Kornimate/medical-research-clean huggingface dataset:
an open-label drug-drug interaction study to evaluate the effect of bcx7353 on cytochrome p450 enzyme activity using probe substrates

Conditions: Hereditary Angioedema

Summary: this is an open-label, single sequence study to evaluate the effect of bcx7353 on hepatic and intestinal cytochrome p450 enzymes using probe substrate drugs in healthy subjects. pharmacokinetics of the probe substrate drugs will be measured prior to and following administration of multiple doses of bcx7353.

this is a single centre, single sequence, open-label, study to evaluate the effect of bcx7353 on hepatic and intestinal cytochrome p450 (cyp) 3a4 (midazolam iv and po, respectively), cyp2c9 (tolbutamide), cyp2c19 (omeprazole) and cyp2d6 (dextromethorphan) enzyme activity using probe substrate drugs in healthy subjects. pharmacokinetics of the probe substrate drugs will be measured prior to and following administration of multiple doses of bcx7353. twenty healthy male and female subjects are planned for dosing. each subject will receive the following treatments: day 1: 1 mg midazolam will be administered as an iv bolus simultaneously to administration of 500 mg tolbutamide, 40 mg omeprazole, and 30 mg dextromethorphan orally. day 2: a single oral dose of 2 mg midazolam. days 3 to 9: 350 mg bcx7353 once a day. day 10: 1 mg midazolam will be administered as an iv bolus simultaneously to administration of 500 mg tolbutamide, 40 mg omeprazole, 30 mg dextromethorphan and 350 mg bcx7353, orally. day 11: a single oral dose of 2 mg of midazolam along with 350 mg bcx7353.

Eligibility criteria:
key inclusion criteria: * written informed consent * body mass index 18 to 32 kg/m2 * abides by study restrictions * attends all study visits and agrees to remain in study center for the confinement period * acceptable birth control measures for male subjects and women of childbearing potential key exclusion criteria: * clinically significant medical history, current medical or psychiatric condition. this includes a history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, or cardiac disease * clinically significant ecg finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline * poor or ultra- metabolizers of cyp2c19 or cyp2d6 use of over the counter or prescription medication within 14 days of dosing and anticipated use through the follow-up visit * use of medication or consumption of any substance that is known to inhibit or induce metabolic enzymes or transporters within 30 days of dosing * participation in any other investigational drug study within 90 days of screening * recent or current history of alcohol or drug abuse * regular recent use of tobacco or nicotine products * positive serology for hbv, hcv, or hiv * pregnant or nursing * donation or loss of greater than 400 ml of blood within 3 months * serious adverse reaction or serious hypersensitivity to any drug
l-arginine and asymmetric dimethylarginine (adma) and lifestyle protocols

Conditions: Diabetes Mellitus, Type 2; Obesity; Arginine; Asymmetric Dimethylarginine

Summary: low serum l-arginine (arg) and high asymmetric dimethylarginine (adma) can predict microvascular complications in type 2 diabetes (t2dm). the investigators examined whether or not arg and adma are affected by dietary factors or lifestyle modification in overweight/ obese and t2dm subjects.

the investigators tested the effects on serum arg and adma of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or t2dm subjects on circulating arg and adma (n=43)

Eligibility criteria:
inclusion criteria: * obese and/ or t2dm subjects exclusion criteria: * type 1 diabetes * insulin-treated t2dm * active coronary disease (recent \[≤ 6months\] myocardial infarction, unstable angina, recent coronary catheterization, or coronary bypass grafting * individuals with significant impairment in liver enzymes (≥ 2.5 the upper limit of the normal range) * serum creatinine higher than 1.5mg% * known malabsorption, alcoholism or illicit use of drugs * abnormal thyroid function tests * concomitant or recent use of glucocorticoids * uncertain mental state (to avoid invalid informed consent or lack of compliance).
biomarkers in stored tumor samples from younger patients with liver cancer

Conditions: Liver Cancer

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this laboratory study is looking at biomarkers in stored tumor samples from younger patients with liver cancer.

objectives: * to characterize, at a molecular level, archived samples of tissue from young patients with fibrolamellar carcinoma and hepatocellular carcinoma in non-cirrhotic livers matched for age and sex. * to perform genomic analysis on these tissue samples using array comparative genomic hybridization. * to perform targeted gene mutation analysis on these samples by pcr. * to perform proteomic profiling on fixed tissues in these samples by various proteomic methods, including ihc and mass spectrometry. * to look for association between molecular aberrations and clinicopathologic features in these samples. outline: archived tissue samples are collected from the pathology department at vanderbilt university medical center and from the mayo clinic in rochester, minnesota. tissue samples are analyzed by genomic analysis using array comparative genomic hybridization, target gene mutation analysis by pcr, and proteomic profiling on fixed tissues using various proteomic methods, including ihc and mass spectrometry. samples are also examined for association between molecular aberrations and clinicopathologic features found in each disease. clinical patient data (i.e., age, sex, race, date of diagnosis, risk factors, histology, surgical staging, follow-ups, date of death, and adjuvant therapy) are also collected.

Eligibility criteria:
inclusion criteria: disease characteristics: * diagnosis of fibrolamellar carcinoma or hepatocellular carcinoma in a non-cirrhotic liver * archived tumor specimens available for analysis from vanderbilt university or mayo clinic exclusion criteria: * not specified patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: childhood hepatocellular carcinoma childhood liver cancer adult primary liver cancer adult primary hepatocellular carcinoma
ht-100 long-term study in dmd patients who completed halo-dmd-02

Conditions: Duchenne Muscular Dystrophy

Summary: this study, halo-dmd-03, is a follow-on study to halo-dmd-01 and halo-dmd-02, and allows continued open-label access to ht-100 for subjects who have completed these studies. halo-dmd-03 will provide safety and strength and function data on continuous long-term dosing. data from this study will be used to inform the safety, tolerability, and dose selection for a future trial of ht-100 in boys with duchenne muscular dystrophy (dmd).

as a follow-on study to the initial clinical studies of ht-100 in dmd (protocols halo-dmd-01 and halo-dmd-02), this open-label study is designed to provide data on continuous long-term dosing. subjects will be entered into the study without cessation of dosing, in a staggered fashion, into the same cohort assignment they had in the predecessor studies. up to 30 subjects who have completed dosing in halo-dmd-02 will be offered the opportunity to continue on the same dose regimen until market approval of ht-100 or termination of the study by the sponsor. reasons for termination could include, among others, safety concerns or lack of efficacy, based on analysis of combined data from all ht-100 studies. safety data from subjects approaching the end the halo-dmd-02 participation will be individually reviewed by the medical monitor and the subject's physician (principal investigator \[pi\]). if the medical monitor and the pi agree there are no clinically significant safety signals (absence of clinically significant laboratory or clinical abnormalities to date), the subject will be considered eligible and offered continuation of dosing. to avoid an interruption in dosing, subjects will immediately be screened for participation and enrolled upon completing the predecessor trial, halo-dmd-02. participation is in this study halo-dmd-03 is optional. safety and pharmacodynamics (pd) monitoring will continue throughout the subject's study participation. dose reduction/modification might occur or individual subjects' participation in the trial may be discontinued if any adverse events (aes) suggest that ht-100 is not sufficiently well tolerated.

Eligibility criteria:
inclusion criteria: 1. completed both previous studies halo-dmd-01 and halo-dmd-02 2. ability to provide written informed consent 3. ability to understand and follow site and protocol instruction for the entire duration of the study exclusion criteria: answering yes to any of the following make the subject not eligible to participate in the study. 1. clinically significant major disease not related to dmd that would make it not safe to be in the study or affect ability to follow the protocol 2. history of severe allergic or anaphylactic reactions 3. recent report of drug/alcohol abuse

Keywords: dmd neuromuscular duchenne
computation prediction of drug response based on omics data

Conditions: Breast Cancer

Summary: the goal of this observational study is to assess the performance of computational medicine technology in predicting patients response to anticancer drugs based on omics data.the main question it aims to answer is test consistency between the computing drug response and the response of real-world clinical trials. participants will take part in silico.

a companion trial in silico was planned to compare head-to-head with a real clinical study of anti-tumor registered new drugs to verify the consistency between the efficacy prediction results of virtual clinical studies and the efficacy results of traditional clinical trials. subjects simultaneously entered real world clinical trials and virtual clinical trials built by computer modeling and artificial intelligence technology. the results of traditional clinical trials were compared with those of virtual clinical trials to calculate the consistency of virtual clinical trials. by predicting the population with consistent efficacy, locking the response population to new drugs, using the innovative technology of computational medicine, grasping the omics characteristics of the response population, and using this as a starting point to determine the target population of clinical trials, so as to determine new screening conditions, design new clinical trials, accurately match the effective population, and revolutionary change the efficiency of clinical trials, thereby shortening the process and cost of clinical trial development.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of triple-negative breast cancer 2. the subjects agreed to participate in the traditional clinical trial and signed informed consent. 3. the subjects agreed to participate in the virtual study and signed informed consent. exclusion criteria: 1. subjects do not meet the inclusion criteria of traditional clinical trial. 2. subjects suffered from other cancer disease

Keywords: in silico clinical trial anti-cancer drug
funguria in hospitalized patients

Conditions: Candidiasis

Summary: the purpose of the study is to test the hypothesis that a subpopulation of patients with candiduria are at significant risk for disseminated disease and would benefit from treatment, while others are at low risk from complications and therefore require no antifungal therapy.

this protocol will attempt to generate a detailed clinical profile of patients with funguria and identify subgroups of patients with funguria at high risk for candiduria and determine the relative risks for obtaining candiduria. in addition, it will look at identifying subgroups of patients with funguria at high risk for candidemia and identifying subgroups of patients with funguria at high risk for death. finally, it will attempt to determine if funguria independently predicts fungemia or death. data will be complemented by surveillance of a comparable population without funguria.

Eligibility criteria:
inclusion criteria: 1. subjects with fungi isolated from the urine of any colony count. 2. patients seen at either harbor-ucla medical center or cedars sinai medical center. exclusion criteria: 1. persons with a previously positive urine fungal culture during the current hospital admission.

Keywords: candidiasis, funguria
safety and efficacy study of dexamethasone in the treatment of patients with macular edema following retinal vein occlusion (rvo)

Conditions: Macular Edema

Summary: this study will assess the safety and efficacy of 700 μg dexamethasone posterior segment drug delivery system (dex ps dds) applicator system in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.


Eligibility criteria:
inclusion criteria: -presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (brvo) or central retinal vein occlusion (crvo) exclusion criteria: * history of glaucoma, ocular hypertension or optic nerve head change * any active bacterial, viral, parasitic, or fungal infections in either eye * eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start * history of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start * use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start * use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start * use of topical ophthalmic corticosticosteroids within 2 weeks of study start
development of a blood test to improve the performance of breast cancer screening

Conditions: Breast Cancer; Breast Benign

Summary: the purpose of this study is to collect blood and tissue to help develop tests that might be able to detect cancer earlier. the investigator will be collecting these samples and reviewing test results from participants who have had an area of concern found on breast imaging, as well as from participants who are scheduled to have a routine breast cancer screening mammogram.


Eligibility criteria:
inclusion criteria: * females with one or more bi-rads 4 radiographic lesions who are undergoing ultrasound, stereotactic or mri-guided breast biopsy at mskcc or at an msk alliance member site. if multiple imaging modalities were employed (mammogram, ultrasound, mri) and no integrated score is provided, then the highest bi-rads score will be used. * age ≥ 18 years at the time of breast biopsy * willing to provide blood samples for research purposes before biopsy. * able to provide written informed consent exclusion criteria: * women with a bi-rads 4 lesion who had the lesion previously biopsied * females with a current active malignancy other than non-melanoma skin cancers. females are considered not to have a "current active" malignancy if they have completed therapy and have no evidence of systemic disease for at least three years from the initial diagnosis * currently pregnant women * history of bilateral mastectomy. * participant has or is currently participating in another grail-sponsored protocol

Keywords: breast imaging 17-598
prognostic analysis of esophageal cancer with complete pathological response after neoadjuvant therapy

Conditions: Esophageal Cancer

Summary: esophageal cancer is one of the most common malignant tumors worldwide, with high invasiveness and lethality. currently, the treatment for resectable locally advanced esophageal cancer mainly consists of a treatment model centered on surgical treatment with the participation of multiple disciplines. neoadjuvant treatment regimens include chemotherapy, chemoradiotherapy, and chemotherapy combined with immunotherapy. complete pathological response (pcr)is currently regarded as one of the important indicators for evaluating the efficacy of neoadjuvant treatment. previous studies have shown that 14%-39% of patients with complete pathological response after neoadjuvant treatment still experience recurrence and metastasis within two years after surgery, suggesting that pcr after esophageal cancer surgery does not mean clinical cure. perhaps there is a highly risk clinical subgroup need to research. therefore, based on the prospective clinical database of the national cancer center and in cooperation with multiple national cancer regional medical centers, this study analyzes and explores the prognosis of patients with locally advanced esophageal squamous cell carcinoma with pcr after neoadjuvant treatment, characterized by the chinese population.


Eligibility criteria:
inclusion criteria: * patients treated neoadjvant treatment followed by esophagectomy from 2018 to 2023 * patients with thoracic esophageal squamous cell carcinoma * the preoperative clnical stage is ct1n+m0/ct2-4an0-3m0, with potential resectability * patients with complete pathological response (ypt0n0m0) * without distant metastasis was found in the preoperative examinations, and the tumor did not directly invade the pancreas, spleen, trachea, aorta or other adjacent organs such as the lungs exclusion criteria: * patients with previous history of malignant tumors * patients with multiple primary cancers * deficient neoadjuvant treatment or salvage surgery * incomplete clinical data

Keywords: complete pathological response neoadjuvant recurrence esophageal squamous cell carcinoma survival
real-world pharmacological treatment pattern of neuropathic pain in china

Conditions: Diabetic Peripheral Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy; Neuropathic Pain

Summary: the aim of this study is to investigate the pharmacological treatment pattern among patients with diabetic peripheral neuropathic pain (dpnp) and chemotherapy-induced peripheral neuropathy (cipn) in china.

diabetic peripheral neuropathic pain (dpnp) and chemotherapy-induced peripheral neuropathy (cipn) are common subtypes of neuropathic pain. the treatment pattern, subsequent medication usage, and adherence information of medication among these patients are still not clear. there is also an unmet need for the use of relevant analgesic medications in this area. this real-world data study aims to understand patients' characteristics, clinical diagnosis and treatment patterns, medication adherence, real-world effectiveness among dpnp and cipn patients in china and will explore the current unmet needs of dpnp and cipn, in order to inform physicians' decision-making in clinical practice

Eligibility criteria:
participants who meet all the following criteria will be included in the dpnp cohort. 1. participants were diagnosed with diabetic neuropathy and presented with the pain symptom between 1st january 2018 and 31st december 2021; 2. participants received at least one targeted medication between 1st january 2018 and 31st december 2021; 3. participants were ≥18 years on the index date; 4. participants had at least one medical visit record within 12 months after the index date participants who meet any one of the following criteria will be excluded from the dpnp cohort. (1) participants were diagnosed with epilepsy, schizophrenia, or bipolar disorder before or on the index date participants who meet all the following criteria will be included in the cipn cohort. 1. participants had neuropathy that was induced by the chemotherapy between 1st january 2018 and 31st december 2021, regardless of the presence of pain symptoms; 2. participants received at least one targeted medication between 1st january 2018 and 31st december 2021; 3. participants were ≥18 years on the index date; 4. participants had at least one medical visit record within12 months after the index date participants who meet any one of the following criteria will be excluded from the cipn cohort. 1. participants were diagnosed with epilepsy, schizophrenia, or bipolar disorder before or on the index date; 2. participants had neuralgia or neuropathy caused by tumor metastasis or non-chemotherapy-induced factors (e.g., radiotherapy, myasthenia gravis syndrome, paraneoplastic syndrome, direct tumor invasion, local tissue compression, postoperative traumatic pain, immune therapy-related pain, comorbidity-induced pain, etc.)

Keywords: diabetic peripheral neuropathic pain chemotherapy-induced peripheral neuropathy neuropathic pain treatment pattern
water versus saline as irrigation fluid for ureteroscopy

Conditions: Ureteral Stricture; Hydronephrosis; Urothelial Carcinoma; Urolithiasis

Summary: the purpose of this study is to determine the rate of absorption of fluids (water or saline) during ureteroscopy and to assess the effects on electrolyte levels. the investigators also want to measure how much better the urologist can see the ureter based on the type of irrigation fluid that is used.

the use of fluid irrigation is important during urologic procedures. there is little research done on the use of water versus saline for irrigation during ureteroscopy. this study will evaluate whether the use of water or saline during ureteroscopy has any clinical implications. the investigators will compare the amount of fluid absorbed and differences in electrolytes between the two participant groups.

Eligibility criteria:
inclusion criteria: * \> 18 years of age * participants meeting medical requirements to undergo ureteroscopy exclusion criteria: * none
resilience mobile app for teens and young adults with cancer

Conditions: Cancer

Summary: the goal of this pilot trial is to examine whether a mobile app version of the promoting resilience in stress management (prism) intervention is acceptable, easy to use, and helps improve quality of life and mental health symptoms.

adolescents and young adults (ayas) with cancer are at risk of distress, anxiety, depression, and poor quality of life. the use of mobile applications for psychosocial symptom self-management is appealing to this demographic population but this has not yet been developed and tested. prism is a novel, brief, evidence-based 1:1 intervention that teaches stress management, goal-setting, meaning making, cognitive-behavioral, and mindfulness strategies. here, we propose to test a mobile health (mhealth) version of prism, mprism. in a pilot randomized controlled trial, we will evaluate the feasibility, acceptability, and exploratory efficacy of mprism using a waitlist control design.

Eligibility criteria:
inclusion criteria: * age 12-25 years * diagnosis of new malignancy within 12 months of enrollment treated with chemotherapy and/or radiation therapy at seattle children's hospital (sch) * patient able to speak/read/write english or spanish language * cognitively able to participate in mhealth psychosocial intervention and interactive interviews exclusion criteria: * patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age * patients with diagnosis of malignancy \>12 months * patients with relapsed, recurrent, or refractory disease * patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible) * cognitively or physically unable to participate in mhealth psychosocial intervention and surveys

Keywords: mobile health quality of life adolescent young adult psychosocial factors