Kornimate/medical-research-clean huggingface dataset:
cyberknife after breast conservative surgery

Conditions: Breast Cancer

Summary: accelerated partial breast irradiation with cyberknife (ck-apbi) is a promising innovative approach for early breast cancer after conservative surgery, for addressing the need of a radiotherapy target only to the surgical cavity in selected patients, exceeding the limits of other pbi/apbi.

the large majority of local recurrences in breast cancer after breast conserving treatment are close to the original tumor site. this evidence suggested to restrict the radiotherapy target to the surgical cavity in selected patients. consequently, shorter fractionation strategies focused only on tumor bed with a small cuff of surrounding subclinical disease, i.e. accelerated partial breast irradiation (apbi), were developed. stereotactic radiotherapy was thought, consisting of a short course of intense treatment focused on the target tissue. there is very little experience with ciberknife for early breast cancer until now. this study is a prospective non-randomized study designed to assess the acute, sub-acute, late toxicity, cosmesis and globally the feasibility of cyberknife (ck-apbi). from june 2013 to june 2018 we are going to enroll 80 patients considered eligible for the present study. all patients will be followed for at least 2 years. a first enrollment of 20-25 patients is scheduled as first assessment. breast magnetic resonance imaging (mri) will be aided to mammography and ultrasound examination for confirming the best selection of patients. for the assessment of acute toxicity, cosmetic results by three different observers (physician, patient, external observer), medium term and late toxicity, patients were evaluated and the results recorded immediately before and after radiotherapy, then after 1 month, three, six, nine, and twelve, and twenty-four months. the toxicity will be correlated to the main radiotherapy treatment dosimetry and delivery recorded.

Eligibility criteria:
inclusion criteria: * patients were ≥45 years of age with stage i-iia histologically confirmed breast carcinoma, with tumor-free (at least 2 mm or more) inked histologic margins at surgical resection. exclusion criteria: * invasive lobular or multicentric carcinoma; * extensive associated non-invasive ductal carcinoma (synchronous or previous); peritumoral vascular invasion (\>3 vessels); * brca mutation carriers, * \>4 involved axillary lymph nodes, * distant metastasis, * non-epithelial malignancies of the breast, * synchronous contralateral invasive carcinoma, * paget disease, * history of previous malignancy (except non-melanoma skin cancers and in situ oral cavity and cervix carcinoma); * further exclusion criteria were pregnancy, collagen vascular disease, aesthetic additive prostheses, severe cardiac, pulmonary and liver diseases, infectious, psychiatric illness compromising the correct acquisition of informed consent.
thrombolysis with rhpro-uk in 4.5-6 hours after acute ischemic stroke in a double-blinded,controlled trial

Conditions: Acute Ischaemic Stroke

Summary: this is a randomized,controlled, double-blinded, phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhpro-uk) versus basic treatment for patients with acute ischaemic stroke in 4.5-6 hours after stroke onset.


Eligibility criteria:
inclusion criteria: 1. ischemic stroke with symptoms of neurological deficits. 2. aged 18 to 80 years,male or famale. 3. nih stroke scale（nihss）scores of 4 to 25. 4. treatment 4.5 to 6 hours after stroke onset.(stroke onset time is defined as the last time a patient with no clinical neurological deficit,for patients who wake up with stroke symptoms, consider that stroke occurs when the patient begins to fall asleep). 5. the symptoms of stroke last at least 30 minutes without significant improvement before treatment. 6. ct showed negative or signs of early infarction. 7. patients and/or their families are willing to participate in this study and agree to sign informed consent. exclusion criteria: 1. patients with premorbid modified rankin scale(mrs) score ≥2 2. ct showed multiple infarctions（low density\> 1/3 cerebral hemisphere）. 3. transient ischemic attack. 4. epileptic seizure when stroke onset. 5. intracranial tumor, arteriovenous malformation and aneurysm. 6. iatrogenic stroke. 7. thrombectomy is planned. 8. cardioembolism and atrial fibrillation. 9. myocardial infarction history within 3 months. 10. severe cerebral trauma or stroke history within 3 months. 11. blood pressure is still out of control after aggressive antihypertensive treatment.uncontrolled blood pressure is defined as systolic blood pressure≥ 180mmhg or diastolic blood pressure≥100mmhg. 12. high density lesions (bleeding) and subarachnoid hemorrhage is revealed by emergency ct examination. 13. active visceral hemorrhage. 14. patients with intracerebral hemorrhage history. 15. patients with diabetic retinopathy history. 16. puncture in 1 week which can not be oppressed. 17. major surgery or severe trauma within 2 weeks. 18. intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days. 19. heparin treatment within 48 hours (aptt above normal upper limit). 20. taking anticoagulant drugs orally, and pt \>15s or inr \>1.7. 21. high risk of acute hemorrhage include platelet count\<10\^9/l. 22. taking thrombin inhibitors or factor xa inhibitor with abnormal results of sensitive laboratory examination(e.g. aptt, inr, plt, fib、tt or appropriate ⅹ a factor activity test, etc.). 23. blood glucose \ 22.2 mmol/l. 24. pregnancy, lactating or menstrual women. 25. patients who have difficulty swallowing and are unable to take medications orally. 26. clinician thinks patient doesn't fit to participate in the test of other diseases or conditions.
melphalan and autologous stem cell transplant followed by bortezomib and dexamethasone in treating patients with previously untreated systemic amyloidosis

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: the purpose of this study in patients needing treatment for al amyloidosis is to see how well treatment with iv melphalan works and then, if some clonal plasma cells are still present about 2 to 3 months after melphalan treatment, to see how well treatment with bortezomib and dexamethasone works to reduce the rest of the clonal plasma cell disease.


Eligibility criteria:
disease characteristics: * histologically confirmed amyloidosis * diagnosed within the past 12 months * clonal plasma cell disorder, as demonstrated by any of the following: * presence of m-protein in serum and/or urine by immunofixation and/or serum free light chain assay * clonal population of plasma cells in the bone marrow based on kappa/lambda staining of a marrow biopsy * negative genetic testing for hereditary forms of amyloidosis * no amyloid-specific syndrome (e.g., carpal tunnel syndrome or skin purpura) as the only evidence of disease * vascular amyloidosis only in a bone marrow biopsy specimen or in plasmacytoma is not indicative of systemic amyloidosis * no advanced cardiac amyloidosis * must have symptomatic involvement of no more than 2 of the following visceral organ systems: * kidneys * liver/gastrointestinal * peripheral/autonomic nervous system * heart * no persistent pleural effusions * no clinically overt multiple myeloma with \> 30% plasma cells in the bone marrow or lytic bone lesions * able to undergo autologous stem cell transplantation patient characteristics: * swog performance status 0-3 * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * bilirubin \< 2.0 mg/dl * creatinine clearance \< 51 ml/min allowed * lvef \> 45% by echocardiogram * no new york heart association class iii-iv congestive heart failure * no history of cardiac syncope * no recurrent symptomatic arrhythmias * no oxygen-dependent restrictive cardiomyopathy * no myocardial infarction within the past 6 months * pulmonary diffusion capacity \> 50% predicted by pulmonary function testing * no uncontrolled infection * no other active malignancy, except for any of the following: * adequately treated basal cell or squamous cell skin cancer * in situ cervical cancer * adequately treated stage i cancer from which the patient is currently in complete remission * any other cancer from which the patient has been disease-free for 5 years * no hypersensitivity to bortezomib, boron, or mannitol * no hiv positivity * no serious medical or psychiatric illness that would preclude study compliance prior concurrent therapy: * at least 14 days since prior investigational drugs * no prior therapy for monoclonal plasma disease

Keywords: primary systemic amyloidosis
a pet study of the effects of p38 map kinase inhibitor, vx-745, on amyloid plaque load in alzheimer's disease (ad)

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Summary: this study will assess the effects of administration of vx-745 for 12 weeks on amyloid plaque burden in alzheimer's disease (ad). subjects who meet entry criteria will undergo 11c-pib (carbon-11-labeled pittsburgh compound b) positron emission tomography (pet) at baseline and after 45 days of dosing with vx-745. cognitive testing will also be conducted at baseline and day 45.


Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * diagnosis of mild cognitive impairment (mci) due to probable ad or of mild ad * mmse range: 20 to 28 * evidence of amyloid pathology by amyloid pet scan * participants may be taking medications for ad, provided that the dose of these medications has been stable for \>3 months * proficiency in dutch and adequate visual and auditory abilities to be able to perform all aspects of the cognitive and functional tests * adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments. exclusion criteria: * evidence of neurodegenerative disease other than ad * inability for any reason to undergo pet and fmri scans (including notably: history of allergic reaction of any severity to 11c-pib injection; pacemaker, vascular stent or stent graft) * psychiatric disorder that would compromise ability to comply with study requirements * significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder or metabolic/endocrine disorders or other disease that would preclude treatment with p38 map kinase inhibitor and/or assessment of drug safety and efficacy * recent (\<90 days) changes to ad medications prescribed for cognitive reasons or with the potential to impact cognition * participation in a study of an investigational drug less than 6 months or 5 half-lives of the investigational drug, whichever is longer, before enrollment in the study * male subjects with female partner of child-bearing potential who are unwilling or unable to adhere to contraception requirements * female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingoophorectomy * positive urine or serum pregnancy test or plans desires to become pregnant during the course of the trial * any factor deemed by the investigator to be likely to interfere with study conduction
a study of mab-3f8 plus granulocyte-macrophage colony-stimulating factor (gm-csf) versus 13-cis-retinoic acid (ra) plus gm-csf in primary refractory neuroblastoma patients

Conditions: Primary Refractory Neuroblastoma

Summary: this is a multicenter, randomized, controlled, open-label study. patients meeting inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of mab-3f8 plus gm-csf or ra plus gm-csf. patients who do not respond to their assigned treatment after two cycles may cross-over to receive the alternate treatment. disease response and safety will be assessed in all patients after cycle 2 and after cycle 4.


Eligibility criteria:
inclusion criteria: * have a diagnosis of stage 4 neuroblastoma diagnosed in accordance with the international neuroblastoma staging system: either (a) histologic confirmation which may involve immunohistochemical, ultrastructural, and/or cytogenetic studies, or (b) elevated urinary catecholamines plus tumor cells/clumps in the bone marrow. * have evaluable disease or biopsy-proven stable disease in bm by histology or mibg scan with mibg-positive disease confined to the bone or bone marrow, plus urine catecholamine results, documented \>3 weeks after conventional chemotherapy or \>6 weeks after stem-cell transplantation. ct, mri, or bone scan (if necessary) can be done at 2-3 weeks after conventional chemotherapy confirming that the chemotherapy, radiotherapy, and abmt are not realistic curative options. * be between 18 months to 13 years old at diagnosis. * have recovered to grade 2 or better toxicities since their prior therapy. * must, if female of childbearing potential, be willing to use two forms of medically acceptable contraception (at least one barrier method) and have a negative pregnancy test at screening and monthly thereafter through the first four cycles of treatment. * have a performance score of at least 60 from lansky play performance scale if aged up to 16 years or at least 60 from karnofsky scale if aged more than 16 years. * have voluntarily agreed to participate. exclusion criteria: * have measurable disease ≥ 1 cm assessed by ct or mri. * have progressive disease (any new lesion; increase of any measurable lesion by \>25%; or previous negative marrow positive for tumor). * have disease detectable in cns (confirmed by ct or mri of the brain at screening or within 8 weeks of randomization). * be receiving alternative therapy for the treatment of neuroblastoma, e.g. radiotherapy or chemotherapy within 3 weeks of randomization. * require additional therapy (such as radiotherapy) during the first two treatment cycles. * have detectable human anti-mouse antibody titers at screening. * have received prior anti-gd2 investigational therapies. * have a history of allergies to mouse proteins. * have an active infection requiring iv infusion of antibiotics. * be currently receiving long-term chronic treatment with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (acth), or systemic corticosteroids.

Keywords: neuroblastoma 3f8 primary refractory
a trial of shr-7787 injection in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of shr-7787 injection monotherapy for patients with advanced solid tumors. to explore the reasonable dosage of shr-7787 injection monotherapy for patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. ability to understand and voluntarily agrees to participate by giving written informed consent for the study; 2. patients with unresectable recurrent or metastatic solid tumors; 3. there is at least one lesion could be measured; 4. an eastern cooperative oncology group (ecog) performance status (ps) score of 0 or 1; 5. adequate organ functions as defined; 6. life expectancy ≥3 months. exclusion criteria: 1. patients with known active central nervous system (cns) metastases; 2. subjects who had other malignancy in five years before the first dose; 3. patients with tumor-related pain that cannot be controlled as determined; 4. patients with serious cardiovascular and cerebrovascular diseases; 5. uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion; 6. patients with severe infections; 7. history of immunodeficiency; 8. history of autoimmune diseases; 9. unresolved ctcae grade \>1 toxicity attributed to any prior anti-tumor therapy 10. active infection; 11. pregnant or nursing women; 12. known history of serious allergic reactions to the investigational product or its main ingredients.
the efficacy and safety of dexibuprofen syrup

Conditions: Fever; Respiratory Tract Infection

Summary: the purpose of this study is to compare the safety and efficacy of dexibuprofen syrup and ibuprofen syrup in patients with fever due to common cold.


Eligibility criteria:
inclusion criteria: * common cold with fever * age 6 months to 14 years exclusion criteria: * gastric ulcer * bleeding tendency * liver disease * kidney disease * hypertension * hypersensitivity to the drug

Keywords: fever due to acute upper respiratory tract infection
a comparative study between three different plating techniques in management of mandibular parasymphyseal fractures.

Conditions: Mandibular Fractures

Summary: the main goal in management of mandibular fractures is to restore the pre-injury form and function, with the least disability and shortest recovery period.

currently there are a diversity of metallic hardware used for fixation of jaw fractures. however, the proper selection of the suitable technique is still a matter of debate. the aim of the current study was to compare between the effect of two miniplates, 2.3 high profile miniplates and three dimensional (3d) miniplates for internal fixation treatment of mandibular para-symphyseal fractures.

Eligibility criteria:
inclusion criteria: 1. patients with symphyseal/ parasymphyseal mandibular fracture. 2. patients presenting within 7 days of trauma. exclusion criteria: 1. associated fractures that could affect occlusion or dimensions 2. medically compromised patients who are unfit for management under general anesthesia 3. patients with gross infection at the site of fracture 4. patients not willing to return for follow-up 5. patients with associated bone pathology

Keywords: parasymphyseal mandibular fracture internal fixation miniplates 3d miniplate
surgery versus no surgery for osteoarthritis (oa) of the knee

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study is to discover whether arthroscopic surgery is helpful in controlling the symptoms of osteoarthritis of the knee.

although arthroscopic surgery has been widely used for osteoarthritis of the knee, scientific evidence to support its efficacy is lacking. this study will compare optimized physical and medical therapy alone with arthroscopic treatment in addition to optimized physical and medical therapy.

Eligibility criteria:
inclusion criteria: * idiopathic or secondary osteoarthritis of the knee with grade ii to iv radiographic severity as defined by the modified kellgren and lawrence classification exclusion criteria: * patients with inflammatory or post-infectious arthritis * those who had undergone previous arthroscopic treatment for knee osteoarthritis * those with isolate grade iii to iv medical compartment osteoarthritis with greater than 5 degrees of varus deformity.
unraveling the relation of patient's profile and therapeutical effects of atypicals, including quetiapine effect

Conditions: Mania; Schizophrenia

Summary: with this observational study we want to examine if the intensity of agitation, the intensity of psychotic symptoms and the presence of sleeping disorder predict the success of the treatment with a atypical antipsychotic after 12 weeks of treatment with patients with a psychotic and/or manic episode. in this study it will be examined what the percentage of patients with a 2-point improvement at the cgi-scale is. of these group, the responders, retrospective the profile of the responders will be analysed (key-factors and confounders). please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * patients with a manic episode or patients diagnosed with schizophrenia (psychotic episode) * patients who start a treatment with an atypical antipsychotic : quetiapine, olanzapine or risperidone * patients who are prepared to consent to make the coded data available to astrazeneca * patients with a cgi ≥ 4 exclusion criteria: * patients with a serious underlying disease (including renal or hepatic insufficiency, cancer, cardiovascular diseases and suchlike). * contra-indications for quetiapine, olanzapine or risperidone according to the smpc for these products * patients unable to give informed consent according to the attending physician

Keywords: patients with a manic episode patients diagnosed w/schizophrenia, who start a treatment with an atypical antipsychotic & who are at least scored as moderately ill on the cgi at baseline
chinese sports injury treatment situation and development trend of big data research

Conditions: Sports Injury

Summary: this project is planned to be based on the medical insurance database collected by the china health insurance research association (chira). as a national academic research institution, chira collects medical insurance patient data, covering more than 20 provinces across the country. the data of more than 60 municipalities, provincial capitals, and prefecture-level cities are unique and authoritative in my country. based on the chira database, big data analysis for chinese sports medicine patients, starting from the names of medical institutions, admission/discharge diagnosis and classification of medical items, etc., to investigate the development trend of arthroscopic surgery in china and understand my country's arthroscopic diseases the distribution characteristics and changing trends of the quantity.

sports medicine is a multidisciplinary comprehensive discipline, and is positioned as a secondary discipline in the country. it is a clinical application-based discipline that combines medicine and sports to solve sports-related diseases from a medical perspective. the treatment range is centered on the joints. the main treatment method is arthroscopic technology to solve sports-related injuries. together with postoperative rehabilitation, the goal is to achieve the greatest recovery of motor function. this project is planned to be based on the medical insurance database collected by the china health insurance research association (chira). as a national academic research institution, chira collects medical insurance patient data, covering more than 20 provinces across the country. the data of more than 60 municipalities, provincial capitals, and prefecture-level cities are unique and authoritative in my country. based on the chira database, big data analysis for chinese sports medicine patients, starting from the names of medical institutions, admission/discharge diagnosis and classification of medical items, etc., to investigate the development trend of arthroscopic surgery in china and understand my country's arthroscopic diseases the distribution characteristics and changing trends of the quantity.

Eligibility criteria:
inclusion criteria: 1. discharge diagnosis of patients with sports injury-related injuries (icd codes are m12, m13, m15-m19, m20-m25, m65-67, m70, m71, m75, m76, m94 and s33, s40, s43, s46, s51, s53, s63, s8, s73, s93) 2. patients whose service item name in the detailed database contains the keyword "arthroscope". any one of the above will be included in this topic. exclusion criteria: 1. after the data is cleaned, it does not meet the requirements of sports injury patients; 2. the data content contains obvious defects and cannot be backfilled.