Kornimate/medical-research-clean huggingface dataset:
a study of circulating exosome proteomics in gallbladder carcinoma patients

Conditions: Proteinosis; Gallbladder Carcinoma

Summary: this research will be the first study for exosome purified from blood in gallbladder carcinoma patients. proteomics studies will be done in both tumor tissue and the circulating exosome from blood specimens. then, the potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma.

background: exosomes are formed by inward budding of late endosomes, producing multivesicular bodies (mvbs), and are released into the environment by fusion of the mvbs with the plasma membrane. it has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced. tumor exosome production, transfer and education of bone marrow cells supports tumor growth and metastasis. aims of the study: proteomics studies will be done in both tumor tissue and the circulating exosome from the gallbladder carcinoma patients. then, the potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma. materials and methods: the investigators will conduct a case-control study in 11 hospitals from china. cases will be the patients with newly-diagnosed gallbladder carcinoma. the controls will be matched （1：1）by sex，race and age which will be selected from the patients receiving cholecystectomy due to gallstones from the same hospital with the cases. a total of 50 patients with gallbladder carcinoma will be recruited. the investigators will obtain the blood and tumor tissue samples for further analysis of proteomics studies. exosome from blood specimens will be isolated and purified by sucrose gradient ultracentrifugation. the potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma. data will be collected from january 2018 to december 2018.

Eligibility criteria:
inclusion criteria: * diagnosed with gallbladder carcinoma by imaging tests (cases) diagnosed with chronic cholecystitis by imaging tests (hospital controls) exclusion criteria: * the pathology diagnosis and imaging does not matched patients with other malignant tumors patients with other severe systemic diseases
secondary prevention of atrial fibrillation (impact of renin-angiotensin-aldosterone system inhibition)

Conditions: Atrial Fibrillation

Summary: in the present application, we propose to refine and extend current insight into aaf mechanism and therapy by examining the importance of pharmacologic raas inhibition, ace genotype, and their interaction in secondary af prevention. we have 3 specific aims: 1. to confirm that raas inhibition therapy reduces the incidence of af recurrence. 2. to test the hypothesis that the incidence of af recurrence in the absence of raas inhibition therapy is higher among patients with the d allele. 3. to explore the hypothesis that raas inhibition therapy is more effective for preventing af recurrence in patients with the dd genotype than in those with di or ii genotypes.


Eligibility criteria:
inclusion criteria: * subjects must be in atrial fibrillation confirmed by 12 lead ekg. * blood pressure \> 90 mmhg * patient without cardiopulmonary symptoms * 18+ years of age exclusion criteria: * contraindiction to warfarin * recent (within 6 months) mi or cardiac revascularization * recent (within 6 months) cva or tia * nyha class iv chf * active thyroid disease * major hepatic dysfunction * renal dysfunction (\>2 mg/dl) * hyperkalemia (\>4.6 meq/l) * hyponatremia (\<130 meq/l) * currently taking a vaughn-williams type i or iii antiarrhythmic drug * history of arb intolerance * contraindication to arb therapy * pregnancy * female of childbearing age * age \< 18 years of age * inability to give informed consent * other medical conditions calling 1 year survival into question
a study to test the safety and efficacy of mk0249 in patients with adhd (0249-018)(completed)

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Summary: the purpose of this study is to investigate the safety and efficacy of an investigational treatment for attention deficit hyperactivity disorder (adhd) when compared to placebo.


Eligibility criteria:
inclusion criteria: * patient is between 18 and 55 years of age (inclusive) * patient is an adult with a current dsm-iv diagnosis of adhd of inattentive or combined subtype, as assessed via a structured interview using the acds and aisrs * females of child-bearing potential must use acceptable methods of birth control during the study and for 1 month post-therapy exclusion criteria: * patient has a history of a neurological disorder resulting in ongoing impairment * patient has a lifetime history of a psychotic disorder, bipolar disorder, or post-traumatic stress disorder * patient has evidence of ongoing depression * patient is sensitive or allergic to methylphenidate * patient has glaucoma * patient has a previous history of narrowing or blockage of the gi tract * patient has a history of a sleep disorder (e.g., insomnia, sleep apnea, nightmares, or night terrors) within 6 months prior to screening * patient has a history of a cardiovascular disorder within 6 months prior to screening * patient has moderate or severe persistent asthma * patient has a history of substance abuse or dependence not in sustained full remission for at least one year according to dsm-iv * patient has taken part in a research study within the past 30 days of signing informed consent
electroacupuncture treatment of peripheral neuropathy after taxane chemotherapy for breast cancer

Conditions: Breast Cancer

Summary: electroacupuncture treatment of peripheral neuropathy after taxane chemotherapy for breast cancer

chemotherapy induced peripheral neuropathy has a significant impact on the integrity of chemotherapy cycle and quality of life of breast cancer patients. the latest research reports indicate that electroacupuncture has a certain therapeutic effect on peripheral neuropathy. in addition, existing studies have confirmed that the peripheral neuropathy of breast cancer induced by taxane is related to genetic factors. this study is based on electroacupuncture treatment of peripheral neuropathy induced by paclitaxel drugs, while screening snps related to peripheral neuropathy induced by taxane drugs, and establishing a prognostic model. eligible patients diagnosed as stage i, ii or iiia breast cancer with peripheral neuropathy for at least 2 weeks were assessed by functional cancer treatment assessment/gynecological oncology group neurotoxicity scale (fact/gog-ntx) and the european organization for research and treatment of cancer quality of life questionnaire cipn twenty item scale (eortc qlq-cipn20). all items in the above two scales are scored using likert's 5 and 4 levels. the researchers will temporarily divide the study into two groups, and if necessary, the researchers will add this group. laboratory personnel are unaware of all clinical and outcome data.

Eligibility criteria:
inclusion criteria: * breast cancer patients diagnosed by pathology; * eoog score is 0 or 1; * the age range for enrollment is between 18 and 75 years old; ④ accept chemotherapy regimens based on taxane drugs (alone or in combination); ⑤ previously received taxane chemotherapy for more than 6 months; ⑥ according to the national cancer institute (nci) common terminology for adverse events (ctcae) 5.0, reporting cipn symptoms of grade 1 or higher for more than 2 weeks; ⑦ voluntarily participate in this clinical trial and sign the informed consent form; * accept regular follow-up visits; ⑨ there is complete pathological data available. exclusion criteria: * non breast cancer patients; * received electroacupuncture treatment within 6 months prior to the start of the study; * patients who experience intolerable toxic side effects during standard dose chemotherapy and terminate the chemotherapy cycle; * prior to enrollment, there was a history of peripheral neuropathy; * unstable heart disease or myocardial infarction within the first 6 months of the study; ⑥ active skin diseases or surface skin ulcers or infections that cannot tolerate electroacupuncture treatment; ⑦ uncontrolled epilepsy patients with uncontrolled seizures; ⑧ merge with other malignant tumor patients; ⑨ pregnancy and lactation period; ⑩ refusal to join clinical trial patients

Keywords: breast cancer electroacupuncture taxanes snps chemotherapy
effect of adding lactoferrin on oral iron on anemia in chronic kidney disease patients

Conditions: Anemia of Chronic Kidney Disease

Summary: the aim of this study is to evaluate the effects of adding lactoferrin to the every-other-day oral iron supplementation in iron deficiency anemia and chronic kidney disease patients.

1. ethical committee approval has been obtained from ethics committee of faculty of medicine, alexandria university. 2. all participants should agree to take part in this clinical study and will provide informed consent. 3. sixty chronic kidney disease patients with iron defficiency anemia,will be recruited from the kidney and urology center (kuc) and alexandria main university hospital (amuh). the 60 participants will be randomly assigned into 2 arms. control arm (n=30): will be treated with oral ferrous glycine sulfate (100mg) every other day for 3 months intervention arm (n=40): will be treated with oral lactoferrin (one sachet that contains 100mg) with oral ferrous glycine sulfate (100mg) every other day for 3 months. 4. all patients will be subjected directly at time of enrollment to the following; complete history taking and demographic data (age, sex, ...) 5. blood samples will be drawn to measure the initial values of hemoglobin, hematocrit, serum iron, tibc, serum transferrin saturation (tsat), and hepcidin as primary outcome. 6. all patients will be followed up and treated during the study time. all relevant routine investigations and medications will be recorded. 7. at each visit, the subjects will be questioned about study compliance (diet and medications), concomitant medications, and adverse events. 8. the results obtained from the work will be tabulated and statistically analyzed using the appropriate statistical methods. 9. the findings will be discussed in view of the achievement of the aim, their significance and their comparison with other available works and information.

Eligibility criteria:
inclusion criteria: 1. males and females aged ≥ 18 years old 2. patients with egfr ≥30 and ≤60 ml/min/1.73m2. 3. absolute iron deficiency anemia (hgb \<10g/dl, serum ferritin \<300ng/ml and transferrin saturation \< 30% ) exclusion criteria: 1. patients on intermittent hemodialysis (ihd) 2. patients with any known cause of anemia other than iron deficiency or ckd (e.g., sickle cell anemia) 3. patients who received epo 4 weeks ago 4. patients who received iv iron 8 weeks ago 5. patients who received blood transfusion 8 weeks ago 6. current history of gi bleeding 7. malignancy history 8. pregnancy or lactation in female participants 9. patients non-adherent to at least 80% of the regimen

Keywords: lactoferrin anemia chronic kidney disease oral iron
coronavirus pediatric serological study

Conditions: SARS-CoV2 Infection

Summary: the coronavirus pediatric serological study's aim is to provide a better insight of children's immune response after sars-cov-2 infection. serological tests were conducted on blood samples taken 3 to 5 months after the children's viral infection. the study was performed in collaboration with the institute of medical immunology, were antibody levels were measured and immunoglobulin subclasses profiles were studied.

the hospital laboratory provided us the list of children under 15 years old tested for sars-cov-2 in saint-pierre hospital (brussels) by pcr on nasopharyngeal swab between march 1 2020 and december 31 2020. the medical files of all children that were tested positive for sars-cov-2 were reviewed and clinical information was collected. for each positive child, the family was contacted by phone 3 months after the proven viral infection in order to ask permission to take a single blood test. covid19 serologies were performed in the hospital laboratory, and blood samples were then sent to the institute of medical immunology, were antibody levels and immunoglobulin subclasses were studied.

Eligibility criteria:
inclusion criteria: - tested positive for sars-cov-2 by pcr on naso-pharyngeal swab performed in saint-pierre hospital (brussels) between march 1 2020 and december 31 2020 exclusion criteria: * /

Keywords: sars-cov-2 immune response children
dynacleft® effects on soft tissues and on quality of life for incomplete unilateral cleft lip infants

Conditions: Cleft Lip and Palate

Summary: the purpose of this study is to examine the effectiveness of the dynacleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent dynacleft® and that of their families.


Eligibility criteria:
inclusion criteria: retrospective group: * unilateral cleft lip with or without cleft palate * patients of a single surgeon (matthew greives, md) * patients with complete photographs: * after birth, first visit * at cleft lip repair (3-4 months) * post-operative cleft repair (about 1 year of age) prospective group: * patients with incomplete unilateral cleft lip with or without cleft palate * patients of any surgeon exclusion criteria: retrospective group: * bilateral cleft lip or complete unilateral cleft lip * patients operated on by other primary surgeons * patients with incomplete photo records will be evaluated to determine if the patient should be excluded prospective group: * patients with bilateral cleft lip or complete unilateral cleft lip * patients whose parents refuse to consent to inclusion * patients with tape allergies to the adhesive of the dynacleft® * patients with syndromic craniofacial conditions or tessier type facial clefts

Keywords: dynacleft
safety study of amg 531 in japanese subjects with itp

Conditions: Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Summary: the purpose of the study is to evaluate the efficacy of starting dose of amg 531 as measured by platelet counts by cohort dose-escalation design.

the purpose of the study is to evaluate the efficacy of starting dose of amg 531 as measured by platelet counts by cohort dose-escalation design.

Eligibility criteria:
inclusion criteria: - japanese patients with diagnosis of itp according to the diagnostic criteria proposed by research committee for idiopathic hematopoietic disorders of the ministry of health, labor and welfare exclusion criteria: - documented diagnosis of arterial thrombosis in the previous year; history of venous thrombosis and receiving anticoagulation therapy

Keywords: amg 531, itp, phase 2, japanese
a study of avastin (bevacizumab) in combination with herceptin (trastuzumab) and xeloda (capecitabine) in patients with her2-positive breast cancer

Conditions: Breast Cancer

Summary: this single arm study will assess the efficacy and safety of avastin in combination with herceptin and xeloda as first-line treatment of patients with her2-positive locally recurrent or metastatic breast cancer. patients will receive 3-weekly treatment cycles of herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).the anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * breast cancer with measurable locally recurrent or metastatic lesions; * candidate for chemotherapy; * her2-positive disease; * ecog ps of \<=2. exclusion criteria: * previous anticancer therapy for metastatic breast cancer; * previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy \>=6 months before enrollment); * chronic daily treatment with corticosteroids (\>=10mg/day), aspirin (\>325 mg/day) or clopidogrel (\>75mg/day); * other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer; * uncontrolled hypertension or significant cardiovascular disease.
effects of corn oil plus vitamin e and b6 on lipids, pcsk9 and endothelial function

Conditions: Atherosclerosis

Summary: this will be a randomized clinical trial carried out on subjects with suboptimal control of cholesterolemia who will consume 30 g per day of a vitaminized corn oil (plus b6 and e vitamins), in order to evaluate the effects on lipid profile, endothelial function and pcsk9

in order to assess the mid term effects of vitaminized corn oil on endothelial function and on early markers of functional damage of the arterial wall, moderately hypercholesterolemic subjects will be supplemented for 8 weeks with 30 g/day of both a vitaminized corn oil (plus b6 and e vitamins) or olive oil. the two intervention periods will be spaced by a 4 week washout period.

Eligibility criteria:
inclusion criteria: * total cholesterol between 200 and 280 mg/dl and/or ldl cholesterol between 130 and 190 mg/dl * triglycerides lower than 200 mg/dl * cardiovascular risk at 10 years lower than 10% * informed consent exclusion criteria: * secundary prevention for cardiovascular diseases * bmi higher than 30 * assumption of lipid lowering drug or supplement * alcohol abuse * alterations in thyroid, liver or kidney functions, muscle diseases
neutrophil function during therapy with protease inhibitors in chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: the aim of this study is to characterize neutrophil function in patients undergoing chronic hepatitis c triple therapy with protease inhibitors in comparison to dual therapy with peginterferon and ribavirin and with interferon free treatment regimen to thereby elucidate the possible mechanisms of protease-inhibitor associated infections.

chronic hepatitis c infection (chc) is a major health problem, potentially leading to liver related mortality via complications of liver cirrhosis or hepatocellular carcinoma, and affects more than 185 million persons worldwide. antiviral therapy evolved during the past 25 years from standard interferon, the combination with ribavirin and pegylated interferon (p/r) to the addition of protease inhibitors and is currently on the edge to an interferon-free era with the first such substances being approved in 2014. however, current standard therapy for chc genotype 1 patients without cirrhosis consists of ribavirin and pegylated interferon (p/r) in combination with boceprevir (boc) or telaprevir (tpv), which are direct acting antivirals and represent the first-generation protease inhibitors. triple therapy for chc has been reported to be associated with a quantitative and qualitative increase in treatment-related (serious) adverse events compared to the former standard therapy without protease-inhibitors. moreover, reports of serious infectious complications during triple therapy - especially in patients with acquired immune deficiencies like liver cirrhosis - that lead to considerable morbidity and mortality, have accumulated recently. the mechanisms of this increased susceptibility to infections remain unclear. however, boc is known to inhibit neutrophil elastase activity. aims of this study were therefore to analyse infections that occurred in chc outpatients during therapy in the study centre, to prospectively characterize neutrophil function in patients undergoing chc triple therapy in comparison to dual therapy with peginterferon and ribavirin and to thereby elucidate the possible mechanisms of protease-inhibitor associated infections.

Eligibility criteria:
inclusion criteria: * chronic hepatitis c * planned antiviral therapy exclusion criteria: * immunosuppressive medication * active infection at baseline * treatment with antibiotics within the last two weeks
expansion of integrated ai solution for diabetic retinopathy screening in thailand

Conditions: Diabetic Retinopathy

Summary: efficiency and effectiveness of real-world diabetic retinopathy screening by artificial intelligent (ai) are limited. investigators will implement ai for diabetic retinopathy screening in 13 health districts in thailand and investigate the efficiency, effectiveness as well as patients and health care personnel's satisfaction by an implementation research.


Eligibility criteria:
inclusion criteria: 1. type 1 or 2 diabetes mellitus patients whose name are in primary hospital record 2. no full-time ophthalmologists in those primary hospital 3. age more than or equal to 18 years 4. eligible for fundus photo imaging at least 1 eye exclusion criteria: 1. type 1 or 2 diabetes mellitus patients whose name are in primary hospital record that have full-time ophthalmologists 2. patients who previously diagnosed with other causes of macular edema, for example, age-related macular degeneration, radiation retinopathy, retinal vein occlusion etc. 3. history of retinal laser or surgery 4. other ocular diseases that require referral to ophthalmologists 5. not eligible for fundus photo imaging for both eyes (any causes)

Keywords: diabetic retinopathy, screening, deep learning algorithm, human grader