Kornimate/medical-research-clean huggingface dataset:
clinical study of lewis antigen assay combined with ca19-9 assay to assess prognosis in patients with pancreatic cancer

Conditions: PDAC

Summary: ca19-9 is an acidic glycoside containing sialic acid, called ganglioside. lewis blood group antigen is the precursor for the synthesis of ca19-9, which is formed by the combined action of sialic acid transferase and fucosyltransferase (fut3). the ability to produce soluble blood group substances is determined by the alpha (1,2) fucosyltransferase gene (fut2), which can be divided into secretory se, weakly secretory sew, and non secretory se. the lewis antigen positive (lewis+) population has normal ca19-9 secretion function, while the lewis antigen negative (lewis -) population (about 7%) usually shows no or low secretion of ca19-9. therefore, when ca19-9 is used as a biomarker, the combined detection of lewis antigen status is a marker to judge the prognosis of pancreatic cancer, which can divide pancreatic cancer patients into high/medium/low malignant phenotypes.

1. this study adopts a prospective, multicenter design, and classifies pancreatic cancer patients and predicts their prognosis through lewis antigen detection and ca19-9 detection. 2. observe the survival time of pancreatic cancer subjects to observe the consistency between lewis typing and prognosis, and evaluate the sensitivity of lewis antigen detection. 3. evaluate the specificity of lewis antigen detection by observing the distribution of lewis subtypes in non pancreatic cancer subjects. 4. explore the prognostic distribution of age, different lewis subtypes, and overall survival cycle for lewis antigen detection.

Eligibility criteria:
inclusion criteria: 1. voluntarily enrolled, regardless of gender, aged ≥ 18 and ≤ 75 years old, and the patient can understand and is willing to sign an informed consent form; 2. ecog 0-2 3. pathologically confirmed as pancreatic ductal adenocarcinoma; or confirmed by pathology and clinical examination as pancreatic ductal adenocarcinoma. 4. willing to accept routine ca19-9 testing, lewis antigen sample collection and testing (2-3ml), and follow-up non pancreatic cancer subjects enrolled in this study must meet all the following criteria 1. voluntary enrollment, regardless of gender, age ≥ 18 years, ≤ 75 years old, and the patient can understand and is willing to sign an informed consent form 2. willing to accept lewis antigen sample collection and testing (2-3ml) exclusion criteria: 1. suffering from the second or double primary malignant tumor besides pancreatic cancer at the same time 2. patients with pancreatic cancer who cannot trace the specific anti-cancer treatment plan 3. hiv positive 4. other situations that researchers believe need to be excluded
a trial of antenatal treatment of alloimmune thrombocytopenia

Conditions: Alloimmune Thrombocytopenia; Fetal Alloimmune Thrombocytopenia

Summary: the purposes of this study are to provide medical management by giving treatment to the mother that will bring up the fetal platelet count and to minimize the number of invasive procedures to the fetus (which may result in serious fetal injuries).


Eligibility criteria:
inclusion criteria: pregnant women are eligible for inclusion into the very high risk group if they: * are pla-1 (platelet antigen a1) negative and have known platelet incompatibility with their fetus * have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation (as best as could be estimated) * are less than 19 weeks gestation pregnant women are eligible for inclusion into the high risk group if they: * are pla-1 negative and have known platelet incompatibility with the fetus * have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation (as best as could be estimated) * are between 12-30 weeks gestation pregnant women are eligible for inclusion into the standard risk group if they: * are pla-1 negative and have known platelet incompatibility with the fetus * have not had a previous child who suffered an antenatal hemorrhage * are between 20-30 weeks gestation exclusion criteria: women are not eligible for inclusion into the very high risk group if they: * have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation * are greater than 19 weeks gestation women are not eligible for inclusion into the high risk group if they: * have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation * are greater than 30 weeks gestation women are not eligible for inclusion into the standard risk group if they: * have had a previous child who suffered an antenatal hemorrhage * are greater than 30 weeks gestation

Keywords: alloimmune thrombocytopenia fetal alloimmune thrombocytopenia
impact of fructose consumption on intestinal permeability in non-alcoholic fatty liver disease (nafld) - a pilot study.

Conditions: Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis

Summary: the spectrum of nafld as emerging epidemic ranges from steatosis to steatohepatitis (nash), cirrhosis and hepatocellular carcinoma (hcc). disease progression is poorly understood and treatment options are limited. fructose overconsumption has been associated with gut permeability and progression of nafld. to unravel the mechanisms of fructose-induced intestinal changes, volunteers will receive a 4-week fructose challenge prior to assessment of intestinal permeability/translocation using endomicroscopy, sugar probes, serum markers of intestinal damage, inflammation, iron/copper homeostasis and histological/molecular analysis of intestinal biopsies. findings in volunteers will be compared with liver patients undergoing study procedures without fructose challenge. translational in vitro experiments will explore cellular responses to fructose and endotoxin. this project should provide novel insights into dietary induced alterations of the gut integrity in progression of nafld to nash.


Eligibility criteria:
1. healthy men and women from 18 to 85, no disease history, no intake of regular medication. 2. patients with confirmed (at least one imaging positive) intrahepatic fat accumulation (nafl), male and female 3. patients with confirmed nash (biopsy within 6 months prior to study), male and female 4. diagnosed hcv, genotype 1, male and female signed informed consent general exclusion criteria (for all groups) 1. pregnancy and lactation 2. imprisoned persons 3. inflammatory bowel conditions (celiac disease, crohn's disease, ulcerative colitis) 4. prior bariatric surgery 5. alcoholic steatohepatitis and/or alcohol consumption \> 140 gramms per week (or \> 30g/day) 6. other liver diseases (autoimmune, genetic, cholestatic, wilson disease, weber-christian disease, partial lipodystrophy of the face sparing type, abetalipoproteinemia, and jejunal diverticulosis with bacterial overgrowth.) 7. virus hepatitis (a, b, c) (except for group (4): defined as hcv, genotype 1) 8. known allergic reaction to the drugs used (see material and methods) 9. intake of drugs known to accumulate intrahepatic lipids (e.g. steroids/glucocorticoids, tamoxifen, amiodarone, perhexiline maleate, synthetic estrogens, antiretroviral agents, tetracycline, minocycline, certain pesticides, methotrexate) 10. intake of drugs known to drive fibrosis/cirrhosis (e.g. azathioprine, oral contraceptive pills) 11. inability or contraindications to perform study procedures 12. general and absolute endoscopy contraindications

Keywords: non-alcoholic fatty liver disease non-alcoholic steatohepatitis nafld nash
toxicities of cervix and corpus uteri carcinomas treatment and evaluation of impact on sexual function

Conditions: Corpus Uteri Carcinoma

Summary: evaluate the toxicities of cervix and corpus uteri carcinomas treatment

evaluate the toxicities of cervix and corpus uteri carcinomas treatment on sexual function after treatment (radiotherapy and/or surgery)

Eligibility criteria:
* inclusion criteria: * patients whose treatment is provided to centre oscar lambret * with a corpus uteri adenocarcinoma, no metastatic, treated by: * surgery and observation without complementary treatment * or surgery and adjuvant radiotherapy * or surgery and curietherapy of vaginal dome * with a cervix carcinoma, stade ia2 to iib proximal, treated by : * external radiochemotherapy and curietherapy * or only surgery * or pre-surgical curietherapy and surgery * age \> 18 years

Keywords: carcinoma uterus not metastatic
rtms for adults with autistic spectrum disorder

Conditions: Autism

Summary: rtms over dorsolateral prefrontal cortex is effective in reducing repetitive behaviors in adults with autistic spectrum disorder rtms over posterior superior temporal sulcus is effective in improving social ability in adults with autistic spectrum disorder

first, we will apply one session intermittent theta burst stimulation over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control with one week interval in adults with autism spectrum disorder. second, we will apply 5 sessions intermittent theta burst stimulation within one week over dorsolateral prefrontal cortex or posterior temporal sulcus depending on the results of our first phases.

Eligibility criteria:
inclusion criteria: * adults with autistic spectrum disorder exclusion criteria: * schizophrenia * bipolar affective disorder * major depressive disorder * any systemic disease especially epilepsy
a study of aducanumab in participants with mild cognitive impairment due to alzheimer's disease or with mild alzheimer's disease dementia to evaluate the safety of continued dosing in participants with asymptomatic amyloid-related imaging abnormalities

Conditions: Cognitive Dysfunction; Alzheimer's Disease

Summary: the primary objective of the study is to assess the safety impact of continuing aducanumab dosing in asymptomatic amyloid-related imaging abnormalities (aria) in participants with mild cognitive impairment (mci) due to alzheimer's disease (ad) or with mild ad dementia. the secondary objective of the study is to characterize aria, from both the imaging and the clinical perspective and to characterize the safety, tolerability, pharmacokinetics (pk), and immunogenicity of aducanumab.


Eligibility criteria:
inclusion/ exclusion criteria key inclusion criteria: * ability of the participant or his/her legally authorized representative to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations. * must have at least 6 years of education or work experience to exclude mental deficits other than mci due to ad or mild ad dementia. * must have evidence of cerebral aβ accumulation, based on a positive pet scan of the brain. previously obtained positron emission tomography (pet) scan (within 12 months of screening) is permissible. previous pet scan images must be submitted to the central imaging vendor to confirm that study inclusion criteria are met. * must consent to apolipoprotein e (apoe) genotyping. * must meet all of the following clinical criteria for mci due to ad or mild ad dementia according to nia-aa criteria \[albert 2011; mckhann 2011\], and must have the following: mci due to ad (a cdr global score of 0.5, and an mmse score between 24 and 30 (inclusive)), or mild ad dementia (a cdr global score of 0.5 or 1, and as mmse score between 20 and 26 (inclusive)). key exclusion criteria: * any uncontrolled medical or neurological/neurodegenerative condition (other than ad) that, in the opinion of the investigator, might be a contributing cause of the participant's cognitive impairment (e.g., substance abuse, vitamin b12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, lewy body dementia, frontotemporal dementia, head trauma). * clinically significant unstable psychiatric illness (e.g., uncontrolled major depression, uncontrolled schizophrenia, uncontrolled bipolar affective disorder) within 6 months prior to screening. * transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to screening. * vaccinations within 10 days prior to randomization (day 1). * female participants who are pregnant or currently breastfeeding. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: aducanumab biib037
discomfort evaluation during atraumatic restorative treatment in children

Conditions: Dental Caries; Primary Teeth; Post Dental Restoration

Summary: this study evaluates the patient 's discomfort when submitted to partial caries removal through the atraumatic restorative treatment compared to chemo-mechanical caries removal using papacarie™ gel.

this study will evaluate the patient 's discomfort through oximeter (measuring the heart rate of the caries) prior to removal of the carious tissue, and when subjected to partial caries removal through the atraumatic restorative treatment compared to removal of chemo - mechanical caries with papacarie gel ™.

Eligibility criteria:
inclusion criteria: * normoreactive, * in good general health conditions, * cooperative during screening, * with at least one oclusal caries cavity in primary molars. * caregivers and/or children's parents must accept and sign the consent form. * children must accept their participation by nodding (assent). exclusion criteria: * pulp exposition, * spontaneous pain, * mobility, * fistula, * swollen area around the tooth, * furcation, * cervical lesion, * restorations, * sealants, * developmental defect of enamel.
phase i study of the third generation adenovirus h5.001cbcftr in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: objectives: i. assess the safety and feasibility of gene transfer with the third generation adenovirus h5.001cbcftr in patients with cystic fibrosis.

protocol outline: h5.001cbcftr, an adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, is administered endobronchially. cohort of 2 patients receive 1 of 6 h5.001cbcftr concentrations. there is no intrapatient dose escalation.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- cystic fibrosis diagnosed as follows: sweat sodium or chloride greater than 60 meq/l by pilocarpine iontophoresis or cystic fibrosis genotype clinical manifestations estimated 2-year survival greater than 50%, i.e.: fev1 at least 30% of predicted pao2 greater than 55 mm hg on room air paco2 less than 50 mm hg on room air --prior/concurrent therapy-- at least 2 months since systemic glucocorticoids at least 90 days since participation in investigational therapeutic study --patient characteristics-- pulmonary: no pneumothorax within 12 months no asthma or allergic bronchopulmonary aspergillosis requiring glucocorticoids within 2 months no sputum pathogens unless sensitive to at least 2 antibiotics no hemoptysis of more than 250 ml blood over 24 hours within 1 year other: no active adenoviral infection ad5 (or similar type) antibody seropositive no other contraindication to protocol participation, e.g.: drug abuse alcoholism psychiatric instability inadequate motivation documented azoospermia (men) bilateral tubal ligation or hysterectomy (women) screening exams within 4 weeks prior to registration

Keywords: cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease
visual outcomes and contrast sensitivity in patients implanted with tecnis eyhance intraocular lens

Conditions: Intraocular Lens

Summary: to compare visual outcomes for various distances, reading speed, contrast sensitivity, glare occurence, defocus curve and subjective satisfaction in patients implanted with the extended depth of focus lens (tecnis eyhance) in one eye and monocal aspheric lens (tecnis zcb00) in second eye. patients undergo visit in 3,6 and 12 months after the surgery.

the goal of refractive cataract surgery is to remove the opacity, or cataract and to produce the desired refractive outcome. in most cases, the desired outcome is an emmetropic eye, or an eye that sees 20/20 snellen for distance vision post-surgery with the implant of a monofocal iol. this, however, does not offer much in the way of intermediate and near vision. the increased desire for simultaneous distance, intermediate and near vision has increased the popularity of multifocal iols (miols). however miols provide visual acuity for all distances, they has occurence of optical phenomena such as glare and halo and lower contrast sensitivity. extended depth of focus (edof) lens should provide distance vision as good as monofocal lens and intermediate vision better than monofocal but without any optical phenomenon or decreased contrast sensitivity. this study is conducted from 11/2019 to 08/2021 in the ophthalmology department of faculty hospital kralovske vinohrady in prague. the research protocol was explained to all participants and informed consent was signed before enrolling patient to the study. the study was approved by the ethics committee of faculty hospital kralovske vinohrady and will enrolled up to 25 patients with presence of cataract in both eyes. bilateral clear corneal phacoemulsification and iol implantation is performed by one surgeon using the same technique in both eyes. the surgical process involved topical anesthesia, superior 3-step clear corneal incision (2,2mm), 5,0mm curvilinear capsulorhexis, phacoemulsification, bilateral irrigation- aspiration and iol implantation. one eye is implanted with edof iol second eye with monofocal iol. type of iol is chosen randomly and double masked. patients are scheduled for visit at 3,6 and 12 months after the surgery.

Eligibility criteria:
inclusion criteria: * presence of cataract in both eyes * no other ocular pathology affecting visual acuity * bilateral phacoemulsification cataract surgery was arranged for both eyes * corneal astigmatism up to 0,75 cylinder (measured by iol master biometry) * dioptric power of both selective lens within 1,5 d range in one patient * selecting iol power between 18 d and 27 d power range exclusion criteria: * complicated cataract * corneal opacities or irregularities * amblyopia * anisometropia * coexisting ocular pathologies * glaucoma * history of ocular surgery * refusal or unable to maintain follow-up

Keywords: edof lens cataract
steps trial - spheramine safety and efficacy study

Conditions: Parkinson Disease

Summary: the purpose of the study is to explore the safety, tolerability and efficacy of spheramine (cultured human retinal pigment epithelial cells on microcarriers) in parkinson's disease patients with advanced disease who have insufficient symptom control by optimum oral medication. patients are randomized to receive spheramine injections into both hemispheres or a sham surgical procedure in a ratio of 1:1. a three month pretreatment period must be completed prior to surgery. time to endpoint is 24 months.

this study has previously been posted by berlex, inc. and schering ag, germany.berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc., schering ag germany has been renamed to bayer schering pharma ag, germany. bayer healthcare pharmaceuticals, inc.and bayer schering pharma ag, germany are the sponsors of the trial.

Eligibility criteria:
inclusion criteria: * advanced parkinson's disease for at least 5 years * good response to l-dopa * age 30 to 70 years * optimum oral therapy exclusion criteria: * tremor only * dementia * very severe dyskinesia * previous brain surgery including deep brain stimulation * malignant disease
treatment and prognosis of patients with chronic hbv infection

Conditions: Hepatitis B Virus Infection

Summary: hepatitis b virus (hbv) infection is a major global health issue with 257 million chronically infected individuals. of note, china has the largest population accounting for one third of the world's infected population. approximately, about 300 000 people die each year due to the consequences of hbv. in 2016, the world health organization (who) proposed the goal for elimination of hepatitis b as public health threat by 2030 and china will be a major contributor towards this global goal. currently, two approved therapeutic strategies are available including pegylated interferon (ifn) or nucleos (t) ide analogues (na), which could suppress hbv replication and slow disease progression. here, investigators hope to launch a cohort study to reveal the clinical features relating to therapeutic efficacy of antiviral therapy and the prognosis of patients with differential therapeutic strategies.

patients with chronic hbv infection were recruited in the current study and divided in to peg-ifn-alpha alone group, nas alone group and the combination therapy group. the serum hbv dna level, hbv serological test and biochemical examination including serum transaminase level and afp were recorded every three or six months. the serum, feces, urine and liver (if necessary) samples were collected during follow-up. and the clinical outcomes of patients were evaluated. the clinical and biological features of patients with different clinical outcomes will be compared to explore the factors affecting the antiviral therapeutic efficacy.

Eligibility criteria:
inclusion criteria: patients with evidence of chronic hbv infection exclusion criteria: chronic liver injury mainly caused by other reasons, such as autoimmune diseases, alcohol, drugs and so on.

Keywords: hepatitis b virus infection antiviral therapy prognosis
autologous bmmnc combined with ha therapy for paod

Conditions: Peripheral Arterial Occlusive Disease; Critical Limb Ischemia

Summary: the purpose of this study is to evaluate the safety and efficacy of hyaluronan combined with autologous bone marrow mononuclear cells for the treatment of critical paod patients.

this is a multicenter, non-blinded and randomized study to evaluate the safety and efficacy of hyaluronan (ha) combined with autologous bone marrow mononuclear cells (bmmnc) therapy for critical peripheral arterial occlusive disease (paod) patients. a total of 30 subjects will be recruited into the study. the subjects will be randomized into 3 different arms. during the phase i study, 9 subjects recruited while another 21 additional subjects will be recruited in phase ii after the review of dsmb and consultation of taiwan fda on the results of the phase i study. each subject will be administered 5\~10 injections of rv-p1501, the number of injections depends on the size of the subject's ischemic leg. each subject will receive treatment once. subjects will be assigned to the treatments in random order. evaluations including abi, pwt/pfwt, clinical status, ef, cta, biochemistry and hematology checked during the inclusion and exclusion evaluation, and will be taken at baseline, 1 week, 2 weeks, 4 weeks, 12 weeks, and 24 weeks after the treatment.

Eligibility criteria:
inclusion criteria: * patient age ≥ 20 * patients with severe paod and diagnosed with rutherford category 3, 4, or 5 * contraindication to angioplasty or bypass surgery, or post-angioplasty or bypass surgery for once but with limited or no effect. * patient without hypertension or hypertensive patient with adequate-controlled blood pressure. * with signed informed consent exclusion criteria: * patient undergone any organ transplantation * inability to undergo bone marrow aspiration * pregnant woman * life expectancy \< 1 year * cognitive impairment * active malignancy in 5 years prior to treatment * bleeding diathesis or pulmonary embolism * patient with active major cardiovascular diseases such as unstable angina, arrhythmia, heart failure, impaired cardiac function (ejection fraction \< 45%), or stroke * estimated glomerular filtration rate (egfr) \< 30 * glutamic oxaloacetic transaminase (got) and glutamic pyruvic transaminase (gpt) values higher than 80 u/l * patient with severe diabetes mellitus (hba1c \> 8%) * patient with alcohol addiction * patient with drug abuse * patient with infections or skin disease on the ischemic leg. * allergic to ha * patient whose blockage region only occurred in the femoral artery or at foot.

Keywords: hyaluronan bone marrow mononuclear cells