cyrilzakka/clinical-trials huggingface dataset:
Correlation of Preoperative Olfactory Identification Function With Frailty and Postoperative Complications and Mortality

The aim of this research project is to evaluate whether olfactory identification impairment is a reliable predictor of preoperative frailty and of postoperative complications and mortality in a population of older patients scheduled for elective surgery.

1. The investigators will measure preoperative olfactory identification function and evaluate whether olfactory impairment predicts frailty, using the Edmonton Frail Scale and handgrip strength.
2. The investigators will analyze whether preoperative olfactory impairment predicts postoperative complications and mortality.

Olfactory impairment increases with age, affecting more than 50% of the population aged between 65 and 80 years old. Recently, many studies have demonstrated a strong association between olfactory impairment and overall mortality risk. At the moment, the underlying physiopathology linking olfactory impairment to mortality remains unknown and only putative mechanisms are suggested.

Among them, accelerated physiological brain aging seems to be involved, making olfactory decline a possible marker of frailty. To date, only a few studies (mostly using subjective olfactory assessment) investigated the potential relationship between olfactory impairment and frailty. Surgery, and more broadly the perioperative period, remains a major source of morbidity and mortality. Meanwhile, the average age of the surgical population continues to rise, making preoperative risk assessment an essential step in order to detect the most vulnerable patients. Yet, it is well-known that frailty is associated with worse perioperative outcome. The first objective of this research project is thus to evaluate olfactory identification function of preoperative older surgical patients in light of an assessment of their frailty status. Frailty will be tested with the Edmonton Frail Scale and handgrip strength, which are both validated tools. The second objective is to correlate postoperative morbidity and mortality with preoperative olfactory function. Hopefully, this research project will address the misunderstood link between olfactory impairment and mortality, focusing on frailty assessment and using surgery as a heavy stressor for the older patient.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective surgery (covering general, gynecologic, urologic, orthopedic, plastic, head and neck, spine neurosurgery)

Exclusion Criteria:

* Day case surgery
* History of neurological or psychiatric disorder
* History of severe head trauma
* History of olfactory trouble or chronic rhinosinusitis or sinus surgery
* History of suspected or diagnosed COVID-19
Safety Study To Assess Growth In Children With Seasonal Allergic And/Or Perennial Allergic Rhinitis Treated With GW685698X Aqueous Nasal Spray Or Placebo Nasal Spray

The purpose of this study is to assess any effect in children with seasonal and/or perennial allergic rhinitis by GW685698X aqueous nasal spray (versus vehicle placebo nasal spray) on growth using knemometry.


Eligibility Criteria:
Inclusion criteria:

* Females (ages 6 to 11) who have not begun menses.
* Males (ages 6 to 12).
* Tanner Stage 1.
* History of SAR (Seasonal Allergic Rhinitis) or PAR (Perennial Allergic Rhinitis) of at least one year with either a current level of allergic rhinitis symptoms that warrants treatment and/or expected symptoms during a majority of the study period.
* Positive skin test to an appropriate seasonal or perennial allergen.

Exclusion criteria:

* History of abnormal growth or gross malnutrition.
* Clinically significant laboratory abnormality.
* History of any condition that may have substantially affected growth.
* Historical or current evidence of clinically significant, uncontrolled disease of any body system.
* Any asthma other than mild, intermittent asthma controlled by short-acting, beta-agonists.
* Recent major surgery and/or trauma to the legs.
* History of adrenal insufficiency.
* Current or prior treatment with any medication that may have a potential for an ongoing effect on linear growth.
* Use of corticosteroids, by any route, within 4 weeks prior to Visit 1.
* Any nasal condition or deformity that would impair nasal breathing or deposition of medication.
* Physical impairment that would affect the subject's ability to participate in the study.
GonoScreen: Efficacy of Screening STIs in MSM

A Multicentre, controlled, randomized trial of 3 site (urethra, pharynx and rectum) sampling performed every 3 months (3x3) for Neisseria gonorrhoea (Ng)/Chlamydia trachomatis (Ct) screening (comparator) vs. no screening (intervention).

This study is a multicentre, controlled, randomized trial of 3x3 Ng/Ct screening (comparator) vs. no screening (intervention). It will be performed in the PrEP cohorts situated at the Institute of Tropical Medicine (ITM), Hôpital Saint-Pierre (HSP), Liège University Hospital (CHU), University Hospital of Gent (UZG) and Erasmus Hospital (EH). All men in follow up at these five centres who report having had sex with another man in the previous year and are enrolled for PrEP follow up will be eligible to participate in the study. After signing informed consent participants will be randomized via a computer-generated schema to either 3x3 screening or no Ng/Ct screening. In both arms, participants will be followed up in an identical fashion including 3x3 screening. The only difference between the arms will be that in the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done. The Sexually Transmitted Infection (STI) Laboratory will only process the samples/report the results from the non-screening arm at the end of the study. In both arms, all individuals with symptoms compatible with Ng or Ct will be tested and treated for these infections according to current best practice guidelines. At the end of the 12-month study period, participants whose most recent tests were positive for Ng or Ct will receive treatment for these.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide informed consent
* Men (born as males) and transwomen aged 18 or more
* Has had sex\*\* with another man in the last 12 months
* Enrolled in Belgian PrEP program at ITM/HSP/EH/CHU/UZG with approval for TDF/FTC (Tenofovir disoproxil fumarate/Emtricitabine) reimbursement from a Belgian Medical Aid
* Willing to comply with the study procedures and to attend the clinic for the 3-monthly visits

Exclusion Criteria:

* Enrolment in another interventional trial
* Tests HIV-positive at screening
* Symptoms of proctitis or urethritis
Effect of Topic Pirfenidone in Diabetic Ulcers

Pirfenidone is a synthetic molecule, which acts as a potent modulator of the effect of various cytokines (TNF-α, transforming growth factor-β, platelet derived growth factor and vascular endothelial growth factor, among others) that possesses anti-inflammatory and anti-fibrinolytic properties.

The aim of this study is to compare the effect of topic treatment with pirfenidone compared to conventional treatment in chronic diabetic foot ulcers.

The hypothesis is that treatment with topic pirfenidone in chronic diabetic foot ulcers (Wagner 1 to 2) reduces the ulcer size and shortens the healing time compared to conventional treatment. This is a randomized, controlled and crossover study. Patients will be randomly assigned to conventional treatment or topic pirfenidone for eight weeks. At the end of this period they will change groups. Each week ulcers will be for size, depth, length and evidence of infection. The ulcers will have proper debridement in the conventional treatment group and debridement plus topical pirfenidone application in the pirfenidone group. Subjects will be instructed to do daily ulcer cleansing and for those in the topical pirfenidone group, in addition to cleansing they will be instructed to apply the gel twice a day.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women
2. Type 1 or 2 diabetes
3. Age ≥ 18 years
4. Wagner 1 or 2 diabetic foot ulcer
5. Diabetic ulcer for more than 8 weeks duration
6. Willing to participate in the study with signed informed consent

Exclusion Criteria:

1. Ankle/brachial index \< 0.4 (critic ischemia)
2. Use topical or systemic antibiotics
3. Inability to attend to the weekly evaluations
4. Inability to do daily ulcer cleansing
5. Autoimmune diseases
6. Active pharmacologic topical or systemic ulcer treatment
7. Treatment with immunosuppressors such as steroids, radiotherapy, chemotherapy
8. Pregnancy or lactation
Whole-genome Sequencing Study in Patients With Diminished Ovarian Reserve

The study aims to explore the genetic pathogenesis of diminished ovarian reserve via whole-genome sequencing technology in Chinese women.

Diminished ovarian reserve (DOR), a pathological condition of reduced quantity and quality of oocytes, has severe impairment on women fertility. Some women experience DOR may develop into premature ovarian insufficiency (POI), which defined as a cessation of function of ovaries in women younger than 40 years old. The pathogenesis of DOR is multiple and the etiology of most DOR remains obscure. Genetic factors, including chromosome abnormality, genetic variation, and non-coding RNA abnormal regulation are considered the major mechanisms of DOR. More than 12 gene mutations, detected by whole-exome sequencing (WES), have been implicated as potential causes of DOR. However, we have found that coding gene mutation detected by WES may only account for a small part of DOR. Whole-genome sequencing (WGS) has been developing into an important strategy for identifying exons, introns and mitochondrial DNA mutation. However, the application of WGS is still lacking in detecting pathogenic genes of DOR. Therefore, this study intends to explore the possible pathogenic genes by WGS in order to deeply and comprehensively understand the pathogenic mechanism of DOR.

Eligibility Criteria:
Inclusion Criteria:

DOR group:

1. age between 18 and 40 years;
2. number of oocytes obtained in previous ovarian stimulation cycles ≤3;
3. bilateral ovarian antral follicle count (AFC) \< 5-7;
4. serum anti-Mullerian hormone (AMH) \<0.5-1.1ng/ml.

Control group:

1. age between 18 and 40 years;
2. bilateral AFC ≥8;
3. serum AMH ≥1.2ng/ml;
4. regular menstrual cycles occurring every 25-35 days.

Exclusion Criteria:

The exclusion criteria of the two groups were:

1. an abnormal karyotype;
2. a history of other endocrine diseases such as polycystic ovary syndrome, hyperprolactinemia and hyperthyroidism;
3. a history of radiotherapy, chemotherapy and ovarian surgery.
Education Tools to Support Pediatric Survivor Care

This study aims to evaluate the impact of electronic educational materials on adolescent and young adult ("AYA") survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.

Despite increased risk for morbidity and mortality related to cancer treatment, over half of young adult survivors of childhood cancer do not engage in the recommended healthcare designed to detect late effects and secondary cancers. There is a scarcity of data on adherence to survivor-focused healthcare, particularly at the critical transition from pediatrics to adult care. In order to improve transition outcomes, the investigators need to create media to educate survivors about need for adherence to adult survivor healthcare.

This study aims to evaluate the impact of electronic educational materials on AYA survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18-25 years of age,
* Diagnosed with cancer at ≤ 18 years of age,
* ≥ 2 years since the last cancer treatment,
* seen at least once in the Aflac CSP in the past 2 years or transitioned out of the Aflac CSP to adult survivor care since 2013.

Exclusion Criteria:

* Patients and/or parents will be excluded from participation in the study if the participant is non-English speaking.
* Young adult survivors who are cognitively impaired and unable to complete the questionnaires.
* Participants that do not consent to the recording of their interviews.
Harmonized and Pooled Database, Named PRIME.

We merged the dataset of three large observational studies of invasive ventilation in critically ill patients.

PRIME contains the individual patient data of 3 large observational studies of ventilation, 'PRactice of VENTilation in critically ill patients without ARDS' (PRoVENT), 'PRactice of VENTilation in critically ill patients in Middle-income Countries' (PRoVENT-iMiC) and 'Extubation strategies and in neuro-intensive care unit patients and associations with outcomes' (ENIO).

Eligibility Criteria:
All patients in the PRIME database are eligible for participation in the initial analysis presented here. We will exclude patients receiving ventilation fir another reason than acute brain injury.
Acupuncture in Cardiovascular Disease

The purpose of this study is to determine if acupuncture decreases adrenaline levels in heart failure, thereby potentially improving survival and quality of life.

Acupuncture is used to lower blood pressure in patients with hypertension, and to relieve angina in patients with coronary artery disease. While the biological mechanisms of acupuncture analgesia have been studied intensely in animals and humans, the biological mechanisms for modulation of the cardiovascular system in humans remain largely unexplored. Acupuncture at traditional acupoints, and at nonacupoints, decreases the blood pressure response during mental stress in normal humans. This depressor effect cannot be fully explained by a decline in muscle sympathetic nerve activity (MSNA). Further, in humans with heart failure (HF) in whom MSNA is elevated, we have preliminary data that acupuncture significantly decreases the MSNA response during mental stress. The following hypotheses will be tested: 1) acupuncture, performed at traditional acupoints and non-acupoints in normal humans, stimulates skeletal muscle afferent neurons causing a release of endogenous opioids, which oppose sympathetic excitation and vasoconstriction in visceral vascular beds, such as the kidney; 2) in humans with HF in whom MSNA is elevated and renal vasoconstriction is the rule, acupuncture utilizes similar mechanisms as in normal humans to produce exaggerated inhibition of MSNA and reflex renal vasoconstriction. Positron emission tomography and microneurography will be utilized to answer the following questions in normal humans and patients with heart failure: 1. Is acupuncture attenuation of BP during mental stress mediated by a decrease in renal vasoconstriction? 2. Is acupuncture sympathoinhibitory? 3. Is acupuncture modulation of the autonomic nervous system mediated by muscle afferents? 4. Is acupuncture modulation of the autonomic nervous system mediated by activation of endogenous opioids? Understanding the mechanisms of acupuncture modulation of the autonomic nervous system in humans may help clarify its role as a therapeutic modality in cardiovascular diseases, such as heart failure.

Eligibility Criteria:
* Chronic congestive heart failure class II-III
* No unstable angina
* No myocardial infarction within 3 months
* No peripheral neuropathy
Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation

The primary objective of this non-interventional study is to describe the evolution of Hidradenitis suppurativa (HS) symptoms 12 months after secukinumab initiation based on the patients' assessment of pain, oozing, and bad smell.

This study is a prospective (primary data), national, descriptive, non-interventional, multicentre study conducted by medical practice and hospital-based dermatologists across different geographical regions in France.

This real-world study does not change the physician-patient relationship or patient management or follow-up. Physicians remain free with their prescriptions and patient follow-up procedures. In fact, secukinumab initiation and all treatment decisions will be made according to routine medical care and independently of study participation.

Recruited patients will be longitudinally followed-up for the duration of the study, up to 24 months (± 3 months) after secukinumab initiation or secukinumab treatment discontinuation before the end of the 24 months of follow-up (early discontinuation).

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients ≥ 18 years old,
2. Patients who do not object to participation in the study,
3. Diagnosis of HS clinically confirmed,
4. Initiation of secukinumab treatment for HS in compliance with the summary of product characteristics,
5. The physician's decision to initiate secukinumab has been taken according to his/her own practice and regardless of study participation.

Exclusion Criteria:

1. Patients with any medical or psychological condition which, in the physician's opinion, may prevent participation in the study,
2. Patients participating in a clinical trial.
Early Versus Late CRRT in ACLF Patients With Septic Shock and AKI

Consecutive patients with ACLF (Acute on Chronic Liver Failure) and septic shock with AKI (Acute Kidney Injury) who give written informed consent will be included in this prospective trial at ILBS. At baseline s, endotoxin levels, NT-Pro BNP, , urine N-GAL will be done for all patients. A 10 ml serum sample will be stored for doing a cytokine profile. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also be done. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease, patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group, patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.


Eligibility Criteria:
Inclusion Criteria:

- Patients with ACLF defined based on APASL criteria with septic shock associated AKI

Exclusion Criteria:

* Patients with age less than 18 years
* Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
* Pregnancy
* Chronic kidney disease on hemodialysis
* Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI due to glomerulonephritis, interstitial nephritis or vasculitis
* Patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group (serum potassium\>6 meq/lt, metabolic acidosis ph\<7.12, acute pulmonary edema, severe volume overload with hypoxemia non-responsive to diuretic treatment)
* Patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit
* Extremely moribund patients with an expected life expectancy of less than 24 hours
* Failure to give informed consent from family members.
* Hemodynamic instability requiring very high dose of vasopressors
Femoral Remodeling Following Total Hip Arthroplasty With OMNI Apex Modular™ and OMNI Apex ARC™ Stem Compared to Competitive Designs

This study compares the change in bone density which occurs after hip replacement with different femoral stem devices.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age 20 years, maximum age 80 years
* Osteoarthritis of the hip
* Elective THA
* Signed Informed Consent

Exclusion Criteria:

* Osteoporosis
* Revisions
* Clinically obese (\>40 body mass index \[BMI\])
* Femoral dysplasia
* Trochanteric osteotomy
* Inflammatory arthritis
* Breast-feeding, pregnancy, or women of childbearing potential without documentation of a negative pregnancy test and not utilizing contraception
* Patients with a history of having taken or currently taking bisphosphonates, PTH, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the investigator's opinion are known to affect bone mineral density in a substantial way
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Use of other investigational agent in the last 30 days
* Unable to sign Informed Consent
HbA1c and Neurocognitive Disorders

Preliminary evidence suggest a possible relationship between HbA1c and perioperative neurocognitive disorders (NCD). We are going to investigate whether the preoperative value of HbA1c 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 HbA1c and perioperative neurocognitive disorders (NCD). We are going to investigate whether the preoperative value of HbA1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.

Eligibility Criteria:
Inclusion Criteria:

* 1) 45 - 80 years
* 2) American Society of Anesthesiologists physical status I to III
* 3) elective general, urological, gynecological and orthopedic surgery under general anesthesia
* 4) native speakers of the Greek language

Exclusion Criteria:

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

An extended replication of Jaen \& Dalton (2014), the investigators aim to investigate the role of odors and associated trigger beliefs on symptom perception and airway inflammation in individuals with asthma

Participants with asthma are randomly assigned to a 15-min (phenylethyl alcohol) odor inhalation, accompanied by either an asthmogenic suggestion (nocebo), or a therapeutic suggestion (placebo). Airway inflammation, lung function, and asthma symptoms are measured in response to the odor/suggestion, up to 24 hours after odor inhalation. The investigators are also measuring worry and heart rate variability as potential mediators of the response.

Eligibility Criteria:
Inclusion Criteria:

* A physician diagnosis of asthma

Exclusion Criteria:

* FEV1 lower than 60% predicted
* clinical condition other than asthma