Kornimate/medical-research-clean huggingface dataset:
an observational study of oral fluoroquinolones and the risk of retinal detachment

Conditions: Retinal Detachment

Summary: the purpose of this study is to assess the association of retinal detachment (separation of the retina \[the innermost layer of the eyeball\] from its connection at the back of the eye) with exposure to oral ciprofloxacin or oral fluoroquinolones.

this is an observational (in which the investigators observe the outcomes of the study participants but do not intervene by, e.g, assigning the treatments) and retrospective (a study in which the exposures and outcomes occurred before the study began) study. it will use data from the optuminsight and truven commercial claims and encounters databases, each of which will be evaluated separately using 3 designs: (1) case-control (a design that compares the cases \[study participants\], ie, those with retinal detachment to controls, ie, a sample of similar people who did not have a retinal detachment) to assess whether their exposures to fluoroquinolones (fqs) differed. two case-control studies are planned, one (replication) that mimics a previously reported study, the other (revised) that addresses more potential confounders than did that study , (2) cohort (a design that follows the participants exposed to fqs and those not exposed to fqs to assess whether the two groups had different risks of developing retinal detachment), (3) case-only (a design where the exposure history of individuals who had retinal detachment are examined to assess whether they were more likely to have had it when they were exposed to fqs than when they were not).

Eligibility criteria:
inclusion criteria: * at least 1 year of enrollment in the study for medical and pharmacy benefits after their cohort (group) entry (the day of their first ophthalmologist visit) for case-control design * oral fluoroquinolone like levofloxacin or ciprofloxacin must be dispensed to participants for cohort design * at least one visit to an ophthalmologist and enrolled at least for 1 year in the study for medical and pharmacy benefits prior to the date of first occurrence of the exposure of levofloxacin or ciprofloxacin for cohort design * at least one visit to an ophthalmologist and enrolled at least for 1 year in the study for medical and pharmacy benefits prior to the diagnosis of their first retinal detachment (separation of the retina \[the innermost layer of the eyeball\] from its connection at the back of the eye) for case-only design exclusion criteria: - prior diagnosis of retinal detachment , prior diagnosis or procedure for inflammatory conditions of the eyeball, or hospital admission between cohort entry and the date of the retinal detachment

Keywords: retinal detachment fluoroquinolones ciprofloxacin levofloxacin gatifloxacin gemifloxacin moxifloxacin norfloxacin ofloxacin beta-lactam
study of the efficacy and safety of ferrlecit in the maintenance dosing in hemodialysis patients.

Conditions: Anemia

Summary: this is a phase 4 clinical investigation of the efficacy and safety of ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving erythropoietin.

a multi-center, open-label, parallel group study of the efficacy and safety of ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving erythropoietin. patients with normal iron indices receive one of two doses of ferrlecit administered weekly throughout the treatment period. efficacy was assesses at designated timepoints throughout the study and after the last ferrlecit dose.

Eligibility criteria:
inclusion criteria: * male of female, 18 years old or older. * have been receiving chronic hemodialysis therapy * on stable epo dosing regimen. * have signed patient informed consent. * predetermined serum ferritin and tsat levels. * clinical instability - inability to achieve adequate dialysis, abnormal serum albumin and serum glucose. * pregnant or lactating. * a known sensitivity to ferrlecit exclusion criteria: * scheduled for renal transplant. * a serious concomitant medical disorders incompatible with participation in the study. * unable to cooperate or comply with the protocol. * use of any investigation agent within 30 days prior to study or during the course of the study. * judged by the investigator as unsuitable for enrollment for any reason.
acute ischemic stroke endovascular therapy: a multicenter registry study

Conditions: Acute Ischemic Stroke; Large Vessel Occlusion; Thrombectomy; Thrombosis

Summary: a multicenter registry of endovascular treatment for acute ischemic stroke.

the ocin-ais-evt registry is a prospective, multicenter, blinded outcome evaluation, observational trial, and aims to determine the functional outcomes and safety of endovascular treatment for ais, due to vessel occlusion in anterior and posterior circulation, in routine clinical practice. the primary endpoint is functional outcome, defined as a shift (improvement) in scores on the modified rankin scale (mrs) at 90 days (±7 days).

Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke caused by anterior or posterior circulation vessel occlusion confirmed by computed tomography angiography (cta) or magnetic resonance angiography (mra) or digital subtraction angiography (dsa) 2. undergo intravascular therapy (i.e. access to a cath lab and an arterial puncture) 3. the patient or his/her legal representative agreed to participate in the study and has signed the informed consent. exclusion criteria: 1) no exclusion criteria
6-month open-label safety study of pd 0332334 in elderly patients with generalized anxiety disorder (gad)

Conditions: Generalized Anxiety Disorder

Summary: this is an open-label, multi-site, 6-month study of an investigational compound in elderly outpatients, age 65 years old or above, to assess the long-term safety and tolerability of the compound in the treatment of elderly subjects with generalized anxiety disorder (gad).

termination reason: on february 23rd 2009, a decision to terminate further development for pd 0332334 was communicated to investigators in this study. the decision to terminate this study was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * men or women age \> 65 years. * a primary diagnosis of generalized anxiety disorder according to the diagnostic and statistical manual-iv (dsm-iv). * subjects must have a ham-a score of 16 or higher at both screening and baseline visits. exclusion criteria: * women who are pregnant or contemplating pregnancy (eg, via in vitro fertilization) during the study through 30 days after the last dose of study medication. * subjects with evidence of a current (within the past 6 months) clinically significant or unstable hematological, autoimmune, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, immunological or retinal disorder; subjects with an active infection within the past 2 months. * subjects who have an ongoing, unresolved, clinically significant cardiovascular or cerebrovascular medical problem. * mini mental status exam (mmse) score \<24 or possibility of undiagnosed dementia, cognitive or amnestic disorder, including, but not limited to mild cognitive impairment.

Keywords: generalized anxiety disorder elderly
immune tolerance study with aldurazyme® (laronidase)

Conditions: Mucopolysaccharidosis I

Summary: the purpose of this study is to see if treatment with an antigen-specific immunosuppressive can decrease or stop an antibody response to laronidase (aldurazyme®) during enzyme replacement therapy with laronidase in severe mucopolysaccharidosis i (mps i) participants.


Eligibility criteria:
inclusion criteria: * written informed consent is required from the parent(s) or legal guardian(s) prior to any protocol-related procedures being performed. (a separate informed consent will be requested from the parent(s) for their genotyping, which is independent of the inclusion) * participant's parent(s) or legal guardian(s) allow their child's participation and are willing and able to comply with trial procedures * the participant must be up to and including 5 years of age at the time of enrollment * clinical diagnosis of the severe (hurler) phenotype of mps i * confirmed presence of 2 nonsense mutations in the alfa-l-iduronidase (idua) gene (that is, compound heterozygosity or homozygosity). for the purpose of enrollment, genotyping may be performed by a local laboratory. if no genotyping is performed by a local laboratory, a sample is collected for analysis by a central laboratory before enrollment * documented idua deficiency with fibroblast, plasma, serum, leukocyte or dried blood spot idua enzyme activity assay exclusion criteria: * the participant has a clinically significant organ disease including: cardiovascular, hepatic, pulmonary, neurologic, or renal disease, other serious intercurrent illness or extenuating circumstances that, in the opinion of the investigator, precludes participation in the trial or potentially decrease survival * the participant has previously received treatment with laronidase * the participant has known severe hypersensitivity to any excipients of the delivery solution for laronidase or to any of the other investigational drugs used in the study * the participant has undergone a haematopoietic stem cell transplant (hsct), regardless of outcome, or is currently under consideration for such a transplant. if a family later decides to obtain hsct, the participant will be discontinued from the trial * the participant has received an investigational product within the 30 days prior to enrollment * the participant has prior treatment in any experimental protocol (for example, fibroblast injections) that might potentially induce antibodies to laronidase or might affect the interpretation of the participant's antibody response to laronidase * the participant has received vaccination(s) within 1 month prior to enrollment, or is unwilling to postpone vaccinations during the tolerance induction period in the trial * the participant is homozygous for thiopurine methyltransferase (tpmt) deficiency, as determined by the genotype (the presence of 2 known null alleles for tpmt) or phenotype (near to complete absence of tpmt enzyme activity) * the participant has a prior history of tuberculosis or a positive test for latent tuberculosis infection

Keywords: mps i, mucopolysaccharidosis, hurler syndrome
the role of vitamin d in corneal epithelial barrier function, ocular microbiome, ocular inflammation, and visual acuity of children with allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: a double-blind study to evaluate the role of vitamin d in corneal epithelial barrier function, ocular microbiome, ocular inflammation, and visual acuity of children with allergic conjunctivitis.

the prevalence of allergic conjunctivitis (ac) has rapidly increased in recent decades, resulting in a significant global public health concern. the ocular surface is a unique mucosal immune compartment in which immunological features act in concert to foster a tolerant microenvironment (immune privilege). the corneal epithelial barrier is the first line of defense that forms a protective barrier against pathogens, pollutants, and allergens. the ocular microbiota has a role in maintaining the homeostasis of the ocular surface and preservation of barrier function. vitamin d functions as enforcing intercellular junctions and maintaining intestinal epithelial barrier integrity; metabolites from the gut microbiota may also regulate expression of vitamin d receptor (vdr). low serum vitamin d levels have been shown to predispose to a variety of allergic disorders. a recent study shows that corneas contain vitamin d and vdr; vitamin d enhances corneal epithelial barrier function. however, research data of the role of vitamin d in ocular microenvironment of ac are insufficient and controversial. in recent research, the investigators found allergic inflammation of ocular surface weakened corneal epithelial barrier, modulated the signal pathway of retinal pigment epithelial cells, and enhanced scleral tissue remodeling, resulting in myopia in progression. however, there are few studies available to investigate the role of vitamin d in ocular surface microenvironment, ocular inflammation, and visual acuity in ac. moreover, understanding the interaction of vitamin d, ocular microbiota, and ocular inflammation may provide a new target for the development of therapeutic interventions of ocular allergy and restore visual function.

Eligibility criteria:
inclusion criteria: 1. children aged 6-18 years with allergic conjunctivitis (ac) diagnosed by ophthalmologists or allergists exclusion criteria: 1. previous eye surgery 2. active eye infection 3. any active inflammatory eye disease except ac 4. systemic steroid use within 28 days of study

Keywords: allergic conjunctivitis, immune privilege corneal epithelial barrier microbiota vitamin d ocular microenvironment visual acuity vitamin d receptor gene polymorphism ocular surface and intraocular inflammation
optimizing drug doses in critically ill

Conditions: Traumatic Brain Injury; Kidney Functional

Summary: the primary objectives of this study are to examine whether augmented renal clearance (arc) compromises renally eliminated drug therapeutic serum concentrations in patients with traumatic brain injury (tbi) and to estimate the optimal dose needed to achieve therapeutic serum concentrations of the probe medication levetiracetam in patients with tbi.

purpose: the primary objectives of this study are to examine whether augmented renal clearance compromises renally eliminated drug therapeutic serum concentrations in patients with traumatic brain injury (tbi) and to estimate the optimal dose needed to achieve therapeutic serum concentrations of the probe medication levetiracetam in patients with tbi. participants: the population will be comprised of patients with traumatic brain injury requiring levetiracetam for seizure prophylaxis admitted to the neurosciences intensive care unit procedures (methods): this is a multi-center, prospective, non-randomized pharmacokinetic study in patients with tbi. in patients who meet the inclusion criteria, a 12-hour urine collection for measuring creatinine clearance levetiracetam urine concentrations will be performed daily for 7 days. serum levetiracetam concentrations will be obtained twice daily for 7 days.

Eligibility criteria:
inclusion criteria: 1. adults ≥ 18 years 2. patients with tbi requiring levetiracetam for seizure prophylaxis 3. anticipated length of stay in the sicu or nsicu \> 48 hours 4. informed consent provided by the patient's designated medical proxy exclusion criteria: 1. pregnancy 2. patients with renal dysfunction (ckd stages 3 - 5 and/or scr \> 1.4 mg/dl) 3. patients receiving renal replacement therapy 4. brain death or suspected imminent brain death within the next 48 hours 5. patients with history of nephrectomy or renal transplant
training early social language in autism

Conditions: Autism Spectrum Disorder

Summary: the aim of the study is to determine whether a targeted behavioral intervention can lead to both changes in early communication skills and in neural responses in toddlers and preschoolers with autism.

the mirror neuron system (mns) broadly refers to a network of brain regions that responds both when a person performs an action and when that person observes someone else performing the same action. this system emerges in infancy and develops over time to support more complex social abilities. it has been hypothesized that autism involves fundamental impairments to the mns, which can explain the deficits in joint attention, imitation, communication and social cognition. this study investigates the mns in 100 toddlers and preschoolers recently diagnosed with autism or with a suspected diagnosis of autism. first, children with (suspected) autism complete a battery of behavioral measures and mns activity will be assessed using electrophysiology (eeg; event-related potentials) while the child participates in specific tasks. then, the children with (suspected) autism will be randomly assigned to one of two behavioral intervention programs (i.e., targeted joint attention intervention or parent education intervention) that will be carried out by interventionists and parents for 10-12 weeks. at the end of the intervention, these children will be re-evaluated on behavioral tasks and eeg to investigate changes as a result of the intervention. the investigators hypothesize that the joint attention intervention will lead to significant changes on both the neural and behavioral measures of mns functioning.

Eligibility criteria:
inclusion criteria: * children between the ages of 18 and 59 months with a confirmed or suspected dsm5 diagnosis of autism spectrum disorder * the included parents or guardians are required to be the primary caregivers of these children * families must speak english in the home at least 75% of the time. exclusion criteria: * seizure disorder (may influence eeg data) * gestational age \<32 weeks * history of serious head trauma * genetic syndrome (e.g., fragile x syndrome)
emotional and cardiac impact of postpartum haemorrhage

Conditions: Postpartum Hemorrhage Treated With Sulprostone

Summary: to assess the impact and to identify the main risk factors for psychological and cardiac morbidity (post-traumatic stress disorder, anxiety and depression) in case of postpartum hemorrhage

the help- mom study is an observational study that seeks to identify the major determinants of morbidity induced by postpartum hemorrhage (pph) in the short and medium term. even if pph remains the leading cause of death in the world and in france , its main impact in so-called developed countries is not so much maternal mortality ( which is very small ) but induced morbidity.data from the literature suggest that in a number of cases, pph is associated with cardiac abnormalities. the nature of the abnormalities, their potential impact on the functioning of the cardiovascular system of women and their evolution over time (possibility of persistent sequelae) are not known. similarly, it is known that the postpartum period of normal pregnancy followed by a normal delivery is at risk of psychological disorders in the mother. the pph is a very serious situation where sometimes the vital prognosis of the mother was committed. again, determining the exact nature and consequences of psychological harm secondary pph are not known. finally, fertility and the risk of recurrence after an episode pph are also poorly understood. outside hysterectomy hemostasis which permanently affects the fertility of the patient, the severity and type of management of pph most likely affect fertility. only a long-term monitoring could help address this issue. thus, help mom - study aims to address these issues. to do this, help mom, was divided into two sub- studies : 1) help-mom 1 "multidisciplinaire" which corresponds to the cohort of patients in whom psychological state will be studied in the immediate waning pph then during a 6 months through appropriate questionnaires , 2 ) help-mom 2 "cardio" that corresponds to the cohort of patients who experienced a cardiac abnormality in the initial management and will therefore be included in a cardiac monitoring.

Eligibility criteria:
inclusion criteria: helpmom1 : * patients with postpartum hemorrhage and receiving sulprostone * patient affiliated with social security helpmom2 : * enrolled helmom1 * presence of one or more items from the following list at the moment of pph: * elevated troponin ("classical" or ultra) exceeds 5 times the normal value (about\> 0.20 g / ml depending on the laboratory) and / or * electrocardiographic abnormalities (st-segment abnormalities and / or t wave abnormalities searched in all 12 leads) and / or * rate of bnp (brain natriuretic peptide) greater than 100 pg / m exclusion criteria: helpmom1: * age \< 18 years * hemorrhage caused by a miscarriage, a clandestine abortion, fetal death in utero or medical or voluntary termination of pregnancy. helpmom2: - patient with pace maker

Keywords: postpartum haemorrhage sulprostone cardiac impact emotional impact cardiac magnetic imaging resonance
pslt compared to prostaglandin analogue eye drops

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: this study aims to compare the efficacy of pslt and the topical use of prostaglandin-like hypotensive eye drops in the treatment of ocular hypertensive or glaucomatous patients in decreasing intraocular pressure and measuring changes in functional, structural and biomechanical parameters evaluated by computerized perimetry and optical coherence tomography (oct) related to pressure change resulting from treatments

patients with a diagnosis of ocular hypertension or bilateral glaucoma, naive or on treatment with up to two classes of hypotensive eye drops will be invited to participate in the study. these patients will have both eyes included in the study. a randomization will be made to allocate one eye to receive treatment with pslt (treatment group), while the contralateral eye will receive treatment with prostaglandin eye drops (control). patients will be followed up for 12 months and periodically tonometry, computerized perimetry, water overload test and oct will be performed.

Eligibility criteria:
inclusion criteria: * diagnosis of ocular hypertension (iop ≥ 24 mmhg in both eyes) or diagnosis of open-angle glaucoma (poag) in both eyes * proper visualization of angle structures and 360 degree open angles in both eyes * no previous intraocular surgery with the exception of phacoemulsification with intraocular lens implantation * no use of systemic medications known to increase iop exclusion criteria: * patients using more than two glaucoma medications * evidence of any other eye disease that could affect iop measurement * diagnosis of other types of glaucoma * patient with mean deviation (md) less than -12 decibels (db) on visual perimetry (severe disease) * patients with unilateral glaucoma
improving hba1c levels by methylcobalamin vitamin in diabetic volunteers

Conditions: Diabetes Mellitus

Summary: the current study was conducted to evaluate the prognostic implications of vitamin b12 admission on bmi and hba1c levels in type 2 diabetic patients treated with dapagliflozin as a routine medication.

eighty diabetic patients were enrolled in this study; 37 females and 43 males with inclusion criteria of vitamin b12 levels less than 233 ng/ml. the participants were divided into two groups, the dapagliflozin group (active comparator group) received only the diabetic-controlling drug dapagliflozin 10 mg/daily orally for twelve months, whereas, vitamin b12 and dapagliflozin group (experimental group) received vit. b12 supplements as methylcobalamin 500 µg orally once daily with dapagliflozin 10 mg/daily orally for twelve months. glycemic control was measured by monitoring levels of hba1c and vitamin b12 in the participant's blood four times at time intervals of three months during the study period. additionally, the weight measurements were recorded during the study period at time intervals of three months and bmi was calculated. the data obtained was treated by statistical analysis using spss software (version 20) for the significant correlation of the independent variables of the study groups after vitamin b12 supplementation.

Eligibility criteria:
inclusion criteria: * diabetic patient treated with dapagliflozin exclusion criteria: * the levels of vitamin b12 more than 200 ng/ml