Kornimate/medical-research-clean huggingface dataset:
ramelteon tablets 8mg drug use surveillance: survey on insomnia associated with sleep-onset difficulty

Conditions: Insomnia

Summary: the purpose of this study is to investigate the safety and efficacy of ramelteon (rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.

this is a drug use surveillance planned to examine the safety and efficacy of ramelteon tablets when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia (planned sample size, 3000) the usual adult dosage is 8 mg of ramelteon administered orally once daily at bedtime.

Eligibility criteria:
inclusion criteria: 1. sleep-onset difficulty associated with insomnia exclusion criteria: 1. patients with previous history of hypersensitivity to an ingredient of rozerem tablets 2. patients with severe liver dysfunction 3. patients taking fluvoxamine maleate

Keywords: drug therapy
a study of a glaucoma therapy to treat open-angle glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to assess the comfort of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * adults of either sex and any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) exclusion criteria: * under 18
coronary artery and systemic autoimmune disease: diagnostics and treatment

Conditions: Autoimmune Diseases; Coronary Artery Disease

Summary: this study evaluates in vivo intracoronary imaging using intravascular ultrasound and optical coherence tomography and safety and efficacy of new generation fully bioresorbable vascular scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis, systemic lupus erythematosus) and concomitant coronary disease patients.

the aim of this study is to assess in vivo intracoronary anatomy using intravascular ultrasound and optical coherence tomography and assess the efficacy and safety of new generation fully bioresorbable vascular scaffolds in a systemic autoimmune and coronary heart disease patient population. the following four well defined systemic autoimmune entities are linked to increased cardiovascular risk: rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis and systemic lupus erythematosus. one of the main causes of death in systemic autoimmune subjects is cardiovascular disease. in-vivo intracoronary anatomy and pathology regarding systemic autoimmune diseases is unknown. furthermore, all forms of revascularization in such patients yield sub-optimal results, with poor outcomes using even the most modern drug eluting metallic stents. this may be linked to a long term exaggerated chronic inflammation response to the metallic components. thus, fully bioresorbable vascular scaffolds may prove more efficacious in systemic autoimmune subjects.

Eligibility criteria:
inclusion criteria: * age of 18+ years * signed and dated informed consent form * manifest autoimmune disease, consisting either of: rheumatoid arthritis or systemic lupus erythematosus or systemic sclerosis or mixed connective tissue disease under the care of a clinical immunologist * clinical indication for a coronary angiography as determined by a cardiologist exclusion criteria: * age of 75+ years * glomerular filtration rate of under 30 ml/min * severely decreased left ventricular function (ejection fraction \<35%) * pregnancy or nursing * unclear immunological diagnosis
interest of high-throughput sequencing of rnas for the diagnosis of heterogeneous genetic diseases

Conditions: DNA Sequencing; Diagnosis of Genetic Diseases of Heterogeneous Origin

Summary: the advent of high throughput genomic dna sequencing has led to major advances in the diagnosis of genetic diseases of heterogeneous origin. thus, our hospital laboratory has developed in recent years several diagnostic tests based on the targeted sequencing of coding sequences of gene panels (from about twenty genes for dna repair diseases to nearly five hundred genes for the intellectual disability). these targeted analyzes, carried out by capture, have thus solved 25 to 80% of the cases according to the indications, without allowing the diagnosis of the totality of the patients. for these negative cases, the search for mutations in the coding sequences was then extended to whole exome sequencing, thus providing several additional diagnoses. patients still remain without diagnosis after this exome study. these could be complex cases of genetic or even non-genetic origin, but also monogenic pathologies linked to mutations that are not identifiable by coding sequence analyzes, and especially affecting messenger rnas.


Eligibility criteria:
inclusion criteria common to all participants: * patient minor or major * patient suffering from a pathology studied in the laboratory by high throughput sequencing: intellectual disability, myopathies, neurosensory disease (bardet-biedl syndrome, retinitis pigmentosa, ....), dna repair diseases (cockayne syndrome, ...) * sampling allowing the extraction of available rna (or rna available in the bank) * patient (or its legal representative) having already given their consent, on the one hand for carrying out genetic analyzes to determine the cause of their disease, and on the other hand for the conservation of part of their non used for further use in order to continue diagnostic investigations in the light of evolving knowledge and for research purposes. * patient (or its legal representative) agreeing to use data from his medical file and those associated with genetic diagnosis for research purposes * patient affiliated to a social security scheme inclusion criteria for the test phase * pertogenous mutation (s) known inclusion criteria for the prospective phase * magnetic molecular diagnosis, after the usual investigations (high-throughput sequencing of a panel of genes on genomic dna, sequencing of exome, or even genome. non-inclusion criteria: ◾ refusal of the patient (or his / her legal representative) to participate in the study.
improving patient access to stroke therapy study

Conditions: Ischemic Stroke; Transient Ischemic Attack

Summary: limited access is a major hurdle in the treatment of ais; many hospitals, especially rural hospitals, do not have the infrastructure or medical support to effectively treat ais patients.5 failure to recognize the signs and symptoms of stroke by the patient and/or emergency medical services (ems) is another barrier to the timely treatment of ais. several studies, including the paul coverdell national acute stroke registry (pcnasr), have reported low rates of adherence to stroke care guidelines, suggesting that many ais patients do not receive proper treatment according to established guidelines. thus, there remains an increasing need to assess and address the barriers that prevent patient access to proper ais treatment. annually, approximately 20,000 patients are discharged from wisconsin hospitals with the diagnosis of stroke and an estimated 4,000 patients die from stroke each year in wi. to date, there have been no statewide studies initiated in wisconsin to assess the regional barriers to the treatment of ais patients with thrombolytic or endovascular therapy, and many hospitals do not routinely collect and analyze ais patient data. the goal of the improving patient access to stroke therapy (impact) pilot study is to engage community hospitals statewide to identify the regional barriers to ais therapy in wi.


Eligibility criteria:
inclusion criteria: * age \> 18 years * clinical diagnosis of acute ischemic stroke or transient ischemic attack (tia) * icd-9-cm code indicative of stroke or tia exclusion criteria: * clinical diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage * stroke or tia occurred while patient was hospitalized

Keywords: iv-tpa activase endovascular therapy
radiographic assessment of the healing pattern associated with periradicular endodontic microsurgery

Conditions: Periapical; Infection

Summary: endodontic periradicular microsurgery is a dental procedure to treat apical periodontitis in cases in which healing has not occurred after non-surgical treatment or if it is not feasible. recent advances in techniques and materials have resulted in more predictable outcomes. piezotome is a new and innovative device, but limited evidence is available regarding its use in endodontics. the aim of this study is to assess the healing pattern of conventional periradicular microsurgery and piezoelectric periradicular microsurgery in 2- dimensional and 3-dimensional imaging, and further to perform histological analysis for the presence, location, and arrangement of bacteria in the excised apical portion of the root canal system.

after meeting the inclusion criteria, a total of 44 patients in need of endodontic microsurgery with persistent symptoms after acceptable primary root canal treatment or failed retreatment with persistent symptoms/periapical lesions will be included in this study. participants will be randomly allocated to group one; conventional periradicular surgery or group two; piezoelectric periradicular microsurgery. a preoperative digital periapical and limited view cone beam computed tomography (cbct) radiographs will be taken for each patient. at 12-18 months recall visit a second digital periapical radiograph and limited view cbct will be taken. all images will be evaluated on high-definition lcd display with installed imagej software and cbct software, and window settings will be fixed for all cases. radiographs will be evaluated by two calibrated dentists. the excised root tip with their surrounding tissues will be fixed immediately after harvesting for 24 hours at 4 °c by immersion in 1% glutaraldehyde and 1% formaldehyde and referred to histopathologic laboratory. fixed specimens will be demineralized in 10% formic acid and processed. serial sectioning with hematoxylin and eosin staining will be done to locate the areas with the most severe reactions. in addition, the taylor modification of the brown-brenn staining will be used to detect the presence of bacteria.

Eligibility criteria:
inclusion criteria: * medically fit patients * age (18-65 ) * teeth that are periodontally healthy * coronally sealed root canal treated teeth exclusion criteria: * patients with an active systematic disease that may affect the short- and long-term outcomes or restrict surgical intervention * emotionally distressed patients * patients who had received analgesics or antibiotics prior to surgery will be postponed * cases where orthograde endodontic treatment is feasible, will be retreated at the post-graduate clinics and not included in this study * teeth with poor prognosis (e.g., non-restorable, vertical root fracture, short roots, non-strategic tooth, endo-perio lesion
a study of ym155 plus rituximab in subjects with non-hodgkin's lymphoma who have received prior treatment

Conditions: Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to evaluate response rate, survival, safety and tolerability of ym155 given in combination with rituximab in subjects with non-hodgkin's lymphoma.

this is an outpatient study. all subjects enrolled in this study will receive ym155 and rituximab given during 14 day cycles. each subject will be assessed at the end of each cycle to determine if he or she may continue to the next cycle. each subject will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met. if a subject discontinues treatment without progressive disease (pd) that subject will complete follow-up visits every 12 weeks for 1 year or until initiating another systemic anti-lymphoma treatment, exhibiting pd, or death. each subject will be contacted by the study site every 12 weeks for survival following the end of treatment visit. the contacts will continue until death or for no more than 1 year.

Eligibility criteria:
inclusion criteria: * any stage, histologically confirmed cd20-positive primary or transformed diffuse large b cell lymphoma (dlbcl)or grade 3 follicular lymphoma (fl) * ineligible for or have previously received an autologous stem cell transplant (asct) * relapsed following receipt of the last dose of systemic chemotherapy or asct * at least one prior chemotherapy regimen. prior chemotherapy regimen must have contained anthracycline (unless contraindicated) * if the subject is female, she must be non-pregnant and non-lactating at the baseline visit. all sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period * eastern cooperative oncology group (ecog) performance status \</= 1 exclusion criteria: * use of any standard/experimental anti-lymphoma drug therapy within 21 days of the baseline visit * use of systemic steroids within 5 days of the baseline visit (except for the purposes of pre-medication prior to study regimen treatment) * prior allogeneic stem cell transplant (sct) * the subject has been previously treated with ym155 * the subject has known human immunodeficiency virus (hiv), hepatitis b surface antigen, or hepatitis c antibody * the subject has received other investigational therapy or procedures within 21 days prior to the first study drug administration

Keywords: non-hodgkin's lymphoma relapsed cd20-positive ym155
comparing the efficacy and safety of biphasic insulin aspart 30 and biphasic human insulin 30 on blood sugar control in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (oad) therapy.


Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosed for at least 6 months * insulin-naive (less than or equal to 1 week of daily use of insulin therapy) * treatment with metformin as monotherapy or in combination therapy with other oad(s) for at least 3 months prior to this trial * currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks * currently at least one of other oad(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks * glycosylated haemoglobin (hba1c) between 7.5-11.0% * body mass index (bmi) between 18.5 - 35.0 kg/m\^2 * be able and willing to perform continuous glucose monitoring system (cgms ) and self-monitored blood glucose (smbg) exclusion criteria: * known or suspected allergy to trial product(s) or related products * any contraindication of metformin * receipt of investigational drug within the last 3 months prior to this trial * any history of chronic insulin therapy (more than 1 week of daily use) * systemically treated with thiazolidinediones (tzds) for more than one month within 6 months prior to this trial * pregnancy, nursing mother, or unwillingness to use adequate contraception
oral habits effect on orofacial dysfunction and oral health related quality of life.

Conditions: Oral Habits; Oro-Facial Dysfunction

Summary: the aim of the present study is to determine the effect of oral habits on orofacial dysfunction and oral health related quality of life among a group of egyptian children.

child's ohrqol is assessed in terms of four main categories: oral symptoms as pain and discomfort, functional limitations as reduced masticatory efficiency due to malocclusion, emotional limitations as reduced self-esteem and social limitations as being teased by other children. deleterious oral habit is believed to be associated with emotional disturbances and orofacial dysfunction which will certainly affect child's ohrqol. sucking habits, mouth breathing habits and tongue thrusting habits are found to be the most deleterious habits, especially in the selected age group of (5-7) years. it was found that these three deleterious habits are the most practiced habits among egyptian children aging from 6-9 years (19.6%). up to the investigator's knowledge, there are very scanty studies investigating the effect of orofacial dysfunction on ohrqol in children, only one of them was conducted on children practicing oral habits, but none of them was conducted on egyptian children.

Eligibility criteria:
inclusion criteria: * cooperative egyptian children aging from (5 - 7) years. * medically free children. * children whose families accept to participate in this study. exclusion criteria: * children with untreated caries. * children with previous untreated dental trauma. * children with previous orthodontic treatment * children with upper respiratory disease * children having one or more of the following conditions: mih, amelogenesis imperfecta, dentinogenesis imperfecta, hypodontia, dental fluorosis.
ocular tolerance, safety and ocular pharmacokinetics after 1 drop of t1225 0.5, 1.0, 1.5% in 48 healthy volunteers

Conditions: Eye Infections, Bacterial

Summary: to compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of t1225 after one drop instillation

the aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after a single administration of t1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

Eligibility criteria:
inclusion criteria: * male or female aged from 18 to 45 years old; * written informed consent; * healthy volunteers (without any ocular symptom); * normal ocular examination in both eyes (corrected visual acuity (va) \>= 6/10 - slit lamp examination without clinical relevant abnormalities - tear break-up time (but) ≥10 seconds - lachrymal secretion in the schirmer test \>= 10 mm in 5 minutes - lissamine green test total score \< 4 +). exclusion criteria: * ocular trauma, infection or inflammation within the last 3 months; * blepharitis; * conjunctival hyperaemia (score \>= 2 +); * watering (score \>= 2); * contact lenses; * ocular surgery, including lasik and prk, within the last 12 months; * topical ocular treatment within the last month; * systemic antibiotics within the last 7 days; * any medication during the study (except: paracetamol and contraceptives).
a pilot study to assess the dynasense system

Conditions: Pressure Ulcers

Summary: the study is designed to test the dynasense system, which is a patient movement and orientation monitoring system. the study is intended to determine that: * the dynasense system identifies patients that are not turning adequately on their own and therefore require caregiver-assisted turns. * the dynasense system identifies patients that are turning adequately on their own and therefore do not require a caregiver-assisted turn. * the dynasense system helps ensure compliance with an institution's established patient turning protocol.


Eligibility criteria:
inclusion criteria: * adult male or female 18 to 110 years of age; * inpatient currently on the unit and expected to remain for at least 12 hours; * able and willing to comply with the study procedures; * subject (or his/her agent) is able to read, understand, and provide informed consent in the english language. exclusion criteria: * subject is a female subject under the age of 60 who is pregnant, planning on becoming pregnant, or is currently breastfeeding. 1. any woman under the age of 60, must have a negative urine pregnancy test prior to being enrolled in the study; or 2. be postmenopausal for at least 2 years, or 3. have had a bilateral tubal ligations, or 4. have had a bilateral oophorectomy, or 5. have had a hysterectomy. * subjects with a known tape allergy or sensitivity to ekg leads or similar types of adhesives used in common medical products. * subjects who cannot have the patient sensor applied on the surface of the patient's anterior torso. * subjects who have a pacemaker or implantable cardiovascular-defibrillator (icd). * subjects with dementia, alzheimer's disease or other mental disabilities and incapacitation that would prevent the subject from providing written informed consent. if the subject is unable to provide informed consent due to mental incapacity, then the subject's durable power of attorney may provide informed consent and sign the informed consent on behalf of the subject. * subjects who refuse to have an area of hair on their chest be clipped or shaved, if needed for patient sensor adhesion. * subjects, who in the opinion of the principal investigator, are at increased risk by participating in the clinical study. * subjects who have participated in another clinical study within the past 30 days or are currently participating in another clinical study at the time of screening.

Keywords: pressure ulcers bed sores patient turn protocol patient movement patient monitoring
study of the vaginal microbiota in women under fertile age

Conditions: Vaginal Disease

Summary: characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders

the study aimed to characterize, in women under fertile age, the composition and dynamics of the vaginal microbiota as well as to in-depth study correlations among microbiota and gynecological disorders

Eligibility criteria:
inclusion criteria: * age between 18 and 45 years; * presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, and subjective vaginal discomfort); * presence of at least 3 amsel criteria; * nugent score ≥ 7; * lactobacillary grade ≥ 2 (lbg) (according to donders classification); * presence of blastospores and/or pseudohyphae evaluated by fresh mount microscopy exclusion criteria: * age \< 18 years; * nugent score \< 7; * presence of sexually transmitted disease due to chlamydia, neisseria gonorrhoeae, or trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis; * clinically apparent herpes simplex infection; * human papillomavirus or human immunodeficiency virus infections; * use of antibiotic, antifungal, probiotic, or immunosuppressive drugs during the past four weeks; * use of vaginal contraceptives; * pregnancy or breastfeeding, chronic diseases, neoplastic disease, diabetes, genital tract bleeding)