Kornimate/medical-research-clean huggingface dataset:
a clinical study to assess the safety and efficacy of an ophthalmic solution (skq1) in the treatment of dry eye syndrome (des)

Conditions: Keratoconjunctivitis Sicca

Summary: the purpose of this study is to evaluate whether skq1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.

single-center, double-masked, randomized, placebo-controlled study comprising 4 visits over the course of approximately 5 weeks. the study included a 1-week placebo (skq1 vehicle) run-in period between visit 1 and visit 2, and approximately 28 days of twice daily (bid) dosing (visit 2 - visit 4). qualified subjects were randomized 1:1:1 to receive either 1.55 µg/ml skq1 ophthalmic solution, 0.155 µg/ml skq1 ophthalmic solution, or placebo (vehicle of skq1 ophthalmic solution). the following primary endpoints were tested: * corneal fluorescein staining in the inferior region pre-cae at visit 4 (day 29), as measured by the ora calibra scale in the worst eye at baseline; * worst dry eye symptom (ocular discomfort, dryness, or grittiness - as determined from subject diary data recorded during the 1-week run-in period between visit 1 and visit 2) evaluated over the seven days preceding visit 4 (not including day of visit) during the treatment period.

Eligibility criteria:
inclusion criteria: * be male or female of any race, at least 18 years of age * have provided written informed consent * have a reported history of dry eye syndrome * have a history of use or desire to use eye drops for dry eye exclusion criteria: * have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters * have previously had lasik surgery within the last 12 months * have used restasis® within 30 days of visit 1 * be a woman who is pregnant, nursing or planning a pregnancy * be unwilling to submit a urine pregnancy test if of childbearing potential * have a known allergy and/or sensitivity to the test article or its components, including the preservative benzalkonium chloride * be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of visit 1 * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Keywords: dry eye dry eye syndrome skq1 keratoconjunctivitis dry eye disease
hmpl-813 in treating patients with glioblastoma

Conditions: Glioblastoma

Summary: this is an open-label study, to evaluated epitinib, which is a selective epidermal growth factor receptor tyrosine kinase inhibitor (egfr tki), to treat glioblastoma patients with egfr gene amplification. as epitinib could cross blood-brain barrier (bbb), inhibition of egfr may provide a novel mechanism in treating glioblastoma.

epitinib could cross bbb and show its efficacy in brain metastasis tumors. patients with histologically confirmed glioblastoma; standard treatment failed or no standard treatment as well as egfr gene amplication are eligible. patients will receive epitinib 120mg or 160mg epitinib daily. epitinib is orally administered qd until patients reach intolerance or progression of disease. tumor assessment takes place every 4 weeks. simon two stage design was used, estimated making sample size of 35 cases.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed glioblastoma 2. standard treatment failed or no standard treatment 3. egfr gene amplification 4. clearly measurable lesions (according to response assessment in neuro-oncolog (rano)) 5. age ≥ 18 6. eastern cooperative oncology group (ecog) score ≤2 exclusion criteria: 1. use of antiepileptic drugs were used\] within 2 weeks before enrollment 2. immunotherapy, anti-angiogenesis or egfr tki and its downstream pathway signaling molecules and other targeted drugs within 4 weeks before enrollment; temozolomide chemotherapy, cranial radiotherapy or other systemic anti-tumor therapy within 3 weeks before enrollment 3. previous toxic effects of anticancer therapy have not yet been recovered (defined as not restored to 0 or 1 level, except alopecia) or have not been fully recovered from previous surgery 4. uncontrolled active infections such as acute pneumonia, hepatitis b virus (hbv) and so on 5. eye disease or dry eye syndrome history 6. positive pregnancy tested result
dexamethasone solution for the treatment of oral lichen planus

Conditions: Lichen Planus

Summary: the objective of this single center, 4-week, open label randomized, phase ii study is to evaluate and characterize the tolerability and clinical effectiveness of dexamethasone 0.5mg/5ml solution in a mucoadhesive vehicle (mucolox™) for the treatment of oral lichen planus.

potentially eligible subjects will be screened by one of the investigators by asking patients to rate their worst oral pain or pain score (0-10) over the previous week (see appendix). those answering with at least a score of "7" (1/10) and that meet all other eligibility requirements (see section 3) will be eligible for enrollment. all patients will sign informed consent for study participation. each study visit is anticipated to take approximately 45 minutes. treatment will be administered on an outpatient basis. study medication will be prescribed by authorized study staff physicians at no expense for the patient. subjects will be evaluated clinically at baseline before starting treatment and at the end of the four-week period, for a total of two visits. comprehensive subjective and objective data will be collected and intraoral photographs will be obtained. oral mucosal disease will be evaluated using both patient reported (questions/visual analog scales) and clinician assessed measures. subjects will be prescribed compound dexamethasone 0.5mg/5ml solution in mucolox™ (arm a) or dexamethasone 0.5mg/5ml solution only (arm b). all subjects will also receive a prescription for fluconazole 200 mg tablets once-a-week as prophylactic antifungal therapy. any subjects that are already taking an antifungal oral medication at the time of the study enrollment will continue their prescribed medication and will not need to take the additional weekly fluconazole dose. subjects will return for evaluation after four weeks at which time the study end-points will be assessed. if there is worsening of oral lichen planus that requires initiation of new immunomodulatory medications (systemic or topical), patients will remain on treatment, but will be regarded as unevaluable for the primary endpoint.

Eligibility criteria:
inclusion criteria: * age 18 years and older. * patients with symptomatic oral lichen planus (worst vas sensitivity score ≥ 7 over the last week). exclusion criteria: * patients already on topical or systemic steroids. * inability to comply with study instructions. * uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements. * vas sensitivity score \< 7.

Keywords: oral lichen planus dexamethasone solution
cpr surface choice on chest compression quality

Conditions: Cardiac Arrest; Simulation of Physical Illness

Summary: the objective of our randomized simulation study on mannequins with a population of basic life support students is to compare the quality of chest compressions, taking depth as the main variable, in two simulated scenarios of out-of-hospital cardiac arrest on a bed: one where cardiopulmonary resuscitation is performed on the bed and another where the patient is transferred to the ground for cardiopulmonary resuscitation.


Eligibility criteria:
inclusion criteria: * those individuals who sign the informed consent and do not meet exclusion criteria exclusion criteria: individuals with any limitation or contraindication for physical exercise: * arthritis * heart disease * advanced lung disease * severe physical disability * morbid obesity * chronic fatigue * pregnancy withdrawal criteria: * those individuals who, due to limitations in physical exercise, do not reach 2 minutes of compressions * students who have not obtained the certificate of successfully completing the course.

Keywords: cardiopulmonary resuscitation cardiac arrest simulation study chest compressions
probiotics for gallstones in post-bariatric surgery patients：a prospective randomized trial

Conditions: Clostridium Butyricum Miyairi; Gallstones; Gastrointestinal Quality of Life Index

Summary: morbid obesity has become a major global health problem, and the use of bariatric surgery is increasing. one common complication seen following bariatric surgery is the formation of gallstones. contributing factors to gallstone formation include hypomotility of gall bladder and supersaturation of bile due to rapid weight loss and mobilization of cholesterol. previous studies revealed oral probiotics could reduce the cholesterol level by as much as 22% to 33%. the possible mechanisms included bile salt hydrolase activity, assimilation of cholesterol by the bacteria, binding of cholesterol to the bacterial cell wall and physiological actions of the end products of short chain fatty acid fermentation. therefore, the aim of this study was to determine the ability of probiotics to prevent gallstones formation after bariatric surgery and to evaluate the impact of oral administration of probiotics on the post bariatric surgery patients 's quality of life. gastrointestinal quality of life index is a widely accepted questionnaire for evaluating the quality of life for patients receiving bariatric surgery. it consists of five domains: digestive symptoms; physical function; emotional condition; social condition and effect of medical treatment, which could access the quality of life of bariatric patient effectively and completely.


Eligibility criteria:
inclusion criteria: 1. patients receiving bariatric surgery for morbid obesity 2. patiets at ages between 20 to 65 y/o 3. patients willing to follow up regulary after bariatric surgery. exclusion criteria: 1. patients having gallstones before bariatric surgery 2. patients refusing taking probiotics or refusing regular follow up after bariatric surgery
a prospective compliance registry for patients with metastatic castration resistant prostate cancer (mcrpc)

Conditions: Prostatic Neoplasms

Summary: the primary purpose of this study is to determine the rate of compliance to abiraterone acetate and prednisone (aa + p) treatment in colombian castration-resistant metastatic prostate cancer (mcrpc) participants experiencing adequate response to treatment, in a real-world clinical setting.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology * distant metastatic disease documented by positive bone scan or metastatic lesions on computerized tomography (ct) or magnetic resonance imaging (mri) * prescribed and currently (at enrollment) being treated with abiraterone acetate and prednisone (aa + p) for the treatment of castration-resistant metastatic prostate cancer (mcrpc) according to the local product label * having received a minimum 1 cycle of aa + p (4 weeks), and maximum 4 consecutive cycles of aa + p (16 weeks ) prior to study enrollment * eastern cooperative oncology group (ecog) performance status grade of 0, 1 or 2 at enrollment exclusion criteria: * participants who have received and terminated abiraterone acetate treatment for prostate cancer (pca) in the past * received an investigational drug (including investigational vaccines) or used an invasive investigational medical device less than or equal to (\<=) 30 days before the start of the study or the first data collection time point * presence of any condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscures the assessment of the abiraterone acetate treatment in mcrpc * known brain metastases * pathological finding consistent with small cell carcinoma of the prostate
endoscopic submucosal dissection of large recto-sigmoid lesions under spinal anesthesia

Conditions: Colorectal (Colon or Rectal) Cancer

Summary: the investigators collected data on all consecutive patients who underwent esd for recto-sigmoid laterally spreading tumors (lsts) \>35 mm under sa between january 2021 and march 2024. the investigators evaluated the technical success and safety of sa in terms of araes, and pain, measured via visual assessment scale (vas).

background and study aim: endoscopic submucosal dissection (esd) of large colorectal lesions requires the patient to be in a still position for a long time. both deep sedation and general anesthesia carry a substantial risk of anesthesia-related adverse events (araes), especially in frail patients. conversely, mild-to-moderate sedation does not prevent involuntary movements of the patient. spinal anesthesia (sa) is a safe and simple technique that provides analgesia and motor block without systemic drug administration or orotracheal intubation. as the use of sa in colorectal endoscopic resections has not been described so far, we aimed to evaluate the feasibility and performance of sa in large (\>35 mm) recto-sigmoid lesion esd. patients and methods: the investigators collected data on all consecutive patients who underwent esd for recto-sigmoid laterally spreading tumors (lsts) \>35 mm under sa between january 2021 and march 2024. the investigators evaluated the technical success and safety of sa in terms of araes, and pain, measured via visual assessment scale (vas). the secondary endpoints were as follows: intra- and post-procedural need for additional opioid or other analgesic drug administration, esd-related adverse eventss, length of hospital stay, and median esd duration.

Eligibility criteria:
inclusion criteria: * age ≥18 years * american society of anaesthesiologists (asa) score i-iv * ability to give informed consent exclusion criteria: * age \<18 years * asa score v * allergy to medications used for spinal anesthesia * pregnancy * breastfeeding

Keywords: esd spinal anesthesia colorectal lesions lst laterally spreading tumor endoscopic submucosal dissection deep sedation
3d evaluation of the lip support in a full-arch implant-supported rehabilitations

Conditions: Digital Technology; Prosthesis User; Lip; Oral Soft Tissue Conditions; Occlusion

Summary: the goal of this observational study is to evaluate the impact of a full arch implant-supported prostheses in the lip support. in a complex rehabilitation cases, the process between the diagnosis and the delivery of a prostheses may lead with many clinical and laboratorial choices which influence the final design of the prosthetic work and consequently the facial profile of the patient. the use of 3d facial scanners and advanced superimposition methodology allows the investigators to objectively measure several relevant parameters such as vertical occlusion of dimension and lip support.

digital technologies have evolved exponentially in the dental medicine field endorsing a change between the conventional methods to virtually based methodologies in daily clinical and laboratorial practice. combining facial aspects and proportions with dento-gingival parameters are the basis when planning a new smile design and a final rehabilitationfacial surface images can be used for more predictable measurement and quantification of vertical dimension of occlusion and lip support before, during and after a full mouth rehabilitation. besides that, the information obtained by facial scanners have a major impact in treatment planning process especially in multidisciplinary complex cases with the simulation of the treatment, identification of patient's expectations and the implementation of an effective communication tool. the 4d-virtual patient is the future regarding the management of a patient in dental medicine, since the beginning of the process with data acquisition for the diagnosis to the definitive oral rehabilitation procedures. similar to any methodology, it is important to understand what are the basis of the facial scanning and what protocols can obtain better results in terms of accuracy and reliability.

Eligibility criteria:
inclusion criteria: * individuals with at least a full-arch implant supported rehabilitation in the upper arch * individuals with a provisional or a definitive implant-supported prosthesis * individuals with a stable occlusion function * individuals with compliance to collaborate with the research protocol exclusion criteria: * individuals with history of hypersensitivity to external light or any similar condition * individuals in an active surgical treatment period * individuals in an active orthodontic treatment in the opposite arch * individuals in an active facial treatment * individuals who did not attend the maintenance visits

Keywords: three-dimensional imaging prosthodontics full-arch facial scanner
tricuspid regurgitation study

Conditions: Tricuspid Regurgitation; Right Ventricular Dysfunction; Left Ventricular Dysfunction

Summary: the effect of cardiac pacing leads on tricuspid regurgitation is unclear. this study will determine whether using a smaller diameter leads and an alternate position in the ventricle, the proximal septum, will reduce tricuspid regurgitation than larger leads placed in the apex.

leads are commonly placed in the right ventricular apex. it is not known whether placing similar leads higher on the septum where there will be less redundancy or pressure on the septal leaflet will change the extent and severity of tricuspid regurgitation following pacemaker/icd implantation. data has shown that right ventricular pacing can give rise to right ventricular dysfunction, which in turn may give rise to enlargement of the right ventricle and cause tricuspid regurgitation. the study will answer the clinically relevant questions on device lead-related tricuspid regurgitation. this study is a single center prospective study at the mayo clinic, rochester. the study will enroll 200 eligible subjects and follow for 12 months. 50 pacemaker subjects will be randomized to right ventricular apex pacing 50 pacemaker subjects will be randomized to right ventricular septum pacing 50 pacemaker subjects will be randomized to left ventricular pacing via coronary sinus 50 icd subjects will be enrolled with right ventricular apex pacing. a baseline heart failure assessment and two dimensional echocardiography will be performed before device implant. a two dimensional echo will be performed 24 hours after device implant. if significance tr is present a three dimensional echo will be performed. at 12 months post implant heart failure assessment and two dimensional echo will be performed.

Eligibility criteria:
inclusion criteria: * 18 years of either sex * patient is recommended to receive a pacemaker or an icd * provide informed consent exclusion criteria: * pregnant or breastfeeding women * congenital heart disease * pre-existing moderate or severe tr * an existing pacemaker or defibrillator * pulmonary hypertension * pacemaker dependence * unable to give informed consent * not feasible for patient to be followed up at mayo clinic * acute myocardial infarction within 7 days

Keywords: reduce tricuspid regurgitation reduce right ventricular pacing lead position lead size
immunogenicity and safety of the concomitant administration of a tdap vaccine and meningococcal acwy conjugate vaccine in healthy subjects aged 11-25 years

Conditions: Meningococcal Disease; Meningococcal Meningitis

Summary: immunogenicity and safety of the concomitant administration of a tdap vaccine and meningococcal acwy conjugate vaccine in healthy subjects aged 11-25 years


Eligibility criteria:
inclusion criteria: * male and female 11-25 years old healthy subjects; * who had received the primary immunization with a vaccine containing dt or tdap antigens and a t, td, or tdap booster injection at least 5 years prior to study entry exclusion criteria: * previous ascertained or suspected disease caused by n. meningitidis * previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) * serious acute, chronic or progressive disease * history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component * known or suspected impairment/alteration of immune function, either congenital or acquired

Keywords: meningitis healthy subject vaccine
pulmonary embolism following viper's bites: a case report

Conditions: Pulmonary Embolism (PE); Snake Envenomation

Summary: viper envenomation constitutes a medical emergency predominantly occurring in rural regions, where specific viper species are endemic, with their distribution influenced by climatic variations. the literature describes numerous complications associated with viper bites, including neurological disturbance, hematological abnormalities, and irreversible renal failure. we report the case of a 65-year-old female patient admitted to the intensive care unit for viper envenomation characterized by extensive local edema. diagnostic investigations, including laboratory tests and imaging studies, revealed the presence of a bilateral pulmonary embolism. the patient was subsequently treated with antivenom therapy, followed by initiation of low molecular weight heparin. despite the recognized high risk of viper envenomation described in the literature, the patient experienced an uncomplicated clinical course and was discharged in stable condition with no further complications.


Eligibility criteria:
inclusion criteria: * age above 18years old exclusion criteria: * not bitten by snakes
effect of etomidate on hemodynamics and adrenocortical function after cardiac surgery

Conditions: Coronary Artery Disease; Mitral Valve Regurgitation

Summary: the purpose of this study is to evaluate the effect of a single dose of etomidate for patients undergoing cardiac surgery with the use of cardiopulmonary bypass (cpb) on post-cpb adrenocortical responsiveness, on requirements of hemodynamic support, and on use of intensive care resources.


Eligibility criteria:
inclusion criteria: * male or female patients undergoing elective * coronary artery bypass graft (primary or re-operation) * mitral valve reconstruction/replacement for mitral valve regurgitation * age between 18 and 80 years (extremes included) * subject itself has signed the informed consent * no clinically relevant deviation from the laboratory's reference range of biochemistry, hematology, or urinalysis testing exclusion criteria: * participation in another ongoing interventional trial * known adrenocortical insufficiency * use of etomidate or propofol within 1 week preoperatively * use of glucocorticoids within 6 month preoperatively * known sensitivity to etomidate, propofol, or emulgator * severe hepatic dysfunction (bilirubin \> 3mg/dl) * severe renal dysfunction (plasma creatinine \> 180mikromol/l) * sepsis, endocarditis or other chronic inflammatory disease * manifest insulin-dependent diabetes mellitus * positive hiv serology * hemodynamically significant carotid stenosis requiring treatment * serious illnesses: endocrine, neurological, psychiatric, metabolic disturbances * pregnancy or breast-feeding female; females will be subject to pregnancy testing * requirement of rapid sequence induction * emergency surgery * history of asthma

Keywords: etomidate propofol adrenocortical insufficiency hemodynamic process vasoactive agonists coronary artery bypass ischemic coronary heart disease mitral valve reconstruction/replacement mitral valve regurgitation heart valve prosthesis cardiopulmonary bypass