Kornimate/medical-research-clean huggingface dataset:
precisely estimation of the prognostic value of lymph node in escc

Conditions: Esophageal Squamous Cell Carcinoma

Summary: data were collected on a large multi-institution dataset consisting of escc patients who underwent surgery between january 2003 and december 2013 at ten institutions in the people's republic of china. the datasets were approved for research by the institutional review board of each participating center. prior to surgery, all patients received computerised tomography (ct) of the chest and abdomen and eus as part of their routine staging workup. patients received whole body fdg-pet to eliminate the possibility of distant metastases if the attending physician considered it was necessary. all patients in the dataset received a surgical r0 resection; patients who received an r1 or r2 resection were excluded. notably, there is nothing approaching a consensus on the extent of lymph node dissection for escc patients. patients who received neoadjuvant therapy were excluded due to the influence of neoadjuvant therapy on lymph node status and pathologic t stage. the primary endpoints were overall survival (os), which was defined as the time between surgical resection and death from any cause, and cancer-specific survival (css), defined as the time from surgical resection to death caused by escc. after receiving esophagectomy, patients were followed up by clinical examination every three months for the first year, every three to six months for the second year, and every six to twelve months from then on.


Eligibility criteria:
inclusion criteria: 1. minimum age: 18 years 2. patients underwent r0 resection and lymphadenectomy. 3. ecog ps less than or equal 2 4. adequate bone marrow function: leukocytes \> 3,5 x 10\^9/l absolute neutrophil count \> 1,5 x 10\^9/l platelet count \> 100 x 10\^9/l hemoglobin \> 10 g/dl 5. adequate hepatic function: total bilirubin \ 50 ml/min 6. written informed consent before randomization exclusion criteria: 1. r1 or r2 resection 2. patients underwent neoadjuvant therapy 3. fertile patients without adequate contraception during therapy 4. psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 5. history of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:\* central nervous system disorders or psychiatric disability including dementia or epileptic disease; \* active uncontrolled intercurrent infections or sepsis 6. previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. the inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator
neoadjuvant bev plus dof vs dof in lagc and its association with circulating tumor cell

Conditions: Locally Advanced Gastric Carcinoma

Summary: background local advanced gastric carcinoma (lagc) is suggested to be potentially cured by r0 resection, and neoadjuvant chemotherapy can increase the r0 resection rate but not enough. bevacizumab (bev), an anti-tumor angiogenesis monoclonal antibody, combined with chemotherapy has been shown effective in advanced gc. in addition, ctc has been suggested as an indicator of the anti-tumor drugs' efficacy. therefore, in this study, the investigators plan to evaluate the efficacy and safety of neoadjuvant bev plus docetaxel/oxaliplatin/5-fu/cf (dof) versus dof in mainly gastric antrum lagc, and to investigate whether ctc is an effectiveness indicator. methods 86 patients diagnosed as iiib-iiic gc have been enrolled and randomly assigned (1:1) to receive neoadjuvant bev (5 mg/kg, d1) plus dof (docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-fu, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; cf, 200 mg/m2, d1 and d2) or dof each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles. the primary endpoint is r0 resection rate. ctc was detected every 8 weeks. all patients signed the informed consent.


Eligibility criteria:
inclusion criteria: * histologically confirmed locally advanced adenocarcinoma of the stomach. * age of 18 to 70, karnofsky score higher than 80. * t3-4，n1-3，m0 (ajcc 7th), potentially resectable. * no severe functional damage of major organ, normal blood cell, normal liver and kidney function. exclusion criteria: * clinical findings of distant metastasis or peritoneal carcinomatosis * prior systemic (chemo- or targeted) treatment. prior radiotherapy to the upper abdomen * previous malignancy within 5 years, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer * upper gastrointestinal bleeding * any contraindication to treatment with docetaxel, 5-fu or oxaliplatin
a 19-week cognition study of levetiracetam in children with partial onset seizures

Conditions: Epilepsy, Partial

Summary: a 12-week evaluation period will be used to characterize potential cognitive and neuropsychological effects of lev (20 - 60 mg/kg/day), as adjunctive treatment in children 4 - 16 years old, inclusive, with refractory partial onset seizures when compared to adjunctive treatment with placebo.


Eligibility criteria:
inclusion criteria: * pediatric subjects (4 - 16 years old) diagnosed with refractory partial onset seizures for a minimum of six months prior to visit 1 experiencing at least two partial onset seizures during the four weeks prior to visit 1 will be enrolled * subjects should be on a stable regimen of one or a maximum of two other antiepileptic drugs (aeds) for at least 2 weeks prior to visit 1 * subject must have an intelligence quotient (iq) as assessed during visit 1 of at least 70 * subject and parent/guardian should be fluent in english exclusion criteria: * subject must not have had previous treatment with levetiracetam unless, in the opinion of the investigator, the subject's previous treatment was inadequate in dose or duration to provide an accurate assessment of the therapy, or the effect of levetiracetam was confounded by concomitant medication * subject is receiving benzodiazepines on a routine or chronic basic and is unable to discontinue use four weeks prior to visit 1 * subject has seizures too close together to accurately count * subject has a current psychiatric disorder other than mild to moderate attention deficit, behavior, or learning disorders

Keywords: partial onset seizures epilepsy levetiracetam keppra cognition behavior pediatry
comparison of rotating vs. fixed platform of the columbus knee prosthesis

Conditions: Osteoarthritis; Rheumatoid Arthritis; Post-traumatic; Arthrosis

Summary: a population of 100 patients randomised to rotating and fixed pe inlays in the columbus knee prosthesis received a navigated tkr. knee society score as primary endpoint, oxford score, and postoperative rom after one year will be compared.

mobile bearing tibial platform designs are advocated to improve functional results of total knee replacement (tkr), and to reduce wear in the longer term. this study investigates short term functional results with two patient groups who are systematically different in the fixed or mobile tibial bearing only. methods: 100 knees in 97 patients are stratified according to age and gender and randomized into two groups fixed bearing (fb) with 52 knees and mobile bearing (mb) with 48 knees. all receive the same posterior cruciate retaining implant but the tibial tray and bearing (b. braun aesculap columbus cr and rp) by two experienced surgeons and follow an identical rehabilitation regime. physical examinations are performed in a double-blinded manner before the operation and three, six and twelve months thereafter, using the oxford and knee society scoring systems.

Eligibility criteria:
inclusion criteria: * indication for elective tka * agreement to participate in this study * patient age between 40 and 90 years exclusion criteria: * malalignment of the knee to be operated of more than 20° varus or 15° valgus * former operations on the concerned knee (except diagnostic or therapeutic arthroscopy with only meniscus refixation or cartilage smoothing) * joint replacement of another joint of the same leg * infections in the operated joint during the follow-up period * thromboses during the follow-up period * preoperative classification according to asa 4, 5 or 6

Keywords: prosthesis design range of motion, articular arthroplasty, replacement, knee
acute health effects due to ultrafine particles from candles and cooking

Conditions: Candle Burning; Cooking; Lung Function Decreased; DNA Damage; Subjective Health; Asthma

Summary: people spend up to 90% of their life indoor, and the way we live and behave in our homes has substantial effects on our health and well-being. particle contamination is suggested to have substantial negative effects on health, with candles and cooking emitting the largest amount of particles, thus being the largest contributors to indoor air pollution. the overall aim of the present project is to contribute to increased understanding of the association between indoor particulate air pollution and health and well-being.

introduction: people spend up to 90% of their life indoor, and the way we live and behave in our homes has substantial effects on our health and well-being. particle contamination is suggested to have substantial negative effects on health, with candles and cooking emitting the largest amount of particles, thus being the largest contributors to indoor air pollution. little is known about the potential adverse health effects of candles and cooking, and people with asthma may be more susceptible. aim: to investigate local and systemic effects of short-term exposure to lit candles and cooking among young asthmatics. design: in a randomised double-blinded cross-over study non-smoking asthmatics (18-25 years) were exposed for five hours at three different exposure conditions separated by 14 days; a) clean filtered air, b) lit candles and c) cooking emissions under controlled environmental conditions. measurements: tsi p-trak ultrafine particle counter was used for particle counts. health effects, including lung function (fev1/fvc) and fraction of exhaled nitric oxide (feno) were evaluated in relation to local and systemic effects prior to, right after and 24 h. after exposure. analysis: mixed methods approach taking both time and exposure into account.

Eligibility criteria:
inclusion criteria: * aged 15-25 * medically treated / physician diagnosed mild seasonal asthma * never smoker or ex-smoker ≥ 6 months * allergy \> 1 common allergy exclusion criteria: * any other disease that could influence the study parameters * conditions that prevent safe access to the climate chambers (such as claustrophobia) * perennial asthma * need for continuous medical treatment for asthma * pregnancy

Keywords: particle contamination indoor air acute health effects rct asthma
immunonutrition supplementation in head and neck cancer patients undergoing cancer treatment study

Conditions: Head and Neck Cancer

Summary: this is a prospective, randomized, open-label intervention study to evaluate the effectiveness of immunonutrition supplementation in head and neck cancer (hnc) patients during cancer treatment.

the study population will be adult hnc patients receiving radiotherapy and chemotherapy treatment. the targeted number of subjects is 116 patients (58 subjects in each arm). participants will be randomly assigned to receive standard medical nutrition therapy (individualized dietary assessment and counselling, and standard nutrition supplementation as necessary) or standard medical nutrition therapy with high energy, high protein, immunonutrient-enriched oral nutrition supplementation. immunonutrition supplementation will begin 1 week prior to cancer treatment and continued throughout the cancer treatment, and to be taken in 3 servings/day. the study involves interviewing of subjects for dietary and nutrition assessment; measurement of weight, body composition, handgrip strength; and data collection from subjects' medical records.

Eligibility criteria:
inclusion criteria: * written informed consent obtained * adult hnc patients, male or female, above 18 years of age * primary hnc diagnosis, stage i to iii; including: cancer of the nasopharynx, oropharynx, oral cavity, hypopharynx, or larynx, etc. * referred and planned for curative-intent cancer treatment (radiotherapy and chemotherapy) * eastern cooperative oncology group (ecog) performance status \< 2 exclusion criteria: * inability or unwillingness to provide written informed consent or comply with the requirements of the protocol * patients with metastatic stage or recurring/relapse of cancer at same site * planned for palliative cancer treatment * underlying severe hepatic failure or renal dysfunction (egfr \< 30ml/min/1.73m2) * underlying severe sepsis, neutropenia, immune-deficiencies or autoimmune diseases * consumption of supplements or enriched foods containing immunonutrients (omega- 3, arginine or nucleotides) in the previous month prior to study; including dietary supplements such as: fish oil capsules, arginine tablets/powder, rna capsules, etc. * known allergy or intolerance to components of the immunonutrition supplement (cow's milk, fish or soy) * enrolment in other cancer treatment trials

Keywords: immunonutrition arginine omega 3 fatty acid radiotherapy cancer treatment head and neck cancer
an eight-week study to evaluate the efficacy and safety of sr58611a in elderly patients with generalized anxiety disorder

Conditions: Anxiety Disorders

Summary: the primary objective of this study is to demonstrate the efficacy of sr58611a 350 mg twice a day compared to placebo in elderly patients with generalized anxiety disorder (gad), as assessed by the 14-item hamilton anxiety rating scale (ham-a). secondary objectives are to evaluate the tolerability and safety of sr58611a in elderly patients with gad, to evaluate the efficacy of sr58611a compared to placebo on disablility and quality of life in elderly patients with gad and to evaluate the tolerability and safety of 24 weeks of additional treatment with sr58611a in elderly patients with gad.


Eligibility criteria:
inclusion criteria: * patients diagnosed with generalized anxiety disorder (gad) as defined by diagnostic and statistical manual of mental disorders (dsm-iv-tr) criteria and supported by the mini international neuropsychiatric interview (mini) plus generalized anxiety disorder module exclusion criteria: * minimum total score of less than 22 on the 14-item ham-a scale * total score of 18 or higher on the montgomery-asberg depression rating scale (madrs) * mini-mental state examination (mmse) score of 22 or less the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: anxiety anti-anxiety agents
safety and efficacy of imatinib versus interferon-α plus cytarabine in patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukemia

Conditions: Chronic Myelogenous Leukemia

Summary: the purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and ara-c for patients who have chronic myeloid leukemia (cml) in the chronic phase. patients in this study will be randomized (1:1) to receive either interferon plus ara-c or imatinib as initial treatment.


Eligibility criteria:
inclusion criteria: * must have signed consent for amendment 5 * must have completed visit 62 of the core iris trial or be in follow-up * must be on sti571 treatment * if on ifn treatment, must be willing to cross over to sti571 treatment exclusion criteria: * patients who have discontinued from the study and are in follow-up * patients who are on ifn treatment and do not want to cross over to sti571 treatment * patients who have not consented to amendment 5 * patients who did not complete the amendment 5 protocol additional protocol-defined inclusion/exclusion criteria may apply

Keywords: cml sti571 imatinib interferon interferon alpha cytosine arabinoside chronic myeloid leukemia philadelphia chromosome positive
stroke volume variation vs central venous pressure guidance fluid management in endovascular aortic repair

Conditions: Postoperative Complications

Summary: hypothesis: fluid management guided by stroke volume variation (svv), compared with central venous pressure (cvp), guidance results in better clinical outcomes. primary outcomes: perioperative, up to 48 h postoperative, serum lactate and creatinine level. methods: adult patients undergoing endovascular aortic aneurysm repair (evar) will be randomized into 2 groups: svv group managed by svv guidance and cvp group managed by cvp guidance. outcome analyses: compare serum lactate, creatinine as well as other postoperative complications between both groups.

objective: to compare postoperative clinical outcome in adult patient undergoing evar. primary outcome: postoperative serum lactate and creatinine. secondary outcome: postoperative complications. methods: eligible patients will be randomized to 2 groups. both groups will be managed intraoperatively in the same way, except fluid management protocol. svv group will be managed according to stroke volume variation (svv) protocol, i.e., control svv 10-13% and give fluid when svv \> 13%. cvp group will be managed using central venous pressure (cvp) protocol, i.e., control cvp 8-12 mmhg and give fluid when cvp \< 8 mmhg. outcome analyses: postoperative serum lactate and creatinine of both groups will be compared using unpaired student-t test. secondary outcomes will be compared using chi-square test.

Eligibility criteria:
inclusion criteria: 1. 40-80 years old 2. patient had aortic aneurysm both thoracic and abdominal types 3. scheduled for elective evar procedures 4. new york heart association (nyha) or american society of anesthesiology (asa) classification i-iii 5. body mass index (bmi) 18-24 kg/m2 6. provided informed consent before surgery exclusion criteria: 1. scheduled for emergency or redo surgery 2. received prior fluid therapy (\>2,500 ml/day over the 48 h before the surgery) 3. presence of congenital heart disease, cardiomyopathy, rheumatic heart disease, or significant arrhythmia or cardiopulmonary dysfunction, or significant renal or liver diseases 4. preoperative use of vasoactive drugs (e.g. digoxin, nitroglycerine, nifedipine) for ≥3 months 5. difficulty (or contraindication to) placing a central venous catheter 6. inability to cooperate (e.g. mental disorder, disturbance of consciousness, mental retardation) 7. presence of blood-borne infectious disease (e.g. syphilis, acquired immunodeficiency

Keywords: stroke volume variation central venous pressure serum lactate serum creatinine
perioperative treatment outcomes of early nsclc

Conditions: NSCLC

Summary: this is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes of perioperative nsclc patients receiving different treatment strategies. according to the inclusion and exclusion criteria, perioperative nsclc patients admitted to the study center from january 1, 2020, to one year after the study initiation will be retrospectively screened and collected.


Eligibility criteria:
inclusion criteria: * stage i-iii nsclc patients confirmed by histological or cytological examination based on the 8th edition of the ajcc staging system. * patients who have undergone radical lung cancer surgery. * patients who have received neoadjuvant treatment before radical lung cancer surgery, including chemotherapy, targeted therapy, or immunotherapy both alone or combined. exclusion criteria: * patients with other previous malignancies, except those who achieved complete remission at least two years before radical lung cancer surgery and did not require additional treatment. * patients with incomplete key baseline and treatment information，including clinical stage, pathological type, neoadjuvant treatment, pathological response, imaging response after neoadjuvant. * patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown. * prior surgery, radiotherapy or systemic therapy for nsclc, including radiofrequency ablation, etc.

Keywords: nsclc； perioperative treatment
a long term extension study of e2080 in lennox-gastaut patients

Conditions: Lennox-Gastaut Syndrome

Summary: to investigate the safety of long term administration of e2080 in the patients with lennox-gastaut syndrome who completed the e2080-j081-304 study.


Eligibility criteria:
inclusion criteria: 1. participants who have completed the evaluation of week 12 of the e2080-j081-304 study. 2. male participants with reproductive ability and female participants with child-bearing potential, or their partners, had to be able to take medically appropriate contraceptive measures. 3. participants who have provided a written informed consent to participate in this clinical trial until the evaluation of week 12 of the e2080-j081-304 study. 4. participants who had a family member or a caregiver capable of recording the reporting diary, providing participant information necessary for the study, assisting treatment compliance, and accompanying the participant on scheduled visit days during the study period. exclusion criteria: 1. participants who were judged by the investigator that they are unfit to participate in this clinical study for safety reasons based on the information up to the evaluation of week 12 of the e2080-j081-304 study. 2. participants who were judged by the investigator that they are likely to become non-compliant with administration during the clinical trial period. 3. participants who were judged by the investigator that they were unfit to participate in this clinical trial.

Keywords: epilepsy seizures
trial assessing safety and efficacy of gammanorm® in autoimmune diseases

Conditions: Autoimmune Diseases

Summary: this observational trial assesses the safety and efficacy of gammanorm® in autoimmune diseases.


Eligibility criteria:
inclusion criteria: 1. adult man or woman older than 18 years, 2. patient with autoimmune disease such as cidp, mmn, pm, dm, mi, itp, nam or any other off-label use of gammanorm®, 3. patient who has a prescription of gammanorm® treatment for immunomodulation, 4. patient accepting to participate in the study by oral consent after having received oral and written information on the study. exclusion criteria: 1. patient treated with gammanorm® for immune substitution, or other authorized use 2. patient who refuses to participate in the study.