cyrilzakka/clinical-trials huggingface dataset:
Study of Knowledge Translation of Clinical Practice Guidelines for Ventilator Associated Pneumonia

The purpose of this prospective, multicentre, time-series study is to develop, implement, refine, and evaluate a sustainable behaviour change strategy in the intensive care unit (ICU).

Background:

In order to improve the care of our patients, it is necessary for research evidence to be translated into clinical practice. There are gaps in our understanding of knowledge translation (KT) and this is evident in the Intensive Care Unit (ICU), specifically as it applies to the prevention, diagnosis and treatment of ventilator-associated pneumonia (VAP). VAP is associated with a high burden of illness in the critically ill and there is an extensive amount of research evidence on this disease. It has been demonstrated that best practice as defined by research evidence is not uniformly applied to VAP. In addition, recent advances in VAP knowledge need be disseminated and implemented in order to improve patient safety and outcomes from VAP. A systematic process of knowledge transfer is crucial to translate this research into evidence-based bedside practice and the development and implementation of evidence based Clinical Practice Guidelines (CPGs) may facilitate VAP knowledge uptake. In addition, there is a need to study knowledge translation (KT) in the ICU since there is little information about optimal KT and CPG implementation strategies in this environment and efforts that are effective in other clinical areas may not result in meaningful change in the ICU.

Research Question:

What is the effect of VAP CPGs implemented by a multidisciplinary behaviour change strategy (consisting of multifaceted educational strategies led by local opinion leaders and augmented with reminders) on VAP guideline concordance and on clinical VAP outcomes in the ICU?

Research Plan:

Data will only be collected on consecutive patients mechanically ventilated for at least 48 hours. The following health care professionals will be studied to assess the behaviour change strategy for the VAP CPGs: physicians (intensivists, ICU fellows, ICU rotating residents), nurses, respiratory therapists, dieticians, physiotherapists and ICU administrators.

The study will be conducted in 3 phases:

1. Development of a behaviour change strategy consisting of three components:

   * Local opinion leader team
   * Educational strategy
   * Reminder system
2. Prospective implementation of the behaviour change strategy over a 24 month period
3. Prospective evaluation of the behaviour change strategy over a 24 month period

   * Concordance with VAP guidelines over time
   * Factors associated with VAP guideline concordance
   * Clinical VAP outcomes pre- and post-guideline implementation

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 17 years old
* Mechanically ventilated \> 48 hours \< 96 hours

Exclusion Criteria:

* Previous enrollment in the study
Laser Doppler Flowmetry in Assessing the Vitality of Traumatised Teeth

Teeth injuries are considered one of the most challenging events that occur in dentistry, especially in children. After an injury, there is a possibility that the blood supply to the tooth may become affected and compromised leading to nerve and blood vessels death with the tooth described as a non-vital tooth.

The conventional diagnostic tools available to assess tooth nerve/blood supply are not always reliable. Child cooperation and understanding contribute greatly to this shortfall. Failure to assess the vitality of the tooth may result in pain, swelling or infection of the tooth or de-vitalising a normal tooth which may render the tooth weak for the future and possibly losing the tooth.

The laser Doppler flowmetry is a non-invasive, non-painful technique and shown to be more reliable than the traditional techniques. We aim to assess if this device can predict and assess whether the tooth is alive or dead during the follow up visits of the injury along the other conventional tests.

A clinical study will be carried out which consists of a one year follow up to monitoring traumatised front teeth in children attending the department of paediatric dentistry.

The vitality/sensibility of traumatised teeth will be assessed using laser Doppler flowmetry, electrical pulp testing and ethyl chloride. Measurements will be performed by a single operator (chief investigator) and will be carried out at baseline, 3, 6, 9 and 12 months follow up period.

Eligibility Criteria:
Children would be recruited into this study when they:

* Between 6-16 years old.
* Medically fit (ASA I, II).
* Able to communicate using English language.
* Have an acceptable level of cooperation.
* Have at least one traumatised anterior tooth, regardless of the type of trauma, with uncertain pulpal vitality requiring monitoring for a minimum of 12 months and minimal coronal restoration (covering less than half the labial crown surface).
* Have at least one vital and non-traumatised anterior tooth to act as a control.

Exclusion Criteria:

* Medically and mentally compromised children.
* Children with learning disabilities.
* Children with communication barrier including those unable to communicate using English language.
* Heavily restored teeth covering more than half the labial surface of teeth.
* Patients on routine analgesics, antidepressants or antihypertensive drugs.
* Vital teeth with pulp canal obliteration.
BPPV With CRP: Single Versus Multiple Cycles

Unilateral posterior canal benign paroxysmal positional vertigo (BPPV) cases will be randomized to treat with single or multiple cycles of canalith repositioning procedure.The treatment outcomes will be assessed at 7th and 28th days.

Patients present with brief episodes of vertigo will be evaluated by Dix-Hallpike test. Cases with positive Dix-Hallpike test, unilateral, posterior canal, will be randomized with block of four. Either single or multiple cycles of canalith repositioning procedure will be performed. Four treatment outcomes will be blindly assessed at 7 and 28 days.

Eligibility Criteria:
Inclusion Criteria:

1. Recurrent episodes of vertigo
2. 15 years of age or older
3. Positive Dix-Hallpike test: unilateral, posterior canal

Exclusion Criteria:

1. Received vestibular suppressant within 6 hours
2. With other diseases or conditions cause of vertigo or central nervous system disease
3. With diseases or conditions contraindicate for Dix-Hallpike test or CRP eg: cervical spine disease, back/ neck stiffness, retinal detachment
4. Positive Dix-Hallpike test: bilateral, other canals
5. Complications from CRP eg: nausea, vomiting, canalith jam
6. Cannot read the questionaire
Performance of the Salt Lake Mask System

Assessment of the performance of the Salt Lake mask system acting as a patient interface in the provision of PAP therapy. This study will assess the suitability of this mask system in its current form for use.

Sleep-disordered breathing (SDB) is a significant direct cause of morbidity and mortality, as well as being a significant indirect cause of morbidity and mortality impacting greatly upon health and quality of life when left untreated. Positive Airway Pressure (PAP) therapy is an effective and proven form of medical treatment for many types of SDB.

In order for PAP therapy to be effective, patient interfaces(masks) need to be both effective in their delivery of this treatment and accepted by prospective and current patients for use. This study will investigate the ability of the Salt Lake mask system to act effectively as a patient interface in PAP therapy, and its ability to be accepted by patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to give written informed consent
* Patients who can read and comprehend English
* Patients using the Swift FX mask system
* Patients who can trial the mask for 7 nights
* Patients who have used PAP therapy for a minimum of 6 months.

Exclusion Criteria:

* Patients not willing to give written informed consent
* Patients who can not read and comprehend English
* Patients using an inappropriate mask system
* Patients using Bilevel flow generators
* Patients who are pregnant
* Patients who are unable to comply with the protocol
* Patients who have used PAP therapy for less than 6 months.
Genetic Research on High Myopic Individuals in Northern China

HM, which can dramatically cripple the eyesight of those affected, is a rampant ophthalmic disorder around the globe. It is in recent years that substantial studies covering the relationship between distinct variations and HM susceptibility sprang expeditiously. However, these studies have not yielded sufficiently credible and universally significant conclusions. Consequently, the study is conducted by including HM subjects residing in Northern China to explicitly illustrate this issue.

As a serious pattern of myopia, high myopia (HM) generally refers to a condition where the spherical equivalent (SE) refraction exceeds -6.00 diopters (D) or the axial length (AL) is longer than 26.00 mm. Abundant studies have indicated the strong correlation of HM with multiple vision-threatening ophthalmic diseases, including rhegmatogenous retinal detachment, retinoschisis, retinochoroid atrophy and open-angle glaucoma. It is reported that the worldwide prevalence of HM has surpassed over 2.9% in recent years. And a study on subjects living in Minnesota from the 1960s to the 2010s demonstrates that the data has progressively increasing from 2.8% to 8.3%, which is not related with gender or race, although no evident significance has yet been proved in some groups. What's worse, it is speculated that HM patients are expected to account for 9.8% of the global population by 2050, which will gravely hinder the progress of social development. As a result, it is of profound implications to explore the pathogenesis of HM and the prospective therapeutic or remedial strategies.

What has been universally acknowledged is that both environmental and genetic factors matter much in the onset and exacerbation of myopia, with the latter particularly predominating in the etiology of HM. Accordingly, discussing the causation of HM from heredity version is likely to be the most promising research field, which is just the researchers' interest at the present.

Eligibility Criteria:
Inclusion Criteria:

* HM participants are characterized by AL ≥ 26.00 mm or SE ≤ -6.00 D in at least one eye.

Exclusion Criteria:

* Individuals with other ocular or systemic connective tissue diseases were excluded.
A Tailored Interactive Website for Promoting Condom Use Among Young Adults

This study will develop and evaluate the effectiveness of tailored web-based messages in promoting condom use among young adults.

Adolescents and young adults are at the greatest risk for acquiring a sexually transmitted disease (STD). Approximately 3 million people between the ages of 18 and 24 become infected with an STD each year. Education about the risks and consequences of unprotected sex is a powerful tool that can be used to prevent or reduce the risk of infection. The program in this study will deliver messages to educate participants about condom use and the risk of STD infection. The study will evaluate the effectiveness of a tailored interactive online risk reduction program versus a standard online risk reduction program in reducing the risk of STD infection in young adults.

Participants in this open-label study will be recruited from one of two clinics in the Denver, Colorado area: Denver Metropolitan Health Clinic or Planned Parenthood of the Rocky Mountains. Participants will be randomly assigned to receive internet-based messages from either the Youthnet program or the control program while filling out a risk assessment survey. Participants in the Youthnet program will be asked their gender and ethnicity so they may be assigned to a role model of the same gender and ethnicity via a computer program. This role model will appear online 5 times during the survey to deliver interactive messages that will be tailored to HIV/STD risk reduction and will specifically address attitudes about condom usage. The control program will deliver 5 general, non-tailored messages containing information on reproductive health not specific to condoms or STDs. Participants will be assessed at baseline and a follow-up session 3 months after enrollment. Frequency of condom use and attitudes toward condom use will be assessed using behavioral scales.

Eligibility Criteria:
Inclusion Criteria:

* Client of Denver Metropolitan Health Clinic or Planned Parenthood
* English-speaking
* Access to a computer and an existing e-mail account
* Will be in Denver for at least 4 months

Exclusion Criteria:

* Not a resident of the Denver metropolitan area
* No existing e-mail address
* No access to a computer
Inpatient Penicillin Delabeling for Low-Risk Patients

This study seeks to enroll patients admitted to a children's hospital with identified penicillin allergy. A screening checklist is performed to identify patients with very low or low risk histories of penicillin allergy to offer direct oral challenges to the antibiotic class to de-label patient's with drug allergies.

This is a pilot study looking to utilize a novel criterion to identify low risk penicillin allergies for patients admitted to a children's hospital to evaluate safety and efficacy of direct oral challenges to patients with very low or low risk histories as identified in novel criterion.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>2 years
* Patients identified via EMR as having a penicillin, amoxicillin, amoxicillin/clavulanic acid allergy

Exclusion Criteria:

* Female patients aged \>8 years of age
* Patients with hemodynamic instability
* Patients identified with moderate or high risk histories per protocol
* Patients currently taking oral antihistamines in 48 hours prior to direct challenge
* Patients currently taking oral steroids in 48 hours prior to direct challenge
* Patients currently receiving medications for nausea, shortness of breath,
BullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth

Given the limited impact of existing school-based interventions and the time associated with implementing them during school time, more efficient and effective intervention methods are needed. Programs that can be delivered to middle school youth irrespective of whether they are attending school physically or virtually may be especially relevant as school boundaries become more fluid. BullyDown addresses this critical need by providing a scalable program that could be quickly and cost-effectively disseminated nationally.


Eligibility Criteria:
Inclusion Criteria:

* 7th or 8th grade
* English speaking
* Own their own cell phone
* Home internet
* Provide informed assent

Exclusion Criteria:

* Non-English speakers
* Unable to read the screener
* Know someone else in the RCT
* Know they are not on an unlimited text messaging plan
PET/CT Imaging of Angiogenesis in Patients With Neuroendocrine Tumors Using 68Ga-NODAGA-E[c(RGDyK)]2

The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of angiogenesis PET/CT with the radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 in patients with neuroendocrine tumors (NETs).

The radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 targets the Arg-Gly-Asp (RGD) sequence known to bind with the αvβ3 integrin that is expressed on the surface of angiogenic blood vessels or tumor cells. The radioligand can be used to visualize tumor angiogenesis using PET/CT.

A total of 120 NET patients will be subjected to an angiogenesis-PET/CT scan. Follow-up will be performed (from the time of the angiogenesis PET/CT) at 6 months for disease specific survival (DSS) and a 1 year follow-up for PFS and OS. The uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 (Standardized Uptake Values, SUVmax) in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with gastro-entero-pancreatic Neuroendocrine Tumors (GEP-NET; grade: G1-G3) or broncho-pulmonary NET.
* WHO performance status 0-2
* Must be able to read and understand the patient information in Danish and to give informed consent

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Weight more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
* History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E\[c(RGDyK)\]2
* In case of broncho-pulmonary NET, the subtype must not be small cell lung cancer (SCLC)
The Impact of Expressive Emotional Writing on Facilitating Grief Resolution in Adults With Spinal Cord Injury

The aim of this study is to evaluate the therapeutic benefits of a 10-week online coach-guided EEWP on psychosocial health among adults with SCI.

Paralysis in people with spinal cord injury (SCI) leads to grief from the loss of physical capacity, social or occupational role function, and life goals. Expressive emotional writing (EEW) provides an outlet for these individuals to explore and express feelings and emotions that arise from their losses related to limb paralysis. Using a randomized controlled trial design, the proposed project will attempt to confirm the benefits of an online coach-guided EEW program for improving psychosocial health among adults with SCI. Benefits of participating in the program will be evaluated using validated assessments to measure reduction of grief intensity and improvement in other psychosocial dimensions and social participation.

Eligibility Criteria:
Inclusion Criteria: (1) diagnosis (with evidence) of SCI (traumatic or non-traumatic) with limb weakness; (2) aged \> 18 years; (3) access to the internet and a computer or to a smartphone that can perform videoconferencing, (4) sufficient English language and cognitive proficiency to complete self-report study questionnaires and understand program content in English, and able to communicate verbally or through writing.

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Exclusion Criteria: (1) severe cognitive impairments that prevent online learning and completion of the evaluation; (2) suicidal intent requiring emergency care; (3) consistent psychotherapy within the last 6 months; (4) current or planned participation in psychological therapy or a clinical trial during the study period that could affect the outcomes of the study; or (5) congenital SCI (e.g., spinal bifida)

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Antiepileptic Drugs and Vascular Risk Markers

The purpose of this study is to determine if certain seizure medications raise levels of cholesterol and other blood components which could increase the risk of heart attacks and strokes.

There is some evidence that certain seizure medicines may raise levels of cholesterol and other blood components which could increase the risk of heart attacks and strokes, however, more research is needed. Individuals with acute subarachnoid hemorrhage traditionally are treated with seizure medicines, but it is not clear which one is best, or if any such medication is necessary at all.

This study is intended to find out if certain seizure medications raise levels of cholesterol and other blood components which could lead to an increased risk of heart attacks and strokes.

In this study, 200 people with acute subarachnoid hemorrhage will be randomized to treatment with one of three different seizure medicines-phenytoin, valproate, or levetiracetam-or to receive no seizure medication at all. In each participant, cholesterol and other blood markers that relate to heart attack and stroke risk will be measured shortly after hospital admission and again 8 weeks later. At the 8-week point most participants will have their seizure medication discontinued, and the same blood tests will be repeated.

Information from this study could lead to changes in how seizure medications are prescribed both in the subarachnoid hemorrhage population and in other people who are prone to seizures.

Eligibility Criteria:
Inclusion Criteria:

* Acute subarachnoid hemorrhage, Hunt-Hess Grades I-IV
* Within 48 hours of admission

Exclusion Criteria:

* Grade V subarachnoid hemorrhage
* Being treated with a lipid-lowering agent
* Contraindication to phenytoin, valproate, or levetiracetam (e.g. history of allergy to one of these agents)
* Contraindication to receiving no antiepileptic drug treatment (e.g. history of pre-existing epilepsy, seizure activity on admission EEG)
Post- Approval Hintermann Series H® Study 1

The H3 TAR device received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) on June 4, 2019, and as a condition of that approval, this study is being conducted to provide long-term safety and effectiveness of the H3 TAR System among patients included in the Primary Safety and Effectiveness (PSE) Cohort (P1600361).

This will be a Prospective, single-center, single arm study.

The Hintermann Series H3® (H3) prosthesis is a mobile bearing total ankle replacement (TAR) indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis, etc.).

This will be a Prospective, single-center, single arm study. All living subjects who participated in the PSE cohort, regardless of whether or not the subject has had a revision/removal followed through the 10-year post-operation visit. 298 subjects were originally included in the PSE cohort.

Through 10 years follow up. Based on the last surgery date, it is projected the study will be completed with the final 10-year follow-up visit to occur in December 2024.

Patients will undergo clinical and radiographic evaluation at 5 and 10 years (+/- 90 days) post-operation.

Performance Goals (PGs) will be constructed for the 10-year endpoint. As with the PGs used in the PMA study, these will be based on a prospectively defined, systematic meta-analysis of available published literature and registry data for the control (a legally marketed mobile bearing ankle). The details of the meta-analysis will be pre-specified in a protocol for this purpose. Both the protocol and the meta-analysis will be completed prior to the completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature
* Primary diagnosis of osteoarthritis, post-traumatic arthritis or rheumatoid arthritis
* Primary total ankle replacement
* Unilateral or the first ankle implanted if bilateral and the surgery dates for both sides are at least 6 months apart
* Implanted with the correct device without screws (for investigational arm),
* 3rd generation Hintermann Series H3 Total Ankle Replacement;
* Poor pre-operative American Orthopaedic Foot and Ankle Society Hindfoot Score (\< 60 points)
* Implanted in 2013 or earlier). Note that all subjects implanted in 2013 or earlier were included regardless of whether they were revised prior to the 2 year endpoint.
* Gave informed consent (unless IRB/Ethics Committee waived this requirement)

Exclusion Criteria:

* Prior TAR or arthrodesis at the involved ankle joint