Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of triple combination therapy in patients with glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: this study will investigate the safety and efficacy of triple combination therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (iop) on brimonidine/timolol ophthalmic solution.


Eligibility criteria:
inclusion criteria: * glaucoma and/or ocular hypertension in both eyes * requires iop-lowering treatment in both eyes exclusion criteria: * other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye) * current or anticipated use of ocular medications other than study medications, except for intermittent use of artificial tears * use of oral, injectable or topical corticosteroids within 21 days * iridectomy or laser peripheral iridotomy in the study eye within 3 months * uncomplicated cataract surgery in the study eye within 6 months * incisional glaucoma surgery in the study eye within 12 months
assessment of cognitive function in patients undergoing elective carotid endarterectomy

Conditions: Cognitive Impairment

Summary: assessment of cognitive function in patients undergoing elective carotid endarterectomy classical treatment for ica stenosis is carotid endarterectomy (cea), which has been proven effective in preventing future stroke as well as improving cerebral perfusion. however, the influence of cea on cognition is less defined, it remains unclear whether cea can improve cognitive function. a change in cognition is one of the most threatening diseases of recent years, cognitive impairment significantly impacts patients, families, and healthcare system. the difference in the cognitive outcome may be accounted for microembolic events and adverse changes in haemodynamic circumstances. the aim of our study is to identify those factors what may have role in the postoperative cognitive decline. the study was approved by the ethical committee of the university ( se rkeb: 17/2019) and written informed consent will be obtained from all patients. the investigators intend to enroll patient aged more than 18 years undergoing elective carotid endarterectomy at our hospital ( semmelweis university heart and vascular center). exclusion criterion included young age (less than 18 years), incapacity and urgent surgery. the investigators would like to register at least 100-150 patients in our study. most relevant anamnestic dates, the results of the laboratory and radiological reports will be recorded. cognitive functions will be assessed one day before, one day and six month after the surgery using mmse and a questionnaire called frailty to characterize beside cognitive function the physiological reserve of the patients too. the investigators manage patients undergoing carotid endarterectomy with general anaesthesia, using inhaled or total intravenous agents. during the operation the investigators record beside the routine monitoring (intraarterial blood pressure, ecg, oxygen saturation, etco2, mac) the cerebral tissue oxygen saturation using a near-infrared cerebral oximeter (invos cerebral/somatic oximeter) and the activity of the brain using ge entropy module. the investigators would like to register the changes in the haemodynamic and cerebral condition and compare these results against the clinical outcome and the changes of the questionnaires. statistical analyses will be performed using statistical package for the social sciences.


Eligibility criteria:
inclusion criteria: * aged more than 18 years, undergoing elective carotid endarterectomy exclusion criteria: * younger than 18 years, incapacity, urgent surgery, lack of consent
online fatigue intervention program for people with scleroderma

Conditions: Systemic Sclerosis

Summary: this research is being done to evaluate if an online fatigue intervention program will decrease fatigue, pain and increase confidence managing fatigue and being able to do daily tasks. this study involves competing a series of questionnaires before and after the intervention , and attending and participating in the online videoconference fatigue program for 1 1/2 hour meetings each week over a 6-week period of time.

if eligible and give consent, participants will be asked to complete 2 online questionnaires. the first questionnaire asks basic information such as your age, gender, educational level, and amount of time diagnosed with systemic sclerosis. the second questionnaire asks about your disease symptoms. you will also be asked to complete questionnaires about your fatigue, pain, mood, confidence in managing your disease and performing daily tasks, and knowledge and use of energy saving techniques. once you compete the questionnaires, you will be asked to compete a survey about times and days you would be available to attend the online videoconference fatigue program meeting over a 6 week period of time. once the time and dates for the fatigue program are scheduled, you will be expected to attend and take part (using visual and audio) in each 1 ½ hour meeting for 6 weeks online. the fatigue program includes information on causes of fatigue, ways to protect joint and save energy, ways to manage stress, pain, good eating habits, and exercise. outside of meetings, you will also be expected to do any "homework" assignments in between the group meetings such as setting goals and doing activities to reach your goals. at the end of the 6 weeks, you will be asked to complete the same questionnaires you did at the beginning of the study regarding, fatigue, pain, and ability to perform daily tasks. you will also be asked to complete an evaluation of the course. 3 months later, you will be asked to take part in a 45 minute telephone interview to talk about your fatigue and how you are using the ideas from the program.

Eligibility criteria:
inclusion criteria: * resident of the united states * diagnosis of systemic scleroderma * 18 years of age or older * have use of a device with internet and email access, and video conferencing capabilities (both audio and visual) * communicate in english * have fatigue (combined score of \>12 on 3 questions that rate degree of fatigue, severity of fatigue, and level of stress caused by fatigue on a scale from 1 - 10) * be willing and available to complete the study protocol which consists of attending a 1.5 hour virtual meeting once a week for 6 weeks. exclusion criteria: * pregnancy * not having use of a device with internet, email access, and video conferencing capabilities (both audio and visual) * not able to communicate in english * score \< 12 on the fatigue screening questions * not willing or not able to complete the study protocol or participate in the program at the designated times and days.
molar-incisor hypomineralization vs periodontal health

Conditions: Molar-Incisor Hypomineralization; Peridontal Disease

Summary: background: to investigate the effect of molar incisor hypomineralization (mih) on periodontal health, to evaluate the relationship between gingival crevicular fluid (gcf) volume, and gcf biomarkers such as matrix metalloproteinase-8 (mmp-8), matrix metalloproteinase-20 (mmp-20), and transforming growth factor-beta 1 (tgf-β1), and mih. methods: the study was conducted on 40 pediatric patients diagnosed with mih (study group/sg), and 40 pediatric patients healthy for mih (control group/cg). clinical periodontal measurements (plaque index (pi), gingival index (gi), probing pocket depth (ppd), and gcf volume were performed. concentrations of mmp-8, mmp-20, and tgf-β1 in gcf were determined using enzyme-linked immunosorbent assay (elisa). mann-whitney u test and t-test were used for comparisons between groups. significance was set at p=0.05 for statistical analysis.


Eligibility criteria:
inclusion criteria: * the ages of 8 and 14 who were diagnosed with mih in their maxillary permanent first molars, * had healthy maxillary permanent first molars, * scored 3 (positive) or 4 (definitely positive) on the frankl behavior scale, * had no mental or physical disability, * did not need urgent treatment and/or were not in pain, * agreed to participate in the study with their parents and signed the consent form. exclusion criteria: * children with systemic, chronic, and/ or metabolic diseases, * under active orthodontic treatment, with developmental defects of enamel (excluding mih), or born prematurely

Keywords: gingival crevicular fluid matrix metalloproteinase 8 matrix metalloproteinase 20
safety and efficacy study of a viscoelastic-free method for implantable collamer lens (icl) implantation

Conditions: Myopia

Summary: this study evaluates the safety and efficacy of a viscoelastic-free method for implantable collamer lens(icl) implantation to treat high myopia. the subjects undergo randomization of icl implantation using the viscoelastic-free method on one eye and undergoing standard method on the other one. the post-operative data are collected for analysis.

implantable collamer lens(icl) implantation has been proved to be an effective refractive option for surgical correction of high myopia. currently, standard method utilizing the viscoelastic agent to fill and maintain the anterior chamber during the implantation, this requires an additional step to remove the viscoelastic agent at the end of the surgery and may cause the intraocular pressure spike in the early post-operative phase due to the incomplete removal of the viscoelastics. the new method is viscoelastic-free, which can be achieved by using balanced salt solution irrigation during the implantation. this study is a prospective, randomized, paired-eye study to compare the safety and efficacy of the viscoelastic-free method with the standard method. subjects enrolled in the study will be randomized to receive viscoelastic-free method on one eye and undergo standard method on the other one.the clinical outcomes of two groups will be assessed at several follow-ups: 2 hours, 1 day, 1 week, 1 month, 3 months and 6 months post-operatively.

Eligibility criteria:
inclusion criteria: * documented stable refraction for at least 1 year(within 0.5d) * best spectacle-corrected visual acuity (bcva) of 20/40 or better * clear central cornea * -0.5d to -18.0d of myopic refractive error * normal anterior chamber depth at least 2.8 mm to endothelium * endothelial cell density (ecd) more than 2000 cell/mm2 * pupil diameter smaller than 7.0 mm under mesopic condition * discontinued 3 weeks for hard contact lens and 1 week for soft contact lens wear exclusion criteria: * preexisting ocular diseases or conditions other than myopia, evidence of progressive or acute ocular disease * evidence of connective tissue disease or other systemic diseases that may confound the results of the study; * narrow angle of anterior chamber * pregnant, lactating, or planning to become pregnant during the course of the trial

Keywords: phakic intraocular lenses viscoelastic
randomized evaluation of redo ablation procedures of atrial fibrillation with firm guided procedures

Conditions: Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation

Summary: a prospective, multicenter, randomized study to assess the safety and effectiveness of firm-guided procedures in conventional "redo" rf ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.

the hypothesis of this study was that focal impulse and rotor modulation (firm) guided procedures will eliminate the source of clinical arrhythmias in subjects with clinical indications for repeat af ablation procedures. this study is a prospective, multicenter, randomized, controlled study to assess the safety and effectiveness of firm procedures followed by ablation including pulmonary vein isolation versus a standard conventional procedure including pulmonary vein isolation for the redo-treatment of persistent or paroxysmal atrial fibrillation after one failed previous pulmonary vein isolation.

Eligibility criteria:
inclusion criteria: * experiencing at least one (1) documented episode of spontaneous persistent or paroxysmal atrial fibrillation during the last 3 months by rhythm strip/ecg. * one (1) previous af ablation (pvi-only - any technology) after jan-01-2013, but not within the last 3 months. * left atrial diameter \< 6.0 cm via transthoracic echo or transesophageal echo; or \<6.5 cm via ct or mri with 6 months prior to the procedure. * sustained spontaneous or induced af (\>5 min uninterrupted). exclusion criteria: * presence of structural heart disease with clinical significance * nyha class iv * ejection fraction \< 35% * previous af ablation within the last 3 months * asd closure device, laa closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker. * history of myocardial infarction (mi) within the past three (3) months * atrial clot/thrombus noted within 72 hours of the procedure

Keywords: firmap, rotor, firm-guided procedure
multiple applications of expressgraft-c9t1 skin tissue as a treatment for diabetic foot ulcers

Conditions: Diabetes; Diabetic Foot Ulcer; Non-healing Wound

Summary: some people with diabetes get foot ulcers that do not heal. these ulcers can get infected and cause other medical problems. five patients with these foot ulcers volunteered to participate in the first part of this study (c9t12015, nct02657876). they are called cohort 1 in this registration. cohort 1 received one application (piece) of an experimental skin tissue to make sure it was safe. this study will extend the safety test of the experimental skin tissue. it will find out if it is safe to use more than once to cover non-healing ulcers. this extension will include two more groups, cohort 2 and cohort 3. cohort 2 may get up to 5 applications. cohort 3 may get up to 10 applications. the number of applications will depend on how well the wound is healing. participants will be in the study up to one year.


Eligibility criteria:
volunteers will be consented. then there will be a run-in period for the doctor to run some tests. if the tests show the study would be good for the patient, the doctor will enroll them as participants in the trial. inclusion criteria: to be considered for inclusion, a participant: * agrees to practice birth control for the duration of the study * has documented type 1 or type 2 diabetes and an hba1c score of 10 or below * has protocol-defined sufficient blood pressure and flow to the foot * has stable medications for 2 weeks before treatment (other than diabetes medications or antibiotics) * is able and willing to attend scheduled visits and comply with study procedures * if a smoker, agrees to try quitting and will accept counseling for it (cohorts 2 and 3 only) * has documented informed consent for study enrollment * has had an uninfected, appropriately-sized diabetic ulcer on the foot for at least 4 weeks but not more than 1 year exclusion criteria: the doctor may not consider for inclusion a participant who: * is pregnant, nursing, or a prisoner * has had osteomyelitis in the foot with the ulcer in the last 30 days * has a history of poor compliance * has received drugs or therapies not allowed per protocol * has used an investigational product within the last 60 days * has ever received therapy for the study ulcer with any cell and/or tissue product (ctp) * has a study ulcer in a condition not appropriate for the study * has a medical condition or history that, per protocol or in the opinion of the study doctor, might put the safety of the participant in danger
ultrasound guided central vein catheterization and complications

Conditions: Brain Tumor

Summary: there has been no study comparing the complication rates between internal jugular vein catheterization and subclavian vein catheterization when they are performed using sonographic view. this prospective study would reveal the sort of complication and its rate.


Eligibility criteria:
inclusion criteria: * patients undergoing surgeries requiring central vein catheterizations for anesthetic management. exclusion criteria: * refuse * hematologic disorder * anatomical abnormalities of central vein structure

Keywords: open heart surgery lung surgery spine surgery hepatobiliary surgery
development of a prediction platform for adjuvant treatment and prognosis in resected pancreatic cancer using organoid

Conditions: Pancreatic Cancer Resectable

Summary: the investigators create organoid from the pancreatic cancer tissue obtained via eus-fna and eus-fnb within the pancreatic cancer diagnostic process. and also the investigators create organoid from the pancreatic cancer tissue obtained after surgery as part of the pancreatic cancer treatment process. check for the reactivity to anti-cancer drugs through cell viability assay after treating with various anti-cancer drugs, such as anti-cancer drugs used as adjuvant chemotherapy for pancreatic cancer to the organoid. also, perform genomic analysis on each organoid, and then check if there are any unique genomic mutations for each organoid. by recognizing the relationship between the unique genomic mutations and reactivity to the anti-cancer drug within pancreatic cancer patients eligible for surgery, the investigators aim to strategize appropriate adjuvant chemotherapy after surgery, thus developing a platform to predict the outcomes of each patient.


Eligibility criteria:
inclusion criteria: 1. 18 years old or older 2. newly discovered pancreatic cancer and not a relapse 3. diagnosed with pancreatic cancer via eus-fna, eus-fnb before surgery 4. patients who can undergo surgery for pancreatic cancer 5. diagnosed with pancreatic cancer from the final tissue pathology diagnosis after surgery 6. who is in need of adjuvant chemotherapy after surgery 7. able to make decisions for oneself for participation 8. has obtained voluntary consent in written form (if 70 years of age or older, receive consent from the guardian as well) exclusion criteria: * none
study of the immunity of patients with lung cancer and covid-19 infection

Conditions: Lung Cancer; COVID; Corona Virus Infection

Summary: observational, retrospective data collection and prospective igg analysis, and multicenter study. the main objective of the study is th description of the characteristics and evolution of patients with lung cancer who have acquired covid-19 infection. for the identification of patients who contract covid-19 infection, the igg+ blood test by elisa method will be used.

non-post-authorization study, retrospective of data collection and prospective of igg analysis, observational and multicenter. the study will be extended to all the sites of the spanish lung cancer group, more than 170 centers and 500 professionals, and it is expected that around 1,500 igg tests will be carried out. the study has three phases: the scope of phase i is the identification of acquired immunity (igg) in patients with lung cancer, whether or not they have presented symptoms of having suffered from covid19. in addition, the description of the characteristics and evolution of patients with lung cancer who have contracted covid-19 infection will be carried out. for the identification of patients who contract covid-19 infection, the igg+ test in blood will be used by elisa method. the scope of phase ii is the confirmation of the presence of antibodies (igg) in patients who tested positive in phase i of the study a few weeks after the first diagnosis made through the solid study. the scope of phase iii is the confirmation of the presence of antibodies (igg) in patients with lung cancer who have been vaccinated with any of the available and authorized vaccines for sars-cov2 and 6 months after said administration.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with lung cancer at any stage of the disease 2. age ≥ 18 3. patients who have signed the informed consent for this study exclusion criteria: 1. patients who have not signed or do not wish to sign the informed consent for this study

Keywords: igg coronavirus covid-19 lung cancer
evaluation of the effect of cgf in promoting mechanical-stretch induced in vivo skin regeneration

Conditions: Scar

Summary: the purpose of this study is to evaluating whether autologous concentrate growth factors(cgf) is safe and/or effective to accelerating skin regeneration and soft tissue expansion.


Eligibility criteria:
inclusion criteria: * age of 14 to 65 years; * expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back; * persistent high level of expander internal pressure; * need for further skin expansion; exclusion criteria: * • not fit for soft tissue expansion treatment; * evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy; * significant renal, cardiovascular, hepatic and psychiatric diseases; * significant medical diseases or infection (including but not limited to the carrier of hepatitis b virus or hiv) * bmi \>30; * history of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis; * history of allogenic bone marrow transplantation; * long history of smoking; * evidence of malignant diseases or unwillingness to participate.
polymorphism of apoe in alzheimer's disease: genetic study in castile and leon (spain)

Conditions: Alzheimer Disease

Summary: the general objective of this randomized and longitudinal clinical study was to estimate the frequencies of apoe variants both in the user population of the "messengers of peace" residences and the "associations of relatives of alzheimer's patients" in castile y leon, since, due to its geographical location at the crossroads, it has received multiple genetic contributions from both northern europe, the mediterranean area and northern africa. the main questions it aims to answer are: * what are the allelic frequencies of apoe variants in the population of individuals with alzheimer's disease in castile and leon? * is there a correlation between the apoe4 variant and the lipid profile in the blood of individuals with alzheimer's disease in this region?

in the context of alzheimer disease research, it is widely recognized that the apoe gene plays a fundamental role in the genetic predisposition of this disease. with three major alleles: apoe2, apoe3, and apoe4, genetic variability in the apoe gene has been the subject of extensive attention in previous research and its association with increased risk of alzheimer's disease has remained consistent. within this framework, three hypotheses are proposed focused on understanding the specific influence of apoe on alzheimer's disease and exploring the possible underlying mechanisms. within this framework, three hypotheses are proposed focused on understanding the specific influence of apoe on alzheimer disease and exploring the possible underlying mechanisms: 1. - research hypotheses: the genetic variant apoe4/4 is significantly related to a higher risk of developing alzheimer's disease compared to individuals who do not carry this genotype. 2. - research hypotheses: the apoe2/2 genetic variant is associated with a lower risk of developing alzheimer's disease compared to other genotypes. 3. - research hypotheses: people who carry the apoe4 isoform have elevated levels of total cholesterol and ldl-cholesterol.

Eligibility criteria:
inclusion criteria: * be between 60 and 90 years old. * subjects with a diagnosis of ad in the case group. * subjects free of ad diagnosis in the control group. * subjects who voluntarily and consented to participate free of charge. * have completed the written consent exclusion criteria: * subjects who, at the time of sample collection, had behavioral or other alterations that made the sample collection procedure impossible. * subjects who, at the time of sample collection, presented oral alterations incompatible with the technique.

Keywords: alzheimer's disease apoe polymorphism geographical distribution cardiovascular factors total cholesterol