Kornimate/medical-research-clean huggingface dataset:
myopia control with orthokeratology contact lenses in spain

Conditions: Myopia, Progressive; Children, Only; Contact Lens Complication; Perception, Self; Axial Myopia

Summary: the purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the menicon z night orthokeratolgy contact lens for reducing myopia progression in children.

the purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the menicon z night orthokeratolgy contact lens for reducing myopia progression in children in comparison with a group of distance, single-vision glasses over a 2-year period. efficacy was evaluated by assessing differences in the axial length between groups. safety was evaluated by comparing the incidence of adverse events between groups. differences between groups in patient-reported outcomes were evaluated using a questionnaire that assessed vision-related quality-of-life measures.

Eligibility criteria:
inclusion criteria: * be 6 to 12 years of age, both ages inclusive * a low-to-moderate level of myopia (between -0.75 and -4.00 d) and of astigmatism (≤ 1.00 d) * neophyte contact lens wearer * be successfully fitted with spectacles or orthokeratology contact lenses * be able to achieve, through spherical refraction correction, a logmar visual acuity of 0.8 or better in each eye * be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits * white european ethnicity exclusion criteria: * systemic or ocular disease affecting ocular health * use of any systemic or topical medications that could affect ocular physiology or contact lens performance * any lid or anterior segment abnormalities for which contact lens wear could be contraindicated * cclru grade ≥ 2 for any given anterior segment ocular clinical signs * aphakic, amblyopic, and atopic individuals * refractive astigmatism ≥ ½ spherical refraction * previous contact lens wear
vascular endothelial dysfunction in sleep apnea

Conditions: Obstructive Sleep Apnea of Adult

Summary: this double-blind placebo-controlled parallel group randomized study design will be used to test whether 4 weeks of atorvastatin 10 mg daily reduces levels of inflammatory markers in osa patients treated with cpap (standard of care). the purpose of this study is to investigate: 1) whether statins reduce endothelial inflammation and pro-thrombotic conditions in osa, including in patients adherent to cpap (aim 1); and 2) whether statins reduce endothelial inflammation and pro-thrombotic conditions by improving endothelial cholesterol metabolism and trafficking in osa (aim 2).

obstructive sleep apnea (osa), a condition that affects a quarter of american adults, triples the risk for cardiovascular diseases and increases all-cause mortality. standard therapy with continuous positive airway pressure (cpap) does not improve cardiovascular risk. based on the investigators' mechanistic observation that the abnormal cycle of endothelial inflammation can be disrupted with statin therapy, the investigators now propose randomized clinical trial of statins vs. placebo to determine its effects on endothelial dysfunction in osa patients treated with cpap, which may provide the basis for practical clinical trials of statins for reducing cardiovascular risk in osa.

Eligibility criteria:
inclusion criteria: * aged ≥18 years * newly diagnosed with obstructive sleep apnea (osa) who were never treated with cpap. osa is defined as apnea-hypopnea index (ahi) ≥5 events/hour of sleep. exclusion criteria: * a history of coronary artery disease, heart failure, stroke, diabetes, malignancy, chronic pulmonary, kidney or rheumatologic disease, muscle pain/fatigue, smoking within the past 5 years * regular use of any medications

Keywords: cpap atorvastatin
lonsurf® (trifluridine/tipiracil) plus chemotherapy in metastatic colorectal cancer prospective study in taiwan

Conditions: Metastatic Colorectal Cancer

Summary: primary endpoint : to evaluate the disease control rate (dcr) secondary endpoints: to evaluate the progression-free survival (pfs), overall survival(os) and safety profile

70 per-protocol patients plan to recruit 70 evaluable patients (with expected dropout rate of 22%, the sample size would be 90 subjects.) simon's two-stage design (simon, 1989) will be used. the null hypothesis that the true response rate is 0.45 will be tested against a one-sided alternative. in the first stage, 42 patients will be accrued. if there are 19 or fewer responses in these 42 patients, the study will be stopped. otherwise, 28 additional patients will be accrued for a total of 70. the null hypothesis will be rejected if 39 or more responses are observed in 70 patients. this design yields a type i error rate of 0.05 and power of 0.8 when the true response rate is 0.6.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed adenocarcinoma of the metastatic colorectal cancer; 2. previously treated with fluorouracil-, oxaliplatin-, and irinotecan-based chemotherapy, and anti-vascular endothelial growth factor (anti-vegf) biological therapy; 3. the ras wild-type patients need to receive anti-egfr therapy; 4. presence of at least one measurable tumor lesion which is defined as lesion that can be measured in at least one dimension (longest diameter) with a minimum size of : 10mm by ct scan, mri and pet-ct(no less than double the slice thickness and a minimum of 10mm)(according to recist guideline version 1.1); 5. eastern cooperative oncology group (ecog) performance status (ps) of 0, 1 or 2; 6. investigators prescribe lonsurf® for metastatic colorectal cancer patients who had prior treatment with anti-vegf and anti-egfr agent on routine basis. depending on ras status, patients with ras mutant receive lonsurf® as 3rd line treatment, those with ras wild type receive lonsurf® as 3rd/4th line treatment; 7. patients received either oxaliplatin or irinotecan. exclusion criteria: 1. patients previously received lonsurf® (trifluridine／tipiracil) or regorafenib; 2. with active central nervous system (cns) metastasis (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth); 3. with clinically significant gastrointestinal hemorrhage; 4. previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years; 5. the patient at high risk from treatment complications including but not limited to symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, uncontrolled diabetes, liver or renal failure and psychiatric illness or social situation that would preclude study compliance; 6. active infection.

Keywords: trifluridine/tipiracil combination chemotherapy metastatic colorectal cancer irinotecan oxaliplatin
samsca post marketing surveillance study

Conditions: Hypervolemic and Euvolemic Hyponatremia

Summary: this post-marketing surveillance will be conducted in accordance with the local regulation of new drug re-examination. the surveillance will be conducted for 6 years of the re-examination period (01sep2011\~31aug2017). each subject will be observed at least for 4 days during the surveillance period.

this study will be conducted as a prospective, single-arm, multicenter study. findings on examination, diagnosis, opinions and observations implemented as per general medical practice during the observational period will be documented in the case report forms by the investigators or responsible staffs at the institution since the surveillance is an observational study.

Eligibility criteria:
inclusion criteria: * subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study : 1. patients who have hyponatremia in euvolemic or hypervolemic states, defined as serum sodium level \< 125 meq/l or hyponatremia that is symptomatic and has resisted correction with fluid restriction 2. patients who are prescribed samsca® treatment as per investigator's medical judgment 3. patients who gave written authorization to use their personal and health data 4. patients starting samsca® treatment after agreement is in place investigators will refer to the product market authorization (label) for inclusion criteria. exclusion criteria: * subjects presenting with any of the following will not be included in the study: 1. patients who have been treated with samsca® 2. patients with known or suspected hypersensitivity to tolvaptan or to any ingredient of the drug 3. patients requiring urgent intervention to raise serum sodium acutely. 4. inability of the patient to sense or appropriately respond to thirst. 5. hypovolemic hyponatremia 6. concomitant use of strong cyp3a inhibitors 7. anuric patients 8. volume depletion patients 9. hypernatremia patients 10. women who are pregnant or possibly pregnant and lactation 11. patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption investigators will refer to the product market authorization (label) for exclusion criteria.
tdcs & auditory hallucinations in schizophrenia

Conditions: Schizophrenia

Summary: the aim of this study is to evaluate tdcs effects on schizophrenia symptoms, particularly on auditory verbal hallucinations. tdcs applied with cathodal (inhibitory) electrode over the left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral prefrontal cortex.


Eligibility criteria:
inclusion criteria: * ages 18-60 * primary diagnosis of diagnostic and statistical manual, fifth edition, schizophrenia * persistent auditory verbal hallucinations * right handed * under stable doses of antipsychotic medication for ≥4 weeks * normal hearing by self-report and physical exam * use of effective method of birth control for women of childbearing capacity * capable to provide informed consent. for patients judged to be incapable to provide informed consent the legal guardian of the patient must agree to participation in the study and provide signed informed consent exclusion criteria: * current or past history of substance dependence or abuse (excluding nicotine) * other current axis i disorders * history of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tdcs (pacemaker, medication pump, cochlear implant, implanted brain stimulator) * frequent and persistent migraines * history of adverse reaction to neurostimulation * participation in study of investigational medication within 6 weeks * pregnancy * women who are breast-feeding * current significant laboratory abnormality

Keywords: dorsolateral prefrontal cortex left superior temporal gyrus auditory hallucinations transcranial direct current stimulation (tdcs)
desolo - sit peri-launch: a comparison of symbicort single inhaler therapy and conventional best practice for the treatment of persistent asthma in adults

Conditions: Asthma

Summary: the purpose of this study is to determine whether symbicort dosed according to the symbicort maintenance and reliever therapy (smart) concept is superior to standard asthma treatment according to the local german treatment guidelines.


Eligibility criteria:
inclusion criteria: * patients with asthma, either well-controlled on a regular therapy with a combination of long-acting beta-agonists and inhaled corticosteroids or symptomatic on therapy with inhaled corticosteroids alone. exclusion criteria: * any other significant lung disease other than asthma * any disease that might put patients at risk if they participate in the study
somatostatin receptor imaging in acute myocarditis and cardiac sarcoidosis

Conditions: Acute Myocarditis; Cardiac Sarcoidosis

Summary: this prospective imaging study investigates the diagnostic ability of gallium-68 dota-toc (68ga-dota-toc) positron emission tomography/computed tomography (pet/ct) in the clinical work-up of patients with 1) clinically suspected acute myocarditis (n=30-40) and 2) clinically suspected cardiac sarcoidosis (n=30-40) using clinical diagnostic criteria as well as endomyocardial biopsy as reference. furthermore, 68ga-dota-toc pet/ct findings will be compared with results from contrast-enhanced magnetic resonance imaging (mri) and in case of cardiac sarcoidosis even fluorine-18 fluorodeoxyglucose (18f-fdg) pet/ct, which are both performed as part of the clinical routine work-up.


Eligibility criteria:
inclusion criteria: * willingness to participate in the study * provision of written informed consent * all patients between the age of 18 and 85 of both genders * newly clinically suspected acute myocarditis or newly clinically suspected cardiac sarcoidosis with or without known extra-cardiac sarcoid exclusion criteria: * pregnancy or lactation * severe obesity (limited by the scanner) * other known significant cardiac disease, including previous myocarditis * known tumour disease, especially (neuro)endocrine tumours * terminal disease(s), advanced psychiatric disease and/or significant dementia * recent or current immunosuppressive treatment * recent or current somatostatin analogue (octreotide) therapy * known relative/absolute contraindications for contrast-enhanced mri and/or pet/ct imaging * known contraindications for endomyocardial biopsy

Keywords: myocarditis cardiac sarcoidosis inflammatory cardiomyopathy cardiomyopathy heart disease cardiovascular disease somatostatin 68ga-dota-toc positron emission tomography
a study to evaluate the safety, tolerability and preliminary efficacy of app13007 to treat inflammation and pain after cataract surgery

Conditions: Ocular Inflammation and Pain After Cataract Surgery

Summary: this is a phase 2a, 2-part study (designated parts a and b) that will evaluate app13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matching vehicle placebo. part a will be conducted first to evaluate 0.05% app13007 and matching vehicle placebo in an approximate 1:1 ratio in approximately 42 subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all eligibility criteria. based on the results of part a, part b of the study may be open for enrollment to evaluate 0.05% and/or 0.1% app13007 at various dosing frequency in approximately 84 subjects, also in an approximate 1:1 ratio, active vs. placebo. in each part, subjects will return periodically for study assessments during the treatment period and then for a follow-up visit approximately 1 week after stopping the study drug.


Eligibility criteria:
inclusion criteria: * expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye. * in investigator's opinion, have early treatment diabetic retinopathy study estimated potential of 0.7 (20/100) or better in study eye. * have \> 10 and ≤ 30 cells in anterior chamber. * have an intraocular pressure ≤ 30 mmhg. exclusion criteria: * have an anterior chamber cell count \> 0 or any evidence of intraocular inflammation. * have a score \> 0 on ocular pain assessment in either eye.
intensive care unit risk score

Conditions: Mortality in Intensive Care Units; Complications Infection; Alarm Fatigue

Summary: subject of the planned project is the retrospective analysis of routine data of digital patient files of the department for anaesthesiology and surgical intensive care medicine, to test whether the predictive values of intensive care scoring systems with regard to perioperative mortality and morbidity can be improved by continuous score calculation and by using machine learning and time series analysis methods.

a scoring system usually consists of two parts - a score (a number reflecting the severity of the disease) and a probability model (equation indicating the probability of an event, e.g. the death of the patient in hospital). scoring systems have been used in intensive care medicine for decades and can help to assess the effectiveness of treatment or identify comparable patients for study purposes. scoring systems that are used in intensive care medicine are for example * acute physiology, age, chronic health evaluation ii (apache ii) * simplified acute physiology score ii (saps ii) * multiple organ dysfunction score (mods) * sequential organ failure assessment (sofa) * logistic organ dysfunction system (lods) * mpm ii-admission (mortality probability models (mpm ii) * organ dysfunction and infection score (odin) * three-day recalibrating icu outcomes (trios) * glasgow coma score (gcs) * discharge readiness score (drs) the above-mentioned scoring systems are already being collected regularly in the respective hospital's departments. in a recent study by badawi et al. it could be shown that scoring systems allow more accurate predictions when calculated continuously. however, due to the patient collectives investigated, these results can only be transferred to other patient groups to a limited extent. furthermore, only the scoring systems apache, sofa and drs were analyzed. therefore, in the present study, all of the above scoring systems will be calculated continuously (once per minute) using routine data from the digital patient records and optimized by applying machine learning and methods of time series analysis. on the anesthesiologically managed intensive care units of the respective hospital, there is no campus-wide standard with regard to alarm management. accordingly, we estimate the rate of alarm fatigue (ignoring alarms due to many false alarms) to be very high. in order to optimize the alarm management, alarms from the patient monitoring devices will be evaluated retrospectively and combined with the data mentioned above to determine, for example, whether more frequent alarms are to be expected for certain types of diseases (e.g. sepsis), or scores (e.g., high apache score) and how the alarm limit setting can be optimized.

Eligibility criteria:
inclusion criteria: - patients with admission between 01.01.2006 and 30.09.2023 exclusion criteria: * patients under 18 years of age. * incomplete patient records. * intensive stay of less than 24 hours.

Keywords: scores intensive care unit patient monitoring alarm management
creation of a register of patients with neonatal-onset epileptic encephalopathy

Conditions: Epileptic Encephalopathy

Summary: electrical activity emerges in the third trimester of pregnancy, plays an important role in the construction of cortical maps, and is impaired in patients with severe early epileptic encephalopathies (eoee). eoee are rare and severe epileptic syndromes characterized by epilepsy that begins within the first three months of life and is associated with rapid deterioration of motor, cognitive and behavioral skills. there is a genetic basis for the eoee. together with other laboratories, the investigators have identified de novo pathogenic variants in the kcnq2 gene encoding the kv7.2 subunit of the kv7 / m potassium channel, a channel known to control neuronal excitability in the brain and spinal cord. via the current m (im). pathogenic variants of the kcnq2 gene represent the main cause of eoee and the term kcnq2-related epileptic encephalopathy (kcnq2-ree) is now used to define this condition. kcnq2-ree patients have a remarkably homogeneous phenotype at the start, with epilepsy that begins in the first days after birth, seizures that result in tonic muscle spasms that last from 1 to 10 seconds, and an interictal eeg called "suppression-burst". "that is, paroxysmal bursts of activity interspersed with periods of electrical silence. in this group, more than 50% of the patients present a remission of the epilepsy and a quasi-normalization of the eeg which can occur a few weeks to several months after the onset of the seizures. despite this positive evolution in terms of seizures, the developmental progression is abnormal and the phenotype is severe with an absence of language, autistic behavior and a subsequent development of motor disorders such as diplegia, spasticity, ataxia or dystonia. the ambition of this project is to increase knowledge of epileptic encephalopathies linked to kcnq2 at the clinical and molecular levels, to decipher the pathophysiological mechanisms and to propose therapeutic strategies. this project aims to better describe the clinical, eeg, imaging, developmental and long-term follow-up characteristics of patients carrying the kcnq2 mutation identified in the laboratory.


Eligibility criteria:
inclusion criteria: * epilepsy beginning before 1 month of life, and requiring the initiation of anti-epileptic treatment * without occasional cause * without brain malformation explaining epilepsy * no opposition from parents / guardians * possibility for parents to complete parent questionnaires exclusion criteria: * neonatal attacks of occasional cause (glycemic disorder, infection, etc.) * acquired neonatal epilepsy (post-anoxic encephalopathy, stroke sequelae, etc.) * neonatal epilepsy related to a brain malformation

Keywords: eoee epilepsy kcnq2
mechanical plaque control and gingivitis reduction in fixed appliance patients

Conditions: Dental Plaque; Gingivitis

Summary: the purpose of this study is to determine whether the use of a sonic toothbrush alone is more effective than two other toothbrushing protocols on dental plaque elimination in patients with fixed orthodontic appliances.


Eligibility criteria:
inclusion criteria: * no systemic diseases * orthodontic appliance (min. 10 completely erupted permanent teeth with brackets/bands) * informed consent exclusion criteria: * presence of caries lesion * antibiotic therapy within the previous 6 months * diagnosis of early onset periodontitis

Keywords: orthodontics toothbrush interdental brush oral hygiene