cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a Multifaceted Intervention to Reduce Medication Administration Errors in Neonatal Intensive Care Units

The purpose of this study is to determine whether an educational program for caregivers associated with convenient tools is effective to reduce medication preparation and administration errors in the Neonatal Intensive Care Units (NICU).

Medication errors are frequent in neonatal intensive care units and consequences are more severe than in adults. Although errors happen in each step of medication management process, a large proportion of errors occur during medication preparation and administration.

This study will test the hypothesis that rates of medication errors during preparation and administration will be reduced by implementing an education program for NICU caregivers (Nurses) and providing convenient tools.

The trial has a stepped wedge design, in which the NICU's from three hospitals in France will be randomized (Group A, B and C) to the timing of implementation of the educational intervention.

According to the allocation (Group A, B or C), the education intervention will include a complete main program of nine weeks and one to three maintenance educational periods.

Medication administration errors rates will be measured before (baseline measurements) and after each educational interventions (main or maintenance interventions).

Errors will be identified by direct observations of nurse's acts by external observers.

Eligibility Criteria:
Inclusion Criteria:

* All nurses working in the intensive care units in the day time.

Exclusion Criteria:

* Nurses working as a float or pool nurses.
* Nurses working at night.
Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio

The study has been designed as a randomised, parallel-group, double-blind, 3 arm study to investigate the comparative pharmacokinetics, safety, immunogenicity and tolerability between AVT80 and Entyvio in healthy volunteers.

The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to receive a single dose of either AVT80, geographical region 1 Entyvio or geographical region 2 Entyvio.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol.
* Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index (BMI) of 17.0 to 32.0 kg/m2 (inclusive).
* Participant must be 18 to 55 years old inclusive, at the time of signing the ICF.

Exclusion Criteria:

* Participant has a history of relevant drug and/or food allergies.
* Participant has a history of hypersensitivity to Entyvio, AVT80, or their constituents.
* Participant has any past or concurrent medical conditions that could potentially increase the participant's risks or that would interfere with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (e.g., demyelinating disorders).
Clinical and Radiographic Evaluation of MTA Pulpotomy Versus Conventional Pulpectomy in Primary Molars With Irreversible Pulpitis

This study is designed to compare between MTA Pulpotomy (Removal of coronal pulp tissue, placing MTA and covering with Stainless steel crown) Versus Conventional Pulpectomy (Removal of radicular pulp tissue, placing Zinc Oxide/Eugenol and covering with Stainless steel crown) in irreversible pulpitis in primary second molars.


Eligibility Criteria:
Inclusion Criteria:

* Patients:
* Aged 4-7 years, cooperative, in good general health and medically within normal
* Teeth:
* Restorable mandibular second primary molars.
* History of irreversible pulpitis.
* Preoperative radiograph:
* Absence of periapical or inter-radicular radiolucency.
* Absence of widening of periodontal ligaments (PDL) space.
* Absence of internal or external root resorption.

Exclusion Criteria:

* Patients:
* With systemic disorders.
* Physical or mental disabilities.
* Unable to attend follow- up visits.
* Refusal of Participation.
* Refusal to sign the informed consent.
* Teeth:
* Previously accessed teeth.
* Mobile mandibular second primary molar.
* Swelling in the vestibule or on palpation.
* Pain on percussion.
Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children

The purpose of this study was to compare the efficacy and tolerability of acetaminophen, dipyrone and ibuprofen to fever control in children.

For the efficacy asses were compared:

* the time to start the action;
* the action duration;
* the difference between the basal temperature and the lower temperature in the study period.

For the tolerability asses all adverse events were recorded, as well as your intensity and the relation to the treatment.


Eligibility Criteria:
Inclusion Criteria:

* male and female children aged 06 months to 06 years old, weight above 5 kilo and axillary temperature above 37,5 celsius degree.

Exclusion Criteria:

* patients with a bad general heath state
* patients with neoplasia, pepic ulcer, gastrointestinal bleeding,history of fever convulsion;
* intolerant to dypirone, ibuprofen, acetaminophen or any other nonsteroidal antiinflammatory drug;
* moderated or severe dehydration;
* conscience state alteration;
* not capable of ingest oral drugs;
* patients being treated with steroids;
* patients treated with antiinflammatory, analgesic and antipyretic drugs in the last 06 hours before the study.
HOPE Social Media Intervention for HIV Testing and Studying Social Networks

This study \[HOPE: Harnessing Online Peer Education\] seeks to determine the efficacy of using online social networks to scale peer community leader models to increase HIV prevention within African-American and Latino men who have sex with men. The peer community leader model, which teaches community popular opinion leaders about how to disseminate behavior changes messages throughout the community, has been proven to increase HIV prevention behaviors. Social media and online communities, such as Facebook, may be a cost-effective platform for scaling these models. Primarily upper middle-class White populations used the Internet in its early years, however, Internet use within African-American and Latino households has recently increased dramatically, especially on social media. People using the Internet may be at the highest risk for contracting HIV and are using novel Internet approaches to find sex partners, such as through social media. This is the first study to examine the effectiveness of the HOPE social media intervention to increase HIV testing among at-risk groups in the United States.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Male
* Sexually active with another man in the last 12 months
* Willing and capable of understanding and assenting to an online informed consent form
* Has (or willing to create) a social media page.

Exclusion Criteria:

* Does not satisfy inclusion criteria
Drug Resistance Mechanism of Enterobacteriaceae and Its Strategies

The first aim of this study is to explore the drug resistance mechanism of Enterobacteriaceae bacteria and to evaluate the treatment effect of ceftazidime-avibactam (CAZ-AVI) in combination with aztreonam (ATM) against Metallo-β-lactamases (MBL) producing Enterobacterales in vivo. The investigators then use CRISPR/Cas9 technology to remove Enterobacteriaceae bacteria resistance and virulence genes

Clinical information of subjects, including diseases, departments, medication history, days of hospitalization, and treatment outcomes will be collected; Bacterial species names will be identified and drugs sensitivity will be detected; For patients with bloodstream infection of MBL-producing Enterobacterales, ceftazidime-avibactam (CAZ-AVI) was administered at the dose of 2.5 g every 8 hours and aztreonam (ATM) at the dose of 2 g every 8 hours.

The primary outcome measure was 30-day all-cause mortality, while secondary outcomes were clinical failure at day 14 and length of stay (LOS) after bloodstream infection diagnosis. Cox regression analysis, including a propensity score (PS) for receiving CAZ-AVI plus ATM, was conducted to assess the primary and secondary outcomes. The CRISPR/Cas9 gene curation technology was used to eliminate the drug resistance and virulence factors of Enterobacteriaceae in the mouse intestinal colonization model.

Eligibility Criteria:
Inclusion Criteria:

* Subjects clinically suspected of infection caused by Enterobacterales
* Subjects with bloodstream infection by MBL-producing Enterobacterales

Exclusion Criteria:

* Infections caused by viruses, fungi, atypical pathogens, and other non-Enterobacteriaceae bacteria
* subjects who are unwilling to enter the research group
Posterior Capsular Injection With Femoral Nerve Block for Total Knee Arthroplasty

To assess pain control after total knee replacement surgery using two different nerve block techniques. The 2 methods are:

1. Continuous femoral nerve block with ultrasound guided posterior capsular injection
2. Continuous femoral nerve block with ultrasound selective tibial nerve block.

Patients undergoing total knee replacement surgery experience severe post-operative pain. Continuous femoral nerve block combined with selective tibial nerve block provides optimal pain control in the anterior and posterior aspect of the knee respectively. However, in patients with pre-existing neuropathy of the sciatic nerve, the blockade of tibial nerve is contraindicated because of increased risk of nerve damage that may lead to exacerbation of neurologic symptoms. In such patients where selective tibial nerve block cannot be offered, ultrasound guided posterior knee capsular injection may be an alternative technique for controlling posterior knee pain after surgery. Posterior capsular injection by surgeons intraoperatively, when combined with femoral nerve block has been shown to provide pain control after total knee replacement. With posterior capsular injection, the main trunk of the tibial nerve is spared and only the terminal nerve endings innervating the posterior knee joint is blocked providing effective pain control. In this study, the efficacy of ultrasound guided posterior capsular injections performed pre-operatively will be compared to tibial nerve block in controlling knee pain after surgery.

The results of this study may help establish the efficacy of ultrasound guided posterior capsular injection as an alternative to tibial nerve block in patients undergoing total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Patients having primary, unilateral total knee arthroplasty
* Age 18-80

Exclusion Criteria:

* History of neurologic disease, neuropathy, diabetes, or major systemic illness
* Allergy to local anesthetic solution or NSAIDs
* Pregnancy
* Chronic use of narcotics
* Inability to give consent/cooperate with study
Efficacy and Safety of DKF-306 in Patients With Periodontal Diseases

This is a multi-center, randomized, double-blinded, placebo-controlled study to evaluated the efficacy and safety of DKF-306 in patients with periodontal diseases.


Eligibility Criteria:
Inclusion Criteria:

* Aged 19 years and older
* Periodontal diseases
* Having not less than 16 permanent teeth including at least 4 molars (third molars excluded)
* Having teeth with not less than 2 sites of both probing pocket depth (PPD) ≥ 4 mm and gingival index (GI) ≥ 2 in at least 2 quadrants
* Agrees not to use over-the-counters (oral, ointment, toothpaste, film, etc.) or quasi-drugs (gargle and mouthwash) to alleviate or treat the symptoms of gingivitis or periodontitis during the study
* Voluntarily signed the informed consent form
* Willing to participate in the study

Exclusion Criteria:

* Hypersensitivity to ingredients of investigational products
* Hypersensitivity to Azo dyes, acetylsalicylic acid or other prostaglandin synthase inhibitors
* Following diseases or state in the mouth:

  1. rampant caries or decayed tooth/teeth remained untreated for a long time
  2. multiple restorations which may be related to periodontal inflammation
  3. poor oral hygiene with heavy plaque or calculus deposition
  4. soft or hard tissue tumor
  5. systemic chronic diseases with oral manifestations
  6. fibrotic gingival enlargement
* Use of orthodontic appliances or removable partial denture(s)
* Having teeth or state in need of immediate treatment such as periodontal abscess, a tooth indicated for extraction, etc.
* History of aggressive periodontitis or acute necrotizing ulcerative gingivitis
* Received dental treatments such as endodontic treatments or periodontal therapy (including both nonsurgical and surgical therapy) within 3 months from randomization
* Received the following drugs for more than 2 weeks within 3 months from randomization:

  1. systemic/local antibiotics in the mouth or non-steroidal anti-inflammatory drugs
  2. cyclosporine or corticosteroids
  3. phenytoin, calcium antagonists, anticoagulants or antiplatelets
* Initiated drugs in treatment of chronic diseases within 3 months from randomization
* Received the same drug with investigational products within 3 months from randomization
* Medical conditions or diseases affecting the efficacy and safety of investigational products at the investigator's discretion
* Heavy smoker (20 cigarettes or more a day)
* Pregnant or breast-feeding
* Plans to have a child or unwilling to comply with using medically accepted contraception methods during the study
* Alcohol or drug abuse
* Other investigational products or procedures within 3 months from screening
* Not eligible due to other reasons at the investigator's discretion
The Swedish Two-County Trial of Mammography Screening

Population-based randomized controlled trial carried out in two Swedish counties, Dalarna and Ostergotland to find out the impact of early detection on mortality from breast cancer.

The Swedish Two-county study is a randomized controlled trial of invitation to mammography screening. The trial took place in Kopparberg (W), now called Dalarna, and Ostergotland counties in Sweden. The trial randomized 77,080 women aged 40-74 years to invitation to screening (active study population, ASP) and 55,985 women to no invitation to screening (passive study population, PSP). The trial started in 1977 in W-county and in 1978 in E-county. Women in age 40-49 years were invited to single-view mammography screening on average every 24 months, and women aged 50-74 years on average every 33 months. Approximately seven years after randomization a significant 31% decrease in breast cancer mortality was observed in the ASP group, whereupon the PSP was invited to screening once and the screening phase of the trial ended. The mortality data have been reported every two years during the follow-up period and published in peer-reviewed medical journals. The investigators have follow-up data to the Dec 31 2015. The 29-year follow-up data has been published in 2012 in Radiology. Publication of the long-term data reflects the fact that deaths avoided by early detection include some that would have occurred a considerable time later than the screening.

Eligibility Criteria:
Inclusion criteria

* Female
* Aged 40-74
* No history of breast cancer

Exclusion criteria

• Breast cancer diagnosis prior to randomization
Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor concentrate after implantation of continuous-flow left ventricular assist device (CF-LVAD) reduces the frequency of clinically significant bleeding within 3 months after implantation in comparison to the usual care. Adult patients with functional defects of VWF measured after implantation of continuous LVAD are randomly assigned to prophylactic treatment.

This time point was chosen because the bleeding events are maximal within the first 3 months after implantation.

* Adult patients \> 18 years who need a CF-LVAD due to advanced heart failure.
* Functional To determine the potential indication of Wilfactin® in the field of CF-LVAD and avoid widespread use and to establish evidence-based recommendation To improve the knowledge of the role of VWF concentrate in bleeding and angiogenesis after CF-LVAD implantation and to provide some results about mechanism involved angiogenesis or hemostasis.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \> 18 years who need a CF-LVAD due to advanced heart failure.
* Functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time \>180 sec and or VWF:Act/VWF:Ag≤ 0.7)
* Informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)

Exclusion Criteria:

* Treatment with Wilfactin® within the last seven days
* Previous adverse reaction to Wilfactin®
* Absence of functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time \>250 sec and or VWF:Act/VWF:Ag\<0.7)
* Patient with a known thrombophilia
* Patient with a known severe bleeding disorder
* Patient refusal or environment
* Minor patients
* Pregnant women
CREATE Trial, Prospective, Observational Study

Observation of the safety and effectiveness of Cre8 stent, Cre8 evo stent in patients with ischemic heart disease with long coronary lesions

The purpose of this study is to observe the prognosis of 300 patients with long lesions over 30 mm treated with a new-generation Cre8 stent, Cre8 evo stent that is polymer-free and releases fat-soluble ampilimus in the real world. In addition, in the case of inserting a 46mm very long stent through sub-analysis, we also want to check whether stent expansion is performed through OCT rather than IVUS.

Eligibility Criteria:
Inclusion Criteria:

1. 19 years of age or older
2. Clinical evidence of coronary artery disease, including asymptomatic ischemia, stable angina, and acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, ST-segment elevation myocardial infarction)
3. Coronary artery lesion length 30 mm or more
4. Those who voluntarily agreed in writing to participate in this clinical study

Exclusion Criteria:

1. Remaining life expectancy is less than 1 year
2. Subjects with known hypersensitivity or contraindication to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor
3. In case the other researcher judges that it is inappropriate to participate in this study (pregnant women, the elderly, etc.)
Core Outcome Set for Head, Neck and Respiratory Disease in Mucopolysaccharidosis II

The Mucopolysaccharidoses (MPS) are a family of genetic metabolic disorders, caused by specific enzyme deficiencies which result in accumulation of partially degraded glycosaminoglycans (GAGs) within various tissues. As GAGs are common in the body a number of different organ systems can be affected. Involvement of the upper and lower respiratory tract in MPS Type II results in significant airway compromise, with progressive airway obstruction being responsible for a significant proportion of the morbidity and mortality associated with this condition. Hearing loss is a universal finding in MPS, with a third of patients suffering with severe profound hearing loss. There is an unmet need for strong clinical evidence to guide treatment of head, neck and respiratory disease in MPS disorders. A Core Outcome Set (COS) describes the minimum outcome data that should be measured in a clinical study for a particular condition. The lack of an agreed COS for MPS II in general, and specifically head, neck and respiratory disease, makes comparison between studies difficult. There is also a lack of information detailing patient and parent perspectives on the MPS disorders. The ideal COS for head, neck and respiratory disease associated with MPS II would combine both patient/parent and clinician opinion and could be used in the design of all subsequent clinical studies. Following literature review the investigators have created a list of outcomes previously reported for qualitative and quantitative studies investigating head, neck and respiratory disease in MPS II. For the proposed research the investigators will seek opinions of patients, parents, clinicians and scientists to rate these outcomes via the Delphi method. Outcomes scored highest by patients, parents, clinicians and scientists will form a COS for head, neck and respiratory disease in MPS II. The development of a COS can help limit variability outcomes in studies investigating different interventions in MPS II.


Eligibility Criteria:
Inclusion criteria:

* Confirmed MPS II diagnosis.
* Aged between 12 and 25 years old.
* Parents/ main care givers of child with MPS Type II.
* Adults aged 18 or over.
* Clinicians responsible for direct care and management of at least 2 pediatric MPS Type II patients in the last 12 months.
* Scientists who have worked with MPS Type II within the last 5 years

Exclusion criteria:

* Unconfirmed MPS Type II diagnosis.
* Aged below 12 and above 25 years old.
* Not directly involved in a day to day care.
* Clinicians who only occasionally look after pediatric MPS Type II patients.
* Scientists who have not worked with MPS Type II within the last 5 years
Effect of Axial Length of the Globe on Retinal Nerve Fibre Thickness

the goal of this obsrevational study is to learn about retinal nerve fibres and if their numbers changed with axial length of the globe or not. the main question to answer is there is effect of long axial length on the thickness of the retinal nerve fibers participants will be asked to:

* measure the axial length with ultrasound
* measure the thickness of retinal nerve fibers with optical coherence tomography

Aim of the work:

To investigate the effect of axial length on the peripapillary retinal nerve fiber layer.

Patients and methods Study design: Cross sectional comparative study. Location: Ophthalmology department, Sohag teaching hospital. Ethical approval: A written informed consent will be taken from all patients about the aim of the study, the nature of the planned investigation. An approval of the ethical committee of Sohag Faculty of Medicine will be fulfilled.

Methodology The study will include 80 patients healthy volunteers who underwent ophthalmologic examinations including retinal nerve fiber layer (RNFL) thickness analysis with optical coherence tomography (OCT), auto refraction, and axial length measurement.

Inclusion criteria:

Healthy volunteers attending the outpatient clinic for surface ocular diseases.

Exclusion criteria:

* Glaucoma patients.
* Media opacity (corneal, lens or vitreous opacity)
* Previous ocular surgery.
* Diabetic patients.
* Retinal diseases.

Method of the study:

1. Detailed ophthalmological and medical history.
2. Detailed slit lamp examination.
3. Visual acuity (VA) and best corrected visual acuity (BCVA) using Snellen chart and recorded in decimal notation.
4. Auto refraction using Topcon auto refractometer RM-800.
5. Optical coherence tomography (OCT) scan of retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness using Avanti scanner Optovue.
6. Axial length (AL) measured by E-Z scan 5500 sonomed A-scan ultrasound and biometry.

The patients will be divided into 3 groups:

Group 1 patients with axial length less than 21 mm. Group 2 patients with axial length 21-24 mm. Group 3 patients with axial length more than 24 mm.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers attending the outpatient clinic for surface ocular diseases.
* patients who are cooperative with optical coherence tomography (OCT) device.

Exclusion Criteria:

* Glaucoma patients.
* Media opacity (corneal, lens or vitreous opacity)
* Previous ocular surgery.
* Diabetic patients.
* Retinal diseases.