Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of kpi-121 in subjects with dry eye disease

Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Summary: the primary purpose of this study is to determine the efficacy and safety of kpi-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. the product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (qid).

this is a phase ii, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of kpi-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease. approximately 400 subjects will be screened and up to 150 subjects will be randomized at up to 12 centers located in the united states. subjects will be randomized to 1 of 2 study arms in an approximate 1:1 ratio. the study arms are: 1) kpi-121 0.25% ophthalmic suspension administered 1-2 drops in each eye qid for up to 28 days or 2) vehicle administered as 1-2 drops in each eye qid for up to 28 days. this study will include up to 6 clinic visits over 6 weeks. at visit 1 screening (14 ± 1 days prior to day 1), subjects who meet screening inclusion/exclusion criteria will begin a 2-week run-in period during which they will be treated with 1-2 drops of single-masked vehicle in each eye qid for 14 ± 1 days. at visit 2, randomization (day 1), subjects who continue to meet inclusion/exclusion criteria will be eligible for randomization to 1 of the 2 arms of the study (i.e., kpi-121 0.25% ophthalmic suspension or vehicle). following randomization, subjects will be instructed to return to the clinic to have a complete study evaluation at study visits 4 and 6 (days 15 ± 1 day and 29 ± 1 day, respectively). subjects will further be instructed to return to the clinic for diary collection and in-clinic symptom assessment only at visits 3 and 5 (days 8 ± 1 day and 22 ± 1 day, respectively). the last dose of investigational product and the final study visit will occur upon completion of 28 ± 1 days of exposure to investigational product. subjects will be released from the study at the end of visit 6 (day 29 ± 1 day).

Eligibility criteria:
inclusion criteria: • have a documented clinical diagnosis of dry eye disease in both eyes exclusion criteria: * known hypersensitivity/contraindication to study product(s) or components. * history of glaucoma, iop \>21 mmhg at the screening or randomization visits, or being treated for glaucoma in either eye. * diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening. * in the opinion of investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Keywords: pain corticosteroid dry eye hyperemia ocular discomfort
improving health and wellness for people with serious mental illness in puerto rico

Conditions: Chronic Disease; Serious Mental Illness

Summary: this study evaluates the effectiveness of a culturally tailored intervention, bridges to better health and wellness (bridges), aimed at reducing chronic disease disparities among puerto ricans with serious mental illness (smi). participants receive monthly sessions with health care managers to address patient-provider stigma and care coordination.

bridges is a multi-level healthcare manager intervention (hmi) that addresses both patient and provider barriers to healthcare. it includes culturally adapted modules to reduce stigma and promote chronic disease prevention. the study uses a hybrid type 1 effectiveness-implementation randomised controlled trial to test its impact on primary care service use, chronic disease outcomes and stigma reduction over 12 months.

Eligibility criteria:
inclusion criteria: adults receiving psychiatric or psychological services at the wellness center or the mayaguez medical center - primary care diagnosed with at least one serious mental illness smi (e.g., schizophrenia, bipolar disorder, major depression, etc.) have at least one risk factor or a diagnosis of a chronic health condition (e.g., diabetes, overweight, hypertension, etc.). be willing to receive or continue preventive medical care with a primary care physician. exclusion criteria: have started psychiatric or mental health services at least one month before have been diagnosed with a general mental health condition (e.g., depression or anxiety).

Keywords: bridges stigma preventive primary care healthcare managers wellness
vasopressin and v2 receptor in meniere's disease

Conditions: Meniere Disease

Summary: summary: some of sicknesses are well known to be provoked by inadequate adaptation to physical and/or psychogenic stress in their daily life. meniere's disease is also a common inner ear disease accompanied with vertigo, hearing loss and tinnitus especially in civilized people under stressed life style. its oto-pathology was firstly revealed in 1938 to be inner ear endolymphatic hydrops through the temporal bone study. to elucidate the neuroscientific relationship between "stress" and "inner ear", we examined plasma vasopressin (the anti-diuretic "stress" hormone) and its receptor, v2r in the endolymphatic sac (the "inner ear" endo-organ for endolymph absorption) in meniere's patients.

methods: between 1998 and 2006, we enrolled and assigned 105 intractable meniere's patients to examine plasma vasopressin during remission of vertigo attacks (controls: 30 patients with chronic otitis media). using the real-time pcr method, we examined v2r mrna expression in the endolymphatic sac in 12 patients (controls: 6 patients with acoustic neurinoma). by means of cell culture and cyclic amp assay, we also examined cyclic amp activity in the endolymphatic sac in 3 patients (controls: 3 patients with acoustic neurinoma).

Eligibility criteria:
inclusion criteria: * patients were eligible for enrollment if they had received a clinical diagnosis of meniere's disease according to the 1995 aao-hns criteria (committee, 1995). these criteria can be briefly described as follows: 1. repeated attacks of vertigo: a definitive spell is spontaneous vertigo lasting at least 20 minutes. a mixed type of spontaneous nystagmus is observed during attacks. 2. fluctuating cochlear symptoms: the hearing test usually reveals a marked fluctuation of the threshold in the low and middle tone range. exclusion criteria: * any other neuro-otologic diseases.

Keywords: meniere's disease stress vasopressin endolymphatic sac v2 receptor cyclic amp plasma vasopressin level and v2r mrna expression level in the endolymphatic sac both were significantly higher in patients with meniere's disease. in meniere's disease, there were significant negative co-relationships between vasopressin and v2r. the cyclic amp activity was basically up-regulated in the endolymphatic sac in meniere's disease.. the cyclic amp sensitivity for vasopressin was significantly elevated in the endolymphatic sac in meniere's disease.
effects of bioness in rehabilitation of stroke

Conditions: Stroke

Summary: a four-weeks randomized clinical two-period crossover-design study will be conducted. each patient will be randomized in a two separate consecutive treatment periods (parallel group design). "group a" will be treated with functional electrical stimulation (fes) and a second "gruppe b" will be treated without fes for two weeks. after this period group a and group b will switched.

prediction of motor recovery in the upper-limb (ul) / lower-limb (ll) in patients with stroke is generally based on clinical examination. however, according to former studies neurophysiological measures may also have a predictive value. in the acute phase, the combination of the motor score and seps are best predictive of outcome. neurophysiological measures alone are of limited value in predicting long term outcome. however, predictive accuracy is substantially improved through the combined use of both of these measures and clinical variables. a four-weeks randomized clinical two-period crossover-design study will be conducted. each patient will be randomized in a two separate consecutive treatment periods (parallel group design). "group a" will be treated with functional electrical stimulation (fes) and a second "gruppe b" will be treated without fes for two weeks. after this period group a and group b will switched.

Eligibility criteria:
inclusion criteria: * adults between the ages of 18 and 75 * inadequate ankle dorsiflexion during the swing phase of gait, resulting in inadequate limb clearance * medically stable for at least one week following the last episode of stroke * stable medication for four weeks * adequate cognitive and communication function to give informed consent, understand the training instructions, use the device, and give adequate feedback * ability to walk with or without an assistive device (except parallel bars) at least 10 meters exclusion criteria: * • lower motor neuron injury with inadequate response to stimulation * history of falls greater than once a week * severe cardiac disease such as myocardial infarction, congestive heart failure, or a demand pacemaker * patients who have other electrical stimulation devices implemented * patients with epilepsy and with autoimmune diseases
acute and chronic pain after video-assisted thoracoscopic surgery for lung cancer

Conditions: Lung Cancer

Summary: the aim of this study is to evaluate whether preoperative ct- guided hookwire localization would influence the incidence and intensity of acute and chronic pain after vats.

postoperative pain after thoracic surgery has gained recognition as a adverse outcome and head-scratching problem. the incidence of choric postoperative pain (cpsp) in thoracic surgery has been reported to be 20%-80%. however, there has been not an standard treatment for cpsp. many study has showed the risk factors of cpsp in thoracic surgery, such as vats type, operation time, duration of drainage, preoperative pain, repeat surgery, gender, postoperative chemotherapy or radiation therapy , etc. it is important that moderate-to-severe acute postoperative pain will be transformed into cpsp. that offers a new management goal in postoperative pain prevention.ct-guided hookwire localization have been proven to be benefical for vats to diagnose and treat small pulmonary , it can shorten operation timing and increase surgery success rate. however, it causes roughly 23.8% severe pain and complaints included wire dislodgement, pneumothorax and haemorrhage during and after insertion. the question is whether or not the moderate-to-severe acute postoperative pain from hookwire localition will change the incidence and intensity of cpsp in vats. nurses play a pivotal role in advanced practice, research, and education in the field of pain management. the pain management of hookwire localization may be a new vison in further research.

Eligibility criteria:
inclusion criteria: * aged 18-75 * patients who underwent underwent ct-guided localization before vats * asa i-ii * bmi 18.5-30 * no serious complications after localization * sign informed consent exclusion criteria: * could not complish underwent ct-guided localization * selfexpression or visual dysfunction * having emergency surgery * a severe psychiatric illness * having chronic pain problems in the chest area * pregnant women

Keywords: lung cancer video-assisted thoracoscopic surgery hookwire location
effects of tbs on reading in adult struggling readers

Conditions: Developmental Reading Disorder; Dyslexia, Developmental

Summary: the purpose of this project is to understand how reading is related to brain function. to do this, participants will perform some reading tasks and then have magnetic resonance imaging (mri) brain scans. participants will then receive transcranial magnetic stimulation (tms) to the reading areas of the brain, followed by a second mri brain scan. this will temporarily activate reading abilities. we want to better understand how the reading system in the brain functions.

subjects will come in for up to 2 sessions, each lasting between 1 - 4 hours. subjects will complete reading and cognitive tasks associated with reading, and receive tms as well as 2 mri brain scans, in order to assess brain regions important to reading. initial, basic screening including mri and tms safety screening will be conducted over the phone during the recruitment phone call and/or screening forms will be emailed to prospective subjects for their review. those individuals that qualify will be scheduled for session 1. session 1 will take between 1 and 3 hours. subjects who pass health/mri/tms screening will complete cognitive/reading screening measures as well as the demographic information survey. they will also be trained on the mri and tms procedures. if all screening criteria is met, subjects will be asked to return for a second session which will include the mri and tms portions of the study. session 2 will take place on a separate day and consist of renewal of the health/mri/tms screening forms prior to the mri scan or tms administration. the baseline mri portion of the session will last approximately 1.5 hours including screening, training, and scan time. the mri scan will be followed by the tms portion which will last approximately 45 minutes. the post-tms mri will take place immediately following the tms session and will last approximately 45 minutes. reading assessments will be administered before the baseline mri and again after tms stimulation/before post-tms mri, each lasting approximately 10 minutes.

Eligibility criteria:
inclusion criteria: * must meet the study reading criteria based on their reading and reading-related screening test results * native speakers of english * right handed * minimum of low average intellectual functioning (ss\>=80) on at least one subscale on the wechsler abbreviated scale of intelligence-2 exclusion criteria: * hearing deficits (\>25db at 500+ hz), visual deficits (\>20/40), serious emotional problems, certain neurological conditions (e.g., uncontrolled seizure disorders) * braces on teeth, a cardiac pacemaker; hearing aid; other metal in their body or eyes (which may include certain metallic-embedded tattoos), including but not limited to pins, screws, shrapnel, plates, dentures or other metal objects * tms or mri screening and contraindication forms which do not pass technician review
feasibility study of evaluating breast cancer patients with ductal lavage

Conditions: Breast Cancer

Summary: the primary purpose of this research is to analyze the cells present in the fluid obtained via ductal lavage from the nipple of a woman with a known diagnosis of breast cancer. a portion of the lavage fluid may be used in future breast cancer biomarkers. remaining lavage fluid will be used to analyze its biochemical composition, for investigational purposes only.


Eligibility criteria:
inclusion criteria: 1. 18 years of age 2. biopsy-proven unilateral invasive breast cancer of any histology or ductal carcinoma in situ 3. patient desires or requires treatment with mastectomy 4. any patient who has undergone prior excisional biopsy of their primary breast tumor must have had margins positive for disease, or must have either mammographic or ultrasonographic evidence of probable residual disease in the breast. 5. patients receiving induction chemotherapy remain eligible for participation in the study regardless of tumor response; those with a clinical complete response remain eligible. 6. voluntarily signed informed consent. - exclusion criteria: 1. male gender 2. lobular carcinoma in situ as the only cancerous histology 3. prior margin-negative excisional biopsy of primary breast tumor, with no evidence of residual disease 4. patient being treated with breast conservation therapy inability to understand the nature of the procedure pregnancy and/or active lactation
effect of concurrent hookah and alcohol consumption on smoking topography and toxicant exposure

Conditions: Alcohol Use, Unspecified; Hookah Smoking

Summary: the purpose of the current study is to investigate in a prospective randomized cross-over trial, the impact of alcohol versus a placebo drink on smoking behavior and topography (duration and frequency of puffing), abuse liability, and toxicity. it is hypothesized that drinking alcohol before smoking will be associated with longer puffs and shorter duration between puffs and greater abuse liability and toxicity.


Eligibility criteria:
inclusion criteria: 1. report using hookah at least 1 time per month over the past 6 months 2. are at least 21 years old 3. speak and understand english 4. do not currently suffer from lung disease including asthma, cf, or copd 5. do not currently suffer from heart disease 6. are not currently pregnant or breast-feeding or have plans to become pregnant or begin breast-feeding at any point during the study 7. no current, regular use of \>5 cigarettes or other tobacco products (e.g., e-cig, cigar, etc.) per month. 8. no current marijuana use \> 5 times per month 9. no use of illicit drugs during the past 30 days 10. willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours and abstain from alcohol for at least 24 hours prior to each of the two sessions 11. live within 25 miles of the study location. 12. have a friend who is eligible and willing to participate. 13. consume 2 or more or one or more drinks per episode for men and women, respectively 14. drink alcohol at least one time per week 15. not currently be seeking treatment for alcohol use 16. able to answer at least two hookah-specific screening questions from the screener. - exclusion criteria: 1. hookah use less than one time per month over the past 6 months 2. under the age of 21 3. unwilling to abstain from alcohol for 24 hours and tobacco and nicotine products 12 hours prior to each study visit 4. live more than 25 miles from the study location 5. pregnant or breast feeding or plan to become pregnant or begin breast feeding at any point in the study -
basal bolus vs. sliding scale for treatment of diabetic patients in medical wards

Conditions: Diabetes Mellitus Type 2

Summary: a comparison of two treatment approaches for hyperglycemia in diabetic patients hospitalized in the medical department. the first approach is called basal-bolus in which 4 insulin shots are given daily ( 3 short acting before meals and one long acting before bed time). the second approach is called sliding scale in which short acting insulin alone is given before meals and before bed time according to the patient's glucose values. the aim is to keep fasting glucose between 140-180 mg/dl.


Eligibility criteria:
inclusion criteria: * patients admitted to internal medicine ward with blood glucose (bg) between 140-400 mg/dl. * known history (\>6months) of diabetes. * aged 18-80 years old. * previous therapy including either diet alone or any combination of oral hypoglycemia agents, glucagon-like peptide 1 (glp-1) analogs and long acting insulin analogs or neutral protamine hagedorn (nph). exclusion criteria: * pregnancy * patients with ketoacidosis * patients with unknown history of diabetes * patients with type 1 diabetes mellitus * patients with clinically relevant hepatic disease or renal impairment ( serum creatinine≥2.5 mg/dl) * use of corticosteroid therapy * patient with any mental disorder preventing him to cooperate and give informed consent. * patients on multiple daily doses of insulin regimen.
omentectomy and metabolic syndrome

Conditions: Metabolic Syndrome; Morbid Obesity

Summary: the aim of the present study was to evaluate the additional effect of sudden visceral fat reduction by omentectomy on metabolic syndrome, acute phase reactants and inflammatory mediators in patients with morbid obesity undergoing laparoscopic roux-en-y gastric bypass.

although weight loss controls metabolic syndrome and reduces the level of inflammatory markers in patients with morbid obesity, patients may enjoy the benefit achieving metabolic control before significant weight loss occurs.

Eligibility criteria:
inclusion criteria: * bmi \> 35 kg/m2 * metabolic syndrome diagnosed exclusion criteria: * type 1 diabetes * uncontrolled type 2 diabetes * cirrhosis or active hepatitis * pregnancy * recent mi or stroke

Keywords: omentectomy metabolic syndrome acute phase reactants
embolism in covid-19 positive patients

Conditions: COVID-19 Pneumonia; Embolism; Genetic Predisposition

Summary: covid-19 outbreak has caused death of millions of people because of not only the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection itself but also infection dependent complications. abnormalities in thrombotic events leads to some of these complications which eventually result in emboli. the endothelial damage caused by the virus interacting with ace2 on the host cells leads to the activation of coagulation cascade. accumulation of byproducts of the cascade might have some roles in embolism inducing risk of organ damage, other life-threatening problems, and even death. to enlighten the factors triggering embolism, the investigators have focused on genetic changes such as polymorphisms and mutations in certain genes in dna samples coming from intensive care unit (icu) patients.

this study has conducted to find the possible links between genetic make up of icu patients with severe covid-19 and embolism. 13 polymorphisms and mutations that the investigators targeted are located on factor ii, factor v, factor xiii, mthfr, angiotensin converting enzyme (ace), endothelial cell protein c receptor (epcr), and fgb. the investigators have found significant changes in the mutant allele frequencies in most of the factors. the main workflow to study a point change on dna sequence begins with dna isolation from a biological material. in this case, we received blood samples in ethylenediaminetetraacetic acid (edta) tubes from icu patients with severe covid-19. the investigators hypothesis claims that genetic factors triggering thrombotic events might increase the severity of the diseases by inducing the risk of emboli. after dna isolation, desired loci on dna were amplified via polymerase chain reaction (pcr). amplicons including the mutations and polymorphisms need to be purified before next generation sequencing (ngs). the investigators analyze the data using integrative genomics viewer (igv) program and check the genetic profile (wt, het, mut). some of the changes are meaningful by themselves while some other need to be considered as combinations. compound heterozygosity and diagnosis for thrombophilia require cooccurrence of the changes. to compare allelic frequencies, the investigators include the average of the data coming from more than 2000 individuals with no know thrombophilia cases. in the investigators focus cohort, the investigators have the data of 47 covid-19 patients in icu.

Eligibility criteria:
inclusion criteria: * being tested positive for covid-19 * icu patients developing severe pneumonia upon covid-19 infection exclusion criteria: * previously tested positive for genetic factors increasing thrombosis risk * icu patients developing severe emboli regardless of covid-19 infection

Keywords: thrombophilia genetic factors covid-19