Kornimate/medical-research-clean huggingface dataset:
mr-guided radiotherapy to breast with dose escalation to regional lymph nodes

Conditions: Breast Cancer

Summary: radiotherapy to the breast and lymph nodes is routinely planned using ct scans. the introduction of magnetic resonance imaging (mri) has the potential to better visualise the lymph nodes and so define a smaller treatment area or 'target'. this means that the dose delivered to the target could be increased without increasing the dose to normal tissues. the mirabelle study is designed to test if this is possible by recruiting patients diagnosed with breast cancer including lymph node disease. the investigators will ask participants to have a ct scan and an mri scan before they have radiotherapy. the investigators will then plan radiotherapy using both these scans and compare the possible dose delivered to the lymph nodes using the mri and ct defined lymph nodes. this will not affect the patient's future treatment.

mr imaging has the potential to improve both the localisation of pan-ln treatments and the subsequent treatment delivery using mr-linac technology. the mirabelle study will apply the mr sequences developed in ln-negative volunteers/patients to the context of node-positive breast cancer patients with the aim of reducing the delineated nodal volume thereby facilitating dose-escalation to involved lns. the benefit of using mri for ln localisation as compared to conventional ct imaging will be investigated by determining whether a higher dose can be delivered using mri- as compared to ct-based delineation. any increase in dose will be deemed a success as this has potential to improve tumour control. in addition, inter-observer errors in outlining will be explored to investigate whether these are reduced using mri. reduced inter-observer errors would result in smaller margins for error such that less normal tissue could be irradiated.

Eligibility criteria:
inclusion criteria: * age ≥18 years * female or male * invasive carcinoma of the breast (left or right-sided) * ct1-t4,n3,m0-1 disease * due to proceed to primary treatment (chemo, surgery, radiotherapy and/or endocrine therapy) * histopathological involvement of axillary lymph nodes confirmed on fna or bx * likely to undergo locoregional radiotherapy as part of their breast cancer management exclusion criteria: * implanted pacemakers and/or pacing wires * cochlear implants * programmable hydrocephalus shunts * implanted neurostimulation systems * implanted drug infusion pumps * ferromagnetic implants * claustrophobia
a clinical trial to evaluate the safety and pharmacokinetic

Conditions: Osteoporosis, Postmenopausal

Summary: a phase 1 clinical trail to evaluate the safety and pharmacokinetic characteristic after administration of fixed-dose combination or loose combination of hug186 in healthy adult male or menopausal female volunteers


Eligibility criteria:
inclusion criteria: 1. men, age≥19 years of age, postmenopausal women are eligible. postmenopausal is defined as any of the following: * amenorrhea for 12 or more months * fsh and estradiol in the postmenopausal range per local normal range. 2. body weight of ≥ 55 kg, bmi 18.5 to 30.0 3. no morbid symptom or sign, based on physical examination, with no innate or chronic disease. 4. subject that is considered appropriate for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis) that is performed according to the characteristics of investigational drugs. 5. subject that agree to apply sun cream in case of daylight exposure for more than 1hours 6. subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent. exclusion criteria: 1. a clinically significant disease or history in hepatobiliary system, kidney, digestive system, respiratory system, hemato-oncological system, endocrine system, neuro-psychiatric system, musculo-skeletal system, immune system, otorhinolaryngological system or cardiovascular system. 2. a history of hypersensitivity to investigational drugs and its additives or clinically significant hypersensitivity to any other drug. 3. history of drug abuse, or positive in drug screening test. 4. use of inducer or inhibitor of metabolic enzymes for drugs like barbiturate. 5. use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of investigational drug, and this will affect this study or the safety of the subjects at discretion of study investigator. 6. participation in another clinical trial or a bioequivalent study within 3 months prior to the first administration of investigational drug (the finish time of previous study is the day of the last administration of study drug) 7. whole blood donation within 2 months or component donation within 1 month, prior to the first administration of investigational drug, or transfusion within 1 month prior to the first administration of investigational drug. 8. prolonged excessive alcohol consumption (\>21 units/week, 1 unit=10g of pure alcohol), or subjects who can not abstain from drinking from 24 hours prior to hospitalization until the discharge. 9. smoking more than 10 cigarettes per day, excessive caffeine consumption (example: instant coffee \> 5 cups/day) 10. subjects who are judged to be inappropriate for this study by investigators according to other reasons including clinical lab test result
transcranial direct current stimulation (tdcs) as a treatment for cigarette craving and cognitive deficits in schizophrenic

Conditions: Schizophrenia; Cognition; Cigarette Smoking

Summary: this is a study of the effects of tdcs on smoking, craving for cigarettes, cognition, and psychiatric symptoms in schizophrenic patients who are current smokers or have a history of regular cigarette smoking. it assesses smoking with co monitoring, nicotine and nicotine levels, and craving with qsu scale and response to craving slides. cognition is measured by mccb, symptoms are measured by panss and hallucination scale. this is a double-blind sham-controlled study with active tdcs 2ma or 20 minutes over 5 days, and sham tdcs for 40 seconds on each sham occasion.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia spectrum disorder history of cigarette smoking exclusion criteria: * seizure disorder or current treated neurological illness current acute exacerbation of psychotic state

Keywords: schizophrenia cigarette smoking cognition craving matrics
association between confocal laser endomicroscopic (cle) features and colorectal mucosal microbiome

Conditions: Colorectal Neoplasia; Colorectal Inflammation; Hyperplasia; Mucosal Microbiome

Summary: the purpose of this study is to determine whether an association between endomicroscopic pattern and colorectal mucosal microbiome exists.

the gut microbiome plays a pivotal role in the intestinal pathophysiology. the mucosal microbiome is in the front face of microbiome-host cross-talk. confocal laser endomicroscopy (cle) can provide realtime mucosal images during ongoing endoscopy. we hypothesized that the mucosal pattern, here evaluated by endomicroscopy, may constitute specific microbiome niches and participate the evolvement of the mucosal microbiome.

Eligibility criteria:
inclusion criteria: * 18 years old ≤ age \< 80 years old * scheduled for colonoscopy in qilu hospital exclusion criteria: * antibiotic usage within 2 months * probiotic or prebiotic usage within 2 months * ascites * jaundice * liver cirrhosis * impaired renal function * coagulopathy * fever * pregnancy * breastfeeding * inability to provide informed consent * known allergy to fluorescein sodium
effects of exercise and acupuncture on chronic insomnia

Conditions: Chronic Insomnia

Summary: introduction: chronic insomnia is a sleep disorder, characterized by difficulty in initiating and/or maintaining sleep, presence of non-restorative sleep, frequent awakenings or difficulty returning to sleep after each awakening, with a frequency of 3 nights/week, for at least 3 months. pharmacologic therapy is the most commonly method used for its treatment, however, pharmacotherapy is associated with side effects. thus, non-pharmacological therapies have been suggested as an alternative. objective: to verify the effects of exercise associated with acupuncture on chronic insomnia. methods: 40 patients with chronic insomnia will be randomly assigned into two groups: control (n = 20) and acupuncture (n = 20). the volunteers of the control group will be submitted to 12 weeks of aerobic exercise, performed on a treadmill, with frequency of 3 times / week and duration of 50 minutes / day. acupuncture volunteers will perform aerobic exercise, following the protocol of the control group, plus acupuncture therapy once a week. the sleep evaluation will be evaluated by polysomnography and questionnaires. expected results: a 12-week combined therapy could potentiate the previously described positive effects of exercise in the treatment of chronic insomnia.


Eligibility criteria:
inclusion criteria: * age 30-60 years; * clinical diagnosis of chronic insomnia according to the dsm-v (performed by a physician specialized in sleep medicine); * insomnia complaint at least 3 times a week for at least 3 months; * be physically inactive (exercise less than 2 times a week). exclusion criteria: * evidence that insomnia is directly related to medical conditions or side effects os medications; * obstructive sleep apnea syndrome; * ecg abnormalities that prevent physical exercise or use of beta-blockers; * uncontrolled clinical diseases (diabetes, hypertension, cardiovascular, neurological or renal diseases); * use or history of abuse of alcohol or psychoactive substances; * use of sleeping pills\>2 times a week; * shift workers.

Keywords: physical activity disorders of onset and maintenance of sleep non-pharmacological treatment acupuncture
use of standing frame and "innowalk pro" in patients with tbi

Conditions: Brain Injuries

Summary: this study will explore physical and physiological responses to mobilization of patients with acquired brain injuries in subacute phase using a classic standing frame and a standing device with simultaneous passive movement of legs, "innowalk pro".

several studies underline the importance of early mobilization of patients with brain injuries, leading to shorter hospital stays, less contractures, and improved general function. the routine mobilization treatment in the rehabilitation of patients with severe brain injuries in sunnaas rehabilitation hospital is initial use of a tilt table where tilt angle is gradually increased, and when tolerated, standing in a classic standing frame where the patient's lower body is fixed to the device in an upright standing position. "innowalk pro" is a robotic standing device where legs are fixed, but passively moved by electric motors in an upright standing position. an assumption is that standing in "innowalk pro" might be better tolerated at an earlier stage of rehabilitation than standing in a classic standing frame.

Eligibility criteria:
inclusion criteria: * severe brain injury / stroke \<1 year post injury. * medically stable * paresis in lower extremities, minimal walking function (even with personal assistance) (fim movement (walk), score 1-2) * planned stay in sunnaas rh for a minimum of 2 weeks from time of inclusion * tolerate 5 minutes in 40 degrees 'upright' position in tilt table (custom orthostasis test) * body weight ≤95 kg * body height ≤190 cm exclusion criteria: * fractures in the lower extremities or in the columna with movement or strain restrictions or with pain. * aggressive and provocative behavior that affects the ability to collaborate. * other conditions where upright position is contraindicated

Keywords: standing blood pressure heart rate surface electromyography of muscles in legs perceived exertion
patella fracture : a randomized controlled trial

Conditions: Patella Fracture; Aging

Summary: this is a multi-centre, randomized controlled trial comparing operative and non operative treatment for displaced patella fractures in elderly, low-demand patients.

patients with a displaced patellar fracture who meet the inclusion criteria and provide consent will be randomized to one of the two treatment arms. one group (group a) will receive standardized non-operative treatment with immediate weight-bearing as tolerated in a knee immobilizer and early rom exercises begun at 2 weeks post injury. the other group (group b) will receive orif of their displaced patellar fracture with a standardized post-operative protocol. post-operative rehabilitation will be standardized across both groups. patients will be weight bearing as tolerated immediately in a removable knee immobilizer, with progressive range-of-motion exercises begun at two weeks following surgery or randomization. the knee immobilizer will be used full-time (with the exception of removal for physiotherapy and bathing) for 6 weeks after surgery or randomization. at six weeks post-treatment, patients will be allowed to perform active extension and will initiate progressive strengthening exercises of the extensor mechanism.

Eligibility criteria:
inclusion criteria: * male or female patients 65 years of age or older and ambulatory prior to injury (with or without walking aids). * closed fracture of the patella displaced by 5 mm or greater (displacement will be determined by measuring the widest displacement on any x-ray view with the knee in full extension). * the patient scores between 3 and 6 on the clinical frailty scale. this score corresponds to a low-demand patient who is ambulatory and functionally independent * within 14 days of injury, the patient is able to perform a straight leg raise with less than 30 degrees of extensor lag. * able to read and understand the study consent form document. * willing and able to sign consent, follow the study protocol and attend follow-up visits. exclusion criteria: * associated extremity injuries or polytrauma injuries that would otherwise require surgery or interfere substantially with rehabilitation or outcome in the opinion of the investigator. * neurovascular injuries at the level of the knee requiring surgery. * pathologic fractures. * periprosthetic fractures, or other knee surgery which would contra-indicate inclusion in the study (e.g. previous patella orif or previous surgery involving patella such as patella tendon or quads repair). * medical contra-indication to surgery. * likely problems, in the judgment of the investigators, with maintaining follow-up (e.g. patients with no fixed address, intellectually challenged patients without adequate support, etc.).

Keywords: patella fracture, elderly
prognostic significance of bioscore in nonmetastatic breast cancer

Conditions: Breast Cancer

Summary: assess the validity of applying the bioscore system to predict the disease-free survival (the percentage of people in a study or treatment group who have not experienced disease relapse in a defined period of time.) in breast cancer patients presenting to our

retrospective cohort analysis of breast cancer patient's records for patients treated with surgery as an initial intervention at our department from 2015 to 2018 will be identified. multivariate analyses of factors, including pathological stage (ps), t stage (t), nodal stage (n), grade (g), estrogen receptor (er) status (e) and human epidermal growth factor receptor (her2) status will be recorded to identify associations with disease-free survival dfs. a score of 0-4 will be assigned for each factor by considering the hazard ratio magnitude. analysis of the correlation between pathological stage, t stage (t), nodal stage (n), grade (g), estrogen receptor (er) status (e) and human epidermal growth factor receptor (her2) status combined score and the disease free survival (dfs ).

Eligibility criteria:
inclusion criteria: - female patients newly diagnosed breast cancer patients presented to clinical oncology department, assiut university in the period between (2015_2018). histologically confirmed invasive breast carcinoma (ibc) age: ≥18 and older eastern cooperative oncology group (ecog) performance status of 0, 1 or 2. complete medical records and follow up exclusion criteria: * male patients no definitive surgery incomplete medical records or follow-up status unavailability of hormonal receptor status carcinoma in situ or other rare tumors of the breast as phylloides tumors, pregnancy and lactation
safety surveillance study of acam2000® vaccinia vaccine

Conditions: Smallpox

Summary: this is an enhanced safety surveillance study that will occur within the military service member population. primary objective: * to evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with acam2000® vaccination. secondary objectives: * to evaluate the rates of cardiovascular adverse events in temporal association with acam2000® vaccination. * to evaluate the rates of neurological adverse events in temporal association with acam2000® vaccination.

the armed forces health surveillance activity (afhsa) will perform comprehensive health surveillance through the operation of the defense medical surveillance system (dmss). demographic and medical information gathered within monthly reports from the dmss will be collected from approximately 100,000 to 200,000 military service members who received the acam2000® smallpox vaccine.

Eligibility criteria:
inclusion criteria : * male and female military personnel \>= 17 years of age. * have received the acam2000® smallpox vaccine. exclusion criteria : * not applicable.

Keywords: smallpox smallpox vaccine vaccinia virus military
hla sensitization following major cortical allograft bone procedures

Conditions: Bone Cancer

Summary: the purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone.

patients who have bone cancer often have the cancerous bone removed by surgery and replaced with a piece of bone taken from a donor (a person who donates parts of their body to be used for transplants after their death). however, sometimes this replacement bone does not heal together with the patient's bone. the reason the bone does not heal is not known but it is thought that the patient's body may react to the donor bone by producing antibodies against cells on the donor bone. the purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone. you have been asked to participate in this study because you are scheduled to undergo this type of surgery.

Eligibility criteria:
inclusion criteria: * patients twelve years or older who are scheduled for massive fresh-frozen human structural bone allograft implantation at participating centers will be given the opportunity to participate in the study. all patients must have a reconstruction of the involved long bone with either an intercalary graft, an osteoarticular graft, or an allograft/endoprosthesis composite graft. the junction or union site studied will be the cortical-cortical, host allograft junction site, not the cancellous interfaces. exclusion criteria: * patients who do not require major weight bearing cortical allograft bone grafts will be excluded. also, women who are or could potentially become pregnant will be excluded from the study.
phenotyping and genotyping of duffy antigen

Conditions: Plasmodium Vivax

Summary: malaria remains the world's leading parasitic endemic. almost half of the world's population lives in endemic areas. many at-risk people in african countries remain without access to malaria control. malaria kills approximately 400,000 people each year, most of whom are children under the age of 5 in africa. since 2005, an increasing number of plasmodium vivax infections have been observed in duffy-negative populations in south america and africa, calling into question the essential role of the pvdbp-darc interaction. the objective of the investigators is therefore to study and understand the invasion pathways used by plasmodium vivax in duffy-negative subjects.


Eligibility criteria:
inclusion criteria: * major subjects * with malaria and willing to have their blood samples analyzed for this research exclusion criteria: * subjects refusing to participate in the study

Keywords: malaria malaria, vivax pvdbp-darc interaction plasmodium vivax duffy-negative duffy binding protein pvdbp duffy antigen receptor for chemokines
a study of olezarsen (isis 678354) administered to participants with severe hypertriglyceridemia

Conditions: Severe Hypertriglyceridemia

Summary: the purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (tg) from baseline.

this is a multi-center, randomized, double-blind, placebo-controlled study in 617 participants. participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. the length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (ole) study with up to 1-year treatment.

Eligibility criteria:
key inclusion criteria: * fasting tg ≥ 500 mg/dl (5.65 mmol/l) at screening and qualification * patients must be on lipid-lowering therapy that should adhere to standard of care (soc) per local guidelines. lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to screening to minimize changes in these medications during the study. key exclusion criteria: * hemoglobin a1c (hba1c) ≥ 9.5% at screening * alanine aminotransferase or aspartate aminotransferase \> 3.0 × upper limit of normal * total bilirubin \> upper limit of normal unless due to gilbert's syndrome * estimated gfr \< 30 ml/min/1.73 m\^2

Keywords: isis 678354 fasting triglycerides apolipoprotein c-iii very low-density lipoprotein cholesterol high-density lipoprotein-cholesterol non-high-density lipoprotein-cholesterol olezarsen