Kornimate/medical-research-clean huggingface dataset:
hepatocellular carcinoma 3 gene methylation combination detection kit (pcr fluorescent probe method) multicenter clinical trial

Conditions: Hepatocellular Carcinoma (HCC)

Summary: the purpose of this clinical trial was to systematically study the clinical performance and accuracy of the human dab2ip, chfr and grasp gene methylation combined test kit (pcr-fluorescent probe method) produced by jiangsu kunyuan biotechnology co., ltd. the test reagent was compared with the clinical reference standard (pathological diagnosis and/or imaging diagnosis) to verify the clinical performance of the product. at the same time, for each gene that can be detected by the assessment reagent, the digital pcr method is used as a comparison method to verify the accuracy of the assessment reagent detection. the validity of the assessment reagent can meet the requirements of its intended use from the above two aspects, and provide sufficient clinical evaluation data for the registration and application of the product in china.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older, gender unlimited; 2. subjects for whom sufficient blood samples can be obtained (whole blood volume not less than 10 ml); 3. subjects who meet one of the following conditions: (i) initial treatment subjects with symptoms and/or signs suspected of hepatocellular carcinoma as determined by the clinician; people with hbv or hcv infection, excessive alcohol consumption, non-alcoholic steatohepatitis, cirrhosis of the liver from other causes (lc), benign hepatopathy (bhl), and a family history of liver cancer; iii subjects with other tumors, including but not limited to esophageal, stomach, colorectal, pancreatic, lung, breast, prostate, etc.; 4. voluntarily participate in the experiment and sign the informed consent. exclusion criteria: 1. liver cancer subjects who have received previous treatment, such as radiotherapy and chemotherapy, surgery, etc.; 2. subjects with other malignant tumors; 3. subjects with recurrent liver cancer confirmed or suspected by the investigator; 4. subjects whose information is missing or untraceable; 5. the researcher believes that the subjects should not be included in this study for other reasons.

Keywords: hepatocellular carcinoma hbv or hcv infection nonalcoholic steatohepatitis liver cirrhosis benign hepatopathy family history of liver cancer
eye movements recording using a smartphone: comparison to standard video-oculography in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study aims to compare measurements obtained through the e-vog application (mobile application, usable on mobile phones or tablets, to measure eye movements) with measurements from the standard video-oculography device (eye-tracker®t2), in patient with multiple sclerosis.

based on literature, investigators hypothesize that it would be relevant to focus more broadly on subclinical abnormalities of oculomotricity in multiple sclerosis (ms). however, the difficulty of accessing video-oculography platforms (or eye-tracking devices) is probably one of the main limitations to performing this type of assessment. to respond this problem, the "resources and skills center-multiple sclerosis" (crc sep) team at the nice university hospital center (france) has developed a mobile application (named e-vog), usable on mobile phones or tablets, to measure eye movements. e-vog reproduces the classic paradigms of video-oculography to collect data similar to standard video-oculography recording (saccade latency and speed, anti-saccade error rate, presence of fixation abnormalities). e-vog will not replace standard video-oculography platforms, because its technical characteristics are not as high. but investigators hypothesize that this application could constitute a screening tool for subclinical oculomotor abnormalities, usable by neurologists in consultation, directly on their mobile, which would make it possible to select a smaller population of patients in whom a further exploration by standard video-oculography would be indicated. memory center of the rainier iii gerontologic center (princess grace hospital - monaco) is equipped with a standard video-oculography device, also named eye-tracking device (eye-tracker®t2), which records eye movements at a high frequency and measures saccades parameters (latency, speed, amplitudes etc...). this study is a collaborative study between the center rainier iii team and the crc sep team in nice. its objective will be to compare measurements obtained through the e-vog application with measurements from the standard video-oculography device.

Eligibility criteria:
inclusion criteria: * male or female. * 18 years old and above. * referred by a neurologist to perform a video-oculography (eye-tracking) examination as part of routine care. * with multiple sclerosis (defined according to mcdonald's 2017 criteria). * covered by a health insurance system * volunteer, able to give free, informed and written consent. exclusion criteria: * general anaesthesia within 3 months. * neurological, ophthalmological or general pathology preventing the realization of a video-oculography examination. * oculomotor abnormality detectable on clinical examination by the neurologist prescribing the standard video-oculography examination.

Keywords: demyelinating disease multiple sclerosis video-oculography eye-tracking eye movements subclinical oculomotor abnormalities oculomotor disorders
late biomarkers in adult survivors after out-of-hospital cardiac arrest

Conditions: Cardiac Arrest, Out-Of-Hospital

Summary: blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. plasma, serum and pax-rna will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.

blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. plasma, serum and pax-rna will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion. samples will be analysed in batch for biomarkers of brain injury, inflammation etc. primary outcome is functional outcome (modified rankin scale 4-6) at six months after cardiac arrest. secondary outcomes are neurocognitive function according to the montreal cognitive assessment (moca), symbol digits modalities test (sdmt).

Eligibility criteria:
inclusion criteria: * survivors of out-of-cardiac arrest who participate in the extended follow-up study of the stepcare trial at selected sites only exclusion criteria: * patients not participating in the extended follow-up at participating sites

Keywords: biomarkers brain injury inflammation dementia
testing a ptsd m-health intervention to improve alcohol treatment outcomes

Conditions: Posttraumatic Stress Disorder; Alcohol Use Disorder

Summary: the purpose of this study is to learn whether a mobile health application (mhealth app) for posttraumatic stress disorder (ptsd) with brief support can help individuals who are in treatment for alcohol problems.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years old * currently in addictions treatment * meet criteria for a current diagnostic and statistical manual of mental disorders-5 (dsm-5) aud diagnosis * a score of 33 or greater on the ptsd checklist (pcl-5) * own a smart phone or other type of wi-fi-enabled device with app capabilities exclusion criteria: * injection drug use in the past year * patients who are unable to speak and/or understand english * patients who are currently engaged in specific therapy for ptsd (prolonged exposure therapy, cognitive reprocessing therapy, emdr)
the optimal dose of indomethacin suppository for preventing post-ercp pancreatitis

Conditions: Pancreatitis; Cholangiopancreatography, Endoscopic Retrograde; Indomethacin

Summary: this study is a single-center, randomized, single-blind, parallel controlled clinical study to explore the optimal dose of postoperative indomethacin suppository for the prevention of post-ercp pancreatitis. the purpose of this study is to explore the optimal dosage of indomethacin suppository for pep prevention, to study the control effect of indomethacin on hyperamylaseemia, and to further explore the group of patients who benefit most from this therapy.

this is a single-centre, randomized, single-blind, parallel-controlled designed clinical study to explore the optimal dose of postoperative indomethacin suppository for the prevention of post-ercp pancreatitis. the study will enroll 192 patients who undergo ercp in the department of gastroenterology of the first affiliated hospital of soochow university from november 2022 to october 2023, and they will be randomly assigned to 3 groups of 64 each according to the date of surgery and hospitalisation number in a random number list formed by spss software.

Eligibility criteria:
inclusion criteria: * according to the "chinese ercp guidelines (2018 edition)", patients with various biliary and pancreatic diseases who have indications for ercp examination and treatment, who are at least 18 years old and have no contraindications, and who can tolerate the examination; * preoperative blood coagulation function, liver and kidney function indicators are in the normal range; * the patients agreed to participate in this experiment, signed the informed consent form, and was approved by the hospital ethics committee. exclusion criteria: * contraindications to indomethacin and other nsaids: such as allergy to indomethacin, severe heart failure, active peptic ulcer/bleeding, perioperative period of coronary artery bypass surgery, etc.; * there are severe cardiovascular and cerebrovascular diseases, respiratory insufficiency and coagulation dysfunction, etc., and cannot tolerate ercp examination; * those who have recently used indomethacin and other non-steroidal anti-infective drugs; * pregnant or lactating women.

Keywords: indomethacin suppository post-ercp pancreatitis
assessment of the role of probiotics in prevention of ventilator-associated pneumonia in neonates

Conditions: Ventilator Acquired Pneumonia

Summary: evaluate the preventive value of probiotics on vap among ventilated neonates.

mv is a critical component of neonatal intensive care, providing essential respiratory support for neonates with severe respiratory distress. however, its use is associated with an increased risk of vap, a serious nosocomial lung infection. vap is defined as a pneumonia diagnosed in patients undergoing mv for at least 48 hours and is recognized as the second most common nosocomial infection in neonatal and pediatric intensive care units. its incidence ranges from 1 to 63 episodes per 1,000 ventilation days, with variability influenced by the socioeconomic and healthcare development of different regions.given the complex pathophysiology of vap, numerous prevention strategies have been proposed for nicus.among these strategies, probiotics have emerged.

Eligibility criteria:
inclusion criteria: * all term neonates who required mechanical ventilation with ett for more than 48 hours. exclusion criteria: 1. early-onset neonatal sepsis 2. pre-existing pneumonia 3. a patient who was unfit for enteral intake. 4. prematurity \<37 gestational weeks. 5. surgical causes of mechanical ventilation 6. multiple congenital anomalies and suspected chromosomal anomalies.

Keywords: vap, nicu
an explorative trial to evaluate the pharmacodynamic effect of spd557 on reflux parameters in refractory gerd patients

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters of spd557 tablets (0.5 mg t.i.d., on top of ppi treatment) in patients with gastroesophageal reflux disease (gerd) with persistent symptoms despite taking a stable dose of proton pump inhibitors. additionally the effect on symptoms will be explored and safety and tolerability will be evaluated.


Eligibility criteria:
inclusion criteria: 1. written icf signed voluntarily before the first trial related activity. 2. subjects with a history of gerd symptoms (i.e., heartburn and/or regurgitation) during the last 6 months 3. subjects on a stable dose of ppis, compliant for at least 6 weeks prior to screening. 4. ≥3 days per week with heartburn and/or regurgitation symptoms of at least moderate severity and a minimum of 25 liquid containing reflux events over 24h (ph/mii monitoring). exclusion criteria: 1. subjects with prior endoscopic anti-reflux procedure or major gi surgery or subjects with major gi disorders. 2. presence of severe and clinically uncontrolled cardiovascular, liver or lung disease, neurologic, cancer or aids. 3. alarm symptoms suggestive of malignancies or organic disease.

Keywords: gerd gastroesophageal reflux disease spd557 proton pump inhibitors
tolcapone treatment of pathological gambling

Conditions: Pathological Gambling

Summary: the goal of the proposed study is to evaluate the efficacy and safety of tolcapone in pathological gambling.

the proposed study will consist of 8 weeks of treatment with tolcapone in 10 subjects with pathological gambling. the hypothesis to be tested is that tolcapone will be effective in reducing the urges to gamble in patients with pathological gambling. the proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility criteria:
inclusion criteria: 1. men and women age 21-75; 2. meet diagnostic criteria for current pathological gambling based on dsm-iv criteria and confirmed using the clinician-administered structured clinical interview for pathological gambling (sci-pg) (grant et al., 2004); 3. gambling behavior within 2 weeks prior to enrollment; 4. women of child bearing age are required to have a negative result on a beta-human chorionic gonadotropin pregnancy test; 5. women of childbearing potential utilizing a medically accepted form of contraception defined as double barrier, oral contraceptive, injectable contraceptive, implantable contraceptive devices, and abstinence. exclusion criteria: 1. infrequent gambling (i.e. less than one time per week) that does not meet dsm-iv criteria for pg; 2. unstable medical illness or clinically significant abnormalities on laboratory tests, ekg, or physical examination at screen as determined by the investigator; 3. history of elevated liver enzymes (ast/alt) or other liver abnormalities; 4. history of seizures; 5. myocardial infarction within 6 months; 6. current pregnancy or lactation, or inadequate contraception in women of childbearing potential; 7. a need for medication other than tolcapone with possible psychotropic effects or unfavorable interactions as determined by the investigator; 8. clinically significant suicidality (defined as score 2 or higher on ham-d item 3); 9. current co-morbid axis i disorder determined by the structured clinical interview for dsm-iv (scid), (first et al., 1995) - except for nicotine dependence; 10. lifetime history of bipolar disorder type i or ii, schizophrenia, or any psychotic disorder determined by scid; 11. clinically significant cognitive impairment (defined as score less than 88 on 3ms); 12. current or recent (past 3 months) dsm-iv substance abuse or dependence; 13. positive urine drug screen at screening; 14. initiation of psychotherapy or behavior therapy for pathological gambling within 3 months prior to study baseline; 15. previous treatment with tolcapone; 16. treatment with an investigational medication or depot neuroleptics within 3 months; 17. refusal to sign the tolcapone information sheet.

Keywords: gambling addiction
mri detection of microbleeds in glioma patients

Conditions: Glioblastoma

Summary: systematic retrospective medical chart and medical imaging file review of all patients receiving brain mri for the follow-up of glioblastoma.


Eligibility criteria:
inclusion criteria: * adult patients * diagnosed with brain glioblastoma * receiving treatment with cranial radiotherapy and/or chemotherapy * having at least one follow-up mri conducted that used a susceptibility weighted imaging sequence exclusion criteria: * underage * absence of formal diagnosis of glioblastoma * no available medical imaging file with mri susceptibility weighted imaging sequence
validation of automated cardiac output measurement

Conditions: Cardiac Output, Low; Surgery

Summary: automated software analysis now allows for quick estimation of cardiac output from the echocardiographic 5-chamber view. this study will validate the automated software method against pulmonary artery thermodilution and against conventional cardiac output measurement with echocardiography.


Eligibility criteria:
inclusion criteria: * postoperative cardiac surgery patient * pulmonary artery catheter in situ * extubated exclusion criteria: * no echocardiographic image available * no consent * moderat-severe aortic insufficiency * moderat-severe tricuspid insufficiency * moderat-severe mitral valve insuffficiency * arythmia intracardiac shunt moderat-severe hemodynamic instability
efficacy and safety of telitacicept for prevention of flares in sle patients

Conditions: Systemic Lupus Erythematosus

Summary: this study is a randomized, double-blind, placebo-controlled single-center clinical trial. the aim of this study is to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in sle patients with low disease activity.

background: there are still two major problems in the treatment of sle: flare and long-term organ damage. bliss-52 showed there was some reduction of flare (80% vs 71%) in belimumab , but the difference was not significant. another study tested the efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe sle in which analysis of atacicept 150 mg suggested benefit. telitacicept , a baff/april dual-target-inhibitor, which has been proved to be effective in treatment of sle. but there is no study to show its effectiveness for prevention of flares in sle patients with low disease activity. in this study, we take telitacicept as maintain treatment in stable sle patients to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in sle patients with low disease activity.

Eligibility criteria:
inclusion criteria: 1. age 18-70 years; 2. sle patients with low disease activity (selena-sledai score\< 8 at screening ); disease duration more than 3 months；no british isles lupus assessment group (bilag) a and no more than one b; 3. a stable treatment regimen with fixed doses of prednisone (≤ 30mg/day), antimalarial, or immunosuppressive drugs (mycophenolate mofetil/azathioprine/ciclosporin /tacrolimus/methotrexate/leflunomide) for at least 3 months; 4. sign the informed consent. exclusion criteria: 1. hepatic or renal dysfunction: alanine aminotransferase (alt)/ aspartate aminotransferase (ast) \> 2 times upper normal limits; gfr \< 60ml/min; 2. exposure to cyclophosphamide within past 6 months before screening; 3. exposure to any b cell targeted therapy (rituximab/belimumab/telitacicept) within past 6 months before screening; 4. pregnant women, lactating women; 5. history of malignancy within the last 5 years, excluding adequately treated skin tumors (basal cell or squamous cell carcinoma) or carcinoma in situ of cervix; 6. active hepatitis or a history of severe liver disease; 7. current infections (hiv/tuberculosis/covid-19, etc.) at screening; 8. a significant decrease in immunoglobulin level, igg\<5g/l; 9. not suitable for the study in the opinion of the investigator.
incidence of poorly controlled diabetes in surgical population

Conditions: Diabetes Mellitus

Summary: our study aims to determine the incidence of undiagnosed and poorly controlled diabetes among surgical patients in singapore using preoperative hba1c as a screening tool.

the study aims to determine the incidence of undiagnosed and poorly controlled diabetes among surgical patients in singapore using preoperative hba1c as a screening tool. the investigators aim to follow up on the incidence of perioperative complications in this cohort. in the longer term, the investigators hope to evaluate the role of a preoperative diabetic screening and intervention program as an opportunistic "teachable moment" for surgical patients. this may help to achieve greater control of the disease burden in singapore. specific aims: specific aim 1: to establish the incidence of undiagnosed diabetes/prediabetes among surgical patients in singapore, based on hba1c level ≥ 6.1% prior to surgery specific aim 2: to establish the incidence of poorly-controlled diabetes among surgical patients in singapore, based on hba1c level ≥ 8% prior to surgery specific aim 3: to identify and characterize any association between preoperative hba1c level and postoperative outcomes

Eligibility criteria:
inclusion criteria: 1. age \>21 years old 2. able to give informed consent 3. scheduled to have preoperative blood taken during clinic visit exclusion criteria: 1. age \< 21 years old 2. unable to given informed consent 3. not required to have routine preoperative blood tests taken

Keywords: incidence of diabetes mellitus hba1c
effect of rosuvastatin on function of high density lipoprotein cholesterol in type 2 diabetes

Conditions: Diabetes

Summary: the patients who have achieved ldl-c levels below the currently recommended targets may still experience cardiovascular events. to reduce further the risk of coronary heart disease (chd), raising hdl-c and lowering tg may be the secondary therapeutic target. however, increased hdl-c levels do not mean increase in functional hdl-c. it also remains controversial whether functional hdl is more important than total circulating levels of hdl-c in reducing chd. actually, the increased concentration of hdl alone might be ineffective indicating that qualitative changes in hdl levels in response to drug interventions are required to result in clinical benefit. the investigators set up a clinical trial investigating effect of (rosuva)statin treatment on functional hdl-c levels particularly in asian populations, who have relatively low hdl-c.

1. study design study subject number of subjects (n = 30) 2. study outcome primary outcome - functional hdl-c secondary outcome - non-hdl cholesterol 3. evaluation of functional aspect of hdl cholesterol efflux from macrophages ldl-induced monocyte chemotactic activity (mca) assay quantitation of gene expression of monocyte chemotactic protein-1 (mcp-1)

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes 2. hba1c ≥ 7.5% 3. age ≥ 30 4. low hdl-c (\<40 mg/dl in men or \<50 mg/dl in women) and having 1 or more risk factors: 1) body mass index (bmi) ≥ 25 kg/m2 (overweight); 2) ldl-c level ≥ 130 mg/dl; 3) tg level ≥150 mg/dl; 4) systolic blood pressure (sbp)/diastolic blood pressure (dbp) ≥140/90 mmhg or taking antihypertensive medication; 5) current smoker; 6) family history of chd. exclusion criteria: 1. contraindication to rosuvastatin 2. pregnant or breast feeding women 3. reproductive-age women who refuse contraception 4. type 1 diabetes, gestational diabetes, or diabetes with secondary cause 5. chronic hepatitis b or c (except healthy carrier of hbv), liver disease (ast/alt \> 3-fold the upper limit of normal) 6. renal failure (cr \> 2.0) 7. cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) 8. not appropriate for lipid lowering treatment 9. medications which affect glycemic control 10. diseases which affect efficacy and safety of statin 11. other clinical trial within 30 days

Keywords: diabetes dyslipidemia hdl function cholesterol efflux mca assay mcp-1