cyrilzakka/clinical-trials huggingface dataset:
NLR and PRL in Neurocognitive Disorders

Preliminary evidence suggest a possible relationship between Neutrophil-Lymphocyte Ratio (NLR) and Platelet-Lymphocyte Ratio (PLR) and perioperative neurocognitive disorders (NCD). We are going to investigate whether the values of NLR and PLR in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.

It is estimated that approximately 10% of elderly undergoing surgery will develop cognitive changes perioperatively, while in some reports the incidence rises up to 80%. Despite the reported high prevalence of perioperative neurocognitive disorders (NCD), their exact etiology is still largely unknown.

Preliminary evidence suggest a possible relationship between Neutrophil-Lymphocyte Ratio (NLR) and Platelet-Lymphocyte Ratio (PLR) and perioperative neurocognitive disorders (NCD). We are going to investigate whether the values of NLR and PLR in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.

Eligibility Criteria:
Inclusion Criteria:

* 45 - 80 years
* American Society of Anesthesiologists physical status I to III
* elective general, urological, gynecological and orthopedic surgery under general anesthesia
* native speakers of the Greek language

Exclusion Criteria:

* refused to participate or sign the informed consent form
* had undergone surgery or anesthesia within the last 30 days
* had any prior or current history involving an affliction of the central nervous system
* were diagnosed with severe cognitive decline based on the 16 - item Informant Questionnaire on Cognitive Decline (IQCODE - 16)
* suffered from severe hearing or visual impairment
* any psychiatric disorder
* had a score \>5 in the Geriatric Depression Scale (GDS - 15)
* or a score in females \< 4 males \< 2 in the Lawton - Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
* reported alcohol consumption \> 35 units/week
* drug dependence
* had undergone previous neuropsychological testing
* Diabetes Mellitus type II with \> 10 years of diagnosis
* Diabetes Mellitus type I
* Hemoglobin A1c (HbA1c) \> 7.5%
* suffered from hemodynamical instability (\> 20% alterations of blood pressure perioperatively)
* or desaturation (one or more events of SpO2 \< 80% for more than 2 minutes) peri-operatively
* or blood loss of more than one unit
Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first Exemestane (Aromasin) should be registered.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with postmenopausal breast cancer (including ovariectomy etc.).

Exclusion Criteria:

* Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).
An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.

This is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. Participants will be requested to complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at different time points along the clinical trials pathway.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older
* Able to provide informed consent
* Are being considered for an early phase clinical trial

Exclusion Criteria:

* Patients unable to comprehend English language
Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome

This is a null hypothesis study. The investigators hypothesize that there will be no difference in changes in dynamic compliance when measured at 15, 30, 45 and 60 minute intervals after administration of either surfactant and there will be no differences in the number of doses needed between the two surfactants in premature infants admitted to our NICU.

Premature newborn infants may have impaired lung function as a result of their prematurity. When this occurs, the newborns show poor oxygen and carbon dioxide exchange and difficulty in breathing. The reason for these symptoms is due in part to the lack of special chemicals in the lungs, called phospholipids or surfactant. The lack of these special chemicals causes the babies lung to be difficult to ventilate. Treatment of this condition can require placing an artificial airway (endotracheal tube) into the babies windpipe (intubation) and use of a breathing machine (ventilator). In addition, physicians frequently give these special chemicals (phospholipid) through the childs airway. There are several different types of phospholipids available for this treatment in newborns but very limited amount of studies have been done to examine differences in the ability to ventilate between the various types of surfactant. The investigators propose to examine immediate changes in ability to ventilate (dynamic compliance) at specific time intervals after administration of either type of surfactant; Curosurf or Survanta.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants between 28 and 31 6/7 weeks' gestational age
* Inborn to UM NICU
* \< 12 hours of age
* Respiratory Distress Syndrome
* radiographic evidence
* need for endotracheal intubation
* Oxygen requirement \> 30% FiO2
* Decision to give surfactant by the treatment team

Exclusion Criteria:

* Major congenital anomaly
* Sepsis syndrome in extremis
Training Quality in Anaesthesia and Intensive Care: Tunisian Residents Feed Back

Opinion survey to assess the level of satisfaction and the expectations of the residents in anesthesiology and intensive care in Tunisia ( North Africa)

The first national anonymous survey to assess the theoretical and practical training quality in anesthesia and intensive care and the improvements propositions.

Eligibility Criteria:
Inclusion Criteria:

* Tunisian nationality
* Resident in anesthesiology and intensive care
* training period : 6 months to four year

Exclusion Criteria:

* training done outside tunisia
Evaluation of an Opioid Decrease Strategy in Chronic

Increase in the consumption of analgesics observed in many countries with a mediatic crisis resulting in an increasingly frequent wish of patients to wean themselves from opiates. A recent update (B. Rolland 2017) suggests that upon initiation of an opioid analgesic treatment, the patient should be informed of the risk of opioid dependence and misuse. There is no clearly validated decay scheme in the event of dependence in patients with Chronic Non-Cancer Pain.

Hypotheses:

* Possibility of a rapid decrease in opioid analgesic treatments at DCNC sensitized to the risk of DOP and MOP. (Protocol implemented: Multidisciplinary assessment, workshops and information sheet on chronic pain, treatments and risk of DOP, pharmacological and nonpharmacological adaptation)
* Highlight the need for additional information from patients and prescribers on the risk of DOP and MOP in DCNC.

Main objective: Check if the rapid to semi-rapid regimen (- 25 to -60% dosage in 5 days of HDS) of opioid analgesics, without the use of methadone or buprenorphine agonists, in the case of DCNC at the CETD in Montpellier is efficient in the medium term (6 months).

Secondary objective:

* With our inclusion questionnaire we wanted to check if the patients had been made aware of the risk of opiate dependence and misuse.
* Detect the conditions of prescriptions that can promote the misuse of opiates.
* Evaluating the different components of residual pain at 6 months (type, intensity, anxiety component and depression, function).

Eligibility Criteria:
Inclusion criteria:

* chronic pain patient
* major
* supported at CETD

Exclusion criteria:

-patient with physical and mental incapacity to participate in the study
Prospective Evaluation of the Quality of Life of Elderly Patients Undergoing Transfemoral Percutanous Aortic Valve Replacement (TAVI) for the Treatment of Severe Aortic Stenosis.

In order to overcome the shortcomings of the assessment questionnaires currently available on the assessment of overall quality of life, the "Toronto Aortic Stenosis Quality of Life Questionnaire" (TASQ) was developed as a specific assessment tool for the impact of severe aortic stenosis in elderly patients, through 16 questions covering 5 domains: symptoms and physical limitations, emotional impact and expectations following TAVI, as well as social limitations incurred.

A better knowledge and understanding of the clinical outcomes and quality of life of elderly patients with severe symptomatic aortic stenosis at 12 months of follow-up of a TAVI procedure would further optimize the clinical decision-making process and patient selection who will benefit the most from this intervention in the long term.


Eligibility Criteria:
Inclusion Criteria:

* Male, female, over 18 years old,
* All patients who will have transfemoral percutaneous aortic valve replacement (TAVI) with implantation of a valve delivered on a balloon,
* Patient able to understand the study, and answer the TASQ questionnaire,
* Affiliation to a social security scheme or beneficiary of such a scheme,
* Patient having signed the free and informed consent.

Exclusion Criteria:

* Minor,
* Disorder of comprehension and/or expression,
* Patients unable to answer questions due to an underlying cognitive deficit or physical disability,
* Patients treated with a self-expanding valve,
* Refusal to participate in the study,
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,
* Pregnant, parturient, or breast-feeding patient.
A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis.

This is a randomized, vehicle controlled, double blind study in subjects with axillary hyperhidrosis designed to assess the safety, tolerability and the effect on sweat production of topically applied BBI-4000 for 14 days.

Safety will be assessed though vital signs, physical exam, adverse events, local skin reactions and laboratory tests (blood chemistry and hematology).

Efficacy will be assessed though the gravimetrically measured sweat production and the Hyperhidrosis Disease Severity Score (HDSS).

Pharmacokinetic information will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female subjects from 18 to 45 years of age in good general health.
* Primary axillary hyperhidrosis of at least 6 months duration.
* Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
* Gravimetric test at baseline indicating at least 100mg of axillary sweat production in a 5 min period.
* Use of a medically appropriate contraceptive method.

Exclusion Criteria:

* Prior axillary use of botulinum toxin within 2 years of study entry.
* Prior iontophoresis treatment for axillary hyperhidrosis within 12 weeks of study entry.
* Prior surgical procedures for hyperhidrosis or surgical procedures in the axillary areas for any reason.
* Use of anticholinergic treatment, beta-blocker, alpha-adrenergic or other prescription treatment for hyperhidrosis.
* History of diabetes mellitus, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, prostate hypertrophy, neurological conditions or cardiac abnormalities.
* Known condition that may cause hyperhidrosis.
* Use of an investigational drug within 30 days prior to entry into this study.
Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera

The goal of this clinical trial is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the end-of-treatment visit of a Phase 2 rusfertide study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.

This is an open-label study designed to assess the long-term safety and efficacy of rusfertide. This study aims to provide long-term rusfertide treatment to subjects who complete dosing until the end-of-treatment of a previous Phase 2 rusfertide study and are likely to continue benefiting from treatment with rusfertide based on their improved control of hematocrit levels \<45% and reduced need for therapeutic phlebotomies. This study will provide long-term rusfertide treatment to these subjects and obtain data on safety and efficacy of long-term treatment with rusfertide.

Eligibility Criteria:
Inclusion Criteria:

* Subject who has completed at least 12 months of dosing with rusfertide and successfully completed the end of treatment visit of a previous Phase 2 study of rusfertide.
* Subject understands the study procedures, is willing and able to adhere to study requirements and agrees to participate in the study by giving written informed consent.

Key Exclusion Criteria:

* Subject who, in the opinion of the investigator, should not participate in the study.
* Subject who discontinue early from a previous rusfertide study for reasons other than enrolling in this study.
* Pregnant or lactating females.
* Women of childbearing potential (WOCBP) who do not agree to use medically acceptable contraception (\<1% annual failure rate) during the study and for 30 days after the last dose of study drug.
* Men with partners of childbearing potential who do not agree to use medically acceptable contraception (\<1% annual failure rate) during the study and for 90 days after the last dose of study drug.
* Men who do not agree to use a condom during the study and for 90 days after the last dose of study drug regardless of the partner's childbearing potential.
* A female subject intends to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after receiving the last dose of study drug.
* A male subject intends to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study drug.
* Plan to use investigational treatment other than rusfertide during the course of the study or within 28 days after last rusfertide dose.
* Subject with hypersensitivity to rusfertide or to any of the excipients.
* In the investigator's opinion the subject has progressive disease that cannot be managed by adjusting concurrent cytoreductive therapy.
Prevalence of Type 2 Diabetes Mellitus in Ethiopian Community in Israel: an Update

The prevalence and incidence of diabetes has been reported to vary among populations.Immigrants groups as that have undergone significant life-style changes tend to develop diabetes within a short time. The aim of the study is to assess the prevalence of diabetes mellitus in Ethiopian population ,15-20 years after immigration in Israel.

The study will be conducted in three primary care clinics of the Jezreel Valley (Omer, Givat Hamore and Afula Illit). The computerized medical charts of 500 Ethiopian adults will be reviewed. The following information will be obtained: age, date of arrival in Israel, known history of diabetes, hyperlipidemia, hypertension or other disease, drug therapy, body weight, blood pressure. Following laboratory data will be retrieved: blood glucose, HbA1c, lipid levels , creatinine and uric acid. The criteria used for the definition of diabetes will be based on the criteria proposed by the American Diabetes Association .

Eligibility Criteria:
Inclusion Criteria:

* Male and female Ethiopians Jews who immigrate in Israel in 1991 and were 18 years old or more at immigration.

Exclusion Criteria:

* Type 1 diabetes Mellitus
A Phase II Clinical Trial of Artificial Intelligence-assisted One-stop Radiotherapy for Breast Cancer After Breast-conserving Surgery

Background: Breast cancer became the most prevalent cancer globally in 2020, and post-surgery radiotherapy is crucial for most patients. Traditional radiotherapy is complex and time-consuming, affecting patient experience. To streamline this, an AI-assisted All-in-one (AIO) radiotherapy approach has been developed, integrating steps like target delineation and planning to reduce wait times and enhance accuracy. Preliminary results are promising, with significant time savings and high pass rates in initial assessments. Further exploration is needed to confirm the accuracy, effectiveness, and safety of AIO radiotherapy.

Primary objective: To conduct a prospective phase II clinical trial to determine the feasibility (including efficacy and safety) of AIO radiotherapy, and to provide a basis for establishing standard operating procedures.

Secondary objectives: To assess the impact of AIO radiotherapy on overall survival, local regional recurrence, and distant metastasis rates. To investigate the incidence and contributing factors of cardiac damage after AIO radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* 1. Female patients aged 18-70 years. 2. ECOG performance status of 0-2. 3. Newly diagnosed invasive breast cancer, underwent breast-conserving surgery plus axillary lymph node dissection, with positive axillary lymph nodes (ypN+) and negative surgical margins.

  4. No distant metastasis. 5. Capable of tolerating radiotherapy. 6. For ER/PR-positive patients, willing to receive anticipated 5 years of endocrine therapy.

  7. For HER2-positive patients, willing to receive anticipated 1 year of anti-HER2 targeted therapy.

  8. For patients requiring neoadjuvant/adjuvant chemotherapy, must have completed chemotherapy.

  9. Left ventricular ejection fraction (LVEF) measured by echocardiography is 50%.

  10. Must undergo adjuvant IMRT (Intensity-Modulated Radiation Therapy). 11. Capable of tolerating lying still on the treatment accelerator bed for 30 minutes to complete All-In-One radiotherapy.

  12. Have follow-up conditions and are willing to adhere to follow-up. 13. Signed an informed consent form.

Exclusion Criteria:

* 1. Synchronous bilateral breast cancer; sentinel lymph node biopsy of the axilla was performed without axillary lymph node dissection.

  2. Stage I breast reconstruction surgery or expander implantation surgery on the affected side chest wall.

  3. The purpose of radiotherapy is palliative. 4. Myocardial infarction within the last 3 months or uncorrected unstable arrhythmia or uncorrected unstable angina.

  5. History of chest wall or supraclavicular radiotherapy in the past; past or concurrent second primary malignant tumors (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, and carcinoma in situ of the cervix).

  6. All-in-one one-stop radiotherapy has not been completed.
Changes in the Microenvironment of HPV-induced Head and Neck Cancers in West Indies and Metropolitan Population

Retrospective observational comparative and multicentric study of the microenvironment of HPV-induced head and neck cancers, with comparison between West Indies and Metropolitan populations, and therapeutic implications. This assessment is carried out by in situ multiparametric study with multiple immunofluorescence staining for cluster of differentiation 3, cluster of differentiation 4, cluster of differentiation 8, PROGRAMMED DEATH-1, PROGRAMMED DEATH-L1, PROGRAMMED DEATH-L2, cytokeratin and cluster of differentiation 68 and automated reading. HPV genotypes will be characterized. Learning these techniques will allow me to promote them in West Indies on my way back, and they may be applicable to other HPV-induced cancers.

Global annual incidence of head and neck (HN) cancers is high. It is even a greater concern in West Indies compared to other American countries. Most represented histological type is squamous carcinoma and several risk factors are involved , including tobacco exposure. Moreover, it is now clear that Human Papillomavirus (HPV) is a causal factor in the development of HNSCCs : as many as 5 to 10% of tumors are induced by HPV in the world, and it is responsible of 25,9% of HN tumors. HPV 16 is the most involved (87%). However, HPV epidemiology is different in West Indies with the implication of various genotypes. Detection of HPV infection can be achieved through several methods such as polymerase chain reaction (PCR) or RNAscope, which is a new reliable precise technique which reflects the transcriptional activity of the virus. The differences between the genotype of HPV involved within both populations need to be consider to better identify therapeutic targets.Studying the microenvironment may allow a better understanding of anti-tumoral immunity and may help patient selection in order to achieved better responses to immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Primitive head and neck squamous cells carcinoma diagnosed on surgical resection or biopsic sample, between 2008 and 2015 in metropolitan and Antillean populations. For metropolitan they were included when expressing p16 as assessed by immunochemistry and positive HPV DNA by in situ hybridation or positive HPV PCR. For Antillean population they were included when expressing p16 as assessed by immunochemistry with regards of genotype as assessed by in situ hybridation or by PCR (to be completed).

Exclusion Criteria:

* Secondary tumors,
* Tumor recurrence in a patient for whom we have already tumor tissue, nasopharyngeal tumors, p16 expression by immunochemistry with negative PCR testing for HPV.