cyrilzakka/clinical-trials huggingface dataset:
The Use of Microlearning in Nursing Education

The goal of this randomized controlled study is to evaluation the effect of mobile application-based wound healing course on clinical reasoning skills in nursing student. The main questions it aims to answer are:

* Does microlearning-based courses have an effect on clinical reasoning skills of nursing students compared to traditional courses?
* Does microlearning-based courses have an effect on the retention of knowledge in nursing students compared to traditional courses? Participants will consist of students enrolled in the Surgical Diseases Nursing course in the fall and springs semester of the 2022-2023 academic year in the Department of Nursing at the Faculty of Health Sciences of Karadeniz Technical University.

If there is a comparison group: Researchers will compare experimental group to see if control group.

Today, there is a need to integrate rapidly developing technology into educational environments and to structure educational environments. Micro-learning modules have been used in e-learning platforms recently, with short content and user focus. This randomized controlled study was planned to evaluation the effect of mobile application-based wound healing course on clinical reasoning skills of nursing students. The population of the study will consist of students enrolled in the Surgical Diseases Nursing course in the fall and springs semester of the 2022-2023 academic year in the Department of Nursing at the Faculty of Health Sciences of Karadeniz Technical University. The students enrolled in the Surgical Diseases Nursing course in the fall semester will form the control group, while the students enrolled in the spring semester will form the experimental group. Students in the control group will take the wound healing process course with the presentation of the trainer, and the students in the experimental group will take micro-learning courses. Data will be collected with the "Student Information Form", "Wound Healing Process Information Form" and "Micro-Learning Based Mobile Application Evaluation Form". In addition, students will be evaluated on the simulator of clinical decision-making processes. The micro-learning course will remain open to students in the experimental group for 31 day. In order to measure the permanence of the knowledge, the "Wound Healing Process Information Form" will be filled in again after 31 days to the students in the control and experimental groups in line with the literature. In addition, students will be evaluated on the simulator of clinical decision-making processes. The results obtained after the application will be analyzed and the effect of the micro-learning course on the decision-making processes of the students will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Enrolling in the Surgical Diseases Nursing course for the first time, Being willing to participate in the study, Having Android or IOS system on the mobile phone.

Exclusion Criteria:

* Having preliminary training and experience in wound care and non-healing (health vocational high school graduation, etc.),
TREatment of degeNerative and Neoplastic Diseases With Rituximab

This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of PBO-326 (Rituximab) and Mabthera (Rituximab) in combination with CHOP in previously untreated patients with diffuse B cells Non Hodgkin lymphoma.

At present R-CHOP (Rituximab plus Cyclofosfamide, Doxorrubicine, Vincristine and Prednisone) has became standard of care of patients with B cells Non Hodgkin Lymphoma CD20+.

Study will perform pharmacodynamic (PD) and pharmacokinetic (PK) measurment of a novel Rituximab in comparison with Mabthera and evaluates safety both metabolic as well immunologic.

Study protocolo is designed to provide data on impact of treatment interchange of both study drugs (PBO-326 and Mabthera).

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed subjects with a confirmed pathologic diagnosis of diffuse large B cell non-Hodgkin's lymphoma (DLBCL) based on the 2008 World Health Organization classification.
2. CD20+ lymphoma cells at screening.
3. \> 18 years of age at screening.
4. Ann Arbor Stages I-IV at screening.
5. Any IPI score at screening.
6. Easten Cooperative Oncology Group (ECOG) performance status (0-2) or Karnofsky scale \> 60 at screening.
7. Left ventricular ejection fraction \> 50%.
8. Willing and able to provide written informed consent prior to performing study procedures.
9. Women of childbearing potential must use effective contraceptive methods starting from screening and until 12 months following the last infusion.

Exclusion Criteria:

1. Hodgkin lymphoma.
2. Any lymphoma other than CD20+ Diffuse Large B Cell Lymphoma (DLBCL).
3. Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity .
4. Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
5. Function Liver tests \>2 x upper normal values.
6. Positive Hepatitis B surface antigen or antibodies to Hepatitis C.
7. Any other serious active disease or co-morbid medical condition.
8. Subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study.
9. Pregnant or breast-feeding women or women that intend to get pregnant during study or within 12 months following the last infusion.
10. Treatment with any investigational drug within 90 days before day 1 of study treatment.
Echocardiographic Measurement of Myocardial Work

Echocardiography is recommended for the hemodynamic management of patients with shock. Recently, a new echocardiographic method has been proposed that provides a non-invasive measurement of myocardial work incorporating different components, namely total myocardial work (GWI), constructive myocardial work (GCW), lost myocardial work (GWW) and effective myocardial work (GWE). Echocardiographic measurement of myocardial work takes into account both myocardial deformation and left ventricular afterload (estimated by measuring systolic blood pressure) and, unlike the measurement of left ventricular ejection fraction and global longitudinal strain, could be less dependent on cardiac load conditions, particularly left ventricular afterload. To date, non-invasive measurement of myocardial work has never been validated in critically ill patients, and no study has assessed the effects of different therapies (fluids administration, administration of norepinephrine) on the different components of myocardial work in patients admitted to intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Indication to fluid administration left to the discretion of the attending physician
* Indication to norepinephrine administration or increase in norepinephrine dosage left to the discretion of the attending physician.

Exclusion Criteria:

* Patients under protection.
* Patients with do not ressuscitate order.
* Patients with severe left-side or right-side valvulopathy.
* Patients with atrial fibrillation.
* Patients with ventricular aneuvrysm or severe regional wall motion abnormalities.
* Patients with a pacemaker.
* Patients' objections to the collection of their health data.
Evaluating the Effect of Optical Zones on Correction for SMILE: Vector Analysis

Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in small incision lenticular extraction.

To retrospectively study whether different surgical optical zone sizes affect the correction of diopter and astigmatism in myopia patients. Divided into 2 groups according to the diameter of the optical zone. The vector analysis method was used to analyze the changes and errors of astigmatism in TR and SIR after operation. Generalized Estimation Equation (GEE) model is used for multiple regression analysis to evaluate the potential factors related to the error value.

Eligibility Criteria:
Inclusion Criteria:

* no ocular conditions
* normal topography
* central corneal thickness, \>500µm
* residual stromal thickness, \>280 µm
* pupil diameter, 2.78-4.9 mm (average, 3.76±0.43 mm);

Exclusion Criteria:

* history of intraocular surgery
* pupil diameter, \>4.9 mm or \<2.78mm
* keratoconus or corneal ectasia
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Spain

This is a Spanish, Multicentre, Observational Study to study adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Subjects will be enrolled in a multicenter, longitudinal observational study. Parents/subjects will provide their Informed Consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

- To assess the level of adherence of subjects receiving SAIZEN® via easypod™

Secondary Objectives:

* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
* To identify adherence subject profiling
* To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone via the easypod™ electromechanical device according to Summary of Product Characteristics (SmPC)
* Over the age of \>2 years
* Under \<18 years of age, or over 18 without fusion of growth plates
* Parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough (16 years old) to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country.

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
* Contra-indications to SAIZEN® as defined in the SmPC
* Use of an investigational drug or participation in another interventional clinical study
Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients, age \>18
* Life expectancy \> 6 months
* Histological proven, metastatic, or locally advanced and non-operable, non- pre-treated GIST.
* Patients having never received any tyrosine kinase inhibitor, including as adjuvant therapy
* C-Kit (CD117) positive tumors detected immuno-histochemically
* Measurable tumor lesions with longest diameter \>20 mm using conventional techniques or \>10 mm with spiral CT scan

Exclusion Criteria:

* Documented allergy to the similar drug of AB1010
* Inadequate organ function
* Patients with a history of any other malignancy
Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

The purpose of the study is to determine whether colchicine is safe and effective in the treatment of acute pericarditis and the prevention of subsequent recurrences.

Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data have shown that it may be effective also in treatment of the index attack of pericarditis and the prevention of further recurrences.

Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of acute pericarditis and the primary prevention of recurrences. Colchicine will be used in addition to conventional treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute pericarditis (index attack)
* Age≥ 18 years
* Informed consent

Exclusion Criteria:

* Suspected neoplastic, tuberculous, or purulent etiology
* Known severe liver disease and/or elevated transaminases \>1.5 times the upper limit of normality
* Serum creatinine \>2.5 mg/dl
* Serum creatine kinase (CK) over the upper limit of normality or known myopathy
* Known gastrointestinal or blood disease
* Pregnant or lactating women or women not protected by a contraception method
* Known hypersensibility to colchicine
* Treatment with colchicine at enrolment
Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt

Diet is known to play role in the complex etiology of UC.Patient with UC tend to adapt unguided dietary habits without the guidance of a dietician or physician (Dejong,M.J 2019).so identification of nutritional gaps is needed to facilitate the development of evidence-based dietary guideline and subsequently give correct dietary advice to UC patients(Haskkey,N et al 2017).


Eligibility Criteria:
Inclusion Criteria:

* patients with ulcerative colitis diagnosed by clinical Endoscopic and histopathological methods

Exclusion Criteria:

-

Patients with any co morbidity ( HTN,DM,Primary sclerosing cholangitis, as those patients need some restrictions of diet which may affect the prognosis of the disease)
A Reliability and Validity Study of Urdu Version of Western Ontario And MacMaster Osteoarthritis Index

The aim of the study is to translate and culturally adapt Western Ontario And MacMaster Osteoarthritis Index into Urdu language and to investigate its reliability and validity Pakistani population with primary knee osteoarthritis while assessing its correlation with Lequesne Index.

As per preceding commendation, Western Ontario And MacMaster Osteoarthritis Index will be translated into Urdu language from its English version and adapted culturally in Pakistan. Among primary knee osteoarthritis population, Western Ontario And MacMaster Osteoarthritis Index will be distributed among 87 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. For testing inter-observer reliability and intra-observer reliability of Western Ontario And MacMaster Osteoarthritis Index and Lequesne Index will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. As for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. Statistical Package of Social Sciences software version 24 will be used for the purpose of data entry and analysis. Internal consistency will be assessed by using an intra-class correlation coefficient. The Western Ontario And MacMaster Osteoarthritis Index will be evaluated for content validity, construct validity, criterion validity and responsiveness

Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients
* Age above 40 years
* Participants with primary knee Osteoarthritis
* Patients willing to participate.

Exclusion Criteria:

* History or presence of ;
* Rheumatic diseases,severe articulation inflammation and cardiac disease.
* Participants with secondary knee Osteoarthritis.
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury

To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery, compared to a placebo control with spinal cord repairing surgery, on post-surgery motor function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in subjects


Eligibility Criteria:
Inclusion Criteria:

1. Subjects of either sex and 15-65 years of age.
2. Subjects have spinal cord injury and the subjects must be categorized as Grade A or B by the ASIA Impairment Scale.
3. Subjects have adequate heart, lung, kidney and liver function.
4. Subjects are able to give voluntary and dated informed consent prior to enrollment.

Exclusion Criteria

1. Penetration SCI
2. Brain damage or multiple injuries
3. History of congenital or acquired abnormalities in the spinal cavity
4. History of congenital or acquired immunodeficiency disorders
5. History of malignancies or positive results
6. Current serious/uncontrollable infections or others serious diseases
7. Pregnant or lactating women
8. Allergy to ES135 or any of its excipients
9. Unable to obtain informed consent from subject
Efficacy Study of Folinic Acid to Improve Mental Development of Children With Down Syndrome

The purpose of this study is to determine whether folinic acid can improve developmental quotient of young Down syndrome patients, given that these present signs of folate deficiency which are known to cause reversible neurological, psychiatric and cognitive disorders.


Eligibility Criteria:
Inclusion Criteria:

* Down syndrome without mosaicism
* age 3 to 30 months
* weight over 4 kg
* possible assessment by the revised Brunet-Lezine scale

Exclusion Criteria:

* history of leukemia
* West syndrome or non-stable epilepsy
* non-stable thyroxin treatment
Young Blind Child Melatonin Treatment Study

The primary goal of this study is to identify the presence of desynchronized circadian rhythms in 25 children by measuring melatonin secretion in serial blood or saliva samples, and to rule out any primary sleep disorders.

Subjects will complete 25-hours of hourly salivary, plasma sampling biweekly. Melatonin will be measured in urine, for children under the age of 3. Sleep and behavioral questionnaires will be completed by parents and/or teachers. This study involves an optional, 1-year melatonin treatment sub-study, in which the children will take 0.1 - 3mg daily. A second optional sub-study involves a study of the child's sleep through polysomnography, in order to identify possible sleep disorders.

Eligibility Criteria:
Inclusion Criteria:

* Age 1-20 years
* Blindness for the past year (verified by an ophthalmologic exam), but otherwise in general good health.

Exclusion Criteria:

* Abnormal heart, lung, kidney, liver disease or a primary sleep disorder,
* Significant clinical abnormalities (other than blindness),
* Use of medications with known effects on melatonin metabolism (e.g. beta-adrenergic blocking drugs or tricyclic antidepressants).
Efficacy and Implementation of MINDxYOU Program for Reducing Stress and Promote Mental Health Among Healthcare Providers

Because of the COVID-19 pandemic situation, social and health professionals constitute a population in risk of developing psychopathologies due to the high levels of stress they experience. There is consensus regarding the need of offering these professionals psychotherapeutic evidence-based interventions addressed to reducing their stress levels and promote their wellbeing; because of the current situation, it is believed that online interventions might be the best-fitted approach. The research groups that present this project have leaded a research line that has proved the efficacy of online psychotherapeutic programs in the past. In the present project, the efficacy of the MINDxYOU program will be evaluated; this is an online intervention based on mindfulness techniques, compassion, and acceptance, and that has been developed specifically for social and health professionals. In addition, in order to overcome the gap that separates the validation of interventions and their posterior implementation, this project aims to perform an implementation study in which a hybrid design will be adopted to test the impact of the program in terms of efficacy and the feasibility of the implementation. The investigators will adopt the framework proposed by Hermes. et al., inspired in Proctor's recommendations. The study will be conducted in 2 autonomous communities (Aragón and Andalucía).


Eligibility Criteria:
Inclusion Criteria:

* Working as a doctor, nurse, physiotherapist, psychologist, nursing assistant, ambulance technician, or being a trainee student in any health profession, or working in a nursing home.
* Aged between 18 and 70.
* Ability to understand Spanish.
* Digital literacy and access to a smartphone, tablet, or personal computer with Internet connection.
* Giving informed consent.

Exclusion Criteria:

* Presenting an illness that affects the central nervous system.
* Having a diagnosis of a severe psychiatric condition (including severe depressive disorders, suicidal tendencies, bipolar disorders, panic disorders, anxiety or stress-related disorders, obsessive-compulsive disorders, and substance-related disorders).
* Presenting a medical, infectious, or degenerative illness that is not under control.
Bad Breath Response to Tongue Scraper and Rinses

Medical center personnel were screened organoleptically for bad breath by 2 investigators using Rosenberg scale 0-5, and measurement of breath sample in portable gas chromatograph. With a threshold score of 2 or more, or 75parts per billion(ppb) hydrogen sulfide(H2S), subjects invited to enter clinical trial of the mechanical effect of daily tongue scraping with the adjunctive use of 0.12% chlorhexidine gluconate mouthwash or 0.1% stabilized chlorine dioxide mouthwash. Subjects randomly assigned in double-blind trial for one week. The null hypothesis is there will be no difference between the two rinses as adjuncts to tongue scraping.

Subjects in trial had oral and periodontal exam and scored the Ramfjord teeth(#3, 9, 12, 19, 25, 28) for Plaque Index(PlI), Gingival Index(GI), probing depth (PD), recession. A tongue coating index is scored and sample of coating on dorsum taken for culture of total viable count and percentage of black sulfide-producing colonies on anaerobe agar with lead acetate added. Subjects given hygiene instruction and instruction on use of scraper, then rinse with 20ml assigned mouthwash 30sec. Breath assessed by organoleptic means and mouth air sample concentration of hydrogen sulfide, methyl mercaptan in portable gas chromatograph at 0, 1, 2, and 4 hours. Subjects use scraper and mouthwash twice daily for one week and return for final exam.

Eligibility Criteria:
Inclusion Criteria:

* Adult with threshold score of 2 on organoleptic halitosis evaluation

Exclusion Criteria:

* Taking another experimental drug, or antibiotic.
Aging Well, Sleeping Efficiently: Protecting Health In Later Life

The purpose of this study is to see whether protecting sleep quality in later life is important in continued healthy aging. The value of education in healthy sleep practices along with reducing time in bed each night by going to bed 30 minutes later, and of healthy dietary practices will be tested for their effects on sleep quality, health, and well being.

The goal of this project is to test the efficacy of restricting time in bed and education in healthy sleep practices for maintaining or even enhancing sleep consolidation and depth in subjects aged 75+ who are at risk for decay in sleep quality and daytime well being; to determine the associated benefits for health; and to examine the persistence of such effects for 12 months beyond the end of the 18-month intervention. This project focuses not on pathology but on prevention of sleep decay and preservation of sleep in individuals who have already evidenced successful aging.

Eligibility Criteria:
Inclusion Criteria:

* age 75 or older
* without sleep disorders
* without psychiatric disorders
* Folstein MMSE of 24 or greater

Exclusion Criteria:

* Apnea-hypopnea index greater than 30
* Mean sleep latency less than 6
* Psychotropic medications present