Kornimate/medical-research-clean huggingface dataset:
transepithelial customized cross-linking

Conditions: Keratoconus

Summary: customized remodeled vision (curv) is a new corneal cross-linking protocol for keratoconus, combining a transepithelial approach with customized energy application. our aim is to follow-up our patients and establish the short-and long-term results of curv.

customized remodeled vision is a protocol for oxygen-boosted, tranespithelial cross-linking, customized to apply higher energy at the apex of the cone, relatively lower to the cone area and none to healthy cornea. thus curv promises to halt keratoconus progression, simultaneously offering potential for relatively good visual rehabilitation.our primary outcomes involve spectacle-corrected distance visual acuity and changes in corneal topography/tomography and oct parameters. these parameters include kmax, thinnest corneal pachymetry, maximal anterior and posterior elevation, the fourier analysis-derived irregularity index, and demarcation line depth.

Eligibility criteria:
inclusion criteria: * topographic evidence of keratoconus: * maximum corneal curvature (kmax) ≥47.00 d, * localized steepening on topographic maps, * localized elevation in the anterior and posterior corneal surfaces. exclusion criteria: * hypersensitivity to riboflavin * thinnest corneal pachymetry \< 380 μm * history of corneal surgery, including previous cross-linking * corneal scarring * aphakia * pseudophakia * any visually significant ocular condition

Keywords: keratoconus cross-linking transepithelial oxygen-boosted customized cxl
o-arm stereotactic imaging in deep brain stimulation for parkinson's disease

Conditions: Parkinson Disease

Summary: during deep brain stimulation procedures in parkinson's disease (pd), the most important prognostic element is the positioning of the surgical electrode in the subthalamic nucleus which is the anatomical target. the main objective of this project is therefore to compare 2 techniques thanks to a prospective comparative randomised open-label study: the use of o-arm to acquire stereotactic imaging directly in the operating room and the standard technique requiring stereotactic imaging to be performed in the radiology department.

prior to electrode implantation we perform stereotactic imaging which requires the fixation of a stereotactic frame on the patient's head before imaging (magnetic resonance imaging mri / computed tomography ct). currently, it is necessary to transfer the patient to the imaging department outside of the operating room after the stereotactic frame has been placed, for imaging (either mri or ct) and then to return to the operating room to begin the electrode implantation procedure. since 2016, the new generation o-arm 2 allows the acquisition of stereotactic imaging with the stereotactic frame in place by increasing the field of view (40 cm versus 20 cm previously) directly in the operating room. as a result, the transfer step to the mri and ct scanner preoperatively may no longer be necessary, and the procedure can be started more quickly with greater comfort and safety for the patient and the anaesthesia team. several teams around the world have begun to use framed o-arm as the gold standard for stereotactic imaging. however, no randomised controlled study has been performed to date comparing o-arm stereotactic imaging with pre-operative ct and/or mri reference imaging.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of idiopathic parkinson's disease at the stage of motor fluctuations despite optimal medical treatment * indication for deep brain stimulation (dbs) of the subthalamic nucleus approved by the local multidisciplinary deep brain stimulation committee after an operability assessment (see appendix) * informed and signed patient consent * affiliation to a social security scheme exclusion criteria: * significant cognitive decline assessed in a dedicated multidisciplinary consultation * contraindication to magnetic resonance imaging (mri) * presence of pathologies contraindicating deep brain stimulation * no contraceptive treatment for women of childbearing age * pregnant or breastfeeding woman * anticoagulant or antiaggregant treatment that cannot be stopped * persons under legal protection (persons deprived of liberty or incapable of giving consent or under guardianship or tutelage...) * patient with severe psychiatric disorders

Keywords: stereotactic imaging deep brain stimulation
wallis interspinous dynamic stability system for lumbar disc herniation: a prospective study

Conditions: Lumbar Disc Herniation

Summary: lumbar disc herniation is usually treated by discectomy alone. nonfusion system such as wallis interspinous implants have also been successfully used in disc degenerative diseases. however, the superiority of a discectomy with wallis in comparison to a discectomy alone for primary lumbar disc herniation has yet to be determined.the aim of our study is to investigate whether lumbar discectomy combined with the wallis device provides better radiographic and clinical short-term outcome than posterior lumbar discectomy alone.

the most commonly used therapy for lumbar disc herniation (ldh) are partial discectomy or discectomy with fusion if there was an additional mechanical disorder in the underlying functional spinal unit. however, the problems associated with discectomy are intervertebral disc height loss and the segmental instability, thought to be a risk for failed back surgery syndrome or recurrence lumbar disc herniation. fusion has also been criticised for its side effects of adjacent segment degeneration(asd), pseudarthrosis and bone-graft morbidity. to prevent such complications , a new family of dynamic implants have been established. wallis interspinous implant (abbott laboratories, bordeaux, france) , invented by j. senegas, is one of them. it consisted of a interspinous blocker made out of polyetheretherketone (peek) to limit extension and two dacron tapes around the spinous processes in order to secure the implant and limit flexion. the aim of using this device is to unload the facet joints, to restore foraminal height and to provide sufficient stability especially in extension but still allow motion in the treated segment. previous clinical trials and biomechanical studies are promising, however, the superiority of a discectomy with wallis in comparison to a discectomy alone for primary lumbar disc herniation has yet to be determined. the purpose of this prospective controlled study was to evaluate the clinical effect of lumbar discectomy combined with wallis interspinous device, comparing with posterior lumbar discectomy alone. our hypothesis was that the use of the wallis device would have better clinical and radiological outcomes than lumbar discectomy alone.

Eligibility criteria:
inclusion criteria: 1. 18-70 years old; 2. complaining low back pain or radioactive melosalgia; 3. preoperative image examination showing disc herniation or spinal stenosis caused by herniation of responsible level; 4. no improvement in symptoms after 6-10 weeks of non-surgical treatment. exclusion criteria: 1. previous operations; 2. congenital spinal deformity; 3. lumbar fracture; 4. infection; 5. autoimmune diseases; 6. serious osteoporosis; 7. morbidly obese;

Keywords: lumbar disc herniation wallis interspinous implants lumbar discectomy interspinous dynamic stability system
economic analysis of early vs delayed therapy in newly diagnosed asymptomatic high-risk patients with chronic lymphocytic leukemia/small lymphocytic lymphoma:

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: utilization data will be collected from all patients entered on the trial at canadian centres from the time of registration until death, removal from study, or completion of 10 years of follow-up. protocol-specified health care utilization will be collected within trial case report forms, and will include study visits, radiographic assessments, laboratory investigations, and treatment administration. resource utilization data collection will be supplemented by a self-administered resource utilization form (stanford smrc) to document non-protocol specified utilization. this will include hospitalizations (including days in hospital), emergency room visits, and non-protocol specified ambulatory visits.


Eligibility criteria:
inclusion criteria: * patient must be eligible for the core clc3/s1925 protocol. * patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. * patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either english or french. the baseline assessment must be completed within required timelines, prior to enrollment. inability (lack of comprehension in english or french, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. however, ability but unwillingness to complete the questionnaires will make the patient ineligible. * patients must be accessible for treatment and follow-up. investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
the immediate effect of electrical stimulation transcranial direct current (tdcs) associated with the use of fes, in muscle activity of the tibialis anterior muscle, balance and plantar pressure distribution of individuals with hemiparesis due to stroke

Conditions: STROKE

Summary: background: transcranial direct current stimulation (tdcs) is currently considered a beneficial method for patients with neurological problems due to the modulation of cortex activity as well as the enhancement and prolongation of functional gains achieved during physical therapy. purpose: the aim of the proposed study is to evaluate the immediate effects of a session of tdcs over the primary motor cortex combined with functional electrical simulation (fes) on electrical activity of the tibialis anterior muscle, balance and distribution of plantar pressure in individuals with hemiparesis stemming from a stroke. a further aim is to determine whether the effects of the combination of both stimulation methods are better than those achieved when each method is employed alone. methods/design: a randomized, double-blind, crossover, cross-sectional study will be conducted involving 30 stroke survivors with hemiparesis who meet the eligibility criteria. evaluations will involve an identification and screening chart, the classification of motor impairment using the fugl-meyer scale, the determination of spasticity of the triceps surae muscle (modified ashworth scale), electromyography of the tibialis anterior muscle, static balance and cognitive dual-task balance (stabilometry) and plantar pressure. after the initial evaluations, the participants will undergo four interventions: 1) anodal tdcs + placebo fes + active tibialis anterior contraction; 2) placebo tdcs + active fes + active tibialis anterior contraction; 3) anodal tdcs + active fes + active tibialis anterior contraction; and 4) placebo tdcs + placebo fes placebo + active tibialis anterior contraction. tdcs will be administered over the primary motor cortex and fes will be administered over the tibialis anterior muscle. the order of the different protocols will be randomized and both the evaluator and patients will be blinded to which protocol is being administered.


Eligibility criteria:
inclusion criteria: * 30 individuals with hemiparesis stemming from a stroke; * either gender; * able to maintain a standing position without an assistance device for at least 60 seconds; * signed statement of written consent. exclusion criteria: * adverse health condition (beyond hemiparesis) that affects balance; * use of medication that can affect balance; * positive cutoff point for cognitive deficit (mini mental state examination); * illiteracy; * wernicke's aphasia; * reduced ankle mobility due to history of ankle fracture and use of pins in ankle; * ta muscle strength less than grade 1; * contraindication for tdcs (history of recurrent seizures, recurrent epilepsy and brain tumor in stimulation site); * skin infection at tdcs and/or fes site; * anesthesia or hyperesthesia at fes site.

Keywords: transcranial direct current stimulation functional electrical stimulation hemiparesis electromyography balance
acceptability and tolerance study of a low calorie peptide based paediatric tube feed formula.

Conditions: Cerebral Palsy

Summary: this is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of a low calorie paediatric peptide based tube feed formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; the acceptability data from 15 participants will be collected in order to submit an application to the advisory committee on borderline substances (acbs).

patients well established and stable on a standard or peptide enteral tube feed will be changed to a low calorie paediatric formula for a period of seven days. this group will act as their own controls. each child will receive for a period of seven days the paediatric formula. the dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube. a baseline questionnaire will be completed by the dietitian to ensure eligibility of study, current stool patterns or symptoms and weight at the start of the study. the parents will complete a week intake chart to monitor how much feed has been consumed each day and a tolerance diary to review gastrointestinal symptoms at the start and end of the study.

Eligibility criteria:
inclusion criteria: * exclusively tube fed * paediatrics aged 1 year above who require a low calorie feed * children with neurological impairment (ni) who require long term tube feeding * patients established on a standard or peptide enteral formula (no gastrointestinal intolerances on a current formula) * willingly given, written, informed consent from patient or parent/guardian. * willingly given, written assent (if appropriate). exclusion criteria: * inability to comply with the study protocol, in the opinion of the investigator * known food allergies to any ingredients (see ingredients list) * patients with significant renal or hepatic impairment * participation in another interventional study within 2 weeks of this study.
carbachols headache-inducing effect and changes in cerebral blood flow in migraine patients

Conditions: Headache

Summary: the purpose of this study is to test if carbachol infusion induces headache in migraine subjects as well as intra- and extra-cerebral vasodilatation.

to test if infusion of carbachol induces headache in 12 migraine subjects as well as intra- and extra-cerebral vasodilatation in a double-blinded study

Eligibility criteria:
inclusion criteria: * migraine without aura * weight 50-100 kg exclusion criteria: * other significant diseases * migraine 5 days prior to experiment
a study to assess the validation and mapping of the suicide ideation and behavior assessment

Conditions: Suicidality

Summary: the main purpose of this cross-sectional study is to generate data to support the psychometric properties of the suicide ideation and behavior assessment tool (sibat) and validate its use in participants at imminent risk of suicide.


Eligibility criteria:
inclusion criteria: * participant must be able to speak, read, and write english sufficiently well to complete consent process and self-administer study questionnaires * each participant must sign an informed consent form (icf) indicating that he or she understands the purpose of the interviews and, when applicable, the videotaping required for the study and are willing to participate in the study. adolescents (minors) who in the judgment of the investigator are capable of understanding the nature of the study can be enrolled only after obtaining consent of a legally acceptable representative. assent must be obtained from any participating adolescents (minors) * each participant or legally acceptable representative must check a separate box on the consent form if he or she agrees to have interviews video-recorded. participants who do not consent to video recording will only be administered the sibat exclusion criteria: - participant has any clinically relevant physical or mental conditions including, but not limited to vision problems, physical disability, severe mental illness, or cognitive impairment (such as from acute intoxication or dementia) which, in the opinion of the investigator, would interfere with ability to complete the study interviews
bleeding symptoms of carriers of hemophilia a and b

Conditions: Hemophilia

Summary: to collect and analyze data on female carriers of severe and moderate hemophilia a and b.


Eligibility criteria:
inclusion criteria: * female carriers of hemophilia a and b. exclusion criteria: * pregnancy.

Keywords: carriers of hemophilia
ibd-sleep: a pilot study looking at changes in sleep timing and ibd symptoms

Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Summary: this research study is testing whether changes in sleep timing and morning light treatment may have an impact on symptoms related to inflammatory bowel disease.

this study will test a consumer health light therapy device (re-timer) for people with inflammatory bowel disease to better understand how it affects ibd-related quality of life.

Eligibility criteria:
inclusion criteria: * biopsy-proven ibd * active ibd symptoms * impaired ibd quality of life * age \>/=18 years old * fluency in english * physically able to travel for study visits exclusion criteria: * ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses, are planned for imminent surgery and/or have short bowel syndrome * other significant chronic disease * retinal pathology, history of eye surgery, taking photosensitizing medications * recent history of light treatment * lifetime psychotic or bipolar disorder * acute suicidal ideation * substance use disorder in the past 3 months, cannabis use \>1/week * high risk for or diagnosed with obstructive sleep apnea, and/or narcolepsy * severe hearing problem, intellectual disability or serious cognitive impairment * pregnant, trying to get pregnant, or breastfeeding * night work or travel outside the eastern time zone in the past month
glp-1 and oxyntomodulin release in relation to diet in type 2 diabetes patients.

Conditions: Type-2 Diabetes

Summary: the aim of this trial was to assess glycemic control and incretin release in subjects affected by type-2 diabetes, a condition in which glp-1 release is impaired. it is known that nutrition affects a variety of factors in overall quality of life in diabetes and we hypothesized incretin secretion may improve in acute. as little is known regarding oxyntomodulin secretion in relation to diet, we explored this gut-derived hormone behavior as well. hence, the administration of two meals was carried out; these were equal in terms of calories but different for macronutrients composition. appetite rating was assessed as well through a 100-mm horizontal visual analogue scale, either at fasting and for 4 hours once the meal was completed.

type-2 diabetes (t2d) is a multifactorial metabolic burden whose metabolic features include alterations in glp-1 secretion and ultimately hunger/satiety circuit derangement. manipulating the composition of the diet in order to promote glp-1 secretion may represent a promising lifestyle strategy for obesity and t2d management. the objective of this study was to assess the post-prandial profile of appetite- regulating hormones and assessing the post-prandial appetite ratings using a visual analogue scale (vas), as well as measuring the fasting and postprandial glucose/insulin responses in overweight and/or obese, well controlled patients with t2d. twelve t2d patients (m:f = 7:5) aged 63.1±8.5 years were enrolled in a randomized, controlled, crossover trial. subjects consumed on two different days, at one-week interval, an experimental high fiber vegetarian meal (hfv) rich in dietary carbohydrate and fiber in comparison with a standard, mediterranean-like meal (med). the two meals were isocaloric. appetite ratings, glucose/insulin and gastrointestinal hormone responses were assessed either at fasting and every 30' until 210' for glp-1 and oxyntomodulin and 240' for glucose and insulin after the ingestion of the meal.

Eligibility criteria:
inclusion criteria: * type-2 diabetes history of at least 2 years, age above 18 years, body mass index (bmi) between 25 and 35 kg/m2, and drug naïve and/or with metformin treatment. exclusion criteria: * clinically significant neurological, endocrinological, or other systemic diseases, as well as those with acute illness and chronic inflammatory or infective disease.

Keywords: diabetes glp-1 oxyntomodulin diet visual analogue scale
a study to assess pulsed inhaled nitric oxide in subjects with pulmonary hypertension associated with pulmonary fibrosis

Conditions: Pulmonary Fibrosis; Pulmonary Hypertension

Summary: a randomized, double-blind, placebo-controlled dose escalation study to assess the safety and efficacy of pulsed, inhaled nitric oxide (ino) in subjects with pulmonary fibrosis on long term oxygen therapy.

a phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to assess the safety and efficacy of pulsed, inhaled nitric oxide in subjects with and without pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (part 1 and part 2)

Eligibility criteria:
inclusion criteria: * diagnosed with pulmonary fibrosis by high resolution ct scan performed in the 6 months prior to screening associated with one of the following conditions and confirmed using one of the following guidelines, as per american thoracic society (ags) / european respiratory society (ers) / japanese respiratory society (jrs) / latin american thoracic association (alat): * major idiopathic interstitial pneumonias (iips) diagnosis or suspected as one of the following: * idiopathic pulmonary fibrosis * idiopathic nonspecific interstitial pneumonia * respiratory bronchiolitis-interstitial lung disease * desquamative interstitial pneumonia * cryptogenic organizing pneumonia * acute interstitial pneumonia * rare iips diagnosis by one of the following: * idiopathic lymphoid interstitial pneumonia * idiopathic pleuroparenchymal fibroelastosis * unclassifiable idiopathic interstitial pneumonias * chronic hypersensitivity pneumonitis * occupational lung disease * have been using oxygen therapy by nasal cannula for at least 4 weeks * 6-minute walk distance (6mwd) ≥ 100 meters and ≤ 450 meters at screening and baseline/randomization visits * world health organization (who) functional class ii-iv * forced vital capacity ≥ 40% predicated within the last 6 months prior to the screening run-in period * age between 18 and 85 years (inclusive) exclusion criteria: * pregnant or breastfeeding females at screening * in the last 6 months prior to screening, evidence of any connective tissue disease with fvc \> 60% unless there is evidence of moderate to severe fibrosis on ct scan in the opinion of the local radiologist/investigator

Keywords: pulmonary fibrosis (pf) pulmonary hypertension inhaled nitric oxide ino long term oxygen therapy oxygen