Kornimate/medical-research-clean huggingface dataset:
penn sicca follow-up study

Conditions: Dry Eye; Sjogren's Syndrome

Summary: this study will involve the collection of follow-up data for patients who previously participated in the sjogren's international clinical collaborative alliance (sicca) study at the university of pennsylvania. clinical data and specimens will be collected from subjects with objective evidence of dry eye who were or were not diagnosed with sjogren's syndrome at the time of their initial participation in the sicca study. specimens will be collected from participants which will include tears, saliva, whole blood, serum, dna and possible labial minor salivary gland biopsies when indicated. all individuals will participate in a standard evaluation protocol including an oral, ocular and physical examination, objective tests for dry eyes and dry mouth and, whenever necessary, a labial minor salivary gland biopsy. the biopsy requirement is waived for those who have already had positive lip biopsies in the past.

general study design: this is a single center study that involves follow-up of patients who previously participated in the sjogren's international collaborative clinical alliance (sicca) at the university of pennsylvania. objective evaluation of salivary function will be done by collecting unstimulated whole and stimulated parotid saliva. objective evaluation of lacrimal function will be performed using the schirmer test i, lissamine green staining, and determining tear break-up time. in a subset of patients, when indicated an objective evaluation of lymphocytic infiltration of the minor salivary glands will be performed by histologic analysis of labial salivary gland biopsies. serum autoantibody profiles will be determined. in addition, specimens such as biopsies, saliva, sera, conjunctival cells, and tears will be collected. standardized questionnaires will be used to gain health information.

Eligibility criteria:
inclusion criteria: 1. previously participated in the sicca study at penn 2. be 18 years or older 4. have signed an irb consent form agreeing to the terms of the study exclusion criteria: 1. did not previously participate in sicca study at penn 2. under the age of 18 years
study of the effects of plx on bioparametric measurements.

Conditions: Quality of Life; Antidepressive Agents; Depression, Anxiety; Sleep Initiation and Maintenance Disorders; Body Composition; Stress, Psychological

Summary: the main objective is to study the effects of the intake of a nutraceutical on health indicators, focused on sleep and stress, as well as cardiovascular (blood pressure...), circulating (cortisol) and body composition parameters in a spanish adult population.

anxiety is a normal part of life, and generally is a temporary condition. however, anxiety can occasionally prolong in time, having an impact on everyday activities, and give rise to other conditions, such as depression, drug abuse, cardiovascular disease, and insomnia. there are a number of synthetic drugs that are commonly used to treat anxiety. these are mainly antidepressants and benzodiazepines. however, their high cost, important side effects and a rising interest in natural solutions have driven researchers to search for botanical-based formulas. to this end, there are a number of plants that have been described to possess potential sedative and anxiolytic effects. of note is lemon verbena (lippia citriodora), which is native of western south america but is also cultivated in the mediterranean region and middle east.

Eligibility criteria:
inclusion criteria: 1. over 21 years of age; 2. without any chronic pathology; 3. score on the spielberg trait-state anxiety inventory (stai-s) comprising 20 items, greater than 40 (probable clinical levels of anxiety); 4. pittsburgh sleep quality index (psqi) score greater than 5 (poor sleep quality). exclusion criteria: * failure to meet the inclusion criteria.
treatment of residual hypermetropic refraction on pseudophakic patients using allogenic fresh myopic lenticule

Conditions: Pseudophakia; Hypermetropia; Myopia

Summary: the residual hypermetropic refraction on pseudophakic(trifocal iol) patients is difficult to treat surgically. in addition, there are not many suitable options to offer such patients presenting with this condition. two current common surgeries to treat residual hyperopic refraction are refractive lens exchange (rle) and excimer laser ablation (lasik or prk). laser procedures: photorefractive keratectomy (prk); laser assisted in situ keratomileusis (lasik); risks of lasik include abnormalities of the corneal flap, epithelial ingrowth, corneal ectasia, refractive surprises, irregular astigmatism, decentration, visual aberrations, a loss of bcva, infectious keratitis, symptoms, and diffuse lamellar keratitis. refractive lens exchange (rle); the risks of rle are similar to those of cataract surgery and include endophthalmitis, a loss of accommodation, vitreous loss with posterior capsular rupture, and retinal detachment. the method used at the eye hospital pristina using fresh lenticule implantation by relex-smile is safe and effective method, since there is no flap this prevents invasive damage to the anterior surface of the cornea contrary to the lasik where flap is present posing risk for epithelial ingrowth. before smile,yag-laser capsulotomy should be performed on all patients, regardless of posterior capsule ossification, in pseudophakic patients with residual refraction. when the yag-laser is applied after the smile,there will be a diopter change.

this study is to investigate the effect of fresh myopic corneal lenticule implantation as allogenic implant that will be taken from myopic patients to implant on pseudophakic patients(trifocal iol) with residual hypermetropic refraction(over +0.50dsph) using visumax femtosecond laser - smile module surgery with primary objective to assess (increase) visual acuity . in pseudophakic patients with hyperopic astigmatism residual refraction, corneal topography-guided intrastromal fresh lenticule implantation should be performed and the lenticule was placed according to the low k value.

Eligibility criteria:
inclusion criteria: * residual hypermetropic refraction on pseudophakic patients * low visual acuity exclusion criteria: * active anterior segment pathologic features, * previous corneal or anterior segment surgery, * glaucoma, * retinal detachment
role of the cystic fluid interleukins and tumor necrosis factor (tnf) levels in characterizing pancreatic cysts detected by endoscopic ultrasound (eus)

Conditions: Pancreatic Cancer

Summary: this study aims to find a correlation between cytokines levels and malignancy potential of different cystic types.


Eligibility criteria:
inclusion criteria: * patients with pancreatic cyst exclusion criteria: * none
changes in alveolar macrophage function during acute lung injury

Conditions: Acute Lung Injury

Summary: in this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury.

alveolar macrophages are tissue-resident or recruited cells with key functions in recognition of pathogens, initiation of host defensive ang protective inflammation,and in clearance of pathogens from the airways. however, macrophages are also responsible for efficient clearance of apoptotic neutrophils, termed efferocytosis, which is a prerequisite for the timely resolution of inflammation. in this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury.

Eligibility criteria:
inclusion criteria: * patients in icu with diagnosed ali under mechanical ventilation exclusion criteria: * patients with cardiac dysfunction, using steroid drugs or other drugs can that affect efferocytosis

Keywords: efferocytosis macrophage
comparison of dural puncture epidural versus conventional epidural for labour analgesia in primigravida

Conditions: Labor Pain

Summary: this study aims to compare the analgesic efficacy and safety of the dural puncture epidural (dpe) technique versus the conventional epidural (ce) technique for labor analgesia in primigravida.

the conventional epidural (ce) technique has been the gold standard for decades, providing continuous and adjustable pain relief during labor. however, the advent of new techniques, such as the dural puncture epidural (dpe) technique, has led to ongoing research and debate over which method offers superior outcomes in terms of efficacy, onset of analgesia, maternal satisfaction, and safety. the ce technique involves the placement of an epidural catheter into the epidural space, where local anesthetics and adjunctive drugs are administered to provide pain relief. while this technique is highly effective, it is not without limitations. some parturients may experience a slow onset of analgesia, uneven drug distribution, or the need for frequent catheter adjustments, which can delay adequate pain relief and decrease maternal satisfaction . furthermore, the ce technique has been associated with potential complications such as unilateral blocks, inadequate sacral analgesia, and the necessity for higher doses of local anesthetics, which may increase the risk of motor blockade and impact labor progression . in contrast, the dpe technique is a novel approach that modifies the ce by incorporating an intentional dural puncture with a small-gauge spinal needle without administering intrathecal drugs. this modification is believed to facilitate the spread of epidurally administered drugs into the subarachnoid space, potentially enhancing the onset and quality of analgesia. the dpe technique aims to combine the benefits of both the ce and the combined spinal epidural (cse) techniques while minimizing their respective drawbacks, such as the hemodynamic instability associated with cse and the slower onset of analgesia often seen with ce

Eligibility criteria:
inclusion criteria: 1. primigravida women aged 18-40 years. 2. gestational age between 37 and 42 weeks. 3. single pregnancy with vertex presentation. 4. patients in active labor with cervical dilation of less than 5 cm at the time of epidural placement. 5. american society of anesthesiologist physical status i or ii. 6. patients who provide informed consent for participation in the study. exclusion criteria: 1. patients with contraindications to neuraxial anesthesia (e.g., coagulopathy, infection at the puncture site). 2. history of preeclampsia, gestational diabetes, or any other significant medical conditions that could influence labor or anesthesia outcomes. 3. patients with a history of previous uterine surgery, including cesarean section. 4. known fetal anomalies or non- vertex presentations. 5. patients with morbid obesity (bmi \> 40 kg/m²). 6. allergy or hypersensitivity to local anesthetic-s used in the study.
prevalence and characteristics of pulmonary embolism on covid-19 patients presenting respiratory symptoms

Conditions: Pulmonary Embolism; Covid-19

Summary: multicentric case-control study that is aims at: * evaluating the prevalence of pulmonary embolism among a large population of consecutive patients admitted for covid-19 pneumonia into two large university hospitals in paris, france: groupe hospitalier paris saint-joseph (ghpsj) and hôpital européen georges pompidou (hegp) * and identifying the characteristics associated with pulmonary embolism by using a nested case control study design within the patients who underwent either unenhanced computed tomograpghy (ct) or ct pulmonary angiogram (ctpa) evaluation.

in december 2019, china reported the first cluster of severe acute respiratory syndrome due to a new coronavirus (sars-cov-2). the disease rapidly spread into a global pandemic of public health emergency worldwide leading to more than 330.000 deaths (data from may 25th, 2020). we have, to date, no demonstration on the efficacy of any drug to cure or prevent severe evolution of the disease (covid-19). the primary target of sars-cov-2 is the lung with frequent occurrence of acute respiratory distress syndrome (ards) justifying supportive care, including invasive mechanical ventilation (imv). the characteristics of ards in covid-19 patients appeared atypical due to the dissociation between initial well-conserved lung compliance and severe hypoxemia, attributed to pulmonary vasoregulation disruption and local thrombogenesis. strikingly high d-dimers levels, caused by both inflammation storm and coagulation activation, have been early reported in covid-19 patients and have been associated with increased mortality. a single observational study suggests that anticoagulation is associated with a decreased mortality in severe covid-19 patients. these reports have led to several therapeutic propositions in terms of anticoagulant therapy from worldwide scientific societies (khider et al jmv 2020). publications recently reported thrombotic complications in series of severe covid-19 patients admitted in icu, but the frequency of pulmonary embolism (pe) in larger cohort of covid-19 patients of any severity remains uncertain. this cohort enrolled patients in whom pe is proven by ctpa and compared them into two subgroups of controls matched for age and sex in whom pe was either excluded or non suspected: 1. covid-19 patients with a negative ctpa and 2. covid-19 patients in whom only an unhenced ct was performed.

Eligibility criteria:
inclusion criteria: * patients \>18 years, * admitted for acute covid-19 pneumonia and have recieved a chest ct scan during hospitalization, * covid-19 diagnosis confirmed by a positive result of a rt-pcr, * ct findings of covid-19 pneumonia. exclusion criteria: * respiratory distress syndrome explained by other cause * patients who refuse to participate to the study.

Keywords: pulmonary embolism covid-19 ct d-dimers ards
a study to document long-term safety and continued benefit of irinotecan and carboplatin or irinotecan in subjects with refractory solid tumors (rollover study -001, -002)

Conditions: Pediatric Solid Tumors

Summary: the purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in bms protocol ca124-001 or ca124-002.


Eligibility criteria:
inclusion criteria: * completion of at least 6 cycles of therapy on bms clinical protocol ca124-001 or ca124-002 and who continue to derive clinical benefit and are not experiencing intolerable toxicity from the therapy * karnofsky score of at least 50 for subjects \> 10 years of age; lansky play scale of at least 50 for children 10 years of age and younger * recovery to baseline or grade 1 from toxicities (except alopecia or asthenia) resulting from previous therapies * males and females, ages 1 - 21 years of age at the time of consent into ca124-001 or ca124-002 exclusion criteria: * a serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy * requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy, or any other investigational drug while on study * inadequate bone marrow and renal function * concurrent receipt of dilantin®(phenytoin), phenobarbital, primidone, tegretol®(carbamazepine), depacon®, depakene®, depakote®, and deproic®(valproic acid)
integrating treatment for mental disorders in methadone clinics in ukraine

Conditions: Depression; Opioid Use Disorder

Summary: the medium study (u01da045384) is a cluster-randomized trial based in ukraine. the main goal of the study is to test the implementation strategies for mental health treatment services in oat clinics. the study enrolled 12 oat clinics from 12 geographically and epidemiologically diverse regions and randomized them 1:1:1 to three implementation arms: standard of care (soc), echo facilitation, and echo plus pay-for-performance (p4p) incentives. project echo, is an evidence-based telehealth intervention, connecting clinicians with national experts for short thematic didactic sessions and case discussions. all sites are provided with a modified screening, brief intervention and referral to treatment (msbirt) intervention manual for mental disorders and regular supply of two selective serotonin reuptake inhibitors (ssri) medications. all current and new patients at participating sites (n\~2000 at study start) are automatically eligible for ssri prescription. the main outcomes of the study are the elements of mental health continuum of care (screening, diagnosis, treatment and retention). these outcomes are assessed in the entire patient population using de-personalized data extracted from the electronic medical record system. a sub-sample of patients (n=1,350) was recruited into a cohort and consented to assess prevalence and severity of mental disorders, various factors related to the uptake of and retention in mental health treatment (addiction severity, other substance use, co-morbidities), as well as other important covariates. these assessments are done at baseline, 6, 12, 18 and 24 months after enrollment.


Eligibility criteria:
inclusion criteria: * all patients receiving oat at participating sites exclusion criteria: * not willing to participate * unable to sign informed consent

Keywords: depression opioid use disorder opioid agonist treatment ukraine
ict-based monitoring for arrhythmia detection after af ablation

Conditions: Arrhythmias, Cardiac; Atrial Fibrillation

Summary: to compare the efficacy and stability of an ict-based centralized clinical trial monitoring system against the efficacy and stability of an existing outpatient-based electrocardiogram (ecg) and holter monitoring system for arrhythmia detection after atrial fibrillation ablation, and to test whether such continuous monitoring can better detect arrhythmia that is undetectable by existing methods and how this may affect treatment outcomes

this clinical trial is a prospective, randomized, controlled, multicenter study in patients who are capable of using and consent to use a smartphone-based ecg monitoring after ablation for atrial fibrillation. the patients will be randomly assigned to either the holter monitoring or ict-based centralized clinical trial monitoring system group in a 1:1 ratio and will undergo monitoring from immediately after the procedure to 12 months after discharge.

Eligibility criteria:
inclusion criteria: 1. age ≥ 20 years, but \< 80 years 2. patients with non-valvular atrial fibrillation 3. patients with sustained atrial fibrillation despite ≥ 6 weeks of continuous antiarrhythmia therapy or those who underwent an ablation procedure for tachy-bradycardia syndrome within the previous week 4. patients who can be followed-up for at least 3 months after ablation 5. patients who can use and consent to use smartphone-based ecg monitoring 6. patients who can use a smartphone (android, version 5.0 or lower; development planned for version 6.0 or higher) 7. those who can connect to the internet via lan or wifi and are in an environment where they can use a gateway and smartphone. exclusion criteria: 1. patients who cannot be monitored by a smartphone or bluetooth device 2. patients who cannot use a smartphone, bluetooth device, or the internet due to old age 3. patients with contraindications to standard therapy, such as continued anticoagulant therapy before and after atrial fibrillation ablation 4. patients belonging to a population vulnerable to clinical trials

Keywords: arrhythmias, atrial fibrillation
mibo thermoflo lid temperature evaluation

Conditions: Dry Eye

Summary: this study is a prospective, contralateral, single-site, single-visit unmasked evaluation of external and internal eyelid temperature after treatment with the mibo thermoflo.


Eligibility criteria:
inclusion criteria: * potential subjects must satisfy all the following criteria to be enrolled in the study: 1. the subject must read, understand, and sign the statement of informed consent and receive a fully executed copy of the form. 2. appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. between 18 and 80 (inclusive) years of age at the time of screening. 4. subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion). exclusion criteria: * potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. currently pregnant or breastfeeding. 2. any systemic disease (e.g., sjögren's syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., hiv), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with participation in the study. 3. clinically significant (grade 3 or 4 on the fda classification scale) slit lamp findings (e.g. corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection). 4. grade 3-4 percentage of partial meibomian glands on the pult 5-point grading scale. 5. any active ocular infection or inflammation 6. any history of eyelid surgery or abnormality 7. history of metal implants in the eyelids 8. any known hypersensitivity or allergic reaction to ultrasound coupling gel. 9. lasik surgery within 2 weeks of the baseline visit. 10. participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 11. history of mibo thermoflo or lipiflow treatment within the last 6 months. 12. employee or immediate family member of an employee of clinical site (e.g., investigator, coordinator, technician).
early intrapleural tpa instillation versus late

Conditions: Tissue Plasminogen Activator

Summary: chest tubes are used for air or fluid removal from the pleural space. when a chest tube is placed, it can be hard for the fluid to drain.tissue plasminogen activator (tpa) and dnase are given through the chest tube to help with draining the fluid. we are doing this research to see if early addition of tpa-dnase immediately after chest tube placement will help with better fluid draining.

the purpose of this study is to determine the timing and efficacy of early administration and late administration of t-pa/dnase via thoracostomy (n=60). patients will be identified from the intensive care unit, coronary care unit, and wards/stepdown units. prior to chest tube placement, patients will be randomized to one of the two treatment arms (early use of t-pa-dnase verus late use of t-pa-dnase). route of administration will be via their thoracostomy tube over a period of three days twice daily.

Eligibility criteria:
inclusion criteria: * adult patients, age 18 years or older * patients with an indication for a thoracostomy tube placement for a pleural effusion exclusion criteria: * patients that require a thoracostomy tube for a pneumothorax * pregnant women * sensitivity to t-pa, or dnase * patients taking carbamazepine or nitroglycerin * lung volume reduction surgery on side of pleural effusion

Keywords: chest tube thoracostomy pleural diseases lung neoplasms pulmonary embolism pneumothorax thoracic surgery deoxyribonucleases fibrinolytic agents drainage pleural effusion