cyrilzakka/clinical-trials huggingface dataset:
Characterization of Natural IL-6 Inhibition in Healthy Individuals

The aim of the project is to investigate whether or not there are any difference in cardiometabolic outcomes in individuals with high or low levels of c-aAb against interleukin-6 (IL-6).

The study is the first to investigate individuals with extreme amounts of c-aAb levels against IL-6 and to contribute with knowledge on a possible new phenotype.


Eligibility Criteria:
Inclusion Criteria:

* Fulfill Danish blood donor criteria
* Have extreme amounts of IL-6 c-aAb or matched as control (low amounts of IL-6 c-aAb)

Exclusion Criteria:

* Failure to fulfill Danish blood donor criteria
Urdu Version Of Cornell Musculoskeletal Discomfort Questionnaire: Reliability And Validity Study

The study aims to translate and adapt Cornell Musculoskeletal Discomfort Questionnaire cross-culturally into the Urdu language for the Pakistani population for investigating the reliability and validity of Cornell Musculoskeletal Discomfort Questionnaire in the Pakistani population and to study the correlation between Nordic Musculoskeletal Questionnaire and the Visual Analogue Scale.

The English version of the Cornell Musculoskeletal Discomfort Questionnaire will be translated into Urdu and culturally adapted, as per a previous recommendation. The Cornell Musculoskeletal Discomfort Questionnaire will be given to one hundred and fifty workers of Masood Textile Mills, who would be chosen based on convenience sampling and inclusion and exclusion criteria. The inter-observer and intra-observer reliability of the Cornell Musculoskeletal Discomfort Questionnaire, Nordic Musculoskeletal Questionnaire, and Visual Analog Scale will be evaluated in this study. On the same day, the questionnaire will be filled out created two times. An Inter - observer assessment will be done with 2 hour break between distributions of questionnaires. The initial observer then will gather a third assessment over one-week period (intra-observer assessment). For data entry and analysis, Statistical Package of Social Sciences Version 24 will be utilized. Internal consistency will be checked using the Cronbach alpha value, and test retest reliability will be assessed using the Intraclass coefficient.

Eligibility Criteria:
Inclusion Criteria:

* Participants having an age limit of 18 to 55.
* Could read and understand the Urdu language.
* Both males and females working more than 6 hours in sitting and standing positions.

Exclusion Criteria:

* Having any fracture in any part of the body.
* Having any congenital or acquired disability that restricts them in their daily living.
Strattice in Repair of Inguinal Hernias

This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh. Performance and outcomes measures to be compared include postoperative resumption of activities of daily living, nature and incidence of short- and long-term pain and complications, and incidence of hernia recurrence.


Eligibility Criteria:
Inclusion Criteria:

* adult male
* symptomatic and palpable inguinal hernia
* open, elective, primary unilateral inguinal hernia repair

Exclusion Criteria:

* bilateral inguinal hernia repair
* BMI \>35
* chronic immunosuppression, active chemo/radiation therapy, uncontrolled diabetes, severe liver disease or COPD
* chronic prostatitis, orchitis, testicular pain
* local or systemic infection at time of repair
* known collagen disorder
* chronic pain syndrome or under active pain management
Influence of Sodium Intake in spondyLoarthriTes

The aim of the SALT study is to analyze the relationship between dietary sodium intake and disease activity in patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria:

* patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis
* women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potentiale, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)

Exclusion Criteria:

* catient treated by cyclosporine, diuretics, angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists.
* current treatment with an anti-IL-17A agent (secukinumab or ixekizumab or bimekizumab or brodalumab) or with an anti-IL23 agent (ustekinumab, guselkumab, risankizumab or tildrakizumab) or previous treatment less than 6 months old.
* patients on systemic corticosteroids with corticosteroid therapy \> 10 mg prednisone equivalent
* pregnant woman
Suicide Attempts and Tramadol : a Case Report

In France, over the last years the use weak opioid analgesics decreased́, whereas that of strong opioid analgesics (OFMA). Hospitalizations for opioid overdose increased́ by 128% from 2000 to 2015, and deaths related to prescribed opioid overdose increased significantly, by 161%, from 2000 to 2014.In addition, recent studies suggest a link between opioid system dysfunction and suicidal behavior.

In parallel, studies are emerging showing the potential interest of using Tramadol as an antidepressant. Indeed, this opiate analgesic also acts on the serotonergic and dopaminergic systems, and would have an antidepressant effect.Thus, the investigators can legitimately wonder whether the use of Tramadol as an antidepressant might not pose a problem in patients at risk of suicide.

This study aims to describe a clinical case of a patient hospitalized in the Department of Psychiatric Emergency and Post-Emergency (Montpellier University Hospital) who developed a severe addiction to Tramadol (consumption up to 5 times the maximum recommended dose per day) and evaluate whether this may have increased her suicidal risk, in order to warn prescribers about the suicidal risk of Tramadol.


Eligibility Criteria:
Inclusion criteria:

* Multiple suicide attempts
* Tramadol addiction

NA : patient case report

Exclusion criteria:

- None
Brain Stimulation and Cognitive Training in Healthy Older Adults

The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in healthy older individuals.

The goal of the present study is to assess behavioral (primary) and neural effects of a multi-session cognitive training combined with transcranial direct current stimulation (tDCS). Many studies to date have found tDCS to be an efficient method to enhance various cognitive functions by modulating cortical excitability in young adults, but its behavioral impact and underlying mechanisms in aging still need to be elucidated. Healthy older adults will participate in a three-week cognitive training with concurrent online tDCS application. Cognitive performance (primary), as well as structural and functional imaging data will be examined before, during and after the intervention. In order to draw conclusions about the effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. Furthermore, to assess neural correlates of performance improvement, functional and structural parameters will be measured with MRI before and after training. Follow-up sessions to assess long-term effects are planned four weeks and six months after the post assessment. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training, as compared to training alone, in older adults. Moreover, improved understanding of tDCS effects on cognitive training performance and underlying neural correlates may help to develop novel approaches for cognitive decline in healthy and pathological aging.

Eligibility Criteria:
Inclusion Criteria:

* Older adults (65 - 80 years);
* Right handedness;
* Unobtrusive neuropsychological screening

Exclusion Criteria:

* Mild cognitive impairment (MCI) or dementia; other neurodegenerative neurological disorders; epilepsy; previous stroke;
* Severe and untreated medical conditions that precludes participation in the training, as determined by responsible physician;
* History of severe alcoholism or use of drugs;
* Severe psychiatric disorders such as depression (if not in remission) or psychosis;
* Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women)
Cortisol Response to Moderate and Deep Sedation in Children

Currently, it is unknown whether sedation itself induces a rise in serum cortisol levels or if cortisol levels rise under only the most invasive of procedures, regardless of the type of anesthetic agent used. Animal data shows significant alterations in steroid intermediates under anesthesia regardless of the procedure performed. Prior studies in children show general anesthesia and even epidural anesthesia can cause a rise in serum cortisol, but the effects of moderate and deep sedation on cortisol levels during different types of procedures are unknown. General medical practice varies considerably among providers; some provide stress dosing (extra and sometimes high doses of steroids) for sedation for both non-invasive and invasive procedures for patients with known adrenal insufficiency, but the doses given vary considerably. Others provide stress dosing only for the most invasive procedures in this population of patients. Currently there is no published normative data on changes in cortisol levels under moderate and deep sedation in adrenally sufficient children, so the normal response we are trying to mimic is unknown.

We propose to measure salivary cortisol levels prospectively in adrenally sufficient children undergoing moderate and deep sedation to determine the normal cortisol response to the stress of sedation for both invasive and non-invasive procedures.

Up to 300 adrenally sufficient children will be prospectively recruited to measure salivary cortisol levels during moderate and deep sedation for non-invasive procedures (e.g. MRI, echocardiogram, or other imaging studies), and invasive procedures (e.g. surgery, endoscopy) to determine what the normal cortisol response is to the stress of sedation during these procedures using various anesthetic agents.

The primary outcome variable will be to determine peak salivary cortisol measurements during non-invasive and invasive procedures under different levels of sedation using various anesthetic agents, and correlate these with known norms in children to determine if the patient's hypothalamic-pituitary-adrenal axis is under stress.


Eligibility Criteria:
Inclusion Criteria:

* Child presenting for routine sedation to the TAMC Pediatric Sedation Center.
* Age 3 months to 18 years of age.
* If female age 12 or greater OR menstruating, must not be pregnant.

Exclusion Criteria:

* Must not have the diagnosis of adrenal insufficiency or any concerns for possible adrenal insufficiency, to include recent tapering of exogenous steroids in the last 6 months.
* Current treatment with oral steroids or has been on oral steroids in the last 3 months.
* The use of regular inhaled corticosteroids for asthma controller treatment or intranasal steroids for allergic rhinitis is specifically NOT an exclusion criteria.
Risk and Importance of Peroperative Nasal Hemorrhage in the Treatment of Lacrimal Duct Obstruction in Young Children

The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a "pushed" probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO).

In the investigator's experience, this risk seemed to minus using a pushed probe rather than the classical pulled-type probes.

A lower risk of hemorrhage could lead to a change in the anesthetic procedure. The gold standard in NLDO is the use of an orotracheal intubation. It could then be replaced by the use of an orolaryngeal mask. A forthcoming study will evaluate the results of this anesthetic change.


Eligibility Criteria:
Inclusion Criteria:

* \< 6 years of age
* Unilateral lacrimal duct obstruction with programmed surgery
* Surgery scheduled wih a "pushed" mono-canaliculonasal intubation
* No opposition of parents for he participation of their child

Exclusion Criteria:

* Coagulation disorder
* Previous history of nasolacrimal intubation (homo or contra-lateral)
* Non covered by health insurance
A Study to Assess the Long-term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder

The purpose of this study is to evaluate the long-term (6-month) efficacy, safety, and tolerability of alprazolam XR in adolescents with panic disorder.

Due to recruitment difficulties in this adolescent population, the clinical program for alprazolam XR was cancelled and this study was terminated on 1 September 2004. There were no safety concerns that led to this decision.

Eligibility Criteria:
Inclusion Criteria:

* A primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of panic disorder with or without agoraphobia based on the Mini-International Neuropsychiatric Interview for Children and Adolescents
* Subjects with an average of 1) at least one 4-symptom panic attack per week over the last 4 weeks before screening; 2) at least one 4-symptom panic attack per week over the last 4 weeks before baseline; and 3) at least one 4-symptom panic attack in the 7 days prior to baseline
* To enter Study A6131007, subjects must have completed Study A6131002, had an acceptable tolerability to study drug, and in the clinical judgment of the investigator, could have benefited from continued study treatment.

Exclusion Criteria:

* Subjects must continue to meet all of the exclusion criteria enumerated in the Acute Efficacy Study (Protocol A6131002) with the following exception: Subjects will be allowed to undergo cognitive-behavioral or other panic-specific therapy and any other psychotherapy (e.g., supportive and/or family therapy) during the expected study period in this study.
Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain

The main objective of this clinical investigation is to show the superiority of a rehabilitation based on the use of Blueback® Physio compared to a rehabilitation without the use of Blueback® Physio in terms of reducing the time needed for a patient to control the voluntary contraction of the transversus abdominal muscle and to return to autonomy.

The Blueback® Physio is a wireless device for indicating, for a given patient, the relative level of contraction of the transversus abdominal muscle.

Blueback® Physio is a CE marked class I medical device. This medical device allows to measure and visualize in real time the activity of the transversus abdominal muscle, one of the deepest muscle of the abdominal wall. It is placed on the patient, during a rehabilitation session with a mhysiotherapist.

The objective is to optimize the three key phases followed by the healthcare professional: teaching his patient to feel the contraction of the muscle, learning to control this contraction, then learning to master this contraction when the patient is in double task (movements rehabilitation targeting other muscles, cognitive tasks or other tasks of everyday life that strain the spine).

In the ABC-TRACC study, the objective is to compare the time needed for patient to get a good motor control on his transversus abdominal muscle if he is using the Blueback® Physio during his sessons or not.

Eligibility Criteria:
Inclusion Criteria:

* Included in the PRESDO program,
* Suffering from chronic low back pain (= low back pain installed for more than 2 months),
* Beneficiary of a social security,
* For which his consent has been obtained in writing with regard to his participation in the protocol.

Exclusion Criteria:

* Bedridden or using a wheelchair,
* Having a contraindication to performing the muscular exercises provided for in the protocol,
* Having any other condition which, in the opinion of healthcare professionals, could affect its ability to complete the study or could present a significant risk,
* Simultaneously participating in another clinical research protocol or having recently participated in another research for which the exclusion period has not been completed.
A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults

The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1020, mRNA-1030, and mRNA-1010 vaccines against vaccine-matched influenza A and B strains.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 18 kilograms (kg)/square meter (m\^2) to 35 kg/m\^2 (inclusive) at the Screening Visit.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding.

Exclusion Criteria:

* Participant has had close contact to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening Visit.
* Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1.
* Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
* Participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 180 days prior to screening (for corticosteroids ≥10 milligrams \[mg\]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
* Participant has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤28 days prior to the study injection (Day 1) or plans to receive a licensed or authorized vaccine within 28 days after the study injection.
* Participant has received a Northern Hemisphere (NH) 2021-2022 seasonal influenza vaccine or any other influenza vaccine within 180 days prior to Day 1.
* Participant tested positive for influenza by CDC-recommended testing methods within 180 days prior to Day 1.
* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.

Note: Other inclusion/exclusion criteria may apply.
The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia

This is a prospective observational study designed to evaluate Immature Platelet Fraction or Immature Platelet Count and Platelet Function Analyzer-100/200 Closure Time-ADP (in vitro bleeding time) as markers of bleeding risk in thrombocytopenic preterm neonates admitted to the Neonatal Intensive Care Unit.

Thrombocytopenia is a known risk factor for clinically significant bleeding in neonates. However, there is a poor correlation between degree of thrombocytopenia and bleeding risk. A better marker of bleeding risk suitable for use in neonates could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions, and potentially protecting vulnerable infants from exposure to unnecessary transfusion-related risks. The investigators recently found that the Platelet Function Analyzer (PFA) Closure Time-Collagen/ADP (CT-ADP) was a better marker of bleeding than the platelet count in preterm neonates. However, the CT-ADP requires 0.8 mL blood limiting its potential widespread use. The Immature Platelet Fraction (IPF) is a new laboratory marker measuring the % newly released and more active platelets, measured from the same sample as the platelet count. This is a prospective observational study designed to evaluate IPF as marker of bleeding risk in thrombocytopenic neonates admitted to the Neonatal Intensive Care Unit, compared to platelet counts alone. And also, to validate the previously found association between PFA-100/200 CT-ADP and bleeding in a bigger cohort, to compare the IPF with the PFA-100/200 CT-ADP as bleeding predictors and to assess whether the PFA-100/200 CT-ADP combined with the IPF is able to predict bleeding in thrombocytopenic preterm neonates.

Eligibility Criteria:
Inclusion Criteria:

* Have a gestational age \<32 weeks and a birth weight ≥500 grams;
* Have a platelet count \<100 x 109/L; and
* Have a parent/guardian willing to provide written informed consent.

Exclusion Criteria:

* Are not expected to survive for \>24 hours by the Attending Neonatologist;
* Are thought to have a familial thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (associated congenital malformations, platelet morphology).
Imaging of Prostate Cancer Using Two-dimensional MR Spectroscopy and Diffusion Tensor Imaging

The goal is to develop MR imaging techniques to improve delineation of cancer extent, and to improve differential diagnosis between prostate cancer and benign prostate hyperplasia or other benign diseases.


Eligibility Criteria:
Inclusion Criteria:

1. A male older than 21 years of age and under age of 80,
2. Either a normal healthy volunteer; a patient who has confirmed prostate cancer and decided to receive prostatectomy; or a patient who has persistent elevated PSA higher than 4.0 ng/ml, and with a prior benign biopsy scheduled to receive the second biopsy.

Exclusion Criteria:

1. Unwilling to give informed consent,
2. Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
3. Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
4. Have received orthodontic work involving ferromagnetic materials,
5. Claustrophobic,
6. Unable to lie down still for 60 minutes.