Kornimate/medical-research-clean huggingface dataset:
lymphadenectomy in early ovarian cancer

Conditions: Ovarian Cancer; Lymphadenectomy

Summary: to assess the impact of comprehensive staging surgery with no lymphadenectomy on survival and quality of life in patients with early-stage ovarian cancer.

objectives: compare the efficacy and safety in patients with international federation of gynecology and obstetrics (figo) stage ia -iia epithelial ovarian cancer, undergo completion staging surgery including systematic pelvic and para-aortic lymphadenectomy versus comprehensive staging surgery without lymphadenectomy. outline: this is a randomized phase iii multicenter study. patients will receive comprehensive staging surgery without lymphadenectomy or completion staging surgery including systematic pelvic and para-aortic lymphadenectomy, and the adjuvant chemotherapy will accord to national comprehensive cancer network (nccn) guidelines. patients are followed up every 3 months within the first 2 years, and then every 6 months. projected accrual: a total of 656 patients will be recruited for this study within 5 years.

Eligibility criteria:
inclusion criteria: 1. women aged 18 years to 70 years. 2. primary diagnosis of epithelial ovarian cancer figo stage ia-iia ( recevive no prior treatment or receive incomplete initial surgery)，with indications of adjuvant chemotherapy：①high-grade serous carcinoma; ②grade 3 endometrioid carcinoma; ③clear cell carcinoma; ④grade 2 endometrioid carcinoma with capsule ruptured or pelvic tissues extension ⑤low-grade serous carcinoma、grade 1 endometrioid carcinoma and mucinous carcinoma of the ovary with pelvic tissues extension. 3. patients who have given their signed and written informed consent. 4. good performance status (ecog 0/1). exclusion criteria: 1. non epithelial ovarian malignancies and borderline tumors. 2. suspicious lymph nodes at preoperative radiological evaluation. 3. intraoperative clinically suspicious lymph nodes (bulky nodes). 4. secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma figo ia g1/2, non melanoma skin cancer, breast cancer t1 n0 m0 g1/2) or with any signs of relapse or activity. 5. prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy. 6. diseases of the lymph system (including lymph edema of unknown origin). 7. prior retroperitoneal lymph node dissection (systematic or sampling). 8. any other concurrent medical conditions contraindicating surgery. 9. pregnancy. 10. any reasons interfering with giving of informed consent , abiding by protocol, or regular follow-up.
massage for low back pain in nursing staff

Conditions: Low Back Pain

Summary: objectives: semi experimental clinical trial aimed at verifying the effectiveness of massage for lower back pain occupational as well as to assess the influence of technique in performing work activities and life in the team nursing.

method: 18 officials received 7-8 massage sessions, twice per week, with the same protocol points. data were collected on baseline, after one and two months and they responded 2 questionnaires (functional assessment of oswestry and risk assessment in movement and transfer scale) and the numeric pain scale.

Eligibility criteria:
inclusion criteria: 1. voluntary participation in the study of employees with availability of time for submission to the sessions 2. not be pregnant 3. hold shift of at least 6 hours daily 4. do not go on vacation or leave care during the study period 5. reporting back pain self-reported or confirmed by medical diagnosis 6. not having passed off due to back pain in past 6 months 7. do not submit spondylolisthesis, disc herniation and sciatic pain self-reported or confirmed by medical diagnosis 8. do not use anti-inflammatory drugs 9. individuals that showed greater than 0 (zero) in the numerical pain scale (10) score higher than 15 on the functional assessment questionnaire oswestry exclusion criteria: * employees who left the study or that lost more than one session

Keywords: low back pain
pamidronate administration in breast cancer patients with bone metastases

Conditions: Breast Cancer; Neoplasm Metastasis

Summary: the study objective is to evaluate the differences, in terms of first occurrence of a skeletal event, in patients with breast cancer and symptomatic bone metastases, when pamidronate is administered during 2 years, or when it is administered during 6 months, followed by a six month rest period, and again a 6 month treatment period.

background: pamidronate (pmt) is effective in reducing skeletal related events (sre) in breast cancer (bc) patients with bone metastasis (bm). its best way of administration and optimum treatment duration are still to be determined. objective: evaluate the efficacy of continuous administration (arm a) vs. alternate administration (arm b) of pmt to delay time to first sre in bc pt presenting with symptomatic bm. methods: patients aged \>18, eastern cooperative oncology group (ecog) performance status ≥ 2, adequate renal function, and bc symptomatic bm were eligible. bm was defined as presence of 3 or more hot spots (hs) in skeletal scintigraphy (ss), or any number of hs in ss if osteolytic, osteoblastic or mixed bone lesions determined by radiography, or 2 or less hs in ss if magnetic resonance or ct scan confirmation of bm. symptomatic bm was defined as pain associated to ss hs, or sre (pathological fractures or spine cord compression or radiation bone treatment or tumour induced hypercalcemia), or treatment with analgesia due to bone pain. patients were allowed up to 1 previous chemotherapy and 2 previous hormone therapy lines for metastatic disease. antineoplastic therapy could be changed at any time during the study. eligible patients were stratified (isolated bone metastasis or associated to node or skin lesions vs. bone metastasis associated to visceral disease) and randomized to receive 2 hour-iv. pmt 90 mg every 3-4 weeks for 18 months (arm a) or iv. pmt 90 mg every 3-4 weeks for 6 months, followed by a 6 months rest, and a new 6 months on-treatment period (arm b). quality of life (qol) was measured with short form (sf)-36 questionnaire.

Eligibility criteria:
inclusion criteria: * written informed consent. * up to two previous or current hormone therapy treatments for metastatic breast cancer are allowed. * normal or borderline renal function (serum creatinine \< 1.5 x upper normal limit \[unl\]). * normal calcium levels in serum, or slightly non-symptomatic high levels (\< 1.25 x unl). * performance status 0, i or ii in world health organization (who) scale. exclusion criteria: * treatment with bisphosphonates in the 30 previous days, or any time if the indication was treatment of metastatic bone lesions. * treatment with bisphosphonates is only allowed if the indication is hypercalcaemia. * metastases in central nervous system (cns). * hypersensitivity to bisphosphonates or other components of the formula. * pregnant or lactating women. * previous or current treatment with a second chemotherapy line or a third hormone therapy line for metastatic disease.

Keywords: breast cancer patients with symptomatic bone metastases
lung cancer screening by artificial intelligence device

Conditions: Lung Cancer

Summary: lung cancer screening is currently not recommended in non-smokers due to paucity of evidence. emerging evidence suggests that first-degree family history is a strong risk factor for lung cancer in asian non-smokers. in asia, lack of resource is a major challenge in successful implementation of lung cancer screening. artificial intelligence (ai) is a promising tool to overcome this resource. in this study, we aim to study the clinical utility and demonstrate the feasibility of using an ai assisted programme for lung cancer screening in asian non-smokers with a positive family history. this is a single-arm non-randomized lung cancer screening study. 1000 non-smokers, age 50 to 75 year old, with a first-degree family history of lung cancer, will be enrolled. participants will undergo low does computed tomography (ldct) of thorax and blood taking at enrolment. ldct films will be interpreted by ai softwares for presence of lung nodules. participants with lung nodules will be further investigated and followed up according to the risk of malignancy. the primary endpoint is the prevalence of early-staged lung cancer detected by first-round ldct thorax in this population.


Eligibility criteria:
inclusion criteria: patients are eligible to be included in the study only if all of the following criteria apply: 1. age 50-75 years old 2. non-smoker (defined as less than 100 cigarettes in lifetime) 3. having a first-degree family history of lung cancer 4. physically fit for curative treatment if early-staged lung cancer is found 5. able to provide written informed consent 6. consent to follow up visits and follow up ct scan if indicated 7. consent to blood taking for translational research exclusion criteria: patients who meet any of the following exclusion criteria at screening are not eligible to be enrolled in this study: 1. history of malignancy 2. smoking history (defined as more than 100 cigarettes in lifetime) 3. clinical symptoms suspicious for lung cancer e.g. haemoptysis, chest pain, weight loss 4. medical comorbidities that preclude curative treatment (surgery) for lung cancer, such as severe heart disease, acute or chronic respiratory failure, home oxygen therapy, bleeding disorder 5. pregnant ladies or ladies planning for conception 6. history of tuberculosis or interstitial lung disease 7. pneumonia requiring antibiotic treatment within the last 12 weeks 8. ct thorax or chest performed within 2 years (including ldct or ct coronary angiogram) 9. unable or unwilling to provide written informed consent
imaginal exposure ii study: in-vivo

Conditions: Eating Disorder; Anorexia Nervosa; Bulimia Nervosa; Exposure

Summary: the purpose of this study is to test if imaginal exposure therapy can decrease symptoms of eating disorders and anxiety.

an initial meeting consisting of a screening, questionnaires, and a brief psychoeducation on imaginal exposure therapy, followed by 8-10 sessions with a licensed psychologist (the pi) or a clinical psychology graduate student who is supervised and trained by the pi. in session 1, patients will create a script with the therapist on an eating disorder fear. in sessions 2-10 the therapist and patient will then imagine this eating disorder related fear based on the script. each session will be modified to focus on "hot spots" or the most feared aspect of the script. sessions will be audiotaped and videotaped and participants will be asked to listen to the sessions nightly for homework. sessions will be weekly or twice per week for 8-10 weeks after the initial screening session.

Eligibility criteria:
inclusion criteria: * must be at least 18 years of age (no age limit) * must currently meet criteria for anorexia, sub-clinical anorexia, bulimia, or sub-clinical bulimia (using the eating disorder diagnostic scale), or have met criteria for one of these eating disorders in the last year, or endorse significant eating disorder fears * must have at least one significant eating disorder related fear. exclusion criteria: * under 18 years of age * individuals who have binge eating disorder or an unspecified eating disorder, or who do not meet eating disorder related criteria * individuals who meet criteria for mania, psychosis, or suicidal ideation * participants who are not able to secure transportation to complete therapy sessions

Keywords: eating disorder anorexia nervosa bulimia nervosa imaginal exposure therapy
mechanism of xinglouchengqi decoction in improving nerve injury in the acute stage of stroke by eeg and metabolomics

Conditions: Stroke

Summary: using eeg and metabolomics to evaluate the clinical efficacy of xinglouchengqi decoction in improving nerve injury in the acute stage of stroke and the mechanism

traditional chinese medicine treatment is the original advantage in china for early stroke intervention. xinglouchengqi decoction is an important prescription for the treatment of acute stage of stroke proposed by academician wang yongyan. early intervention can significantly improve the condition of patients and reduce the degree of neurological function deficit, but its mechanism of action is not clear.eeg, network graph theory and metabonomics are applied in evaluating the treatment of stroke, and to explore the mechanism of xinglouchengqi decoction to improve the nerve injury of acute stroke patients. 30 stroke patients with acute period will be as the research object, using the observational cohort studies, to measure the dynamic of nerve function defect, eeg signals and other clinical information. based on eeg to construct the brain functional network in the acute stage of stroke and to study the brain network mechanism of xinglouchengqi decoction in improving the nerve injury of patients. meanwhile, based on the study of metabolomics, the potential biomarkers and the metabolic pathway will be analyse to explore the pharmacodynamic substance.

Eligibility criteria:
inclusion criteria: those who met the diagnostic criteria for acute anterior circulation ischemic stroke; first stroke, no previous history of organic encephalopathy; the onset is less than 72 hours; it is in line with the tcm diagnosis of phlegm heat; aged 40 to 80 years old. exclusion criteria: transient ischemic attack (tia) ; those who have received thrombolytic therapy; the examination confirmed that the stroke was caused by the brain tumor, brain trauma or blood disease; cerebral embolism caused by rheumatic heart disease, coronary heart disease and other heart disease combined with atrial fibrillation; complicated with liver and kidney hematopoietic system endocrine system and other serious diseases and osteoarthropathy; prior mental disorder or severe dementia; patients with concurrent infection and fever; patients with primary or secondary epilepsy; those who had taken sedative drugs or sleeping drugs 3 days before the examination.
study about no antimicrobial prophylaxis in totally laparoscopic distal gastrectomy

Conditions: Gastric Cancer; Complication of Surgical Procedure

Summary: laparoscopic gastrectomy has fewer infectious complications compared to open surgery. recently, the incidence of postoperative infectious complications was greatly reduced due to the development of surgical techniques and improvement of prevention and control of surgical infection. previous multicenter, phase ii study (ksweet-01) revealed that the incidence of infectious complications of laparoscopic gastrectomy without prophylactic antibiotics was not significantly higher than previously reported data. therefore, this study aim to prove the safety of totally laparoscopic distal gastrectomy without prophylactic antibiotics, specially reference to the postoperative infectious complications.

the purpose of this study was to investigate the non-inferiority of incidence of infectious complications in the experimental group that did not use prophylactic antibiotics compared to the control group using prophylactic antibiotics. the primary endpoint is the incidence of surgical site infections within 30 days after surgery and the difference limit of the non-inferiority of the experimental group is assumed to be - 0.05 (5%). assuming that the incidence of postoperative infectious complications in the control group is 5% and the incidence of infectious complications in the experimental group is assumed to be about 8%. it is assumed that the significant level is 5% and the power is at least 80%. according to the above method, a total of 260 patients (130 patients in each group) are needed when 117 patients are needed in each group and about 10% of drop rates and protocol violence are considered.

Eligibility criteria:
inclusion criteria: * a patient undergoing totally laparoscopic distal gastrectomy for the gastric cancer located in the low or middle part of the stomach * a patient who underwent limited lymphadenectomy (d1 or d1+) with clinical t1-2n0m0 stage based on 8th edition of the international union against cancer (uicc) tumor node metastasis (tnm) classification * from 18 to 75 years old * eastern cooperative oncology group (ecog) status 0-1 * american society of anesthesiologists (asa) score i-ii * a patient with appropriate bone marrow function, renal function, lung function, and liver function * before the surgery, decide to participate in this study and agree with the written informed consent exclusion criteria: * a patient who underwent previous abdominal surgery * combined other abdominal organ cancer * a patient who received chemotherapy and radiotherapy within the last 6 months * combined organ resection other than cholecystectomy * a patient undergoing emergency surgery due to perforation or bleeding * a patient who have received antibiotic treatment for other infectious diseases within one month of operation * severely malnourished patient

Keywords: gastric cancer laparoscopic gastrectomy prophylactic antibiotics infectious complications
memantine effects on sensorimotor gating and neurocognition in schizophrenia

Conditions: Schizophrenia; Schizo Affective Disorder; Schizoaffective Disorder; Healthy

Summary: this application seeks to determine if neurophysiological metrics of memantine (mem)-enhanced early auditory information processing (eaip) in schizophrenia (sz) mediate gains in auditory processing fidelity (apf) and auditory learning.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective-depressed or healthy subjects * ages 18-50 for all subjects * double barrier contraception for all subjects * not pregnant for all subjects exclusion criteria: * dsm-iv axis i or ii diagnosis for for healthy subjects * mem or amantadine for patients * current substance abuse for all subjects * current recreational drug use for all subjects * history of other significant medical illness (e.g. cancer, diabetes, heart disease, hiv, seizures) for all subjects * open head injury or closed head injury with loss of consciousness \> 1 min for all subjects * hearing or visual impairment for all subjects * pregnancy for all subjects * dementia for all subjects * mental retardation for all subjects
tissue resistivity in breast cancer patients

Conditions: Breast Cancer

Summary: the resistivity measurements will be done by introducing a needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues.

patients affected by breast cancer will have their tissue analysed immediately following their surgical excision for the treatment of breast cancer. two probes will be used: a linear probe of 4 needle-electrodes positioned in a row that is able to perform electrical impedance spectroscopy (eis) measurements and a circular probe of 8 needle-electrodes arranged into a circular pattern that is able to generate cross sectional images (electrical impedance tomography maps). firstly, the linear probe will be inserted in the tumor parenchyma at a penetration depth of about 2 mm and the tissue impedance measurement will be performed along a broad spectrum of frequencies for few minutes. approximately 10 seconds for each measurement will be needed. subsequently, if the size of the tissue will allow it, the circular probe will be inserted in the tumor parenchyma at the same penetration depth and 10 cross sectional maps will be generated (approximately 30 seconds in total). both information obtained using the linear and the circular probes will be integrated for a full characterization of the tissue under examination.

Eligibility criteria:
inclusion criteria: * age \>18 years * first radiological diagnosis of breast adenocarcinoma needing a histological confirmation * written informed consent exclusion criteria: * tumor mass diameter \< 1 cm * surgical specimen (harbouring tumoral + peritumoral tissue) diameter \< 2 cm
safety and effectiveness study of chemotherapy in combination with erlotinib,or sequential erlotinib for treatment in patients with nsclc

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate and compare safety and effectiveness of chemotherapy in combination with erlotinib,or sequential erlotinib for treatment in patients with egfr - tki resistance of egfr mutations

from the first cycle of treatment (day one) to two month after the last cycle

Eligibility criteria:
inclusion criteria: 1. sign the informed consent 2. ≥18 years 3. according to recist 1.1 standard, at least one measurable lesions 4. histology and cytology confirmed with unfavorable surgical locally advanced stage (stage iiib) or metastatic nsclc (iv), sensitive egfr gene mutation 5. palliative treatment has received two medicine first-line platinum-based chemotherapy and egfr - tki second-line treatment and objective clinical benefit (cr, pr or sd is more than 6 months), resist standard curative effect evaluation for progress 6. ps=0,1,2 7. no serious blood, heart, lung, liver and kidney dysfunction, and immune deficiency 8. hb≥9g/dl；wbc≥3\*109/l，anc≥1.5\*109/l，plt≥75\*109/l 9. men or women of childbearing age in the experiment are willing to take contraceptive measures 10. estimated survival period for 3 months or more exclusion criteria: 1. the palliative chemotherapy ever use docetaxel and pemetrexed 2. small cell lung cancer non small cell hybrid 3. women during pregnancy or lactation 4. in the past the anti-tumor treatment of any outstanding ease of \> ctcae 2 levels of toxicity 5. ccr\<30 ml/min (calculated by cockcroft-gault formula) 6. hepatic insufficiency： tbil\> 1.5×uln alt and ast \> 2.5×uln (patients with liver metastasis\>5×uln) alkaline phosphatase\>2.5 ×uln(patients with liver metastasis\>5×uln) 7. severe symptomatic heart disease 8. symptomatic brain metastases 9. in the last 5 years have been or are suffering from other histological types of malignant tumor 10. there are serious or uncontrolled systemic diseases 11. during the study period planned radiotherapy on target lesion 12. during the study period, plans to use other antineoplastic therapy 13. clinical study on treatment of 30 days beginning period prior to participate in any study drug

Keywords: pfs
dermatoscopy guided resection for skin cancer

Conditions: Basal Cell Carcinoma; Cutaneous Squamous Cell Carcinoma; Surgical Margin

Summary: in this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. the outcome is radical/non radical resection of the lateral margins in the pathology report.

in basal cell carcinoma and especially cutaneous squamous cell carcinoma the prognosis is very good if the tumour is radically removed in the primary resection. in this study we propose that the use of dermatoscopy in deciding the surgical margins can increase the proportion of radically removed tumours. in this randomized clinical trial the use of dermatoscopy in deciding the surgical margins in patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma is assessed. the outcome measure is radical/non radical resection of the lateral margins. in the control group dematoscopy is not used in deciding the surgical margin. 400 patients with suspected or verified bcc or cscc will be included, 200 in each group.

Eligibility criteria:
inclusion criteria: * patients with primary suspected or verified basal cell carcinoma or cutaneous cell carcinoma exclusion criteria: * recurrent tumours * previous radiotherapy of the tumour area * if the patient cannot understand the study i nformation

Keywords: dermatoscopy