cyrilzakka/clinical-trials huggingface dataset:
Renal Impairment Study

The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI): 18 to 34 kg/m² (both inclusive)
* Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels \>40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).
* Subjects with renal impairment:

eGFR \<90 mL/min/1.73 m\*2 determined from serum creatinine 2 -10 days prior to dosing.

Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit

- Healthy subjects eGFR ≥90 mL/min/1.73 m\*2 determined from serum creatinine 2 -10 days prior to dosing.

Needs to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).

Exclusion Criteria:

* Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)
* Relevant impairment in liver function.
* Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
* Any organ transplant \< 1 year before participation in this study.
* Subject under dialysis or planned to start dialysis during participation in the study.
* Failure of any other major organ system other than the kidney.
Comparison of Intermediate Cervical Plexus Block and Superficial Cervical Plexus Block

Central venous catheterization is a common procedure in hospitals. Internal jugular vein (IJV) cannulation is the most preferred vein for this purpose. During the procedure, infiltration of local anesthetic (LA) agents into the skin and subcutaneous tissues is a commonly used method to provide patient comfort and reduce pain. There is an increasing need to improve the quality of health care delivery. An important component of health service quality is patient satisfaction. The aim of this study is to compare the superficial cervical plexus block and the intermediate cervical plexus block applied under the guidance of ultrasound in terms of patient satisfaction and procedural comfort during central catheterization of the internal jugular vein.

This prospective randomized study will be performed on patients undergoing central venous catheterization into the internal jugular vein. Patients who agreed to participate in the study will be divided into two groups using the closed-envelope randomization method; Group S: Superficial cervical plexus block group Group I: Intermediate cervical plexus group

After routine monitoring and RAMSEY 2 level sedation is achieved, a superficial or intermediate cervical plexus block will be applied according to randomization by a researcher experienced in a peripheral block. Patient pain level (to be evaluated with the Numeric Pain Rating Scale) during the block and catheterization procedure (first needle insertion, dilatation, catheter placement, and suture phase). Thirty minutes after the procedure, patient satisfaction will be evaluated with a Likert-type scale.

Eligibility Criteria:
Inclusion Criteria:

* Adult volunteer patients who require central catheterization into the internal jugular vein for any reason
* Patients with mental and health status who can understand the research questions.
* Patients who read the informed consent form and gave a signed declaration of acceptance

Exclusion Criteria:

* Patients with psychiatric disorders
* Patients who are in poor general condition and require urgent intervention
* Patients who cannot answer the survey questions
* Patients followed as intubated
* Patients with hypersensitivity to the local anesthetic agents to be used in the study or to the substances contained in it.
* Patients with contraindications for cervical plexus block application
* Patients who are unwilling to participate in the study for any reason
Observational Study of the Management of Infants With Congenital CMV

This is an observational, prospective/retrospective multicentre, cohort study of children diagnosed with cCMV. This study will contribute to a wider study also recruiting participants in Europe and other countries worldwide. No investigations or treatment will be carried out that are not part of routine clinical practice. Infants with cCMV are routinely followed up from an infectious diseases, audiology, ophthalmology and neurodevelopmental perspective until approximately 6 years of age, or longer if there are ongoing issues. Some children will be retrospectively diagnosed with cCMV in later childhood. Recruitment can be from any centre that manages these patients and has agreed to participate in the study.

Cytomegalovirus (CMV) is the most frequent cause of congenital infection worldwide, occurring in 0.2-2% of live births. It is also the most frequent cause of non-genetic hearing loss, and an important cause of neurodevelopmental delay. Clinical diagnosis of maternal infection during pregnancy is unreliable in most patients and laboratory diagnosis can be challenging, especially in non-primary infections. Screening of congenital CMV infection (cCMV) in newborns is not recommended in most countries and only targeted screening is performed in some cases (children who fail hearing screening or with abnormalities compatible with cCMV in physical exams).

The main focus of the study is to identify patient and treatment characteristics that are associated with outcome. This will allow improved patient care in the future.

Eligibility Criteria:
Inclusion Criteria: Patients of either sex that have been diagnosed with cCMV infection:

* Through confirmed detection of CMV in urine or saliva, by CMV-DNA PCR (or viral culture / Shell-vial) and/or CMV detection in blood or CSF by PCR within the first 21 days of life.
* Children with cCMV retrospectively diagnosis by positive CMV-DNA PCR in dried blood spots (DBS), collected within 21 days of life.
* Diagnosed by positive CMV-DNA PCR in dried umbilical cord blood or donated/stored umbilical cord blood sample
* Children whose parents give their informed consent to participate in the study
* Age less than 11 years old

Exclusion Criteria:

* Refusal to sign written informed consent of parents/ legal guardian.
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker

The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.

The purpose of this study is to assess the performance of Sleep Disordered Breathing Monitoring function (SDB) in pacemakers by comparing device diagnostic data to the results of in-lab PolySomnoGraphy (PSG) recording during the same night

Eligibility Criteria:
Inclusion Criteria: Any patient enrolled in the study must fulfil all of the following criteria:

* Patients eligible for implantation of a single or dual-chamber pacemaker according to current available guidelines
* Patients who are scheduled for implant of a REPLY 200 SR; or REPLY 200 DR pacemaker
* Patients who provide signed and dated informed consent

Exclusion Criteria:

* Inability to understand the purpose of the study or refusal to co-operate
* Unavailability for scheduled follow-ups at the implanting centre
* Already included in another clinical study that could affect the results of this study
* Inability or refusal to provide informed consent
* Patient is minor (less than 18-years old)
* Patient is pregnant (women of childbearing potential should have a negative pregnancy test prior to enrolment)
* Patient is forfeiture of freedom or under guardianship
Intravenous Administration of Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery

The aim of the study is to compare the effectiviness of biatrial pacing versus intravenous administration of metoprolol in the prevention of atrial fibrillation after cardiac surgery


Eligibility Criteria:
Inclusion Criteria:

* elective CABG and aortic valve cardiac patients,
* previous use of beta blocker

Exclusion Criteria:

* Previous episodes of Atrial fibrillation or flutter,
* II or II degree atrioventricular block, uncontrolled heart failure
* Sick sinus syndrome
Quantification and Characterization of Circulating Epithelial and Endothelial Cells in Gougerot-Sjögren Syndrome, Compared to Systemic Sclerosis

Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities, whose physiopathology remains largely unknown. Quantification and characterization of epithelial and endothelial circulants in Gougerot-Sjögren's syndrome could reflect the intensity of the epithelial aggression, and thus possibly constitute a biomarker.

Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities.

The criteria for classification of the disease include dry syndrome, positive salivary gland biopsy and detection of anti-Sjögren's-syndrome-related antigen A (anti-SSA) and anti-Sjögren's-syndrome-related antigen B (anti-SSB) antibodies. The presence of antibodies is thus important for the diagnosis but not essential, because in some patients the salivary gland biopsy is positive and the antibodies are absent. Therefore, the identification of new biomarkers could be very useful to confirm the diagnosis of primary Gougerot-Sjögren's syndrome and to identify subgroups of patients.

The pathophysiology of the disease remains largely unknown. Currently, primary Gougerot-Sjögren's syndrome is thought to originate from inflammation of the epithelial tissue of the salivary glands. However, it is currently unknown whether this autoimmune epithelitis is accompanied by a contingent of circulating epithelial cells, the characterization of which might be accessible by liquid biopsy.

So far, the circulating epithelial cells that have been identified have been identified in the context of cancer: in this case they are called circulating tumor cells. Their detection during primary Gougerot-Sjögren's syndrome could reflect the intensity of epithelial aggression, and thus possibly constitute a biomarker.

In other connectivities, data on circulating cells have already been published. In systemic scleroderma, another connectivitis affecting mainly middle-aged women, circulating progenitor cells have already been detected and are thought to have the capacity to differentiate into endothelial cells, thus playing a potentially important role in the pathophysiology of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Female patients over the age of 18
* Written and signed consent by the participant and the investigator
* Affiliated person or beneficiary of the social security system
* Test group: patients with Gougerot-Sjögren's syndrome connectivitis meeting the ACR/EULAR classification criteria
* Positive control group: patients with diffuse systemic scleroderma connectivitis meeting ACR/EULAR classification criteria

Exclusion Criteria:

* Association of the two diseases in the same patient
* Progressive cancer
* Subject protected by law, under guardianship or curatorship
* Inability to give free and informed consent to participate in the study
* Withdrawal of consent
Calprotectine in Spondyloarthritis

To date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. A growing interest in this biomarker is emerging in rheumatology, several publications have focused on its interest in rheumatoid arthritis, highlighting an association between serum calprotectin levels and disease activity. In spondyloarthritis, a few studies seem to show that it could be a marker of disease activity. Although a 2012 study found no difference in serum calprotectin levels between subjects with spondyloarthritis and controls. Still others have shown that it could be a predictive factor of radiological evolution in the same disease key. These data support, despite the questionable results of the Klingberg study, the value of this dosage in spondyloarthritis. The objective of this work is to show that this assay could be useful to differentiate spondyloarthritis from other pathologies with similar clinical presentation such as fibromyalgia. Difficulties classically encountered in common practice in rheumatology


Eligibility Criteria:
Inclusion Criteria:

Patients in the active line of the rheumatology department with one of the following criteria:

active spondyloarthritis (BASDAI \>4), or spondyloarthritis in low activity (BASDAI\<4), or fibromyalgia without associated inflammatory rheumatism, or healthy subjects (without inflammatory rheumatism and without fibromyalgia. Patients who have not objected to the use of their samples

Exclusion Criteria:

Minor patient Subject not affiliated to the social security system Subject deprived of liberty Patient under guardianship or curatorship
Structural Imaging Assisted Retinal Fluorescence Lifetime Imager (STARFLI)

To investigate the feasibility of a combined OCT/FLIM device

To investigate the feasibility of a combined Optical coherence tomography/ Fluorescence Lifetime Measurement (OCT/FLIM) device.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be willing to give written informed consent
* Age: Patients and Probands 18 years or greater
* Both eyes will be assessed in the study

Exclusion Criteria:

* Patients not willing or able to sign informed consent
* Patients younger than 18 years
* Patients with epilepsy
Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis

Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis


Eligibility Criteria:
Inclusion Criteria:

* Patients with remitting multiple sclerosis according to mac Donald criteria
* aggressive remitting multiple sclerosis according to following criteria:
* 2 or less disabling relapse during the 12 months before inclusion
* 1 or more
* EDSS between 2 and 5
* aged less or equal to 40 years old for the women
* effective contraception

Exclusion Criteria:

* patients less than 18 years old
A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients

This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) in First-Line ALK (Anaplastic Lymphoma Kinase) Positive East Asian Non-Small Cell Lung Cancer Patients. The objective of the study is to demonstrate that Crizotinib is superior to first-line chemotherapy pemetrexed/cisplatin or pemetrexed/carboplatin in prolonging Progression Free Survival (PFS) in East Asian patients with advanced Non-Squamous NSCLC whose tumors harbor a translocation or inversion event involving the ALK (Anaplastic Lymphoma Kinase) gene locus.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung.
* Positive for translocation or inversion events involving the ALK gene locus.
* No prior systemic treatment for locally advanced or metastatic disease. Patients with brain metastases only if treated and neurologically stable for at least 2 weeks and are not taking any medications contraindicated in Exclusion Criteria
* Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome \[PRO\] measures.

Exclusion Criteria:

* Current treatment on another therapeutic clinical trial.
* Prior therapy directly targeting ALK.
* Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. Appropriate treatment with anticoagulants is permitted.
* Ongoing cardiac dysrhythmias of NCI CTCAE Grade \>=2, uncontrolled atrial fibrillation of any grade, or QTc interval \>470 msec.
* Pregnancy or breastfeeding.
* Use of drugs or foods that are known potent CYP3A inducers/inhibitors Concurrent use of drugs that are CYP3A substrates with narrow therapeutic indices.
* Known HIV infection
* History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.
* Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or end-stage renal disease on hemodialysis, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.
the Impact of COVID-19 Pandemic on the Incidence and Outcome of Complicated Appendicitis

During the COVID-19 pandemic, we noticed a rise in complicated appendicitis cases presenting to our medical center. We collected objective data on all patients admitted to the surgical department with appendicitis during February 2020 - March 2020 compared to the same 2 month period in 2019, to understand the pandemic's affect on the rate of complications of acute appendicitis.

Coronavirus pandemic (COVID-19) first broke out in Wuhan and Hubei China during december 2019. On 30 January, WHO declared it a Public Health Emergency of International Concern (PHEIC) .

Currently, the number of cases worldwide stands stands at more than 76 million confirmed cases according to the World Health Organization (WHO) records. First documented case in Israel was reported on 21st of february 2020.

During the months of February and April, due to continued rise in confirmed cases, rigid "stay at home" restrictions were issued. These restrictions have had a significant effect on daily life. Under these new "stay at home" policies, many aspects of everyday life were greatly diminished and restricted under threat of heavy fines. This effect also extends to reduction in healthcare seeking. decline in emergency department (ED) visits was reported. A drop in routine cancer screening appointments was reported.

Delayed healthcare seeking also had an affect on the severity of various medical conditions on presentation. fear of the COVID-19 pandemic may have resulted in delayed diagnosis, and therefore higher complication rates in common medical conditions.

acute appendicitis (AA) is among the most common causes of lower abdominal pain leading patients to attend the emergency department. As such, AA could serve as a good indicator for the possible effect that the fear of the COVID-19 pandemic had on patients tendency for late diagnosis and complication rate.

Gomes Laparoscopic Grading System of AA, classifies appendicitis into five laparoscopic grades according to gross morphologic findings during surgical laparoscopy. grades 1 and 2 regarded as non-complicated appendicitis, while grades 3, 4 and 5 regarded as complicated appendicitis.

Following the restrictions imposed during the COVID-19 pandemic, we noticed a rise in complicated appendicitis cases presenting to our medical center. We collected objective data on all patients admitted to the surgical department with appendicitis during February 2020 - March 2020 compared to the same 2 month period in 2019. Data such as the time period from onset of symptoms to presenting to the ED, inflammatory markers, complicated appendicitis (if any), type of complication, post operative complications. We aim to assess whether the "stay at home" restrictions had any adverse effects on severity or outcomes of AA.

Eligibility Criteria:
Inclusion Criteria:

* appendicitis

Exclusion Criteria:

* any other diagnosis
Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer

To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of undertaking prostate biopsy as part of their clinical management.

To assess patient's experience and complications of the CAMPROBE and compare the results with known published outcomes from standard transrectal biopsies .

To use data from the pilot study to determine the feasibility of a randomised trial comparing CAMPROBE with the current standard method of prostate biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Fit and well enough to undergo a repeat prostate biopsy
* Men who have previously had a transrectal ultrasound biopsy of the prostate and due to have a repeat biopsy as part of normal care
* Men on active surveillance
* Men on PSA monitoring

Exclusion Criteria:

* Contraindication for a repeat prostate biopsy
* Contraindication for a transperineal prostate biopsies
* Previous perineal or anal surgery
* MRI suggesting anterior lesion or extra capsular disease
* MRI suggesting lesion that needs fusion image targeting
* Unable to lie down and with legs in a stirrup for at least 45 minutes