Kornimate/medical-research-clean huggingface dataset:
medico-economic interest of the patient matched cutting blocks (ancillary) myknee ® lbs during the poses of complete prosthesis of knee gmk ®. multicentric, prospective, controlled, opened, randomised study about a medical device. (my knee)

Conditions: Osteoarthritis

Summary: over 70.000 total knee arthroplasty (tka) are performed in france every year, with a 10% yearly increase since the early 1990s. the clinical experience shows a strong rate of success on pain relief and on function. longevity of the implants has been shown to be determined by the biomechanical design of the prosthesis, and by the implantation technique, especially the correct positioning of the bone cuts during the surgery. to improve the precision of these cuts, the patient matched cutting blocks developed by medacta allow to adapt the bone cuts to the patient's anatomy, improving the reliability of this procedure. a reduction of the surgery time lengh and bleeding would be other benefits expected with this type of ancillary. the objective of this trial is to study the reliability of patient matched cutting blocks for total knee arthroplasty, by both clinical and radiological assessment, the effect on morbidity reduction during and after the procedure and also the benefit it could bring on an economic point of view.


Eligibility criteria:
inclusion criteria: all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment. exclusion criteria: distorded axes or laxity requiring the establishment of constrained prosthesis

Keywords: ancillary tailored medico-economic study, total knee replacement primary or secondary osteoarthritis
efficacy study on silver-coated ett cleaned with a novel device

Conditions: Ventilator Associated Pneumonia; Critically Ill

Summary: the purpose of this study is to test the efficacy of a novel cleaning device in keeping silver-coated endotracheal tubes free from bacterial colonization.

several studies have suggested that biofilm formation inside the ett plays a pivotal role in vap development and drug-resistance induction. silver-coated ett have proven effective in delaying but not in preventing ett colonization and biofilm formation, due to a barrier effect of biofilm and accumulated debris. advanced ett cleaning devices are able to remove debris and biofilm and reduce the total ett microbial load to a certain extent. the investigators hypothesize that the routine use of endoclear in patients intubated with a silver-coated ett will reduce ett microbial colonization. the investigators therefore want to assess the reduction of ett microbial colonization in patients intubated with a silver-coated ett and cleaned with endoclear compared to the current standard of care of silver-coated ett (blind suctioning). they plan to achieve this result by analyzing the tubes of each enrolled patient after it has been removed, either because the patient does not need it anymore due to his/her better clinical conditions, or because there is a need of tracheostomy or because he/she dies. specifically they will analyze how the endoclear cleaning maneuver affects microbial colonization in the inner layer of the ett and how this can determine distal airway inoculation and, ultimately, vap development. specific aim #1: investigators will test the hypothesis that routine use of endoclear in patients intubated with a silver-coated ett will reduce ett microbial colonization. specific aim #2: investigators will test the hypothesis that keeping etts free from microbial colonization will prevent septic inoculation of distal airways specific aim #3: investigators will test the hypothesis that prevention of ett biofilm development will reduce drug resistance rates found in ett and distal airways isolates the investigators will conduct a randomized clinical trial on 40 patients intubated with silver-coated ett and randomized to receive standard ett cleaning vs cleaning with the endoclear device.

Eligibility criteria:
inclusion criteria: * admission to medical, surgical or neuro icu * subjects must be enrolled within 24 hours from intubation * subjects expected to be intubated for at least 48 hours or longer * subjects have been intubated with a silver-coated ett exclusion criteria: * current and past participation in another interventional trial conflicting with the present study * pregnant women * prisoner status

Keywords: medical devices ventilator-associated pneumonia (vap) ventilator-associated events (vae) endotracheal tube microbial diversity drug-resistance biofilms endotracheal intubation mechanical ventilation
fmri to examine the effect of cbtm to increase resiliency for ptsd

Conditions: Stress Disorders, Post-Traumatic

Summary: a substantial proportion of public safety personnel (psp) develop service-related posttraumatic stress disorder (ptsd). ptsd is associated with a range of negative outcomes and its exact underlying neurophysiological mechanism is still not well understood. cognitive behavioral therapy (cbt) is commonly prescribed to treat ptsd, and recent studies suggest that it may be effective in preventing the condition. we have developed a 5-session class focused on teaching introductory cbt skills to prevent and manage psychological distress, and we are currently in the process of launching a clinical trial to demonstrate its effectiveness in preventing ptsd and related conditions in psp. in the proposed adjunctive study to this trial, we will quantitate the brain connectivity signature that is specific to the ptsd-resilience, and examine whether the classes increase this resilience-related brain mechanism.

our ultimate research goal is to develop and validate a preventive strategy for ptsd. we aim to 1) demonstrate neurophysiological evidence (using fmri) of preventive cbtm classes for ptsd, and 2) validate the utility of the proposed imaging-based biomarker for ptsd-related resiliency. emerging evidence suggests that a program such as cbtm classes could promote resiliency to ptsd in healthy individuals at high risk for trauma exposure. further, our preliminary brain imaging data analysis suggests that we can quantitate the brain connectivity pattern that may reflect resilience to ptsd. we thus hypothesize that cbtm will increase the ptsd resilience-related brain connectivity pattern expression. in this novel pilot imaging study, we will recruit 40 psp without ptsd or other mental disorder from 120 participants participating in our larger clinical trial. twenty will be from each arm (cbtm and wait-list). the effect of cbtm on fmri-based measures will be compared between arms.

Eligibility criteria:
inclusion criteria: * must be enrolled in our on-going parallel study - "cognitive behaviour therapy with mindfulness course for building workplace resilience: a pilot randomized controlled trial" exclusion criteria: * if they have received psychological or medication treatment for a mental disorder in the past 6 months or if they score above the clinical cutoff on the following self-report symptom measures: posttraumatic checklist-5 (pcl-5) score \>37; patient health questionnaire-9 (phq-9) score (depression) \>10, generalized anxiety disorder-7 (gad-7) score \>7, and the presence of suicidal ideation in the past six months. individuals falling below these cutoff scores will receive further diagnostic assessment by a supervised phd graduate student in clinical psychology. those meeting criteria for ptsd or other mental disorder in the past 12 months as assessed by the clinician-administered ptsd scale for dsm-5 (caps-5) or the mini international neuropsychiatric interview (mini v.7.0.2) will also be excluded. finally, we will exclude individuals with any contraindication to mri (e.g., claustrophobia and metal implants).
dose finding study of single dose ghb11l1 in healthy adults

Conditions: Influenza, Human

Summary: the purpose of this phase iia trial is to evaluate the immunogenicity of a single dose of ghb11l1 administered by liquid nasal spray for vaccination against influenza a (h1n1) virus. this study is also performed to assess safety, tolerability and pharmacokinetics (shedding) of a single dose of ghb11l1 administered by liquid nasal spray.

ghb11l1 intends to provide a novel vaccination for influenza virus infection. 48 healthy volunteers will be included in this phase iia study investigating three dose levels. 16 subjects will be randomised at a ratio of 3:1 for ghb11l1 or placebo. healthy male volunteers, 18-50 years of age and seronegative with respect to the applied virus antigens (antibody titers \<1:10 detected) will be randomised. ghb11l1 will be administered once on day 1. follow-up visits will be performed on days 2, 8 and 29.

Eligibility criteria:
inclusion criteria: * healthy male volunteers, 18-50 years * seronegative for h1n1 (influenza a/brisbane/59/07 antibody titres \<1:10 detected in haemagglutination inhibition assay) * written informed consent to participate in this study exclusion criteria: * acute febrile illness (\>37.0°c) * signs of acute or chronic upper or lower tract respiratory illnesses (sneezing, cough, tonsillitis, otitis etc.) * history of severe atopy * seasonal influenza vaccination in 2007/2008 and/or later seasons and/or pandemic influenza vaccination at any time * known increased tendency of nose bleeding * volunteers with clinically relevant abnormal paranasal anatomy * volunteers with clinically relevant abnormal laboratory values * simultaneous treatment with immunosuppressive drugs incl. corticosteroids (≥2 weeks) within 4 weeks prior to study medication application * clinically relevant history of renal, hepatic, gi, cardiovascular, haematological, skin, endocrine, neurological or immunological diseases * history of leukaemia or cancer * hiv or hepatitis b or c seropositivity * volunteers who underwent rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to application of study medication * volunteers who have received antiviral drugs, treatment with immunoglobulins or blood transfusions, or an investigational drug within four weeks prior to study medication application * volunteers who have received anti-inflammatory drugs 2 days prior to study medication application * volunteers who are not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study

Keywords: live attenuated flu vaccines influenza a (h1n1) intranasal application replication-deficient influenza virus
a multi-disciplinary pain intervention (mud-pi) for patients with chronic widespread primary pain

Conditions: Chronic Pain, Widespread

Summary: patients who fulfilled inclusion criteria and consented to participate received either treatment as usual at the clinic, or were enrolled in a group-therapy based intervention, the multi-disciplinary pain intervention, led by a medical doctor, physiotherapist and psychologist at the clinic.

the department of pain management and research at oslo university hospital is norway's largest outpatient pain clinic. it treats around one thousand new patients annually suffering from chronic pain of all aetiologies. many of the patients receive interdisciplinary care based on a biopsychosocial framework, by at least two health care providers (physician, physiotherapist, psychologist, occupational therapist and/or nurse). participants were recruited through referrals from primary or secondary care, which were identified by an established interdisciplinary team. patients found potentially eligible for the study were contacted by the research team and consulted with a research physician. patients who fulfilled the inclusion criteria were invited to participate in the study and signed a consent form. patients who declined to participate and non-eligible patients received usual care. inclusion criteria were 1) age 18 or more; 2) pain in at least three out of five bodily regions (defined as the four quadrants and axially); 3) pain persisting three months or more; 4) the patient was able to give informed consent and benefit from group therapy (including sufficient cognitive capacity and language skills); 5) no other medical condition could better explain the symptoms. subjects were randomised either to treatment as usual or a group-based multidisciplinary pain intervention (the mud-pi).

Eligibility criteria:
inclusion criteria: * age 18 or more * pain in at least three out of five bodily regions (defined as the four quadrants and axially) * pain persisting three months or more * the patient was able to give informed consent and benefit from group therapy (including sufficient cognitive capacity and language skills * no other medical condition could better explain the symptoms.
customized multiple orbital wall decompression for sight-threatening graves's ophthalmopathy

Conditions: Thyroid Eye Disease

Summary: graves' orbitopathy (go) is an disfiguring and disabling autoimmune condition. sight-threatening go is an most severe form and occurs in about 5% of patients with graves' disease. it can cause blurred vision, color vision and vision function damage, and affects the quality of life. the goal of this retrospective cohort study is to propose a customized orbital decompression algorithm for patients with sight-threatening graves'ophthalmopathy and to explore the therapeutic effect of customized orbital decompression in sight-threatening patients.


Eligibility criteria:
inclusion criteria: * sight-threatening patients undergoing interdisciplinary discussion and orbital decompression operation. * the sight-threatening go refer to those with don, exposure keratitis or corneal breakdown. * don was diagnosed according to the following clinical findings including optic nerve head edema, visual field defect, impaired color vision, afferent pupil defect, retinal folds, radiologic evidence of apical optic nerve compression or globe subluxation. * diagnosis of exposure keratitis or corneal breakdown was made based on physical exam signs, e.g. microepithelial defects, abrasion or ulcer. a minimum follow-up of 12 months was required for inclusion. exclusion criteria: * patients were excluded if exophthalmos, rather than acute visual loss, was the indication for surgery. * cases with a history of previous ocular surgery, glaucoma, and visual defects from other ocular conditions were excluded from the study.

Keywords: orbital decompression graves' orbitopathy dysthyroid optic neuropathy
iron mediated vascular disease in sickle cell anemia patients

Conditions: Sickle Cell Disease

Summary: the purpose of this research study is to determine the frequency and severity of iron overload in patients with sickle cell anemia and its relationship to blood vessel function. the investigators hypothesize that intermittent transfusions that these patients receive during hospitalizations produces significant iron overload and impairs blood vessel relaxation.

patients with sickle cell anemia often require blood transfusion as part of the treatment for their disease. each teaspoon of transfused blood contains about 5 mg of iron and the levels of iron in sickle cell patients increase rapidly with each transfusion. while iron is necessary for many bodily functions, too much iron damages blood vessels, liver, hormone producing glands (pancreas, pituitary and thyroid) and the heart. it is important to know how iron damages blood vessels because most of the problems experienced by sickle cell anemia patients (stroke, kidney failure, pulmonary hypertension, heart disease) result from blood vessel damage. in this trial, iron in the liver, pancreas, and kidney will be measured noninvasively by mri while vascular function will be measured by ultrasound and tissue doppler. patients will be recruited primarily from the greater los angeles area, although patients from greater distances will be allowed to participate.

Eligibility criteria:
inclusion criteria: * age \> 13 years * documented diagnosis of sickle cell anemia (ss, sc, sß0, sß+) * transfused no more than 8 times in a year. exclusion criteria: * cardiac pacemaker, implantable neurostimulator or other mri incompatible device. * history of extreme claustrophobia in mri machine or other reason for inability to do mri without sedation. * inability to be positioned on the mri table for sufficient time to complete the mri exams. * any medical or psychological condition that, in the opinion of the local investigator, would make it unsafe or ill-advised for the subject to participate. * currently not receiving chronic transfusion therapy, defined as greater than 8 transfusions per year.

Keywords: sickle cell disease sickle cell anemia sickled cells blood vessel iron overload
cognitive decline in asymptomatic intracranial stenosis patients: a 1-year follow-up study

Conditions: Magnetic Resonance Imaging; Asymptomatic Intracranial Stenosis; Medical Treatment

Summary: to investigate the cognitive decline after standard medical treatment without stenting in asymptomatic intracranial stenosis patients and the underlying neural mechanism by fmri.

all participants underwent a medical evaluation that included routine laboratory studies before and after 1-year standard medical treatment. upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests and magnetic resonance imaging scan in multimodalities within 7 days after admission and after 1-year when patients received standard medical treatment at the first affiliated hospital of anhui medical university. participants were randomly allocated to patient group and the control group.there are about 20 patients and 20 healthy controls in this study. firstly, a series of neuropsychological tests were obtained by a trained investigator to assess baseline. each assessment will involve a set of assessment tools, the memory as the primary outcome measure and various other tasks and questionnaires to measure cognition (including moca,mmse, ds, stroop test, tmt, vft), memory (cavlt), emotion (hama-17,hamd-14), behavioral and psychological symptoms(npi). all the tests are conducted in two days. the patients had receiving a magnetic resonance imaging scan in multi-modalities. after 1-year standard medical treatment,the patients participants were interviewed to obtain the same assessment and magnetic resonance imaging scan in multi-modalities as before. patients are instructed to focus their answers on the past 15 days. the clinical symptom of participants were followed 6 and 12 months after the admission. afterwards, they were unblinded by the study coordinator.

Eligibility criteria:
inclusion criteria: * patients with intracranial stenosis which was defined as stenosis of 50% or more in intracranial segment of internal carotid artery and middle cerebral artery (mca). * the degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (mra),tomography angiography (cta) and digital subtraction angiography (dsa). exclusion criteria: * history of stroke,transient ischemic attack,seizures or unexplained loss of consciousness. * organic brain defects on t1 or t2 images. * any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder). * implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. history of substance abuse within the last 6 months.

Keywords: magnetic resonance imaging asymptomatic intracranial stenosis patients cognitive function medical treatment
feasibility trial of a mobile adherence tool for adolescents with asthma

Conditions: Asthma

Summary: the purpose of this study is to assess the feasibility of using a mobile health intervention to improve adherence to asthma medication among adolescents in an urban clinic setting. the intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. this study will assess the feasibility and acceptability of this intervention to patients.


Eligibility criteria:
inclusion criteria: * age 11-19 * asthma diagnosis * currently on a daily controller medication for asthma * english-speaking exclusion criteria: * pregnant * foster care * emancipated minor

Keywords: patient compliance mobile applications medication adherence
efficacy and accuracy of combined localization versus single localization in non-palpable breast cancer after neoadjuvant therapy

Conditions: Breast Cancer; Breast-conserving Surgery

Summary: the standard method for localizing non-palpable breast cancer is currently clip localization, its positive margin rate still remains around 20-50%. this study aims to compare the accuracy and efficacy of single vs. combined breast tissue markers in localizing non-palpable breast cancer.


Eligibility criteria:
inclusion criteria: 1. female patients, age≥18 year 2. a score of ≥ 2 on the eastern cooperative oncology group scale 3. patients pathologically diagnosed with breast cancer by core-needle biopsy, received neoadjuvant treatment and the lesion becomes non-palpable before enrollment. 4. patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery exclusion criteria: 1. inflammatory breast cancer or paget's disease 2. breast deformities and other conditions that impact breast conservation success rate 3. patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. patients with severe bleeding disorders or coagulation disorders were also excluded. 4. pregnancy or lactation 5. patients with hook-wire, radioactive 125i seed or other localization techniques in the breast cancer lesions before enrollment 6. patients with stage iv diseases or unresectable lesions in either breast 7. patients combined with other diseases that may affect survival 8. patients with multicentric breast cancer lesions or lesions \> 5 cm in diameter on imaging examinations 9. patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy 10. patients with history of ipsilateral breast cancer radical mastectomy or chest wall radiotherapy
florbetaben pet imaging in ppa

Conditions: Primary Progressive Aphasia; Alzheimer Disease

Summary: the purpose of this research is to better understand how dementia affects activity in different parts of the brain.

this study will examine positron emission tomography (pet) imaging with florbetaben f18. florbetaben f18 is a radioactive tracer that binds to particles in your brain. this process displays activity in the brain. florbetaben f18 is a pet amyloid imaging agent approved by the united states food and drug administration (fda) to estimate the amount of beta-amyloid plaque in adult patients who are being evaluated for alzheimer's disease and other causes of cognitive decline. the purpose of this research is to better understand how dementia affects activity in different parts of the brain. currently, the scientific community is limited by how well it can see inside the brain. the use of a pet scan better helps us understand what the brain looks like in a diseased state. participation in the study will help to understand what brain activity looks like, especially around language regions.

Eligibility criteria:
inclusion criteria: * participants must have a diagnosis of ppa or a related dementia syndrome exclusion criteria: * pregnant * breastfeeding * receiving radiation clinically

Keywords: alzheimer's disease dementia primary progressive aphasia neurocognitive disorders speech disorders