Kornimate/medical-research-clean huggingface dataset:
diagnostics and surveillance of acute meningo-encephalitis among children in cambodia with a focus on japanese encephalitis virus

Conditions: Japanese Encephalitis

Summary: the primary objective of this study is to quantify the clinical burden of japanese encephalitis (je) and the asymptomatic circulation of jev among cambodian children, through two pediatric cohorts: non-febrile children at recruitment and children hospitalized with febrile neurological syndrome (fns). secondary objectives include estimating anti-jev seropositivity rates, identifying individual risk factors and living conditions associated with jev infection, characterizing clinical and biological profiles related to disease severity, and evaluating the role of deficiencies in interferon (ifn) response in severe jev infections.

this is an observational prospective study (with cross-sectional and longitudinal designs) involving two pediatric cohorts recruited from kantha bopha hospitals in phnom penh and siem reap. group 1 will consist of 2000 non-febrile children aged 2-14 years, recruited from trauma units and followed up for two years to monitor jev seroconversion. group 2 will include 2000 children hospitalized with fns, confirmed je participants will be followed up for one year to assess the severity of jev infection. diagnostic tools such as the qiastat molecular diagnostic platform and elisa will be used to detect multiple pathogens, including jev and dengue virus (denv). data collection will involve clinical assessments, etiological testing, and environmental surveys. all collected information will be integrated into a centralized database for analysis.

Eligibility criteria:
inclusion criteria: cohort 1 * all children aged between 2 and 14 years. * no fever or history of fever in the past 14 days. * consenting to return to the hospital for follow-up visits. * consenting to blood sampling. * written informed assent/consent to participate in the study. cohort 2 * hospitalized patients aged between 2 and 14 years. * any neurological disorder. * any fever within the past 72 hours. * written informed assent/consent to participate in the study. * no contraindication for lumbar puncture (lp).

Keywords: japanese encephalitis arbovirus
trace: tirapazamine-radiation and cisplatin evaluation

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.


Eligibility criteria:
inclusion criteria: * previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. * stage iii or iv disease (excluding t1n1, and t2n1 and metastatic disease). * eastern cooperative oncology group (ecog) performance status less than or equal to 2. * absolute neutrophil count at least 1.5 x 10\^9/l, platelet count at least 100 x 10\^9/l, and hemoglobin \> 9g/dl. * serum bilirubin \< 1.25 times upper limit of normal (uln) and aspartate aminotransferase (ast)/alanine transaminase (alt) \< 2.5 times uln. * calculated creatinine clearance (cockcroft-gault) \> 55 ml/min. exclusion criteria: * metastatic disease * primary cancers of the nasal and paranasal cavities and of the nasopharynx * significant intercurrent illness that will interfere with the chemotherapy or radiation therapy during the trial * symptomatic peripheral neuropathy \> grade 2 * clinically significant hearing impairment * significant cardiac disease

Keywords: tirapazamine head and neck cancer cisplatin radiation
effects of systemic no-inhibition on renal hemodynamics in patiens with polycystic kidney disease and chronic glomerulonephritis

Conditions: ADPKD; Glomerulonephritis

Summary: the study tests the hypothesis that systemic and renal nitric oxide availability is changed in polycystic kidney disease and chronic glomerulonephritis.

in a randomized, placebo controlled design, the effects of systemic treatment with monomethyl-l-arginine are studied on: 1. renal hemodynamics 2. renal sodium excretion and lithium clearance 3. blood pressure and heart rate 4. plasma levels of vasoactive hormones in patients with adult polycystic kidney disease and chronic glomerulonephrits. the results are compared with a group of healthy control subjects

Eligibility criteria:
inclusion criteria: healthy controls * age 20 to 60 years * both men and women * weight below 100 kg * normal clinical examination and laboratory screening * fertile women only if using contraception * informed consent according to the regulations of the local etics committee chronic glomerulonephritis * biopsy veryfied chronic glomerulonephritis * p-creatinine \< 250 µmol/l * weight below 100 kg * age 20 to 60 years * both men and women * informed consent according to the regulations of the local etics committee adult polycystic kidney disease (apkd) * diagnosis of apkd by family history and renal ultrasound or renal angiography * p-creatinine \< 250 µmol/l * weight below 100 kg * age 20 to 60 years * both men and women * informed consent according to the regulations of the local etics committee exclusion criteria: healthy controls * history or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening * current medication * drugs or alcohol abuse * pregnancy * previously within one year received more than 0.2 msv radioactive treatment or diagnostic substances * donation of blood less than 1 month before the experiments chronic glomerulonephritis * apart from chronic glomerulonephritis and hypertension no history of diseases of the heart and blood vessels, liver and pancreas, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease. * patients with nephrotic syndrome or secondary glomerulonephritis * current medication other than antihypertensive therapy * drugs or alcohol abuse * pregnancy * previously within one year received more than 0.2 msv radioactive treatment or diagnostic substances adult polycystic kidney disease * apart from apkd and hypertension no history of diseases of the heart and blood vessels, liver and pancreas, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease. * current medication other than antihypertensive therapy * drugs or alcohol abuse * pregnancy * previously within one year received more than 0.2 msv radioactive treatment or diagnostic substances

Keywords: renal hemodynamics nitric oxide
evaluation of a school-based influenza vaccination program

Conditions: Influenza; Influenza Vaccines

Summary: the purpose of this study is to determine whether inactivated influenza vaccines are effective to protect school children and their households from getting influenza infection and further prevent student's absenteeism.

school children were found to be the possible spreaders of the influenza. the successful prevention measure on school children was crucial for controlling the epidemic. in taiwan, the national influenza immunization program on the grade 1-2 students started in winter, 2007. in this intervention study, the two study townships with 27 schools were included as our study population. the three time questionnaires were issued for collecting the health status of the children during the influenza season. the information on the vaccines' safety was also collected after the vaccination. the community collaborative clinics were responsible for taking the specimens.

Eligibility criteria:
inclusion criteria: * all elementary and junior high school students living in shinwu and guanyin townships were eligible to be enrolled into this study * agreed inform consent to participate in this study * complete three times questionaire follow-up exclusion criteria: * one junior high school in shinwu township because it had both high school and junior high school

Keywords: school children influenza vaccination vaccine effectiveness influenza attack rate absenteeism influenza vaccine
lymphovenous anastomosis to prevent breast cancer related lymphedema

Conditions: Lymphedema, Breast Cancer

Summary: lymphedema is defined as a chronic condition, caused by lymphostasis. a major part in the western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. prophylactic lymphovenous anastomosis (lva) could be beneficial in the prevention of lymphedema of the extremities.

the investigator is performing a blinded randomized prospective study on 80 patients undergoing an axilla dissection for their breast cancer treatment. one group will receive a lva at the time of their axilla dissection. other group will receive standard of care. follow-up is 2 year.

Eligibility criteria:
inclusion criteria: * lymph node + breast cancer requiring dissection exclusion criteria: * previous lymphedema * bmi \>35
clinical outcome after total pancreatectomy with islet autotransplantation

Conditions: Islets of Langerhans Transplantation; Pancreatitis, Chronic; Diabetes Mellitus

Summary: a total pancreatectomy with islet autotransplantation (tpiat) can be performed for a number of benign indications, such as chronic pancreatitis. in the current standard of treatment, after non-invasive, endoscopic efforts and other surgical options to relieve the pain, a total pancreatectomy is a last resort option. the pancreas is surgically removed during this procedure. afterwards, the patient will have diabetes mellitus that is usually difficult to control with dependency on exogenous insulin administration. in tpiat, a total pancreatectomy is followed by islet isolation from the resected pancreas and autotransplantation of these islets into the liver by means of a transhepatic intraportal islet infusion. depending on the number and quality of islets, tpiat may lead to full islet function so that no anti-hyperglycemic therapy is necessary or to partial islet function necessitating anti-hyperglycemic therapy. this can be only oral agents with reasonable islet function or complex insulin regimes with poor islet function. however, even with partial islet function, glycemic control is easier with a lower risk of hypoglycemic events and diabetes-related complications, and an overall improvement of quality of life. in this cohort, the endocrine function and glycemic variability will be monitored over time (up to 15 years). additionally, pain scores, pain perception and central sensitization, quality of life, exocrine pancreatic insufficiency and diabetes-related stress will be monitored.


Eligibility criteria:
inclusion criteria: * patients referred for tpiat or tpiat performed since 2014 * active and/or passive understanding of the dutch language * willingness to wear a fgm or cgm device at least in the 2 weeks prior to tpiat, first 3 months after tpiat and for 2 weeks before yearly clinical visits. exclusion criteria: * known malignancies of the pancreas

Keywords: total pancreatectomy autologous islet transplantation tpiat beta-cell function c-peptide
antibiotic use and resistance kap among dental interns

Conditions: Antibiotic Side Effect; Antibiotic Resistant Infection

Summary: the study is designed as a cross-sectional online-based questionnaire, and it will be distributed among dental interns. assess the following among dental interns (1) the knowledge, attitude, and practices (kap) towards antibiotics and antibiotic resistance; (2) the correlation between their kap score and where they spend their internship year? (4) development of the curriculum to provide sufficient training and information about antibiotics and antibiotic resistance.


Eligibility criteria:
inclusion criteria: * dental interns exclusion criteria: * undergraduates dental students * postgraduates dental students
a study of the safety and efficacy of a new treatment for diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.


Eligibility criteria:
key inclusion criteria: * 18 years of age or older with diabetic macular edema; * decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse); * visual acuity in other eye no worse than 20/200 key exclusion criteria: * known anticipated need for ocular surgery within next 12 months; * history of glaucoma or current high eye pressure requiring more than 1 medication; * uncontrolled systemic disease; * known steroid-responder; * use of systemic steroids; * use of warfarin/heparin
csl200 gene therapy in adults with severe sickle cell disease

Conditions: Anemia, Sickle Cell

Summary: this is a phase 1 pilot study of csl200 in adult subjects with severe sickle cell disease. the primary objectives of this study are to evaluate the safety of the following: collection of cd34+ hematopoietic stem / progenitor cells by apheresis after mobilization with plerixafor, reduced intensity conditioning with melphalan, and administration of csl200.


Eligibility criteria:
inclusion criteria: * diagnosis of sickle cell disease with the homozygous hbs homozygous genotype (hbss) or an hbsβ thalassemia variant (ie, hbsβ0 thalassemia or hbsβ+ thalassemia) genotype, confirmed by hemoglobin studies. * fetal hemoglobin (hbf) ≤ 15%. * severe sickle cell disease symptomatology, defined as any one or more of the following: 1. ≥ 2 episodes of acute chest syndrome in the last 2 years. 2. ≥ 3 episodes of severe pain events requiring a visit to a medical facility and treatment with opioids in the last 2 years. 3. \> 2 episodes of recurrent priapism in the last 2 years. 4. red-cell alloimmunization (\> 2 antibodies) during long-term transfusion therapy (lifetime history). 5. chronic transfusions for primary or secondary prophylaxis (lifetime history). 6. trans-thoracic echocardiograph evidence of tricuspid valve regurgitant jet velocity ≥ 2.7 m/sec (lifetime history). 7. clinically significant neurologic event (eg, ischemic stroke) or any neurological deficit lasting \> 24 hours. * not eligible for human leukocyte antigen (hla)-matched hematopoietic stem cell transplantation, defined as follows: no medically eligible, available, and willing 10/10 matched hla-identical sibling donor, unless subject has declined this treatment option (as documented in the informed consent form). * not eligible for, declined, or, as judged by the investigator, failed therapy with hydroxyurea and if still on hydroxyurea is able to interrupt hydroxyurea starting at the beginning of the transfusions, before mobilization and apheresis. exclusion criteria: * hypoxanthine-guanine phosphoribosyl transferase (hprt) deficiency. * thiopurine s-methyltransferase (tpmt) deficiency. * alpha thalassemia. * inadequate bone marrow function, defined as at least 1 of the following: 1. absolute neutrophil count \< 1000/µl. 2. platelet count \< 120,000/µl.
fluzoparib in combination with camrelizumab and temozolomide in advanced melanoma

Conditions: Melanoma

Summary: the purpose of this study is to evaluate how well fuzoparib in combination with camrelizumab and temozolomide works in treating patients with advanced, metastatic melanoma with the homologous recombination (hr) pathway gene mutation / alteration.

treatment with parp inhibitors could represent a novel opportunity to selectively kill a subset of cancer cells with deficiencies in dna repair pathways. non-brca deficiencies in homologous recombination dna repair genes could also enhance tumor cell sensitivity to parp inhibitors. therefore, parp inhibitors are also selectively cytotoxic for cancer cells with deficiencies in dna repair proteins other than brca1 and brca2. in melanoma, genetic hr mutation/ alterations are rather common. retrospective data showed that nearly18-40% of melanoma harbors a mutation in at least 1 of the hr genes in their tumor. the commonly altered genes were arid1a, fanca, atm, brca1, atrx and brca2, atr, brca1 brip1 and sf3b1. these findings indicate that hr mutations / alterations are frequently observed in metastatic melanoma, and they suggest that parp inhibitors could potentially be of a great clinical value in a substantial portion of the patients with advanced melanoma. in this clinical study, clinical efficacy of fluzoparib in combination with camrelizumab and temozolomide will be evaluated by assessing an objective clinical response rate in patients with advanced, metastatic melanoma with the homologous recombination (hr) pathway gene mutation / alteration.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of unresectable or metastatic stage iii or iv melanoma; 2. must have genetic hr and/or sf3b1 mutation/ alteration; 3. must have measurable disease based on recist 1.1; 4. must have an ecog performance status of 0 to 1; 5. must have recovered from all aes due to previous therapies to ≤grade 1 or baseline; 6. anticipated overall survival more than 3 months; 7. male and no pregnant female, able to adapt birth control methods during treatment. exclusion criteria: 1. previously treated with a parp inhibitor; 2. hypersensitivity to fluzoparib or camrelizumab or temozolomide; 3. has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; 4. has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; 5. patients with a history of other (including unknown primary) malignancies within 5 years prior to the first dose of trial treatment;

Keywords: homologous recombination (hr) parp inhibitor anti pd-1 antibody
the evaluation of lung cancer patient treated with epidermal growth factor receptor tyrosine kinase

Conditions: Non-Small-Cell Lung Cancer

Summary: to evaluate non-small cell lung cancer (nsclc) patients clinical profile and the outcome after treatment with gefitinib in pulmonary oncology outpatient clinic dr. soetomo general hospital, surabaya, indonesia.

primary objective: to determine the efficacy of gefitinib in nsclc patient harboring a positive egfr mutation. secondary objective: to evaluate the subjective response of nsclc patients harboring a positive egfr mutation who treated with gefitinib. safety objective: to evaluate the safety and tolerability of gefitinib in nsclc patient harboring a positive egfr mutation.

Eligibility criteria:
inclusion criteria: * nsclc based on histopathologic examination * adenocarcinoma and/or nonadenocarcinoma based on histology examination * clinical stadium stage iiib and iv * age 16-70 years old * received gefitinib as therapy * at least completed 2 (two) data sets of recist 1.1 evaluations during the study period from january 2013 until july 2015 exclusion criteria: * missing data of any variables of the treatment outcomes in the medical record

Keywords: adenocarcinoma non-adenocarcinoma
patient blood management in patients scheduled for cardiac surgery

Conditions: Anemia; Anemia, Iron-Deficiency; Iron Deficiency Anemia Treatment; Iron Deficiency Anemia (IDA); Cardiac Surgical Patients; Blood Loss, Surgical

Summary: the icarus 2 study has the general objective of collecting data in patients undergoing cardiac surgery; in our centre, in order to optimize and improve hemoglobin values, a team of haematologists, assisted by cardio anesthetists and cardiac surgeons, will evaluate the blood tests of patients scheduled for elective cardiac surgery in order to correct any states of hypoferritinemia (low iron in the blood) to promote recovery from blood losses related to cardiac surgery. this objective is strongly encouraged by the good use of blood programs currently in force at our foundation. in particular, the research presented here intends to demonstrate a reduction in the number of intra- and post-operative transfusions.

a significant percentage of patients schduled for cardiac surgery have an absolute or relative iron deficiency (id) with or without anemia. preoperative outpatient treatment of anemia and iron deficiency is one of the pillars of patient blood management (pbm). data collected at our institution show that 35% of patients undergoing cardiac surgery at the foundation receive 2 or more units of concentrated red blood cells at surgery or in the following 7 days. a recently published ambispective study (icarus) demonstrated that intravenous iron supplementation, even in the immediate pre-operative period (i.e 1 or 2 days), reduces the number of post-operative transfusions and the length of hospital stay. similar results were recently obtained by other authors in a randomized study. assuming the correction of id at an earlier stage, the haematological outcome could be significantly better, with a reduction in the percentage of patients transfused and in the average transfusion requirement, increase in haemoglobin levels at discharge, improvement in clinical conditions and possible further reduction of the length of stay. all this could translate into a further reduction in costs related to the intervention. the study is observational and involves the early application of the pbm program based on good clinical practice which includes the correction of absolute or relative id. this deficiency will be treated at least 2 weeks before the planned cardiac surgery: the patient will receive an i.v. of iron in the clinic, in accordance with the indications, doses and route of administration for which the use of the drug is approved and the drug distributed on the market. at the same time as iron administration, vitamin supplementation will be prescribed (vitamin b12 1 mg total subcutaneously) and oral folic acid (5 mg/day).

Eligibility criteria:
inclusion criteria: - all adult patients scheduled for elective cardiac surgery exclusion criteria: * pregnancy * dyalisis * patient's refusal

Keywords: iron anemia cardiac surgery patient blood management
optimizing subcutaneous fentanyl titration: rapid achievement of adequate exposure when treating cancer-related pain.

Conditions: Cancer Pain

Summary: the primary objective is to evaluate the effect of loading boluses when dose incresaing treatment with sc fentanyl in patients with cancer. the primary endpoint of this study is to prove the non-inferiority of fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient. patients will be treated with additional loading boluses and plasma-pk samples will be obtained.


Eligibility criteria:
inclusion criteria: * age ≥18 years; * able to understand the written information and able to give informed consent. * current or planned treatment with sc fentanyl for cancer-related pain exclusion criteria: * pregnancy or/ and breastfeeding * other ways of using fentanyl (sublingual, nasal spray and oromucosal) * liver function cps b or c * the use of strong cyp3a4 inhibitors of inducers \[9\] * presence of somnolence, respiratory depression or ctcae grade 2 adverse events.