cyrilzakka/clinical-trials huggingface dataset:
Prevalence and Healthcare Consumption of ASD Patients Using French Medico-administrative Data

Autism Spectrum Disorder (ASD) is one of the neurodevelopmental disorders described in the DSM5 (American Psychiatric Association, 2013). This heterogeneous syndrome appears in childhood and persists throughout life with different developments from one individual to another. It is clinically characterized by the combination of deficits in social communication with restricted and repetitive behaviors. The prevalence of ASD has seen a significant increase over the last 10 years, with estimates varying greatly from one country to another, ranging from 4.2/1,000 in France to 31/1,000 in Iceland. In France, prevalence has been estimated by two child disability registers set up in the departments of Haute-Garonne (RHE31), Isère, Savoie, and Haute-Savoie (RHEOP), but there is no epidemiological surveillance system to estimate the national prevalence of ASD in the general population. However, the production of reliable epidemiological data at the national and territorial levels is essential for addressing the needs of individuals with ASD and for evaluating public policies.

The main objective of our project is to estimate the annual prevalence of ASD in children, adolescents, and young adults at the national and regional levels using medico-administrative databases (SNDS), to study its evolution over the period 2010-2019 and its geographical distribution in relation to socio-demographic indicators and healthcare accessibility. Our secondary objectives are to validate an algorithm for detecting ASD in the National Health Data System (SNDS) and to estimate the direct medical costs associated with ASD management.

The SNDS databases contain all medical care and treatments reimbursed for Health Insurance beneficiaries provided in the private or public sector. A case detection algorithm will be tested and validated on validation samples. Then, the prevalence of ASD will be estimated, taking into account geographical, socio-economic, and healthcare accessibility indicators, in order to study the factors associated with the significant disparity in rates observed in France and abroad. An estimate of direct medical costs will be made from the health insurance perspective.

Our project therefore proposes the development of reliable indicators on the management of ASD in France with the aim of providing useful indicators and tools for guiding health and disability policies in France, promoting the development of appropriate interventions, and thus contributing to the improvement of the care and support of individuals with ASD as well as reducing inequalities in access to healthcare for these vulnerable populations.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 16 years or younger
* For case : with an ICD-10 code for ASD (F84\*)
* For control : without an ICD-10 code for ASD (F84\*)
Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone

40 patients diagnosed with localised periodontitis will be included at each center, 20 patients will be treated with the control treatment, 20 patients will be treated by test treatment.

2.3 This will be a prospective multicentre parallel arm randomized clinical trial of 6 months' duration. Clinical parameters of periodontal disease will be recorded at baseline and at 6 months. Radiographs will be taken at baseline and at 6 months.Treatment will be performed at baseline and thereafter every three months.

2.5 Study setting Patient screening, inclusions and all clinical examinations will be performed by a board-certified specialist in periodontology at the test centres. Treatment will be performed by a registered separate therapist, either dentist or dental hygienist.

2.7 Treatment allocation Patients will be allocated to one of the following treatments: control (curettes+ ultrasound scaler (USS) supra and subgingivally), test (curettes + USS supra and chitosan brush in oscillating handpiece subgingivally) by computer-generated block randomization to ensure equal sample sizes.

Eligibility Criteria:
Inclusion Criteria:

* 1. Periodontitis as previously defined on at least three teeth but less than 8 teeth.

  2. Above 18 years of age.

  3. Eligible for treatment in an outpatient dental clinic (ie, American Society of Anesthesiologist index (ASA) I and II).

  4. Had full-mouth plaque scores ≤ 20% prior to final inclusion3 5. Signed Informed Consent obtained prior to start.

  6. Psychological appropriateness 7. Consent to complete all follow-up visits

Exclusion Criteria:

1. Prosthetic constructions with technical complications which according to the examiners judgement has contributed to the disease state and not possible to resolve prior to final inclusion.
2. Receiving systemic antibiotics \< 3 months prior to study start.
3. Pregnant or lactating.
4. Any condition or current treatment for any condition, which in the opinion of the investigator and/or consulting physician, may constitute an unwarranted risk.
5. Presence of psychological characteristics such as inappropriate attitude or motivation which, in the opinion of the investigator, are incompatible with the protocol.
6. Unwillingness to undergo treatment.
7. Ongoing or previous radiotherapy to the head-neck region.
8. Ongoing chemotherapy.
Exploration of Gender Differences in Liver Aging

The liver is an important metabolic organ in the body. It participates in central metabolic activities to maintain systemic homeostasis. It is also one of the most vulnerable organs in the process of individual aging. During aging, the volume, blood flow, metabolic capacity and regenerative capacity of the liver decrease. Liver function changes with age can lead to age-related systemic susceptibility diseases.

Therefore, understanding the changes of metabolism and immune function in the process of liver aging and studying the regulation mechanism of liver aging will provide an important reference for understanding the causes of increased susceptibility to liver-related diseases in the elderly population.On the other hand, gender factors also affect organ function, leading to differences in human aging and disease outcomes.At present, the omics research on liver aging is mainly based on tissue-level transcription, protein or metabolomics, and most of the conclusions are focused on hepatocytes. However, for other cell types and microenvironment interactions, people know little about the aging changes at the cellular levelBased on the current research status, this study aims to explore the gender differences in the process of liver aging, using emerging technologies such as the combination of single-cell multi-omics and spatial localization, to reveal the factors driving liver aging from a gender perspective, and to promote the development of accurate interventions for aging and aging-related diseases.


Eligibility Criteria:
Inclusion Criteria:

* Liver function indicators are in the normal reference range.
* Liver imaging examination showed normal.

Exclusion Criteria:

* Patients with previous liver-related diseases.
* Subjects with important organ dysfunction / failure or other serious diseases ( myocardial infarction, malignant tumor, severe neurological or psychiatric history, severe infection, coagulation dysfunction, etc. )
* Moderate malnutrition ( BMI \< 17kg / m2 ) and severe anemia ( Hb \< 60g / L ).
* Subjects and their families who disagreed with the study protocol.
Comparison of Two Different Endoscopic Radial Artery Harvesting Devices

Endoscopic radial artery harvesting in coronary bypass surgery is routinely performed by the investigators. In this study, the investigators want to compare the MiFusion TLS2 (Endotrust GmbH, Germany) device to the LigaSure Maryland Jaw (Medtronic, USA). The vessel harvesting is performed in the standard fashion according to the institutional routine. The patients are randomized preoperatively to one of the devices. The proximal end of the radial artery will be preserved and deep-frozen for histological assessment. Endothelial integrity will be investigated using Hematoxylin-Eosin, CD31 and endothelial nitrogen monoxide synthase.


Eligibility Criteria:
Inclusion Criteria:

* all adult patients undergoing CABG using the radial artery
* capability to give informed consent

Exclusion Criteria:

* no specific exclusion criteria
The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis

The aim of this study is to investigate whether Graded Motor Imagery (GMI) application is as effective as Transcutaneous Electrical Nerve Stimulation (TENS) in individuals with knee osteoarthritis (OA). The objectives are to improve range of motion (ROM) and muscle strength, reduce pain and stiffness, increase pain pressure threshold, and enhance function and physical performance through GMI application.

46 voluntary patients with knee OA, aged between 45-64 years will be randomly divided into two groups: GMI group and TENS group. Interventions will be applied for 8 weeks, 3 times a week (24 sessions). Both groups will receive conventional physiotherapy and home exercises in addition to GMI or TENS treatment. The patients will be assessed before, after treatment and six-week follow-up. Knee pain will be evaluated using the Visual Analog Scale (VAS), pressure pain threshold will be measured using an algometer, pain, function, and stiffness will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), active knee range of motion will be measured using a digital goniometer, muscle strength will be evaluated using a hand-held dynamometer, and function will be assessed using the Timed Up and Go Test.

Eligibility Criteria:
Inclusion Criteria:

* Minimum score of 24 on the Mini Mental State Examination (indicating no mild or severe dementia)
* Diagnosis of moderate unilateral knee osteoarthritis persisting for more than 12 months according to American College of Rheumatology (ACR) criteria
* Experience of pain with a severity rating of 3 or higher on the Visual Analog Scale (VAS) for activities such as stair climbing, sitting, and squatting, lasting for at least 6 months (moderate to severe pain)
* Age between 45 and 64 years
* Residing in the city where the study is conducted
* Ability to walk independently
* Presence of limitations in knee range of motion (ROM)
* Symptomatic and radiographically confirmed OA diagnosis of Kellgren and Lawrence grade I-III

Exclusion Criteria:

* Patients who are unwilling to participate in the study
* Patients presenting with secondary OA due to conditions such as rheumatoid arthritis, gout, septic arthritis, tuberculosis, tumor, trauma, hemophilia, major medical or psychiatric disorders, recent fractures, presence of effusion or open reduction and internal fixation in the knee
* Presence of a neuromuscular disease
* History of intra-articular injections in the past 6 months
* Patients undergoing medication changes
* Presence of any chronic illness that would hinder participation in the treatment program
* Participation in a physiotherapy program for OA in the last 12 weeks
* Movement limitations or limb deficiency in the contralateral lower extremity
* Presence of visual or hearing problems that would affect treatment adherence.
A Study of Internet Delivered Parent Child Interaction Therapy

The purpose of this study is to learn more about how feasible remote parent child interaction therapy (PCIT) is for children with disruptive behaviors and how to augment treatment with wearable devices.

Children with disruptive behaviors aged 3-7 will wear a Garmin watch throughout the course of the study (approximately 12 weeks). Artificial Intelligence (AI) will be applied to analyze the vitals provided by the watch to monitor for disruptive behavior. Parent and child will be enrolled in remote PCIT sessions throughout the course of the trial. This study will not require any in person visits, all materials will be mailed to the patients home or sent electronically. The study will analyze how the use of a wearable device throughout PCIT will help increase the benefit to both parent and child as measured by biometrics via Garmin and by questionnaires preformed throughout the trial.

Eligibility Criteria:
Inclusion Criteria - Children (Aged 3-7):

* Outpatients.
* Able to provide developmentally appropriate informed assent, and legal guardians able to provide informed consent.
* EBP Severity rated above the clinically significant range (≥120; T-score ≥ 60) (Eyberg Child Behavior Inventory- ECBI; Eyberg \& Pincus, 1999).
* Families approached for participation will be asked to commit to complete the treatment:
* At least one primary caregiver and the identified child will have to be able to speak and understand English;
* Must have the ability, technology, and internet access for remote therapy/research visits.

Inclusion Criteria - Adults (Any age):

* Agree to wear Garmin watch.
* Able to provide informed consent.
* Able to speak and understand English.
* Has the ability, technology, and internet access for remote therapy/research visits.

Exclusion Criteria - Children:

* Formal diagnosis of Severe Intellectual disability, Autistic Spectrum Disorder Level 3, or a psychotic disorder for the child.
* Parents not consenting to the study.
* Parents or child is not able to adhere to the study protocol.
* A Child who is reasonable expected to be unable to tolerate wearing the Garmin device for at least 70% of the time during the day and night 70% of the days during the treatment (12 weeks). This is based on the principal investigator's discretion.
* Unable to speak and understand English.
* Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
* Children in foster care.
* Does not have the ability, technology, and/or internet access for remote therapy/research visits.
* Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.

Exclusion Criteria - Adults:

* Unable to speak and understand English.
* Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
A Study to Evaluate the Effects of Single-dose Seltorexant on Electrocardiogram Intervals in Healthy Adult Participants

The purpose of this study is to assess the effects of single dose seltorexant on QT/QTc intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic exposures in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Have signed informed consent form (ICF) indicating they understand the purpose of and procedures required for the study, including the required pharmacogenomic component (which specifies testing of genes predisposing to long or short QT and related cardiac syndromes), and are willing to participate in the study. Consent for sample storage will be obtained in the ICF
* Be Willing to adhere to the prohibitions and restrictions specified in the protocol
* A female participant must be either not of childbearing potential (ie, postmenopausal, permanently sterile) or of childbearing potential and practicing a highly effective method of contraception (failure rate of less than \[\<\]1 percent \[%\] per year when used consistently and correctly)
* A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 1 month after the last study drug administration
* A male participant, who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
* Must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. Heart rate between 45 and 100 beats per minute (bpm), inclusive

Exclusion Criteria:

* Clinically significant abnormal values for hematology, serum chemistry (including thyroid stimulating hormone \[TSH\] at screening only) or urinalysis at screening or at admission to the study site
* Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at admission to the study site as deemed appropriate by the investigator
* Received a known inhibitor of CYP3A4 or CYP2C9 activity within 14 days or a period less than 5 times the drugs' half-life; whichever is longer, before the first dose of the study drug is scheduled
* Known allergy to the study drug or any of the excipients of the formulation
* Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled
* A woman who is pregnant, breast-feeding, or planning to become pregnant during the study
Laboratory Characteristics in Chronic Atrophic Acrodermatitis

The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with chronic atrophic dermatitis to gain better insight into pathogenesis of chronic infection with Borrelia burgdorferi sensu lato.


Eligibility Criteria:
Inclusion Criteria:

* chronic atrophic dermatitis in patients \>18 years

Exclusion Criteria:

* none
Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy

Observational study on the quality of life and pathological state of patients underwent radical cystectomy.

Each patient will be followed for approximately 10 years starting from the date of surgery. The patient may be contacted for yearly follow-up through one of the preferred methods indicated (phone call, email or home address) which will be carried out by the staff of the Urology Department. The data for each patient will then be transferred to the database itself. The data collected will be handled following the most strict GCPs and privacy norms.

The data entered will concern:

* period before hospitalization (symptoms, clinical data) and completion of a pre-surgery questionnaire
* hospitalization period with all its related data
* questionnaires relating to quality of life which will be administered to the patient once a year according to the preferred method expressed by the patient in the informed consent.

Eligibility Criteria:
Inclusion Criteria:

* subjects underwent radical cystectomy
* \> 18 years old
* Ability to read and sign the informed consent

Exclusion Criteria:

* Age \<18 years
* Inability to read and sign the informed consent
VX-770 Expanded Access Program

The purpose of this expanded access program is to provide VX-770 prior to its commercial availability to people with cystic fibrosis (CF) who have at least one copy of the G551D-CFTR mutation and who are in critical medical need and who are not eligible for participation in other Vertex-sponsored studies.

VX-770, a compound being developed by Vertex Pharmaceuticals Incorporated (Vertex) for the treatment of CF, is an orally bioavailable small molecule that targets the underlying defect in CF, the dysfunctional CFTR protein. In Phase 3 studies of VX-770 in patients with CF and a G551D CFTR mutation, improvements in CFTR function (measured by reduction in sweat chloride concentration) and improvements in lung function were observed.

Patients who are interested in the VX-770 Expanded Access should contact their CF physician about participation.

Physicians interested in participating as a site should contact 800-745-4484.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with confirmed diagnosis of CF, with a sweat chloride \>60 mmol/L OR 2 CF-causing mutations AND chronic sinopulmonary disease OR gastrointestinal/nutritional abnormalities.
* Have the G551D-CFTR mutation in at least 1 allele
* Will be aged 6 years or older on the date of signed informed consent form
* Highest FEV1 in the 6 months prior to screening is ≤ 40% predicted value or patient is documented to be active on the lung transplant wait list

Exclusion Criteria:

* If female, currently pregnant
* Abnormal liver function, at screening on recent clinical laboratory testing, defined as \>3 × upper limit of normal (ULN), of any 3 or more of the following: AST, ALT, GGT, serum alkaline phosphatase, total bilirubin
* Is currently requiring invasive mechanical ventilation
* Is currently participating, or has participated in the past 30 days in another therapeutic or clinical study
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female participants 18 to 75 years of age at time of consent.
* Diagnosis of Idiopathic Generalized Epilepsy at least 6 months prior to the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.

  1. Subject has probable GTC seizures in the setting of IGE, meaning GTC seizures and either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-wave on EEG and no focal abnormality (asymmetric spike-wave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks
  2. Subjects with possible GTC seizures in the setting of IGE, meaning GTC and either Normal EEG OR Generalized epileptiform EEG abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed).
* Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
* Ability of subject or caregiver to keep accurate seizure diaries
* Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., each ASM is considered 1 treatment. Other epilepsy therapies including devices and diet therapy are allowed; together these other therapies count as 1 treatment).
* Accurate history of having at least 3 days with a GTC seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a GTC seizure during the first 8 weeks and at least 1 day with a GTC seizure during the second 8 weeks.

Exclusion Criteria:

* History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired conscious for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.
* History of repetitive/cluster GTC seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having repetitive/cluster GTC seizures count during the screening phase.
* Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator