Kornimate/medical-research-clean huggingface dataset:
clinical outcomes of clareon vivity intraocular lens with mini-monovision approach

Conditions: Aphakia, Postcataract

Summary: purpose is to study the clinical outcomes of clareon vivity and clareon vivity toric intraocular lens (iol) implants in patients who are planning to have cataract surgery in both eyes with a mini-monovision approach.

a "mini-monovision" approach is one in which the dominant eye is corrected for distance vision while the non-dominant eye is corrected with a small amount of nearsightedness (-0.5 diopters). this approach can have the benefit of increasing ability to see over a broad range of vision without glasses. the clareon vivity and vivity toric lenses have been approved by the u.s. food and drug administration (fda) for visual correction of aphakia in adult patients following cataract surgery. it has lens technology that provides an extended depth of focus (more range of clear vision for distance, intermediate and near vision) compared to a standard monofocal (single focus) lens. none of the procedures in this study are experimental. however, the study is seeking additional information on clinical outcomes of the mini-monovision approach specifically using the clareon vivity and vivity toric lenses.

Eligibility criteria:
inclusion criteria: * adult patients with bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing bilateral sequential implantation within 21 days using clareon vivity and clareon vivity torics * iol powers between +10d to +30.0d, t3-t6 * potential acuity measured post-operatively 20/25 or better in both eyes exclusion criteria: * history of ocular or refractive surgery * ocular or systemic comorbidities that may alter or reduce visual acuity, contrast sensitivity, binocularity, or impair reading performance such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, strabismus/amblyopia etc. * patients with irregular astigmatism, corneal dystrophies, pupil abnormalities, zonular laxity * intraoperative or postoperative complications
the safety of emicizumab sc injection in korean hemophilia a patients with/without fviii inhibitors

Conditions: Hemophilia A With Inhibitor; Hemophilia A Without Inhibitor

Summary: to evaluate safety and efficacy and pharmacokinetics, fviii inhibitor titers of hemlibra subcutaneous injection (sc inj.) in korean hemophilia a patients with/without fviii inhibitors.

target subject : 1. patients with hemophilia a with fviii inhibitors 2. patients with severe hemophilia a without fviii inhibitors.

Eligibility criteria:
inclusion criteria: 1. patients with hemophilia a (congenital factor viii deficiency) who will receive hemlibra sc inj. according to medical decision by investigator 2. signed informed consent form exclusion criteria: 1. subjects who are hypersensitive to emicizumab 2. subjects who are hypersensitive to mouse or hamster protein 3. subjects with myocardial infarction or the history who are prohibited from administering l-arginine containing drug 4. subjects who participated in other clinical trials within a month before enrollment (or the first administration of hemlibra sc inj.) (unable to participate in other clinical trials related to hemophilia a treatment even after enrollment) 5. subjects who the investigator deems inappropriate for the study. 6. moderate/mild for hemophilia a patients without fviii inhibitors
evaluation of lung t1-mri in pediatric cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: in this observational study, the investigators evaluate the sensitivity of t1-mri to identify lung perfusion changes in pediatric patients with cf (age = 6-11) before and after initiating fda-approved trikafta therapy. the investigators compare these lung t1 mri assessments (% normal lung perfusion) to currently best-available assessments of lung function in cf patients (i.e., mbw (lci( and spirometry (fev1 % predicted).

this is a prospective study with 3 study visits to evaluate the utility of magnetic resonance imaging (mri) and clinical lung function assessments to detect changes in cystic fibrosis (cf) patients before and after administration of the fda-approved trikafta therapy. the 3 study visits include: visit 1: before starting trikafta visit 2: 3 months from start of trikafta visit 3: 6 months from start of trikafta along with the clinical assessments (mbw and spirometry), all participants will undergo an mri scan of the lungs to generate quantitative lung t1 maps. the investigators will compare the lung t1 mri (% normal lung perfusion) to multiple breath washout (lci) and spirometry (fev1 % predicted) as methods to assess lung changes with administration of trikafta. the investigators will obtain additional clinical assessments from participant's medical records. this is a multi-site study involving 3 sites.

Eligibility criteria:
inclusion criteria: • male or female individuals with a diagnosis of cystic fibrosis and have at least one copy of the f508del mutation. exclusion criteria: * subject who cannot hold their breath for up to 15 seconds. * subjects who are pregnant. * subjects with mri contraindication (e.g., heart pacemaker, heart defibrillator, metal in within the body.

Keywords: cystic fibrosis transmembrane conductance regulator
to examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.

Conditions: Diabetes Mellitus, Type 1

Summary: to examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * normal lung function exclusion criteria: * smokers
a long-term study of olipudase alfa in patients with acid sphingomyelinase deficiency

Conditions: Sphingomyelin Lipidosis

Summary: the primary objective of this study was to obtain data regarding the safety of olipudase alfa in participants with acid sphingomyelinase deficiency (asmd) who were exposed to long term treatment with olipudase alfa. the secondary objectives of this study were to obtain data regarding the efficacy of olipudase alfa and to characterize olipudase alfa pharmacodynamics (pd) and pharmacokinetics (pk) following long-term administration.

lts13632 is a multicenter, nonrandomized, open-label, long-term extension study of participants with asmd who have previously participated in a study of olipudase alfa. (dfi13803 for pediatric participants and dfi13412 for adult participants). the maximum study duration per participant was 9 years or until olipudase alfa becomes commercially accessible. notwithstanding the above, every pediatric participant were treated in lts13632 study for at least 3 years to comply with the requirements agreed in the olipudase alfa pediatric investigational plan.

Eligibility criteria:
inclusion criteria: * the participant completed the treatment period of a previous study of olipudase alfa with an acceptable safety profile in the opinion of the investigator and sponsor. * the participant and/or the participant's parent(s)/legal guardian(s) was willing and able to provide signed written informed consent. * the participant who is female and of childbearing potential must have had a negative urine pregnancy test for beta human chorionic gonadotropin (β hcg). * female participants of childbearing potential and sexually mature male participants must have been willing to practice true abstinence in line with their preferred and usual lifestyle or use 2 acceptable effective methods of contraception up to 15 days following their last dose of study drug. exclusion criteria: * the participant had any new condition or worsening of an existing condition which in the opinion of the investigator would make the participant unsuitable for enrollment, or could interfere with the participation or completion the study. * the participant, in the opinion of the investigator, was unable to adhere to the requirements of the study. * the participant was unwilling or unable to abstain from the use of alcohol for 1 day prior to and 3 days after each olipudase alfa infusion for the duration of the treatment period. * the participant was unwilling or unable to avoid, for 10 days before and 3 days after liver biopsies, medications or herbal supplements that are potentially hepatotoxic (only participants who previously participated in the dfi13412 study). * the participant required medication(s) that may decrease olipudase alfa activity (eg, fluoxetine, chlorpromazine; tricyclic antidepressants \[eg, imipramine, desipramine\]). the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
docetaxel and s-1 combination therapy as second-line treatment for advanced gastric cancer

Conditions: Advanced Gastric Cancer

Summary: a single-arm phase ii study to evaluate the efficacy and safety of docetaxel plus s-1 (ds) as second-line treatment in patients with agc.

for patients with advanced gastric cancer, combination chemotherapy has been shown to improve the quality of life and overall survival (os) compared with best supportive care alone. docetaxel is an active agent for treating patients with gastric cancer. s-1, an oral 5-fu prodrug, is active against agc as a single agent or in combination with cisplatin in phase iii trials. therefore, a single-arm phase ii study was conducted to investigate the efficacy and safety of biweekly docetaxel and s-1 (ds) combination therapy as second-line treatment in patients with previously treated advanced gastric cancer.

Eligibility criteria:
inclusion criteria: 1. age: 18-75 years old; 2. histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; 3. the patient has experienced disease progression during treatment or within 4 months after the last dose of first-line therapy without taxanes for metastatic disease. 4. relapse within 6 months after adjuvant chemotherapy; 5. ecog (eastern cooperative oncology group)performance status 0-2; 6. at least 1 measurable lesion should be present（recist1.1） 7. available organ function: neutrophils\>2g/l, hemoglobin\>9g/l, blood platelet \>100g/l; alanine aminotransferase(alt） and aspartate aminotransferase(ast)\<1.5 uln(upper limit of normal); total bilirubin(tbil)\<1.0 uln; cr \<1.0uln 8. signed informed consent. 9. life expectancy ≥3 months; exclusion criteria: 1. previous treatment with taxanes (not including intraperitoneal use of taxanes); 2. known history of hypersensitivity to study drugs; 3. active cns metastases not controllable with radiotherapy or corticosteroids; 4. pregnant or breast feeding women; 5. severe co-morbid illness and/or active infections; 6. active and uncontrollable bleeding from gastrointestinal tract 7. patients receiving a concomitant treatment with drugs interacting with s-1 such as flucytosine, phenytoin, or allopurinol; 8. other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix); 9. known hiv infecton.
glioblastoma psychosocial support program

Conditions: Glioblastoma

Summary: the goal of the study is to conduct a pilot test of the psychosocial support intervention with family caregivers and/or patients coping with glioblastoma.

the specific aims of this study is to pilot test the psychosocial support program for patients with glioblastoma and/or their family caregivers. the investigators will recruit patient-caregiver dyads for the psychosocial support intervention; participants will have the choice whether to take part in the intervention as a dyad or individually given the variability of symptoms and progression of glioblastoma. the investigators will examine acceptability and feasibility of the intervention and examine whether participation in the program can help reduce distress and improve quality of life.

Eligibility criteria:
for patients: inclusion criteria: * patients who self-report a diagnosis of glioblastoma * age \>18 years * english speaking exclusion criteria: * lacks capacity for interview or is unable to provide informed consent * visual or hearing impairments or severe behavioral problems that preclude participation * too sick to participate for caregivers: inclusion criteria: * age \>18 years * english speaking exclusion criteria: * lacks capacity for interview or is unable to provide informed consent * visual or hearing impairments or severe behavioral problems that preclude participation * too sick to participate
olverembatinib for fgfr1-rearranged neoplasms

Conditions: Myeloproliferative Neoplasm; Acute Leukemia

Summary: fgfr1-rearranged myeloid/lymphoid neoplasms are a rare hematologic malignancy with very poor outcome despite intensive chemotherapy. the only curative option is thought to be allogeneic hematopoietic stem cell transplantation (hsct) in remission. this phase ii study is aimed to evaluate the efficacy of olverembatinib, consolidated with hsct in the treatment of fgfr1-rearranged myeloid/lymphoid neoplasm.

fgfr1-rearranged myeloid/lymphoid neoplasms are a rare and highly heterogeneous hematological malignancy, mainly manifested as myeloproliferative neoplasms (mpns) or acute leukemia, including t cells or b cells cell lymphoblastic leukemia/lymphoma (t-cell or b-cell-all/lbl), acute myeloid leukemia (aml) and mixed cell leukemia (mpal). to date, there is no standard treatment. conventional chemotherapy is frequently ineffective. the only curative option is thought to be allogeneic hsct at present, tkis may offer a therapeutic alternative in patients not eligible for allogeneic hsct or to bridge the time between diagnosis and allogeneic hsct. third-generation tkis olverembatinib is a pan- fgfr1 kinase inhibitor, and is supposed to be effective to achieve bone marrow remission in fgfr1-rearranged myeloid/lymphoid neoplasms.

Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed, progressed or relapsed myeloid/lymphoid neoplasms with fgfr1 rearrangement according to the who-2016 diagnostic criteria. patients who have received allogeneic hematopoietic stem cell transplantation or ponatinib should be excluded. 2. ecog score: mpns patients, 0-3 points; al patients, 0-2 points. 3. expected survival period ≥12 weeks. 4. willingness and ability to comply with study procedures and follow-up examination. exclusion criteria: 1. patients who have received allogeneic hematopoietic stem cell or ponatinib. 2. human immunodeficiency virus (hiv) infection, or chronic infection with hepatitis b virus (hbsag positive) or hepatitis c virus (anti-hcv positive). 3. patients who are pregnant, planning to become pregnant or breastfeeding. 4. patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or fail to comply with all required study procedures. 5. patients who suffer from any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.
the integrated traditional chinese and western medicine treat early stage dkd

Conditions: Diabetic Nephropathy Type 2

Summary: efficacy and safety of treatment with traditional chinese medicine huangqi decoctions in patients with early stage of diabetic kidney disease.

the study is a multi-center, randomized, double-blind, placebo-controlled trial. it is performed in longhua hospital, shanghai university of traditional chinese medicine, shanghai jiao tong university affiliated sixth people's hospital, putuo hospital affiliated to shanghai university of traditional chinese medicine, and shanghai baoshan district hospital of integrated traditional chinese medicine and western medicine, china.

Eligibility criteria:
inclusion criteria: 1. identify the diagnosis of type 2 diabetes; 2. it meets the medical history of diabetic kidney disease, according to the mogensen diagnostic staging standard dkd iii; 3. age 18-75 years old, gender ＆ethnicity are not limited; 4. glycated hemoglobin ≤ 10%; 5. blood pressure is controlled below 130/80mmhg exclusion criteria: 1. combine other acei and arb application indications other than hypertension; 2. combine severe primary diseases related to heart, brain, liver and hematopoietic system; 3. patients who have acute metabolic disorders such as diabetic ketoacidosis occur in the past month; 4. patients who hbv serological indicators except hbsab are positive and persistent liver function test transaminase abnormalities; 5. patients with malignant tumors or history of malignant tumors, history of hiv infection, history of psychosis, acute central nervous system diseases, severe gastrointestinal diseases, and banned use of immunosuppressive agents; 6. patients with acute renal failure, combined with urinary tract infection, menstrual period, intense exercise, cold and other stress states; 7. pregnant or lactating women; 8. patients who accepted other clinical trial studies on going ; 9. patients who combined with serious diseases and dysfunctions in other organs.

Keywords: diabetic kidney disease，traditional chinese medicine
influence factors and cognitive characteristics in unipolar and bipolar depression:based on the thinc-it tool

Conditions: Cognitive Impairments

Summary: cognitive impairment is the core symptom of unipolar and bipolar depression, which seriously affects the prognosis of the disease and the rehabilitation of social function. there is no unified conclusion in the field and severity of cognitive impairment, and the cause of cognitive impairment is unknown, which may be related to many factors. in this study,the thinc-it tool was used to study the characteristics of cognitive impairment in unipolar and bipolar depression by longitudinal follow-up, which provides a theoretical basis for the differential diagnosis of unipolar and bipolar depression. early identification and intervention of risk factors can improve the prognosis of the disease.

there is some cognitive impairment in patients with unipolar and bipolar depression. there is no unified conclusion in the field and severity of cognitive impairment, and the cause of cognitive impairment is unknown, which may be related to many factors. the thinc-it is a simple, fast and free cognitive assessment tool for cognitive impairment screening of unipolar and bipolar depression. this study includes three steps. 1. baseline: demographic data, thethinc-it tool , clinical scales（hamd-17,hama、ymrs、psqi） evaluation and laboratory examination（blood glucose, blood lipids, bmi） 2. follow-up (4 week): clinical scales and thinc-it tool were evaluated in unipolar and bipolar depression. 3. follow-up (12 weeks): all patients with bipolar depression were evaluated by clinical scales, thinc-it test.

Eligibility criteria:
inclusion criteria: case group: 1、participants in psychiatric outpatients and inpatients are able and willing to provide informed consent. 2. the participants were male or female aged between 18 and 60, with junior high school education or above. 3. according to icd-10 criteria, participants were diagnosed with unipolar and bipolar depressive disorder. 4. the total score of young's mania scale ((ymrs)) of the participants was less than 5 and hamd-17 was greater than17. 5. subjects received stable mood stabilizers at least two weeks before the study visit, such as ssris antidepressants. 6. the combination or use of supportive psychotherapy is allowed. control group: 1.it did not meet any of the diagnostic criteria in icd-10 in the past or at present. 2.18-60 years old, junior high school education or above. 3.have sufficient audio-visual skills to complete the necessary examinations of the study. 4.willing to participate in this study, and the informed consent form was signed by the subjects. exclusion criteria: 1. current alcohol and / or substance use disorders. 2. any drugs that may affect cognitive function, such as psychotropic stimulants, corticosteroids, and receptor blockers. 3. benzodiazepines were used within 12 hours and alcohol consumption within 8 hours before using the thinc-it tool. 4. the patients have some serious physical conditions. 5. the patients received electroconvulsive therapy ((ect)) in the past 6 months. 6. they are serious negative suicidal concepts and behaviors.
the effect of folic acid on atherosclerosis, cognitive performance and hearing

Conditions: Atherosclerosis; Vascular Disease; Cognitive Decline; Hearing Loss; Inflammation; Age-Related Memory Disorder

Summary: the purpose of this study is to determine if folic acid supplementation can slow down atherosclerotic progression, age-related cognitive decline and age-related hearing loss.

low levels of b vitamins, in particular folate, and high levels of plasma total homocysteine, have been associated with a variety of age-related diseases and disorders, including cardiovascular disease, dementia and hearing impairment. extra folate, for example in the form of folic acid, is known to decrease the concentrations of plasma total homocysteine. we examined whether 0.8 mg/d folic acid could slow down atherosclerotic progression and the above mentioned age-related processes.

Eligibility criteria:
inclusion criteria: * 50-70 years * men and post-menopausal women * women with a surgically removed uterus were required to be \>=55 years exclusion criteria: * plasma total homocysteine \ 26 umol/l * serum vitamin b12 \<200 pmol/l * self-reported current use of drugs which affect folate metabolism * self-reported current use of drugs believed to influence intima-media thickening, i.e., lipid-lowering drugs, hormone replacement therapy * self-reported medical diagnosis of renal, intestinal, thyroid disease * self-reported medical diagnosis of current cancer * self-reported current use of supplements containing b vitamins * self-reported inability or unwillingness to fast for 12 hours * \<80% compliance using placebo pills during a 6-week run-in period * not giving written informed consent * participation in other research studies

Keywords: folic acid atherosclerosis cognitive function hearing inflammation hemostasis arterial stiffness