Kornimate/medical-research-clean huggingface dataset:
intrastromal fresh human corneal lenticule implantation using smile surgery for treatment of irregular corneal astigmatism after penetrating keratoplasty (new approach)

Conditions: Irregular Astigmatism

Summary: the aim of the study is to present the effect of implanting intrastromal fresh corneal lenticule by smile surgery as a new method-approach to correct the corneal shape on purpose to reduce irregular astigmatism and increasing visual acuity after penetrating keratoplasty.

irregular astigmatism occurs when the curvature of the eye is pronounced in any direction, not just the center. the curve could be steeper towards the bottom than on top, or it could be any configuration in which the eye's surface area is uneven. irregular astigmatism usually can result from corneal degenerations(keratoconus,pellucid marginal degeneration,keratoglobus), corneal surgery or trauma. irregular astigmatism is still the main cause of decreased visual acuity after penetrating keratoplasty. our study present new therapeutic method and new technology to manage irregular astigmatism after pk. knowing that the incidence of high and irregular astigmatism after pk is still a frequent complication and source of frustration for patients and corneal surgeons our study present an adequate surgical technique implanting intrastromal human corneal lenticule using smile for treatment of corneal irregular astigmatism after pk trying satisfy patients visual expectations.

Eligibility criteria:
inclusion criteria: * patients with irregular astigmatism * low visual acuity exclusion criteria: * history of glaucoma * retinal detachment * history of ocular inflamation
evalution of immunogenicity, safety and booster response of a rabies vaccine administered concomitantly with japanese encephalitis vaccine in toddlers

Conditions: Rabies; Japanese Encephalitis; Pre-Exposure Prophylaxis

Summary: this study evaluated the safety and immunogenicity of rabies vaccine and japanese encephalitis vaccine in toddlers. all children developed adequate immune responses. rabies vaccination with pcecv did not interfere with the antibody response to japanese encephalitis vaccine. the rabies vaccine pcecv and japanese encephalitis vaccine are safe and immunogenic when administered concomitantly to toddlers.


Eligibility criteria:
inclusion criteria: * male and female 12-18 months old toddlers if they * are in good health at time of entry into the study * are available for all the visits scheduled in the study * have been granted a written informed consent, signed by their parents exclusion criteria: * a history of rabies immunization * a history of japanese encephalitis immunization or disease * a significant acute or chronic infectious disease at the time of enrollment * fever ≥ 38.0°c (axillary) or/and significant acute or chronic infection requiring antibiotic or antiviral therapy within the past 7 days before enrollment * being under treatment with corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment * administration of any vaccine within the past 14 days before enrollment * known immunodeficiency or an autoimmune disease * history of allergy to eggs, egg products * known hypersensitivity to neomycin, tetracycline, amphotericin-b * planned surgery during the study period * being enrolled in any other investigational trial contemporaneously * the family plans to leave the area of the study site before the end of study period * history of febrile convulsions * history of wheezing

Keywords: rabies vaccination pre-exposure prophylaxis rabies virus neutralizing antibody
study of azithromycin for lymphocytic bronchiolitis/bronchitis after lung transplantation

Conditions: Lymphocytic Bronchi(Oli)Tis Post-lung Transplantation

Summary: this study investigates the role of azithromycin treatment for lymphocytic bronchitis/bronchiolitis after lung transplantation.

lymphocytic bronchitis/bronchiolitis is one of the major risk factors for development of chronic rejection/bos after lung transplantation. there is currently no established treatment available for this condition. there is now mounting evidence that il-17 producing lymphocytes (th17) not only participate in chronic allograft rejection/bos, but are also present within the airway wall during lymphocytic bronchiolitis and that il-17 mrna-levels in bronchoalveolar lavage fluid of these patients are upregulated. as such, th17 may account for the increased bal neutrophilia seen in these patients, as il-17 may be responsible for driving il-8 secretion (a neutrophil-attracting chemokine) from various cell types in the airways. since azithromycin has previously been shown to reduce both il-17 induced il-8 production by human airway smooth muscle cells 'in vitro' and bronchoalveolar il-8/neutrophil levels in ltx recipients with established bos, we believe that azithromycin has great potential for treating lymphocytic bronchi(oli)tis by attenuating this th17/il-17/il-8-mediated airway inflammation, possibly even halting the subsequent development of chronic rejection/bos after lung transplantation. in this study, histologic, spirometric, bronchoalveolar an radiologic features will be investigated in patients treated with confirmed lymphocytic bronchitis/bronchiolitis treated with azithromycin.

Eligibility criteria:
inclusion criteria: * signed informed consent * adult (age at least 18 years old at moment of transplantation) * able to take oral medication * histologic diagnosis of lymphocytic bronchiolitis or bronchitis ('grade b') without concurrent acute cellular allograft rejection 'grade a' ≥2 exclusion criteria: * severe suture problems (e.g. airway stenosis) requiring lasering or stenting

Keywords: azithromycin lymphocytic bronchitis or bronchiolitis lung transplantation acute allograft rejection chronic allograft rejection bronchiolitis obliterans syndrome
calm: managing distress in malignant brain cancer

Conditions: Brain Tumor; Brain Metastases; Brain Cancer; Metastatic Lung Cancer; Metastatic Breast Cancer; Metastatic Melanoma; Metastatic Colon Cancer; Metastatic Kidney Cancer

Summary: the purpose of this study is to test an empirically supported psychotherapeutic intervention, managing cancer and living meaningfully (calm), compared to treatment as usual (tau) in those with malignant brain cancer diagnoses.


Eligibility criteria:
inclusion criteria: * self-reported diagnosis of brain metastasis (bmet) or a malignant primary brain tumor (pbt; specifically grade iii or iv and cns diffuse large b cell lymphomas)\* * at least 2-weeks post-surgical resection or biopsy of the brain (if applicable) * score \> 20 on the tics * reported elevated depression (phq-9 score ≥ 10) or death anxiety symptoms (dadds score ≥ 15) * ability to read, speak, and understand english * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * major communication difficulties which would prohibit the psychotherapeutic interaction * inability to meet with the interventionist via an electronic device for telehealth intervention sessions * inability to understand and provide informed consent * prisoners * medical, psychological, or social condition that, in the opinion of the principal investigator, may increase the participant's risk of adverse events and/or prohibit the individual's participation in the intervention.

Keywords: service members veterans
adavanced glycated endproducts and development of cad

Conditions: Atherosclerosis; Inflammation

Summary: blood sample is prospectively taken from consecutive patients underwent coronary angiogram in our center, after getting informed consent from the patients. serum level of advanced glycation end products (ages) was measured and the clinical features of patients (including angiographic results) were entered into our database. clinical follow-up was performed for all patients, and the relationship between ages and paitents' outcome were analyzed. further intervention will be adjusted according to the results,including clinical and basic research in lab.

serum levels of hmgb1, hmgb2, adam10, etc. will be measured in lab and animal studies will be designed to intervene the adverse interaction between abnormal serum concentration of ages, etc. and worse clinical results.

Eligibility criteria:
inclusion criteria: * patients underwent coronary angiogram for suspected coronary artery disease and potential percutaneous coronary intervention exclusion criteria: * patients underwent coronary angiogram for other reasons, including pre-surgery examination * patients with severe co-morbidity, and life expectancy less than one-year

Keywords: advanced glycation end product coronary atherosclerosis inflammation outcome
pressure-limited ventilation versus volume-targeted ventilation in term newborns

Conditions: Respiratory Insufficiency

Summary: a randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.

aims: there is increasing evidence that volume-targeted ventilation (vtv) holds benefits for preterm infants in comparison to pressure-limited ventilation. it is not known whether the same is true in the case of infants born at term. this study aims to compare pressure-limited to vtv in term-born infants. hypothesis: volume-targeted will be associated with significantly earlier extubation compared to pressure-limited ventilation primary outcome: time to extubation. methods: ventilated infants 34 weeks or more gestational age at birth were recruited and randomly allocated to receive either pressure-limited or vtv. adjustments to ventilator settings were made according to the trial protocol. infants were deemed to have met failure criteria if they required hfov or peak pressures of more than 30 cm of water. analysis will be by intention-to-treat.

Eligibility criteria:
inclusion criteria: * mechanically ventilated * born at gestation 34 weeks and above exclusion criteria: * congenital diaphragmatic hernia * congenital heart disease

Keywords: neonatal respiratory mechanical ventilation
clinical and biochemical effects of multipass hemodialysis

Conditions: Uremia

Summary: the purpose of this study is to investigate whether recycled dialysis fluid can supply enough clearance for hemodiaysis patients.

conventional hemodialysis uses large amounts of water, which hinders travel possibilies for home hemodialysis (hd) patients. we have developed a recycling system using 25-30 l dialysate per dialysis. in vitro investigations show that this results in adequate dialysis. 12 hd patients will be studied during two dialysis sessions. the first hd will be a conventional 4 hour dialysis, using single pass dialysate. the second will be an 8-hour hd using multipass (recycled) dialysate 25-30 l. clearance of urea, creatinine, phosphate and cobalamin will be measured both in the patient and the dialysate. patient symptoms will be recorded.

Eligibility criteria:
inclusion criteria: * stable chronic hd patients * informed consent exclusion criteria: * age \<18 years * psychiatric disease

Keywords: dialysis hemodialysis effect of recycled low-volume dialysate on dialysis efficacy
severe head injury brain analysis

Conditions: Brain Injury Traumatic Severe

Summary: safety and feasibility study investigating brain biopsy in severe head injury. when a patient undergoes craniotomy or icp bolt insertion for trauma, a biopsy of brain tissue is taken. blood, saliva, urine and faeces samples are also taken for 7 days following the brain biopsy. csf is collected if a csf drainage device is used.

a minor amendment was submitted to allow histological and immunohistochemical analysis of the samples.

Eligibility criteria:
inclusion criteria: severe traumatic brain injury - exclusion criteria: coagulopathy -

Keywords: traumatic brain injury brain injury classification histology
precision ecmo in cardiogenic shock evaluation

Conditions: Cardiogenic Shock

Summary: venoarterial (va) ecmo is a form of life support for patients with severe cardiogenic shock and cardiac arrest. although it can be lifesaving, currently many patients still die or have long term disability, such as weakness, shortness of breath and cognitive impairments, and it remains extremely expensive. it is important that new ways of identifying which patients will gain the most benefit from ecmo are found, while also avoiding costly futile use when it there is no benefit. the precise study is an australian-led, nation-wide observational study that will investigate whether biomarkers can better guide decisions around to whom and how ecmo is delivered. the study will involve the collection of a small amount of blood (which would normally be discarded) at up to 4 different time points, including just prior to ecmo initiation, and also at days 1, 3, and 7 of ecmo support. these results will then be linked to a national registry which includes the important patient centred outcomes, such as disability at 6 months. this study will lead to the better support of a highly vulnerable population, and improve the efficiency of one of the most complex and costly interventions available.


Eligibility criteria:
inclusion criteria: * patients who will be commencing on va ecmo (for cardiogenic shock or ecpr) * 18 years old or older * patients who will be enrolled in the excel registry (hrec project 534/18) exclusion criteria: * patients who are already on ecmo, or where * there are inadequate resources to complete the study

Keywords: ecmo cardiogenic shock ecpr critical illness intensive care
terlipressin in septic shock in cirrhosis

Conditions: Liver Cirrhosis; Septic Shock

Summary: septic shock is a frequent and severe complication in cirrhosis. current mortality rate ranges between 50 and 80% of cases. refractory shock, hepatorenal failure and variceal bleeding are the main causes of death of these patients. terlipressin administration could prevent these complications and improve survival in this setting. aim: to evaluate the effects of terlipressin administration on hospital survival in cirrhotic patients with severe sepsis or septic shock. methods: prospective, open labelled, controlled trial evaluating 72 cirrhotic patients with severe sepsis or septic shock who will be randomized to receive terlipressin plus alpha-adrenergic drugs or only alpha-adrenergic drugs at shock diagnosis. patients will be submitted to continuous systemic hemodynamic monitoring (s. ganz catheter or vigileo). changes in vasoactive systems and cytokines levels will be also evaluated.

prospective, open labelled, rct evaluating 72 cirrhotic patients with severe sepsis or septic shock (36 per arm) who were randomized to receive terlipressin plus alpha-adrenergic drugs or alpha-adrenergic drugs in the first 24h after septic shock diagnosis. impact of terlipressin administration on shock reversal, changes in vasoactive systems, inflammatory response, incidence of variceal bleeding and type-1 hrs and icu and hospital mortality was investigated

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years; 2. diagnosis of cirrhosis based on histology or on clinical, laboratory and ultrasonographical data; 3. diagnosis of septic shock based on the presence of data compatible with systemic inflammatory response syndrome, a mean arterial pressure below 60 mmhg during more than 1 hour despite adequate fluid resuscitation, and need for circulatory support with vasopressor drugs. exclusion criteria: 1. more than 24 hours of evolution of the shock; 2. cardiac index \< 2,5 l/min; 3. history of hiv infection or clinically relevant pulmonary, renal or cardiac disease except for atrial fibrillation; 4. pregnancy; 5. advanced hepatocellular carcinoma (milan criteria); 6. previous history of transplantation; 7. uncontrolled gastrointestinal bleeding.

Keywords: septic shock cirrhosis survival
to compare the effect of a subcutaneous canakinumab administration to placebo in patients with impaired glucose tolerance or patients with type 2 diabetes with differing baseline diabetes therapies

Conditions: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance

Summary: this was a 10-week, placebo-controlled, randomized study to investigate the effect of injectable il-1b antagonist, canakinumab , in participants with impaired glucose tolerance or type 2 diabetes mellitus (t2dm) already treated on different background diabetes therapies.


Eligibility criteria:
inclusion criteria: 1. patient must fulfill all criteria in one of the following groups: * impaired glucose tolerance (igt) as diagnosed per protocol and not on an anti-diabetic medicine during the study * diagnosis of type 2 diabetes in stable treatment with metformin * diagnosis of type 2 diabetes in stable treatment with metformin (at least 1000 mg/day) in combination with a sulfonylurea * diagnosis of type 2 diabetes in stable treatment with metformin (at least 1000 mg/day), sulfonylurea and thiazolidinedione combination therapy * diagnosis of type 2 diabetes in stable treatment with at least two insulin injections a day with or without metformin 2. hba1c between 6.5% and 8%, inclusive, at screening; this criterion does not apply to the igt group 3. age from 18-74 years, inclusive, and of either sex exclusion criteria: 1. type 1 diabetes or diabetes that is a result of pancreatic injury or other secondary forms of diabetes 2. history or current findings of active pulmonary disease (e.g. tuberculosis, fungal diseases) as defined in the protocol: 3. known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven.

Keywords: type 2 diabetes mellitus canakinumab pre diabetic glucose intolerant oral anti diabetic medication insulin treatment metabolic syndrome
clinical performance of qiastat-dx® meningitis/encephalitis (me) panel plus

Conditions: Meningitis; Encephalitis Infection

Summary: performance evaluation of qiastat-dx® me panel plus using the qiastat-dx® analyzer to demonstrate that the qiastat-dx® me panel plus achieves its intended performance during normal conditions of use by the intended user in the intended environment

the objective of the study is to demonstrate that the qiastat-dx® me panel plus achieves its intended performance during normal conditions of use by the intended user in the intended environment. the primary objective is to evaluate the performance of qiastat-dx® me panel plus in comparison with the results obtained from the reference method. the secondary objective of the study is to evaluate the safety of qiastat-dx® me panel plus with respect to users/operators. the primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with qiastat-dx® me panel plus and reference method. positive percent agreement (ppa) and negative percent agreement (npa) will be determined

Eligibility criteria:
inclusion criteria: * specimen must be cerebrospinal fluid, obtained via lumbar puncture only. * specimen must be a de-identified residual leftover specimen. * specimen must meet the laboratory testing criteria for individuals with signs and/or symptoms of meningitis and/or encephalitis. * specimens must have a minimum 450 µl of residual volume. * specimen must be unique (only one sample enrolled per patient). * prior to qiastat-dx testing, residual csf specimen must have been stored in accordance with the following: * prospective fresh: * room temperature (15 °c to 25 °c) for ≤24 hrs * refrigerated (2 °c to 8 °c) for ≤ 7 days * prospective frozen: * -15 ºc to -25 ºc for ≤ 2 months * -60 ºc to -90 ºc for ≤ 4 months * retrospective archived: * frozen * at the time of qiastat-dx testing, specimen must not have undergone more than three (3) freeze/thaw cycles. * prospective samples only: specimen must have been collected on or after the date of prospective study activation at the clinical collection and testing site. * retrospective samples only: specimens must have a positive diagnosis as per standard of care for any of the following viral targets: herpes simplex virus 1 (hsv-1) herpes simplex virus 2 (hsv-2) human herpesvirus 6 (hhv-6) human parechovirus (hpev) varicella zoster virus (vzv) cytomegalovirus (cmv) exclusion criteria: * residual csf specimen has been centrifuged. * residual csf specimen subject identification or label is unclear or missing. * residual csf specimen container has obvious physical damage.

Keywords: meningitis infection qiastat-dx clinical performance study encephalitis infection
continued access protocol: exablate transcranial mr guided focused ultrasound for the treatment of essential tremors

Conditions: Essential Tremor

Summary: the objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the exablate transcranial system and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (et).

this study is evaluating a new technique for performing thalamotomy for tremor control. while current techniques have possible invasive or radiation effects, the use of exablate if totally non-invasive and without any radiation. after informed consent and screening, eligible subjects will be undergo an exablate treatment. all subjects will be followed at 1 day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.

Eligibility criteria:
inclusion criteria: * men and women, age 22 years and older * subjects who are able and willing to give informed consent and able to attend all study visits * subjects with a diagnosis of essential tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder * subject exhibits a significant disability from their et despite medical treatment * subjects should be on a stable dose of all et medications for 30 days prior to study entry * subject is able to communicate sensations during the exablate transcranial procedure exclusion criteria: * subjects with unstable cardiac status * severe hypertension * subjects with standard contraindications for mr imaging such as non-mri compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. * known intolerance or allergies to the mri contrast agent including advanced kidney disease or severely impaired renal function * significant claustrophobia that cannot be managed with mild medication * current medical condition resulting in abnormal bleeding and/or coagulopathy * receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage * history of intracranial hemorrhage * history of multiple strokes, or a stroke within past 6 months * subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment * are participating or have participated in another clinical trial in the last 30 days * subjects unable to communicate with the investigator and staff * subjects with a history of seizures within the past year * subjects with brain tumors