Kornimate/medical-research-clean huggingface dataset:
hrct, ct cisternography and mr cisternography in assessment of csf rhinorrhea

Conditions: Imaging of Active CSF Rhinorrhea

Summary: to assess the diagnostic accuracy of combined high resolution ct, ct cisternography and mr cisternography in pre operative assessment of active csf leak, compared by endoscopic sinus surgery.

csf rhinorrhea is defined as passage of csf from the subarachnoid space through osseous and dural defect at skull base into the nasal cavity. causes of csf rhinorrhea are classified into traumatic (including iatrogenic) and non traumatic (including spontaneous leak). patients are presented by variable symptoms including clear nasal discharge, headache or with complications like meningitis or even brain abscess, so closure of the defect is of great importance with required accurate localization of the defect and its dimensions. csf rhinorrhea can be also classified into active when with active dripping or inactive when dripping is intermittent. different imaging modalities have been employed to localize and characterize skull base defects responsible for csf leakage including computed tomography (ct), ct cisternography (ctc), magnetic resonance imaging (mri), mr cisternography (mrc) and radionuclide cisternography (rnc). however, there is still no gold standard imaging modality. high resolution computed tomography (hrct) provides accurate bone details, but difficult to differentiate para nasal sinus secretions from csf leak. contrast enhancing ct cisternography has an advantage of definite proof of csf leak and definite anatomical localization of the bony defect, but side effects like headache and meningeal irritation may occur. magnetic resonance imaging (mri) with 3d- constructive interference in steady state (3d-ciss) (mr cisternography) instead of the invasive ct cisternography shows csf as a bright signal without intra thecal contrast injection. also mri provides intra cranial details, but it lacks of bony details. in the present prospective study, we will assess the use of hrct, ctc and mrc imaging modalities in definite diagnosis and localization of active csf leak.

Eligibility criteria:
inclusion criteria: * (1) patients with active traumatic or non traumatic csf leakage. * (2) patients with adequate organ function. exclusion criteria: * (1) patients known to have contrast hypersensitivity. (2) patients with any general contraindication to mri as presence of para magnetic substance as pacemakers or with claustrophobia. (3) patients with contraindication to lumbar puncture: * infection near the puncture site, fever, sepsis. * new focal neurological signs or seizures. * increased intra cranial tension. * space occupying lesion. * vertebral deformity, retropulsion, severe vertebral osteoarthritis or degenerative disc disease renders procedures more technically difficult. * coagulopathy. * patient refusal.
apatinib as the first-line therapy in elderly locally advanced or metastatic gastric cancer

Conditions: Gastric Cancer; Apatinib; Biomarker

Summary: the study is to investigate the efficacy and safety of apatinib for the first-fine treatment in elderly patients with locally advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction, unable or unwilling to chemotherapy, through progression-free survival (pfs). apatinib will be given to patients with an efficacy assessment of stable disease (sd), partial response (pr), or complete response (cr) every 2 cycles. patients were assigned to 500 mg/d apatinib continually until disease progression or intolerable toxicity or patients withdrawal of consent. the dose of apatinib may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (ae). treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg, and the sample size is about 30 individuals. tumor tissue samples will be collected from each enrolled subjects before the start of treatment, and detected using next generation sequencing (ngs)-based comprehensive genomic profiling. the potential biomarkers in predicting apatinib efficacy or safety will be explored.


Eligibility criteria:
inclusion criteria: 1. patients with histologically proven primary locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma; 2. age ≥ 65 years; 3. ecog performance status: 0-2; 4. no previous anti-cancer therapy for the locally advanced or metastatic disease; 5. unable or unwilling to chemotherapy; 6. at least one measurable lesion as defined by recist 1.1; 7. with acceptable hematologic, cardiac, hepatic, pulmonary and renal function; 8. can take apatinib orally; 9. life expectancy: 3 months or more. exclusion criteria: 1. history of other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ); 2. patients with un-controlled blood pressure on medication (\> 140/90 mmhg); 3. patients with other nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases; 4. patients with bleeding tendency, receiving thrombolytics or anticoagulants； 5. patients with massive hydrothorax or ascites; 6. patients with uncontrolled central nervous system (cns) metastases; 7. proteinuria 2+ or 24-hour urinary protein ≥ 1g; 8. history of drug addiction or abuse; 9. patients cannot take apatinib orally for any reason; 10. estimated life expectancy ˂ 3 months; 11. current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials; 12. inability to understand and agree to informed consent.
comparison between endogenous and exogenous ketosis in patients with non-ischemic chronic heart failure with reduced ejection fraction

Conditions: Heart Failure With Reduced Ejection Fraction; Ketosis

Summary: this randomized controlled trial will evaluate the effect of a ketogenic diet and/or exogenous administration of ketone bodies vs conventional diet on the ejection fraction of patients with non-ischemic chronic heart failure, measuring mri biomarkers.

evidence in both animals and humans suggests ketosis could be beneficial for people living with chronic heart failure. to date, no study has compared endogenous vs exogenous ketosis in patients with chronic heart failure. we will randomize (with a 1:1:1 ratio) patients with a confirmed diagnosis of non-ischemic chronic heart failure to undergo one of the following: 1. - a ketogenic diet (\<50 gr of carbohydrates per day) incorporating current recommendations for heart failure (low sodium and liquids) for 10 days. 2. - standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with exogenous ketones (ketone monoester) for 10 days. 3. - standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with bitter taste placebo. the endpoints will be assessed using cardiac mri and blood biomarkers.

Eligibility criteria:
inclusion criteria: * ejection fraction \<40% minimum 1 month. * no change in optimum treatment 1 month at least. exclusion criteria: * ischemic cardiopathy (angio-tomography corroborated cut-point \>50% obstruction, coronary angiography, or cardiac scintigraphy 6 months at least) or angina pectoris symptoms. * reynaud syndrome * metformin or sglt-2 inhibitors treatment, low bmi, nutritional deficiencies. * creatinin clearance \<30ml/min or renal replacement therapy * mri contraindications (prothesis, unsupported pacemakers, claustrophobia, etc) * reynaud phenomenon history

Keywords: endogenous ketosis exogenous ketosis heart failure
osteopathy on ibs symptoms in patients with ulcerative colitis in remission

Conditions: Irritable Bowel Syndrome; Ulcerative Colitis

Summary: type : interventional, randomized single blind study aim : to evaluate 3 sessions of osteopathy on ibs-like symptoms associated with ulcerative colitis in remission number of patients : 50 (randomization 1:1) duration of the inclusion period : 2 years primary end-point : irritable bowel syndrome severity scoring system (ibs sss) at 3 months

osteopathy has been shown to be effective in ibs patients in few studies and to improve ibs-like symptoms in a short series of crohn patients. ibs-like symptoms are frequent in patients with ulcerative colitis in remission (about 20 %). the aim of this interventional, randomized single blind study is to evaluate the impact of 3 sessions of osteopathy on irritable bowel syndrome symptoms in 50 patients (randomisation 1:1) with ulcerative colitis in remission (defined by fecal calprotectin \< 200 µg/g). the two group of patients will have 4 sessions of osteopathy (m0, m1, m2, m3). the "treated group" will have 3 sessions of osteopathy testing followed by osteopathy treatment (m0, m1, m2) and a final testing session at m3. the "untreated group" will have 4 sessions of only testing osteopathy (m0, m1, m2, m3). primary end-points : irritable bowel syndrome severity scoring system (ibs sss) at 3 months (m3) secondary end-points : inflammatory bowel disease questionnaire ol, functional assessment of chronic illness therapy-fatigue at m3, evaluation of osteopathic dysfunctions between m0 and m3, questionnaire for use of medication for ibs between m0 and m3

Eligibility criteria:
inclusion criteria: * signed informed consent * age between 18 and 90 * patient with ulcerative colitis (whatever the montreal grade, e1, e2 or e3) in clinical remission for at least 3 months and with fecal calprotectin \< 200 µg/g * no modification of ulcerative colitis treatment for at least 3 months * patient with ibs-liked symptoms defined as in rome iv classification for irritable bowel syndrome * patient with irritable bowel syndrome severity scoring system \> 75 at screening * patient affiliated to the french social security regimen exclusion criteria: * patient refusal * patient \< 18 yoa * patient with colonic or ileal stenosis * patient diagnosed as undetermined colitis * patient not in remission for ulcerative colitis as defined by an endoscopic mayo score \> 1 within the 3 months preceding the inclusion and/or fecal calprotectin \> 200 µg/g at inclusion * osteopathy session(s) within 1 month before inclusion * patient with inflammatory rheumatic disorders (ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis) * patient with irritable bowel syndrome severity scoring system \<75 at screening * patient above 18 yoa with law guardianship
study on the correlation between tcm syndrome, inflammatory phenotype and biomarker of bronchial asthma

Conditions: Bronchial Asthma

Summary: this study aims to determine the tcm syndrome pattern and the distribution of inflammation phenotype in different stages of bronchial asthma; to explore the correlation between tcm syndrome and inflammation phenotype. secondly screening biomarkers that can be recognized by tcm syndromes and inflammatory phenotypes of bronchial asthma, and provide a basis for individualized diagnosis and treatment of diseases.

the clinical heterogeneity of bronchial asthma was strong.the tcm syndrome was complicated and mostly treated on stage, type, excess and deficiency.the phenotype was numerous and more classified from inflammation type, clinical classification, internal phenotype, etc.the flammatory phenotype was the more common type.the pathological basis of asthma was closely related to the infiltration of inflammatory mediators such as airway eosinophil cells, so it was important to find the specific biomarker. the correlation between tcm syndrome, inflammatory phenotype and its biomarker wsa not clear. so we put forward theoretical hypothesis:there was of correlation between tcm syndrome and inflammatory phenotype of asthma.the biological target was contributes to the confirmation for tcm syndrome and inflammatory phenotype.the following research was planned to be carried out: relying on the registration system of national tcm clinical research base to enroll in 900 cases patients in the acute and remission period of asthma and healthy physical examination crowd, filling in the patient's general demographic data, disease status, lung function, tcm syndrome and score and collecting the sputum, exhaled gas, urine, peripheral venous serum specimens and biomarker to be tested on the same day. based on the clinical research database, confirming syndrome and in phenotype, clarifying the correlation between syndrome and phenotype and selecting identifiable biomarker by using correlation analysis, principal component analysis, multiple regression analysis, neural network analysis and other methods.the research provided evidence for the study of the essence of syndrome and phenotype and provided evidence for individualized diagnosis and treatment of diseases.

Eligibility criteria:
inclusion criteria: 1. patients with definite dignosis of bronchial asthma or healthy volunteer; 2. ages range from 18 years to 80 years old; 3. not anticipated in other clinical studies within 1 month before enrollment; 4. signed informed consent. exclusion criteria: 1. acute asthma exacerbation patients with respiratory failure, mechanical ventilation; 2. patients with unconsciousness, dementia, various mental disorders; 3. complicated with hematological malignancies , heart failure(acute myocardial infarction, cardiac function grade 3 or above), severe liver or kidney diseases; 4. complicated with neuromuscular disorders affecting respiratory and motor function, unable to complete the six-minute walk test; 5. people who are participating in other clinical trials.

Keywords: bronchial asthma tcm syndrome inflammation phenotype biomarker
laparoscopic anterior resection with or without "dog ear" double-stapled anastomosis for rectal cancer

Conditions: Rectal Carcinoma; Laparoscopy; Anastomotic Leak

Summary: the study evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior resection.

laparoscopic surgeons commonly make rectal transection intracorporeally by laparoscopic linear stapler during rectal anterior resection and perform an end-to-end anastomosis by circular stapler. but the so-called 'dog ears', two stapled corners of the rectal stump after laparoscopic linear transection of rectum, are very common. the lateral intersections of double-stapled anastomoses are structural weak spot area, and they are considered to be the potential ischemic areas leading to anastomosis leakage and the possible sites occurring local recurrence. previous study reported a modified technique for rectal reconstruction during open surgery, and they could use circular stapler to eliminate the staple line on the rectal stump and cut off the 'dog ears'. but because of the narrow pelvic cavity, it is very difficult to perform this technique in laparoscopic rectal surgery and there is no related report on laparoscopic application. in this study, we evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique, to eliminate the "dog ears" in laparoscopic rectal anterior resection by laparoscopic suturing on the staple line.

Eligibility criteria:
inclusion criteria: * eligibility rule of enrollment * rectal adenocarcinoma above the peritoneal reflection * at least 18 years old \& at most 80 years old * clinically diagnosed ct1-t4an0-2 disease * no contraindication to laparoscopic surgery * without other malignancies in medical history exclusion criteria: * concurrent or previous diagnosis of invasive cancer within 5 years * locally advanced cancers requiring en bloc multivisceral resection * intestinal obstruction * intestinal perforation * american society of anesthesiologists(asa) class 4 or 5 * pregnant or breast-feeding women * history of mental disorder * participation in another rectal cancer clinical trial relating to surgical technique

Keywords: rectal carcinoma laparoscopy anastomotic leak double-stapling technique
watching live via/vili examinations on a digital screen may reduce patients' anxiety

Conditions: Cervical Cancer; Anxiety

Summary: the purpose of this study is to assess whether the degree of anxiety experienced by women undergoing visual inspection with acetic acid (via) and lugol's iodine (vili) can be reduced by watching the procedure in real-time on a digital screen.

the study took place in the district of dschang, cameroon. women aged between 30 and 49 years, addressed to undergo a pelvic examination with via and vili, were invited to participate. throughout the examination, one part of the women underwent the routine via/vili, with no visual support (control group), whereas the other part of patients were shown the pictures of the cervix in real-time on a digital screen (study group). at the end of the procedure, all women had the possibility to see the pictures retrospectively. randomization determined the women's distribution between the two groups. their anxiety level was measured by asking them to complete the spielberg's state anxiety inventory (stai) both prior to and immediately after the procedure.

Eligibility criteria:
inclusion criteria: * women participating in a cervical cancer screening campaign organized by the district hospital of dschang * women understanding the study procedure and accepting voluntarily to participate by signing an informed consent form (icf). exclusion criteria: * women not able to comply with the study protocol.
purified anthocyanins supplementation in type 2 diabetes mellitus

Conditions: Diabetes Mellitus，Type 2

Summary: anthocyanins, the water-soluble compounds that make plants appear different colors, have been shown to prevent insulin resistance, reduce the blood glucose and oxidative stress in rodents. the purpose of our study is to evaluate a potential protective effect of purified anthocyanins supplement on type 2 diabetes mellitus patients.

the study was designed as a randomized, double-blind label, interventional study on patients with t2dm. the eligible participants are randomly assigned to control and anthocyanins supplement group. during the 12 weeks trial period,the participants were instructed to consume two anthocyanin capsules or placebo capsules twice daily (30 min after breakfast and supper).

Eligibility criteria:
inclusion criteria: * subject is diagnosed with type 2 diabetes mellitus according to the chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows:(1) diabetes symptoms (polydipsia, polyphagia, polyuria, weight loss, skin itching, blurred vision and other acute metabolic network disorder that caused by high blood sugar)combined with random blood sugar ≥11.1 or,(2)fasting plasma glucose(fpg)≥7.0 or (3)2h blood sugar after oral glucose tolerance test(ogtt)≥ 11.1 * subject is between 25 and 75 years of age, inclusive. * subject bmi is ≥18.5 kg/m2 and ≤35 kg/m2 exclusion criteria: * subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2. * subject that use exogenous insulin for glucose control. * subject that has a history of diabetic ketoacidosis. * subject that has coronary artery disease, mental disorder, cancer, cirrhosis, renal disease and hepatic disease. * subject that has had operation less than six months prior to screening visit. * subject that uses supplementation with vitamins or antioxidants.
the role of long non-coding rnas wrap53 and uca-1 as potential biomarkers in diagnosis of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Liver Cirrhosis; Diagnoses Disease

Summary: the aim of this work is to study the role of long non-coding rnas wrap53 and urothelial carcinoma-associated 1 (uca1) as potential biomarkers in diagnosis of hepatocellular carcinoma.

sample size calculation was done in department of medical statistics, medical research institute, alexandria university and the total minimal sample size was calculated. a prospective case control study will be conducted on 80 subjects divided into three groups: group (1): thirty patients having liver cirrhosis and hepatocellular carcinoma diagnosed by tripahsic ct. group (2): thirty liver cirrhosis patients without hepatocellular carcinoma diagnosed by abdominal ultrasound examination. group (3): twenty normal subjects (control group) matching in age and sex with patients in groups 1 and 2. patients will be recruited from the outpatient clinics and inpatient wards of alexandria main university hospital and medical research institute hospital. full informed consent will be taken from the patients and approval of the ethical committee of the faculty of medicine will be fulfilled. exclusion criteria: patients with any inflammatory diseases or other malignancies.

Eligibility criteria:
inclusion criteria: * any subject without any of the exclusion criteria exclusion criteria: * patients with any inflammatory diseases or other malignancies.

Keywords: hcc, liver cirrhosis, uca-1, wrap53
eleven years of menicon z night contact lens wear in reducing myopia progression in children

Conditions: Myopia, Progressive; Children, Only

Summary: to compare axial length growth of white european myopic children wearing menicon z night orthokeratology contact lenses to a control group of distance, single-vision glasses and contact lenses over an 11-year period.

this prospective, controlled, parallel, longitudinal study compared the axial length growth of white european myopic children wearing menicon z night orthokeratology contact lenses to a control group of distance, single-vision glasses and or distance, single-vision soft contact lenses over an 11-year period.

Eligibility criteria:
inclusion criteria: * be 6 to 12 years of age, both ages inclusive * a low-to-moderate level of myopia (between 0.75 and 4.00 d) and of astigmatism (≤ 1.00 d) * neophyte contact lens wearer * be successfully fitted with spectacles or orthokeratology contact lenses * be able to achieve, through spherical refraction correction, a logmar visual acuity of 0.8 or better in each eye * be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits * white european ethnicity exclusion criteria: * systemic or ocular disease affecting ocular health * use of any systemic or topical medications that could affect ocular physiology or contact lens performance * any lid or anterior segment abnormalities for which contact lens wear could be contraindicated * cclru grade ≥ 2 for any given anterior segment ocular clinical signs * aphakic, amblyopic, and atopic individuals * refractive astigmatism ≥ ½ spherical refraction * previous contact lens wear