cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Delirium Simulation Education of Nurses in Intensive Care Unit

Delirium is a common symptom in the intensive care unit, which greatly affects the prognosis of critically ill patients and increases medical costs. Although many studies have implemented preventive measures, they have not been able to significantly improve the prevalence of delirium, because many medical measures devises in the intensive care unit are still necessary for patients. Therefore, early detection of patients with delirium symptoms, risk factors, and immediate Delirium management is important. Nurses are the first line of clinically important roles in assessing delirium symptoms. So, design a delirium simulation education for nurses is important.

Through literature review, the investigators found that research on delirium in the intensive care unit simulated education interventions are insufficient, and longitudinal studies to explore how long the effect can be maintained or delirium assessment and delirium management are designed dependent on theory are lacking. Therefore, the purpose of this study was to investigate the effect of delirium simulation education on delirium knowledge, delirium critical thinking, delirium care self-efficacy and satisfaction among nurses in intensive care units, and to explore the influencing factors.

Eligibility Criteria:
Inclusion Criteria:

1. Nurses who have worked in the intensive care unit for more than 3 months,
2. No physical or mental illness or recent major family events,
3. Never received delirium simulation training.

Exclusion Criteria:

1. Those who are not working in the intensive care unit for less than 3 months,
2. Those who have recently suffered from physical and mental illness or a major family event recently,
3. Those who have received delirium simulation training,
4. Those who are currently working as nursing supervisors.
Donepezil, Residual Excessive Daytime Sleepiness, Obstructive Sleep Apnea

It is a randomized, double-blind, single-center, 30-day study. Patients aged 35-60 years, with apnea and hypopnea index and respiratory disturbance index normalized with CPAP, and Epworth Sleepiness Scale\> 11. Patients undergo baseline and CPAP titration polysomnography, liquor and blood collection, Multiple Sleep Latency Test, anxiety and depression and cognitive assessments.

Obstructive Sleep Apnea (OSA) is a sleep-disordered breathing characterized by recurrent episodes of total or partial obstruction of the upper airway during sleep, which can lead to cognitive, metabolic and cardiovascular consequences. More recently, OSA has been associated with worsening Alzheimer's disease symptoms. Resolving respiratory events during sleep often has a beneficial impact on these consequences. However, even after adequate and optimized treatment with continuous positive airway pressure (CPAP), about 6 to 10% of patients still remain sleepy. Given the high prevalence of OSA, this percentage represents a large number of under-treated and at-risk individuals. This residual excessive sleepiness (RES) may be related to comorbidities and cognitive alterations. Its physiopathology is still unknown. A few studies have tested modafinil as an adjunct treatment for RES patients. Since a) CPAP is ineffective in patients with RES; b) previous studies suggest some benefit with wake promoters; and c) cognitive impairment has also been reported associated with RES; the hypothesis of the present study is that donepezil improves alertness and cognition in patients with OSA and RES, evidencing the role of the cholinergic system in the pathophysiology of RES.

Objective: To evaluate the effects of donepezil on RES in adult patients treated with CPAP.

Thirty-six patients diagnosed with OSA and RES are estimated to be included. Participants will be treated with CPAP for more than 6 months with a mean use greater than 5 hours per day. After blood and cerebrospinal fluid collection, patients will be randomized into 2 groups of 30 days of treatment with donepezil or placebo. RES will be evaluated by the vigilance test and the Epworth Sleepiness Scale.

Eligibility Criteria:
Inclusion Criteria:

* Both gender, Age between 35 and 65 years;
* Confirmed diagnosis of moderate to severe OSA;
* Treatment with CPAP for at least six months;
* Persistent sleepiness with daily CPAP use compliance \> 5 hours per night.

Exclusion Criteria:

* Neurological or psychiatric diseases;
* Chronic use of psychoactive drugs, other sleep disorders than OSA, visual defficiency, illiteracy.
Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children

Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid onset and offset of action.The reported incidence of emergence agitation (EA) following sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still considered as a potentially serious complication because of the risks of self-injury, and because of the stress caused to both caregivers and families.

Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic actions, has been used in pediatric populations.Several prospective clinical trials in children have shown that dexmedetomidine significantly reduces the incidence of EA prior to recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on emergence agitation has not been fully evaluated. The purpose of the present study was to verify the hypothesis that intranasal premedication with dexmedetomidine is effective in reducing emergence agitation after sevoflurane anaesthesia.

Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PAED scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points.

A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. Agitation scores \< 10 were interpreted as an absence of agitation, scores\>= 10 were regarded as presence of agitation.

Eligibility Criteria:
Inclusion Criteria:

* aged2-6 yr, with American Society of Anesthesiologists physical status I or II, scheduled to undergo strabismus surgery during general anesthesia

Exclusion Criteria:

* mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.
Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection

Patients after kidney transplantation who develop donor-specific antibodies (DSA) are at high risk for antibody-mediated rejection (ABMR). Donor-derived cell-free DNA (dd-cfDNA) levels have been shown to be increased in patients with active or chronic active ABMR. This study aims to evaluate if repeated analysis of dd-cfDNA in patients with DSA and kidney allograft biopsy which is triggered by increased levels of dd-cfDNA can lead to early diagnosis of active or chronic active ABMR among these patients.


Eligibility Criteria:
Inclusion Criteria:

* patients 18 years or older
* patients provided written informed consent
* patients after kidney transplantation
* functioning kidney allograft, at least after 180 days after last transplantation
* estimated glomerular filtration rate above 20 ml/min/1.73m\^2
* detection of DSA

Exclusion Criteria:

* patients younger than 18 years
* patients unable or did not provide written informed consent
* pregnant or breastfeeding persons
* patients with increased bleeding risk
* patients with multi-organ transplantation
* patients who underwent kidney allograft biopsy after first detection of DSA
* biopsy-proven antibody-mediated rejection
* participation in another interventional clinical trial
Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

Analysis of the individual radiosensitivity in pediatric oncology


Eligibility Criteria:
Inclusion Criteria:

* Minor patient treated for a brain tumor, Ewing tumor, malignant mesenchymal tumor, neuroblastoma, nephroblastoma, Hodgkin's lymphoma treated with radiotherapy (+/- chemotherapy) for curative purposes.
* Children or adolescents \> 3 years old and \< 18 years old
* Patient with an indication for radiotherapy as part of the primary tumor local control strategy
* Theoretical indication for radiotherapy in standard fractionation (1.8 Gy to 2.2 Gy / fraction: 5 fr/week) whatever the technique and the particle used
* Patient affiliated with a social security scheme
* Patient and/or parents or holders of parental authority having dated and signed an informed consent

Exclusion criteria:

* Patients with contraindications to blood sampling
* Patients with contraindications to radiotherapy
* Palliative radiotherapy
* Patient with previous RT treatment in the same area (re-irradiation)
* Patient with an indication of hypofractionated RT
* Patient follow-up not possible
* Persons deprived of liberty or under guardianship (including curatorship)

Exclusion Criteria:

-
Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses

The objective of the study is to evaluate and compare the performance of verofilcon A to somofilcon A when worn on a daily disposable modality over a period of approximately one week each.

The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates somofilcon A (test lens) and verofilcon A (control lens).

Eligibility Criteria:
Inclusion Criteria:

-

A person is eligible for inclusion in the study if he/she:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
6. Has an astigmatism of ≤ 1.00 D in subjective refraction;
7. Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
8. Demonstrates an acceptable fit with the study lenses;
9. Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.

Exclusion Criteria:

-

A person may be excluded from the study if he/she:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
7. Is aphakic;
8. Has undergone refractive error surgery;
9. Is an employee of the Centre for Ocular Research \& Education;
10. Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or MIKI (EX-MKTG-114) Study;
11. Has participated in any clinical trials within a week prior to the study.
Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer

The purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic hormone refractory prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

Patients who completed the 10 cycles of docetaxel administrations in the preceding XRP6976J/2101 study and wish to continue docetaxel administrations,and who have no alternative therapy for hormone refractory prostate cancer according to the Investigator's judgment.

Exclusion Criteria:

* Continuation in the study would be detrimental to the patient's well-being
* Development of life-threatening and/or toxic conditions not manageable by symptomatic care, dose reduction, or delay of dosing
* Obvious disease progression (rising prostate specific antigen, any increase of ≥ 20 % in the sum of the measurable lesion in comparison to the nadir value, and progression in non-measurable lesion)
* Patients treated with anti-cancer treatment other than study therapy after completion of 10 cycles of study treatment in the XRP6976J/2101 study
Evaluation of Improved Outcomes Among Ambulatory Diabetes and/or Hypertensive Patients - an Intervention Study (CPCLINT)

The goal of this interventional study is to compare improved outcomes among diabetes and/or hypertensive patients sequel to educational intervention. The study aims to answer the following questions:

* What are the patients' levels of health literacy, medication adherence, disease knowledge, attitude to disease, physical activity?
* Does educational intervention by pharmacists improve health outcomes of patients with diabetes and/or hypertension?
* Are there associations between patient-related variables such as health literacy, medication adherence, disease knowledge, attitude to disease? Participants' anthropometric measurements and point-of-care testing for disease monitoring e.g., blood pressure, blood glucose would be carried out. Baseline assessment of participants would be done to evaluate their levels of health literacy, medication adherence, disease knowledge, attitude to disease, physical activity.

Patients' baseline assessment would be carried out, after which they would receive educational materials and would be followed up by pharmacist. The baseline assessments would be repeated at three and six months after the intervention to measure the effectiveness of the intervention.

The anthropometric measurements would include weight, height, waist circumference, hip circumference, from which the body mass index and waist-hip ration would be calculated.

The assessment of the disease knowledge and attitude would be done using validated semi-structured questionnaires earlier designed by the principal investigator and used among ambulatory patients with diabetes and/or hypertension accessing care in tertiary healthcare facilities. The validated International Physical Activity Questionnaire (IPAQ) would be utilized for participants' physical activity assessment.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of 18 years of age
* Patients must be diagnosed with diabetes and/or hypertension
* Patients must be on at least one medication
* Patients who access one of the selected community pharmacies for prescription refill

Exclusion Criteria:

* Non-consented patients
* Patients not based at the study site
Prevention of Graft Reinfection After Liver Transplantation With Anti HCV Monoclonal Antibodies Identified in Chronically Infected Patients or in Patients With Resolved Hepatitis C

End stage HCV-related cirrhosis has become a major indication for liver transplantation (LT). Unfortunately, recurrence of HCV infection on the liver graft occurs in almost all patients following transplantation and causes a persistent infection that leads to chronic hepatitis and cirrhosis in a significant proportion of patients. To date there is no effective way to prevent HCV reinfection of the liver graft in the early phase after transplantation. . Early passive immunotherapy with neutralizing antibodies against HCV should be considered for preventing reinfection of liver transplanted patients associated with HCV. This approach is well established in the case of patients undergoing liver transplantation for chronic hepatitis B virus infection. Our purpose is to produce neutralizing monoclonal antibodies to prevent reinfection of the liver graft.


Eligibility Criteria:
Inclusion Criteria:

* Health insurance
* Resolved HCV infection ( HCV RNA negative since more then 6 months ) -HCV chronically infected ( RNA positive )
* Anti- HCV antibodies positive
* Volunteers and informed patients

Exclusion Criteria:

* Immunosuppression
* HBV or HIV infection
* Pregnancy
* Breast feeding
A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study

Cervix cancer is a major global health concern. A way to screen and immediately treat precancerous lesions (Screen-and-Treat) is greatly needed. Developed by MobileOCT, polarized difference imaging and conventional imaging are used to identify suspicious lesions. We aim to compare this non-invasive method with colposcopy. Patients at the Dickens Clinic will have 3-5 minutes of non-invasive imaging before colposcopy. Pathology will be compared both to colposcopy impression versus MobileOCT.


Eligibility Criteria:
Inclusion Criteria:

* Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on subjects behalf.
* Subjects are 18 years of age or older
* Subjects are scheduled for colposcopy clinic based on screening with abnormal pap smear or have repeat colposcopy indicated for specific clinical indications, based off of American Society of Cosposcopy and Cytology.
* Subjects are women.

Exclusion Criteria:

* Pregnancy.
* Males (males do not have a cervix and thus cannot undergo colposcopy).
Immune Status of Elderly Population Admitted in an Acute Geriatric Unit

Ageing is associated with vulnerability against infections leading to increased morbidity with risk of death. Innate and adaptive immunities are altered with ageing responsible of deficits in immune response against pathogens and after vaccination, and favouring the elderly vulnerability against a new pathogen with increased bacterial, viral, and fungal infections.

If immunity has been widely studied in immunosenescence, there are few prospective, comparative studies with elderly ill patients. Moreover among these studies, pathologies are not well defined.

The main objective of our project is to compare the immune state of elderly hospitalised subjects in an acute geriatric unit to the immune state of elderly healthy subjects selected with strict criteria, in order to precise the impact of polypathology and of various pathologies on immunity state.


Eligibility Criteria:
Inclusion Criteria:

* Subject of 75 or more years old, female or male
* Subject admitted in the service of short stay gériatrique of the hospital Holy Marguerite, whatever is the motive for admittance
* Subject not being under supervision(guardianship), nor guardianship
* Subject benefiting from a benefit system
* Subject having given its assent of participation or for which the reliable person gave her assent in the case of vulnerable person

Exclusion Criteria:

* Subject of less than 75 years old
* Subject refusing to participate in the study or for whom(which) the reliable person refuses the participation of the subject
Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia

A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues (R0) or macroscopic tumor residues \< 1cm (R1)) followed by hyperthermia against normothermia intraperitoneal intraoperative chemotherapy with paclitaxel


Eligibility Criteria:
Inclusion Criteria:

1. age ranged between 18 and 75 years old;
2. histopathologic confirmation of peritoneal carcinomatosis from epithelial ovarian cancer (stage IIIc- FIGO (International Federation of Gynecology and Obstetrics));
3. Karnofsky index \> 70 or performance status ≤2;
4. informed consent form filled out correctly.

Exclusion Criteria:

1. unfulfillment of inclusion criteria;
2. extraabdominal metastasis or stage IV FIGO (liver, lung, bone, etc);
3. concomitance of another malignant neoplasm;
4. renal, hepatic or cardiovascular dysfunction;
5. intolerance during the treatment; - (6) refusal to participate in the study.
Prostate Specific Membrane Antigen PET/CT Imaging in PSMA-Related Disease Patients

To evaluate the potential usefulness of 68Ga/18F-PSMA positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various PSMA-related disease patients.

Subjects with various PSMA-related disease patients underwent 68Ga/18F-PSMA PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-PSMA PET/CT were calculated.

Eligibility Criteria:
Inclusion Criteria:

- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled PSMA PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Antibiotic Prophylaxis to Prevent Post-procedure UTI After VCUG

The current practice of pre-VCUG antibiotic prophylaxis is highly variable. A recent unpublished survey of Society of Fetal Urologists (SFU) completed by this study team found that 87% of respondents reported having patients who develop fUTI following VCUG, with 30% of respondents prophylaxing for fUTI in patients undergoing VCUG. The current lack of best practice guidelines regarding antibiotic prophylaxis prior to VCUG due to low quality of current literature, and a growing concern around risks of unnecessary antibiotic exposure suggests the need for an RCT. The results of this pilot trial will inform the ability to conduct a definitive RCT on this important subject. The results of the definitive trial would have important clinical and economic implications.

What are the Study Objectives? The primary objective of this pilot trial is to determine the feasibility of conducting a definitive trial investigating whether pre-VCUG antibiotic prophylaxis, when compared to placebo, decreases the risk of fUTI in infants undergoing VCUG for genitourinary abnormalities. The pilot trial will address specific feasibility outcomes including process, resources, management and scientific domains. The pilot will lay the groundwork for the eventual full trial. Funding for the full trial will be sought after preliminary data is collected from the pilot study.

The primary objective for the definitive trial is to determine whether single-dose, preprocedural antibiotic prophylaxis compared to placebo lowers the risk of fUTI in children \< 3 years of age who are undergoing VCUG for the following indications: high-grade (SFU Classification III, IV/UTD 2,3) HN, ureteral dilatation, or bladder abnormalities found during renal ultrasound. The secondary outcomes of the definitive trial will include assessment of adverse event outcomes related to antibiotic prophylaxis administration, including antibiotic resistant UTI pathogens, episodes of antibiotic associated diarrhea, and C. difficile.

Eligibility Criteria:
Inclusion Criteria:

1. Children \<3 years of age undergoing VCUG for the following indications: high-grade SFU/UTD hydronephrosis, ureteral dilatation, or bladder abnormalities found during renal ultrasound
2. Parent or legal guardian able to provide informed consent

Exclusion Criteria:

1. Chronic antibiotic use
2. Allergy to Trimethoprim or Trimethoprim-Sulfamethoxazole