Kornimate/medical-research-clean huggingface dataset:
preliminary clinical study on the effect of l-ornithine on the efficacy of ustekinumab in patients with crohn's disease

Conditions: Mild to Severe Crohns Disease

Summary: the goal of this clinical trial is to evaluate the effect of supplementing l-ornithine compared to the control group on the efficacy of ustekinumab in patients with crohn's disease, and to summarize the role of supplementing l-ornithine in the treatment of cd patients. participants will be randomized into two groups: the l-ornithine supplementation group and the control group. the patients in the l-ornithine supplementation group received oral ornithine capsules for 8 weeks. the control group did not receive additional intervention. follow up once a week, and after the study, patients will come to the hospital to finish the evaluation indicators.

the goal of this clinical trial is to evaluate the effect of supplementing l-ornithine compared to the control group on the efficacy of ustekinumab in patients with crohn's disease, and to summarize the role of supplementing l-ornithine in the treatment of cd patients. participants will be randomized into two groups: the l-ornithine supplementation group and the control group. patients in the l-ornithine supplementation group take oral ornithine capsules twice a day, three capsules per time, for 8 weeks, each containing 500mg of l-ornithine. the control group did not receive additional intervention. follow up once a week, and after the study, patients will come to the hospital to finish the evaluation indicators.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, ≤ 75 years old; 2. patients clinically diagnosed with crohn's disease shall refer to the chinese guidelines for the diagnosis and treatment of crohn's disease (guangzhou, 2023) for diagnostic criteria; 3. patients receiving treatment with ustekinumab; 4. agree to participate in this study and sign an informed consent form. exclusion criteria: participants who meet any of the following criteria are not eligible for inclusion in this study. 1. patients with alt or ast exceeding the normal upper limit by more than twice, and tbil exceeding the normal upper limit by more than twice; 2. patients with creatinine clearance rate less than 60ml/min; 3. patients with severe active infections in the intestines or other areas that require the use of antibiotics or antiviral drugs; 4. patients with intestinal tuberculosis, other chronic intestinal infectious diseases, and intestinal malignant tumors; 5. pregnant and lactating women; 6. the fasting blood glucose of patients with diabetes or screening period exceeds 7.0mmol/l or glycosylated hemoglobin exceeds 6.5%; 7. merge patients with severe mental illness, drug use, alcohol abuse, etc. who are unable to cooperate with the study; 8. have participated in any other clinical research within the first month prior to enrollment; 9. the researcher determined that any other disease or condition is not suitable for patients participating in this study.

Keywords: ustekinumab l-ornithine
577nm micropulse laser vs half-dose photodynamic therapy on acute central serous chorioretinopathy

Conditions: Acute Central Serous Chorioretinopathy

Summary: the purpose of this study is to determine whether micropulse laser (mpl) is different to half-dose photodynamic therapy on acute central serous chorioretinopathy.

central serous chorioretinopathy(csc) is characterized by serous detachment of neurosensory retina which can cause lose in visual acuity.some studies have shown that half-dose photodynamic therapy(pdt) is effective on csc,although accompanied with side-effects,such as choroidal ischemia, retinal pigmental epithelium(rpe) atrophy,and rpe rip,and with exorbitant price.recent retrospective studies suggest micropulse laser (mpl) therapy may also be effective without obvious complications in this disease. but to date, there is no study on effectiveness of csc between pdt and mpl. the study is the first prospective randomized controlled trial about 577nm micropulse laser versus half-dose photodynamic therapy on acute central serous chorioretinopathy.the null hypothesis of the study is that there is difference between mpl and half-dose photodynamic therapy on acute central serous chorioretinopathy at first month after treatment.the primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid at 1 month after treatment.

Eligibility criteria:
inclusion criteria: 1. onset for the first time, as an episode duration of less than 6 months 2. patient was between 18 and 55 years of age 3. the presence of subretinal fluid(srf) involving the macula and detected by use of optical coherence tomography (oct) 4. active fluorescein leakage during fluorescein angiography (fa) 5. best corrected visual acuity (bcva) more than 0.1, and less than 1.0 exclusion criteria: 1. previous pdt, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery 2. other macular abnormalities such as choroidal neovascularization(cnv) or polypoidal choroidal vasculopathy(pcv) 3. retinal atrophy 4. pregnancy 5. inability to obtain photographs or to perform fa 6. use of steroid systemically or topically in the last 6 months
treatment for migraine and mood

Conditions: Migraine; Depressive Symptoms

Summary: the researchers propose a three-arm pilot study of mindfulness-based cognitive therapy (mbct) delivered via telephone (mbct-t), video (mbct-v) or enhanced usual care (euc).

this study aims to set the stage for a future definitive large-scale phase iii trial in patients with migraine and depressive symptoms. this pilot is aimed at evaluating the feasibility and acceptability of the telephone and video mbct and euc in people with migraine (defined by the international classification of headache disorders - 3) and depressive symptoms (defined by empirical cut-offs on the patient health questionnaire - 9).

Eligibility criteria:
inclusion criteria: * currently meets ichd-3 (international classification for headache disorders - 3rd edition) criteria for migraine using the american migraine prevalence and prevention diagnostic module * self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria * score between 5-14 on the phq-9 (patient health questionnaire) * age ≥ 18 * ability to read and speak english * capacity to consent * prospective diary-confirmed 4-14 headache days per month, with at least one attack meeting migraine criteria * ≥1 year of migraine exclusion criteria: * meeting ichd-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the american migraine prevalence and prevention diagnostic module * changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake * changes in longer-term migraine prevention (onabotulinum toxin a, injectable or oral anti-calcitonin gene related peptide treatment; neuromodulatory device) within 3 months of intake * changes in acute migraine treatment started within 4 weeks of enrollment * comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the intervention, including but not limited to: active suicidal ideation; recent history of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities; bipolar disorder; obsessive-compulsive disorder, drug use * prior history of engaging in formal mindfulness-based interventions including: mbsr (mindfulness-based stress reduction), mbct (mindfulness-based cognitive therapy), acceptance and commitment therapy, dialectical behavior therapy * current daily meditation practice * inability to adhere to headache diary during baseline evaluation period (recorded fewer than 25/28 days) * unwilling to maintain stable current acute or preventive medication dosages for study duration * any condition that would prevent being a suitable candidate or interfere with medical care needs

Keywords: mindfulness mindfulness-based cognitive therapy
community based prevention/control project

Conditions: Poisoning

Summary: this project is aimed at better understanding how children living in agricultural environments are exposed to pesticides, and how such exposures can be prevented or reduced. the project will develop and implement a community-wide intervention to reduce the transfer of pesticides from the workplace to the home (take home pathway).

this project is aimed at better understanding how children living in agricultural environments are exposed to pesticides, and how such exposures can be prevented or reduced. since 1991 our group has investigated pesticide expsoures among children of agricultural families in washington state, focusing on exposure to organophosphate insecticides. we have demonstrated in these studies that the residential environments of agricultural families have higher pesticide residues than do other homes in this region. we have also found that children living in these residential environments have elevated levels of pesticide metabolites in their urine. we need to better understand how these children are being exposed in order to develop recomendations for exposure prevention or reduction. the current project will develop and implement a community-wide intervention to reduce the transfer of pesticides from the workplace to the home (take home pathway). a complementary project is also underway by the uw-child health center to characterize pesticide exposure pathways for children of farmworkers.

Eligibility criteria:
each family recruited must include one child between the ages of 1-5. recruitment will be confined to the lower yakima valley.

Keywords: pesticide insecticide organophosphate child health exposure prevention
characterization of the patient population with galactosialidosis

Conditions: Galactosialidosis

Summary: the late infantile form of galactosialidosis is potentially amenable to treatment by gene transfer with an adeno-associated viral vector encoding protective protein cathepsin a (ppca) or by infusion of purified protein. the published literature contains limited descriptions of the disease nor is it known how many patients with the disorder are potentially available for protocol enrollment. this preliminary study is designed to define the demographics and clinical characteristics of the patient population with galactosialidosis. individuals for whom dna diagnosis has been performed at st. jude children's research hospital (sjcrh) will be contacted telephonically to learn their current status. in addition, a letter requesting information regarding patients with galactosialidosis will be sent to all pediatric geneticists throughout the united states. selected physicians with expertise in lysosomal storage diseases throughout the world will also be contacted. foundations and associations for the lysosomal storage disorders will also be contacted in an effort to identify additional potential patients with galactosialidosis. the information to be collected in this preliminary study will facilitate development of specific eligibility criteria for future therapeutic studies.

individual patient/families will be interviewed by telephone to learn basic demographic information and disease status. medical records will be requested from primary care providers to provide further information regarding their disorder. individual patients identified through our survey of pediatric geneticists or via the disease foundations or associations will be sent a letter describing our purpose and which includes a consent form for a subsequent telephonic interview. their medical records will also be requested.

Eligibility criteria:
inclusion criteria: * individuals with suspected or confirmed molecular diagnosis of galactosialidosis who are ≥ 6 months of age. exclusion criteria: * individuals with a lysosomal storage disorder who have been shown to have a mutation in a gene other than that encoding ppca.

Keywords: lysosomal storage disease aav vector gene transfer disease characterization
stereotactic body radiation therapy for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the standard treatment for hepatocellular carcinoma (hcc) is surgery, such as, by hepatic resection or liver transplantation, but less than 20% of hcc patients are suitable for surgery. in the remaining patients with inoperable and advanced hcc, trans-arterial chemo-embolization (tace) has been widely used but tace alone rarely produces complete response and commonly develops recurrence. recently several small studies reported high tumor response and local control rate after stereotactic body radiotherapy (sbrt) alone or with tace for inoperable hcc. a single institution phase ii trial with sbrt for inoperable hcc after incomplete tace at korea cancer center hospital showed promising results: the overall response rate of 73% and 2-year local control rate of 95%. they reported severe gastrointestinal toxicity of 11% because there was no normal tissue constraint for gastrointestinal tract and dosage to gastrointestinal tract was restricted to the lowest levels possible. in addition, they found that the presence of gastroduodenal ulcer before sbrt was significantly influenced on severe gastrointestinal toxicity. based on this study, we will conduct a multicenter phase ii trial on maintenance of treatment results and reduction of severe treatment related toxicity below 5%. to achieve this, we strictly apply normal tissue constraints. secondly, we will do esophagogastroduodenoscopy (egd) before sbrt to evaluate gastroduodenal ulcer. after then, we will apply the normal tissue constraint of gastrointestinal tract according to gastroduodenal ulcer.


Eligibility criteria:
inclusion criteria: * male or female patients ≥ 20 years of age * initially diagnosed or recurrent hepatocellular carcinoma (hcc) * unresectable hcc * inaccessible to local ablative treatment * cirrhotic status of child pugh class a or b7 * eastern cooperative oncology group performance status 0 or 1 * tumor size \< 10cm * the volume of uninvolved must be at least 700 ml * incomplete response after trans-arterial chemo-embolization of 1-5 * a single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sessions of sbrt * no evidence of an uncontrolled lesion at any other site * no evidence of complications of liver cirrhosis * no evidence of uncontrolled inter-current illness * patient or guardian must be able to provide verbal and written informed consent exclusion criteria: * patient with previous history of abdominal radiation * direct invasion to esophagus, stomach or colon by hcc

Keywords: hepatocellular carcinoma stereotactic body radiotherapy stereotactic ablative radiotherapy
follow-up of the cardiomyopathy cohort sfb/tr19

Conditions: Cardiomyopathies; Heart Failure

Summary: follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy) recruited at baseline by the sfb-tr19 project. standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of various biomaterials for biobanking purposes.

periodical follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy) recruited at baseline by the sfb/tr19 project. participants will be followed up at least every year - or more frequently based on clinical need. standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of various biomaterials for biobanking purposes.

Eligibility criteria:
inclusion criteria: * participation in baseline examination of sfb/tr19 exclusion criteria: * none

Keywords: heart failure cardiomyopathy myocarditis
nir fluorescence imaging of lymphatic transport using icg

Conditions: Rheumatoid Arthritis

Summary: in this phase 1 study, the lymphatic transport will be examined using near infrared indocyanine green fluorescence imaging (nir-icg) of the upper extremities in healthy individuals using a multispectral imaging system (msimager).

lymphedema from various etiologies (i.e. infection, cancer, surgery, and rheumatoid arthritis) remains a major health concern. efforts to develop effective treatments for this condition have been limited by the absence of quantitative outcome measures for lymphatic function. published articles have supported the fact that human lymphatic contractions can be readily visualized after intradermal administration of micrograms of indocyanine green using laser-induced fluorescence. the use of lasers imposes a risk of eye injury that requires protective eyewear. to address the risk of laser-induced injury, an imaging system was developed by drs. ronald wood and jay reeder in a collaborative effort at the university of rochester. in place of a laser, this system utilizes a tungsten-halogen lamp fitted with a bandpass filter and a multispectral camera for real-time image acquisition and display. this phase 1 study will examine the validity and reliability of this instrument to measure lymphatic transport, contractions, and pressure in the arms of healthy research subjects and establish baseline parameters for subsequent evaluation of rheumatoid arthritis patients in later studies. indocyanine green is a dye that has been used clinically for over 50 years to evaluate hepatic clearance, cardiovascular function testing, and retinal angiography. indocyanine green has typically been administered intravenously at concentrations of 2.5 mg/ml at total doses of 25 mg in adults. in this study, intradermal administration of micrograms of indocyanine green will be used to establish useful dose ranges and concentrations. the dosage regimen for this study is based on prior demonstrations in published articles of successful noninvasive imaging of lymphatic contractions after intradermal administration of microgram amounts of indocyanine green.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent * subjects can be either gender but must be at least 18 years old. * rheumatoid arthritis subjects may fulfill 2010 american college of rheumatology criteria. * active rheumatoid arthritis subjects, with at least 2 tender or swollen joints. * subjects participating in the clearance arm of the study must not have icg injections for at least 10 weeks. exclusion criteria: * individuals with active systemic disorders or inflammatory conditions other than rheumatoid arthritis, (such as chronic infections with hepatitis b, hepatitis c or hiv) that would confound the study results. * known sensitivity to iodine because of residual iodide in indocyanine green * pregnant women should not participate.

Keywords: healthy individual lymphatic transport near infrared imaging indocyanine green icg nir nir-icg msimager rheumatoid arthritis
internet-based cognitive behavioral therapy for depressive symptoms in adolescents with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus; Depressive Symptoms

Summary: this study evaluates the use of an established internet-based cognitive behavioral therapy intervention in a group of adolescents with type 1 diabetes and mild to moderate depressive symptoms. half of the participants will receive the internet-based intervention while the other half will receive usual care.

adolescents with diabetes have a higher incidence of subclinical and clinical depression compared to healthy adolescents. patients with diabetes who are clinically or subclinically depressed are at high risk for poor glycemic control. studies evaluating prevention and treatment strategies for depression in patients with type 1 diabetes have shown that group cognitive-behavioral therapy (cbt) and individual interpersonal psychotherapy (ipt) can reduce the risk of depressive illness in adolescents with diabetes. computerized interventions show evidence of being efficacious, and have been recommended as the "first line" intervention. the competent adulthood transition with cognitive humanistic and interpersonal teaching (catch-it) internet program has shown positive results with adolescents at risk for depression, but has not been used in patients with a chronic illness like diabetes. catch-it is based on established cbt and ipt treatment models. it includes a) an innovative and effective brief practitioner-provided motivation enhancement component (in person at enrollment and through phone calls) and b) self-directed modules for the adolescent that can be accessed on the internet.

Eligibility criteria:
inclusion criteria: * age 13-17 receiving ongoing medical care in the diabetes clinic at children's medical center dallas. * patients must be fluent in english (the materials on the site have not been validated in any other language), be in at least the 8th grade, report/demonstrate comfort with use of a computer, and regular, convenient and discreet access to the internet. * patients must experience at least sub-threshold depression (ces-d score \> 15). * patients must have had the diagnosis of type 1 diabetes for at least 12 months. exclusion criteria: * patients who are medically unstable during their diabetes clinic visit will be excluded (i.e. diabetes ketoacidosis, symptomatic hypoglycemia). * patients who are too severely depressed for this form of intervention (i.e. meet criteria for mdd, endorse suicidal intent, phq-a score ≥ 20), those with a diagnosis or symptoms of severe mental illness (schizophrenia, bipolar disorder), prior psychiatric hospitalization, prior self-harm attempt. * patients receiving ongoing counseling or therapy services within the last year, by a licensed professional (counselor, psychologist or psychiatrist). * patients who are currently taking or begin taking psychotropic medications during study participation will be excluded/withdrawn.
noac therapy guided by paris risk score and d-dimer in patients with acs after pci

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Acute Coronary Syndrome

Summary: the goal of this clinical trial is to compare short-term triple antithrombotic therapy (dapt + rivaroxaban) followed by dapt with standard dapt in selected acs patients with high ischemic risk. the main questions it aims to answer are: * whether the intervention is effective in reducing ischemic events * whether the intervention is safe from increasing bleeding events, especially severe or fatal ones participants will be randomized to receive standard dapt therapy for the entire study duration or low-dose rivaroxaban+dapt for 3 months, followed by standard dapt for the rest of the study duration. patients enrolled should complete 5 follow-ups in the form of clinic visit or telephone call.


Eligibility criteria:
inclusion criteria: * diagnosed with acute coronary syndrome 1-7 days after initial symptom stabilization, * aged 18-65 years old, * elevated d-dimer levels (≥0.28 μg/ml) on admission or paris coronary thrombosis risk score ≥ 3 points, * received percutaneous coronary intervention and not on non-oral anticoagulants, * indicated for dual antiplatelet medication exclusion criteria: * platelet level below 90 x10\^6 * hemoglobin level is less than 11g/dl * history of severe bleeding * history of stroke/tia * severe hepatic/renal insufficiency * indicated for anticoagulation

Keywords: novel oral anticoagulant paris risk score d-dimer acute coronary syndrome percutaneous coronary intervention