Kornimate/medical-research-clean huggingface dataset:
a study of the trabecular micro-bypass stent in combination with cataract surgery in open angle glaucoma subjects.

Conditions: Open-Angle Glaucoma

Summary: to evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.

glaukos corporation conducted a clinical research study at multiple investigational sites within europe (8)

Eligibility criteria:
inclusion criteria: * diagnosed with primary open-angle glaucoma (poag) * subject on at least one glaucoma medication * patient requiring cataract surgery and an intraocular lens implantation exclusion criteria: * prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, alt, slt, shunt implant, collagen implant, cyclo destructive procedures etc) * angle closure glaucoma

Keywords: open angle glaucoma cataract surgery
using the electronic health record to guide management of newborn weight loss

Conditions: Breastfeeding; Breastfeeding, Exclusive; Morbidity;Perinatal; Feeding, Bottle

Summary: weight loss is normal for healthy newborns in the first few days, especially for those exclusively breastfed, who may have low enteral intake for several days. although most newborns tolerate this early period of weight loss well, those with pronounced weight loss become at increased risk of feeding problems and hyperbilirubinemia, which are the two most common causes of neonatal readmission. to facilitate the assessment of risk for an individual newborn, the newborn weight tool (newt) has been developed to categorize each infant's weight loss according to population norms, so that formula can be administered when weight loss is pronounced and avoided when weight loss is normal. the healthy start study will be a randomized, controlled trial testing whether displaying newt to clinicians providing newborn care can improve neonatal health outcomes including formula use, weight loss and readmission. newborns will be randomly assigned either to display weight with newt weight categorization to their providers in the electronic health record (ehr) or to usual care (weight displayed without newt categorization).


Eligibility criteria:
inclusion criteria: * assignment to a bed assignment on the well newborn service at the time of the first weight measured subsequent to birth weight and at \>6 hours and \<=96 hours of age exclusion criteria: * none

Keywords: formula
manual small incision cataract surgery outcomes in an educational setting

Conditions: Cataracts

Summary: the overall objective is to determine the visual outcomes and cost to perform manual small incision cataract surgery (msics) in a small cohort at an academic medical center in the united states. the primary outcome measure will be the percentage of the study group achieving a post operative visual acuity 20/40 snellen. this percentage will be compared to historical cohorts reported for phacoemulsification cataract surgery (pcs), when performed in academic centers. a secondary outcome will be to determine the actual institutional cost of providing msics in the setting of an academic medical center. the hypothesis is that msics is appropriate for a teaching environment (as evidenced by a comparable rate of 20/40 acuity or better at 90 days post op, as compared to pcs), and can be provided at a cost that makes visual rehabilitation affordable to the uninsured and underinsured.

the investigator will perform a study of a pilot implementation of portions of the aravind method of promoting access to care and provision of surgical services in the setting of an academic medical center teaching program. target enrollment is 100 subjects having cataracts. potential subjects will be identified through vision screening programs and if cataracts are found they will be offered msics at a price deemed to be affordable by individuals without insurance. a survey of pima county providers found that $3500 was the lowest price offered to a self-pay patient for one-stage cataract extraction (cpt 66984) for pcs facility fee, surgeon fee, and anesthesia fee. the expectation is that msics can be delivered in a teaching environment at a cost of $500. the investigator wishes to determine if this price point is sustainable and if a continuing model of cataract visual rehabilitation service delivery can be safely, affordably, and ethically delivered to those who cannot afford to pay, while integrating resident education and autonomy into the delivery model. the proposed outcome measure is the proportion of eyes that see 20/40 or better while wearing glasses for those participants that do not have comorbid conditions.

Eligibility criteria:
inclusion criteria: 1. age 21 years or older (adults). 2. medically stable, able to safely undergo surgery. 3. nuclear sclerotic cataract 4. preoperative best corrected visual acuity (bcva) 20/80 or worse 5. expected post-operative potential acuity of 20/40 or better 6. able to pay the $500 cost of surgery at the time of surgery exclusion criteria: potential subjects not satisfying any of the above
extension safety and immunogenicity study of gpnv-001

Conditions: Pneumococcal Infections

Summary: a 6 and 12 month safety and immunogenicity study of participants in study gpnv-001, a novel whole-cell pneumococcal vaccine.

a 6 and 12 month safety and immunogenicity study of participants in study gpnv-001, a novel whole-cell pneumococcal vaccine. up to 20 participants per cohort will be invited.

Eligibility criteria:
inclusion criteria: 1. completion of study gpnv-001 as per protocol with no significant deviations. 2. has provided written informed consent. exclusion criteria: 1. potential participants will be excluded if they have received a pneumococcal vaccine since the end of study visit for study gpnv-001 2. a potential participant has had an episode of pneumonia since completing study gpnv-001
quality of life in italian visually impaired patients

Conditions: Visual Impairment

Summary: clinical register of visual rehabilitation activity and observational study on the validation of the va lv vfq questionnaire in the italian context


Eligibility criteria:
inclusion criteria: * subjects aged 18 years or older, suffering from any visual pathology, who are admitted to specialised visual rehabilitation centres for visual rehabilitation. * ability to understand and sign the informed consent for participation in the study. exclusion criteria: * less than 18 years of age. * cognitive impairment that, in the opinion of the investigator, limits understanding of the informed consent or the questionnaire.
brain function and perfusion in patients with heart failure

Conditions: Heart Failure; Dilated Cardiomyopathy; Perfusion; Cognitive Impairment; Cerebral Hypoperfusion

Summary: the investigators will evaluate the determinants of cerebral impairment in patients with non-ischemic heart failure compared to controls, and its relation to cognitive function. they hypothesize that patients with heart failure have impaired brain perfusion and hemodynamic factors are associated with cognitive dysfunction.


Eligibility criteria:
inclusion criteria control group: * healthy subject, as assessed by clinician * age matched with patient group exclusion criteria control group: * age \< 18 years * carotid artery or intracranial disease, as assessed by echo-doppler (significant stenosis \> 50%) * unable or unwilling to undergo mri * the presence of ferromagnetic material in or on the body, for example tattoos with ferrous ink or pacemakers or cardiac defibrillators. also the presence of pregnancy and claustrophobia. * history of cognitive impairment * unable to understand procedures * unable or unwilling to provide informed consent inclusion criteria dcm-group: * heart failure due to dcm * 15 patients with nyha class ii * 15 patients with nyha class iii/iv exclusion criteria dcm-group: * age \< 18 years * history of myocardial infarction * history of peripheral artery disease * history of cerebrovascular disease or * carotid artery or intracranial disease, as assessed by echo-doppler (significant stenosis \> 50%) * history of cognitive impairment * unable to undergo mri (eg pacemaker) * unable to understand procedures * unable or unwilling to provide informed consent
anethesia efficacy on teeth with mih (molar incisor hypomineralisation)

Conditions: Low-level-laser Theraphy; Anesthesia, Local; Molar Incisor Hypomineralization

Summary: difficulty in achieving anesthesia in teeth with molar incisor hypomineralisation (mih) is a frequently reported clinical problem. the effect of low-level laser on the efficacy of anesthesia in teeth with mih has not been studied yet. aim of this study is to evaluate the effect of the photobiomodulation on the efficacy of anesthesia of maxillary permanent molar teeth with mih. design: the current study was conducted as a prospective, parallel-arm control, randomized, triple-blind clinical trial in children aged between 7to12 years. maxillary permanent molar teeth with mih requiring pulpotomy treatment were included. 70 participants were divided randomly into 2 groups as experiment (with pbmt) and control (placebo) according to the anesthesia technique. in the experimental group, before local infiltration anesthesia was administered, pbmt (a diode laser: 940 nm; continuous mode; 0.5w; 78 j/cm2) was applied perpendicular to the root surface at buccal and palatal area for 60 sec each). in the control group, the laser probe was directed to the mucosa for (buccal and palatal area), but not activated. evaluation of the pain scores were performed during the access cavity preparation of the pulpotomy treatment using the face, legs, activity, cry, consolability (flacc) scale. also, additional anesthesia requirements were assessed for both groups while working on the dentin and pulp


Eligibility criteria:
inclusion criteria: * clinical diagnosis of molar incisor hypoplasia (mih) * maxillary permanent first molars with mih * must be the score 3 of mih (european academy of paediatric dentistry mih diagnostic criteria exclusion criteria: * the teeth showing irreversible pulp pathology (according to the american association of endodontics) * the children who had negative or definitely negative behavior * allergy to local anesthetics * taking any medication that might affect the anesthetic assessment
addition of microrna blood test to lung cancer screening low dose ct

Conditions: Lung Cancer

Summary: to demonstrate that the specificity of the hummingbird microrna profile for the diagnosis of lung cancer in a cohort of patients who meet current eligibility criteria for lung cancer screening in the u.s. is superior to the specificity of ldct.

this is a prospective, longitudinal, blinded, observational diagnostic study on 400 individuals undergoing lung cancer screening with low-dose computed tomography (ldct). there will be two patient cohorts: cohort 1: individuals undergoing their first or subsequent annual ldct screening study; and cohort 2: individuals referred for a follow-up diagnostic chest ct scan due to a lung-rads category 3 or 4 result on a previous ldct scan. at study enrollment a blood sample will be drawn prior to the ldct scan. on this blood sample a novel lung cancer test relying on microrna signatures will be evaluated. the results will be compared with the ct scan results and follow-up tests including pathology. histologic results and follow-up data will be collected on all patients for a minimum of 12 months post-enrollment. during the follow-up period, the results of all diagnostic chest ct scans, lung biopsies or lung resections will be captured from the partners electronic medical record and entered into the case report form (crf).

Eligibility criteria:
inclusion criteria: 1. subject is undergoing ldct screening for lung cancer. 2. subject is 55 to 80 years of age. 3. subject has a minimum 30 pack-year smoking history. 4. subject has not quit smoking more than 15 years ago. 5. subject is without symptoms attributable to lung cancer. 6. subject is able and willing to provide informed consent. exclusion criteria: 1. subject has a history of lung, gastrointestinal, hematological, breast, thyroid, or genitourinary cancers within the past ten years. 2. subject is known to be infected with hiv, hbv, hcv, or tuberculosis or any other biosafety level 3 (bsl iii) pathogen infections.
study of epratuzumab in systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the safety and efficacy of epratuzumab with standard treatments for patients with sle.


Eligibility criteria:
inclusion criteria: * +ana at screening * bilag index b level activity in at least 2 body systems/organs * has sle by acr revised criteria (meets,\<4 criteria) exclusion criteria: * active severe lupus as defined by bilag index level a in any body system or organ. * allergy to human antibodies or murine.

Keywords: lupus, antibody, b-cell immunotherapy
the effects of trout fed with a vegetable based feed on cardiovascular risk markers and plasma proteome

Conditions: Cardiovascular Disease

Summary: fish from the aquaculture sector constitutes an increasing part of the fish consumption in denmark. the most important farmed fish in denmark is the rainbow trout. due to limited access of wild fish for the feed production, alternative feeding regimes of vegetable origin such as vegetable proteins and rapeseed oil are used instead of marine feed. this change in feeding regime may affect flesh quality and health and nutritional properties as the content of long-chain n-3 polyunsaturated fatty acids (n-3 lcpufa) will presumably decrease in the meat. the objective of the study is to investigate the effect of vegetable based feed versus marine feed of farmed trout and its effect in healthy men on cardiovascular risk markers associated with the development of cardiovascular disease (cvd).

in a two month parallel study including 60 healthy men aged 40-70 years, the cardiovascular effect of one daily meal of trout fed with a vegetable based feed are compared with that of trout fed with marine feed (estimated intake of n-3 lcpufa 2.6 g/day) and a standard danish diet with poultry. men are randomised to one of the three groups. red blood cell fatty acid composition, classical cardiovascular disease (cvd)-risk markers (blood pressure and plasma lipid profile), newer cvd-markers (arterial compliance and plasma markers of endothelial function and inflammation) and plasma proteome analysis are measured at the beginning and end of the intervention period.

Eligibility criteria:
inclusion criteria: * age 40-70 * body mass index 18,5 - 30 exclusion criteria: * exercise \>10 h/week * chronical diseases (eg. cardiovascular and diabetes) * regular medication * fish oil supplementation * blood donation 2 month prior or during participation * above maximum recommended alcohol intake * blood pressure \>160/100 mm hg

Keywords: nutrition cardiovascular risk inflammation vascular function
instruments for delirium assessment regarding to analgesia sedation and ventilator status

Conditions: Delirium

Summary: in this prospective, multicenter observational study we assess the diagnostic validity of the following standard screening instruments for delirium regarding sedation, analgesia and ventilator status in critically ill patients: * confusion assessment method for the icu (cam-icu) * intensive care delirium screening checklist (icdsc) * nursing-delirium-screening-scale (nu-desc) the definite delirium diagnosis (definite in terms of reference standard) is made according to the criteria of the diagnostic and statistical manual of mental disorders 4th edition, text revised (dsm-iv-tr) published by the american psychiatric association (apa) which is the gold standard to diagnose delirium. primary research question: does sedation, ventilator status and analgesia influence the sensitivity of delirium screening tools (dst)?


Eligibility criteria:
inclusion criteria: * critically ill patient * patient age \> 18 years exclusion criteria: * neurosurgical patients * severe brain injury, intracerebral bleeding, stroke * inability to communicate due to anacusia or severe hearing loss * insufficient language comprehension * patients \< 24 h total time of intensive care unit stay * deep sedation (rass \< -3) for ≥ 7 days during study participation
transmuscular quadratus lumborum block plus pericapsular injection vs pericapsular injection

Conditions: Hip Pain Chronic

Summary: the purpose of this research study is to compare two different treatment options on their effectiveness to reduce post-operative pain, narcotic (opioid pain medication) usage and recovery time in patients undergoing primary hip arthroscopy surgery. the first treatment option is a transmuscular quadratus lumborum (tql) block plus hip incision site (pericapsular) injection. the tql block is an ultrasound guided injection between the quadratus lumborum and the psoas muscles in the back. the anesthesiologist will perform the tql block the second treatment option is only a hip incision site (pericapsular) injection. in this group, the surgeon will inject local anesthetic into the incision or hip portal sites to decrease sensation.

this is a phase iv, randomized, single-blind, single-center study comparing postoperative pain, opioid usage and post-anesthesia care unit (pacu) recovery time for patients who receive a transmuscular quadratus lumborum block (tqlb) plus pericapsular injection versus pericapsular injection (pci) undergoing primary hip arthroscopy.

Eligibility criteria:
inclusion criteria: * patients between 18 and 65 years of age * patients undergoing primary hip arthroscopy * patients diagnosed with femoroacetabular impingement (fai) * patients who consent to be randomized. exclusion criteria: * patients younger than 18 and older than 65; * patients with a history of chronic pain that have used opioids for pain management for 3 months or longer; * patients with diagnosed or self-reported cognitive dysfunction; * patients with a history of neurologic disorder that can interfere with pain sensation; * patients with a history of drug or recorded alcohol abuse; * patients who are unable to understand or follow instructions; * patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease; * patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures; * patients with bmi over 40; * any patient that the investigators feel cannot comply with all study related procedures.
safety and efficacy study of mre0094 to treat large, single or multiple, chronic, neuropathic, diabetic foot ulcers

Conditions: Foot Ulcer, Diabetic; Diabetes Complications

Summary: this is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers. the purpose of the study is to determine the safety of the experimental drug when applied to large, diabetic foot ulcers. the study will also determine if the experimental drug can safely promote healing of diabetic foot ulcers better than standard treatments currently available to doctors. patients participating in the study may receive an active drug (mre0094) or inactive drug (placebo). what treatment a patient will receive is determined by chance (like drawing a number from a hat). all patients will receive additional care for diabetic foot ulcers during the study. participation in the study can be up to 4½ months.


Eligibility criteria:
inclusion criteria: participants included in the study must: * have type 1 or type 2 diabetes mellitus. * have problems with the nerves in their feet. * have a large ulcer or multiple ulcers on the bottom surface of their foot that has been present for 3 weeks or more and is of sufficient size to qualify for the study. * be able to apply study drug to their ulcer, or have a caregiver do it. * be able to visit the doctor regularly during the 4½ month study. exclusion criteria: participants may not participate in the study if: * their ulcer is caused by bad blood flow to their foot. * their ulcer is infected. * they cannot wear an off-loading device during the study to take pressure off the ulcer. * they have certain other diseases, or are using certain types of drugs.

Keywords: toe ulcer heel ulcer foot ulcer diabetic feet diabetic foot complications of diabetes
study on the efficacy mechanism of natural psychotherapy for neurosis

Conditions: Obsessive-Compulsive Disorder

Summary: explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder

1. to evaluate the cognitive function, cognitive control, emotion and other aspects of neurosis patients, and to understand and master the cognitive behavior indicators of this population. 2. investigate the pathological mechanism of neurotic patients from the aspects of eeg/fmri and biology. 3. to investigate the therapeutic effect of natural psychotherapy on cognitive impairment and related mood, sleep and symptom intervention in neurotic patients. in order to achieve the symptoms of neurosis patients, cognitive impairment and related mood and sleep intervention and promotion, while providing a scientific basis for neurosis rehabilitation.

Eligibility criteria:
inclusion criteria: * were between 16 and 55 years old; * were diagnosed with ocd by an experienced psychiatrist utilizing the structured clinical interview for dsm-5 (scid); * had an illness duration of at least 12 months; * were able to participate in the entire trial and face-to-face on-site assessment exclusion criteria: * pregnant or breastfeeding; * suffered from organic brain diseases or severe physical illness; * had a history of substance or alcohol abuse * were at high risk of suicide

Keywords: obsessive-compulsive disorder natural psychotherapy