rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Prospective Validation of the SHOCKMATRIX Hemorrhage Predictive Model
Status: Recruiting

Management of post-traumatic severe hemorrhage remains a challenge to any trauma care system. Studying integrated and innovative tools designed to predict the risk of early severe hemorrhage (ESH) and resource needs could offer a promising option to improve clinical decisions and then shorten the time of intervention in the context of pre-hospital severe trauma. As evidence seems to be lacking to address this issue, this ambispective validation study proposes to assess on an independent cohort the predictive performance of a newly developed machine learning-based model, as well as the feasibility of its clinical deployment under real-time healthcare conditions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  every severe trauma adult patient to be admitted to a participating center  Exclusion Criteria:  patients already diagnosed with active hemorrhage from computed tomography findings; patients with prior traumatic cardiac arrest patient under 18 years of age opposition of patient or relative - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Every severe trauma adult patient to be admitted to a participating center excluding those already diagnosed with active hemorrhage from computed tomography findings, and those with prior traumatic cardiac arrest - SamplingMethod: Non-Probability Sample
The ONCOCAMP Study
Status: Recruiting

The present study is a retrospective-prospective observational and multicentric study aiming to collect data relating to all patients included in the ROC platform. All ROC centers will be involved in the present study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  signed informed consent registration in the ROC platform - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All consecutive patients entered in the ROC platform from the start of platform activation (November 2018) until the date in which the study is approved by the local ethical committee (The retrospective cohort will be made by more than 40000 patients already included in the platform and entered a GOM path. All consecutive patients who enter in the ROC platform as for clinical practice from the date in which the study is approved by the local ethical committee (Investigator is allowed to enroll patients). - SamplingMethod: Non-Probability Sample
Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function in Children
Status: Not yet recruiting

The goal of this randomized cross-over trial is to learn about the effect of a single bout of 20-min mindfulness-based high-intensity interval training (MF-HIIT), MF-only, and HIIT-only in relative to sitting rest on executive function (EF) in 10-12 years old children. The main question it aims to answer are:

Question 1: Whether a single bout of 20-min MF-HIIT has larger beneficial effect on EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest

Question 2: Whether a single bout of 20-min MF-HIIT has a larger beneficial effect on brain functioning, as measured by the N2 and P3 components of event-related potential (ER) during EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest

Participants will visit the laboratory on 5 separate days (> 2-day washout between days) in which they have not previously participated in structured physical activities.

Participants will complete the testing and/or receive treatments below:

Day 1:

Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient
Treadmill-based exercise test to measure cardiorespiratory fitness (maximum oxygen consumption)

Days 2-5

Each day, participants will complete each of the four intervention conditions (MF-HIIT, MF-only, HIIT-only, sitting)
Participants' heart rate and self-reported affect and rating of physical exertion will be measured
Participants will complete a modified flanker task and a task-switching task to assess inhibitory control and cognitive flexibility
Participants will wear an EEG cap to measure the N2 and P3 components of the event-related potential during the inhibitory control and cognitive flexibility performance

Researcher will compare the cognitive outcome measures following the MF-HIIT, MF-only, and HIIT-only conditions with the sitting condition to see if MF and HIIT has beneficial effects on children's EF.

Further, researcher will compare the cognitive outcome measures following the MF-HIIT compared with MF-only and HIIT-only conditions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 10-12 years old Intelligence Quotient ≥ 85 Capable of performing exercise based on pre-participation health screening No formal diagnosis of cognitive disorders (e.g., attention deficit hyperactivity disorder) and neurological diseases (e.g., epilepsy)  Exclusion Criteria:  Age outside of the range of 10-12 years old Intelligence Quotient < 85 No capable of performing exercise based on pre-participation health screening Has formal diagnosis of cognitive disorders (e.g., attention deficit hyperactivity disorder) and neurological diseases (e.g., epilepsy) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 10 Years - MaximumAge: 12 Years - StdAgeList: Child
Nasal Inflammation Following Endotoxin Challenge in Patients With Asthma
Status: Not yet recruiting

A phase I clinical research study aimed at determining mechanisms that regulate airway mucosal inflammation in asthma endotypes using intranasal administration of endotoxin (lipopolysaccharide from E. coli) in healthy controls and subjects diagnosed with asthma.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants will have asthma diagnosed by a health care provider. Healthy controls are individuals without asthma. Written informed consent  Exclusion Criteria:  Current or recent illness (in the past 4 weeks) Recent asthma exacerbation (past 4 weeks) History of nasal perforation or nasal surgery Nasal polyposis Presence or prior history of cardiac or systemic disease Bleeding disorder, use of systemic anticoagulants, or antiplatelet therapy Immunocompromised state (HIV, immunoglobulin deficiency, systemic immunosuppressants excluding corticosteroids) Use of tobacco or marijuana in the past 2 months or greater than a 10 pack-year smoking history Currently pregnant or breastfeeding - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Role of Dynamic Movement Intervention in Children With Spastic Diplegia
Status: Recruiting

The study aims to investigate the effect of dynamic movement intervention approach on static and dynamic balance, quality of step length and cadence of walking pattern of children with spastic diplegic cerebral palsy.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Age ranged from 4-7 years. They can walk alone short distance and climb stairs holding on rail (Grade I & II according to GMFCS). They can understand and execute instructions. They will be medically stable. Degree of spasticity will be ranged from 1 to 1+ degree according to the Modified Ashworth Scale.  Exclusion criteria:  Visual impairment (visual loss- cataract- myopia- hyperopia). Hearing impairment (deafness) Cognitive problem. Uncontrolled Convulsions. Orthopedic surgery for the affected lower limbs within one year. Botulinum toxin injection within the last 6 months or within the study period. - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 7 Years - StdAgeList: Child
Post-market Clinical Trial of the Dominus® Stent-Graft
Status: Recruiting

Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years of age or older; Patients treated with the Dominus® Stent-Graft Endoprosthesis in accordance with its Instructions for Use; Patient available for appropriate follow-up times for the study duration; Informed patient about the nature of the study, agreeing to its provisions, and signing the informed consent.  Exclusion Criteria:  Patient currently participating in another clinical study of drug or medical device; Life expectancy less than 12 months. - HealthyVolunteers: No - Gender: All - GenderBased: Yes - GenderDescription: 18 Years and older (Adult, Older Adult ) - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with Thoracic Aortic Disease treated with the Dominus® Stent-Graft Endoprosthesis. - SamplingMethod: Non-Probability Sample
Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target
Status: Not yet recruiting

This is a monocentric, comparative, cross-sectional, case-control study seeking to identify abnormalities of the C5a-C5aR1 axis between a population of patients with active IgG4-associated disease (MAG4) and two control groups: healthy subjects without MAG4 and patients with MAG4 in remission.

Eligibility:
- EligibilityCriteria: Inclusion Criteria for patients suffering from IG4-related disease and patients in remission :  age > 18 diagnosis of IgG4-associated disease according to ACR/EULAR 2019 classification criteria (4,5) with a score ≥20. disease activity score (IgG4-RD Responder Index) ≥2 in at least one affected organ  Exclusion Criteria for patients suffering from IG4-related disease and patients in remission :  presence of a differential diagnosis ("IgG4-RD mimicker") or exclusion criterion according to ACR/EULAR 2019 classification criteria (4,5). systemic corticosteroid treatment ≥5 mg/day ongoing or < 1 month ; Study C5-MAG4_RCAPHM21_0433 Protocol Version 1.1 of 16/01/2024 Page 15 of 41 immunosuppressive therapy ongoing or < 3 months ; current biotherapy treatment or < 6 months; absence of signed informed consent; absence of affiliation to a Social Security scheme. patient participating in an ongoing therapeutic trial ; any condition which, in the opinion of the investigator, could influence the results of the study.  Inclusion criteria for healthy volunteers :  - age > 18  Exclusion criteria for healthy volunteers :  infectious episode (temperature >38°C, flu-like signs) in the 30 days prior to inclusion; known inflammatory (including IG4-related disease) or autoimmune pathology; treatment with corticosteroids in progress or taken in the month prior to sampling, or immunosuppressants in progress or taken in the 3 months prior to sampling, or biotherapy in the 6 months prior to sampling; absence of signed informed consent; absence of affiliation to a Social Security scheme; persons taking part in an ongoing therapeutic trial; any condition which, in the opinion of the investigator, could influence the results of the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants
Status: Recruiting

The aim of this study is to investigate different formulations of S-337395.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. Body mass index within the range of 18.5 to approximately 30.0 kilograms/meter squared (inclusive) at screening. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies.  Exclusion Criteria:  History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data. Lymphoma, leukemia, or any malignancy in the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. Breast cancer within the past 10 years. Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Sensitivity to S-337395, or any components of the formulation, or drug or other allergy, that in the opinion of the investigator, contraindicates participation in the study.  Note: Other protocol-defined Inclusion/Exclusion criteria may apply. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children
Status: Recruiting

Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children < 5 years of age

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  invasive mechanical ventilation  Exclusion Criteria:  univentricular hearts - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Day - MaximumAge: 5 Years - StdAgeList: Child
Transinguinal Periperitoneal Technique in Inguinal Hernioplasty
Status: Not yet recruiting

evaluation of feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh inguinal hernia repair in general surgery department in Assiut university hospitals

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients more than 18 years fit for surgery.  Exclusion Criteria:  Patients less than 18 years American Society of Anesthesiologists (ASA) 3 : a patient with severe systemic disease as ( poorly treated hypertension or diabetes , morbid obesity , chronic renal failure , stable angina & implanted pacemaker ) . - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: Patients more than 18 years fit for surgery. 1-Patients less than 18 years 2- ASA 3 : a patient with severe systemic disease as ( poorly treated hypertension or diabetes , morbid obesity , chronic renal failure , stable angina & implanted pacemaker - SamplingMethod: Non-Probability Sample
Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke
Status: Not yet recruiting

There has been an observed decrease in motor and functional ability and non-use of the impaired limb in chronic patients. This is due to the immediate drop in intensive daily therapy (5 days per week for 3 hours/day) that is usually provided during the inpatient (acute) phase upon discharge from the hospital.

In this study, the investigators plan to address the low dosage of therapy in the post-acute discharge phase for stroke survivors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors and CT, CT angiography or MRI brain imaging. Age 21 to 90 years, both males and females. At least > 28 days post stroke. Upper limb motor impairment of Fugl-Myer Motor Assessment (FMA) scale 10 to 60 Has a stable home abode and a carer/ NOK to supervise home based exercise. Ability to sit supported continuously for 60 minutes. Montreal Cognitive Assessment (MOCA) score > 21/30 Able to understand purpose of research and give consent.  Exclusion Criteria:  Non-stroke related causes of arm motor impairment. Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, end stage renal/liver/heart/lung failure, unresolved cancers. Anticipated life expectancy of < 6 months. Inability to tolerate sitting continuously for 60 minutes. Local factors potentially worsened by intensive robot-aided arm therapy and computer-based training: active seizures within 3 months, spasticity of Modified Ashworth Scale grades >2 skin wounds, shoulder, arm pain VAS > 5/10, active upper limb fractures, arthritis, fixed upper limb flexion contractures. Hemianesthesia of affected limb. History of dementia, severe depression, agitation, or behavioural problems. Pregnancy or lactation in females Absence of reliable carer to provide supervision during home training - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder
Status: Not yet recruiting

The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of anhedonia in patients with major depression disorder compared to desvenlafaxine succinate sustained-release tablets, to provide evidence-based basis for clinical rational drug use.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects meet the diagnostic criteria for major depression disorder in the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition (DSM-5); Male or female aged ≥18 and ≤65 years; Subjects who have a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥24 points; Subjects who have a total score of Snaith-Hamilton Pleasure Scale (SHARPS) ≥3 points; Subjects voluntarily participate in the study and sign the informed consent form.  Exclusion Criteria:  Allergic or known to be allergic to toludesvenlafaxine hydrochloride sustained-release tablets and desvenlafaxine succinate sustained-release tablets; Subjects have a severe self-injury/clear suicide attempt or behavior; Scores on MADRS items factor 10 ≥4 points; Subjects who meet the diagnostic criteria for any other psychotic disorders (except for major depression disorder) in DSM-5, or those who have substance disorders or drug abuse within the past six months; Individuals with severe and unstable physical diseases such as cardiovascular disease, liver disease, kidney disease, blood disorders, and endocrine disorders; Hypertensive patients with poor blood pressure control (systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg at screening); Total bilirubin (TBIL) values 1.5 times / alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 times / creatinine (Cr) 1.2 times higher than the upper limit of normal, or Thyroid-stimulating hormone (TSH) outside the normal range at screening; Electrocardiogram (ECG) abnormalities that are clinically significant at period of screening and that the investigator considers as inappropriate conditions for inclusion, such as QTc interval >450 ms in men and QTc interval >460 ms in female; Pregnant or lactating women, recent planned pregnancy and unable to ensure effective contraception during the period; Other conditions that the investigator considers the participant is not suitable for the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Technological Devices and Home Automation System in Neurological Rehabilitation
Status: Recruiting

The use of home automation system may be useful in rehabilitation to collect data about the environment and the amount of therapy. Then, the data may be stored in a cloud and integrated with data collected during training provided by technological devices.

The main goal of this longitudinal pilot study is to define the productivity of the rehabilitation room (i.e., HoSmartAI room) in the IRCCS San Camillo Hospital (Venice, Italy) service, where the investigators will install home automation sensors and treat patients with neurological disease using technological devices (e.g., robotic and virtual reality). The secondary goals are to define the patients' satisfaction, usability of the system and the clinical effect of treatments delivered with technological devices in the HoSmartAI room. The patient will be assessed to personalized the treatment based on their needs. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). At the end of the study, the patients will be assessed to define any clinical improvements. Finally, the investigators will define the characteristics of the patients who will benefit from the rehabilitation provided in the HoSmartAI room.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults (> 18 yy) Diagnosis of neurological disease (e.g. ischemic and/or hemorrhagic stroke, Parkinson's, multiple sclerosis, brain trauma, peripheral neuropathy)  Exclusion Criteria:  Fractures Major depressive disorder Severe visual and/or hearing impairments Dementia Non-pharmacologically controlled epilepsy Severe neglect Severe comprehension deficit - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery.
Status: Not yet recruiting

Study objective:

This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots.

Eligible patients:

Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.

Study intervention:

Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients are eligible to be included in the study only if all of the following criteria apply:  They are to undergo a surgical procedure within the field of plastic surgery where the procedure involves use of topical TXA at the participating center. They are over 18 years of age and capable of independently providing informed consent They have received adequate oral and written information about the study and signed the informed-consent form  Exclusion Criteria:  Patients with known allergy to tranexamic acid. Insufficient knowledge of national language or English. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult