rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Subaxial Cervical Traumatic Injuries
Status: Not yet recruiting

The aim of this study is to assess the mid-term outcomes of treating subaxial cervical traumatic injury cases admitted to the Trauma Unit of Assiut University Hospital.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All patients presenting with subaxial cervical spine traumatic injuries with and without cervical cord injury who complete a minimum of one year follow up  Exclusion Criteria:  Patients who refuse to participate in the study Patients with pathological fractures - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: All patients fulfilling the inclusion criteria presenting to our hospital will be included in the study (Total coverage). Based on hospital records, we usually receive around 100 cases each year. We will also include all patients prospectively recorded in our data base starting from 11-01-2022. This data base includes 96 to date. - SamplingMethod: Non-Probability Sample
Impact of ChatGPT-based Nursing Process Training
Status: Not yet recruiting

The goal of this randomized controlled study is to determine the impact of ChatGPT based nursing process training on nursing students' clinical decision-making competencies and artificial intelligence anxiety.

Population and Sample: The population of the research consists of senior students studying at Gülhane Faculty of Nursing, University of Health Sciences. Power analysis was performed to determine the number of people to be included in the study. The power of the test was calculated with the G*Power 3.1 program. In a similar study in the relevant literature, the effect size regarding the change in clinical decision-making level was calculated as 0.898. In order to exceed the 99% value in determining the power of the study; At the 5% significance level and 0.898 effect size, 44 people, 22 people in the groups, need to be reached (df=21; t=1.721). In the research, it was aimed to reach a total of 60 people, 30 people in the groups, considering the high power of the test and the losses.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being a senior student at the faculty of nursing in the 2023-2024 academic year Agreeing to participate in the research  Exclusion Criteria:  Having previously received ChatGPT training Withdrawing from the research voluntarily Incompletely filled forms - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients
Status: Recruiting

Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients are eligible for inclusion if they meet the following criteria:  Cancer patients aged >18 years receiving cisplatin-containing chemotherapy. A cisplatin dose starting from 75 mg/m2. Various cancer types. Both males and females. No history of organ transplantation or kidney dialysis. Eastern cooperative oncology group performance (ECOG):0-2  Exclusion Criteria:  Patients with peripheral neuropathy. Preexisting unilateral or bilateral moderate to severe sensorineural hearing loss Patients with speech discrimination affection or those who are unable to participate in audiologic evaluation Co-administration of ifosfamide with cisplatin, because of the known risk of nephrotoxicity. Pregnancy or lactation. Infection with the human immunodeficiency virus (HIV). Prior administration of cisplatin. Intraperitoneal chemotherapy. Inadequate liver function (bilirubin > 1.5 times upper normal limit [ULN] and alanine transaminase [ALT] or aspartate transaminase [AST] > 3 times the upper normal limit [ULN] or up to 5.0 upper normal limit [ULN] in the presence of hepatic metastases). Inadequate renal function (creatinine > 1.25 times upper normal limit [ULN], creatinine clearance < 50mL/min). Serious comorbid systemic disorder incompatible with the study (uncontrolled diabetes mellitus or hypertension, myocardial infarction within the last 6 months). Patients diagnosed with kidney cancer. Exposure to any nephrotoxic drugs or agents. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effect of Stress Ball Utilisation on Treatment Duration, Dyspnea Severity and Anxiety Level in Nebuliser Therapy
Status: Recruiting

Nebul Therapy is very effective in quickly improving the symptoms of respiratory system diseases. While applying this treatment, patients are expected to complete a sufficient period of time. However, this waiting and the symptoms of the disease may cause anxiety in the patient.

The aim of the study was to enable patients to spend their nebul period actively by using a stress ball. Thus, it was thought that it would make a positive contribution to dyspnea severity and anxiety levels.

The main questions it aims to answer are:

Does using a stress ball contribute positively to nebulizer usage time? Is the use of a stress ball effective in reducing the severity of dyspnea? Is using a stress ball effective in reducing anxiety levels?

For this purpose, participants will be asked to tighten and loosen the stress ball with one hand during the nebuliser therapy.

They will be expected to continue this with at least two nebuliser therapy per day. A control group will be used to determine the effectiveness of the stress ball. This group will not use a stress ball while receiving nebulizer treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Hospitalized for at least three days Having nebulizer treatment at least twice a day Medicines that have the same effect as prescribed (bronchodilators) Patients who are required to have at least 4 ml of medication in the reservoir Patients who have previous experience of using a nebulizer at home  Exclusion Criteria:  Those who have severe exacerbation attacks People with speech problems People who experience severe dyspnea due to heart disease Those with high anxiety levels for any reason (death of a relative, etc.) Those with muscle or nerve problems in their hands Those who did not consent to participate in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula
Status: Not yet recruiting

The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years; Stage 5 chronic kidney disease, on dialysis or not on dialysis; Requiring the creation of an arteriovenous fistula; Membership of a social insurance scheme; Patient having been informed and having formulated his/her oral non-opposition to participate in the research.  Exclusion Criteria:  Contraindication to the proposed surgery ; Reduced life expectancy in the opinion of the investigator; Medical or biological conditions which, in the opinion of the investigator, could influence the interpretation of the results of the study or the safety of the patient; Patient uncooperative with protocol requirements or unable to attend scheduled visits to the centre; Other surgical or medical intervention planned during the study; Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding; Participating in another clinical trial, or in a period of exclusion from another clinical trial; Patient under guardianship or deprived of liberty. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will be adult patients suffering from chronic renal failure for whom the creation of an arteriovenous fistula is planned. - SamplingMethod: Non-Probability Sample
Sleep for Optimal MEdical StudentS (PROMESS)
Status: Recruiting

Medical students have been shown to have a greater prevalence of poor sleep leading to poorer quality of life than other groups of students. Among medical students, poor sleep quality and insomnia have been associated with higher level of stress, as well as poorer academic performance. Our field surveys carried out in 2022 and 2023 at the Lyon Est medical school make the same alarming observation. They revealed that 53% of students had significant sleep problems.They also showed that students presented high levels of physical and mental fatigue. It is expected that these disorders will significantly degrade their quality of life as well as their health. Indeed, lack of sleep is associated with serious health problems such as illnesses cardiovascular or immune system deficiencies.

The PROMESS - SLEEP project aims to offer solutions to students to improve their sleep during their medical studies. It responds to a demand expressed by students: our field study showed that 40% of 4th year students declared being "very interested and/or interested" in following an intervention that aimed at improving sleep. An early knowledge of sleep optimization tools would allow students to quickly acquire the tools necessary to cope with the difficult conditions encountered during their training and lives of future doctors.The objective of this study is to determine the influence of an intervention program based on sleep improvement and fatigue reduction among medical students.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being a 4th-year or a 5th-year medical student at the Faculty of Medicine Lyon East during the academic year 2023-2024. Having read the information note. Having signed the written consent.  Exclusion Criteria: No exclusion criteria will be applied. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Sedentary Behaviors Reduction and Physical Activity Promotion for Optimal Medical StudentS
Status: Recruiting

Medical students are under great competitive pressure throughout their studies. Our field surveys conducted in 2022 and 2023 at the Lyon Est Faculty of Medicine revealed that 78% of 482 students showed an excessive sedentary lifestyle compared to the threshold set by WHO. It is expected that a low level of physical activity and/or too high a sedentary lifestyle deteriorates significantly their quality of life and their health. In 2014, a British survey of 356 students in Medicine showed that lack of physical activity was an major predictor of burnout symptoms. Numerous studies show that regular physical activity improves the mental health of students and their cognitive performance.

The PROMESS - PHYSICAL ACTIVITY project aims to offer solutions to students to decrease their sedentary behavior and to improve their physical activity level during their medical studies through an intervention program. From a long term perspective, this intervention may also prevent disorders related to inadequate levels of physical activity and/or sedentary behavior. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested and/or interested" in following an intervention that aimed at improving physical activity. The objective of this study is to determine the influence of an intervention based on sedentary behavior reduction and physical activity promotion among medical students.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being a 4th-year or a 5th-year medical student at the Faculty of Medicine Lyon East during the academic year 2023-2024. Having read the information note. Having signed the written consent.  Exclusion Criteria:  -No exclusion criteria will be applied. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Global Paradise System US Post Approval Study
Status: Not yet recruiting

The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed and dated study informed consent Documented history of hypertension Documented history of prior or current antihypertensive medication(s) Mean seated office systolic BP at screening ≥ 140 mmHg Mean pre-procedure home systolic BP of ≥ 135 mmHg Estimated glomerular filtration rate (eGFR) of ≥30 mL/min/m2  RADIANCE CAP patients must provide signed and dated informed consent for inclusion in long-term follow-up. No other criteria are required for inclusion.  Exclusion Criteria:  Patients who meet the following will be excluded from participation:  Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter Patient under the age of 18 years old at the time of consent Patient is pregnant Patients with transplanted kidney Presence of abnormal kidney (or secreting adrenal) tumors  To confirm eligibility for treatment with the Paradise System, the following contraindications listed in the IFU may be determined at the time of procedure prior to treatment:  Renal arteries with diameter < 3mm and > 8mm Renal artery with fibromuscular dysplasia (FMD) Stented renal artery Renal artery aneurysm Renal artery diameter stenosis >30% Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control BP will be identified from the general population by the enrolling center.  Subjects enrolled in the RADIANCE CAP study will be transferred to the US GPS study after completion of their 12-month follow-up visit in the RADIANCE CAP study, to complete the remainder of the long-term annual follow-up visits under the post approval study protocol. - SamplingMethod: Non-Probability Sample
Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids
Status: Recruiting

Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and available for the duration of the study 14-17 years of age upon enrollment Right-handed In good general health as evidenced by medical history Adolescent and parent/guardian are English-speaking, as study assessments are in English Availability of a parent or legal guardian who is willing to provide consent and attend all study visits  Exclusion Criteria:  Traumatic brain injury with ongoing symptoms Sensory (e.g., hearing) or physical (e.g., motor, balance) impairment or significant developmental delay MRI participants: MRI contraindication (e.g., braces, implants, claustrophobia) Any condition that would contraindicate blood draws (e.g., hemophilia, sickle cell) Past or current diagnosis or presence of likely neurological disorder (e.g., epilepsy), psychotic disorder (e.g., schizophrenia, schizoaffective disorder), or bipolar disorder Severe/unstable medical condition (e.g., diabetes, rheumatoid arthritis) Current (past 1-month) use of cannabis or cannabinoid products including CBD unless willing to stop for at least 4 weeks prior to entering the study Currently pregnant, lactating, or positive pregnancy test at screening visit Current homicidal thoughts or suicide attempt in the past year Current suicidal thoughts requiring immediate intervention Concurrent use (past 6 weeks) of oral contraceptives Diagnosed or probable substance use disorder (past 1-month) Positive drug test at baseline visit (e.g., THC, cocaine) Moderate/severe drug or alcohol use in the past 8 weeks Current or recent (past 1-month) COVID-19 diagnosis or febrile illness Treatment with investigational drug or intervention (past 1-month) Current smoker, vaper, or tobacco or nicotine use (past 1-month) Ongoing exposure to abuse - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - GenderBased: Yes - GenderDescription: Females must not be pregnant, breastfeeding, or postpartum less than 6 months - MinimumAge: 14 Years - MaximumAge: 17 Years - StdAgeList: Child
Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery
Status: Not yet recruiting

This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. Manual lymphatic drainage is a gentle massage technique used to reduce swelling. It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Cis female with native breasts and localized breast cancer who are status post-lumpectomy surgery, will receive whole breast radiation therapy with/without nodal irradiation, with standard fractionation or moderate hypofractionation Age >= 18 years Ability to understand and the willingness to sign a written informed consent in English or Spanish  Exclusion Criteria:  Underlying diagnosis of chronic inflammatory illness or collagen vascular disorder, e.g. scleroderma, lupus, rheumatoid arthritis, fibromyalgia as these conditions may significantly affect the likelihood and magnitude of radiation related toxicity Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants Inability to provide written informed consent in English or Spanish Patients receiving ultra-hypofractionation, and/or partial breast or chest wall radiation therapy are excluded Individuals who are cis male, transgender female and cis female without intact native breasts will be excluded - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Participants must be cis female with native breasts. Cis males, transgender females, and cis females without intact native breasts are excluded. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population
Status: Not yet recruiting

Young women represent a population at risk of psychiatric disorders, the first signs of which often appear between the ages of 15 and 25. Psychiatric disorders are a major source of disability and healthcare costs.

The perinatal period is an additional period of psychological vulnerability, during which women are at increased risk of developing or worsening psychiatric disorders. Unfortunately, psychiatric disorders seem to be largely under-diagnosed during this period, and therefore under-treated.

The goal of this Prospective multicenter study is to determine the prevalence of the presence of at least one characterized psychiatric disorder, as defined by the use of the Mini International Neuropsychiatric Interview (MINI), in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment.

Participants will complete self-questionnaires and have a standardized psychiatric evaluation at T2 ultrasound and at 2 months postpartum.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women 18 years and over Pregnant and consulting for scheduled second trimester ultrasound Able to read and write with a good knowledge of French  Exclusion Criteria:  Unable to understand French Illiterate Underage patient at time of second trimester ultrasound Patient under guardianship or curatorship Patient deprived of liberty Patient not affiliated to or not benefiting from a social security scheme Refusal of consent after information Participant in another research project with an ongoing exclusion period - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Pregnant women only - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult