cyrilzakka/clinical-trials huggingface dataset:
Development of Peanut, Sesame, and Tree Nut Allergy in Polish Children at High Risk of Food Allergy

The aim of the study is to assess the prevalence of peanut, tree nuts, and sesame allergy in Polish children at high risk of food allergy. Additionally, the timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population will be assessed.

Introduction: Peanut allergy (PA) has become a health concern world-wide for several decades. Sesame allergy, although less prevalent, is also causing growing concern. Peanut, tree nuts, and sesame allergy co-exist in 60% of children. Although the majority of PA cases come from the general population, there are well-established risk factors for this allergy, such as eczema and egg allergy. In the Learning Early About Peanut (LEAP) Study, early introduction of peanut into the diet of children with moderate-to-severe eczema or egg allergy was proven to be effective in PA prevention. This strategy has now been adopted by national allergy societies in the USA and Australia as part of the weaning guidance for the high-risk populations.However, it is not known whether early introduction of peanut is also justified in other populations where peanut consumption has traditionally been lower. Getting insight into the prevalence of nut and sesame allergy in the cohort of infants and toddlers in Central Europe is needed to guide early dietary intervention strategies.

Methods: 240 children with eczema or egg allergy will undertake extensive assessment of peanut, tree nuts (hazelnut, almond, cashew, pistachio, walnut, macadamia) and sesame allergy status through consumption history, skin testing, specific immunoglobulin E measurement (sIgE) and oral food challenges (OFCs).

Eligibility Criteria:
Inclusion Criteria:

* moderate or severe eczema and/or egg allergy,
* at least one complementary food already introduced,
* signed informed consent.

Assessment of eczema severity: Eczema severity will be assessed based on the objective SCORing Atopic Dermatitis (SCORAD), use of topical steroids, calcineurin inhibitors or systemic treatment as well as history of hospital admission.

Definition of egg allergy: Participants with a documented IgE-mediated egg allergy will be identified by a convincing history of a reaction in the presence of a positive skin prick test (SPT) (wheal diameter of 3 mm or greater with egg white extract) or an SPT ≥ 5mm with no history of a reaction.

Exclusion Criteria:

* inability to withdraw antihistamines for at least 5 days prior to testing,
* use of prohibited medication such as beta-blockers, angiotensin-converting-enzyme inhibitors (ACE-I) and biological treatments affecting the immunological response,
* uncontrolled asthma or eczema which does not warrant readiness for a food challenge within the study time frame,
* chronic urticaria,
* chronic systemic diseases.
Assessment of Complete Response MRI Criterion After Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Standard care for locally advanced rectal cancer consists in a neoadjuvant therapy followed by surgery. Morbidity and mortality remain high after rectal surgery, and often linked with quality of life impairment. 10 to 30% present a pathological complete response after neoadjuvant therapy. Some surgical teams propose "watch and wait" approach for patients selected with clinical complete responses criterion. The problem is to be sur the response is complete. MRI seems to be accurate to select complete responders. We will try to find MRI criterion of complete responses.


Eligibility Criteria:
Inclusion Criteria:

* Rectal adenocarcinoma
* Locally advanced
* Neoadjuvant therapy
* MRI restaging
* Rectal surgery
* Definitive anatomopathology study
Volatile Anesthetics in Cardiac Protection

Patients undergoing stenting procedures, or cardiac or non-cardiac surgery could develop myocardial damage as testified by cardiac troponin release.

Sevoflurane (volatile anesthetic), routinely used in cardiac and non-cardiac anesthesia, has cardioprotective properties that could be useful to reduce cardiac damage, as indicated by cardiac troponin release in different contexts:

* stenting procedures (periprocedural administration)
* non-cardiac surgery (during the whole procedure)
* cardiac surgery (during the whole procedure)

Stenting procedures, cardiac and non-cardiac surgical procedures may carry a significant risk of cardiac damage ultimately leading to prolonged hospital stay and even a non-negligible periprocedural mortality rate. According to the American College of Cardiology/American Heart Association Guidelines all anesthetic techniques and drugs have known cardiac effects that should be considered in the perioperative plan. There appears to be no one best myocardium protective anesthetic technique: the choice of anesthesia is best left to the discretion of the anesthesia care team. To date no anesthesiological drug or techniques proved to reduce perioperative morbidity and mortality in cardiac surgery, only Beta-blockers and locoregional analgesia showed improved outcomes after non-cardiac surgery and no study on anesthesiological drugs has been performed in stenting procedures.

Volatile anesthetics, which are commonly used in general anesthesia to induce and maintain hypnosis, analgesia, amnesia and mild muscle relaxation, have been shown to improve post-ischemic recovery at the cellular level, in isolated hearts, and in animals, both through a pharmacological preconditioning and postconditioning action. Whether the cardioprotective effects of volatile anesthetics are clinically applicable and associated with improved cardiac function, ultimately resulting in a better outcome in patients undergoing cardiac surgery, is still debated. No data exist on patients undergoing non-cardiac surgery or stenting procedures.

A recently published meta-analysis including studies considering all volatile anesthetics showed no reduction in myocardial infarction and perioperative death rate. However the newer volatile anesthetics (desflurane and sevoflurane) seem to have more prominent cardioprotective properties and numerous apparently positive reports targeted to surrogate end-points, yet severely underpowered, have appeared in the literature. Of interest, many of these studies were not included in the above cited meta-analysis.

To address the question of whether the choice of an anesthetic regimen might influence patients' outcome we have planned a RCT to determine the impact of sevoflurane on perioperative cardiac damage in patients undergoing cardiac surgery, non-cardiac surgery and stenting procedures.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery
* Non-cardiac surgery
* Stenting procedures

Exclusion Criteria:

* Age \< 18 years old
* Not signing written consent
Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study

The purpose of this study is to assess whether the use of local anesthetic to numb the nerves that run deeper in the abdominal wall gives better post operative pain control than just infiltrating local anesthetic to the wound edges.

Local anesthetic is often administered during an operation to reduce post operative wound pain. Whilst this is frequently done during an appendectomy there is currently no evidence to suggest whether there is any benefit to the patient to injecting the local anesthetic deeper to block the nerves supplying abdominal wall sensation, compared to using it just in the skin around the wound.

Comparison: Post operative pain scores following appendectomy for patients given skin infiltration of local anesthetic (pre incision), compared to patients given both preincision wound infiltration and deeper field infiltration with local anesthetic(deep to external oblique).

Eligibility Criteria:
Inclusion Criteria:

* Lanz incision appendectomy as starting procedure, including those where an alternative cause for symptoms is found at operation and those where incision is later extended/changed (these may be sub grouped at time of analysis)
* Consent obtained

Exclusion Criteria:

* Laparoscopic appendectomy
* Appendectomy at time of laparotomy/other incision
Evaluation of the Increase of the Driving Speed With Walkaide® Medical Device

Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device in deficits levator foot of central origin.

Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device in deficits levator foot of central origin.

The main objective is the study of changes in walking speed on the 6-minute walk test between the initial walk without orthotic and walking with orthotic Walkaide® medical devie after one month of training.

This is a prospective multicenter study, without control group, qualified as a biomedical research.

Eligibility Criteria:
Inclusion Criteria:

* Passive ankle dorsiflexion of at least 0 ° (strained knee)
* No injection of botulinum toxin in the lower limbs for at months 3 months
* No surgery for at least three months
* Walk 10 meters in less than 60 seconds, without human help, with or without technical assistance
* Score the Functional Ambulation Classification (FAC) ≥ 3
* Ashworth Score ≤ 2 sural triceps
* Written consent signed

Exclusion Criteria:

* Presence of severe cognitive impairment that does not allow the use of the device independently
* History of debilitating disease associated general
* Local embarrassing skin disorder laying the electrodes
* Pacemaker
* Unstable Epilepsy
* Pregnancy and lactation
* Participation Refusal
Efficacy of Electrical Pudendal Nerve Stimulation for Patients With Post Prostatectomy Urinary Incontinence

The purpose of this study is to determine whether electrical pudendal nerve stimulation is more effective than pelvic floor muscle training plus transanal electrical stimulation in treating post prostatectomy Incontinence.

Conservative therapy could be considered a choice of treatment for stress urinary incontinence (SUI) as it seems to have no side effect and causes significant and long-term improvement in symptoms. Pelvic floor muscle training (PFMT) and electrical stimulation are two commonly used forms of conservative treatment for SUI. PFMT improves the structural support of the pelvis. However, many patients have difficulty identifying and isolating their pelvic floor muscles (PFM) and are unable to perform the exercise effectively. Furthermore, patients who can identify the PFM often find that the required daily exercise routine is burdensome. Hence, the primary disadvantage of PFMT is lack of long-term patient compliance. Electrical stimulation (ES) is a non-invasive, passive treatment that produces a muscle contraction. Transanal electrical stimulation (TES) has little side-effect, and the patient compliance is 70-85% in published reports. TES results in PFM contraction by indirect nerve stimulation, mainly by polysynaptic reflex responses. The indirect stimulation and reflexive contraction may be the reason why the effect of electrical stimulation is not as good as that of PFMT when performed correctly. By combining the advantages of PFMT and TES and incorporating the technique of deep insertion of long acupuncture needles, we developed electrical pudendal nerve stimulation (EPNS). In EPNS, long acupuncture needles of 0.40 Х 100 or 125 mm were deeply inserted into four sacral points and electrified to stimulate the pudendal nerves (PN) and contract the PFM. CT transverse plane at the coccygeal apex has showed that the position of the lower needle tip is similar to where (adjacent to PN at Alcock's canal) the Bion device is implanted for chronic PN stimulation. Our previous study showed that EPNS had a better therapeutic effect on female SUI as compared with PFMT + TES. Simultaneous records of perineal ultrasonographic PFM contraction, vaginal pressure and pelvic floor surface electromyogram in our previous study have proved that EPNS can exactly excite PN and induce PFM contraction in female SUI patients. However, EPNS has also shown satisfactory effect in male patients with SUI problems. The purpose of this study is to compare the efficacy of EPNS to PFMT + TES in treating male SUI.

Eligibility Criteria:
Inclusion Criteria:

* incontinence at 1 month or more after RP
* ≥2 incontinence episodes a week on baseline 7-day bladder diary
* no residual cancer after RP on pathological examination

Exclusion Criteria:

* the presence of preoperative incontinence
* treatment with anticholinergics
* urinary tract infection or hematuria
* postvoid residual volume\>100 mL
Effects of Optimizing Nocturnal Glycemic Control on Sleep Parameters in Type 1 Diabetes

Sleep is crucial for physical and mental health. Environmental, social, or professional pressures can cause sleep duration to fall below the recommended 7-9 hours of sleep per night. Young adults with type 1 diabetes, have additional interference with fear, control and management of hypo/hyperglycemia management, alarms from their devices, which delay bedtime, disrupt sleep and generate multiple awakenings and difficulty returning to sleep. Sleep disturbance is correlated with blood glucose variability as recently demonstrated by a coupled analysis of sleep and glucose level collected by Continuous Glucose Monitoring (CGM). In this study, higher glucose variability predicted impaired sleep at the individual level.

Automated insulin infusion has shown impressive results in clinical and real-life studies, with more than 90% of patients achieving good glycemic control. Il seems to improve sleep quality in subjects after 4 weeks in hybrid closed-loop, self-administered studies compared to a control group.

The main objective of our study is to measure the positive influence of a better glycemic control on the different sleep parameters in subjects with type 1 diabetes at the time of the passage in hybrid closed-loop and in comparison to an identical period in open-loop.


Eligibility Criteria:
Inclusion Criteria:

* Patients usually followed by the Diab-eCare service (HCL), male or female, between 18 and 50 years old,
* Confirmed diagnosis of type 1 diabetes for more than 1 year regardless of age of diagnosis,
* Eligible according to current recommendations and the center's practices for a hybrid closed-loop solution including all Dexcom G6,
* On pump, whatever the device used, for at least 6 months and with a Dexcom G6 CGM sensor for at least one month with more than 95% of data obtained,
* BMI\<30 kg/m2,
* HbA1C \<10%,
* Do not oppose to the said research.

Exclusion Criteria:

* Patients with type 2 diabetes,
* Patients with a cause other than diabetes that could disrupt sleep:

  * Known or suspected sleep apnea syndrome with high risk according to the Berlin questionnaire, And/or
  * Presence of risk factors such as severe retinopathy, nephropathy, hypertension, autonomic neuropathy, chronic psychiatric disorders, endocrine or metabolic pathologies that have not been stabilized, therapeutics that may alter sleep (i.e. sleeping pills, corticosteroids, antidepressants, anxiolytics, antihistamines), regular use of cannabis, abusive use of alcohol (regularly \> 3 drinks per day for a man and \> 2 drinks for a woman) And/or
  * Night or shift work,
* Inability to collect data and/or understand the objectives of the study according to the investigator,
* Persons under legal protection,
* Persons not affiliated with a social security system
Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome

The purpose of the study is to identify the effect of fully-immersive virtual reality technology on cognitive functions of children with Down syndrome

Intellectual disability is recognized as one of the most prominent features of DS which is the most common genetic cause of intellectual disability. Cognitive functioning often changes across the lifespan and is moderated by several comorbid factors such as sensory impairments, seizures, autism, sleep disruption, and other medical and psychiatric conditions (Grieco et al., 2015).

There is encouraging evidence supporting the use of non-immersive virtual environments to provide useful learning, rehabilitation, and leisure experiences for people with intellectual disabilities. Therefore, immersive VR applications may also be an effective way to improve motivation and engagement for children with DS in learning settings (Michalski et al., 2022). Therefore, this study aims to investigate the effect of full-immersive VRapeutic software gaming technology on cognitive functions of children with Down syndrome

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Down Syndrome Age from 6-10 years Both Genders will be included IQ Ranges from 50-69(mild intellectual disability) they will be able to understand the instructions able to walk independently

Exclusion Criteria:

* Significant Visual or Hearing problems Significant mental or psychological problems that interfere with understanding instructions musculoskeletal problems or fixed deformities in upper or lower limbs Current hospitalization for urgent Medical reasons
Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

The study will prospectively compare the efficacy and safety of chloride hexidine soluted in alcohol with povidine-jodine soluted in alcohol in forefoot surgery.

It will be a comparative study in which we will swab cultures before skin preparation directly after skin preparation and at the and of the operation (hallux valgus correction and arthrodesis of the first metatarsophalangeal joint.

There will be a quantitative and quality analysis of the swabs. We will also measure allergic reactions. During the post-operative period of 6 weeks we will measure the wound infections stated by Prezies.

Eligibility Criteria:
Inclusion Criteria:

* age above 18 years
* written informed consent
* indication for hallux valgus correction or arthrodesis of the first metatarsophalageal joint

Exclusion Criteria:

* allergic for jodine-povidine and/or chloride-hexidine
* active infection
* skin defect
* blood clotting or coagulation disorder
Netflix Streaming Services in the Operating Room During Total Knee Replacement - a Feasibility Study

The purpose of this research study is to test the safety, tolerability, and effectiveness of watching streamed videos through virtual reality (VR) goggles during surgery.

The results of this study will be used to evaluate whether video-streaming services on VR goggles are worthwhile additions to standard anesthesia care during total knee surgery.

Usual anesthetic care for total knee replacement involves intravenous sedation as well as spinal anesthesia. In this study, participants will receive usual care, and in addition, will be asked to wear VR goggles once they arrive in the operating room. Participants will choose from a selection of 10 shows and movies to watch for the duration of the surgery (approximately 2 hours).

Eligibility Criteria:
Inclusion Criteria:

1. undergoing a primary elective total knee replacement by one of the orthopedic joint surgeons at Virginia Commonwealth University Medical Center
2. 18 years of age or older
3. eligible for spinal anesthesia
4. mentally capable of understanding instructions on how to request anesthesia medication

Exclusion Criteria:

1. identified as a member of regulated vulnerable population
2. ineligibility for spinal anesthesia
3. morbid obesity (body mass index greater than 40)
4. allergy to propofol or midazolam
5. pre-operative daily opioid consumption of more than 10 mg oxycodone every 6 hours (over 60 morphine miligram equivalents per day)
6. daily benzodiazepine consumption
7. history of alcohol or recreational drug abuse
8. hearing or visually impaired individuals
Feasibility of a Trial Evaluating the Effectiveness of Occupational Therapy in Parkinson's Disease

The purpose of this study is to determine the feasibility of a RCT evaluating the effectiveness of occupational therapy in Parkinson's disease.

Parkinson's disease is a complex disabling condition progressively affecting activities and participation of patients. Occupational Therapy aims to optimise functional performance and engagement in meaningful roles and activities. The lack of scientific evidence for the effectiveness of Occupational Therapy (OT) in Parkinson's Disease (PD) highlights the urgent need for high quality intervention studies. The recently developed Dutch clinical practice guideline for OT in PD offers a good basis for conducting an intervention study. This proposed pilot study is an important step towards setting up a large scale RCT to evaluate the effectiveness of OT in improving daily functioning of patients with PD and reducing caregivers' burden.

Eligibility Criteria:
Inclusion criteria patients:

* idiopathic Parkinson's Disease according to UK Brain Bank Criteria
* home dwelling
* indication for occupational therapy (according to criteria in the evidence based guideline)

Inclusion criteria caregivers:

* available to provide informal support minimal two times a week to a patient who participates in the study.

Exclusion criteria patients:

* not capable of completing the self assessment forms (i.e. due to language or severe cognitive problems)
* comorbidity with symptoms that interfere with actively taking part in the intervention (e.g psychosis, severe heart condition). Or limitations in activities are dominated by the co morbid condition rather than by Parkinson's Disease.
* current participation in other allied health research (IMPACT, PARKFIT, ERGODIM)
* having received occupational therapy intervention in the last 12 months
Bone Marker Changes With Teriparatide/Postmenopausal Osteoporosis

To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously, for one month, are able to produce reliable changes in the bone marker in a severe osteoporotic population


Eligibility Criteria:
Inclusion Criteria:

* Presents with severe osteoporosis based on the disease diagnostic criteria and upon physician assessment
* Postmenopausal, nonpregnant, women older than 50 years of age, with previous fracture history such as hip, spine, wrist, ribs, clavicle, humerus, tibia, and fibula or men over 50 years of age with low impact fractures (fragility).
* Outpatients without concomitant diseases and with life expectancy of at least 3 years, according to the medical criteria.
* Cannot be on medicines that can disturb bone metabolism.
* Patients should be capable of self-injection, to learn the use of Pen device and are in agreement with its use.

Exclusion Criteria:

* Directly affiliated with the conduct of this study, or are the immediate family of someone directly affiliated with the conduct of this study (that is, Lilly employees, investigators, site personnel, or their immediate families). Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
* Previously completed or withdrawn from this study or any other study investigating Teriparatide.
* Secondary osteoporosis or any disease that affects the bone metabolism, as renal osteodystrophy, osteomalacia, hypoparathyroidism, and hyperparathyroidism, and intestinal malabsorption.
* Cancer history in the 5 years prior to visit 1, with exemption of basocellular carcinoma treated and cervix carcinoma definitively treated at least 1 year before to visit 1