a model for how to include users in service development in CHS, 4) Enhance the knowledge base of the PHN practice in CHS Anticipated results: The project will bolster the knowledge base for education and professional practices within the service by strengthen the existing research within the field. The anticipated results of the project are that the intervention will increase maternal and parental self-efficacy, reduce the risk of postpartum depression among first-time mothers, reduce parental stress, increase social support, improve maternal attachment, improve generic health status, improve partner relationship and improve child development compared with usual care. The intervention research in this project can be a future model for service improvement in the CHS.

Eligibility Criteria:
Inclusion Criteria:

* First time parents living in the chosen districts

Exclusion Criteria:

* All other parents
Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Recently Diagnosed

Polymyalgia rheumatica (PMR) is prevalent among elderly. Untreated, it leads to major reduction in quality of life. Glucocorticoids are the cornerstone of treatment, but have drawbacks, warranting glucocorticoid sparing treatment. A proof of concept study on Rituximab (RTX) vs placebo showed efficacy in 48 vs 21%(p=0.049) in glucocorticoid free remission after 21 weeks (Marsman et al. 2021). Though promising, the short study duration and small sample size require further confirmation. Therefore a larger randomised controlled trial with longer follow up will be performed on RTX efficacy on glucocorticoid free remission in newly diagnosed PMR patients during glucocorticoid taper.


Eligibility Criteria:
Inclusion Criteria:

* Polymyalgia rheumatica diagnosis fulfilling the 2012 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria
* Diagnoses less than 12 weeks ago
* Glucocorticoid treatment less than 8 weeks and with dose equivalent of prednisolone ≤ 30 mg/day
* Informed consent

Exclusion Criteria:

* treatment with systemic immunosuppressants (other than glucocorticoids) 3 months prior to inclusion;
* (clinical) suspect concomitant giant cell arteritis or other rheumatic inflammatory diseases;
* concomitant conditions that might significantly interfere with PMR pain or movement evaluation as judged by the investigator;
* previous hypersensitivity for RTX or contra-indications to RTX.
Pulmonary Inflammation in COVID-19 ARDS

Patients older than 18 years of age, with COVID-19 related ARDS (C-ARDS) hospitalized in the ICU and invasively mechanically ventilated will be included in the study.

This is an observational cohort study. After informed consent by the next of kin, and within the first 72 hours of invasive mechanical ventilation a blood and a Broncho Alveolar Lavage Fluid (BALF) sample will be collected. If the patients remain invasively mechanically ventilated a second and third blood and BALF sample will be collected every 7-10 days.

The main objective of the core study is to measure a number of biochemical, cellular and inflammatory mediators in the BALF of C-ARDS patients and evaluate their correlation with the course of disease in terms of respiratory mechanics, complications and outcomes.

The mediators selected have been previously used in ARDS investigation to attempt prognostic and predictive enrichment.

Patients hospitalized in the ICU following C-ARDS and requiring invasive mechanical ventilation will be candidates for enrollment.

Patients enrolled in the study (Informed consent obtained from next of kin) will be subject to the realization of optic bronchoscopy within the first 72 h of mechanical ventilation to obtain BALF for analysis. A second and third bronchoscopy and sampling of BALF will be performed every 7-10 days if mechanical ventilation and the clinical conditions allow it. A sample of whole blood will be taken contemporary to each bronchoscopy in order to perform parallel measurements (lungs and peripheral blood). Patients will be followed up until hospital discharge.

BALF samples will be divided to perform different analysis in the immunology, cytology and microbiology labs.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* COVID-19 related ARDS
* Hospitalized in ICU
* Invasive mechanical ventilation

Exclusion Criteria:

* Immunocompromised for previous condition
* transplanted patients
* Known pulmonary bacterial co-infection at the time of admission to the ICU
* Contraindication to the realization of Bronchoscopy (Itracranial Hypertension, severe hypoxaemia with P/F \< 80, severe hemodynamic instability, severe arrhythmia, non correctable coagulopathy)
Post-contracture Release Radiation for Dupuytren's Disease

To determine if the clinical impression of clinicians, ie that patients are improving with the current treatment pathway for Dupuytren's (contracture release followed by radiation), can be substantiated with scientific evidence.

This is an observational, pilot study. Participants will be treated according to a standard treatment pathway, which includes contracture release treatment modalities such as limited fasciectomy, PNA and CCH injection, followed by post-operative radiation. All enrolled participants will undergo radiation treatment as soon as possible following contracture release. Radiotherapy will consist of 5 daily treatments of 300 cGy delivered to the palmar area followed by a 6-8 weeks break then a second 5 day course of radiation at 300 cGy, for a total of 3000 cGy in 10 total fractions. This dosing schedule is commonly used in the published literature. The data to be collected about participants, is their Southampton Dupuytren's score, history and clinical symptoms and photographs of their hand. This information will be obtained at baseline (pre-surgical intervention), at radiation treatment planning, approximately 6 weeks after completion of all radiation and at 1 and 2 years following completion of radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnoses of Dupuytren's disease
* English-speaking

Exclusion Criteria:

- Patients with Dupuytren's disease who are not currently seeking treatment
Clinical Study to Investigate the Efficacy and Safety of SJP002 Ophthalmic Solution in Patients With Dry Eye Syndrome.

This study is to evaluate the efficacy and safety of SJP002 ophthalmic solution compared to placebo in patients with Dry Eye Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age over 19.
* Must meet all criteria listed below at least in one eye.

  1. Fluorescein corneal staining score ≥ 2
  2. Schirmer test ≤ 10mm in 5 mins
  3. Tear break-up time ≤ 10 secs

Exclusion Criteria:

* Ocular disorder that may confound interpretation of study results.
* Wearing contact lenses 72 hrs prior to screening visit and unwilling to avoid wearing contact lenses for the duration of the study period.
* History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to screening visit, and/or any other intraocular surgery within 90 days prior to screening visit.
* Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test.
* Participation in other studies within 30 days of screening visit.
Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus

This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus


Eligibility Criteria:
Inclusion Criteria:

* patients eligible for a treatment by everolimus in association with the exemestane
* Performance status of 0,1 or 2 according to the WHO
* Patients affected of a breast cancer advanced and\\or metastatic HER2 negative expressing the hormonal receptor RH +
* menopausal Patients

Exclusion Criteria:

* Psychiatric disease compromising the understanding of the information or the realization of the study
* Vulnerable people according to the law (minors, adults under protection, private persons of freedom)
* Histories of cancer in 5 years preceding the diagnosis (except breast cancer, squamous-cell)
* Not menopausal women
* Unaffiliated people to the Social Security
* People being for the period of exclusion from another study
* Hypersensitivity in the active substance, in the other by-products of the rapamycin or in one of the excipients.
* Symptomatic visceral achievement
* Legal incapacity or limited legal capacity
BAX 326 Surgery Study in Hemophilia B Patients

The purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in subjects with severe (FIX level \< 1%) or moderately severe (FIX level 1-2%) hemophilia B undergoing major or minor elective or emergency surgical, dental or other invasive procedures.


Eligibility Criteria:
Main Inclusion Criteria:

* Participant and/or legal representative has/have voluntarily provided signed informed consent.
* Participant has severe (FIX level \< 1%) or moderately severe (FIX level 1-2%) hemophilia B (based on the one stage activated partial thromboplastin time (aPTT) assay), as tested at screening at the central laboratory.
* Participant requires surgery
* Participant has previously been treated with plasma-derived and/or recombinant FIX concentrate(s) for a minimum of 150 exposure days
* Participant has no evidence of a history of FIX inhibitors
* Participant is immunocompetent as evidenced by a CD4 count ≥ 200 cells/mm3.
* Participant is human immunodeficiency (HIV) negative or is HIV+ with a viral load \< 200 particles/μL \~ \< 400,000 copies/mL.

Main Exclusion Criteria:

* Participant has a history of FIX inhibitors with a titer ≥ 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening.
* Participant has a detectable FIX inhibitor at screening, with a titer ≥0.6 Bethesda Units (BU) as determined by the Nijmegen modification of the Bethesda assay in the central laboratory.
* Participant has a history of allergic reaction or evidence of an ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
* Known hypersensitivity to hamster proteins or recombinant furin.
* Evidence of an ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
* Abnormal renal function
* Severe chronic liver disease
* Active hepatic disease with ALT or AST levels \> 5 times the upper limit of normal.
* Diagnosis of an iherited or acquired hemostatic defect other than hemophilia B.
* Platelet count \< 100,000/mL.
Prognostic Value of Cardiovascular Risk of sST2 and Troponin I-hs in Patients With Acute Chest Pain

The role of the sST2 biomarker has been widely explored in heart failure, so much so that it was included in the AHA guidelines in 2013 and 2017. Recently, several studies are proposing a role of sST2 in the prognostic stratification of patients with Acute Coronary Syndrome and ischemic heart disease, in association with other biomarkers even proposing a possible therapeutic differentiation. The combined use of sST2 with high-sensitivity troponins could be a promising strategy to identify those patients who, despite having early rule-out after evaluation at the Emergency Department, have a higher risk of onset of cardiovascular events in the medium-long term.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Chest pain of presumable cardiac origin and uncertain etiological diagnosis
* ECG not diagnostic for ischemia
* troponin values within normal ranges

Exclusion Criteria:

* STEMI myocardial infarction
* Sepsis and viral infections
* Patients with ECG abnormalities that make it uninterpretable for ischemic purposes
* Patients with previous coronary events
* History of heart failure
* Known diagnosis of cardiovascular disease, acute or chronic, including pericarditis, myocarditis
* Conditions involving sST2 elevations unrelated to cardiac causes, particularly acute/chronic inflammatory or fibrotic conditions (inflammatory bowel disease, malignancy, moderate to severe pulmonary fibrosis, chronic liver disease; autoimmune disorders)
First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation

This is a phase 1 safety study performed in male or female adult participants with an established diagnosis of severe to profound sensorineural hearing loss that meets the criteria for cochlear implantation and the participant has already chosen to undergo cochlear implant surgery.

Approximately 12 participants will be enrolled in the study. Assessed will be safety and tolerability of FX-322 administered by intratympanic injection. Also assessed will be the FX-322 concentration in cochlear fluid (perilymph), the pharmacokinetic (PK) profile of FX-322 to determine the systemic exposure to FX-322.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult subjects with an established diagnosis of severe to profound sensorineural hearing loss audiometric threshold of 80 dB HL or poorer at 500 Hz that meets the criteria for cochlear implantation and the subject has already chosen to undergo cochlear implant surgery.
2. Willingness and ability to comply with scheduled visits, ear examination, drug administration plan, auditory and laboratory tests, study restrictions, and all study procedures.

Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

1. Persistent perforation of tympanic membrane or other tympanic membrane disorder that would interfere with the delivery and safety assessment of an intra -tympanic medication or reasonably be suspected to affect tympanic membrane healing after injection.
2. Any conductive component defined as air-bone gaps \>10 dB at two or more frequencies.

Other protocol-defined exclusion criteria may apply
Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation

This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.

Propofol is a short-acting, intravenously administered anesthetic. It has become a popular choice for procedural sedation in both children and adults. Despite its many advantages, Propofol is associated with a burning sensation during injection. Propofol pain begins within the first few seconds after administration and often lasts approximately 10-20 seconds until the patient is asleep. Lidocaine is often used in an attempt to reduce Propofol injection pain, but neither its delivery mode nor concentration has been standardized.

The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.

This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the FLACC scale.

Eligibility Criteria:
Inclusion Criteria:

* age 2 months to 17 years
* patient already scheduled for procedural sedation with propofol
* sedation procedure to be performed by a sedationist from Children's Respiratory and Critical Care Specialists

Exclusion Criteria:

* patients who are not receiving deep sedation with propofol
* patients with allergy or other contraindication to lidocaine administration
* patients with central venous catheters as propofol does not burn when given centrally
* patients being premedicated with an analgesic other than nitrous oxide or 1% lidocaine
* patients weighing less than 5 kg to prevent any risk of inadvertent lidocaine overdose.
The Link Between the Clinical Resting Heart Rate and Sympathetic Overactivation

It is a retrospective study with no products limitation to investigate the link between clinical resting HR and SOA. Use HR≤60bpm as control group, compare other three groups with the control group and find out the correlation between HR and SOA indexes.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of subject informed written or oral consent
2. Female and male aged≥ 20 to ≤ 80 years;
3. Records on mean clinical heart rate and SOA indexes were available.

Exclusion Criteria:

1. Participation in another clinical study with an investigational product during the last 6 months;
2. Drug intervention on heart rate 1 month prior to the inclusion;
3. Patients with missing data in the database from the Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai.