rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
teleRehabilitation for pAtients With ParkInson's Disease at Any mOment
Status: Recruiting

The goal of this clinical trial is to test the feasibility and safety of a telerehabilitation and telemonitoring approach in people with Parkinson's disease at any stage. The main questions it aims to answer are: will patients with Parkinson's disease comply with the recommended level of training at home using an ad hoc developed telerehabilitation platform? • Will this training be safe and impact the patient's well-being perception? Participants will be given a tablet and instructed to access an online platform to observe different motor tasks presented in as many video clips by experienced therapists.They will be requested to perform the motor tasks per a predetermined protocol over 3 months. Their compliance with the recommended training will be checked by physiotherapists every 15 days during phone calls, whereas their daily level of motor activity will be recorded by a smartwatch.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of Parkinson's disease (according to Movement Disorder Society criteria) Ability to provide written informed consent.  Exclusion Criteria:  moderate-severe cognitive impairment (MoCA≤18) any other factor known to interfere with the ability to interact with the telerehabilitation platform (e.g. poor visual acuity, lack of family support); comorbidities with adverse impact on functioning or survival or affecting the performance of physical exercise (e.g. serious neoplastic diseases, cardiovascular diseases not controlled pharmacologically including arterial hypertension or hypotension, cardiac arrhythmias, heart failure, musculoskeletal diseases, dizziness or vertigo); severe depression or other neuropsychiatric disorders; expected need for adapting antiparkinsonian drug regimen over a 6 month period. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Beverage Hydration Index: Assessment of Four Rehydration Solutions
Status: Recruiting

No studies to date to evaluate the effects of the three different liquid IV electrolyte products on the beverage hydration index (BHI). Therefore, the purpose of this study is to determine the impact of three different LIV products (Hydration multiplier, Sugar Free formulation with Amino Acids, and Sugar Free with allulose) on hydration status in young and active men and women compared to a control (water). The study will follow the same approach as used by Maughan and colleagues (2016) to measure the fluid balance (the difference between the amount of water consumed and passed as urine) and BHI (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance, as well as determining electrolyte concentrations, osmolality, specific gravity, and sodium and potassium in urine.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  body mass index (BMI) <35 kilgrams per square meter consistent dietary intake and exercise throughout study period consumes 2 liters (women) or 2.5 liters (men) of water per day prior to study visits able to fast for 15 hours  Exclusion Criteria:  sensitivity or be allergic to any components of the study product they will be excluded. tobacco user specialized diet (low carbohydrate/ketogenic diet, carnivore diet, intermittent fasting, etc.) caffeine consumption within 12 hours of study visit strenuous activity within 24 hours of study visit history or presence of a clinically relevant (that required or requires treatment) cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder conditions that alter fluid balance or electrolytes/hydration status consuming any medication which may alter fluid retention/electrolyte levels such as sodium-glucose co-transporter 2 (SGLT2) inhibitor (for type 2 diabetes), laxatives, diuretics, Apremilast, chemotherapy, or lithium. consuming nutritional supplements, performance enhancing drugs, and/or non-steroidal anti-inflammatory drugs within 7 days of study visits excluding screening). employee of Liquid IV be enrolled in another clinical study within 30 days of the first study visit active infection or illness of any kind - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA - Hip Replacement: 3D Planning
Status: Not yet recruiting

The study will analyze hip biomechanical parameters using EOS radiographic measurements pre- and post-operatively (3 months) and post-operatively (3 months) CT scans after total hip replacement (THR), neck-preserving THR of the Minihip type or hip resurfacing (HR). Clinical results will be assessed at 3 months and 1 year after surgery.

To this end, two types of examination are carried out, both of which are used in current practice:

Pre-operatively: EOS radiography
Post-operatively: EOS radiograph and CT scan

Inclusion (m-3; m-1) :

Patient information at pre-operative visit
Non-opposition of patient, family member or legal guardian, if applicable
Questionnaires and clinical examination (standard management)
EOS during anesthetic consultation

Follow-up visit (m+3):

- Post-operative follow-up consultation EOS and CT scan (1 week prior to visit) + questionnaire and clinical examination

Follow-up visit (m+12):

- Post-operative check-up, questionnaire and clinical examination

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female Age ≥ 18 years Planned surgery: total hip arthroplasty, Minihip or RSA Absence of osteoarthritis or osteoarthritis ≤ stage 1 (Tönnis classification) of contralateral hip (Radiographic analysis) Patient having given his/her non-opposition to participate in the study Patient with social insurance Patient willing to comply with all study procedures and duration  Exclusion Criteria:  Patient with comorbidity(ies) likely to affect biomechanical parameter measurements or surgical conditions: Anomalies or anatomical changes of the hip, pelvis or lumbar spine (history of fracture, protrusion, scoliosis, history of orthopedic surgery, dysplasia, torsion disorder) Established genetic disease affecting the musculoskeletal system Severe or morbid obesity Neuromuscular pathologies affecting the limb girdles Severe osteoporosis Bone location of primary or metastatic cancer (spine, pelvis or femur) - Inequality of lower limb length > 2 cm. Minors Protected adults Pregnant or breast-feeding women Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to participate. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients, primary care clinic at Lille University Hospital, single-center study - SamplingMethod: Probability Sample
Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children.
Status: Not yet recruiting

The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Ability to confirm voluntary participation and agree for all the purposes of the test, signing and dating the Term of Free and Informed Assent (TALE), signed by the Free and Informed Consent Form (TCLE) by responsible; Age ≥ 6 years and ≤ 11 years on the day of signing the TALE and the TCLE by the person responsible; Diagnosis of moderate to severe persistent allergic rhinitis (PAR) according to the criteria of Allergic Rhinitis and its Impact on Asthma (ARIA); Presence of sensitization to aeroallergens confirmed by positive result to the immediate reading skin test (PRICK test) and/or the presence of specific IgE to the test radioallergoabsorbent (RAST); Symptom intensity score "nasal obstruction" ≥ 2 points. Total nasal symptoms score (TNSS) ≥ 8 points.  Exclusion Criteria:  Use of prednisolone or other oral or parenteral corticosteroid in the seven (07) days prior to inclusion; Use of H1 antihistamine, anti-leukotriene and decongestant topic in the seven (07) days prior to inclusion; Use or indication for the use of antibiotics at the screening visit and randomization; Presence of adenoid hypertrophy or anatomical disorders known obstructive disorders (e.g. septal deviation) that may be held responsible for nasal obstruction, at the discretion of the investigator; Diagnosis of severe or uncontrolled asthma; Allergy to desloratadine, prednisolone or any other component of the formulation of investigational products (PSIs); Presence of systemic fungal infection; Presence of any uncontrolled infection; Presence of any clinical observation finding (evaluation clinical/physical) or laboratory condition that is interpreted by the investigator physician as a risk to participation in the trial clinical or presence of serious uncontrolled disease(s); Participants who are pregnant or breastfeeding; Participation in clinical trial protocols in the last 12 (twelve) months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator believes that there may be direct benefit to the participant. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 11 Years - StdAgeList: Child
Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch
Status: Not yet recruiting

Over the past few years, various systems have been developed to record ECG traces on an ambulatory basis. The latest connected watch models feature 2-electrode ECG recording. This single or six derivations can be used to derive a wealth of information about the heart's rhythm. The information that can be derived from an ECG recording with a derivation goes far beyond̀ simple differentiation between atrial fibrillation and sinus rhythm. In contrast, in various clinical situations, a tracing restricted to an ICD may prove falsely normal, wrongly reassuring a patient and delaying management. The primary objective of the study is to evaluate the sensitivity of ECG-1D or 6D recordings from a connected watch in measuring electrical parameters, compared with a standard ECG-12D, also to obtain a bank of tracings, to create and validate an artificial intelligence algorithm for the automatic analysis of ECG tracings recorded with a connected watch and also to validate the feasibility and sensitivity of recording an ECG tracing with a connected watch in children.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients hospitalized or seen in consultation in one of the departments of the Haut Lévêque cardiology hospital, Patient of both sexes, minor (from birth to 18 years) or adult, Free, informed and written consent from the patient or, in the case of minors, from the legal parent (at the latest on the day of inclusion and before any examination required for the research), Subject affiliated to or benefiting from a social security regime.  Exclusion Criteria:  Person incapable of giving consent, Person subject to a legal protection measure (safeguard of justice, tutorship or curatorship), A person deprived of liberty by judicial or administrative decision. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
Croup Dosing Study
Status: Not yet recruiting

Croup is a common childhood respiratory disease that often leads to frequent emergency department visits. It is a viral infection that causes cough, throat, and airway swelling, making breathing difficult. Dexamethasone is a medication that helps to reduce swelling, making breathing easier for children. A standard dose of 0.6mg/kg is used in children. However, a lower amount (due to side effects of steroids in children) has been suggested. We will examine whether 25% less than the standard dose is equally effective in treating croup. Investigators will conduct a clinical study with the support of patients with lived experience (which, in this case, are the parents of the children) to better care for children with croup. If proven, this study can improve the outcome in children with croup.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children aged with clinical diagnosis of croup  Exclusion Criteria:  Children who are unable to tolerate or ingest oral dexamethasone, Known hypersensitivity/allergy to dexamethasone, Other causes of stridor (such as acute epiglottitis, bacterial tracheitis, anaphylaxis, foreign body aspiration), Other underlying systemic diseases defined as chronic lung disease, chronic heart disease, chronic kidney disease, and immunodeficiency), Recent exposure to varicella, Treatment with oral or intravenous corticosteroids within the preceding 72 hours. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Months - MaximumAge: 5 Years - StdAgeList: Child
Individualizing Treatment for Asthma in Primary Care
Status: Recruiting

This is a patient level randomized trial for teenagers and adults with asthma who will be randomized to four arms - enhance usual care, rescue inhaled corticosteroids, azithromycin and both rescue inhaled corticosteroids and azithromycin. Participants in all arms will be offered access to an online asthma symptom monitoring system.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  A clinical asthma diagnosis for at least 1 year; 12-75 years of age; A current ACT total score of <20 OR an exacerbation requiring 72 hours or more of parenteral steroids or a hospitalization of at least 24 hours > 30 days and < 365 days prior to enrollment; Able to provide consent (adolescents: assent) in English or Spanish; (i.e., cognitively impaired individuals are deemed not to be able to provide consent and thus do not meet inclusion criteria.) Patients with a coexisting clinical diagnosis of COPD are eligible if they meet any one of the following criteria: (i) Never smoker without secondary lung disease causing airway obstruction. (ii) Current or former smoker with obstruction on PFTs, but normal diffusing capacity of the lungs for carbon monoxide (DLCO) in the past 24 months.  Exclusion Criteria:  Life expectancy <1 year (operationalized by the question to the patient's asthma care clinician "Would you be surprised if this person died in the next 12 months? If yes - include, if no - exclude); No ICS prescribed for the individual (does not have to be using the ICS inhaler); Active treatment for hematological or solid organ cancer other than basal cell or skin squamous cell cancer; Allergy to macrolides or conditions for which macrolide administration may possibly be hazardous (e.g., acute or chronic hepatitis, cirrhosis, or other liver disease; end-stage renal disease; uncorrected hypokalemia or hypomagnesemia; clinically significant bradycardia; or history of prolonged cardiac repolarization and QT interval or torsades de pointes); On daily or every other day oral steroids for any reason; Currently on R-ICS or AZ therapy. Individuals on biologics can be enrolled if they have been on a stable dose for > 6 months and meet the ACT or exacerbation criteria as well as all other criteria. On a medication with known risk (i.e., that is associated with prolonged QT and associated with torsades de pointes even when taken as recommended) or possible risk (i.e., can cause prolonged QT but lacks evidence for risk of torsades de pointes when taken as recommended) - Full lists in Appendix 1. Specified medications for which close monitoring has been recommended in the setting of macrolide administration (digoxin, warfarin, theophylline, ergotamine or dihydroergotamine, cyclosporine, hexobarbital, phenytoin or nelfinavir). - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 75 Years - StdAgeList: Child, Adult, Older Adult
The Use of Antiarrhythmic Drugs in Pediatrics
Status: Not yet recruiting

A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital, a clinical audit

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All Patients with Arrhythmic cardiac diseases admitted at cardiology unit Assiut University Hospital aged from 1 month to 18 years. All patient receiving antiarrhythmic drugs admitted to Assiut University Hospital for Children.  Exclusion Criteria:  • Any patient on drugs other than antiarrhythmics. - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Days - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: All Patients with Arrhythmic cardiac diseases admitted at cardiology unit Assiut University Hospital aged from 1 month to 18 years. - SamplingMethod: Non-Probability Sample
Remote Programming of Cardiac Implantable Electronic Devices 2
Status: Recruiting

Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full CIED check-up and reprogramming is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. In this study we aim to evaluate our previously validated remote programming solution (REACT study, NCT05366660) in outpatient device clinics which are close to the patient's home but remote from the CIED expert.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient of both sexes over the age of 18 Patients implanted with a cardiac pacemaker or an automatic defibrillator and an indication for device check-up (interrogation ± programming) Patient followed at the Bordeaux University Hospital but living more than 90km away Person beneficiary of social security insurance Informed consent confirmed in writing (at the latest on the day of inclusion and before any examination required by the research) Women of procreating age with effective contraception  Exclusion Criteria:  Patients younger than 18 years old Patients who are incapable to understand the study design or to give informed consent. Pregnant or breastfeeding women Persons placed under judicial protection, curatorship, tutorship. Subject deprived of liberty on judicial or administrative decision Persons participating in another study who are still in their period of exclusion - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Milk and Plant Protein Digestion
Status: Recruiting

The goal of this study is to explore the effect of protein quantity and quality in plant-based drinks. Healthy normal-weight males aged between 18 and 45 years will be included in the study.

The main objectives are to examine the differences in postprandial amino acid profiles, and to examine differences in gastric behavior between cow's milk and plant based drinks.

Participants will visit after an overnight fast three times and have blood draws before and after consumption one of the study drinks. There will be MRI scans of the stomach before and after consumption of the drink to assess gastric behavior.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male Age 18 - 45 y Apparently healthy (self-reported) Normal-weight (BMI 18.5 - 25 kg/m2) Willing to be informed about incidental findings of pathology Willing to comply with the study procedures  Exclusion Criteria:  Allergy or intolerance for cow milk, lactose or gluten (self-reported) Gastric disorders or regular gastric complaints, for example heart burn  Use of medication which alters the normal functioning of the stomach, such as:  Medical drug use that influences the GI tract's normal function, e.g. motility, pH etc.: among others use of protein pump inhibitors, antacids, anti-depressants etc. (judged by study doctor) Medical drug use that influences the GI tract's microbiota: antibiotic use within one month prior to the pre-study screening day (judged by study doctor) Following a vegan diet Smoking (>2 cigarettes a week) Having a chronic illness that could affect food digestion and nutrient absorption including but not limited to kidney disease, thyroid disease and diabetes mellitus (self-reported) Alcohol consumption of more than 14 glasses/week Having given a blood donation in the past two months Hb value below 8.5 mmol/L (as measured with finger-prick method at screening)  Having a contra-indication to MRI scanning, including, but not limited to:  Pacemakers and defibrillators Intraorbital or intraocular metallic fragments Ferromagnetic implants Claustrophobia Participating in other research during the study period Not having a general practitioner - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Vital Signs Blood Pressure Trial
Status: Not yet recruiting

The purpose of this study is collect subject vitals with a blood pressure cuff, electrocardiogram (ECG), and photoplethysmogram (PPG). This data can then be used to develop a reliable, accurate, noninvasive, and continuous blood pressure monitoring device.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >17 and <65 years BMI >20 and <35  Exclusion Criteria:  Age <18 or >64 BMI <20 or >35 Pregnancy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 64 Years - StdAgeList: Adult - StudyPopulation: Participants with a range of health conditions are needed for this study, including those with cardiac or blood pressure issues, as well as individuals who are considered healthy. - SamplingMethod: Non-Probability Sample
TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis
Status: Not yet recruiting

Restenosis due to myo-intimal hyperplasia remains a concern after carotid endarterectomy. It occurs in around 6% of cases. Several risk factors for restenosis have already been identified, such as smoking, hypertension, female gender, diabetes, dyslipidemia and small carotid diameter. The main objective of this prospective multicenter study was to determine whether the technical characteristics of the eversion technique have an influence on the rate of restenosis at 1 year.

Between September 2021 and November 2022, we followed all patients undergoing carotid endarterectomy by eversion in 8 French hospitals. Demographic data, operative indications and technical characteristics of the endarterectomies performed were collected. These were defined by the circumferential nature of the carotid bulb according to 3 types (TREC A, B or C), and the length and depth of the endarterectomy according to anatomopathological reports. Post-operative complications were collected as much as doppler ultrasonography at three months and 1 year to quantify restenosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Any patient who is having carotid endarterectomy by eversion according to HAS + ESVS recommendations :  Stenosis > 70% on dopplerin the absence of neurological symptoms attributable to the carotid territory affected by the stenotic artery. Stenosis > 50% with neurological symptoms attributable to the carotid territory affected by the stenotic artery.  Exclusion Criteria:  Any carotid revascularization technique other than eversion (carotid endarterectomy with patch, carotid resection-anastomosis or bypass). Cardiac surgery combined with carotid surgery Minor patients Endovascular carotid surgery Opposition to use patient's data - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Any patient who is having carotid endarterectomy by eversion - SamplingMethod: Non-Probability Sample