Kornimate/medical-research-clean huggingface dataset:
effect of ruboxistaurin on clinically significant macular edema

Conditions: Diabetic Macular Edema

Summary: the purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (smvl) in patients with clinically significant macular edema. smvl is defined as a 15 letter or more decrease from baseline in best-corrected early treatment diabetic retinopathy study (etdrs) visual acuity that is sustained for the patient's last 6 months of study participation. the smvl data from this study will be combined with the smvl data from study b7a-mc-mbdl for the purpose of comparing ruboxistaurin to placebo.


Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetes * 18 years or older * hemoglobin a1c (hba1c) less than or equal to 11% * mild to very severe non-proliferative diabetic retinopathy in the study eye * clinically significant macular edema in the study eye not within 100 microns of center of macula exclusion criteria: * previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye * glaucoma in the study eye * unstable cardiovascular disease * major surgery within past 3 months * significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.
percutaneous temporary placement of a transvenous phrenic nerve stimulator for diaphragm pacing using jugular access

Conditions: Ventilator-Induced Lung Injury

Summary: study conducted to confirm phrenic nerve stimulation using the a transvenous phrenic nerve stimulator in the left jugular vein.

the lungpacer jugular access feasibility system is a prototype for the lungpacer diaphragm pacing therapy system (dpts) and consists of the live catheter, a stimulation system with a multipole panel accessory, an airflow sensor and a heart rate data capture device. the catheter is intended for inclusion in the commercial product. the stimulation system with a multipole panel accessory and a heart rate data capture device is an interim component created to enable initial safety and feasibility testing of the lungpacer dpts concept.

Eligibility criteria:
inclusion criteria: * 18 years of age or older; * able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent; * able to undergo general anesthesia (sedation, intubation, and mechanical ventilation); * acceptable indication for atrial septal defect closure. exclusion criteria: * subject has an ejection fraction of \< 30% * subject has a co-morbid illness or life expectancy \< 2 years * subject has experienced an acute myocardial infarction within 72 hours prior to this procedure * subject is contraindicated for or unwilling to take aspirin or anticoagulants * subject is in cardiogenic shock * subject has other cardiovascular disease requiring open heart surgery * subject is known to have a demonstrated intra cardiac thrombus on echocardiography * subject has been treated with paralytic medications within 72 hours prior to procedure * subject has significant thoracic abnormalities such that placement of a left subclavian line would be difficult * inability to cannulate the left subclavian vein (post-consent exclusion) * subject has a known or suspected phrenic nerve paralysis * subject has co-existing temporary or implanted cardiac electrical devices such as a pacemaker or defibrillator * subject has an active systemic infection or local infection at or around the insertion site * subject is known or suspected to be pregnant or is lactating * subject will be unavailable for, or is unwilling to comply with, follow up requirements of the protocol * subject is currently enrolled in any other study of an investigational drug or device who has received treatment under that protocol with the investigational product during the 30 days prior to screening.
follow-up of hbsag inactive carriers study

Conditions: Hepatitis B

Summary: the definition of hbs antigen (hbsag) inactive carrier status has evolved during time. we spoke first from hbsag" healthy carrier ", then from " asymptomatic carrier ", last from hbsag" inactive carrier ". this definition continue to be not totally consensual. a very low viral load (\< 2000 ui/ml) or undetectable, associated with repetitive normal transaminases and with detectable anti-hbe antibodies were necessary to affirm the inactive carrier status on 2009 easl recommendations. the 2012 easl recommendations confirm that the normality of alanine aminotransferase (alt) with an upper limit of normal (uln) approximately below 40 ui/ml, like low viral load (hbv-dna), does necessary be verified every 3 or 4 months during a year to diagnose an inactive carrier. nevertheless, they admit the possibility for some patients to be inactive carriers with hbv-dna between 2000 and 20000 ui/ml with consistently normal transaminases this study will follow-up hbsag inactive carriers during 5 years, in order to evaluate the incidence of unfavourable liver events: chronic hepatits b, liver cirrhosis, hepatocarcinoma (chc) during this time, and to determine the independant prognosis criteria of unexpected arrival of such events. secondary outcomes will evaluate hbsag quantification for the prognosis of such events or, in contrary hbs seroconversion; will evaluate the influence of b genotype on hbsag level; will evaluate the influence of comorbidities on unexpected arrival of such events.


Eligibility criteria:
inclusion criteria: * hbsag + since one year or more. * hbeag -, anti-hbe antibodies + * hbv-dna \< 20000 ui/ml on all dosages realized during past year (ultra-sensitive pcr with a detection threshold \< 20 ui/ml), at least 2 dosages during past year. * ast and alt transaminases \< uln on all dosages realized during past year (at least 3). * age \> 18 and \< 70 * we will include consecutively all encountered patients (consultation, hospitalization) and diagnosed as hbsag inactive carriers in each participating center. exclusion criteria: * anti-vhc antibodies + * anti-vhd antibodies + * anti-vih antibodies + * genetic hemochromatosis * liver cirrhosis on liver biopsy or with non-invasive methods (fibrometer, fibroscan, fibrotest, hepascore ...) * past or present treatment against hbv * ultrasonic diagnosis of hcc or portal hypertension * non compliant patient whom 5 years follow-up seems uncertain.

Keywords: hepatitis hbv chronic hepatitis hcc cirrhosis quantitative hbsag hbsag inactive carriers
pathophysiological basis of hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: hs is a chronic inflammatory disease manifested by recurrent inflammatory nodules, abscesses and tunnels under the skin. this disease is characterized by an inflammatory process that takes place in hair follicles, sebaceous glands and surrounding tissue. because of its frequent recurrence and chronicity, it represents a major public health problem and there is a need for better diagnosis and new and more effective drugs. this research can be a part of realizing the stated needs.

hs patients, divided into three groups depending on the stage of hidradenitis, would participate in the study. the first and second groups would include stage 2-3 patients (according to the hurley scale) in whom partial or complete clinical remission occurred after biological therapy and surgical treatment was performed according to the guidelines. in the third (control) group, we would classify the samples obtained from the above-mentioned patients, from whom we would take a sample of "normal" skin measuring 1 x 1 cm. with the standard procedure of pathohistological tissue processing after tissue fixation with 10% buffered formalin and embedding in paraffin, tissue sections stained with standard hematoxylin and eosin (he) staining will be analyzed using a light microscope in such a way as to determine the type and amount of inflammatory infiltrate, the amount of granulation tissue and fibrosis and epithelial changes of the surface and follicular epithelium and graded according to intensity into 3 categories. the mentioned tissue samples fixed in formalin and embedded in paraffin will be used to make tissue sections for immunohistochemical staining. the expression of inflammatory cytokines will be analyzed using the indirect peroxidase immunohistochemical method. primary and secondary antibodies will be used for immunohistochemical analyses. the prepared tissue sections will be deparaffinized in a xylene solution and then dehydrated in a series of ethyl alcohols of decreasing concentrations (100%, 96% and 75%). it will then be washed three times with pbs solution and in citrate buffer (10mm, ph 6.0). sections will then be washed with triton x 100 solution (0.3% in pbs) at room temperature. after that, endogenous peroxidase will be inactivated using hydrogen peroxide in methanol (0.3%) for 30 minutes. after washing the tissue sections with pbs solution, normal serum (10%) will be added for 60 minutes. after washing the tissue sections in pbs solution (ph 7.4), the secondary antibody will be added depending on the primary one. tissue rehydration will be done in ethyl alcohols of increasing concentrations (75%, 96% and 100%). after clarification with xylol, the preparation will be incorporated into entalan. the intensity of immunohistochemical staining will be analyzed using the imagej computer program according to the staining intensity.

Eligibility criteria:
inclusion criteria: * hidradenitis suppurativa exclusion criteria: * patients with no hs * patients who do not want to be in the clinical trial
healing of persistent epithelial defects

Conditions: Cornea

Summary: the purpose of this study is to compare the relative efficacy of four different treatment modalities (i.e. aggressive lubrication, bandage contact lens, ambiodisk amniotic membrane, prokera amniotic membrane) in the healing of persistent corneal epithelial defects following retina surgery.


Eligibility criteria:
3.1 inclusion criteria * adults aged 18 and older (inclusive) at the time of study enrollment * recent history of retina surgery * presence of persistent epithelial defect 7 days or later after surgery * english speaking 3.2 exclusion criteria * non-english speaking patients * inability to incapacity to provide consent for the study * history of corneal epithelial or limbal stem cell disease

Keywords: cornea epithelial defect amniotic membrane
optical coherence tomography of nerve fiber layer and ganglion cell complex after cataract extraction

Conditions: Cataract; Primary Open-angle Glaucoma

Summary: optical coherence tomography (oct) for retinal nerve fiber layer (rnfl) and ganglion cell complex (gcc) is done before and after cataract extraction in patients with or without primary open angle glaucoma (poag)

the investigator's study includes two groups of patients, each consists of 25 eyes, group 1 (cataract group)includes patients who are planned for cataract extraction without any other preexisting retinal or optic nerve pathology that may affect the rnfl thickness, while group 2 (combined cataract and glaucoma group) includes patients who are diagnosed with poag controlled on medical treatment with cataract and planned for cataract extraction only. the oct scans with complete ophthalmological examination are done before surgery and 6 weeks after uneventful cataract extraction (phacoemulsification with intraocular lens implantation)

Eligibility criteria:
inclusion criteria: • patients with cataract without any other concomitant retinal, optic nerve head pathology other than poag are included in the study and divided onto two groups exclusion criteria: * patients having any retinal or optic nerve pathology that might have affected nerve fiber layer thickness other than poag eg: high myopia * poag patients who are planned for combined surgery * refractive errors greater than spherical equivalent of 6 diopters (myopia or hypermetropia) * dense cataract hindering oct imaging * history of previous ocular surgery or trauma

Keywords: retinal nerve fiber layer (rnfl) ganglion cell complex (gcc) optical coherence tomography (oct) primary open angle glaucoma (poag) cataract
web-based program for symptom management in fibromyalgia

Conditions: Fibromyalgia

Summary: fibromyalgia is a complex chronic illness affecting 6-12 million americans. self-management strategies play a key role in reducing symptoms and maintaining functioning. the proposed project offers a web-based self management tool that enables fm sufferers to identify significant linkages between their personal symptom levels and their personal self-management efforts over time in order to plan their own optimal approach to disease management.

this phase ii project will complete development of the smart (self-monitoring and review tool) log program for symptom management and health promotion in fm and evaluate its efficacy in a large web-based trial that will closely emulate its planned application in phase iii. the smartlog program is an interactive web-based self-monitoring and feedback intervention that employs proprietary statistical analysis procedures to give the user personally optimized guidance on behavioral, lifestyle and coping strategies that yield effective symptom reduction for that individual. the program incorporates longitudinal collection and analysis of the individual's self-monitoring data followed by delivery of personalized feedback derived from those same personal data. the program helps fm sufferers discover and monitor linkages between specific personal health-related behaviors and management strategies and their symptom levels over time. feasibility was demonstrated in phase i by very high retention rates, ratings of satisfaction and perceived relevance, evidence of impact of utilization on improved well-being over the use period, and qualitative data indicating strong interest in continuation with the program.

Eligibility criteria:
inclusion criteria: * self-reported presence of fibromyalgia exclusion criteria: * none
impact of swaddle blanket on gastroesophageal reflux

Conditions: Gastroesophageal Reflux; Apnea; Bradycardia; Oxygen Desaturations

Summary: gastroesophageal reflux disease (gerd) has been reported in up to 85% of all infants born prematurely, and has been associated with a wide range of symptoms. these include irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung disease, and delays in growth and development. a novel approach to the mangement of gerd in infants is the use of an abdominal band, applying gentle pressure and possibly reducing the reflux of acid from the stomach. the purpose of this study is to evaluate the impact of a swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia, oxygen declines, and ph (acid) changes.


Eligibility criteria:
inclusion criteria: - nicu patients who have a 5 channel study requested by the attending neonatologist - exclusion criteria: -
effect of netarsudil vs brimonidine in ntg patients on latanoprost

Conditions: Normal Tension Glaucoma

Summary: a randomized, multicenter, investigator-masked prospective study of ntg patients currently on latanoprost 0.005% monotherapy, to study the effect of iop change with the introduction of netarsudil 0.02% vs brimonidine 0.1%. subjects will be assessed at a screening visit, and 1 follow-up visit. clinical evaluations will include visual acuity and iop .


Eligibility criteria:
inclusion criteria: * patients 18 years and older * diagnosed with normal tension glaucoma based on the following: * iop ≤ 21mmhg * optic nerve rim thinning and/or retinal nerve fiber layer (rnfl) loss consistent with glaucoma * normal visual field or visual field loss consistent with optic nerve or rnfl defects within the last year * open angles assessed by gonioscopy * have been on latanoprost monotherapy for at least 6 weeks exclusion criteria: if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * patients with angle closure glaucoma or secondary forms of glaucoma due to neovascularization of the angle, uveitic glaucoma, congenital glaucoma, or glaucoma due to congenital anomalies. * other forms of secondary glaucoma. * patients with abnormal anterior segment examination other than cataract will be excluded from the study. * patients who have had incisional surgery for glaucoma (eg: migs). * patients with refractory cme or cme persisting 3 months or more. * children, cognitive impaired and critically ill subjects will not be enrolled. * central corneal thickness (cct) ≤ 500. * prior allergy to brimonidine or netarsudil, and known to have previously failed either brimonidine or netarsudil. * ocular surgery (e.g., cataract, laser, refractive) during the study or 1 year prior to entering the study. the principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.
the test of mastication and swallowing solids and the timed water swallow test

Conditions: Healthy Aging; Gender; Swallowing Disorder

Summary: this study aimed to gather more information regarding two clinically relevant tests: the test of mastication and swallowing solids (tomass) and the timed water swallow test (twst). both tests can be used clinically as part of swallowing disorders evaluation. the aims of the study were to assess the reliability of the two tests, to document the effects of age and gender on the outcome measures of the tomass and twst and to explore the relationship between participants' function in the two tests. to do that, 298 healthy participants were included. all of them did not have dysphagia. most of them were elderly.

background: quantitative measures of swallowing function can increase accuracy, reliability, and improve clinical decision making. the test of mastication and swallowing solids (tomass) and the timed water swallow test (twst) are functional tests of swallowing that provide quantitative results. objectives: to explore the relationship between tomass and twst; evaluate test-retest and interrater reliability; explore age and gender effects; and to gather normative data. methods: healthy community dwelling participants (n = 298, ≥20 years old) were recruited. of those, 126 were included in the reliability study. participants completed the twst and tomass.

Eligibility criteria:
inclusion criteria: * all participants were eligible to participate if they were over 20 years of age, with no known medical history of dysphagia, had an sdq score of less than 11, indicating no suspicion for dysphagia, were able to give a written informed consent, and could follow simple verbal instructions. in addition, all participants indicated that they do not avoid eating crackers due to swallowing disorders or allergies. exclusion criteria: * sdq over 11 or medically reported dysphagia not eating crackers due to swallowing difficulty allergy to gluten
tdcs and its therapeutic effects in ck fever

Conditions: Chikungunya Fever

Summary: one of the major challenges faced by researchers working in the field of rehabilitation science is the ability to provide integrative approaches to the use of clinical practice. in this context it becomes increasingly necessary to construct investigative approaches, so that they can reach clinical practice in a shorter period of time,since the large volume of information produced globally does not impact in the short or medium term on new therapeutic recommendations. among the various chronic painful entities, there is chikungunya fever as a highlight for having a rich clinical chronology in relation to pain. its therapy is used done by drugs in almost all national and international consensuses, therefore therapy against pain in chikungunya fever is limited during the rehabilitation process. it is very important that the science of rehabilitation enhances methods of noninvasive brain modulation that enable, through the excitation or inhibition of specific cortical areas to produce pain inhibiting effects, providing a simple and low cost treatment to the clinical routine.technological advances and non-invasive techniques to modulate brain function have been developed, for instance, transcranial direct current stimulation (tdcs). the objective of the present project is to present the tdcs as a new modality of physical rehabilitation for the patient with chronic pain resulting from chikungunya fever. the purpose of the study is to present physical, behavioral and social results of the application of tdcs in chikungunya fever, suggesting an improvement in the quality of life and functional status of the individual.


Eligibility criteria:
inclusion criteria: * laboratory or medical diagnosis of chikungunya fever, being in the chronic phase of the disease, intellectual and physical capacity preserved for conducting research tests. exclusion criteria: * history of seizures or epileptic disease, pregnancy, states associated with other previously diagnosed rheumatic diseases such as rheumatoid arthritis, gout and lupus, under 18 years and over 65 of age, patients with signs of severity and/or indication for hospitalization.
study of desmoteplase (international nonproprietary name [inn]) in acute ischemic stroke (dias-2)

Conditions: Stroke, Acute

Summary: the purpose of this study is to evaluate desmoteplase (which is a manufactured protein derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of blood through one (or more) of the blood vessels supplying the brain, thereby reopening the blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic stroke.


Eligibility criteria:
inclusion criteria: * eligible for study treatment within 3-9 hours after onset of stroke symptoms. * score of 4-24 on the nihss with clinical signs of hemispheric infarction (i.e. hemiparesis) suggestive of ischemic stroke. inclusion criteria from diagnostic imaging screening: * distinct penumbra (at least 20%), measured by mri (pwi/dwi) or perfusion ct, related to middle cerebral artery (mca), anterior cerebral artery (aca), or posterior cerebral artery (pca) territory in a hemispheric distribution. exclusion criteria: * history or clinical presentation of intracranial hemorrhage (ich), subarachnoid hemorrhage, arteriovenous malformation, aneurysm, or cerebral neoplasm. * rapidly improving neurological symptoms. * pre-stroke mrs score of \> 1 (including previous disability). * suspected acute vertebral or basilar artery occlusion. * current use of anticoagulants and a prolonged prothrombin time. * uncontrolled hypertension. * baseline hematocrit of \< 0.25. * baseline platelet count \< 100,000/mm3.

Keywords: desmoteplase acute ischemic stroke stroke, acute
a study to evaluate subjects with turner syndrome treated with growth hormone

Conditions: Turner Syndrome

Summary: this study is a multicenter, open-label, observational, postmarketing surveillance study of genentech growth hormone (gh) products in the treatment of girls with turner syndrome in the united states and canada.


Eligibility criteria:
inclusion criteria: * are girls with turner syndrome who are being or will be treated with nutropin, nutropin aq, or protropin * are willing to keep follow-up appointments throughout study participation * are girls with turner syndrome who have submitted form 4 upon discontinuation and may also submit form 9 exclusion criteria: * have noonan syndrome * subjects treated within the last 6 months with a non-genentech gh preparation * have closed epiphyses prior to ncgs enrollment * have active neoplasia