Kornimate/medical-research-clean huggingface dataset:
early experience with descemet's stripping automated endothelial keratoplasty

Conditions: Corneal Edema Secondary to Corneal Endothelial Dystrophy

Summary: the purpose of this study is to report the early clinical outcomes in patients undergoing descemet's stripping automated endothelial keratoplasty (dsaek) for corneal edema secondary to corneal endothelial cell dysfunction, and to correlate this clinical data with the latest generation of imaging modalities available for the anterior segment.

a concurrent study for retrospective as well as prospective cases of patients undergoing dsaek procedures for indication of corneal endothelial cell dysfunction. for the retrospective study, all cases of dsaek procedures performed at ut-southwestern for corneal edema secondary to endothelial cell dysfunction will be considered. the clinical outcomes of these surgeries will be analyzed and correlated with the anterior segment imaging from each case. statistical analysis will then be performed on the data collected. for the prospective arm of this trial, we propose to recruit up to 200 current patient cases of corneal edema second corneal endothelial cell dysfunction. these patients will undergo ocular imaging studies in addition to routine ocular exams performed before surgery and at the discretion of the investigational physician at 3 to 6-months and 6 to 9-months after surgical treatment. various imaging modalities would include corneal topography, pentacam, anterior segment oct, wavefront measurement and tandem scanning confocal microscopy (tscm). the patients who have already had the dsaek procedure done in the past will undergo ocular examination as well as various imaging studies at their post op follow up visits. all these modalities are routinely used as standard of care practice and are non-invasive. the data from the ocular examination and various imaging techniques will be pooled and analyzed at the end of the study in order to identify the factors that influence the visual outcome. we believe this will help us learn more about this interesting and innovative technique while at the same time help us improve the method further in order to obtain better results in future patients.

Eligibility criteria:
inclusion criteria: * patients aged 18 and up, where any age over 89 will be recorded as 'greater than 89', who have reviewed and understood the study consent form will be invited to participate in this study. * they will be recruited based on diagnosis of corneal edema secondary to endothelial cell dysfunction undergoing dsaek either alone or in conjunction with phacoemulsification and intraocular lens implantation at the university of texas southwestern medical center at dallas. exclusion criteria: * patients younger than 18 years will not be considered for this trial. * the study will include all patients (no exclusion criteria) who have undergone and will undergo dsaek implantation for corneal edema secondary to corneal endothelial dystrophy with an effort to determine its success.

Keywords: endothelial dystrophy fuchs' endothelial corneal dystrophy
sensable®care system: establishing a communications system for patient fall reduction

Conditions: Fall From Bed

Summary: the purpose of this study is to test the effectiveness, safety and side effects of sensable®care system for inpatients. the sensable®care system uses pressure sensors and computer software to sense how patients are positioned on the bed in order to reduce bed falls. the sensable®care system mattress has sensors embedded in them, which will be monitored by the nurses in your unit. this study has three specific aims: 1. to assess the comfort of the system when used with hospitalized patients; 2. to observe how the system can be integrated into nurses' and hospital staff's regular workflow to help to modify and improve the system. 3. to analyze data from nursing response to alerts generated from hospitalized patients to improve alert system performance.


Eligibility criteria:
inclusion criteria: * gender: male or female * age: 18 years and older * racial and ethnic origin: all ethnic groups * hospital status: admitted in-patient or a patient under observation * expected hospital length of stay: minimum of 23 hours * willingness to participate in the study * moderate to high fall risk scoring a 2 or greater on the mobility or mental/loc/awareness status sections of the hester davis fall risk assessment. exclusion criteria: * declined to participate * patients less than 18 years old * patients who have been identified as a low fall risk or moderate fall risk with score less than 2 on the mobility or mental/ loc/awareness status sections of the hester davis fall risk assessment * women who are documented as pregnant during the study period * patients who are medically unstable; as per the discretion of the primary nurse * patients who are actively in the dying process, at the discretion of the primary nurse

Keywords: fall prevention bed fall acute care patient safety patient monitoring health technology assessment sensor devices and platforms nursing
comparison of two combinations of opioid and non-opioid analgesics for acute periradicular abscess

Conditions: Periapical Abscess

Summary: aim: the aim of this study was to compare the analgesic efficacy of two combinations of opioid and non-opioid analgesics for acute periradicular abscesses. methodology: this study included 24 patients who sought emergency care in a brazilian dental school. the patients were randomly divided into two groups: codeine/acetaminophen - oral prescription of codeine (30 mg) plus acetaminophen (500 mg), every 4 h, for 3 days or tramadol/acetaminophen - oral prescription of tramadol hydrochloride (37.5 mg) plus acetaminophen (500 mg) on the same schedule. patients recorded pain scores in a pain diary 6, 12, 24, 48, and 72 h after treatment, using the visual analogue scale.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute periradicular abscess * age greater than 18 years * spontaneous pain greater than 40 mm measured in visual analogue scale (moderate to severe pain). exclusion criteria: * intake of analgesics or antibiotics within 4 hours prior to emergency surgery * allergy to the drugs used in this study * gastric ulcer, liver or kidney disease * uncontrolled diabetes mellitus or epilepsy * pregnancy or lactation

Keywords: acetaminophen analgesia codeine drug combinations endodontics periapical abscess randomized controlled trial tramadol visual analog scale
pertubation with lignocaine in endometriosis

Conditions: Endometriosis; Dysmenorrhea

Summary: endometriosis is a disease of unknown aetiology that can cause severe dysmenorrhea. an altered immune system with elevated levels of cytokines in the peritoneal fluid as well as increased density of nerve fibres, might explain the pathophysiology of dysmenorrhea in endometriosis patients. lignocaine has anti-inflammatory properties and exerts effect on nerve endings and intra peritoneal macrophages. pertubation with lignocaine might represent an alternative treatment for endometriosis related dysmenorrhea and avoids the side-effects related to hormonal treatments. a double blind randomized clinical trial, was carried out to evaluate pertubation with lignocaine as a therapy for dysmenorrhea.


Eligibility criteria:
inclusion criteria: * age \> 20 years * endometriosis verified by laparoscopy * dysmenorrhea or pelvic pain defined as a pain-score of \>50 mm (vas) * normal fallopian tubes * regular menstrual cycles 21-35 days * treatment with oral contraceptives (oc) ongoing \> 1 month and continued during the trial * previous hormonal treatment discontinued \> 1 month (oc, gestagens) and \> 6 months (gnrh) * no wish for pregnancy during the study * normal pap-smear * negative chlamydia-test * negative pregnancy-test * informed consent given and signed exclusion criteria: * continuous treatment with medication that may increase risk for infection - clinical signs of pelvic inflammatory disease * hyperreactivity to local anesthesia * fibroids \> 2 cm * ongoing treatment with gnrh-analog * ongoing continuous treatment with high dose gestagens * pregnancy * peritubal adhesions * occluded fallopian tubes * inability to understand information or comply with the study procedures * participation in a clinical study within one year before the present study * any disease or laboratory finding considered of importance by the investigator not to include the patient

Keywords: dysmenorrhea, pelvic pain dyspareunia endometriosis
study of biomarkers in tissue samples from patients with breast cancer

Conditions: Breast Cancer

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is looking at tissue samples from patients with breast cancer.

objectives: * identify by mass spectroscopy and site-specific mutagenesis the post-translational modifications of estrogen-related receptor alpha (errα1) that are responsible for errα1 function as a constitutive activator rather than a down-modulator of transcription of estrogen response element-regulated genes in tumors of patients with breast cancer. * produce a panel of monoclonal antibodies to errα1 by standard hybridoma methods that can be used to distinguish between the activator and repressor forms of this receptor in these patients. * validate the utility for immunohistochemistry (ihc) assays of some of the errα-specific sera by performing ihc and quantitative real-time pcr on some primary breast carcinomas. * correlate the results of ihc studies on archival paraffin sections of primary breast tumors using monoclonal antibodies to errα1, errα1 status, currently assayed biomarkers, and course of treatment with patient outcomes. outline: breast tumor tissue samples are obtained from a tissue bank in the form of frozen tumors and paraffin-embedded sections on microarray blocks. monoclonal antibodies (moabs) to errα1 are produced using antigens in these tissue samples and immunohistochemical studies are performed using the moabs. cytogenetic studies are performed on dna purified from these tissue samples.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer * tumor tissue available * the following clinical information must be known: * erbb2 status * nodal status * percent s phase * hormone receptor status: * estrogen receptor and progesterone receptor status known patient characteristics: * menopausal status not specified prior concurrent therapy: * not specified

Keywords: breast cancer
school-based education and screening program with lipid screening as a means to identify familial hyperlipidemia

Conditions: Familial Hyperlipidemia

Summary: determination of fh status by genetic testing in school age children who have demonstrated elevated cholesterol on baseline screening.


Eligibility criteria:
inclusion criteria: elevated cholesterol on baseline screening to use as means of identifying those with an fh variant exclusion criteria: * normal cholesterol
combined colloids and crystalloids versus crystalloids in women with preeclampsia undergoing cesarean delivery

Conditions: Pre-Eclampsia; Cesarean Section

Summary: this study will compare between combination of colloids/crystalloids and crystalloids in women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia

this randomized, controlled, double blind study will be conducted on women with preeclampsia with singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. immediately, after spinal anesthesia administration, patients will receive either 250 ml colloid over 5 minutes followed by 500 ml crystalloid over 55 minutes then 250 ml colloid over 60 minutes (combination group) or 250 ml crystalloid over 5 minutes followed by 500 ml over 55 minutes then 250 ml over 60 minutes (crystalloid group). the studied maternal outcomes will be the urine output, ephedrine requirement, incidence of hypotension, inferior vena cava diameters, nausea/vomiting and bradycardia. neonatal apgar scores will be recorded at 1 and 5 minutes post-delivery.

Eligibility criteria:
inclusion criteria: * preeclampsia: blood pressure ≥140/90 mmhg after 20 weeks' gestation and proteinuria ≥300 mg/24 hours or 1+ on urine dipstick * singleton pregnancy * elective cesarean delivery under spinal anesthesia exclusion criteria: * height \<150 cm * weight \<60 kg * body mass index ≥45 kg/m2 * women presenting in labor * contraindications to spinal anesthesia (increased intracranial pressure or local skin infection) * diabetes mellitus, cardiovascular, cerebrovascular, or renal disease * preoperative administration of intravenous hydralazine or magnesium sulphate * hemoglobin \<10 gm/dl * international normalized ratio \>1.3 * platelet count \<100,000 /mm3 * preoperative serum creatinine \>1.1 mg/dl
functional and cognitive impairment prevention for elderly hospitalized patients

Conditions: Functional Impairment; Cognitive Impairment; Elderly

Summary: the current model of care for the hospitalized elderly patients has been conditioned by many factors unrelated to the disease process that caused the hospitalization and usually worsen the outcome of hospitalization circumstances. many times hospitalized elderly patients spend most of the time in bed (even higher than 83% of bed rest versus 4% of those who stand or are walking). these patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. the consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, deconditioning, pressure ulcers and decreased caloric intake, social isolation, poor quality of life and increased use of resources related to health. exercise training can prevent functional and cognitive decline and modify even the posterior trajectory.

this study is a randomized clinical trial conducted in a department of geriatrics of a tertiary public hospital with 35 beds allocated. hospitalized patients who meet the inclusion criteria will be randomly assigned to intervention or control group. patient recruitment will begin in the first 48 hours of admission to the ward, which will be identified through the list of patients admitted to the hospital and assigned to the department of geriatrics. the doctor who decides the inclusion in the intervention or control group will not be the attending physician. patients or their families (if the patient has cognitive impairment) will be informed of the random inclusion in one group, but will not be informed as to which they belong. randomization will be performed by applying http://www.randomizer.org/. the information in both the intervention group and the control group will obtained in four different stages: the initial visit and at months 3, 6 and 12 after hospital discharge.

Eligibility criteria:
inclusion criteria: * age 75 years and older * able to tolerate exercise * able to ambulate, with or without personal / technical assistance or move unassisted in a wheelchair * able to communicate * non-elective admission to hospital exclusion criteria: * severe dementia (gds 7) * duration of hospitalization \<72 hours * unwillingness to either complete the study requirements or to be randomized into control or intervention group * unstable cardiovascular disease or other unstable medical condition * terminal illness

Keywords: exercise physical fitness geriatrics
performance of a hydrophilic and a hydrophobic intraocular lens of similar design

Conditions: Cataract

Summary: comparison of the capsular bag performance of the rayone hydrophobic aspheric with the rayone aspheric

cataract surgery is nowadays considered a safe surgery with a short rehabilitation time for the patients. two main problems arising post-surgically are the predictability and stability of the implanted intraocular lens (iol) in the capsular back and the formation of posterior capsule opacification (pco). the performance of the iol in the capsular bag influences the anterior chamber depth (acd), tilt and decentration of the iol, as well as formation of pco. the main source of error for calculation of iol power is an inaccurate prediction of the post-surgical acd resulting in short- or farsightedness. furthermore, capsular fibrosis and phimosis can also lead to tilt and decentration of the intraocular lens. pco is one of the most frequent long-term complications after cataract surgery, occuring in about 12% after 1 year, in 21% after 3 years, and in 28% after 5 years post-surgically. pco arises when lens epithelial cells (lecs) migrate and proliferate, growing in between the iol and the posterior capsule, leading to decreased visual acuity. material and design of the iol may have an effect on the formation of pco. it is suggested that 360° square edge design and hydrophobic material of the iol may help in the prevention of pco. hence, the aim of this study is to evaluate the capsular bag performance of monofocal iols with different materials but similar design and their influence on pco formation. 100 eyes of 50 patients will be included into this study. after randomization one eye is implanted with the hydrophilic iol, whereas the other eye gets the aspherical iol. follow-up visits will be 1 - 2 hours and 1 week after the surgery, as well as 6 months, 12 months, and 24 months post-surgically. during this visit a slit lamp examination, measurement of the intraocular pressure, visual acuity assessment, biometrical measurements of the eye, retroillumination photography and analysis of tilt and decentration of the iol using the purkinjemeter will be performed.

Eligibility criteria:
inclusion criteria: * age-related bilateral cataract * age 21 or older * visual acuity \> 0.05 * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * written informed consent prior to surgery exclusion criteria: * relevant other ophthalmic diseases such as pseudoexfoliation syndrome (pex), intraoperative floppy iris syndrome (ifis), cornea pathologies * previous ocular surgery or trauma * pregnancy (pregnancy test will be taken in women of reproductive age)

Keywords: cataract, cataract surgery, intraocular lens
effects of transfusion thresholds on neurocognitive outcome of extremely low birth weight infants

Conditions: Anemia of Prematurity

Summary: to compare the effect of restrictive versus liberal red blood cell transfusion thresholds on long-term neurodevelopmental outcome in extremely low birth weight infants.

extremely low birth weight (elbw) infants uniformly develop anemia of prematurity and frequently require multiple red blood cell transfusions (rbct) during neonatal intensive care. the criteria currently applied to indicate rbct in this population are based on expert opinion rather than evidence and conclusive data of long-term effects of rbct practices do not exist. both, giving rbct to improve oxygen carrying capacity and restricting rbct to avoid rbct associated risks and costs potentially impair long-term development. the proposed blinded randomized controlled trial was designed and will be powered to compare the effect of restrictive versus liberal red blood cell transfusion guidelines on long-term neurodevelopmental outcome in elbw infants. elbw infants will be randomized to receive rbct according to liberal or restrictive rbct guidelines, which both reflect current practice in germany and aim for a clinically relevant difference in mean hemoglobin concentrations. the primary outcome measure is the incidence of death or major neurodevelopmental impairment determined at 24 months of age corrected for prematurity. key secondary outcomes are the incidences of individual components of the composite primary outcome, the mental and physical developmental index scores of the bayley scales of infant development (ii edition), and growth. safety analyses will assess the incidences of all major diseases of prematurity. the results of this trial may help to improve the quality of life of these patients and reduce long-term health care costs.

Eligibility criteria:
inclusion criteria: * infants with a birth weight of 400 - 999g exclusion criteria: * missing written parental consent. * gestational age \> 29 + 6/7 weeks * major congenital anomalies (including chromosomal aberrations, cyanotic congenital heart defects, syndromes likely affecting long-term outcome, and major congenital malformations requiring surgical correction during newborn period). * infants who died before 48 hours, infants in whom the clinical decision to withhold intensive care was made, infants who were not considered viable * participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study

Keywords: prematurity anemia transfusion
long-term effects of hydroxyurea in children with sickle cell anemia (the baby hug follow-up study)

Conditions: Anemia, Sickle Cell

Summary: sickle cell anemia (sca) is an inherited blood disorder that can cause organ damage. the baby hug study is evaluating the use of the medication hydroxyurea at preventing organ damage in children with sca. the purpose of this follow-up study is to evaluate the long-term effects of hydroxyurea in children who have participated in the baby hug study.

sca is an inherited blood disorder in which the body makes sickle-shaped red blood cells that contain abnormal hemoglobin. the sickled cells block blood flow in the vessels that lead to limbs and organs. this can cause pain, serious infections, and organ damage. the baby hug study (nct00006400) is examining whether the medication hydroxyurea can prevent organ damage, especially in the spleen and kidneys, in children with sca. this study is a follow-up study to the baby hug study and will enroll children who have participated in the baby hug study. the purpose of this study is to examine the long-term effects of using hydroxyurea as a treatment for sca, including both the risks and benefits. study researchers will also investigate the optimal age to begin treatment with hydroxyurea in children with sca. this study will enroll children between 2 and 7 years old who participated in the baby hug study. hydroxyurea will not be provided to participants as part of this study, but participants may receive the medication from their own doctors. parents of participants can choose for their child to participate in this study in one of two ways-by enrolling in either a passive follow-up group or an active follow-up group. for participants in the passive follow-up group, study researchers will review participants' medical records every 6 months, in addition to reviewing brain ultrasound tests and computed tomography (ct) or magnetic resonance imaging (mri) scans, if completed. participants will have a blood and urine collection at baseline and year 4 (or at the end of the study, whichever comes first). participants in the active follow-up group will take part in the same study procedures as participants in the passive follow-up group. in addition, at year 2, participants in this group will undergo an additional blood and urine collection, a scanning procedure to obtain images of the liver and spleen, a kidney test, neuropsychological testing, and an ultrasound imaging test to evaluate liver and spleen size.

Eligibility criteria:
inclusion criteria: * all children who completed at least 18 months of follow-up visits in the initial baby hug study * children from the initial baby hug study who are on a chronic transfusion program or who are recipients of a bone marrow transplant exclusion criteria: * any child who was not enrolled in the initial baby hug study for at least 18 months

Keywords: sickle cell anemia hydroxyurea