Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of the aptima® hpv assay using the tigris® system

Conditions: Human Papillomavirus Infection

Summary: the purpose of this study is to provide data on the performance of the aptima hpv assay using the tigris system in detecting hpv types that may cause cervical cancer.

the primary objective of the clinical trial is to evaluate the aptima hpv assay, using the tigris system, in cervical cancer screening programs. this will be achieved by determining the performance of the assay for detecting high-risk human papillomavirus (hpv) types in women with known cervical disease status. the assay will be evaluated in sample populations of women with asc-us pap test results ("asc-us results") and women 30 years of age or older ("30+ years of age") with negative (nilm) cytology results.

Eligibility criteria:
inclusion criteria: * female 21 years or older (asc-us study only) * female 30 years or older (adjunct and asc-us studies) * subject attending a participating clinic and undergoing a pap screening exam during the clinic visit * ability to comprehend and sign an irb-approved informed consent form exclusion criteria: * diagnosis of cervical disease (cancer or precancerous condition) in the past 12 months * abnormal pap test result in the past 12 months * subject under 18 years of age and consenting to the study without the presence of their parent or legal guardian * known to be pregnant * having an illness or medical condition that could interfere with or affect the conduct, results, and/or completion of the clinical trial * having an illness or medical condition that the investigator or physician feels would create an unacceptable risk to the subject if she enrolled into the clinical trial * prior vaccination for hpv

Keywords: cervix cancer cervical intraepithelial neoplasia (cin) human papillomavirus virus (hpv) aptima hpv assay fda-approved hpv dna test tigris dts (direct tube sampling) system clinical sensitivity (%) clinical specificity (%) positive predictive value [ppv] (%) negative predictive value [npv] (%) atypical squamous cells undetermined significance (asc-us) relative risk
yonsei oct (optical coherence tomography) registry for evaluation of efficacy and safety of coronary stenting

Conditions: Coronary Artery Disease; Ischemic Heart Disease

Summary: optical coherence tomography (oct) has been recently studied for evaluation of coronary stenting. because of high resolutions, several reports have shown that oct is appropriate for evaluating neointimal tissue after coronary stent implantation. also, the strut coverage and the characterization of neointimal tissue can be accurately evaluated. furthermore, oct-defined coverage of a stent strut was proposed to be related with clinical safety in drug-eluting stents-treated patients. therefore, the investigators will evaluate the appropriateness of currently using coronary stents (e.g. sirolimus eluting stent, paclitaxel-eluting stent, zotarolimus-eluting stent, everolimus-eluting stent, biolimus eluting stent, epc(endothelial progenitor cell) capture stent, etc) based on the findings of oct. additionally, the investigators will evaluate neointimal hyperplasia, malposition or strut coverage to decide the differences in the stent characteristics, the duration of antiplatelet use, and the differences according to the clinical presentations.


Eligibility criteria:
inclusion criteria: 1. patients with coronary stents 2. patients who will have coronary stents because of coronary artery stenosis exclusion criteria: 1. hemodynamically unstable patients 2. ostial lesions that begin within 15 mm of the left main coronary artery 3. lesions with diameter more than 4 mm 4. patients with allergy to antiplatelet agent (asprin or clopidogrel) 5. patients with hepatic dysfunction (liver enzyme 3 times the upper limit of normal) 6. pregnant and lactating patients 7. patients with life expectancy less than 1 year

Keywords: oct coronary stenting
kinematics of silastic joint replacements in the hand

Conditions: Degenerative Arthritis; Inflammatory Arthritis

Summary: to assess in vivo the kinematics of single piece silastic joint replacements in the hand with magnetic resonance imaging

proximal inter phalangeal joint (pipj) replacement is performed for pain relief in the end stage of arthritis. rheumatoid arthritis is the commonest indication in the metacarpophalangeal joint (mcpj). in the pipj there is a more even spilt between degenerative and rheumatoid arthritis. there are several options for pipj replacement currently licensed for use in the united kingdom although data is not entered in to the national joint registry so the exact numbers and failure rates are unknown. data from the norwegian joint registry indicates that 99% of implanted mcpj and pipj replacements are single piece silastic implants. three main prostheses represent the majority of implants used in the united kingdom, swanson, sutter and neuflex. all these implants have been shown in the literature to fracture either at the hinge or the distal stem - hinge interface. this is true of explants and in vitro simulator testing. long term survivorship in mcpj and pipj replacement is below that of hip and knee replacement. one of the largest single series shows 63% survivorship at 17 year follow up but with radiological evidence of failure in at least two thirds. this compares poorly to the 82.9% survivorship for exeter cemented hip replacements at 22 years. the long term aim of this project is to understand how the implants move. this will help explain failure in particular the newly observe hinge failure in neuflex implants and provide ideas to improve these implants. any modifications can be tested on the in vitro finger joint testing rig the method of mri acquisition will be similar to that described in. this will require optimising. in order to limit movement to a sagittal displacement, a thermoplastic splint will support the wrist and hand up to the level of the proximal palmer crease. a rig will also be made to hold the mcp / pip joints in extension and positions of flexion increasing by 200 to maximum flexion. these will depend upon the patient's range of motion. the investigators will define the centre of rotation of the hinge then points on the shoulder and stem of the implant from which to measure displacement. points on the metacarpal and proximal phalanx will also be defined to allow measurement of the displacement of the implant relative to the bone during the range of movement.

Eligibility criteria:
inclusion criteria: - single piece silastic joint replacement with an adequate range of movement (rom), i.e. an arc of movement of ≥ 50 * age over 18 * able to give informed consent exclusion criteria: * any contraindication to mri scanning * fractured implant * fixed flexion deformity \>30 degrees in the replaced joint * total range of motion \<50 degrees in the replaced joint * awaiting further surgery * abnormal joint instability * previous surgery on the same digit (other than the joint replacement) * replacement of the joint of the opposite hand
pet/mri perfusion and ct perfusion in solid tumors

Conditions: CT Perfusion and MRI Perfusion in Solid Tumors

Summary: diagnostic comparison between pet/ct and pet/mri with integrated perfusion measurement in ct and mr. study aim is to gain knowledge about additional value of ct perfusion and mr perfusion in solid tumors concerning tumor physiology, diagnostic accuracy and possibly prognostic.


Eligibility criteria:
inclusion criteria: * indication as stated above * written informed consent * patients with suspected or confirmed solid malignant tumors of the neck, chest or abdomen who have an indication for a pet/ct exclusion criteria: * pregnant or breast feeding women * non compliance of the patient to follow the study instructions (e.g. hearing problems, dementia) * inclusion in another clinical trial 30 days prior to inclusion * age \< 30years * contraindication for mri (cardiac pacemaker, certain metal implants, claustrophobia * known allergies to contrast ct or mri contrast media * patients with an glomerular filtration rate of \< 60ml/min/1.73m2
intravitreal bevacizumab for diabetic retinopathy

Conditions: Severe Nonproliferative; Proliferative Diabetic Retinopathy; Active Photocoagulated Diabetic Retinopathy

Summary: background: to evaluate the 3-month efficacy of a single dose of intravitreal bevacizumab on the progression of severe non proliferative diabetic retinopathy, proliferative diabetic retinopathy and active photocoagulated diabetic proliferative by evaluation of ischemic areas and regression of retinal and disc neovasculrization. methods: 40 patients were enrolled in a prospective, interventional study. patients were treated with intravitreal bevacizumab 0.1ml (0.25mg). we evaluated visual acuity, neovascularization leakage points, capillary closure ischemic areas and macular edema by clinical examination and fluorescein angiography. a clinical examination was performed at baseline and days 1,14 and 30. active leakage points were measured by fluorescein angiography at 30 days.


Eligibility criteria:
inclusion criteria: * severe nonproliferative * proliferative diabetic retinopathy * active photocoagulated diabetic retinopathy exclusion criteria: * previous vascular occlusion * glaucoma * uncontrolled hypertension, thromboembolic event * renal abnormalities * recent or planned surgery * coagulation abnormalities * panretinal photocoagulation of less than one month before * patients with known serious allergies

Keywords: severe nonproliferative proliferative diabetic retinopathy active photocoagulated diabetic retinopathy intravitreal bevacizumab
comparison of functional outcomes of three surgical approaches in knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: a functional outcomes comparison study of three surgical techniques using minimally invasive surgery mini-incision (mis) for total knee arthroplasty (tka), standard para-patellar tka and the unicompartmental knee arthroplasty performed over a 2+ year post-op period.

the purpose of this research study is to compare post-operative knee function of persons who have undergone one of three types of knee arthroplasty for the treatment of knee osteoarthritis. a variety of functional performance tests will be assessed and compared using a group of evaluations including: functional activity performance tests and questionnaires; leg strength; knee range of motion; and forces at the knee during a series of activities (walking, bending, stepping etc.) via a motion analysis system. the study will compare the three surgical subject groups and one group of healthy, non-surgical subjects for a total of 100 subjects.

Eligibility criteria:
inclusion criteria: * tka subjects: 1. patients requiring primary knee arthroplasty; 2. knee osteoarthritis; 3. subject has sufficient quantity or quality of bone support; 4. subject has no previous or active infection in the affected joint or systemic infection; 5. subject judged to be available for follow-up through at least 1 year postoperative; 6. all subjects in arthroplasty groups will be between 50-70 years of age * healthy subjects: 1. healthy subjects will have no complaints of knee pain or history of knee surgery or known arthritic knee changes. 2. all subjects will have no history of prior lower extremity arthroplasty surgeries or systemic disease which could confound outcome measures. 3. all healthy persons will be 40-70 years. exclusion criteria: 1. insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, significant osteoporosis or metabolic disorders of calcified tissues; 2. unable to return for follow up x-rays and clinical evaluation; 3. unable to comprehending study protocol for any reason; 4. systemic inflammatory joint disease (rheumatoid arthritis), previous infection or those requiring revision knee surgery; 5. subject has an immunological disorder: immunosuppressive treatment characterized by markedly inhibited ability to respond to antigenic stimuli. examples of such conditions include subjects who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), subjects receiving therapy to prevent homograft rejection, subjects who have a documented history of acquired immunodeficiency syndrome (aids), or auto-immune diseases; 6. subject has a neurologic condition that would influence the results of biomechanical analysis of whole body movement.

Keywords: knee osteoarthritis leg strength functional outcomes minimally invasive surgery mini-incision (mis) tka unicompartmental knee arthroplasty standard para-patellar surgery tka gait knee arthroplasty
reliability of fluorescent camera in diagnosis of occlusal carious lesion

Conditions: Caries

Summary: this study will be conducted to compare the diagnostic predictive values of a light induced fluorescence camera and caries detection dye versus visual assessment method in identification of occlusal carious lesion.

a total of 43 volunteer patients will be assigned in this study. each patient must have at least two occlusal carious lesions. each lesion will be evaluated by three diagnostic methods (d), where d1 represents light induced fluorescence camera, d2 represents caries detection dye. and d3 represents visual assessment method (icdas criteria)

Eligibility criteria:
inclusion criteria: * patients should be over 18 years old * patient should have good oral hygiene and general health * patients with at least 2 non-cavitated first and/or second molar teeth in each quadrant of maxilla or mandible exclusion criteria: * known allergy to any component of the dyes used. * patients having caries at proximal, buccal, lingual surface. * previously placed sealants or restorations. * bruxism or malocclusion

Keywords: pit and fissure caries
rationale for new topical anthroponotic cutaneous leishmaniasis (acl) treatment in kabul

Conditions: Wound Healing

Summary: the aim of the randomized double blind trial with 134 patients presenting old world cutaneous leishmaniasis is: * to evaluate the clinical efficacy of electro-thermo-cauterisation (etc) followed by moist wound treatment versus etc followed by moist wound treatment plus 0.05 % pharmaceutical chlorite that has been used in three european countries (germany, austria and switzerland) in wound care management for more than 20 years; * to judge whether early wound care management would present a viable improvement to the actual anti-parasitic treatments mostly neglecting the chronic wound problem and to evaluate its long-term effect on immunity through relapse control 6 months after wound healing.


Eligibility criteria:
inclusion criteria: * at least one suspected lesion positive in giemsa smear exclusion criteria: * patients previously treated for leishmania
study of citicoline for the treatment of traumatic brain injury (cobrit)

Conditions: Traumatic Brain Injury

Summary: the citicoline brain injury treatment (cobrit) is a randomized, double-blind, placebo controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate and severe traumatic brain injury.

traumatic brain injury (tbi) is a major cause of death and disability. in the united states alone approximately 1.4 million sustain a tbi each year, of which 50,000 people die, and over 200,000 are hospitalized. despite numerous prior clinical trials no standard pharmacotherapy for the treatment of tbi has been established in either the acute or post acute setting. citicoline is a naturally occurring endogenous compound. this compound offers the potential of employing neuroprotection, neuro-recovery and neurofacilitation to enhance recovery after tbi. the primary goal of this study is to assess the efficacy of citicoline compared to placebo on functional and cognitive outcome in participants with traumatic brain injury.

Eligibility criteria:
inclusion criteria: 1. non-penetrating traumatic brain injury. 2. age 18 (19 in alabama) - 70 years. 3. gcs criteria on/off paralytics as specified in protocol 4. reasonable expectation of completion of outcomes measures at a network center at six months post-injury. 5. able to swallow oral medication or, if unable to swallow, a gastric tube or peg are placed by 23 hours after injury. 6. reasonable expectation of enrollment within 24-hour time window. 7. english-speaking exclusion criteria: 1. intubated patients with gcs motor score = 6 and not meeting ct criteria. 2. bilaterally fixed and dilated pupils 3. positive pregnancy test, known pregnancy, or currently breast feeding 4. evidence of diseases that interfere with outcome assessment 5. current acetylcholinesterase inhibitor use (appendix 1) 6. imminent death or current life-threatening disease 7. currently enrolled in another study 8. prisoners

Keywords: traumatic brain injury cognition behavioral outcome functional outcome treatment early intervention citicoline
an efficacy and safety study of ravulizumab in adult participants with nmosd

Conditions: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder

Summary: the primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with nmosd.


Eligibility criteria:
inclusion criteria: 1. anti-aquaporin-4 antibody-positive and a diagnosis of nmosd as defined by the 2015 international consensus diagnostic criteria. 2. at least 1 attack or relapse in the last 12 months prior to the screening period. 3. expanded disability status scale score ≤7. 4. participants who enter the study receiving supportive immunosuppressive therapy must be on a stable dosing regimen of adequate duration prior to screening. 5. body weight ≥40 kilograms. 6. contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. exclusion criteria: 1. history of neisseria meningitidis infection. 2. human immunodeficiency virus (hiv) infection (evidenced by hiv-1 or hiv-2 antibody titer). 3. previously or currently treated with a complement inhibitor. 4. use of rituximab or mitoxantrone within 3 months prior to screening. 5. use of iv immunoglobulin within 3 weeks prior to screening.

Keywords: neuromyelitis optica neuromyelitis optica spectrum disorder devic's disease transverse myelitis optic neuritis relapse ravulizumab ultomiris alxn1210 cns autoimmune disorders demyelinating disorders nmo nmosd
descriptive and prospective study of sphincter disorders in the severe traumatic brain injury population

Conditions: Traumatic Brain Injury

Summary: severe traumatic brain injury (tci), defined by an initial gcs of ≤ 8 and/or admitted to a neurosurgical intensive care unit, are responsible for diffuse brain lesions that can lead to multiple deficits, including impairment of sphincter functions: bladder, rectal and sexual. bladder-sphincter disorders are very common after a tbi. urinary incontinence predominates, with a prevalence varying from 50 to 100% in the acute period following a tbi. the variability of the clinical data is explained by the heterogeneity of the populations studied (severity of tbi, duration of coma, time to care) and the tools used to objectify sphincter disorders. the interest of this study is to make an evaluation and a prospective follow-up of sphincter disorders in this population during one year.

a first visit, planned as part of the care, within 3 months of tbi with a clinical examination and 8 to 11 questionnaires, depending on your sex and your transit, to assess cognitive functions, the sphincter sphere, the autonomy and mood achieved as part of your usual care. these questionnaires will be taken with the doctor during consultation, as part of the research, patient will be asked to additionally answer the sexuality questionnaire consisting of 23 questions. the same visit will be carried out at 6 months and at 1 year, also planned as part of the usual care. if beyond 6 months vesico-sphincter complaints persist, a urodynamic examination will be realised in order to compare subjective complaints with a urodynamic examination (flowmeter, cystomanometry with +/- pressure / flow rate curve, sphincterometry). this is a single-center research. the patients will be included in the neurosurgical intensive care unit of the pitié salpêtrière hospital and will be followed in the physical medicine and rehabilitation unit of the same hospital.

Eligibility criteria:
inclusion criteria: * have been the victim of a serious head trauma (initial glasgow ≤ 8 and / or admitted to neurosurgical resuscitation for less than 3 months * admitted to neurosurgical resuscitation at pitié-salpêtrière * aged 18 to 70 * good written and oral comprehension of the french language * glasgow score = 15 at the time of inclusion and able to say no to opposition * patient information and not opposition exclusion criteria: * severe comprehension disorders * history of vesico-sphincteric disorders before tc * neurological and psychiatric history * patient not affiliated to a social security scheme or entitled * patient under guardianship / curators

Keywords: traumatic brain injury sexuality sexual disorders bladder-sphincter dysfunctions anorectal disorders
assessment of esophageal epithelium integrity with mucosal impedance

Conditions: Gastroesophageal Reflux Disease (GERD); Non-erosive Reflux Disease (NERD)

Summary: gastroesophageal reflux disease (gerd) is a common condition affecting more than 100 million adults in the u.s., and it significantly impacts patients' quality of life while imposing billions of dollars of direct and indirect costs each year upon our healthcare system. current diagnostic tests for gerd are highly invasive and medically inadequate, and the goal of this project is to develop a novel, minimally invasive mucosal impedance technique for more accurate detection of gerd while reducing costs.


Eligibility criteria:
inclusion criteria: * patients undergoing standard of care egd with 48-hr ph testing by bravo * previous diagnosis of reflux * at least 18 years of age exclusion criteria: * those less than 18 years of age * unable to give informed consent * use of acid suppressive therapy within the last 10 days * known history of barrett's esophagus, gastric surgery, alcoholism, or significant motility condition

Keywords: reflux gerd egd ph testing
the potential added value of impulse oscillometry in asthma monitoring

Conditions: Asthma

Summary: the goal of this longitudinal observational study is to learn if impulse oscillometry (ios) has an added value in asthma monitoring in adult asthma patients who are prescribed a change in asthma maintenance therapy. the main questions it aims to answer are: * is there a difference in the change in ios parameters and fev1 respectively, stratified according to change in asthma control test? * is there a difference in the change in ios parameters and fev1 respectively, stratified according to change in other questionnaire such as the asthma control questionnaire and the asthma quality of life questionnaire. * are the proposed minimal clinically important differences (mcids) valid for short follow-up periods (3 - 6 months)? participants will undergo lung function testing (full lung function, multiple breath nitrogen washout, impulse oscillometry) and questionnaires (asthma control test, asthma control questionnaire, asthma quality of life questionnaire), once during the baseline visit and once during the follow-up visit three to six months later.


Eligibility criteria:
inclusion criteria: * adult asthma patients with a scheduled consultation at the outpatient hospital to whom a step-up or step-down of their pharmacological asthma treatment is prescribed exclusion criteria: * unstable asthma (defined as need for oral corticosteroids or (respiratory) antibiotic course in the 4 weeks before inclusion or any major medical issue in the 4 weeks before inclusion)

Keywords: impulse oscillometry asthma monitoring