Kornimate/medical-research-clean huggingface dataset:
cross-linking for corneal ulcers treatment trial

Conditions: Corneal Ulcer; Infectious Keratitis; Bacterial Ulcer; Fungal Ulcer

Summary: the primary purpose of this study is to determine if patients randomized to corneal collagen cross-linking plus medical therapy will have a lower prevalence of positive bacterial or fungal cultures immediately after the procedure than patients who received medical therapy alone. the secondary purpose of this study is to determine if patients randomized to corneal collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who receive medical therapy alone.

the proposed study is a randomized controlled trial to determine whether collagen cross-linking improves outcomes in microbial keratitis. patients presenting to the aravind eye hospitals in madurai, india for treatment of microbial keratitis will be recruited for the proposed study. approximately 266 patients will be enrolled in the study. subjects presenting with bacterial keratitis will be randomized to receive medical therapy plus corneal collagen cross-linking at presentation or to receive medical therapy alone. all subjects with bacterial ulcers will receive standard topical antibiotic medications as required after the procedure. subjects with fungal keratitis will be randomized into one of four groups: 1. collagen cross-linking + amphotericin; 2. collagen cross-linking + natamycin; 3. amphotericin alone; 4. natamycin alone. all study subjects will be followed for 12 months to evaluate response to treatment. investigators from the university of california, san francisco (ucsf) will assist aravind eye hospital with the study design, implementation, and analysis of the research, and will help fund the study. the investigators plan to visit aravind to help with the study implementation. ucsf will play an important role in this study by assisting with the study design, implementation, analysis, and funding.

Eligibility criteria:
inclusion criteria: * corneal ulcer that is smear positive for either bacteria or filamentous fungus * pinhole visual acuity worse than 20/70 in the affected eye * not treated already with antimicrobial medications at presentation * age over 18 years * basic understanding of the study as determined by the physician * commitment to return for follow up visits exclusion criteria: * evidence of concomitant infection on exam or gram stain (i.e. herpes, both bacteria and acanthamoeba on gram stain) * impending or frank perforation at recruitment * involvement of sclera at presentation * non-infectious or autoimmune keratitis * history of corneal transplantation or recent intraocular surgery * no light perception in the affected eye * pinhole visual acuity worse than 20/200 in the unaffected eye * participants who are decisionally and/or cognitively impaired

Keywords: cornea ulcer infectious keratitis bacterial fungal
structuration of transcript analysis of genes involved in hereditary cancers

Conditions: Cancer

Summary: molecular diagnosis using high throughput sequencing has become an essential part of oncogenetic care, making it possible to identify people at risk, to guide surveillance, and to direct preventive surgery and treatment. the quality of this 'precision' care depends on the quality of the interpretation of the genomic variants identified. to be usable in oncogenetics, a genomic variant must be correctly interpreted: pathogenic, benign or of uncertain significance (vsi). the impact of these dna variants (vsi) on rna is particularly important for interpretation. today, due to a lack of resources, joint and systematic dna/rna analysis is never carried out. this has inevitably meant that a number of situations of interest have been overlooked. it is now important to go a step further and organise a visible and reliable circuit, allowing routine access to these studies for patients.

systematic dna/rna analysis is never carried out using the current approach, due to a lack of resources. strategies recommend pre-screening variants using in silico analysis, followed by rna studies targeting variants of interest.

Eligibility criteria:
inclusion criteria: * over 18 years of age * patients seen in oncogenetic consultations and who have given their informed consent for genetic analysis in the context of a major predisposition to breast, ovarian or digestive cancer. * person who has read and understood the information note and does not object to taking part in the study * membership of a social security scheme exclusion criteria: * minors * persons deprived of their liberty or adults under guardianship or incapable of giving their consent * failure to obtain informed consent

Keywords: hereditary predisposition to cancer
a methodology development clinical trial of reproxalap in subjects with seasonal allergic conjunctivitis using the environmental exposure chamber

Conditions: Conjunctivitis, Allergic

Summary: an exploratory clinical trial evaluating reproxalap ophthalmic solutions (0.25% and 0.5%) in subjects with seasonal allergic conjunctivitis using the environmental exposure chamber (eec)


Eligibility criteria:
inclusion criteria: * be at least 18 years of age of either gender and any race * have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement * have a positive skin prick test to ragweed pollen within the past year of screening exclusion criteria: * known contraindication or hypersensitivities to any components of the investigational product medication or components * history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis; * presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening * presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial; * presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial * diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), stevens-johnson syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, cryopyrin associated periodic syndrome (caps), or keratoconus * woman of childbearing potential who is pregnant or nursing

Keywords: reproxalap adx-102 allergic conjunctivitis
istodax® for intravenous infusion drug use results survey- relapsed or refractory peripheral t-cell lymphoma

Conditions: Lymphoma, T-Cell, Peripheral

Summary: to ascertain the safety and efficacy of istodax® in actual clinical settings in patients with relapsed or refractory peripheral t-cell lymphoma (ptcl) who receive istodax. 1. planned registration period 4 years 2. planned surveillance period 5 years and 6 months


Eligibility criteria:
inclusion criteria: - patients who have been diagnosed with relapsed or refractory ptcl who receive istodax for the first time. exclusion criteria: n/a

Keywords: istodax survey relapsed or refractory peripheral t-cell lymphoma
personalized peroral endoscopic myotomy for achalasia

Conditions: Achalasia; Postoperative Complications

Summary: achalasia is a rare esophageal motility disorder, characterized by incomplete lower esophageal sphincter relaxation, increased lower esophageal sphincter (les) tone, and aperistalsis of the esophagus. typical clinical symptoms are dysphagia,regurgitation and chest pain. traditional treatments include endoscopic balloon dilatation or botulinum toxin injection, laparoscopic heller myotomy with or without a partial fundoplication. peroral endoscopic myotomy (poem) has been developed as a further endoscopic effective and minimal invasive treatment. the aim of this study is to investigate the efficacy and safety of poem in our department, and to assess short-term and long-term efficacy of poem by using stooler score, echardt score, esophageal barium and manometry.


Eligibility criteria:
inclusion criteria: * patients diagnosed as achalasia according to symptoms, esophageal barium,manometry and esophagogastroduodenoscopy * age over 18 years old * signed written informed consent exclusion criteria: * patients with previous surgery of the stomach or esophagus * with known coagulopathy * active esophagitis,eosinophilic esophagitis or barrett's esophagus * pregnancy * stricture of the esophagus * hiatal hernia \> 2cm

Keywords: achalasia peroral endoscopic myotomy les pressure postoperative complication symptom relief esophageal barium
pet/ct imaging for radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and tolerability and diagnostic performance of bay86-7548 in patients with prostate cancer and healthy volunteers

Conditions: Diagnostic Imaging

Summary: visual assessment of diagnostic pet/ct (positron emission tomography/computed tomography) images obtained after a single intravenous injection of bay86-7548 in patients with cancer.


Eligibility criteria:
inclusion criteria: * healthy volunteers: * males, \>/=50 and \</= 65 years of age * cancer patients: * males \>/= 45 years of age * patients had an mri of the prostate and/or a positive choline or acetate pet/ct for diagnosis (note: mri, choline and acetate pet/ct are optional for primary prostate cancer patients) of recurrence prostate cancer and the primary cancer disease is/ will be histologically confirmed. * the prostate cancer is histologically confirmed and results of histology are available. * patients with primary prostate cancer: \>/= 20 percent of biopsy material should be affected by cancer in the histopathological evaluation. * patients with primary prostate cancer: patient is scheduled to undergo prostatectomy. exclusion criteria: * concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of bay86-7548, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study * known sensitivity to the study drug or components of the preparation.

Keywords: neoplasm pet/ct diagnosis pet tracer
pulse oximeter hypoxia

Conditions: Oximetry

Summary: the aim of this project is to test the accuracy of pulse oximeters (devices intended to measure oxygen saturation in blood noninvasively) during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial hbo2 saturations from 100 to down to 70%. this is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.


Eligibility criteria:
inclusion criteria: 1. the subject is male or female, aged ≥18 and \<50. 2. the subject is in good general health with no evidence of any medical problems. 3. the subject is fluent in both written and spoken english. 4. the subject has provided informed consent and is willing to comply with the study procedures. exclusion criteria: 1. the subject is obese (bmi\>30). 2. the subject has a known history of heart disease, lung disease, kidney or liver disease. 3. diagnosis of asthma, sleep apnea, or use of cpap. 4. subject has diabetes. 5. subject has a clotting disorder. 6. the subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. 7. the subject has any other serious systemic illness. 8. the subject is a current smoker. 9. any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly. 10. the subject has a history of fainting or vasovagal response. 11. the subject has a history of sensitivity to local anesthesia. 12. the subject has a diagnosis of raynaud's disease. 13. the subject has unacceptable collateral circulation based on exam by the investigator (allen's test). 14. the subject is pregnant, lactating or trying to get pregnant. 15. the subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures. 16. the subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Keywords: myhomedoc pulse oximetry oximeter
pet study of cerebral metabolism of 11c-acetoacetate and 18f-fdg in patients under moderate ketosis

Conditions: Healthy

Summary: regional brain glucose hypometabolism occurs during aging and may contribute to the onset of aging-related cognitive impairment in humans. ketones are the main alternative energy substrate to glucose for the brain. several studies show that brain ketone uptake and metabolism are unaltered in cognitively-normal older persons and in alzheimer's disease (ad). nutritional ketosis is reported to have a positive impact on cognitive performances in mild cognitive impairment and ad. nevertheless, changes in regional brain glucose and ketone uptake in adults are poorly understood during diet-induced experimental ketosis. the investigators hypothesis was that during diet-induced ketosis, brain ketone uptake would be directly correlated with the elevation of blood ketone levels and inversely correlated to brain glucose uptake.


Eligibility criteria:
inclusion criteria: * healthy adults * no signs of cognitive impairment exclusion criteria: * not within the age limits * pregnancy or breast feeding * incapacity to withstand a supine position for 40 min * non lacunar infarction * known psychiatric history of schizophrenia, psychotic disorders, major affective disorders (bipolar disorder and major depression \<5 years), panic disorder, obsessive compulsive disorders and other conditions that may affect memory * epilepsy, brain trauma with loss of consciousness, subarachnoid hemorrhage * history of alcool and/or substances abuse (excessive alcool consumption ≥10 drinks/weeks) * parkinson disease * down syndrome * inflammatory disease * abnormal blood pressure, liver or kidney function, blood count * dyslipidemia, hypothyroidism, osteoporosis * presence of a metal object in the body

Keywords: brain metabolism ketones ketogenic diet tep scan
comparative clinical evaluation of three different agents in reducing dental hypersensitivity in periodontal patients

Conditions: Dentin Hypersensitivity; Periodontal Diseases

Summary: the present project will compare the effect of dh reduction using three different dentifrices (sensodyne repair and protect - novamin technology; dentalclean daily regenerator - refix technology; dentalclean daily regenerator - refix technology + potassium citrate) in periodontal patients. the evaluation will be in 6 moments: t1 and t2- immediately before and after scaling and root planing (srp) procedures; t3-after polishing sensitive areas with rubbers cups and the dentifrice determined for each group of patients and t4, 5, 6- after 2, 4 and 8 weeks of srp. profissional assessments and patient perception data will be performed.

periodontal patients may report dentinal hypersensitivity (dh) caused by root surface exposure as part of disease process or as a result of periodontal treatment. although some studies evaluated dh reduction using desensitizing toothpastes, no specific chemical/physical agent is reported for periodontal patients. thus, the present project will compare the effect of dh reduction using three different dentifrices (sensodyne repair and protect - novamin technology; dentalclean daily regenerator - refix technology; dentalclean daily regenerator - refix technology + potassium citrate) in periodontal patients. this randomized, parallel and blinded clinical trial will be divided into 3 groups (sen group: sensodyne; reg group: regenerator; regk group: regenerator + potassium citrate) and evaluated at 6 moments: t1 and t2- immediately before and after scaling and root planing (srp) procedures; t3-after polishing sensitive areas with rubbers cups and the dentifrice determined for each group of patients and t4, 5, 6- after 2, 4 and 8 weeks of srp. air blast sensitivity assessments (schiff scale) and patient perception data on dh will be performed using visual analog scales (vas). the comparison between treatment groups will be done by paired t-test if normal distribution is observed or wilcoxon if non-normal distribution. the significance level adopted will be 5% (p \<0.05).

Eligibility criteria:
inclusion criteria: * patients diagnosed with periodontitis * 18 to 70 years old * systemically healthy * without any allergy to the dentifrices components * patients who needed scaling and root planing procedures * patients who had at least 2 teeth with dh (incisors, canines or premolars). exclusion criteria: * pregnancy * patients in orthodontic treatment * patients with oral tumors, caries, fractured teeth, suspected endodontic involvement or excessive mobility; * patients who used medication that could mask the painful sensation or who had used desensitizing agents in the last 3 months.

Keywords: root exposure periodontal treatment desensitizing agents.
impact of visceral fat on the pathogenesis of age-related macular degeneration

Conditions: Age-related Macular Degeneration

Summary: the purpose of this study is to determine the relationship among the body fat distribution, especially the visceral fat, in patients with age-related macular degeneration in comparison to patients with a normal fundus.

in this study the investigators want to examine the relationship among visceral fat, serum leptin levels, and high-sensitive crp (hscrp), tnf-alpha, amyloid alpha and amyloid beta serum levels in patients with age-related macular degeneration in comparison to patients with a normal fundus.

Eligibility criteria:
inclusion criteria: * man and women over 18 years old * filled informed consent * diagnosis of age-related macular degeneration exclusion criteria: * inherited retinal disease * other acquired retinal macular disease * missing informed consent
anesthetic depth and postoperative delirium trial - 2

Conditions: Delirium; Cognitive Disorders

Summary: recent limited evidence suggests that anesthetic depth may influence postoperative cognitive outcomes, however, the mechanism between this association is unclear.

recently, it has been proposed that use of a processed electroencephalogram (eeg) monitor during surgery may be associated with a lower rate of postoperative delirium. in fact, some suggest that older patients undergoing surgery should routinely be monitored with an anesthetic depth monitor to allow the titration of anesthetics or sedation medications to lighter levels to promote better postoperative cognitive outcomes. recent studies, including preliminary results from our group, have demonstrated electroencephalogram (eeg) suppression to be an independent risk factor for postoperative delirium. prior studies that have focused on risk prediction have shown age and prior cognitive impairment to be the most consistent risk factors for postoperative delirium. however, as of yet, no clinical trial has identified a relationship whether use of processed eeg monitor resulted in a reduction of incident postoperative delirium through a reduction in eeg suppression, with proper consideration of patients' baseline cognitive status as a potential moderator. additionally, use of anesthetic depth monitor to keep patients' anesthetic depth above a specified value has never been validated or proven to be feasible or safe. accordingly, the investigators plan an exploratory study to: 1) determine whether the use of processed eeg to keep anesthetic depth above a specified level, results in a reduction in eeg suppression when compared to standard anesthetic care, 2) to determine whether preoperative level of cognitive function moderates the effect of group assignment on eeg suppression, and 3) to determine the feasibility and safety of using processed eeg-guided to keep patients' anesthetic depth above a specified value. a secondary aim was to determine the effect size for the intervention to reduce postoperative delirium for subjects with and without preoperative cognitive impairment for a future trial.

Eligibility criteria:
inclusion criteria: * 65 years and older of age undergoing non-cardiac surgery, requiring hospital stay of 2 or more days. exclusion criteria: * patients who are not fluent in english or cannot provide informed consent * patients who may not tolerate either light or deep anesthesia (history of heart failure, coronary artery disease, substance abuse) * history of intraoperative recall or awareness during anesthesia * pathologies of the brain which may affect eeg monitoring * patients who are anticipated to have consecutive surgery within 3 days of first procedure * patients who have had surgery with general anesthesia in the past 30 days

Keywords: delirium cognition surgery anesthesia aging electroencephalography
systemic methylprednisolone in chronic rhinosinusitis

Conditions: Chronic Rhinosinusitis; Children

Summary: the place of systemic corticosteroids in the treatment of children with chronic rhinosinusitis (crs) remains unclear. we aimed to assess the effectiveness and tolerability of oral methylprednisolone (mp) as an anti-inflammatory adjunct in the treatment of crs in children.forty-eight children (age 6-17 years) with clinically and radiologically proven crs were included. patients were randomly assigned to either oral amoxicillin/clavulanate (amx/c) and mp or amx/c and placebo (p) twice daily for 30 days. oral mp was administered for the first 15 days with a tapering schedule. primary parameters were mean change in symptom and sinus computed tomography (ct) scan scores after treatment. secondary study parameters were mean changes in individual symptom scores after treatment, relapse rate and tolerability. forty-five patients completed the study, 22 received amx/c and mp, and 23 amx/c and p. both groups demonstrated significant improvements in symptom and sinus ct scores, comparing baseline to end of the treatment (p\<0.001). methylprednisolone as an adjunct was significantly more effective than placebo in reducing ct scores (p=0.004), total rhinosinusitis symptoms (p=0.001) and individual symptoms of nasal obstruction (p=0.001), postnasal discharge (p=0.007), and cough (p=0.009). at the end of the treatment, 48% of the children in the p group still had abnormal findings in ct versus 14% in the mp group (p = 0.013). therapy-related adverse events were not different between groups. although insignificant, the incidence of clinical relapses was also less in the mp group (25%) compared to p group (43%) (p = 0.137). oral mp is well tolerated and provides added benefit to treatment with antibiotics for children with crs.


Eligibility criteria:
inclusion criteria:all patients presented with nasal and/or postnasal purulence, and one or more of the following symptoms: nasal obstruction, cough, halitosis, headache, or facial pain/pressure. the diagnosis of crs was made on the basis of sinonasal symptoms and signs present for a period of more than 3 months in the presence of abnormalities on coronal sinus ct scans. - exclusion criteria:patients were excluded if they had used systemic corticosteroids in the last 2 months prior to the study, systemic antibiotics and inhaler or intranasal corticosteroids in the last 4 weeks prior to the study or if they had other respiratory disorders (cystic fibrosis, ciliary dyskinesia, nasal polyps, large adenoids, asthma), immune deficiency, systemic disease, gastro-esophageal reflux, aspirin sensitivity, and acquired or congenital sinonasal abnormalities, or a contraindication to corticosteroid use. -

Keywords: chronic rhinosinusitis computed tomography scan methylprednisolone