Kornimate/medical-research-clean huggingface dataset:
african-american pharmacogenetics

Conditions: Acute Coronary Syndrome

Summary: this is a genetic and platelet reactivity study of african-american versus caucasian patients undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel. the investigators aim is twofold: to describe differences in allele frequencies between african-americans and caucasians, and to explore associations of platelet reactivity and genetic polymorphisms in these two groups.

the investigators propose a pharmacogenetic cohort study of 100 african-american versus 100 caucasian patients presenting with an acute coronary syndrome, receiving clopidogrel or prasugrel and undergoing pci. the study will have four arms: african-american on clopidogrel; african-american on prasugrel; caucasian on clopidogrel; and caucasian on prasugrel. all patients will undergo genotyping and platelet reactivity testing with the verifynow p2y12 assay, at least 6 hours after receiving a thienopyridine loading dose, but before hospital discharge. all patients will be treated with aspirin 325 mg/day as well. race determination will be based on a patient's self-report, but patients enrolled in the trial must also report that all four of their grandparents were of the same race as theirs. other races (asian, native american, et al) will be excluded from this study.

Eligibility criteria:
inclusion criteria: 1. patients age 18 or older, of both genders 2. presenting with an acs, defined as at least two of the following: * symptoms consistent with myocardial ischemia; * st segment elevation or depression of at least 1 mm in 2 or more contiguous leads on ekg; * a cardiac troponin i level above upper limit of normal. 3. self-reported african-american or caucasian race a. all 4 grandparents of same race 4. no contraindications to prasugrel therapy. 5. patient is scheduled for, or has already undergone, pci. exclusion criteria: 1. known allergies to aspirin, clopidogrel, or prasugrel. 2. patient known to be pregnant or lactating. 3. patient with known history of bleeding diathesis or currently active bleeding. 4. platelet count \<100,000/mm at the time of enrollment. 5. hematocrit \<25% at the time of enrollment. 6. on warfarin therapy at the time of pci, or patient likely to require warfarin therapy post-pci. 7. received fibrinolytics within the past 48 hours. 8. received a glycoprotein iib/iiia inhibitor within the past 48 hours, or if such a strategy for pci involving a glycoprotein iib/iiia inhibitor is planned. 9. taking maintenance thienopyridine therapy in the previous 5 days. 10. known blood transfusion within the preceding 10 days. 11. patients treated with non-steroidal anti-inflammatory drugs (nsaids) within the previous 5 days. 12. patients with known chronic liver disease. 13. age greater than 75 years 14. body weight less than 60 kg 15. history of stroke or transient ischemic attack 16. surgery planned within 1 month 17. patient likely to require coronary artery bypass grafting 18. any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.

Keywords: platelet reactivity genotyping
the effect of probiotic supplementation on cognitive and emotional functions in healthy elderly subjects

Conditions: Healthy

Summary: this study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients.

gut microbiota (gm) has focused as an important target for emotional and cognitive diseases, moreover in a population that show an altered gm such as elderly population as age-related changes. several studies have shown that ageing alter gm, both in diversity and integrity. probiotics have demonstrated that correct or prevent age-related dysbiosis, in order to reduce or prevent intestinal permeability and associated inflammation, inhibit the generation of harmful and/or toxic metabolites, as well as promote the production of beneficial bacterial components. the aim of this study is to assess the effectiveness of a multiprobiotic formulation as a therapeutic strategy to attenuate the emotional and cognitive decline associated with ageing in healthy adults over 55 years of age. the hypothesis is that administration of a multi-species probiotic for 10 weeks will slow and/or ameliorate the decline in emotional and cognitive function inherent to senescence.

Eligibility criteria:
inclusion criteria: * be aged 55 years or over, * voluntarily agree to participate in the study in accordance with the helsinki declaration, * not be participating in another study that could interfere with the results. exclusion criteria: * suffer from any serious mental illness other than depression and anxiety, * score below 10 on the mini-mental state examination (mmse) (severe cognitive impairment) * be using medications that affect cognition, * taking anti-inflammatory drugs, antipsychotics, antibiotics and/or anxiolytics, * have a serious illness (e.g. cancer, parkinson's or alzheimer's).

Keywords: probiotics cognitive emotional aging elderly
coloplast dialoguestudy

Conditions: Stoma

Summary: the main purpose of the study is to document real life experience on sensura with focus on skin condition and quality of life.

it is important to continuously develop and test ostomy products in order to prevent peristomal skin disorders and to enhance the quality of life for people with a stoma. furthermore, it is essential to create awareness about the importance of healthy peristomal skin as many of these conditions are preventable.

Eligibility criteria:
inclusion criteria * signed informed consent before any study related activities * subjects with a colostomy, ileostomy or urostomy * subjects must have had their ostomy for at least 6 months * subjects must have mental capacity to understand the study and questionnaires * subjects must be at least 18 years of age. exclusion criteria * women who are pregnant or breast-feeding * subjects who have more than one ostomy * subjects with an ostomy who use plug * participation in other studies at the same time * previous participation in this study

Keywords: stoma ostomy
project solve: trial of a brief digital problem-solving intervention

Conditions: Anxiety; Depression; Stress

Summary: the goal of this trial is to examine the effectiveness of a universal, self-guided, digital single-session intervention focusing on problem-solving skills in improving adolescent mental health and well-being, relative to an active control intervention focusing on study skills, within the context of school settings during the coronavirus disease pandemic.

more than 20% of adolescents will experience at least one mental health disorder or problem before adulthood that warrants treatment, yet 80% of these adolescents will never receive care. this need-to-access gap appears to be heightened during the current coronavirus disease pandemic and its resulting disruptions to healthcare and education systems. both within and beyond the context of the pandemic, preventive mental health interventions are positioned to help adolescents build and strengthen coping strategies that can preclude the emergence of mental health difficulties that require more resource-intensive levels of clinical care. preventive mental health interventions delivered via digital platforms and within school-based settings might be especially scalable. the current school-based trial is designed to test one such strategy that harnesses technology to boost the scalability of adolescent mental health interventions: a brief (one 30 minute session) digital program designed to empower adolescents (10-14 years old) to solve, rather than be overwhelmed by, everyday problems (project solve). single-session interventions designed to help adolescents cultivate adaptive mindsets have reduced anxiety and depression among adolescents with and without elevated symptoms of these disorders. building on this strong foundation, project solve targets these mental health challenges with problem solving skills-one of the most versatile, commonly used, and potent therapeutic techniques for adolescents.

Eligibility criteria:
inclusion criteria: * adolescent is in grades 6-8 (inclusive) at partnering schools * adolescent is between the ages of 10-14 years (inclusive) at the time of study enrollment * adolescent and at least one guardian consent to adolescent participation in study * adolescent reads english well enough to effectively complete the digital programs * adolescent has access to a digital device exclusion criteria: * adolescent is non-english speaking, as the programs are only available in english * adolescent does not have access to a digital device * adolescent has an intellectual disability that precludes comprehension of the program content
reproducibility of retinal nerve fiber layer thickness measurements using the eye tracker and retest function of spectralis® sd-oct in glaucomatous eyes and healthy controls

Conditions: Glaucoma

Summary: purpose. to evaluate the impact of self-acting eyetracking and retest software on the reproducibility of retinal nerve fiber layer (rnfl) thickness measurements in glaucoma patients and healthy control subjects using spectralis® sd-oct. methods. rnfl thickness was measured in 56 normal and 47 glaucomatous eyes by one operator within one session with a brief rest between measurements. three measurements were taken with the eye-tracker and retest function, and three were taken without this function, alternating between measurement methods. * trial with medical device


Eligibility criteria:
inclusion criteria: * visual acuity of more or equal to 0.5 snellen, refractive error less than ±5.00 diopters (d) spheric and ±3.00 d cylindrical and no history of ocular trauma or of any other severe ocular disease (particularly diseases affecting the optic nerve or surgery other than uncomplicated cataract surgery). * additional inclusion criteria for the glaucoma group were a diagnosis of primary open angle glaucoma (poag) or pex-glaucoma. exclusion criteria: * exclusion criteria for the control group were history of glaucoma or intraocular pressure beyond 21 mmhg and optic disc cupping of more than 0.6
performance of toric hydrogel lenses following a refit with toric silicone hydrogel lenses for 1 month

Conditions: Ametropia

Summary: the aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon a toric lenses after a refit with fanfilcon a toric lenses for 1-month of daily wear.


Eligibility criteria:
inclusion criteria: * is between 18 and 40 years of age (inclusive) * has had a self-reported visual exam in the last two years * is an adapted soft contact lens wearer * has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)-have no less than -0.75d of astigmatism and no more than -2.25 d in both eyes * can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logmar) or better in each eye. * can achieve a distance visual acuity of 20/30 (0.18 logmar) or better in each eye with the study contact lenses. * has clear corneas and no active ocular disease * has read, understood and signed the information consent letter * patient contact lens refraction should fit within the available parameters of the study lenses * is willing to comply with the wear schedule (at least 5 days per week, \>8 hours/day assuming there are no contraindications for doing so) * is willing to comply with the visit schedule exclusion criteria: * has a contact lens (cl) prescription outside the range of the available parameters of the study lenses * has a spectacle cylinder less than -0.75d or more than -2.50 d of cylinder in either eye * has a history of not achieving comfortable contact lens (cl) wear (5 days per week; \> 8 hours/day) * has contact lens best corrected distance vision worse than 20/25 (0.10 logmar) in either eye * presence of clinically significant (grade 2-4) anterior segment abnormalities * presence of ocular or systemic disease or need of medications which might interfere with contact lens wear * slit lamp findings that would contraindicate contact lens wear such as: * pathological dry eye or associated findings * pterygium, pinguecula, or corneal scars within the visual axis * neovascularization \> 0.75 mm in from of the limbus * giant papillary conjunctivitis (gcp) worse than grade 1 * anterior uveitis or iritis (past or present) * seborrheic eczema, seborrheic conjunctivitis * history of corneal ulcers or fungal infections * poor personal hygiene * has a known history of corneal hypoesthesia (reduced corneal sensitivity) * has aphakia, keratoconus or a highly irregular cornea * has presbyopia or has dependence on spectacles for near work over the contact lenses * has undergone corneal refractive surgery * is participating in any other type of eye related clinical or research study.
heterogeneity informed nutrition therapy for gestational diabetes mellitus

Conditions: Gestational Diabetes

Summary: the hypothesis for this study is that women with different physiologic subtypes of gestational diabetes (gdm) (insulin secretion deficit vs. insulin sensitivity deficit) will differ in their glycemic responses to meals with different portions of dietary macronutrients. investigators will determine gdm subtype based on glucose and insulin levels taken at multiple time points during an oral glucose tolerance test. participants will consume two meals with different macronutrient content while wearing a continuous glucose monitor which will allow investigators to assess the glycemic response to the meals.

diabetes mellitus can be classified based on impairments in two different physiologic parameters, insulin secretion and insulin sensitivity. the investigator involved in this trial has previously defined gdm subtypes based on underlying physiology and demonstrated that women with gdm and predominant sensitivity defects have an elevated risk of adverse pregnancy outcomes, while women with predominant secretion defects do not appear to carry the same risk. this supports the idea that not all gestational diabetes is the same. ideal treatment strategies may differ between gdm subtypes. in this trial, investigators will evaluate the postprandial glycemic response to two test meals with different macronutrient content in different gdm physiologic subtypes. two test meals with different macronutrient proportions have been designed by research dieticians. participants will eat test meals at home for breakfast in a randomized order after an overnight fast. participants will complete food and blood sugar diaries, and will wear a continuous glucose monitor, which will measure postprandial glucose.

Eligibility criteria:
inclusion criteria: -diagnosis of gestational diabetes exclusion criteria: * known diabetes mellitus that preceded pregnancy * food allergies to components of the test meals * use of medications known to affect glucose tolerance * have extensive skin changes or diseases making cgm sensor use problematic * demonstrated allergy to cgm adhesive * inability to adhere to the swimming and bathing instructions * plan to have mri, ct scan, x ray or diathermy (heat treatment) during the 7-day cgm study period * inability to adhere to vitamin c guidelines during study period (using more than 500 mg of vitamin c/day which could interfere with the cgm) * use of medications known to affect glucose tolerance * in the opinion of the principal investigator (pi), demonstrate any other factor likely to limit compliance with the protocol

Keywords: gestational diabetes pregnancy diet nutrition
the incidence and risk factors for clostridioides difficle infection in solid organ transplant recipients

Conditions: Infection in Solid Organ Transplant Recipients

Summary: 2.1. study objectives * primary objective(s) * identify the incidence and risk of cdi within one year after kidney, liver, and/or pancreas transplant * secondary objective(s) * identify the risk factors for recurrent cdi post-transplant in patients who were diagnosed with a cdi within one year prior to solid organ transplant * evaluate the impact of cdi on graft survival following solid organ transplant

* single center, retrospective cohort chart review study design * data will be collected on all liver, kidney, pancreas and combined transplant recipients who received their graft(s) from april 1, 2015 to july 31, 2018 * will analyze outcomes from april 1, 2014 to july 31, 2019 * patient list will be generated in epic and meditech * all data will be obtained from epic and meditech * all data will be collected retrospectively after the patient is discharged from the hospital

Eligibility criteria:
inclusion criteria: * solid organ transplant patients who received graft(s) at mdmc from april 1, 2015 to july 31, 2018 * age \>18 years old exclusion criteria: * age \<18 years old * loss to early death defined as within one week from transplantation * patients whose primary address is in puerto rico
prevention of pneumothorax following endoscopic valve therapy in patients with severe emphysema

Conditions: Pneumothorax

Summary: endoscopic valve therapy is an effective therapy for patients with severe emphysema and low interlobar collateral ventilation. although, valve therapy is a minimal-invasive treatment approach, it is associated with complications the most common of which is pneumothorax with a rate of 18-25%. modifying post-operative medical care including bed rest for 48 hours after valve implantation may reduce the risk of post-interventional pneumothorax.

patient enrolment and data acquisition is to be carried out on a prospective basis. it is planned to enrol a total of 130 patients with advanced emphysema and low collateral ventilation. patients will be randomly assigned in a 1:1 ratio to receive modified medical care including a 48 bed rest or standard medical care following valve implantation. all patients will undergo treatment at one study centre in heidelberg.

Eligibility criteria:
inclusion criteria: * fev1 \ 150%, tlc\>100% * emphysema confirmed by computed tomography * po2 \>60 mmhg (with supplemental oxygen), pco2 \< 55 mmhg (room condition) * no significant collateral ventilation (assessed by fissure analysis and/or catheter-based measurement) * no copd exacerbation within the past 8 weeks * daily use of \< 20 mg prednisolon * non-smoking for a minimum of 4 months prior to consent * patient has provided written informed consent exclusion criteria: * bmi \< 18 kg/m² * clinically relevant bronchiectasis * failed cardiac clearance: defined as myocardial infarction within last 6 weeks, decompensation of heart failure * prior lung resection (e.g. lobectomy)
multi-center and multi-modal deep learning study of gastric cancer

Conditions: Stomach Neoplasms

Summary: to assist postoperative pathological diagnosis and classification of gastric cancer by machine learning; to improve the accuracy of pathological diagnosis of gastric cancer by machine learning; to predict the effectiveness of treatment for gastric cancer by deep learning; to construct a model to predict the survival of gastric cancer patients by multimodal deep learning.


Eligibility criteria:
inclusion criteria: * the diagnosis of gastric cancer was confirmed by pathology; * preoperative enhanced abdominal ct; * available detailed clinical and pathological data; * integrated follow-up data. exclusion criteria: * the patients had severe underlying disease; * overall survival was less than 3 months; * no detailed information could be collected.

Keywords: diagnosis prognosis
registry of asthma patients initiating dupixent®

Conditions: Asthma

Summary: the primary objective of the study is to characterize the patients who initiate treatment for asthma with dupixent® in a real-world setting to understand the attributes of treated patients in real life. this includes characterization of: * patient demographics (eg, gender, age, and race) * patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height) the secondary objectives of the study are: * to characterize real-world use patterns of dupixent® for asthma * to assess the long-term effectiveness of dupixent® in asthma patients in a real-world setting * to assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with dupixent® * to collect long-term safety data on study participants in the real-world setting

3-year registry of real-world use of dupixent® for asthma in patients age 12 and over

Eligibility criteria:
key inclusion criteria: * willing and able to comply with the required clinic visits, study procedures and assessments * able to understand and complete study-related questionnaires * provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required * initiating treatment with dupixent® for a primary indication of asthma according to the country-specific prescribing information key exclusion criteria: * patients who have a contraindication to dupixent® according to the country-specific prescribing information * treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day * any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments. note: other protocol defined inclusion/exclusion criteria apply.

Keywords: primary indication of asthma
a study of the vision5 product in patients with glaucoma or ocular hypertension

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Summary: the objective of this phase 1 study is to evaluate the vision5 product's safety and efficacy.


Eligibility criteria:
inclusion criteria: * written informed consent * primary open-angle glaucoma or ocular hypertension in both eyes * best-corrected distance vision of 20/100 or better * stable visual field exclusion criteria: * cup-to-disc ratio greater than 0.8 * laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months * corneal refractive surgery within prior 6 months * past history of any incisional surgery for glaucoma at any time * corneal abnormalities that would interfere with tonometry readings * current participation in an investigational drug or device study or participation in such a study within 30 days of screening