Kornimate/medical-research-clean huggingface dataset:
partial chest wall radiation therapy after surgery for lymph node negative breast cancer

Conditions: Breast Cancer; Breast Cancer Female; DCIS; Stage II Breast Cancer; Stage I Breast Cancer

Summary: the standard treatment for breast cancer when cancer cells were found near or within the margins of the tissue that is removed during breast surgery, is radiation of the entire chest wall. this may be considered overtreatment since the only reason for doing so is that cancer cells were near or in the margins of the breast tissue that was removed. in this study, the amount of radiation treatment will be limited to the area where the remaining cancer cells were found after surgery. the purpose of this study is to find out if partial chest wall radiation therapy is as good as whole chest wall radiation therapy in reducing the risk of breast cancer cancer coming back.


Eligibility criteria:
inclusion criteria: * dcis or stage t1 or t2 invasive breast cancer, lymph node negative * must have undergone mastectomy * presence of cancer cells on or close to surgical margins * negative pregnancy test for women * must receive radiation at stony brook university hospital exclusion criteria - received prior radiation to are to be irradiated
masitinib in severe indolent or smoldering systemic mastocytosis unresponsive to optimal symptomatic treatment

Conditions: Indolent Systemic Mastocytosis

Summary: the purpose of this study is to evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients suffering from smouldering or indolent systemic mastocytosis with severe symptoms of mast cell mediator release, unresponsive to optimal symptomatic treatment.

masitinib is a selective tyrosine kinase inhibitor that modulates mast cell activity via inhibition of c-kit, lyn and fyn kinase signaling pathways. this is a multicenter, randomized, double-blind, placebo-controlled, 2-parallel-group, trial comparing oral masitinib versus placebo in the treatment of patients suffering from smouldering or indolent systemic mastocytosis with severe symptoms of mast cell mediator release (also referred to as handicaps), unresponsive to optimal symptomatic treatment. the treatment period is 24 weeks. participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment, followed by dose escalation to 6.0 mg/kg/day after 4 weeks of treatment. each ascending dose titration is subjected to a safety control.

Eligibility criteria:
inclusion criteria: 1. patient with one of the following documented mastocytosis subtypes (variants): smouldering systemic mastocytosis, indolent systemic mastocytosis 2. an excess of mast cells or a presence of abnormal mast cells in at least two organs (among skin, bone-marrow and gi tract). 3. patient with documented systemic mastocytosis and evaluable disease based upon histological criteria 4. patient with documented treatment failure of his/her symptom(s) (within the past 2 years) with at least two of the symptomatic treatments used at optimized dose: anti h1, anti h2, proton pump inhibitor, antidepressants, cromoglycate sodium, antileukotriene. 5. patient with severe symptoms of mastocytosis over the 14-day run-in period including at least one among pruritus, flushes, and depression: pruritus score ≥ 9, number of flushes per week ≥ 8, hamilton rating scale for depression (hamd-17) score ≥ 19. exclusion criteria: 1. patient with one of the following mastocytosis: cutaneous mastocytosis, systemic mastocytosis with an associated clonal hematologic non mast cell lineage disease (sm-ahnmd), mast cell leukemia (mcl), aggressive systemic mastocytosis (asm) 2. previous treatment with any tyrosine kinase inhibitor 3. treatment with any investigational agent within 8 weeks prior to screening.

Keywords: mastocytosis with handicap mastocytosis mast cell mast cell infiltration skin bone marrow pruritus flushes c-kit c-kit mutation wild type mutation asp-816-val(d816v) indolent systemic mastocytosis smoldering systemic mastocytosis
open technique interpectoral catheter for postoperative analgesia in modified radical mastectomy

Conditions: Mammary Cancer

Summary: patients undergoing modified radical mastectomy were divided into two groups. patients in catheter group were placed a catheter with open technique by the surgeon in the pectoral area. thirty minutes before extubation %1 lidocain 10 ml, %0.5 bupivacain 10 ml and 10 ml %0.9 sodium chloride were given through the catheter for postoperative analgesia. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. visual analog pain scale (vas) scores, rescue analgesic requirement, complications were recorded and compared between two groups 1, 6, 12, 24 hours and 90 days after surgery.

patients undergoing modified radical mastectomy were divided into two groups by computer. patients in catheter group were placed a catheter under clavipectoral fascia in the neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis at the 1/3 lateral part of clavicula. solution included 10 ml of %0.5 bupivacain, %1 lidocain, 10 ml %0.9 sodium chloride totally 30 ml were given via the catheter for postoperative analgesia at the end of surgery. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. patients in both groups were given dexketoprofen 50 mg iv if the vas score was over 4. vas scores, rescue analgesic requirement and timing, complications were recorded and compared between groups 1, 6, 12, 24 hours and 90 days after surgery.

Eligibility criteria:
inclusion criteria: * american society of americans class i-ii exclusion criteria: * male * allergy to local anesthetics or * anticoagulant drug use * central or peripheric nerve disease * pregnancy

Keywords: postoperative analgsia peripheral block catheter modified radical mastectomy
retardation of myopia in orthokeratology

Conditions: Myopia

Summary: the primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.

prevalence of myopia is high in asian countries like hong kong. orthokeratology has shown potential in slowing myopic progression but the efficacy is yet to be confirmed by a randomized clinical trial (rct). the current rct aims at studying the efficacy of orthokeratology in retardation of myopic progression by comparing the eye growth in terms of axial length elongation in children wearing orthokeratology lenses (study group) and those wearing single-vision spectacles (control group).

Eligibility criteria:
inclusion criteria: * myopia (refractive sphere): \> 0.50d and ≤ 4.00d * astigmatism: \< ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25d; astigmatism of other axes ≤ 0.50d * spherical equivalent (se): \> 0.75d and ≤ 4.50d * anisometropia: ≤ 1.50d in both refractive sphere, refractive cylinder and se * best corrected monocular visual acuity: equal to or better than 0.10 in logmar scale in both eyes * willingness for randomization * willingness to wear contact lenses or spectacles on a daily basis * availability for follow-up for at least 2 years exclusion criteria: * strabismus at distance or near * contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex * prior experience with the use of rigid lenses (including orthokeratology) * prior experience with myopia control treatment (e.g. refractive therapy or progressive add spectacles) * systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication) * systemic or ocular conditions which may affect refractive development (e.g. down syndrome, ptosis)

Keywords: children corneal reshaping myopia myopia control orthokeratology
5-sense score validation study

Conditions: Epilepsy Intractable

Summary: the purpose of this study is to assess how well a new scoring system called the 5-sense score can predict where seizures start in the brain using stereoelectroencephalography (seeg). the 5-sense score is a 5-point score based on routine presurgical work-up, designed to assist in predicting whether seeg can identify a focal seizure onset zone, thereby sparing patients the risk of undergoing this invasive diagnostic procedure.


Eligibility criteria:
inclusion criteria: * patients aged 15 years or older in whom no direct surgical approach can be offered and who are discussed in the multidisciplinary team discussion * availability of complete non-invasive presurgical work-up (including high-resolution mri according to the in-center epilepsy protocol, video-telemetry with the recording of a minimum of one habitual clinic and eeg seizure, available as original files for review) exclusion criteria: * no telemetry/scalp eeg in center * no protocol mri in center * subdural/grid electrodes

Keywords: epilepsy surgery stereo-electroencephalography
tislelizumab in combination with chemotherapy as a neoadjuvant treatment for advanced endometrial cancer

Conditions: Endometrial Neoplasms

Summary: the goal of this clinical trial is to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a neoadjuvant treatment for advanced endometrial cancer.

this is a multicenter, prospective, single-arm open-label study designed to enhance surgical r0 resection rate, reduce residual lesions, decrease distant metastasis and disease recurrence rates, and prolong the survival of patients with advanced endometrial cancer (stage iii-ivb figo 2023) by neoadjuvant chemotherapy combined with tislelizumab.

Eligibility criteria:
inclusion criteria: 1. voluntary participation and signed informed consent form; 2. age ≥18 years; 3. eastern cooperative oncology group performance status 0-1; 4. the international federation of gynecology and obstetrics (figo 2023) stage iii-ivb of endometrial cancer; 5. has not received any systematic anti-tumor treatment for advanced diseases in the past; 6. have measurable disease according to recist v1.1 criteria; 7. patients must meet the following criteria for laboratory tests to ensure adequate organ function: * anc ≥1,500/mm3, or ≥1.5×109/l * platelet count≥75,000/mm3 or 75 x 109/l * hemoglobin≥9 g/dl or ≥5.6 mmol/l * glomerular filtration rate estimated（egfr） according to the chronic kidney disease epidemiology collaborative group formula （ckd-epi eq6）was≥40 ml/ 1.73m2 * serum total bilirubin ≤ 1.5x upper limit of normal range（uln） * both ast and alt were ≤3 x uln 8. the expected lifespan exceeds 3 months. exclusion criteria: 1. received pd-1 target therapy other than tislelizumab or other antibody or drug therapy that specifically targets t-cell costimulation or checkpoint channels within 6 months before enrollment； 2. has human immunodeficiency virus infection, active viral hepatitis, and active tuberculosis infection； 3. active leptomeningeal disease or uncontrolled, untreated brain metastases resulting in elevated intracranial pressure; 4. major surgical procedures had been performed within 4 weeks before consent was obtained； 5. other conditions deemed by the investigator to be ineligible for enrollment.

Keywords: oncology endometrial cancer tislelizumab
a study to assess the safety and efficacy of tocilizumab in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (ra). patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. the anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients at least 18 years of age with active ra for at least 3 months; * patients of reproductive potential must be using reliable methods of contraception. exclusion criteria: * major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study; * treatment with methotrexate (mtx) within 6 months of entering study; * patients who have stopped previous mtx treatment due to toxicity or lack of response; * women who are pregnant or breast-feeding.
ct7, mage-a3, and wt1 mrna-electroporated autologous langerhans-type dendritic cells as consolidation for multiple myeloma patients undergoing autologous stem cell transplantation

Conditions: Multiple Myeloma

Summary: the purpose of this study is to see if the investigator can help the immune system to work against myeloma. this study will see if a vaccine made with altered dendritic cells will make t cells work against tumor cells. the stem cells collected for the transplant will also be used to grow dendritic cells in the lab. the dendritic cells will carry the antigens. these cells then will be injected under the skin. the investigators will do lab studies before and after the vaccination to find out if the vaccine is working.


Eligibility criteria:
inclusion criteria: * symptomatic multiple myeloma, iss stages i-iii, within 12 months of starting therapy. * completion of induction therapy with very good partial response (vgpr), or better, by international myeloma working group (imwg) criteria. * deemed eligible for asct by standard institutional criteria. * age ≥18 years. * documentation of ct7, mage-a3, or wt1 expression in the bone marrow and/or bone marrow aspirate. exclusion criteria: * prior autologous or allogeneic sct. * previous immunization against ct7, mage-a3, other cancer-testis antigens, or wt1. * known immunodeficiency, hiv positivity, hepatitis b, or hepatitis c. * history of autoimmune disease (e.g., rheumatoid arthritis, sle), other than vitiligo, diabetes, or treated thyroiditis, which are allowed. * history of severe allergic reactions to vaccines or unknown allergens. * participation in any other clinical trial involving another investigational agent within 4 weeks prior to first immunization. * lenalidomide-related toxicities before asct necessitating its discontinuation as part of treatment.

Keywords: ct7 mage-a3 wt1 mrna-electroporated autologous langerhans vaccine autologous stem cell transplantation 13-009
study of nmb (company's name) drug ejecting balloon for arteriovenous fistulae

Conditions: Obstructive Lesions of Arteriovenous Dialysis Fistulae

Summary: the purpose of this study is to demonstrate the safety and effectiveness of the use of nmb's percutaneous transluminal angioplasty (pta) balloon.


Eligibility criteria:
inclusion criteria: * patients 18 years and older * patients with arteriovenous fistula with obstructive lesion * patient who is willing and able to sign a written informed consent exclusion criteria: * age \< 18 * female with child bearing potential * previous participation in another study with any investigational drug or device within the past 30 days * life expectancy of less than 12 months
elucidating the symptomatic, explanatory and prognostic characteristics of geriatric patients hospitalized for covid-19

Conditions: Covid19

Summary: statement : * the emerging coronavirus 2019 (covid-19) disease, linked to the sars-cov-2 (severe acute respiratory syndrome coronavirus 2) pathogen, has been spreading worldwide since december 2019, affecting millions of people and causing hundreds of thousands of deaths, particularly among the elderly. * the first epidemiological evidence available reveals a different expression of the disease in the elderly, associated with a high risk of delayed diagnosis and implementation of protective measures and a particularly high morbidity and mortality, especially among the frailest. * to date, there is no effective model for predicting the severity of covid-19 in an individual. the investigators hypothesize that there are specificities of covid-19 in the elderly, both etiological, diagnostic and prognostic, all of which are not yet known and understood.


Eligibility criteria:
inclusion criteria: * hospitalization in the geriatric unit of the university hospital (uh) of angers from 15/03/2020 and until the closure of the covid-19 geriatric sector exclusion criteria: * opposition to the use of the information collected for research purposes.

Keywords: elderly coronavirus disease
a study of the safety and effectiveness of synvisc-one® (hylan g-f 20) in patients with primary osteoarthritis of the hip

Conditions: Osteoarthritis, Hip

Summary: the primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving synvisc-one compared to control.


Eligibility criteria:
inclusion criteria: * the participant had symptomatic osteoarthritis (oa) in the target joint * the participant had a diagnosis of primary oa of the hip at screening according to the american college of rheumatology (acr) criteria * the participant, if female and of childbearing potential, must had a negative pregnancy test and had taken oral contraceptives for at least 1 month prior to treatment and continued for the duration of the study (up to and including the final study visit), or agreed to use 2 forms of contraception (e.g., condoms plus spermatocide), otherwise females must be surgically sterile, or postmenopausal for at least 1 year exclusion criteria: * the participant had symptomatic oa in the contralateral hip with a western ontario and mcmaster universities osteoarthritis index (womac) a1 numerical rating scale (nrs) score of ≥ 4 at screening (symptomatic oa with a womac a1 nrs score of 0-3 in the contralateral hip was allowed) * the participant if a woman was pregnant, lactating, or unwilling to use adequate contraception * the participant had prior viscosupplementation therapy in the target hip joint within 26 weeks of screening * the participant had a known history of hypersensitivity to avian protein or any components of hyaluronan-based injection devices * the participant had a known history of hypersensitivity to steroids, lidocaine, and/or acetaminophen * the participant had a known history of hypersensitivity to injected contrast agent at a previous radiological examination (e.g., computed tomography \[ct\] scan, angiogram, etc.), or known history of hypersensitivity to shellfish or iodine, or any other impediment to the hip injection procedure * the participant had active infection in the area of the injection site * the participant had any major surgery, arthroplasty or arthroscopy in the target hip or lower extremities within 26 weeks of screening, or planned surgery in the lower extremities throughout the duration of the study infectious complications * the participant used an investigational drug, device or biologic within 12 weeks of screening * the participant had any significant medical condition that the investigator feels would interfere with study evaluations and study participation
pt-led triage for patients with hip o knee osteoarthritis

Conditions: Knee Osteoarthritis; Hip Osteoarthritis

Summary: the aim of this project is to compare pt-led triage in secondary care setting for patients with hip or/and knee osteoarthritis (oa) with standard care (i.e. assessment of orthopedic surgeon). comparison between cost-effectiveness, selection accuracy, patients perceived quality of care, quality of life and physical function will be made. a further aim is to explore patients expectations and experiences of pt-led triage in a secondary care setting.

osteoarthritis (oa) is a common musculoskeletal disorder and the number of people in need of surgical treatment for hip and knee oa is increasing. the waiting time for consultation with an orthopedic surgeon (os) is long and the majority of the patient referred for assessment are not appropriate for surgical intervention. to reduce the number of patients seen by an os and thereby shorten the waiting time, sahlgrenska university hospital started a physiotherapist-led (pt-led) triage project in 2017. with pt-led triage the patients are assessed by a physiotherapist to establish the most appropriate care management; if the patient is appropriate for surgery, should be referred for continued rehabilitation, or referred back to the referring physician. to our knowledge this model of care with pt-led triage in secondary care setting have not been scientifically evaluated in sweden. the aim of this project is to compare pt-led triage in a secondary care setting with standard care (i.e. assessment of os for patients with knee or /and hip oa). a further aim is to determine if a digital triage tool can accurately predict when a primary knee or hip referral is deemed for nonsurgical versus surgical intervention by the surgeon following the first consultation. patients referred from primary care to sahlgrenska university hospital with primary hip and/or knee oa will be included and randomized to consultation with either pt (triage) or os (standard practice). data about patient reported health-related quality of life, pain, function, and patients' perception of quality of care will be collected using questionnaires at baseline, 3 and 12 months after the consultation. data about waiting time for consultation, proportion of patients appropriate for surgery, further investigations, and data to be able to perform cost analysis will be collected from patients´ journals, the patient administration systems, both locally and via the region västra götaland´s database (vega). a qualitative approach will be used to further investigate patients expectations and experience of a pt-led trige.

Eligibility criteria:
inclusion criteria: * referred to sahlgrenska university hospital * primary osteoarthritis in the hip or knee * understanding and speaking swedish exclusion criteria: * prior assessment by and referral from an orthopedic surgeon for the current problem * secondary osteoarthritis (posttraumatic osteoarthritis, femoral head necrosis), when stated on the referral * referred to a specific surgeon

Keywords: pt-led triage osteoarthritis knee hip
brain metabolic network of pet in patients with advanced non-small cell lung cancer

Conditions: Advanced Non-small-cell Lung Cancer

Summary: this study is a retrospective study, screening patients with systemic pet / ct scan in our department, enrolling the ones who meet the criteria, collect their information and resting state brain pet images.then make the brain metabolic network analysis and statistical analysis to explore the pet brain metabolic network of non-small cell lung cancer patients and the effect of chemotherapy drugs on brain metabolic network in patients with advanced lung cancer.

1. enroll participants 2. collect pet/ct images 3. images analysis 4. statistical analysis

Eligibility criteria:
inclusion criteria: * patients with advanced non-small cell lung cancer without any treatment and pathological confirmed non-small cell lung cancer. exclusion criteria: * brain tumors (primary or metastasis), previous surgery, radiotherapy, chemotherapy, stroke, head trauma, psychiatric history (insomnia, depression, mania, schizophrenia and other psychiatric disorders), or history of drug dependence (e. g. sedatives, sleeping pills or sedatives)