cyrilzakka/clinical-trials huggingface dataset:
Immersive Virtual Reality for Dual-task Training in Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial

Mild cognitive impairment (MCI) is a pre-dementia state marked by a higher risk of conversion to dementia. Presently, strategies to delay the progression of MCI to dementia, such as routine exercise and cognitive activities, are limited and only moderately efficacious. Cognitive-motor dual task training, enhanced in a virtual reality environment, is a novel intervention for individuals with MCI.

A randomized controlled trial will be conducted. 54 patients with MCI will be recruited from an outpatient clinic. The participants will be randomly allocated to one of the three study arms. All three groups will participate in 2 training sessions per week for 7 weeks. Each session lasts 32 to 40 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 - 80 years of age
* Diagnosis of mild cognitive impairment (MCI)
* Able to walk independently without assistance, whether from a person or a walking aid

Exclusion Criteria:

* Diagnosed dementia (at the point of recruitment)
* Presence of end stage lung, cardiac, liver and/or renal disease
* Unstable acute medical conditions that prevent one from exercising on a treadmill
* Presence of active arthritis, with symptoms affecting function
* Cerebrovascular and/or cardiac events in the last 6 months
* Parkinson's disease
* History of hip fracture within the last 6 months
* History of epilepsy with seizures in the last 2 years
* Poor vision, not correctable by glasses
* Hearing difficulty (if unable to hear well at normal conversational volume)
* Acute backache with pain affecting ambulation
* Acute lower limb pain with pain affecting ambulation
* Cervical spondylosis with myelopathy or cervical spine issues
* Chronic vertigo
* Vestibular problems, causing issues with balance
Effects of Fenofibrate on Gene Expression in Healthy Volunteers

The purpose of this study is to assess how fenofibrate modify gene expression in circulating monocytes of healthy volunteers after 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female,
* To be aged 40-65 years,
* To be post menopausal female not receiving hormone replacement therapy,
* To have normal homocysteine, folate and vitamin B12 levels at baseline (results available for initiation of treatment),
* To be in good health as determined by medical history, physical examination, ECG, vital signs, serum/urine biochemistry and hematology.

Exclusion Criteria:

* Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, neurologic/psychiatric or emotional, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, (drug) allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking the study medication,
* Subjects who have been treated with fenofibrate in a previous study,
* Subjects who have taken a single dose of an investigational drug within 30 days or multiple doses of any investigational drug within 60 days prior to dosing
Hypotension Prediction Index Based Perioperative Protocolized Hemodynamic Management in Geriatric Orthopedic Surgery

Blood pressure optimization has been considered as a crucial factor to avoid perioperative vital organ hypoperfusion, and perioperative hypotension has been addressed as a risk factor for complications and adverse clinical outcomes.

Hypotension prediction index (HPI) is an novel machine-learning derived parameters, and was developed to predict the risk of future hypotension.Series of clinical studies have verified its clinical efficacy in avoiding perioperative hypotension.

Major orthopedic surgeries, such as spine surgery, joint surgery, long bone fracture surgery, are quite common in elder people, who are vulnerable to perioperative adverse outcomes.Thus the investigator design this study to testify the clinical efficacy of implementing HPI in perioperative goal-directed hemodynamic therapy in elder patients receiving major orthopedic surgery.


Eligibility Criteria:
Inclusion Criteria:

* adults elder or equal to 60 years old receiving scheduled orthopedic surgery

Exclusion Criteria:

* Patients with a history of arrhythmia, congestive heart failure, preoperative neurocognitive disorder, cerebrovascular event, chronic obstructive pulmonary disease, chronic kidney disease, ongoing infectious disease, will be excluded.
Heparin Based on Ideal Body Weight for Cardiopulmonary Bypass in Obese Patients

The optimal heparin regimen during cardiopulmonary bypass (CPB) has not been well established in obese patients.

Results of a preview study show that the standard heparin management based on total body weight in obese patients during CPB resulted in excessive heparin level, which could lead to excessive postoperative bleeding.

To avoid this overdosing, an initial heparin bolus based on ideal body weight in obese patients was proposed.

The main objective of the study is to evaluate the effects of heparin injection, based on ideal body weight, on intraoperative plasma heparin levels and activated coagulation time (ACT) in a population of obese patients, compared to a group of obese patients undergoing CPB surgery with heparin management based of total body weight.

The secondary objectives are to evaluate the relationship between heparin level and ACT in each group of patients and at different time points during CPB, and to compare the incidence of bleeding, intraoperative transfusions and complications in the two groups of patients.


Eligibility Criteria:
Inclusion criteria:

* Obese patients (BMI ≥ 30 kg/m²)
* Planned cardiac surgery under cardiopulmonary bypass
* Coronary-artery bypass graft, or valve surgery)
* Age ≥ 18 yo

Exclusion criteria:

* Allergy to heparin
* Emergency surgical intervention
* Redo surgery
* Heart transplantation
* Surgery for circulatory assistance
* Pre-operative heparin use
Bee Venom for the Treatment of Parkinson Disease

The purpose of this study is to evaluate the efficacy of repeated (monthly) injections of bee venom on motor symptoms of Parkinson's disease over a period of one year, also the potential effects of this treatment on disease progression compared to placebo (saline injections).

The investigators plan to assess the potential efficacy of repeated (monthly) injections of bee venom on the motor symptoms of Parkinson disease over a period of one year. The investigators will also assess the potential effects of this treatment on disease progression. All assessments will be conducted in comparison to placebo (saline injections).

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Parkinson disease according to the Parkinson's Disease Society Brain Bank criteria (Hughes et al., 1992)
* Age \> 40 ans (exclusion of juvenile forms)
* Hoehn and Yahr stage 1,5-3 off
* Pathological DaTSCAN
* MRI excluding atypical or secondary forms of parkinsonism
* Negative testing to bee venom (intradermoreaction)
* Affiliated to the French Social Security System

Exclusion Criteria:

* Parkinson disease Hoehn \& Yahr stage \< 1,5 or \> 3
* Positive intradermoreaction to bee venom
* IgE positive to bee venom
* Known allergy to bee venom
* Contra-indications to treatment with bee venom (Alyostal®)
* Atypical or secondary parkinsonian syndrome (verified by MRI)
* Treatment with antipsychotics over the past 6 months
* Cardiac, hepatic or renal failure
* Normal DaTSCAN
* Contra-indications to MRI scanning
* Pregnancy
* Major depression or other severe acute/ongoing psychiatric disorder
* Cognitive impairment (MMS \>24)
* Patient under guardianship
Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula

The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.


Eligibility Criteria:
Main Inclusion Criteria:

Infants:

* with cow's milk allergy confirmed by a double-blind food challenge performed in the last 2 months,
* successfully fed an eviction diet for at least 2 weeks

Main Non-inclusion Criteria:

Infants:

* fed with an extensively hydrolyzed formula with no improvement of the symptoms,
* who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
* fed a vegetable based formula
* fed an amino acid based formula or who should be fed with an amino acid based formula according to recommendations
* who had an anaphylactic reaction in the past
Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II

Modified Radical Mastectomy accounts for 31% of all breast surgeries and considered the fundamental surgical management for breast cancer. Nearly 40-60% of patients experience severe acute postoperative pain. This pain might persist for 6-12 months and result in post-mastectomy pain syndrome and complex regional pain syndrome (causalgia)

There are some local or regional nerve blocks in breast surgeries performed as core components of multimodal analgesia and enhanced recovery after surgery (ERAS), including thoracic epidural (TEB), interscalene brachial plexus, paravertebral, ultrasound-guided pectoral nerve block ( PECS II ), ultrasound-guided serratus anterior plane block (SAPB) and erector spinae plane block .

Thoracic epidural (TEB) is the gold standard technique following breast surgery, but there is still a problem with the adequacy of thoracic and axillary blockage during lymph node dissection .

Modified PECS's block" or PECS block type II aimed to block the axilla that is vital for axillary clearances and the intercostal nerves, necessary for wide excisions which can provide analgesia after breast surgery.

In the ultrasound-guided serratus anterior plane block (SAPB), the local anesthetic (LA) is injected in the compartment between the serratus anterior and latissimus dorsi muscles. SAPB anesthetizes the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve thus providing analgesia for breast and lateral thoracic wall surgeries

Eligibility Criteria:
Inclusion Criteria:

* Women aged 35-65 years.
* BMI 18.5 - 25 kg/m2.
* American Society of Anesthesiologists (ASA) I-II.

Exclusion Criteria:

* Patient refusal.
* Coagulopathy.
* Mental and psychiatric disorders.
* History of chronic pain.
* Hypersensitivity or contraindication to any of study drugs
* Previous chemotherapy.
Effect of Olopatadine on Allergic Tear Mediators

The purpose of the research is to determine which inflammatory substances are involved in causing allergic symptoms in the eye. Allergic conjunctivitis is a common problem with symptoms of temporary redness, itching, tearing, and swelling of the eyes. Substances released by cells in the affected tissues cause allergic reactions in the eye and elsewhere in the body.

Ocular allergies are extremely common, affecting up to 80 million people in the USA. Our research question is:

Are there differences in inflammatory mediators and cell surface activation markers in patients undergoing seasonal allergic conjunctivitis compared to those with sight threatening disease such as Atopic Keratoconjunctivitis (AKC) and will the use of the anti-allergy eye drop, PATANOL® (olopatadine hydrochloride) affect these parameters?

Experimental Design:

Ocular surface cells (by impression cytology) and tears (via capillary tube) are collected from allergic, non-allergic, and AKC subjects undergoing an reaction induced either by seasonal allergen or topical allergen provocation (specificity and dose determined via skin testing). Ocular surface cells are evaluated for surface activation markers. Tears are evaluated for mediator content. Tears are also incubated with peripheral blood eosinophils and lymphocytes to see effects on adhesion to conjunctival epithelial cells.

Eligibility Criteria:
Inclusion Criteria:

* Skin test positive
* Able to put drops in eyes
* Able to have tears collected
Impact of Non-Commercialism Policy in Seattle Schools

This pilot study on the impact of a non-commercialism policy in Seattle schools will assess and evaluate obesity-related health outcomes of a real-life policy decision, recently voted on and adopted by the Seattle School Board. The policy reduces the exposure to advertising and other marketing pressures, including those from commercial food vendors.


Eligibility Criteria:
no restrictions
Creatinine Clearance as a Predictor of Successful Withdrawl of Continuous Renal Replacement Therapy in Intensive Care

Acute renal failure is a common complication in patients admitted to intensive care. Due to the increasing incidence of acute renal failure, the use of Continuous Renal Replacement Therapy (CRRT) is on the rise in the intensive care unit. The use of CRRT exposes patients to some complications (bleeding, hemodynamic instability, antibiotic underdosing, malnutrition and infections), justifying the importance of optimizing the quality and reliability of this technique. Renal function is classically assessed by diuresis and creatinine. Creatinine clearance is an indirect measure of glomerular filtration rate. Measuring creatinine clearance is a simple, accessible and relatively inexpensive method. Traditionally, clreatinine clearance has required 24-hour urine collection. However, it has been shown that two-hour urine collection is also an accurate tool.

There is little information and few recommendations as to when to discontinue CRRT. A predictive index for the withdrawal of CRRT would reduce the duration of treatment, reduce complications and costs, and speed up patient rehabilitation.

Various parameters have been described as tools for deciding when to stop dialysis: diuresis before stopping CRRT, urine and blood creatinine, daily urinary urea excretion, and sodium and water balance. Among these factors, urine output and creatinine appear to be promising predictive factors. The measurement of creatinine clearance combines these two factors and can therefore be a good tool for predicting the return of adequate renal function. Retrospective work carried out by Fröhlich et al in 2012 suggested that creatinine clearance measured over 2 hours could be a good marker for successful withdrawal.

The hypothesis of the study is that creatinine clearance measured over 2 hours after stopping CRRT is be predictive of the success of the withdrawal from this type of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Dialysis for AKI with minimum 12 hours of continuous renal replacement therapy (CVVH-CVVHD)
* Patient in whom dialysis withdrawal is being considered
* Patients over 18 years of age

Exclusion Criteria:

* Pre-existing chronic end-stage renal failure on chronic dialysis
* Extrarenal purification during hospitalization prior to admission to intensive care unit
* Inability to assess the primary outcome
* Kidney Transplantation
* Pregnant Women
* Person not affiliated to a national health insurance
* Decision to limit or stop therapy
* Isolated hyperkalemia
* Refusal of patient participation
Preliminary Study of Sonic Hedgehog Signaling Pathway in the Pathogenesis of Rheumatoid Arthritis

Rheumatoid arthritis(RA) with a high incidence and high morbidity, the pathogenesis has not been fully elucidated. Fibroblast-like synovial cells excessive proliferation and synovial angiogenesis is the most important cause of RA synovitis and joint destruction. Our study was to find the role of Sonic Hedgehog(SHH) pathway in regulating proliferation of fibroblast-like synovial cells and modulating excess angiogenesis of synovial tissue.

4ml blood from active RA patients(n=35) and healthy volunteers (n=35) will be collected

* peripheral blood mononuclear cells will be detached
* messenger ribonucleic acid expression of Sonic Hedgehog pathway associated factors in both groups will be detected

Synovial tissues from 4 RA patients and 4 patients with traumatic or meniscal injury who need to carry out knee joint replacement operation will be collected

* inflammatory feature of synovial tissue will be observed
* the expression of Shh, Ptch1, Gli1 and Smo in synovial tissue will be detected by immunohistochemistry assay
* fibroblast-like synoviocytes will be cultured from synovial tissue of RA patients

Eligibility Criteria:
Inclusion Criteria:

* definitely diagnosed
* the disease is active (DAS28\>3.2)

Exclusion Criteria:

* combined with severe organ dysfunction
* combined with other rheumatic diseases
Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI in Granulosa Cells

To study the influence of different daily rec-FSH dosages (150 IU versus 300 IU), performed in the same patient in consecutive cycles, on the relation between FSH- and LH-receptors of the granulosa cells of the growing follicle.

This is a prospective cross-over study. Investigators want to study the effect of different dosages of recombinant FSH in the same patient on the expression of the FSH- and LH-receptors in the granulosa cells and on the endocrine milieu in the blood and the follicular fluid. An improved understanding of the mechanism leading to progesterone elevation might initiate a change in the ovarian stimulation approach, thereby not only preventing progesterone elevation and its negative consequences on ART (Assisted Reproductive Technology) outcome, but also improving individualization of the ovarian stimulation treatment according to the patients' characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Desire to perform oocyte freezing for social fertility preservation, age 18 - 38 years
* BMI of 18-32 kg/m2
* Regular menstrual cycles with a length of 24-35 days
* Anti-Muellerian-Hormone levels between 1.3 - 6.25 ng/ml (Ferraretti and Gianaroli, 2014; Calzada et al., 2019)

Exclusion Criteria:

* Occurrence of ovarian hyperstimulation syndrome (OHSS)
* Occurrence of poor ovarian response (AFC \< 5 and AMH \< 0,5ng/ml) in previous ovarian stimulation treatment (20)
* Polycystic ovary syndrome (PCOS) (21)
Mcgrath Videolaryngoscope Versus Macintosh Laryngoscope in Patients With Manual In-line Stabilization

Video laryngoscopy provides easily a good laryngeal view compared to direct laryngoscopy. It is particularly, useful in patients with anticipated difficult intubation, and also widely used for educational purposes. Among video laryngoscopy, Mcgrath is a recently-developed, portable video laryngoscopy with a liquid crystal display (LCD) monitor and disposable curved blade.

Mcgrath is known to provide excellent laryngeal visibility even in case of anticipated-difficult and anticipated-unsuccessful intubation as well as normal airway management. However, compared with direct laryngoscopy, the success rate of intubation and the time required for anticipated difficult intubation have been reported conflicting results in previous studies. The aim of this study was to compare the intubation success rate, the intubation time and the ease of use with Mcgrath video laryngoscopy and direct laryngoscopy during intubation.

1. In the operating room, all patients are monitored with an electrocardiograph, noninvasive blood pressure, pulse oximeter, capnograph and Bispectral index (BIS) monitor. After pre-oxygenation with 100% oxygen for 1 minute, intravenous anesthesia (TIVA) with propofol and remifentanyl is administrated and followed by rocuronium (0.6mg/kg). When patients are lost their consciousness, manual mask ventilation is proceeded with 100% oxygen for 2 minutes.
2. Transoral endotracheal intubation is performed using Mcgrath videolaryngoscope (Group ML) and direct laryngoscope (Group DL) using manual in-line stabilization. At this time, the time required for intubation is measure by other medical personnel not engaged in this research.
3. The anesthesiologist assesses Cormack Lehane laryngeal visual field,external laryngeal manipulation, intubation difficulty scales (IDS) and the difficulty of intubation.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for general anesthesia requiring tracheal intubation. Patients are aged 19 to 70 years and are American Society of Anesthesiologists physical status I, II.

Exclusion Criteria:

* Patients requiring rapid sequence intubation Patients with poor teeth or high risk of aspiration pneumonia Cervical spine pathology, pharyngeal pathology
Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients With Intermittent Claudication Compared to Best Available Treatment?

Intermittent claudication (IC) is caused by a blockage in the artery of the leg, causing muscle pain. Although some evidence of the efficacy of neuromuscular electrical stimulation (NMES) in the management of patients with IC exists, further high quality research is required. This proposed study is vital to identify the contribution of clinical change using NMES, compared to the current gold standard recommended practice of supervised exercise therapy (SET) and, actual standard of care offered in the majority of the UK and Ireland, including best medical therapy (BMT). The device is expected to increase the walking distance in patients with intermittent claudication (IC), and therefore have a benefit on the same when provided in addition to supervised exercise programmes. It is also expected to cause a reduction in pain symptoms and reduced likelihood of major intervention in late stage peripheral arterial disease (PAD). The principal research objective is to assess the clinical efficacy of a neuromuscular electrical stimulation (NMES) device as an adjunct to the local standard care that is available at the study randomisation sites, in order to improve walking distance in patients with intermittent claudication (IC).


Eligibility Criteria:
Inclusion Criteria:

* Capacity to provide informed consent
* Aged 18 or above
* Positive Edinburgh Claudication Questionnaire
* ABPI \<0.9 OR positive stress test (fall in ankle pressure \>30mmHg, 40 secs post 1 min treadmill at 10% gradient, 4 km/h)

Exclusion Criteria:

* Severe IC requiring invasive intervention as determined by the treating clinician
* Critical limb Ischaemia as defined by the European Consensus Document
* Co-morbid disease prohibiting walking on a treadmill or taking part in supervised exercise therapy.
* Popliteal entrapment syndrome
* Commenced vascular symptom specific medication in previous 6 months e.g. naftidrofuryl oxalate, cilostazol
* Pregnancy
* Any implanted electronic, cardiac or defibrillator device
* Acute deep vein thrombosis
* Broken or bleeding skin including leg ulceration
* Peripheral neuropathy
* Recent lower limb injury or lower back pain
The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants

This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula.


Eligibility Criteria:
Inclusion Criteria:

* Singleton, 10-14 days of age at randomization
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula fed
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or formula intolerance