Kornimate/medical-research-clean huggingface dataset:
screening of biomarkers and related mechanisms for rix

Conditions: Xerostomia Due to Radiotherapy (Disorder)

Summary: a large number of patients undergoing radiotherapy and chemotherapy are suffering from dry mouth. due to reduced saliva secretion, patients may experience symptoms such as difficulty chewing and swallowing. in severe cases, they may also experience pain and burning sensation in the oral mucosa, decreased taste, ulcers, which seriously affect the quality of life of patients. however, radiation-induced dry mouth lacks early objective predictive indicators (molecular biomarkers) and the mechanism is unclear. only when patients experience clinical symptoms will symptomatic treatment be taken to alleviate them. therefore, elucidating the mechanism of radiation-induced dry mouth syndrome (rix) and achieving early prediction, detection, and intervention of rix are crucial in improving the prognosis and quality of life of radiotherapy patients. it is urgent to seek early and precise detection targets in clinical practice to predict dry mouth caused by irreversible damage to salivary gland tissue. this study aims to collect blood samples from patients with severe dry mouth before and after radiotherapy and chemotherapy in clinical practice. multiple omics techniques will be used to search for predictive molecular biomarkers for rix, construct a predictive model, and verify the sensitivity and specificity of the biomarkers. the goal is to predict the occurrence of rix early in clinical practice, intervene in advance, greatly improve the prognosis of radiotherapy and chemotherapy patients, and enhance their quality of life.


Eligibility criteria:
inclusion criteria: * histological diagnosis of head and neck cancer; * plan to undergo curative treatment with radiotherapy alone or in combination with synchronous chemotherapy, immunotherapy, or targeted therapy; * age greater than or equal to 18 years old, fully understand the purpose and significance of this study, voluntarily participate and sign an informed consent form. exclusion criteria: * metastatic diseases; * history of head and neck radiotherapy; * severe dry mouth before radiotherapy; * suffering from advanced chronic diseases: heart failure - new york heart association functional classification iii/iv, renal failure - estimated glomerular filtration rate under 30ml/min/1.73m2, liver failure - child pugh score c or d.

Keywords: head and neck tumor radiotherapy biomarkers xerostomia
a study to evaluate liver stiffness with shear wave elastography

Conditions: Chronic Liver Disease; Advanced Fibrosis; Advanced Cirrhosis

Summary: the purpose of the study is to assess the diagnostic accuracy of endoscopic ultrasound (eus) shear wave elastography in liver fibrosis staging in both normal subjects and subjects with advanced liver fibrosis/cirrhosis

this is a prospective, paired study. study subjects who are scheduled to undergo eus at mayo clinic will be identified through epic. chart review will be performed including review of prior imaging, medical history, and laboratory results as available in epic to determine study eligibility. subjects without history of chronic liver disease (screened by low fib-4 score) and those with known advanced fibrosis/cirrhosis will be eligible for the study. eligible study subjects will then be contacted either before, or at the time of their endoscopy procedure to discuss study participation. all subjects will then receive standard clinical care based on the indication for the eus procedure. during the eus procedure, study subjects with undergo shear wave measurements obtained in a non-invasive manner as part of the endosonographic evaluation of the liver. 10 measurements (including shear wave velocity (vs), elastic modulus (e)) will be obtained for point swe (pswe). measurements will be obtained from both left and right lobes of liver unless technically infeasible to do so. study subjects will then undergo a paired mr elastography (same day or at later date) after completion of eus and only if consistent and reliable shear wave measurements were obtained (e.g., vsn \> 70%(reliability index of each measurement expressed in percentages), iqr/m (interquartile range/ median) is \<15% for vs and \<30% for e). enrolled study subjects who had undergone a previous mre (within 6 months of enrollment) would be eligible for the study, without the need to undergo further research mre. after completion of mr elastography, the subjects will then continue through their routine clinical care and will not be followed up by research staff. the expected duration of subject participation is anticipated to begin at the time of study enrollment and terminate after completion of mr elastography. there will be no additional follow up.

Eligibility criteria:
inclusion criteria: * adults over 18 years of age who are undergoing eus procedures. * subjects with history of chronic liver disease, advanced fibrosis or cirrhosis * subjects without any history of chronic liver disease * subjects who underwent mr elastography within six (6) months of enrollment will be eligible to participate in the study. * subjects able to give appropriate consent to the study or have an appropriate representative to do so. exclusion criteria: * subjects who may have mri-incompatible metal implants/devices. * subjects with severe claustrophobia who may not tolerate mr elastography.
study of the pathogenesis and pathophysiology of familial neurohypophyseal diabetes insipidus

Conditions: Diabetes Insipidus; Diabetes Insipidus, Neurohypophyseal

Summary: objectives: i. determine whether diverse mutations of the vasopressin-neurophysin ii (avp-npii) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by directing the production of an abnormal preprohormone. ii. determine whether the avp-npii gene-directed preprohormone accumulates and destroys magnocellular neurons because it cannot be folded and processed efficiently.

protocol outline: this project involves 2 clinical studies. members of known kindreds participate in study i; members of kindreds who have not been surveyed, genotyped, or phenotyped participate in study ii. in study i, participants undergo clinical, hormonal, radiologic, and biochemical studies. assessment on unrestricted fluid intake includes body weight, urine volume, osmolality, creatinine, sodium, potassium, urea, glucose, arginine-vasopressin (avp), oxytocin, and aquaporin-ii. participants with diabetes insipidus (di) undergo a standard fluid deprivation test; those without di undergo standard water load and hypertonic saline testing. previously untreated di patients may be given intranasal or subcutaneous desmopressin or oral chlorpropamide (adults only) for 2 or 3 days. magnetic resonance imaging of the pituitary-hypothalamic area is performed on all patients with and without gadolinium. infants and children are studied annually for the first 5 years or until they develop di. affected adults are studied every 2-5 years. unaffected adults are re-tested only if they subsequently report de novo symptoms suggestive of di. in study ii, participants undergo similar genotype and phenotype testing. kindreds demonstrating the familial neurohypophyseal diabetes insipidus phenotype and genotype are added to study i. kindreds found to have a different type of di are directed into a companion protocol.

Eligibility criteria:
* verified or suspected familial neurohypophyseal diabetes insipidus with or without an identified mutation of the vasopressin-neurophysin ii gene affected and unaffected members of kindreds entered

Keywords: diabetes insipidus endocrine disorders rare disease
evaluation of efficacy and safety of lovaza (omega-3-acid ethyl esters) in recurrent, symptomatic atrial fibrillation

Conditions: Fibrillation, Atrial

Summary: the purpose of this study is to evaluate efficacy and safety of omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.


Eligibility criteria:
inclusion criteria: * men and women age 18 years or older * history of symptomatic atrial fibrillation (either paroxysmal or persistent) * provide written informed consent and authorization for protected health information disclosure exclusion criteria: * permanent (chronic) atrial fibrillation * antiarrhythmic drug therapy which cannot be stopped * use of amiodarone with prior 6 months * history of unsuccessful cardioversion * history of certain cardiovascular conditions or cardiac surgery within prior 6 months * history of stroke within prior 6 months * implanted cardio-defibrillator * certain circulatory, thyroid, pulmonary, liver, kidney, musculoskeletal or metabolic conditions, or cancer (except non-melanoma skin cancer) * poorly controlled diabetes

Keywords: lovaza omega-3 fatty acids omacor paroxysmal atrial fibrillation
adjuvant chemotherapy in patients with clinical stage iii rectal cancer undergoing neoadjuvant chemoradiotherapy

Conditions: Rectal Neoplasms

Summary: the purpose of this study is to evaluate the efficacy of adjuvant chemotherapy in patients with clinical stage iii rectal cancer who received neoadjuvant chemoradiotherapy on the basis of postoperative pathological stage.

previous studies have proved that neoadjuvant radiotherapy can decrease the rate of local recurrence rather than distal metastases in advanced rectal cancer. moreover, the local control was not responsible for survival benefit. adjuvant chemotherapy is capable of eliminating the micrometastasis, rendering better prognosis to rectal cancer. however, the application of adjuvant chemotherapy depends largely on the evidence from colon cancer. at present, controversy remains on the clinical value of adjuvant chemotherapy in patients with rectal cancer who received neoadjuvant chemoradiotherapy. besides that, the pathological stage followed by neoadjuvant chemoradiotherapy may have an effect on the evaluation of adjuvant chemotherapy. according to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage i to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. for patients with yp stage ii or iii, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.

Eligibility criteria:
inclusion criteria: * the lesion must be within 12 cm of the anus as measured by endoscopy * histologically confirmed diagnosis of rectal carcinoma * ct, mri and eus verified as clinical stage iii rectal cancer without involvement of other organs * without multiple primary cancer * sufficient organ function * able to provide written informed consent exclusion criteria: * younger than 18 years or older than 75 years * synchronous or metachronous malignancy within 5 years. * patients with intestinal obstruction or perforation or bleeding who require emergency surgery. * patients with a history of pelvic irradiation. * asa grade iv or v. * women who are pregnant (confirmed by serum b-hcg in women of reproductive age) or breast feeding. * severe mental illness. * patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery. * patients who received steroid therapy within one month. * patients or family members misunderstand the conditions and goals of this study.

Keywords: rectal neoplasms adjuvant chemotherapy neoadjuvant chemoradiotherapy
impact of antibiotic prophylaxis in per-oral endoscopic myotomy for esophageal motor disorders

Conditions: Esophagus Disorder; Esophageal Achalasia

Summary: no recommendation regarding antibiotic prophylaxis and preparation modalities are available for patients with esophageal motor disorders who benefit from per-oral endoscopic myotomy (poem). the aim of our study was to evaluate the impact of antibiotic prophylaxis on the poem's safety. this study was a comparative and multicentric retrospective analysis of a database prospectively maintained. patients over 18 year's old with esophageal motor disorders confirmed by prior manometry, who underwent poem were included. the primary endpoint was the occurrence of complications, as classified by cotton, based on whether or not antibiotic prophylaxis was administered.


Eligibility criteria:
inclusion criteria: * adults patients presenting a major esophageal motor disorder confirmed by prior manometry according to the chicago classification and treated by per-oral endoscopic myotomy after a multidisciplinary meeting decision exclusion criteria: * under-age patients were excluded

Keywords: antibiotic prophylaxis per oral endoscopic myotomy
genetic polymorphisms, steatosis and diabetes

Conditions: Type 1 and 2 Diabetes

Summary: * our research hypothesis is to show that a certain number of genetic polymorphisms of the proteins involved in glucose, lipid and adipocyte metabolism are factors that favour the development of steatosis in patients with type 2 diabetes. * we also wish to evaluate more thoroughly lipid anomalies associated with the presence of steatosis, notably with regard to monocyte expression of ldl receptors. we hypothesize that hepatic steatosis is accompanied by activation of transcription factors involved in lipogenesis, notably srebp factors. the activation of these factors could cause an increase in the expression of ldl receptors, leading to increased ldl catabolism. * chronological description of the study during an outpatient consultation at the endocrinology department, diabetic patients, programmed to undergo an examination to assess their diabetes will be invited to participate in the study. once written informed consent has been provided and clinical data has been recorded, patients with type 1 or type 2 diabetes will have standard biological examination, which is systematically done in such patients (fasting glycemia, hba1c, aspartate aminotransferase, alanine amino transferase, gammaglutamyl-transferases, pal, bilirubin, blood proteins, albuminemia, total cholesterol total, hdl cholesterol, triglycerides, sedimentation rate, c-reactive protein, fibrinogen). as well as the systematic biological tests, 3 additional tubes will be taken to screen for genetic polymorphism in 3 proteins (microsomal transfer protein, adiponectin receptor - 1, apolipoprotein a - ii). in addition, magnetic resonance imaging and magnetic resonance spectroscopy will be done to look for the presence of liver steatosis and to measure carotid intima-media thickness.


Eligibility criteria:
inclusion criteria: inclusion criteria type-2 diabetics: * type 2 diabetes * hba1c\>6.5% * 27\<bmi\<55 inclusion criteria type-1 diabetics: * type 1 diabetes * bmi\<55 diagnosis of type-1 diabetes based on the clinical history of the patient and/or the presence of anti-glutamate decarboxylase auto antibodies and/or a plasma level of c peptide below 0,5 ng/l. inclusion criteria healthy volunteers: * non diabetic * alcohol consumption \< 2 glasses per day * without hyperglycemic treatment (corticoids, ...) * without liver disease (cirrhosis, hepatitis, ...) exclusion criteria: * pacemaker * daily alcohol consumption above 4 glasses per day * patients treated with glitazones during the 3 months preceding inclusion * presence of implants * claustrophobia * patient \< 18 years * patient under guardianship or not intellectually independent * pregnancy
evaluation of renal protection of dexmedetomidine versus midazolam as a sedative for septic patients in intensive care unit

Conditions: Renal Failure

Summary: evaluation of renal protection of dexmedetomidine versus midazolam as a sedative for septic patients in intensive care unit


Eligibility criteria:
inclusion criteria: * age (18-80) years old. sex:both male and female. * intubated and mechanically ventilated patients. exclusion criteria: * 1.patient's relatives refusal. 2. burns as admitting diagnoses. 3.patients with any renal pathology(such as chronic glomerulonephritis, pyelonephritis and diabetic nephropathy). 4. pregnancy or lactation. 5. serious central nervous system pathology (acute stroke, uncontrolled seizures, severe dementia). 6. acute hepatitis or severe liver disease (child-pugh class c). 7. unstable angina or acute myocardial infarction, left ventricular ejection fraction less than 30%, heart rate less than 50/min, second- or third-degree heart block, or systolic blood pressure less than 90 mm hg despite continuous infusions of 2 vasopressors before the start of study drug infusion.
compare effectiveness of eplerenone vs atenolol in reversing the remodelling resistance arteries in subjects with ht

Conditions: Hypertension

Summary: to investigate the impact of antihypertensive therapy with the selective mineralocorticoid receptor blocker, eplerenone, on small resistance artery remodeling, compared to the effect of equivalent blood pressure control achieved with a b-blocker, atenolol.


Eligibility criteria:
inclusion criteria: * pt with essential hypertension who have never been treated or untreated within the previous 6 months exclusion criteria: * history of malignant hypertension * sitting diastolic blood pressure \> 115mmhg or sitting systolic blood pressure \> 200mmhg
flow-af: a study to evaluate electrographic flow™ (egf) mapping technology

Conditions: Atrial Fibrillation, Persistent

Summary: this study is to evaluate electrographic flow™ (egf) mapping algorithm technology (ablamap® software).

the objective of this study is to evaluate the reliability of electrographic flow™ (egf) mapping algorithm technology (ablamap® software) to identify sources of atrial fibrillation and guide ablation therapy in patients with persistent atrial fibrillation.

Eligibility criteria:
inclusion criteria: 1. suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias. 2. above eighteen (18) years of age or of legal age to give informed consent specific to state and national law. 3. subjects with a history of documented symptomatic, persistent or longstanding persistent atrial fibrillation \< 36 months. 4. subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months. 5. treatment of atrial fibrillation with ablation therapy presenting with recurrent symptoms of atrial fibrillation (not applicable to de novo subjects) exclusion criteria: 1. left atrial diameter \> 5.5 cm. 2. left ventricular ejection fraction (lvef) \< 35%. 3. presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation. 4. coagulopathy, bleeding diathesis or suspected procoagulant state. 5. known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure. 6. positive pregnancy test results for female patients of childbearing potential or breast feeding. 7. acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study. 8. mitral valve stenosis and/or severe mitral regurgitation. 9. valvular atrial fibrillation. 10. prosthetic valves. 11. new york heart association (nyha) class iv. 12. history of myocardial infarction (mi) within 3 months prior to procedure. 13. atrial septal defect (asd) or left atrial appendage (laa) closure device. 14. atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis or pericarditis). 15. life expectancy \< 12 months based on medical history or the medical judgement of the investigator. 16. presence of any transvenous pacing, implantable cardioverter defibrillators (icd), cardiac resynchronization therapy (crt) leads.
fundic gland polyps and proton pump inhibitor (ppi) drugs

Conditions: Fundic Gland Polyps

Summary: the class of proton pump inhibitor (ppi) medications such as omeprazole has proven extremely effective in the treatment and prevention of gastric and duodenal ulcers. although the fda approval for ppi therapy is limited to 6-8 weeks, many individuals remain on these agents for years, and human studies have suggested that long-term use of a ppi can result in enterochromaffin-like (ecl) cell hyperplasia, as well as being associated with the development of fundic-gland polyps of the stomach. these findings raise the concern of the possibility that long-term use of ppis may predispose to the development of neuroendocrine tumors in patients. the investigators aim to examine clinical parameters, including history of ppi use and fasting gastrin levels, as well as histologic characteristics (particularly the presence of ecl-cell hyperplasia) of patients found to have fundic gland polyps during endoscopy. the investigators hypothesize that there is a correlation between fundic gland polyps of the stomach and the use of proton pump inhibiter medications.


Eligibility criteria:
inclusion criteria: * age 18 and above. * able and willing to sign informed consent. * the patient had a gastric fundic gland polyp detected on egd that was removed and sent to pathology or patient had no fundic gland polyps on egd but are on ppis and will serve as controls. exclusion criteria: * unwilling or unable to sign informed consent for the study.

Keywords: proton pump inhibitor gastric carcinoid tumors gastric cancer fundic gland polyps
compassionate use of sodium stibogluconate (pentostam) for cutaneous and mucocutaneous new world leishmaniasis

Conditions: Leishmaniasis, Cutaneous; Leishmaniasis, Mucocutaneous

Summary: patients with biopsy proven new world cutaneous or mucocutaneous leishmaniasis will be treated with sodium stibogluconate (pentostam).


Eligibility criteria:
inclusion criteria: * biopsy proven new world cutaneous or mucocutaneous leishmania exclusion criteria: * prolonged qt * liver disease * pancreatitis

Keywords: new world cutaneous or mucocutaneous leishmaniasis
a study of oprozomib, melphalan, and prednisone in transplant ineligible patients with newly diagnosed multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of phase 1b of the study is to determine the maximum tolerated dose (mtd) of oprozomib in combination with melphalan and prednisone (omp). the purpose of phase 2 of the study is to estimate the overall response rate (orr) and complete response rate (crr) of the omp combination.


Eligibility criteria:
key inclusion criteria: 1. newly diagnosed symptomatic multiple myeloma patients who are transplant ineligible with measureable disease as indicated by one or more of the following: 1. serum m-protein ≥ 500 mg/dl 2. urine m-protein ≥ 200 mg/24 hour 3. serum free light chain: involved free light chain (flc) level ≥ 10 mg/dl, provided serum flc ratio is abnormal 2. eastern cooperative oncology group (ecog) performance status 0-2 3. creatinine clearance (crcl) ≥ 30 ml/min, either measured or calculated using the formula of cockcroft and gault \[(140 - age) × mass (kg) / (72 × serum creatinine mg/dl)\]. multiply result by 0.85 if female. key exclusion criteria: 1. any prior systemic antimyeloma therapy except oral steroids (dexamethasone up to a total dose of 160 mg or equivalent within 14 days prior to the first dose of study treatment is allowed). use of topical or inhaled steroids is acceptable. 2. congestive heart failure (new york hearth association class iii to iv), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to first dose 3. known or suspected hiv, active hepatitis a, b c or virus infection (exception: subjects with chronic or cleared hbv and hcv infection and stable liver function tests \[bilirubin, ast\] will be allowed). 4. significant neuropathy (grade 2 with pain or higher) at the time of first dose. 5. plasma cell leukemia. 6. poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 7. known amyloidosis