rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Users of Remote Conferencing and Compression of Sound Dynamics : Auditory Effects
Status: Not yet recruiting

The COMPRESSED project is a descriptive, bi-centric and non-invasive study carried out by the CERIAH - IDA - Institut Pasteur and the Haute École Léonard de Vinci in Brussels on volunteer participants identified in two groups :

be subject to high exposure to compressed sound, as defined by professional participation in events on broadcast platforms using sound signal processing systems, over the last 3 years,
be subject to moderate or limited exposure to compressed and manipulated sound, equivalent to that of a student following certain distance learning courses. on a videoconferencing platform, alternating with other face-to-face courses, with the ability to listen during breaks, which have been taught for a maximum of 2 years.

The main objective of the COMPRESSED study is to evaluate the auditory effects of exposure to manipulated sounds (compression, filtering, equalisation, accentuation, etc.) from sound distribution platforms on the auditory system of participants who are regularly exposed to these sounds as a result of their professional activity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  For all participants:  Age 18 or over, Work with platforms using sound signal processing systems, Fluent in English, Fluent in French, Declare that they have no hearing loss.  For participants in the high exposure group:  - Have had a professional activity over the last three years using broadcasting platforms with sound signal processing systems,  For participants in the moderate or limited exposure group:  - Have worked between one semester and two years with platforms using sound signal processing systems.  Exclusion Criteria:  Conductive or mixed hearing loss, i.e. where the hearing loss affects both the outer and/or middle ear and the inner ear. Have an asymmetric hearing loss, i.e. a difference in average hearing loss between the left and right ear of more than 20 dB, Have a history of otitis and/or an ENT disease that permanently affects hearing (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis), Not fluent in English Be under guardianship, Deprived of liberty by judicial or administrative decision, or subject to legal protection. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects with sustained exposure to compressed sounds, as defined by professional participation in broadcast platform events using sound signal processing systems, over the last 3 years, Or Subjects with moderate or limited exposure to compressed and manipulated sound, equivalent to that of a student taking distance-learning courses on a videoconferencing platform, alternating with other face-to-face courses, with the possibility of pauses in listening, exposed for a maximum of 2 years. - SamplingMethod: Non-Probability Sample
Restoration of the Gut Microbiome After Cesarean Section
Status: Not yet recruiting

This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. We will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Gestational age < week 38+0 days Proficient in spoken/written Danish Single pregnancy (no twins or triplets) Pre-pregnancy BMI between 18.5 and 35 kg/m2 No chronic intestinal, endocrine, cardiac, or kidney disorders No known gestational complications (gestational diabetes, preeclampsia, gestational hypothyroidism) No regular use of prescription medication or any drugs that, in the research team's opinion, may interfere with the study's results. Willingness to abstain from giving the child products with probiotics (fermented dairy like yogurt or A38 are allowed).  Exclusion Criteria:  Maternal:  Use of antibiotics within one month of stool donation Acute gastroenteritis within one month of stool donation Use of antibiotics within one month of birth Time since last travel abroad relative to data of fecal donation according to the requirements for blood donations ("Regler for tappepauser" - blooddonor.dk) Positive test results for pathogens during donor material screening. Antibiotic treatment at birth (vaginal births only) Spontaneous onset of labor or emergency cesarean section before scheduled cesarean section.  Infant:  Instances of major birth defects or intrauterine growth retardation (IUGR) Infants requiring pediatric support at the time of transplant administration - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
NODE (groiN ultrasOunD cancEr)
Status: Not yet recruiting

This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women, over 18 years, with histologically confirmed SCC, adenocarcinoma or melanoma of the vulva Clinically stage I or II on medical imaging (CT scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease Participant must be suitable to undergo IFL/SNB according to local clinical practice management guidelines Signed written informed consent Negative serum pregnancy test ≤ 30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause Patient lives within 40 km of a medical diagnostic imaging centre (site investigator approval required for special circumstances)  Exclusion Criteria:  Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease) Squamous cell carcinoma (SCC) of the vulva with depth of invasion ≤1 mm Clinical or medical imaging evidence of regional and/or distant metastatic disease Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) Other prior malignancies <5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ Estimated life expectancy of ≤6 months - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
TPAP for Comfort in OSA
Status: Not yet recruiting

TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what is called TPAP . TPAP is a pressure control algorithm that lowers the pressure from the set pressure at the beginning of inspiration and does not return the pressure to the full set level until about halfway through expiration. The present study, TheraPAP Comfort, aims at assessing whether TPAP improves patient comfort vs. CPAP during supine wakefulness.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 - 70 age range AHI (apnea/hypopnea index) > 10 on a previous HST (Home Sleep Test) CPAP-naive participants BMI (Body Mass Index) >= 18 kg/m^2  Exclusion Criteria:  Current clinically significant sleep disorder other than OSA (Obstructive Sleep Apnea) of a severity that would interfere with study participation or interpretability of data (including central sleep apnea, per central AHI > 5 events/h). Any chronic lung diseases. Chronic oxygen therapy. A serious illness or infection in the past 30 days as determined by investigator. Patients with hypoglossal nerve stimulation implant. Any non-previously mentioned vulnerable population. Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Ligament Balancing in Total Knee Arthroplasty
Status: Not yet recruiting

The goal of this interventional pilot study is to evaluate if performing ligament balancing on the medial collateral ligament (MCL) in a more systematical manner with a novel instrument can produce more objective and repeatable ligament lengthening in Total Knee Arthroplasty. The main questions it aim to answer are:

Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?
Can a novel instrument for ligament balancing acquire more objective and repeatable results, without risk of injury?

Participants must consent prior to the surgery, but inclusion is only done once ligament balancing is indicated during surgery. Patients will be follow-up as standard protocol for Total Knee Arthroplasty patients at the hospital.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men and women over 40 years of age that require total knee arthroplasty Idiopathic osteoarthrosis, osteonecrosis or avascular osteonecrosis Otherwise fairly healthy/ no significant health issues  Exclusion Criteria:  Age under 40 years of age Pregnant Revisions or reoperations Considerable earlier injury to the knee Isolated patellofemoral osteoarthrosis - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 40 Years - StdAgeList: Adult, Older Adult
Study of Behavioral Dysfunctions and Related Neuronal Correlates in Patients With Dystonia
Status: Recruiting

Dystonias represent hyperkinetic movement disorders characterized by protracted muscle contractions, such as to cause torsional movements and anomalous postures in different parts of the body. Although they occur more often in a focal form (blepharospasm, oromandibular dystonia, cervical dystonia, laryngeal dystonia, attitudinal cramps of the limbs) than segmental (involvement of several contiguous muscle groups, e.g. facial muscles and neck muscles), they are nevertheless capable of significantly influencing the quality of life, with consequent social and health costs. Although described as a predominantly motor disorder, the presence of non-motor symptoms in dystonias associated with alteration of the fronto-striatal circuits is increasingly recognized. Neuroimaging studies have highlighted that the striatum and, more specifically, striatal dopamine, is involved in high cognitive processes such as attention, reward-based learning and decision making. Clinical conditions associated with cortico-striatal circuit dysfunction and abnormal meso-striatal or meso-cortical dopamine transmission also appear to influence temporal estimation, delay discounting, showing an impulsive preference for immediate rewards over delayed gratification.

Based on these premises, the present project aims to evaluate the cognitive and affective aspects of dystonias, in line with neuroimaging research documenting structural and functional dysfunctions in the respective brain regions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  > 18 years old; Informed consent; Montreal cognitive assessment > 21;  Exclusion Criteria:  Patients with cervical dystonia with anterocollis spasm; Sensory-motor deficits that can hinder neuropsychological assessment Contraindications to performing Magnetic Resonance Imaging - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
The Experience in Neurorehabilitation Setting: a Qualitative Study
Status: Recruiting

In this exploratory qualitative study with a hermeneutic phenomenological approach, we will describe and understand the experience of treatment and hospitalization in hospitalized people suffering from stroke, multiple sclerosis, Parkinson&#39;s disease and patients post-neurosurgery for oncological causes. Patients will be interviewed in a semi-structured manner and sampling will take place for each of the pathology groups according to the saturation method.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:● Patients hospitalized at the IRCCS San Camillo.  patients in Stroke, Multiple Sclerosis, Parkinson&#39;s Disease and post-operative patients in Neurosurgery for oncological pathology Patients who have given valid consent. Patients able to understand, read and speak Italian. Aphasic patients without comprehension deficits and able to communicate effectively with augmented communication media. hospitalized for at least 21 days and not close to discharge, or that this occurs at least after 21 days.  Exclusion Criteria:● Patients unable to give valid consent.  Minor patients or patients over 85 years of age. Patients with cognitive deficits such that they cannot effectively support the interview. Patients with psychiatric pathology Patients unable to understand, read and speak Italian. Patients with pathologies for which they are not undergoing neurorehabilitation treatment. - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients with Stroke, Multiple Sclerosis, Parkinson&#39;s Disease and post-operative Neurosurgery patients admitted to the IRCCS San Camillo will be recruited. - SamplingMethod: Non-Probability Sample
Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK)
Status: Recruiting

The goal of this clinical trial is to compare CXL with combined treatment with CXL and t-PTK.

The main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients must be 18 years or older at the time of signing the informed consent form. There is no upper age limit. Progressive keratoconus with indication for CXL Corneal thickness ≥ 420 μm  Exclusion Criteria:  Other eye disease causing visual impairment - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Comparison of the Efficacy of Transcranial Direct Current Stimulation (tDCS) of the Primary Motor Cortex (M1) or the Prefrontal Cortex Combined With Aerobic Activity for Alleviation of Fibromyalgia Symptoms.
Status: Not yet recruiting

The goal of this study is to demonstrate the effectiveness of treating fibromyalgia using combination of electrical stimulation with aerobic activity.

Participants will be randomly assigned to stimulation in a ratio of 1:1:1. 120 participants (40 in each group). The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation for 3 weeks.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed Fibromyalgia Pain scale level of 4 or higher Fail to achieve adequate pain relief with Fibromyalgia treatments stable Fibromyalgia treatment for at least 4 weeks. Ability to perform aerobic exercise  Exclusion Criteria:  Other Causes of pain Psychotic disorder Severe Depression Cognitive disorder Drug or alcohol abuse in the last 6 months pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Essilor® Stellest® Lenses Multicentre European Study (SLOMES)
Status: Not yet recruiting

The goal of this post-market clinical follow up Study is to demonstrate the efficacy, safety, acceptability, and quality of life implications of Essilor® Stellest® spectacle lenses in slowing myopia progression in European children and adolescents. Participants will receive Essilor® Stellest® at inclusion visit and will be asked for a full time wear (>12 hours daily) for 24 months. The primary endpoints are the change in axial length and cycloplegic autorefraction from baseline to 24 months compared to expected change based on axial length and refraction centile positions at baseline.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - Myopia as determined by cycloplegic autorefraction as follows:  Each meridian SER of plano to - 8;00 D in each eye Astigmatism < 2.50 D Anisometropia ≤ 1.50 D - Monocular corrected VA of at least 0.2 LogMAR in both eyes - Age: 6 - 16 years old, inclusive at the time of inclusion - Ability to understand treatment and give valid assent - Ability to comply with the protocol to get reliable study measurements  Exclusion Criteria:  - Concomitant or previous therapies for myopia  - Eye diseases/conditions:  Strabismus by cover test at near or distance Any ocular disease that would influence refractive development e.g. retinal disease, cataract, ptosis Any systemic or neurodevelopmental conditions that may influence refractive development - Use of ocular or systemic medication which may affect myopia progression or visual acuity through known effects on retina, accommodation, or significant elevation of intraocular pressure - Participation in another study which may influence vision or interfere with study assessments - Myopia onset before 5 years of age - Contact lens wearers - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 16 Years - StdAgeList: Child
Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode
Status: Recruiting

Controlled, prospective, qualitative and quantitative trial. The goal of this trial is to evaluate the mutual assistance early intervention device efficacy and its impact on insight and personal recovery of participants living with a first psychotic episode. This intervention lasts 5 days with 1 session per day of 1 hour 30 minutes. Three evaluations, before the intervention, after intervention and 1 month after the hospitalization's end.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Man or woman between 18 and 40 years old First psychotic episode under the guidance of a doctor Brief psycotic trouble (SM-V) Presenting a first psychiatry hospitalization (all modalities hospitalizations combined) Fluent in French language (read and written) Patient affiliated to a social protection system or beneficiary of Medical Aid of State Patient having signed informed consent for his participation in the protocol  Exclusion Criteria:  Patients whose clinical condition does not allow them to participate in research Patients placed in isolation rooms during the intervention - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Stellate Ganglion Block for Prevention of Post Mastectomy Depression
Status: Not yet recruiting

Complications after mastectomy include chronic pain and depression.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Female patients Age ranging from 18 to 65 years American Society of Anesthesiologists (ASA) no more than II Had unilateral cancer breast Scheduled to do unilateral modified radical mastectomy  Exclusion Criteria:  Pregnant female Existing Horner syndrome Had any neuromuscular disease Had allergy to local anesthetics History of use of analgesics Had any deformity or a previous surgery in the neck or ipsilateral arm or breast Had any contraindication to the procedure (coagulation disorders, local infection, sepsis) Had any contraindication to the sympathetic blockade (decompensate cardiopulmonary or hemodynamic disorders) History of psychotic disorder including depression, bipolar disorder or personality disorder Patient with Beck Depression Inventory (BDI) score more than 13 - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Female patients scheduled to do unilateral modified radical mastectomy - MinimumAge: 21 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Alexander Technique on Labor Pain and Anxiety
Status: Recruiting

This study will examine the effect of the Alexander Technique on labor pain and anxiety during labor. This study is designed as a randomized controlled experimental study. The population of the study consists of primiparous pregnant women who applied to Istanbul Provincial Health Directorate Başakşehir Çam and Sakura City Hospital, D-Block Maternity Hospital between November 2023 and May 2024. In calculating the sample size, G*Power (3.1.9.6) program was used to calculate the sample size with an error of 0.05, effect level of 0.5, power of 95%, and the required sample size for 2 groups was calculated as 34 people for each group with a total of 68 people.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Volunteer to participate in the study, Between the ages of 18-35, Primiparous and singleton pregnant, Women at term (between 37 and 41 weeks of gestation) will be included in the study.  Exclusion Criteria:  Risky pregnancies, Women who become pregnant as a result of assisted reproductive techniques, Delivery by caesarean section, Wanting to leave without working, Women undergoing analgesia at any stage of the labor process will be excluded from the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult
First Observatory of Precocious Puberty.
Status: Not yet recruiting

The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact.

Due to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs.

The establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient.

The investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Precocious puberty group (PP) :  Suspected precocious puberty (girl aged < 8 years or boy aged < 9 years when the first signs of development* appear) Suspected precocious puberty (girl aged < 8 years or boy aged < 9 years when the first signs of development* appear)  Advanced puberty group (AP) :  Suspected advanced puberty (girl aged ≥ 8 and < 10 years or boy aged ≥ 9 and < 11 years when the first signs of development* appear) First consultation with the investigator (pediatric endocrinologist).  Control group :  Boy or girl without signs of pubertal development (Tanner 1); Matched to the PP group on sex and age (+/- 1 year); Consultation with the same investigator over the same period (same quarter) as a patient in the PP group  Exclusion Criteria:  All groups  Consultation with the same investigator over the same period (same quarter) as a patient in the PP group Family not speaking French, language barrier. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MaximumAge: 11 Years - StdAgeList: Child - StudyPopulation: Patients will be recruited in private heathlcare: 2880 patients distributed between the 2 following groups: PP (Precocious puberty group) and PA (Advanced puberty group), and 480 children in the control group. - SamplingMethod: Non-Probability Sample