Kornimate/medical-research-clean huggingface dataset:
the natural history of wounds in patients with dystrophic epidermolysis bullosa (deb)

Conditions: Dystrophic Epidermolysis Bullosa; DEB - Dystrophic Epidermolysis Bullosa

Summary: this study is a non-interventional, observational study that will evaluate the natural history of wounds in patients with dystrophic epidermolysis bullosa (deb) for inclusion into the krystal biotech phase iii protocol of b-vec (previously kb103). wound recurrence and wound size will be evaluated for up to four months.

the objective of this study is to analyze the selected wounds' natural history prior to including the selected wounds in the evaluation of safety and efficacy in krystal biotech's phase iii protocol of b-vec. subjects will be enrolled upon obtaining consent and meeting eligibility criteria. patient screening is done on-site, followed by the imaging of at least 1 wound, but up to 15 wounds. all remaining imaging will be performed remotely with a smartphone or tablet application. patients are on-trial for approximately four months.

Eligibility criteria:
inclusion criteria: * written informed consent is provided. patients 18 years of age and older, and parent(s)/legal guardian(s) of patients younger than 18 years of age, must provide written informed consent prior to participating in the study; additionally, informed assent will be obtained from patients younger than 18 years of age as specified by local requirements. * patient must have a documented diagnosis of deb based on genetic analysis showing a mutation in col7a1 or, in the opinion of the investigator, a confirmed diagnosis of deb based on histologic criteria (antigen mapping or electron microscopy). * age: 6 months and older * patient must have at least 1 wound that is suitable for imaging, in the opinion of the investigator, at the time of enrollment. * patient is willing and able to undergo the protocol-specified procedures. exclusion criteria: * in the opinion of the investigator, inclusion poses an unacceptable risk to the patient or interpretation of these study data.

Keywords: deb dystrophic epidermolysis bullosa col7a1
a phase iib safety and efficacy study of de-126 ophthalmic solution in primary open-angle glaucoma or ocular hypertension- angel study

Conditions: Open-angle Glaucoma, Ocular Hypertension

Summary: treatment of elevated pressure in the eye (intraocular pressure, or 'iop') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. this study is being conducted to determine how well de-126 ophthalmic solution works (efficacy) in safely lowering iop when dosed as topical eyedrops. this study will evaluate the safety and efficacy of four (4) concentrations of de-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension. the iop will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower iop). safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. while the most important time-point to measure iop in this study and evaluate efficacy will be at the final study visit (month 3), iop values will also be evaluated at other visits throughout the 3-month treatment period.


Eligibility criteria:
inclusion criteria: * provide signed written informed consent * diagnosis of poag or oht in both eyes * qualifying corrected visual acuity in each eye * qualifying central corneal thickness in each eye * qualifying day 1 iop measurement at 3 time-points in both eyes * qualifying anterior chamber angle exclusion criteria: * history of ocular surgery specifically intended to lower iop * subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period * advanced glaucoma in either eye * any corneal abnormality or other condition interfering with or preventing reliable goldmann applanation tonometry * any ocular surgery or ocular laser treatment within 90 days prior to visit 1 (screening) and throughout the study in either eye * females who are pregnant, nursing, or planning a pregnancy

Keywords: glaucoma
can intravenous vitamin c improve skin hyperpigmentation in long-term hemodialysis patients?

Conditions: Kidney Failure, Chronic

Summary: intravenous vitamin c may improve skin hyperpigmentation in chronic hemodialysis patients

melanogenesis is caused by enzymatic conversion of tyrosine to melanin pigments.ascorbic acid has the ability to inhibit peroxidase and may thus inhibit melanin synthesis.

Eligibility criteria:
inclusion criteria: * chronic hemodialysis patients exclusion criteria: * allergic to vitamin c, using steroid, etc
effect of elliptical training on metabolic homeostasis in metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the growing prevalence of metabolic syndrome (mets) in the worldwide is becoming a serious health problem and economic burden. mets has become a crucial risk factor for the development of type 2 diabetes mellitus (t2dm) and cardiovascular diseases (cvd). the rising rates of cvd and diabetes, which are the two leading causes of death. to prevent the progression of mets to diabetes and cvd, regular physical activity is required. elliptical trainer device is a relatively new modality of exercise and is advertised to be superior to a treadmill because of the low joint impact and the more reasonable costs of an elliptical trainer compared to a treadmill. additional quantitative research is needed to further evaluate the effectiveness of elliptical trainers and the physiological and perceptual responses to the machine.

forty sedentary mets patients (from both sexes) will be randomly divided to group a and group b. -group a (elliptical training group): this group (n=20) will receive aerobic training on an elliptical trainer for 16 weeks (3 sessions per week). the session will start with 5 minutes warming up at 50 % of maximal heart rate (mhr), 20-minute continuous et at 70% of mhr, 12 minutes (4×3) intervals at 90% of mhr with a 3-minute active recovery at 70% of mhr between intervals, and finally 5-minute cool-down period at 50% of mhr. group b: this group will continue their normal daily physical activities without any additional training

Eligibility criteria:
inclusion criteria: * the mets subjects who will have three or more of the following criteria: 1) waist circumference more than 102 cm, triglycerides more than 150 mg/dl, 3) blood pressure (bp) more than 130/85 mmhg, 4) high-density lipoprotein (hdl) less than 40 mg/dl, . exclusion criteria: * renal, pulmonary, cardiac, vascular, respiratory, hepatic, autoimmune disorders. * smoker, addictive, cancer, and alcoholic patients. * lower limb arthritis or any orthopaedic problem will hinder the training. * participation in any type of sport training in the previous 6 months. * pregnant or lactating women. * patients with thyroid gland dysfunction.
oral vancomyin for primary clostridium difficile infection prophylaxis in patients receiving high-risk antibiotics

Conditions: Clostridium Difficile Infection; Prophylaxis; Vancomycin

Summary: the purpose of this study is to determine if oral vancomycin used as primary clostridium difficile prophylaxis can reduce the incidence of this infection in high-risk patients.

clostridium difficile infection is a common healthcare-associated infection and one that is associated with significant morbidity as well as a risk for mortality. current practice throughout the united states is targeted at infection prevention measures such as hand washing and isolation. despite these measures, incidence of clostridium difficile infections continue to rise as some institutions, including our own. recently, a study published in clinical infectious diseases found oral vancomycin for secondary prophylaxis to reduce the incidence of recurrence. no studies to date have evaluated primary prophylaxis with oral vancomycin. this will be a single center, prospective study to evaluate oral vancomycin use as primary clostridium difficile prophylaxis. patients treated by infectious disease physicians will be identified as "high risk" and after pager notification the id physician will have the option to start oral vancomycin 125 mg by mouth daily if they determine it to be appropriate. risk factors include age older than 65 years, taking gastric acid suppression medication, and receiving select broad-spectrum antibiotics. oral vancomycin will be continued until de-escalation of antibiotics or hospital discharge and patients will be evaluated for clostridium difficile infection development from the current hospital admission up to 4 weeks following antibiotic discontinuation.

Eligibility criteria:
inclusion criteria: * "high-risk" patients defined as: age older than 65, on gastric acid suppression, and select antibiotics * gastric acid suppression includes proton pump inhibitors and histamine-2 receptor antagonists * selected antibiotics include fluoroquinolone (ciprofloxacin, levofloxacin), clindamycin, a 3rd or 4th generation cephalosporin, a broad-spectrum aminopenicillin (ampicillin-sulbactam, piperacillin-tazobactam), or a carbapenem exclusion criteria: * failure to meet all three requirements for "high risk" * vancomycin allergy * active clostridium difficile infection prior to inclusion * prophylactic oral vancomycin prior to study inclusion (i.e. prolonged vancomycin taper) * receipt of medications that also treat clostridium difficile (metronidazole, rifaximin, fidaxomicin) * pregnant or breastfeeding
effect of topical glaucoma therapy on tear film stability in healthy subjects

Conditions: Healthy

Summary: long term treatment with anti-glaucomatous drugs has been shown to increase the incidence of dry eye syndrome with all known consequences such as ocular discomfort and epithelial keratitis. given that thinning of the tear film appears to be a risk factor for the development or the aggravation of dry eye syndrome, the current study seeks to investigate whether tear film thickness is changed after topical treatment with anti-glaucomatous drugs in healthy subjects. for this purpose, tear film thickness will be measured at baseline and after single instillation of one of 5 study drugs in one randomly chosen eye. in addition, one group of 20 subjects will receive no drug and will serve as a second control. drug effects on tear film thickness will be compared to the fellow, non-treated eye. in addition, effects on tear film thickness of timolol with preservatives (timoptic 0.5%) will be compared to timolol without preservatives (timophtal sine 0.5%) and three lubricants with different viscosity (genteal ha, hylo-comod, thealoz).


Eligibility criteria:
inclusion criteria: * men and women aged over 18 years * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, ametropia \< 6 dpt. exclusion criteria: * regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug * symptoms of a clinically relevant illness in the 3 weeks before the first study day * patients with known hypersensitivity to the study drug or any ingredients * history or current copd or asthma * av-block grade ii or more * ametropy ≥ 6 dpt * pregnancy

Keywords: topical lubricants tear film thickness anti-glaucoma drugs break up time anti-glaucoma treatment
a study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of patients with bipolar i disorder

Conditions: Bipolar Disorder; Affective Disorders, Psychotic; Mood Disorders; Mental Disorders

Summary: the purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of bipolar i disorder.

this is a 4-week study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of bipolar i disorder with an optional 6-month open-label (ol) extension for qualified patients following completion of the study. on days 1-28 patients will receive placebo or topiramate 2x/day by mouth except for the 1st and last doses which will be a single evening dose and a single morning dose, respectively. study drug will be titrated in 100-mg increments to 400 mg/day and patients maintained on a stable dose through day 28. during the ol extension phase, topiramate will be titrated over 5 days to 200 mg/day. after day 7, topiramate may be tapered down to 100 mg/day or up to 600 mg/day, as clinically indicated.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of bipolar i disorder (confirmed by the kiddie-schedule for affective disorders and schizophrenia-present and lifetime version \[k-sads-p/l\]) * ymrs score greater than or equal to 20 * general good health as determined by medical history, physical examination, and laboratory evaluations * ability to swallow tablets * patient's parent or guardian must be fully capable of monitoring the patient's disease process and compliance to treatment * parent(s) or legal guardian(s) must read and sign the informed consent form after the nature of the study has been fully explained and assent must be obtained from patients exclusion criteria: * dsm-iv axis i disorder diagnoses of autistic disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders not otherwise specified (nos) * dsm-iv diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within the 3 months prior to baseline. acute or intermittent substance abuse prior to screening will not be exclusionary, depending upon the clinical judgment of the investigator * chronic antidepressant treatment within 4 weeks of randomization (5 weeks for fluoxetine), use of psychostimulants in the 7 days prior to baseline, use of any other psychotropic medications within 3 days or 5 half-lives, whichever is less, prior to baseline, or requirement for treatment with other psychotropic drugs on an ongoing basis * weight less than 33 kg or current or past history of anorexia nervosa * serious or unstable medical or neurological conditions

Keywords: bipolar mania pediatric children adolescent topiramate anticonvulsants central nervous system agents protective agents neuroprotectiive agents
extension study of bmn 044 in duchenne muscular dystrophy (dmd)

Conditions: Duchenne Muscular Dystrophy

Summary: the aim of this study is to provide continuing access to bmn 044 treatment for subjects previously treated with bmn 044. the information gained from this study is expected to further characterize the efficacy and safety of bmn 044 over a longer treatment period.

this is a phase 2 multi center, multi national, open label, long term extension study. up to approximately 50 male subjects with duchenne muscular dystrophy (dmd) who have previously been treated with bmn 044 will be enrolled. subjects will receive either iv infusions or sc injections at pre-defined doses. safety and tolerability, pharmacokinetics (pk), pharmacodynamics (pd) and efficacy assessments will be conducted at regular intervals throughout the study. subjects will be permitted to continue in this study until the subject meets any of the defined withdrawal criteria, biomarin decides to halt the clinical development of bmn 044, or bmn 044 receives marketing authorization.

Eligibility criteria:
inclusion criteria: * subjects previously treated with bmn 044 or a comparator treatment in a bmn 044 sponsored study or investigator initiated trial and who are not eligible for another ongoing bmn 044 study. * continued use of glucocorticosteroids for a minimum of 60 days prior to study entry with a reasonable expectation that the subject will remain on glucocorticosteroids for the duration of this study. * willing and able to comply with all study requirements and procedures. * willing and able to provide written, signed informed consent, or in the case of subjects under the age of 18 years(or 16 years, depending on the region), provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to the conduct of any research-related procedures. exclusion criteria: * subjects who have previously been treated with bmn 044 who had a serious adverse experience or met safety stopping criteria, that remains unresolved, which in the opinion of the investigator could have been attributable to bmn 044. * history of significant medical disorder which may confound the interpretation of safety data * acute illness within 4 weeks prior to the first dose of bmn 044 (week 1) which may interfere with the measurements. * symptomatic cardiomyopathy. * baseline aptt above the upper limit of normal (uln). * baseline platelet count below the lower limit of normal (lln). * use of anti coagulants, anti thrombotics or anti platelet agents within 28 days of the baseline visit. * prior use of any investigational product (other than bmn 044) or investigational medical device must be discussed with the medical monitor prior to screening. * current or history of drug and/or alcohol abuse.

Keywords: duchenne muscular dystrophy dmd dystrophin bmn 044 pro044 biomarin
oral paclitaxel efficacy safety and pk in recurrent and metastatic breast cancer

Conditions: Recurrent or Metastatic Breast Cancer

Summary: the objective of this study is to evaluate the efficacy, safety and pharmacokinetics of dhp107 (oral paclitaxel, korea brand name: liporaxel®) compared to iv paclitaxel in patients with recurrent or metastatic breast cancer.


Eligibility criteria:
key inclusion criteria: 1. subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination 2. subjects with diagnosis of her2-negative breast cancer that was confirmed by ihc or in situ hybridization (ish) assessment of tumor samples 3. subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting 4. subjects who have a performance status of ≤2 on the eastern cooperative oncology group (ecog) scale. 5. subjects who have measurable disease according to the response evaluation criteria in solid tumors version 1.1 (recist version 1.1). key exclusion criteria: 1. subjects who have received prior taxane therapy in the metastatic setting 2. subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study. 3. subjects with neuropathy grade ≥2 based on ctcae v4.03 at the time of study entry 4. subjects with symptomatic, untreated metastases to the central nervous system (cns) at the time of screening. 5. subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (c1d1).

Keywords: breast cancer dhp107 paclitaxel liporaxel
detection of ad biomarkers in tear fluid

Conditions: Cognitive Impairment

Summary: detection of ad biomarkers in tear fluid


Eligibility criteria:
inclusion criteria: * . inclusion criteria were an mmse score ≥ 20 and a cdr score from 0 to 1, thereby including patients across the whole clinical spectrum (i.e. from subjective cognitive disorder to (mild) dementia). exclusion criteria: * exclusion criteria at baseline were neurological diseases (such as normal pressure hydrocephalus, morbus huntington, brain tumor, epilepsy, encephalitis, recent transient ischemic attack (tia) or cerebrovascular accident (cva) (\< 2 years), or tia/cva with concurrent (within three months) cognitive decline) and a history of psychiatric disorders (such as schizophrenia, bipolar disorder or psychotic problems, current major depressive disorder (within 12 months), or alcohol abuse).
a global, postmarketing observational safety study to evaluate the safety and tolerability of fycompa (perampanel) as add-on therapy in epilepsy patients aged greater than or equal to 12 years

Conditions: Epilepsy

Summary: the purpose of this study is to evaluate the safety and tolerability of fycompa (perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.

this is a global, observational, cohort study in patients with epilepsy. multiple treating physicians will prescribe perampanel to approximately 500 patients, who then will be observed for approximately 52 weeks.

Eligibility criteria:
inclusion criteria 1. male or female patients age greater than or equal to 12 years (or as regionally appropriate) at the time of informed consent 2. patients prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the screening visit 3. patients who provide informed consent exclusion criteria 1. participation in another study involving administration of an investigational drug or device whilst participating in this observational study 2. prior participation in a perampanel clinical study 3. hypersensitivity to perampanel

Keywords: epilepsy