cyrilzakka/clinical-trials huggingface dataset:
A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization

The study is a first step in establishing the safety and efficacy of the CytaCoat technology when applied to a medical device such as a nasal prong and the clinical data generated will serve as a basis for continuous studies in clinically significant settings such as the neonatal care units.


Eligibility Criteria:
Inclusion Criteria:

1. Legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF).
2. Subject is between 18 and 65 years of age.
3. Subjects that have intact, wound free and scar free skin at the Nasal Prong target site.
4. Subject that have intact, irritation-free nasal mucus membrane.

Exclusion Criteria:

1. Pregnant or nursing women.
2. Subjects who are active smokers or using snuff.
3. Subjects currently suffering from a common cold, sinusitis, allergies or sleep apnea.
4. Subjects suffering from and/or subjects that have experienced nosebleed within 1 month prior to entering the study.
5. Subjects using and/or subjects that have used oral or topical antibiotics within 2 weeks prior to entering the study.
6. Subjects using and/or subjects that have used oral or topical anti-inflammatory drugs within 1 week prior to entering the study.
7. Subjects participating in any other clinical study.
8. Subjects diagnosed with any type of skin infection (bacterial, viral or fungal) or inflammatory skin disease including psoriasis, eczema or severe acne
9. Subjects diagnosed with any type disease affecting mucus membranes.
10. Subjects suffering from any other condition or symptoms preventing the subject from entering the study, according to the investigator´s judgment.
11. Subjects who have a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the Nasal Prong target site
12. Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment.
Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study

Complications due to infection after colorectal surgery are frequent, affecting up to 25% of patients. Infection increases mortality, lengthens hospital stays, increases costs and decreases long term survival for cancer patients. Perioperative inflammation leads to hypercatabolism, denutrition and immunosuppression, all of which are associated to postoperative infection. Data from various sources suggests that modulating perioperative inflammatory response through the injection of corticosteroids would benefit the patient by reducing the number of postoperative complications after major surgery. Pre- or perioperative intravenous administration of a single corticosteroid flash is a means of modulating systemic inflammation that has been suggested for numerous types of surgeries, including pancreatic surgery. The objective of this study is to assess whether a preoperative single corticosteroid flash (methylprednisolone: 20 mg/kg IV at anesthetic induction) reduces the risk of serious complications after elective colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient undergoing elective colorectal surgery (diverticulitis, malignant or benign tumor, inflammatory intestinal disease, re-establishing continuity, endometriosis, or other)
* Bowel continuity is restored immediately after surgery, with or without a protective stoma.
* Patient with proper understanding who has been informed about the study, and who has consented to being part of the study

Exclusion Criteria:

* Adult under guardianship
* Patient who is not covered under the national health system
* Women who are pregnant or breastfeeding
* Colorectal resection with concomitant hyperthermic intraperitoneal chemotherapy
* Patient under long term corticosteroid therapy
* Preoperative natremia \> 147 mmol/L
* Hypokalemia (\< 3,3 mmol/L)
* Patient with a contraindication to Methylprednisolone Mylan® :

  * Active infection
  * Active viral disease (namely hepatitis, herpes, varicella, shingles),
  * A psychotic condition that is not currently treated with medication,
  * Vaccination with a live vaccine or live attenuated within the last 3 months,
  * Hypersensitivity to methylprednisolone or to any of the excipients found in Methylprednisolone Mylan®
Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle

Changes of luteinizing hormone (LH), estrogen and progesterone during the menstrual cycle influence the ocular physiology in both anterior and posterior segments. From the literature review, there were no significant differentiation in tear physiology, anterior chamber dept, lens thickness and refractive status. Some studies demonstrated then the central corneal thickness was thinner in the follicular phase, but this is non-conclusive. Advance in ophthalmic technologies provide few studies of posterior segment changes during the menstrual cycle, however, there were quite difference in methodology such as detection methods of ovulation.

There were 2 studies of posterior segment changes during the menstrual cycle. Akar et al showed significant decrease of neuroretinal rim area and increase of cupt area in late luteal phase. Ulas et al found that choroidal thickness was significant thicker in mid-luteal phase. However, the study of retinal vascular density by optical coherence tomography angiography (OCTA) during the menstrual cycle has never been published before.

Eligibility Criteria:
Inclusion Criteria:

* Female with age 25-40 yr
* Normal body mass index (18.5-24.9)
* Regular menstrual cycle (28-32 days)
* Written informed consent

Exclusion Criteria:

* Pregnant women
* Lactating women
* Having childbirth or miscarriage within 6 months
* Systemic diseases which need taking the regular medication
* History of ocular disease such as glaucoma, retinal vascular diseases and macular disease
* History of hormonal taking such as oral contraceptive pills within 6 months
* History of intraocular laser and intraocular surgery
* Refractive error; spherical equivalent \>4 diopters
* Can not taking the images by Optovue® such as spine diseases

Withdrawal criteria

* Pregnancy detection during the study period
* Receiving sex hormone during the study period such as emergency contraceptive pills
Perfusion Index Predicts Post-spinal Hypotension in Obese Parturients for Cesarean Section

Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients.

The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient.

Abstract Background Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients.

The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient.

Methods After approval of ethical committee and written informed consent, fifty Parturients aged between 18- 40 years, ASA I and II with term singleton pregnancies with BMI between 25 \&40 admitted for cesarean section under spinal anesthesia were recruited in this prospective, observational study. The primary outcome is the correlation between baseline perfusion index and post spinal hypotension. The secondary outcome is the correlation between BMI and the incidence of hypotension after spinal anesthesia. Heart rate, blood pressure, perfusion index before and after spinal induction using Masimo device, level of sensory block, dose of ephedrine required to correct hypotension, dose of atropine required to correct bradycardia, incidence of nausea, vomiting and shivering were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Fifty parturient
* Aged between 18- 40,
* ASA I and II
* With term singleton pregnancies
* With 25 ≥ BMI≤ 40
* Conducted for cesarean section under spinal anesthesia

Exclusion Criteria:

* Emergency cases,
* Placenta previa,
* Preeclampsia,
* Cardiovascular and cerebrovascular diseases,
* Patient with contraindication for regional anesthesia
* Patient with peripheral vascular diseases as DVT.
Observational Prospective Turkish Inception Cohort of Uveitis and Spondyloarthritis

Spondyloarthritis (SpA) encompasses a group of inflammatory rheumatic diseases characterized by axial and/or peripheral arthritis, along with extra-articular manifestations such as enthesitis, dactylitis, uveitis, and skin lesions. Axial spondyloarthritis (axSpA), the hallmark of which is chronic sacroiliitis, can progress to vertebral fusion ("bamboo spine") in advanced cases. The prevalence of axSpA varies globally, ranging from 0.1% to 1.4%, with a higher incidence in men and a typical onset in the second or third decades of life. Diagnostic approaches include imaging techniques such as sacroiliac MRI and radiographs, alongside clinical criteria like inflammatory back pain, NSAID responsiveness, peripheral arthritis, and HLA-B27 positivity. Disease management primarily involves NSAIDs, with biologics used for refractory cases, and disease activity is monitored using indices such as BASDAI and ASDAS.

Acute anterior uveitis (AAU) is the most common extra-articular manifestation of SpA, particularly associated with HLA-B27 positivity. It often presents unilaterally with redness, pain, and photophobia but can lead to severe complications if inadequately treated. Around 50% of patients with HLA-B27-positive AAU have underlying SpA, and the prevalence of uveitis increases with longer disease duration. While the link between SpA and AAU is well-established, further research is needed to determine optimal systemic treatment and follow-up protocols. This study aims to assess the prevalence and clinical characteristics of SpA in patients presenting with AAU at ophthalmology clinics.


Eligibility Criteria:
Inclusion Criteria:

* patients with uveitis

Exclusion Criteria:

* patients diagnosed spondyloarthiritis before from the uveitis attack
* patients with infectious uveitis
Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.


Eligibility Criteria:
Inclusion criteria:

1. Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
2. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

Exclusion criteria:

1. Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
2. Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
3. Impaired renal function defined as glomerular filtration rate\<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
4. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
5. Pre-menopausal women (last menstruation \< or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
6. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
7. Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).
8. Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.
Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients

To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)


Eligibility Criteria:
Inclusion Criteria:

* Patient with Follicular Lymphoma (FL)
* Confirmed diagnosis of Follicular lymphoma
* 18 years or above
* Verbal and written information about the study

Exclusion Criteria:

* No previous treatment for Follicular Lymphoma
* Clinical suspicion that the Follicular Lymphoma has transformed to aggressive lymphoma
* Several diseases such as malignancies etc.
* Screening laboratory values
* Current participation in any other interventional clinical study
* Breast feeding women or pregnant women
* Women of childbearing potential not willing to use adequate contraception
Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy

The purpose of this study is to evaluate the safety and time to progression of HLA-A\*2402 or A\*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in patients with Neovascular Maculopathy, including Age Related Macular Degeneration

VEGF receptor 1 and 2 are essential targets to pathogenic angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated once a week for 12 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. In the study, our primary aim is to evaluate the safety and tolerability of these peptide vaccine. The second aim is evaluate the immunological and clinical response of this vaccine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Neovascular Maculopathy including Age Related Macular Degeneration.
* Resistant against PDT or Anti VEGF therapy or Patient disagree with these therapies.
* with HLA-A\*2402 or A\*0201

Exclusion Criteria:

* Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception) Breastfeeding Active or uncontrolled infection Unhealed external wound Concurrent treatment with steroids or immunosuppressing agent Uncontrolled brain and/or intraspinal lesion(s) Decision of unsuitableness by principal investigator or physician-in-charge
Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices: GALAXY Study

The GALAXY FIXATIONTM System and Orthofix implantable devices study intends to evaluate the clinical performance and safety profile of the study medical/investigational devices in the standard clinical practice. The study will be conducted in three sites located in Italy considered reference sites for the treatment of adults and paediatric patients with fractures of the long bones, vertically stable pelvic fractures, or vertically unstable pelvic fractures as a treatment adjunct, where the usage of GALAXY FIXATION™ System and Orthofix implantable devices were part of the normal clinical practice. The participant investigators will retrospectively include a maximum of 118 patients in which GALAXY FIXATIONTM System and Orthofix implantable devices were used. No diagnostic or therapeutic intervention outside routine clinical practice will be applied.


Eligibility Criteria:
Inclusion Criteria:

1. The patient directly or indirectly (through a respondent) expressed his willingness to participate in the Study by signing and dating informed consent.
2. Patient who had a regular indication for the following surgical intervention with the GALAXY FIXATION™ System and Orthofix implantable devices according to manufacturer's IFUs:

   * fractures of the long bones or;
   * Vertically stable pelvic fractures or vertically unstable pelvic fractures as a treatment adjunct.
3. Patients equal or older than 29 days.
4. Patients who had a regular indication for external fixation according to the investigator criteria.
5. Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study

Exclusion Criteria:

1. The patient is participating in other clinical studies or did he/she participate in the 3 months before signing the informed consent in other clinical studies.
2. The patient needed the application of or had already in-situ concomitant devices that couldn't be safely removed (except for permitted concomitant devices).
3. The patient was treated with more than one GALAXY FIXATION™ System or non Orthofix implantable devices.
4. Patient who had mental or physiological conditions who are unwilling or incapable of following postoperative care instructions.
5. Patient who had previous infections in the fracture area.
6. Patients who had malignancy in the fracture area.
7. Patients who had neuromuscular deficit or any other conditions that could influence the healing process.
8. Patients who had suspected or documented metal sensitivity reactions as it could result in a treatment failure in the intended population
A Study to Evaluate the Effectiveness of the Induced Reflex Cough Test Plus Urodynamics to Identify Stress Urinary Incontinence in Female Subjects With a History of Stress Urinary Incontinence

This study is to evaluate the effectiveness of identifying stress urinary incontinence (SUI) in female subjects using the Induced Reflex Cough Test (IRCT) administered with urodynamic testing by evaluation of sensitivity and specificity.


Eligibility Criteria:
Inclusion Criteria:

* Women \>25 years of age
* History of SUI (except for healthy controls)
* Healthy or stable medical problems (no change in 3 months)
* Willingness and ability to undergo all the study procedures
* Stable medications are allowed except for prescription and over-the-counter medications with anticholinergic or α-agonistic properties that can affect the bladder or urethra; these must be discontinued at least 2 weeks prior to evaluation
* Able to understand and sign the informed consent document.

Exclusion Criteria:

* Body mass index (BMI) \>40
* History of severe arthritis of the hips, knees, or feet that could limit mobility during the study
* Prior treatment of any kind (surgical or pharmacologic) for incontinence at least 30 days before the cough testing session including treatment with slings, botox, interstim and all bulking agents
* Prior pelvic radiation
* Post-void residual urine \>100 mL at screening
* Pelvic Organ Prolapse Quantification (POP-Q) stage \>2
* Positive urine culture at screening or dip stick for \>1+ leukocyte esterase on the day of the procedures
* Positive pregnancy test
* Evidence of infection with hepatitis or human immunodeficiency virus (HIV)
* Dementia
* Clinically significant changes on the electrocardiogram (ECG) in women \>50 years of age or in the clinical laboratory values as determined by the investigator
* History of urge symptoms, diagnosis of interstitial cystitis, irritable bowel disease (requiring medications)
* History of neurological deficit or injury that could affect laryngeal cough reflex, for example, central nervous system related conditions such as stroke or multiple sclerosis, head and neck cancer, major laryngeal surgery
* History of neurological disorders leading to bladder abnormalities including stroke, Parkinsonism, multiple sclerosis, spinal cord surgery or spinal cord injury
* Active hemorrhoids or history of recent (within 1 year) rectal surgery
* Previous major pelvic or abdominal surgery (within 6 months)
* Tobacco smokers and non-smokers who have \>15 pack-year history or frequent (\>2 times per week) marijuana smoking
* Active sexually transmitted disease or genital herpes outbreak or symptomatic pelvic inflammatory disease
* Pessary in place
Feasibility and Acceptability of an Educational Intervention to Improve the Management of Depression in Primary Care.

Qualitative study based on interviews and questionnaires with patients participating to an educational intervention to improve the management of depression in primary care.

Objective is to assess feasibility and acceptability of an educational intervention to improve the management of depression in primary care To elaborate an educational program for the management of depression in primary care.

To assess feasibility and acceptability of an educational intervention to improve the management of depression in primary care To elaborate an educational program for the management of depression in primary care.

And perspectives are to elaborate an educational intervention to care depression in primary care

Eligibility Criteria:
Inclusion Criteria:

* age between 18-65y
* moderate depression (CIM 10)
* first or second episode
* able to read and understand French language

Exclusion Criteria:

* psychotic symptoms
* severe depression
* bipolar disorder
* suicide risk
* substance abuse
Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension

Clinical improvement has been demonstrated after cardiorespiratory rehabilitation in patients with pulmonary hypertension. Rehabilitation is therefore now part of the recommendations for good practice. However, no data is available to elucidate the mechanism of this improvement: an improvement in myocardial reserve or an improvement in peripheral muscular capacity? The main objective of this study is to evaluate the difference in right ventricular contractile reserve before and after cardiorespiratory rehabilitation during stress ultrasound in pulmonary hypertension in 10 patients with pulmonary hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Major patients
* Proven pulmonary hypertension: PAPm ≥ 25mmHg, known PH
* Group 1,3,4 or 5 of the pulmonary hypertension classification
* Clinical stability \> 1 month clinically determined by clinician
* NYHA II or III class
* Signature of informed consent form following appropriate information
* Patient affiliated to the Social Security System

Exclusion Criteria:

* Associated left heart disease
* Complex congenital heart disease
* Acoustic window which does not allow the echocardiography to be performed correctly
* Permanent cardiac arrhythmia
* NYHA IV class and NYHA I class
* Inability to perform at least a minimal effort on an ergometer
* Unstabilized acute coronary syndrome
* Compensatory heart failure
* Disturbances of ventricular rhythm veins, may not be narrowed.
* Prevalence of high-risk embolic intracardiac thrombus
* Prevalence of high-risk embolic intracardiac thrombus
* Preference of a medium to high abundance peericard-like thinning.
* Venous thromboembolic venous thromboembolic disease (\> 3 months)
* Left ventricular ejector obstruction (severe and/or symptomatic)
* Persons under guardianship, under curatorship, protected by law
* Persons deprived of their liberty
* Pregnant and parturient women
* Major not able or unable to express consent
* Minors
* Inability to perform cardiac rehabilitation
* Modynamic instability
* Follow-up impossible for geographical or psychological reasons
* Inadequate command of the French language