Kornimate/medical-research-clean huggingface dataset:
a novel spleen-dedicated stiffness measured by fibroscan to evaluate cirrhotic portal hypertension (chess2105)

Conditions: Portal Hypertension

Summary: portal hypertension contributed to the main complications of liver cirrhosis. currently, hepatic venous pressure gradient (hvpg) was the reference standard for evaluating portal pressure in patients with cirrhosis. however, the practice of hvpg is limited to require the extensive experience and highly specialized centers. in recent years, non-invasive methods were proposed to predict the degree of cirrhotic portal hypertension. of them, liver stiffness measured by fibroscan had shown good performance for predicting clinically significant portal hypertension. however, the correlation between liver stiffness and hvpg was poor when hvpg was more than 12mmhg. since the spleen was stiffer than the liver, the current vibration-controlled transient elastography examination is dedicated to the liver, rather than the spleen. very recently, a novel spleen-dedicated stiffness measured by fibroscan was proposed. the prospective, multicenter study aims to evaluate the correlation between ss (measured by the novel fibroscan) and hvpg, and further develop a novel model based on ss for predicting the liver decompensation in patients with compenstaed cirrhosis.

portal hypertension contributed to the main complications of liver cirrhosis. currently, hepatic venous pressure gradient (hvpg) was the reference standard for evaluating portal pressure in patients with cirrhosis. however, the practice of hvpg is limited to require the extensive experience and highly specialized centers. in recent years, non-invasive methods were proposed to predict the degree of cirrhotic portal hypertension. of them, liver stiffness measured by fibroscan had shown good performance for predicting clinically significant portal hypertension. however, the correlation between liver stiffness and hvpg was poor when hvpg was more than 12mmhg. since the spleen was stiffer than the liver, the current vibration-controlled transient elastography examination is dedicated to the liver, rather than the spleen. very recently, a novel spleen-dedicated stiffness measured by fibroscan was proposed. the prospective, multicenter study (chess2105 leaded by the first hospital of lanzhou university and shulan (hangzhou) hospital) aims to evaluate the correlation between ss (measured by the novel fibroscan) and hvpg, and further develop a novel model based on ss for predicting the liver decompensation in patients with compenstaed cirrhosis.

Eligibility criteria:
inclusion criteria: 1. age above or equal to 18-year-old 2. fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis 3. signed informed consent exclusion criteria: 1. non-cirrhotic portal hypertension 2. lactation or pregnancy 3. suspicious or confirmed hepatocellular carcinoma 4. asplenia or splenectomy 5. incomplete clinical information

Keywords: cirrhosis spleen stiffness portal hypertension hepatic venous pressure gradient
multiomic analysis of serum in acute period of traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the goal of this experimental observation study is to figure out differently expressed biomarkers in serum in traumatic brain injury patients, compared with bone fracture patients. the main questions it aims to answer are: 1. which proteins and metabolites are differently expressed in tbi patients' serum? 2. which proteins or metabolites can serve as the new serum biomarkers for diagnosing tbi? participants will be treated by routine treatments, and their serum samples will be collected in the emergency room.

this experimental observation study is designed to find out some new characteristics in acute severe traumatic brain injury. to filter the stress response in blood, patients with traumatic fracture are chosen as the control group. blood samples of patients who pass the eligibility criteria will be collected immediately in the emergency room. then the samples will be preprocessed in the laboratory to get serums. these collected serums will be preserved in -80℃ until completing all sample collection. after completing collection, all samples will be sent to proteomic and metabolomic detection. the bioinformatic data will be analyzed to answer these main questions: 1. which proteins and metabolites are differently expressed in tbi patients' serum? (as a whole characteristic of acute severe tbi) 2. which proteins or metabolites can serve as the new serum biomarkers for diagnosing tbi? (deeply digging the value of characteristic of acute severe tbi)

Eligibility criteria:
inclusion criteria: * with cerebral contusion in 24hrs for case group, or with traumatic bone fracture in 24hrs for control group. * the glasglow coma scale ranges in 3-8 for case group. * need to have routine laboratory examination of blood sample. * patients or agents sign the informed consent. exclusion criteria: * with bone fracture for case group, or with brain injury for control group. * have orthopaedic history for case group, or have neurological history for control group. * death in 24 hours. * immunosuppressed state. * severe multiple organ dysfunction. * with infection. * pregnant.

Keywords: traumatic brain injury biomarker multiomic analysis diagnosis
a zero acute kidney injury strategy for percutaneous coronary intervention in patients with chronickidney disease

Conditions: Acute Kidney Injury; Coronary Artery Disease; Percutaneous Coronary Intervention

Summary: the purpose of this study is to compare the outcomes of percutaneous coronary intervention (pci) in patients with chronic kidney disease (ckd) using smaller doses of contrast dye that are validated as being at low risk of causing injury to the kidneys, with the larger doses that are traditionally used contemporary practice.

this study will evaluate whether using lower doses of contrast dye leads to lower rates of kidney injury compared to current standard of care. in particular, effort will be taken to maintain the total amount of contrast dye below a scientifically-validated threshold calculated on the basis of each participant renal function. participants will already be scheduled to undergo a pci. because a smaller amount of contrast dye will be used, an intravascular ultrasound (ivus) will be used to help the doctors see and open the blockages in participant's coronary arteries. ivus is already used to optimize pci results, but will be used more extensively in this case. the amount of contrast dye received will be tailored on each participant kidney function. prospectively enrolled patients will be matched with historical controls who underwent pci with non-intravascular imaging based approach.

Eligibility criteria:
inclusion criteria: * consecutive patients undergoing elective and urgent (i.e., non-emergent) pci * age \>18 years * egfr \<60 ml/min/1.73 m2 * angina or equivalent and/or documentation of inducible myocardial ischemia * presence of =1 coronary stenosis, evaluated \>70% by visual estimation (on a previously performed coronary angiography) or with an ffr =0.80 * ability to provide written informed consent exclusion criteria: * emergent pci due to either hemodynamic instability, st-elevation myocardial infarction or sudden cardiac death * pci on chronic total occlusion * prior pci within 3 weeks * age \>90 years * left ventricular ejection fraction \<20% * need for mechanical circulatory support * pregnancy * prisoners * non-english speaking patients * inability to provide written informed consent
lapband adjustment to improve early weight loss

Conditions: Obesity

Summary: subjects having a gastric band fitted will have the first band adjustment done at surgery. the stoma will be set to 7mm using the endoflip system to measure stoma size. thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. it is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing gastric band surgery * over 18 years of age exclusion criteria: * actively bleeding varices

Keywords: gastric band lapband bariatric surgery
role of vitagliptin and vitamin d in the treatment of non alcoholic fatty liver disease (nafld)

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: sedentary lifestyle and poor dietary choices are leading to a weight gain epidemic and increasing the risk for developing nonalcoholic fatty liver disease (nafld). the strong relationship between insulin resistance and nafld suggests that adding vitamin d to insulin sensitizing therapies such as galvus (vitagliptin) might be beneficial in the prevention or improvement in nafld. considering the close relationship between nafld and t2dm and lipid metabolism, we assume that adding vitamin d to galvus, may be effective for nafld by improving lipid metabolism and by improving type 2 diabetes mellitus (t2dm).

sedentary lifestyle and poor dietary choices are leading to a weight gain epidemic and increasing the risk for developing nonalcoholic fatty liver disease (nafld). the strong relationship between insulin resistance and nafld suggests that adding vitamin d to insulin sensitizing therapies such as galvus (vitagliptin) might be beneficial in the prevention or improvement in nafld. considering the close relationship between nafld and t2dm and lipid metabolism, we assume that adding vitamin d to galvus may be effective for nafld by improving lipid metabolism and by improving t2dm. methods: 60 patients with nafld (diagnosed by ultrasound, increase alt level and hepatomegaly) will be enrolled, and divided into 2 arms galvus plus vitamin d vs. galvus alone. biochemistry, hepatic triglycerides, histology, m rna gene expression of collagen, mtp, srep-1, ppar-alpha, and ldlr will be measured. 2 separate liver biopsies will be performed at screening and 6 months from baseline. expected results: long-term combination therapy with vitagliptin and vitamin d significantly reduced steatosis, inflammation and fibrosis in the liver compared with long-term monotherapy. we expect also that the combination therapy also significantly increased the expression of microsomal triglyceride transfer protein (mtp) and peroxisome proliferators-activated receptor-α1 (ppar-α1) in the liver, compared with monotherapy, which may have lead to the improvement in lipid metabolic disorder . conclusion: combination therapy of vitagliptin and vitamin d, for 24 weeks improve the histopathology findings in nafld.

Eligibility criteria:
inclusion criteria: * 18-65 years old * men and women with nafld per us * increased alt level * hepatomegaly * liver biopsy within 2 years exclusion criteria: * other liver diseases (hbv, hcv) * hepatocellular carcinoma * decompensated liver disease * use of steroids

Keywords: nafld galvus vitamin d
albumin-bound paclitaxel combined with carboplatin as neoadjuvant chemotherapy in luminal b/her-2 negative breast cancer

Conditions: HER-2 Negative Breast Cancer

Summary: this is an open-label, single arm, two-stage simon design study for women with luminalb/her-2 negative breast cancer treated with nanoparticle albumin-bound paclitaxel and carboplatin. the primary objective of the trial is to evaluate of the efficacy and safety of nanoparticle albumin-bound paclitaxel combined with carboplatin as neoadjuvant chemotherapy in luminal b/her-2 negative breast cancer. the primary endpoint of the study is to assess pathological complete response rate（pcr）using the response evaluation criteria in solid tumors (recist 1.1). the total number of patients to be included in this study is 78 patients. the duration of the study, from first patient visit to last patient visit will be approximately 12 months.


Eligibility criteria:
inclusion criteria: * 1.age: from 18 to 70 years old, female. * 2.has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of t2-4nanym0. * 3.immunohistochemical detection of er+, pr+, her-2 negative (if her2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no her-2 gene amplification) and ki-67 expression \>20% of patients; * 4.at least one measurable objective lesion according to recist 1.1 criteria. * 5.ecog performance status of 0-1. * 6.bone marrow function: neutrophils ≥ 1.5×109/l, platelets ≥ 100×109/l, and hemoglobin ≥ 90 g/l. * 7.liver and renal function: serum creatinine ≤ 1.5 times the upper limit of normal. ast and alt ≤ 2.5 times the upper limit of normal total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with gilbert's syndrome. * 8.has good compliance with the planned treatment, understand the study process and sign written informed consent. exclusion criteria: * 1.any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy. * 2.patients with grade ii or higher heart disease scored by the new york heart association (nyha). * 3.severe systemic infection, or with other serious diseases. * 4.patients with known hypersensitivity or intolerance to chemotherapeutic agents or their excipients. * 5.other malignancies have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin carcinoma. * 6.pregnant or lactating, and who refuse to take appropriate contraception during the course of this trial. * 7.have participated in other study studies within 30 days prior to the first dose of study drug. * 8.patients who, in the opinion of the investigator, are not suitable for participation in the study.

Keywords: neoadjuvant chemotherapy
clinical study of in situ regeneration of endometrium

Conditions: Infertility, Female, of Uterine Origin; Endometrial Fibrosis

Summary: thin endometrium will lead to hypomenorrhea，infertility and recurrent pregnancy loss and there are few effective methods to increase the endometrial thickness and improve the fertility outcomes. patients with thin endometrium will be divided into three groups and receive estrogen therapy, stem cell therapy and growth factor therapy respectively. this randomized controlled clinical study is carried out to explore the optimal treatment method and best indications for thin endometrium.


Eligibility criteria:
inclusion criteria: 1.patients with thin endometrium (4mm≤ emt \<7mm )or scarred endometrium (scarred area≤70%) which is nonresponsive to estrogen stimulation 2.infertile patients with clear fertility desires 3.20-42 years old 4.normal ovarian function or with frozen embryos 5.willing to participate in follow-up exclusion criteria: 1. endometrial thickness \ 70% 2. uterine cavity out of shape and the cavity depth\<6.5mm 3. abnormal chromosome karyotype 4. uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis 5. systemic diseases: hypertension, diabetes, and so on 6. contraindications to pregnancy 7. contraindications to hormone replacement therapy 8. medical history of pelvic tumors or receiving pelvic radiotherapy 9 .involved in other clinical studies 10. unable to adhere to the follow-up

Keywords: thin endometrium infertility
global profiling of gene and protein expression associated with coronary heart disease reversal

Conditions: Heart Diseases; Cardiovascular Diseases

Summary: the purpose of this study is to characterize changes in gene and protein expression in peripheral blood in patients with, or at risk for, heart disease during an intensive lifestyle modification program.

this project will use an integrated approach that examines dna variation and the functional products of genes at both the messenger rna (mrna) and protein levels to provide a global view of molecular changes associated with drastic lifestyle modifications designed to reverse coronary heart disease (chd). dna variants and/or changes in gene and protein expression associated with chd reversal may provide important clues to understanding molecular mechanisms of subclinical chd development and progression.

Eligibility criteria:
inclusion criteria: * diagnosis of coronary artery disease (cad) * stable angina * angioplasty * evidence of \>50% luminal narrowing on coronary angiogram * acute myocardial infarction * bypass surgery * stent placement or * two or more cad risk factors * systolic pressure \>140 mm hg or diastolic pressure \>90 mm hg) * high total cholesterol (\>200 mg/dl) * physician diagnosed diabetes * body mass index (bmi) \>30 * family history of heart disease in parents or siblings * 21 years of age or older * mentally competent to provide informed consent exclusion criteria: * known history of autoimmune disease * systemic/chronic disease requiring chemotherapy or long term treatment

Keywords: heart diseases cardiovascular diseases lifestyle modification diet exercise
virtual reality and fear of falling in parkinson's disease

Conditions: Parkinson; Parkinson Disease; Parkinson's Disease and Parkinsonism

Summary: background: falls are common in elderly individuals and those with neurological conditions like parkinson's disease. parkinson's disease causes postural instability and mobility issues that lead to falls and reduced quality of life. the fear of falling (fof), a natural response to unstable balance, can exacerbate postural control problems. however, evaluating fof relies primarily on subjective self-reports due to a lack of objective assessment methods. objectives: this mixed-methods feasibility study aims to develop an objective method for assessing fear of falling during motion and walking using virtual reality. this protocol examines a range of fof-related responses, including cognitive, neuromuscular, and postural stability factors. methods: individuals without and with parkinson's disease will complete questionnaires, movement tasks, and walking assessments in real and virtual environments where fof can be elicited using virtual reality (vr) technology. data from center-of-pressure measurements, electromyography, heart rate monitoring, motion capture, and usability metrics will evaluate the method's acceptability and safety. semi-structured interviews will gather participants' and researchers' experiences of the protocol. discussion: this method may allow accurate assessment of how fof impacts movement by measuring cognitive, neuromuscular, and postural responses during gait and motion. virtual environments reproduce real-life scenarios that trigger fof. rigorously assessing fof with this approach could demonstrate its ability to quantify the effects of fof on movement. conclusions: this protocol aims to improve fof assessment by evaluating multiple responses during movement in virtual environments. it addresses current measures' limitations. a feasibility study will identify areas for improvement specific to parkinson's disease. successful validation could transform how fof is evaluated and managed.


Eligibility criteria:
inclusion criteria: * people ≥ 40 years old. * participants diagnosed with parkinson's disease by a neurologist, regardless the type. * modified hoehn and yahr stages i to iii. * able to follow instructions and understand questions. * able to walk independently and without walking aids. * people who experience excessive fear of falling and fear of movement. * able to communicate verbally. * stable use of parkinson's disease or other comorbidities medications. exclusion criteria: * impaired vision and hearing. * unstable medical condition. * co-existing neurological or orthopedic conditions that may limit mobility and affect participation. * dizziness, vertigo, headache, and motion-sickness. * cognition impairments. * pregnancy.
quality of life of patients with psoriasis treated with methotrexate: prospective, randomized, double-blind, parallel group study.

Conditions: Severe Plaque Type Psoriasis

Summary: methotrexate (mtx) is considered the 'gold-standard' drug for the treatment of severe psoriasis. health-related quality of life (hrqol) is impaired in patients with psoriasis, more so if disease is severe.


Eligibility criteria:
inclusion criteria: age range 18 to 65 years both sexes severe plaque-type psoriasis (bsa \>10% or pasi \>12) - exclusion criteria: pregnancy lactation malignancy or immunosuppression including hiv liver disease renal disease non compliant psychiatric illness hypersensitivity to methotrexate in the past -
korean obesity surgical treatment study

Conditions: Bariatric Surgery Candidate; Obesity, Morbid

Summary: this trial is a multi-center, single-arm, prospective, observational cohort study of patients undergoing primary bariatric surgical procedures in korea. a total of 100 patients will be recruited over a 1-year period from 2016 to 2017, and will be followed for a mean follow-up period of 1 year after surgery. the eligible subjects who have given their consent to participate will undergo one of two surgical procedures; sleeve gastrectomy and roux-en y gastric bypass. the primary objective of this clinical trial is to measure the changes in body weight (kg) and waist circumference (cm) of the enrolled patients at postoperative 1 year. secondary outcomes are improvement or remission rates of obesity-related co-morbidity (hypertension, type 2 diabetes, dyslipidemia, and sleep apnea), and the change in quality of life. additionally, postoperative incidences of morbidity and mortality, micronutrient status, body composition, and cost-effectiveness of surgical intervention will be examined.


Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) ≥ 35 kg/m2 or bmi ≥ 30 kg/m2 with co-morbidities such as hypertension, glucose intolerance, dyslipidemia, and sleep apnea 2. being suitable for general anesthesia 3. being able to give informed consent and committed to follow-up 4. female patients should have a negative urine pregnancy test at screening and agree to use reliable method of contraception for 1 year. exclusion criteria: 1. prior bariatric surgery of any kind 2. being unable to understand the risks, benefits and compliance requirements of this trial 3. pregnancy or planning on being pregnancy 4. non-korean speaker 5. american society of anesthesiology (asa) class iv or higher 6. malignancy within 5 years.

Keywords: primary bariatric surgery morbid obesity south korea sleeve gastrectomy roux-en y gastric bypass