Kornimate/medical-research-clean huggingface dataset:
help therapy for dry amd

Conditions: Non-exudative (Dry) Age-related Macular Degeneration (AMD)

Summary: this is an open-label, single center clinical investigation to evaluate the efficacy and safety of heparin-induced extracorporeal lipoprotein precipitation (h.e.l.p.) therapy as a treatment for non-exudative (dry) age-related macular degeneration (amd). a total of 14 clinic visits are scheduled, one baseline visit, 8 visits for h.e.l.p. therapy treatments (to be performed over a period of 12 weeks for each patient) and 5 follow-up visits to be performed one week following the 4th h.e.l.p. therapy session and 12 weeks, 24 weeks, 36 weeks and 52 weeks after the final h.e.l.p. therapy session.


Eligibility criteria:
inclusion criteria: * diagnosis of non-exudative (dry) amd * male or female, between 50 and 90 years * presence of soft, confluent drusen in study eye * at least one large (\>125 μm) drusen * visual acuity (va) between 20/32 and 20/100 early treatment diabetic retinopathy study (etdrs) vision * fibrinogen level \>100mg/dl * willing to continue lipid-lowering medication throughout the treatment phase if such medication was taken already before the study * willing to continue regular supplemental intake of age related eye disease study (areds) vitamins or comparable supplements throughout the study course * written informed consent exclusion criteria (related to the underlying disease): * any evidence of wet amd in either eye * history of treatment for wet amd in either eye * geographic atrophy involving fovea in study eye * fellow eye \<20/400 va * presence of cataract requiring treatment during study * presence of glaucoma requiring new treatment during study * presence of diabetic or other vascular retinopathy * previous retinal laser or surgical therapy * epiretinal membrane in study eye * any other ocular condition requiring therapy during the study exclusion criteria (general): * participation in another clinical trial within 30 days * concurrent participation in another clinical trial * pregnancy or lactation * inability to give or understand informed consent * inability to maintain treatment and follow-up schedule * hypersensitivity to fluorescein * test positive for infectious status from hiv-, hbv- and hcv- infection exclusion criteria (h.e.l.p. apheresis): * heparin intolerance * heparin induced thrombocytopenia (hit) ii * hemorrhagic diathesis * ulcers in the gastrointestinal area * hemorrhage * coagulation disorder and neoplasm * liver diseases * severe heart failure and valvular defect * condition following apoplexia * dementia * during pregnancy and lactation * c1 esterase inhibitor deficiency or hereditary complement component 3 (c3) deficiency

Keywords: age-related macular degeneration (amd) age related eye disease study (areds) best-corrected visual acuity (bcva) early treatment diabetic retinopathy study (etdrs) heparin-induced extracorporeal ldl-cholesterol precipitation (help) visual function questionnaire (vfq)
standardization of 6 minute walk test

Conditions: Pulmonary Hypertension

Summary: the 6 minute walk (6mw) gives information about the exercise capacity and it is an important tool for clinical decisions and for the prognostic evaluation of ph patients. the test is technically simple to perform, inexpensive and reproducible. during the 6mw o2 saturation, heart rate, walking distance (in this study after every minute) and the level of dyspnea (borg-dyspnea scale) may be recorded; however, at present, mainly the walking distance is evaluated. the test is sometimes criticized, because of the dependence on the patient's motivation. the purpose of the present study is to standardize the test by the incorporation of objective factors. the investigators are correlating the change of heart rate and dyspnea (borg scale) with the achieved walking distance during subsequent examinations performed with different effort.

on two different days the patients have to absolve four 6mw on different levels of effort - on both days a traditional test will be performed and additionally a test with more effort or with less effort. the order of the tests will be randomized. these two days of the examinations should be within a maximum of three months, provided that there is no sign of relevant clinical changes. after every minute the walking distance is determined. heart rate and the o2 saturation are measured by pulsoxymetry during the whole test. every two minutes the patients are asked about their dyspnea (borg scale). the purpose of the present study is to standardize the test by the incorporation of objective factors and to detect the correlation between the walking distance and the level of effort during exercise. the investigators expect that the reliability and objectivity of 6mw may increase by the standardization. the additionally performed cardiopulmonary exercise testing helps to evaluate and stratify patients.

Eligibility criteria:
inclusion criteria: * diagnosis of pulmonary hypertension or exercise-induced pulmonary hypertension by right heart catheterisation * informed consent exclusion criteria: * myocardiac infarct within the last 12 months * uncontrolled ventricular arrhythmia * uncontrolled bradycardic or tachycardic supraventricular arrhythmia * relevant operations within the last 12 weeks * change of the hemodynamic therapy within the last 6 weeks * joint diseases or diseases of peripheral vessels and nerves which may make the results of the six minute walk test unreliable

Keywords: six minute walk
topical cyclosporine and disease progression

Conditions: Disease Progression; Disease Severity; Staining; Schirmers; OSDI

Summary: the purpose of this study is to evaluate the effect restasis has in regards to disease progression.


Eligibility criteria:
inclusion criteria: * mild to moderate dry eye symptoms exclusion criteria: * current use of restasis
registry for patients with acquired resistance to small molecule kinase inhibitors in non-small-cell lung cancer

Conditions: Unresectable or Metastatic Non-small Cell Lung Cancer (NSCLC)

Summary: the purpose of this study is to try to learn more about how small molecule kinase inhibitors work in treating lung cancer. some early studies have shown that gefitinib, erlotinib and similar drugs are more likely to work if a particular dna change (also known as a mutation) is found in a protein that is important in lung cancer. this protein is called the epidermal growth factor receptor (egfr). since small molecule kinase inhibitors sometimes stop working, we would like to examine your tumor to learn why these medicines are not working as well. your tumor will be examined for a variety of things including changes in the dna of the egfr. we will also sequence parts of the genes for her2, her3, her4, and kras, other proteins thought to be important in lung cancer.

the goal of this protocol is to determine mechanisms of resistance to epidermal growth factor (egfr) tyrosine kinase inhibitors (egfr-tki) in non-small cell lung cancer (nsclc). a number of trials have shown small molecule kinase inhibitors to be active agents in the treatment of nsclc \[1\]. clinically these drugs have been noted to produce dramatic but infrequent responses. mutations in the epidermal growth factor receptor have been shown to correlate with sensitivity to gefitinib and erlotinib\[2,3\]. however, we know that most patients who have initial responses to egfr-tki eventually progress. the mechanism of acquired clinical resistance to these inhibitors in patients incompletely understood. this is a protocol to study clinical characteristics and biopsy tissue of patients with non-small cell lung cancer who have had previous clinical response to small molecule kinase inhibitors and subsequently experience progression of disease. the tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of sensitivity and resistance to small molecule kinase inhibitors.

Eligibility criteria:
inclusion criteria: patients diagnosed with unresectable or metastatic non-small cell lung cancer (nsclc) and who fulfill the following eligibility criteria will be considered eligible for this study. * patient must have previously received treatment with small molecule kinase inhibitors targeting at least, in part, egfr patients may have received other treatments since treatment with small molecule kinase inhibitors including radiation or chemotherapy) * development of disease progression while actively receiving tyrosine kinase inhibitor * signed informed consent exclusion criteria: * none

Keywords: non-small cell lung cancer nsclc metastatic disease resistent disease rna analysis 04-103
clinical evaluation of the safety and efficacy of a new multifocal contact lens

Conditions: Myopia; Ametropia; Presbyopia; Refractive Error

Summary: the purpose of this study was to demonstrate substantial equivalence of the new dailies® aquacomfort plus® multifocal (dacp mf) contact lens to the commercially available focus® dailies® progressives (fdp) contact lens.


Eligibility criteria:
inclusion criteria: * sign informed consent document. * presbyopic and require a spectacle add of up to and including 3.00 diopters (d). * currently wear soft contact lenses. * willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule. * manifest cylinder less than or equal to 1.00 d. * able to achieve best corrected visual acuity (bcva) of 20/25 or better (snellen) in each eye at distance (as determined by manifest refraction). * able to achieve distance visual acuity of 20/40 (snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment. * any use of systemic or ocular medications for which contact lens wear could be contraindicated. * history of corneal or refractive surgery. * biomicroscopy findings greater than grade 2 at baseline. * a pathologically dry eye that precludes contact lens wear. * monocular (only one eye with functional vision). * wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis). * history of intolerance or hypersensitivity to any component of the investigational products. * concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days. * eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment. * other protocol-defined exclusion criteria may apply.

Keywords: myopia presbyopia refractive error contact lenses multifocal
action pac: adolescents committed to improvement of nutrition & physical activity

Conditions: Overweight; Obesity

Summary: using a previously created weight management program for adolescents, the intervention will be implemented through school-based health centers (sbhc) and will be delivered by sbhc providers trained in motivational interviewing. students at intervention school sites will be compared to students at control school sites. all students will have baseline, 1 year, and 2 year follow-up to assess if students in the intervention school sites will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students at control school sites.


Eligibility criteria:
inclusion criteria: * enrolled in 9th or 10th grade at participating schools exclusion criteria: * blood pressure in the range of stage 2 hypertension * previously diagnosed type 1 or type 2 diabetes * use of corticosteroids, antipsychotics, metformin, antihypertensive medications, and medications used for dyslipidemia * inability to perform moderate to vigorous physical activity * not ambulatory * a score of 20 or more on eating attitudes test (eat)-26 screening measure * developmental disorders that affect weight or ability to understand the study procedures or counseling

Keywords: adolescent overweight obesity weight loss nutrition physical activity school-based primary care motivational interviewing
advance health mobile app for the self management of diabetes type2

Conditions: Diabetes Mellitus Type 2

Summary: digital health using mobile health (mhealth) tools, such as telehealth and text messaging, and or mobile apps can improve blood glucose levels in patients with type 2 diabetes. this intervention is designed to improve self-management of diabetes and blood glucose levels in diabetic patients.

patients with type 2 diabetes may experience improvements in their blood glucose levels thanks to mhealth technologies like mobile apps and telehealth text messaging. the goal of this intervention is to help diabetic people better control their blood glucose levels and diabetes. the intervention arm will employ a smartphone application designed specifically for individuals with type 2 diabetes, with the goal of improving their self-management behaviors. features of the app include real-time health monitoring, appointment scheduling, medication tracking, patient data storage, treatment and follow-up recommendations, and health education and promotion.

Eligibility criteria:
inclusion criteria: * the presence of t2d and at least 1 recorded hba1c level of 8.0% or higher in the past 6 months * age between ages 21 and 85 years, * receiving primary care at the clinical site * having fluency in english/ urdu in reading and writing * having a smartphone * agreeing to take part in the study exclusion criteria: * planning to move away from the study site * being pregnant or in lactation, (6) being unable to send or read text messages on a mobile phone, * having a history of receiving or planning surgery.
testing a novel community-based occupational therapy model

Conditions: Mental Disorders, Severe

Summary: this study will perform a needs assessment within an outpatient mental health unit, deliver an occupational therapy model of care, track patient and organizational outcomes, and provide training to staff to implement the model.

in this project the investigators' overall objective is to implement a narrative medicine-based occupational therapy (ot) model of care that brings client voices to the forefront of treatment planning and intervention to enhance the existing interdisciplinary system of service delivery within midtown community mental health (mcmh). the investigators hope to accomplish this objective via the following specific aims:1) assess current programming - particularly processes surrounding client assessment, treatment planning, intervention, care-coordination/residential placement, and discharge - within mcmh sites to better understand limitations/gaps previously identified by the site manager that impact equitable and effective treatment 2) adapt an existing care model - the art of healing wellness model (aohw) - to meet the needs of mcmh, implement the model using an ot practitioner, and track feasibility/acceptability outcomes. 3) re-assess mcmh programming post implementation to identify/demonstrate change resulting from the model 4) using ot in the role of consultant, offer training to current mcmh staff to enable implementation of the adapted aohw by mcmh (baccalaureate level) care coordinators 5) preliminarily evaluate usability of the adapted aohw by mcmh staff via focus groups following training and staff implementation

Eligibility criteria:
inclusion criteria • patient on a pre-determined treatment team at the outpatient mental health recruitment site exclusion criteria * under 18 * pregnant
ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of pbc with aih features ii

Conditions: Hepatitis, Autoimmune; Primary Biliary Cholangitis

Summary: a randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of pbc with aih features ii to asses efficacy and safety.


Eligibility criteria:
inclusion criteria: 1. patients aged 18-75 years; 2. the diagnosis of pbc is clear and does not meet the paris criteria for diagnosing pbc overlap aih, but it needs to meet 3xuln \< alt \< 5xuln or 3xuln \< ast \< 5xuln or 1.3xuln \< igg \< 2xuln, and liver pathological biopsy excludes moderate or higher interface inflammation; 3. agreed to participate in the trial, and assigned informed consent. exclusion criteria: 1. the presence of hepatitis a, b, c, d, or e virus infection; 2. patients with presence of cirrhosis; 3. patients with presence of fulminant liver failure; 4. liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or wilson's disease; pregnant and breeding women and women of childbearing age in need of reproduction; 5. severe disorders of other vital organs, such as severe heart failure, cancer; 6. parenteral administration of blood or blood products within 6 months before screening; 7. recent treatment with drugs having known liver toxicity; 8. taken part in other clinic trials within 6 months before enrollment. 9. patients with contraindications of glucocorticoid

Keywords: glucocorticoid ursodeoxycholic acid
effect of semi-sitting position on mask ventilation

Conditions: Ventilation

Summary: we compare the effect on semi-sitting position on mask ventilation in anesthetized and paralyzed obese patients


Eligibility criteria:
inclusion criteria: * obese patients undergoing general anesthesia exclusion criteria: * diseases or structural abnormalities in the upper airway * those who were at risk of aspiration * cardiovascular or respiratory diseases * pregnancy
generating advancements through longitudinal analysis in x and y variations (galaxy)

Conditions: Sex Chromosome Aneuploidy

Summary: galaxy is a registry research study that plans to learn more about individuals with x\&y variations (also called sex chromosome aneuploidies) through collecting information from medical records.this includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the us. the purpose of the galaxy registry is to collect and store this information with the overall goal to improve health outcomes in individuals with x\&y variations and the care they receive.


Eligibility criteria:
inclusion criteria: 1. genetically-confirmed diagnosis of a sex chromosome aneuploidy condition 2. any age 3. any gender 4. informed consent for individuals \>18 years of age, parent/guardian permission for individuals \<18 or proxy-consent from legally authorized representative if impaired decision making exclusion criteria: a. lack of documentation of genetic testing confirming sca diagnosis

Keywords: x&y variations chromosome variations klinefelter xxy xxx xyy tetrasomy pentasomy trisomy
innovative stratification of arrhythmic risk (isar-trial): long-term prediction

Conditions: Infarction, Myocardial

Summary: the purpose of this study is to investigate the performance of established and new risk preditors in predicting long term-mortality (up to ten years) of post-infarction patients.


Eligibility criteria:
inclusion criteria: acute myocardial infarction exclusion criteria:

Keywords: assessment, risk autonomic nervous system
long-term, open-label study of cp-690,550 for treatment of rheumatoid arthritis in japan

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine the long-term effectiveness and safety of cp-690,550 for the treatment of rheumatoid arthritis. subjects are only eligible for this study after they have completed participation in another "qualifying" study of cp-690,550.


Eligibility criteria:
inclusion criteria: * subjects who have completed their participation in a randomized "qualifying" study of cp-690,550 for the treatment of rheumatoid arthritis exclusion criteria: * serious medical conditions that would make treatment with cp-690,550 potentially unsafe

Keywords: long term open label study in japan cp-690 550 tofacitinib
addition of cisplatin to adjuvant chemotherapy for early stage breast cancer in high-risk women

Conditions: Tubular Breast Cancer; Mucinous Breast Cancer; Invasive Duct Carcinoma of Breast

Summary: the investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as adjuvant chemotherapy is more effective for high risk, her2 negative breast cancer .

in this trial, patients will be randomly assigned in a 2:1 ratio to receive cisplatin-based adjuvant chemotherapy and to standard adjuvant chemotherapy.

Eligibility criteria:
inclusion criteria: 1. women aged ≥18 years and ≤70 years 2. have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma 3. not received treatment for breast cancer before operation 4. triple-negative breast cancer confirmed by pathology, or pathology confirmed as the hr positive breast cancer at the same time meet the following conditions: axillary lymph node positive breast cancer, tumor size≥2 cm and ki - 67 \>20% or tumor size ≥2 cm and grade iii or tumor size ≥2cm and aged \<35 years 5. her2 negative: immunohistochemistry her2 (1 +) or her2 (0), or fluorescence in situ hybridization (fish): not amplified 6. performance status (ps) 0-1 7. adequate bone marrow function:wbc≥4.0×109/l, absolute neutrophil count（anc）≥1.5×109/l, platelets（plt）≥100×109/l, hemoglobin（hb）≥90g/l;aspartate aminotransferase(ast),alanine aminotransferase (alt)≤1.5 upper normal limit , creatinine≤1.5 upper normal limit, bilirubin≤1.5 upper normal limit 8. no obvious main organs dysfunction exclusion criteria: 1. metastatic breast cancer 2. patient is pregnant or breast feeding 3. any evidence of sense or motor nerve disorders 4. bilateral primary breast cancer (dcis in one side not included) 5. patients with medical conditions taht indicate intolerant to adjuvant chemotherapy, including uncontrolled cardiovascular disease, severe infection 6. have received chemotherapy because of any malignancy other than breast cancer 7. known severe hypersensitivity to any drugs in this study
optimizing pre-exposure prophylaxis (prep) among latino men who have sex with men (msm) in puerto rico

Conditions: HIV Prevention

Summary: to develop, assess and compare the effectiveness of a motivational interviewing intervention for increasing pre-exposure prophylaxis (prep) uptake among latino men who have sex with men (msm) in puerto rico.


Eligibility criteria:
latino msm group - inclusion criteria: * biological male * age 21 or older * self-reported hiv negative or unknown status * not using prep (participants who have discontinued prep use can participate in the study), spanish fluency (ability to write and read in spanish) * presenting at least one of the eligibility criteria for prep as established by the cdc (including men who have had an infection (sti) in the past 6 months, hiv positive sexual partner) * access to a portable technology device (e.g., phone, tablet, laptop) or desktop computer access to internet connection exclusion criteria: * hiv positive individual * evidence of being under the effects of alcohol or drugs * indication of unstable or serious psychiatric symptoms * evidence of major cognitive impairment * inability to speak and read in spanish healthcare providers group - inclusion criteria: * age 21 or older * providing prep related health services at time of enrollment (e.g., case management, clinical services) * spanish fluency (ability to write and read in spanish) exclusion criteria: * evidence of being under the effects of alcohol or drugs * indication of unstable or serious psychiatric symptoms * evidence of major cognitive impairment * inability to speak and read in spanish