Kornimate/medical-research-clean huggingface dataset:
risk factors of radiation pneumonitis

Conditions: Radiation Pneumonitis

Summary: a prospective observational study to evaluate clinical, dosimetrical, functional, and biological factors in predicting radiation pneumonitis.

we propose a prospective observational study to investigate the combinational effect of radiotherapeutic dosimetric parameters \[mean lung dose \& percentage of lung volume receiving at least 20gy (v20)\] and biological parameters \[interleukin-6(il6) \& transforming growth factor beta (tgfb)\] in predicting radiation pneumonitis, fibrosis, and change of qol among at least fifty-three lung cancer patients. eligibility included pathological or cytological proven small cell or non small cell lung cancer, thoracic rt planned for more than 30gy \[if fraction size \>= 3gy/fx\] or 40gy \[if fraction size \ =6mv. radiation pneumonitis and fibrosis will be assessed according to common toxicity criteria 3 \[ctc-3\] weekly during rt and in every follow up visits. chi-square test, logistic regression, and proportional hazard ratio method will be used to investigate whether the parameter(s) can be effective in predicting radiation related sequelae.

Eligibility criteria:
inclusion criteria: * non-pregnant adults (age \>=20 y/o) * pathological or cytological proven small cell or non small cell lung cancer * thoracic rt planned for more than 30gy \[if fraction size \>= 3gy/fx\] or 40gy \[if fraction size \< 3 gy/fx\] * ecog ps 0-2 * body weight loss \<=10% in previous 6 months exclusion criteria: * prior thoracic rt

Keywords: radiation pneumonitis radiotherapy planning, computer-assisted
multifaceted physioterapeutic intervention at workplace

Conditions: Musculoskeletal Pain; Quality of Life

Summary: background: individual approaches at the workplace might not be sufficient to control work related musculoskeletal diseases (wmsds) since they are multifactorial and refractory cases might need an additional rehabilitation program. objective: to evaluate multifaceted intervention efficacy to manage the wmsds. methods: a nordic musculoskeletal questionnaire was applied pre and post intervention to determine the efficacy of a multifaceted program, including ergonomics, exercise program and acupuncture/physical therapy exercises orientation at the workplace in 126 workers of a hearing-aid industry. additionally, a self-perception survey (likert scale) concerning absenteeism, quality of life and work ability helped to evaluate the program that lasts one year and ten months.

the work-related musculoskeletal disorders (msds) have substantially increased worldwide from the 1980s in brazil, msds are the leading cause of occupational diseases. the harm to society is enormous and justifies the study of methods to prevent them and / or reduce them. many authors have evaluated isolated approaches to manage the problem, but as this is usually multifactorial, a set of interventions could bring better results. physiotherapy is a specialty that works to improve working conditions through ergonomic interventions, physical therapy treatments and gymnastics and thus contributes to prevention and treatment of these disorders. the objective of this study is: to determine the effect of this set of interventions on the quality of life of workers and the productivity of a company that has been evaluated in a previous study to this. the study population will consist of 185 employees of a multinational company that manufactures and sells hearing aids in brazil. of those, 126 made up the experimental group (headquarter) and 59 control group (subsidiaries). two questionnaires, one on musculoskeletal symptoms and another on risk factors at work are applied. an ergonomic evaluation of activities and tasks will be held, which will assist the diagnosis of situations which may be modified by ergonomic measures. management of pre-existing complaints by acupuncture and orientation of specific exercises are used. the program's effectiveness analysis will be done by two methods: a questionnaire assessing the perception of workers about the their quality of life at work and the number of musculoskeletal complaints pre and post-intervention.

Eligibility criteria:
inclusion criteria: * must work in the industry for at least one year exclusion criteria: * workplace of the study is not the main one

Keywords: ergonomics multifaceted intervention industry physiotherapy physical exercises workplace acupuncture work quality of life absenteeism efficiency musculoskeletal pain wmsd
the safety and efficacy of cart-19 cells in relapse and refractory patients with cd19+ b-cell lymphoma

Conditions: B Cell Lymphoma

Summary: this is a clinical study to observe the safety and feasibility of chimeric antigen receptor 19 (cart-19) cells in relapsed and refractory patients with cd19+ b cell lymphoma.

this is a study for the patients with b cell lymphoma. subjects will be staged and the suitability of their t cells for cart-19 manufacturing will be determined at entry phase. subjects will be collected their t cells and modify them, the modification is a genetic change, that cd19:4-1bb:cd3 modified t cells, in order to tells the t cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. the cart cells will then be expanded in vitro and then administered to subjects. the purpose of this study is to assess ssess the safety and feasibility of cart-19 cells in the patients with relapsed and refractory cd19+ b cell lymphoma.

Eligibility criteria:
inclusion criteria: 1. 18 years to 70 years, expected survival \> 3 months; 2. cd19 positive b-cell lymphoma; 3. kps \>80; 4. having at least one measurable lesions; 5. cardiac function: 1-2 levels; liver: tbil≤3uln，ast ≤2.5uln，alt ≤2.5uln; kidney: cr≤1.25uln; bone marrow: wbc ≥ 3.0×109/l, hb ≥90 g/l, plt ≥ 80×109/l）; 6. no serious allergic constitution; 7. no other serous diseases that conflicts with the clinical program; 8. no other cancer history; 9. no serious mental disorder; 10. informed consent is signed by a subject or his lineal relation. exclusion criteria: 1. pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test); 2. uncontrolled active infection, hiv infection, syphilis serology reaction positive; 3. active hepatitis b or hepatitis c infection; 4. recent or current use of glucocorticoid or other immunosuppressor; 5. with severe cardiac, liver, renal insufficiency, diabetes and other diseases; 6. transaminase \>2.5uln, bilirubin \>3uln，creatinine\>1.25uln 7. participate in other clinical research in the past three months; previously treatment with any gene therapy products; 8. researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;
stepping up: a trial of activity monitoring devices in patients undergoing autologous stem cell transplant

Conditions: Multiple Myeloma; Lymphoma; Transplant-Related Disorder

Summary: the purpose the research is to obtain preliminary data about the change in fitness from admission to discharge in patients undergoing an autologous stem cell transplant (asct) , assessed by the 6 minute walk test as the primary objective and the sf-36 as the secondary objective. all subjects will wear a fitbit monitor while admitted for the asct to record their daily activity.

this study will enroll 20 subjects with a diagnosis of multiple myeloma or lymphoma (10 with each diagnosis) scheduled to undergo asct at cedars-sinai medical center. after signing the informed consent form, intake data will be collected on all subjects will include age, diagnosis, karnofsky performance status, and comorbidity index. subjects will complete an sf-36 questionnaire that assesses their functional and emotional status. each subject will undergo a 6-minute walk test (6mwt) while wearing a fitbit monitor to record the number of steps taken. after admission, subjects will be randomly assigned to either the control or intervention group. subjects in the control arm will receive an activity monitor but the physician, nurse, and patient will not receive any feedback from the device. patients will be blinded to any data capture from their activity monitor. participants in the intervention arm will receive an activity monitor and they will receive feedback from the activity tracker and the in-room tv screen. study participants in this arm will engage with their physicians and nurses around achievement of daily step goals by viewing the in-room tv display of daily step counts on rounds. after discharge, all subjects will again complete the sf-36 questionnaire and perform a 6mwt at a routine clinic visit, within 30 days of the transplant procedure. descriptive statistics in the form of mean and standard deviation will be used to summarize patient physical activity as measured by 6mwt.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma or lymphoma with plan to undergo autologous stem cell transplant * at least 18 years of age * english or spanish speaking * have access to an ios or android device * able to provide informed consent. exclusion criteria: * pre-existing physical limitations which would preclude achievement of the ambulation goals * inability to wear the activity monitor * jehovah's witness patients enrolled in the bloodless transplant program are excluded as they require strict bed rest for long periods of time
acceptance of the cp950 sound processor

Conditions: Hearing Loss, Sensorineural

Summary: acceptance of cp950 sound processor with experienced cp810/cp910/cp920 bte sound processor users.


Eligibility criteria:
inclusion criteria: 1. eighteen years of age or older 2. at least 6 months experience with a nucleus 24 series or later implant in at least one implanted ear 3. at least 3 months experience with the cp810,cp920 or cp910 sound processor 4. native speaker in the language used to assess speech perception performance 5. willingness to participate in and to comply with all requirements of the protocol 6. able to score 30% or more at +15 snr with ci alone exclusion criteria: 1. unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device 2. additional disabilities that would prevent participation in evaluations 3. nucleus 22 implant
local excision of clinical t3 rectal adenocarcinoma showing major response(yct0-1) after neoadjuvant chemoradiotherapy

Conditions: Rectal Cancer

Summary: the purpose of this study is evaluation of the safety and the efficacy of transanal local excision in patients with ct3 rectal cancer which was downstaged into yct0-1 after neoadjuvant chemoradiotherapy.

this study is a prospective multicenter single-arm phase ii clinical trial. rectal cancer patients with ct3 stage will receive neoadjuvant chemoradiotherapy, and be evaluated the response of the tumor in 6 to 10 weeks after completion of neoadjuvant chemoradiotherapy. for those who have good response (yct0-1) will underwent transanal local excision under the patients' agree.

Eligibility criteria:
inclusion criteria: * age: more than 20 years * biopsy-proven adenocarcinoma of the rectum * clinical staging, ct3nxm0 * rectal cancer located 8 cm from the anal verge * restaging in 6-10 weeks after completion of neoadjuvant chemoradiotherapy, yct0-1n0m0 * ecog performance status 2 or less exclusion criteria: * synchronous colon cancer or other malignancy * obstructing rectal cancer * pregnant or breast-feeding * receiving any other study agents * history of prior colorectal cancer or inflammatory bowel disease * hereditary colorectal cancer (fap, hnpcc)

Keywords: rectal neoplasms colorectal neoplasms local excision
descriptive epidemiology study for patients with paraphilia sex offenders and receiving androgen antagonists

Conditions: Paraphilia

Summary: the main objective of the study is to describe the french population of individuals with paraphilia who have committed a sexual offence in whom androgen antagonists was prescribed. the secondary objectives are the description of social demographic profiles, the personal and family histories,psychiatric co-morbidities, the side effects of androgen antagonists treatment. this study, the first of its kind in france, may allow to better understand the social demographic and clinical profile of sexual offenders with paraphilias treated with androgen antagonists. to be included, the subject must have committed a sexual offense and must present a diagnosis of paraphilia with an indication of treatment with androgen antagonists. paraphilia is defined by the diagnostic and statistical manual as a sexual behavior disorder characterized by "sexually arousing fantasies, needs or recurrent and intense sexual behaviors generally involving (1) of non-human objects, (2) the suffering or humiliation of oneself or partner, (3) children or other persons without their consent, occurring during a period of at least six months "(criterion a). this disorder is responsible for sexual behavior which is "clinically significant disturbances in social, occupational or other important areas of functioning" (criterion b). the inclusion of approximately 200 subjects is expected in this study. the inclusion period will last for 12 months. data will be codified and only a few investigators will have access to these data. the statistical analyse will use the usual descriptive parameters: mean, standard deviation, median, interquartile range and range for quantitative variables, frequencies and cumulative frequencies (if applicable) for qualitative variables.


Eligibility criteria:
inclusion criteria: * diagnosis of paraphilia based on dsm-iv-tr * antecedent of sexual offence exclusion criteria: * no diagnostic of paraphilia

Keywords: androgen antagonists
dexmedetomidine in modifying immune paralysis in patient with septic shock

Conditions: Septic Shock

Summary: in this study the investigators aim to assess the role of using dexmedetomidine as sedative in septic shock patients in comparison with midazolam. the investigators aim to assess the effect on immune response and inflammatory mediators and effect on vasopressors.

sedation protocol all patients will receive analgesia with fentanyl at ﬁxed dose of 0.5 µg.kg.hr-1. each patient will receive the study drug within 6 hours after icu admission. depth of sedation will be assessed using richmond agitation and sedation scale (rass) scores (6), which range from -5 (unarousable) to +4 (combative). study treatments will be infused without loading dose. group i patients will have dexmedetomidine (4 µg.ml-1) and group ii patients will have midazolam (0.33 mg.ml-1). both drugs will be prepared in 0.9% sodium chloride in 50-ml syringe. both the agents will be titrated to maintain the rass in a range of -3 to -1. dexmedetomidine infusion will be started at 0.1 µg.kg-1.hr-1 and will be adjusted by 0.1 µg.kg-1.h-1 to a maximum of 0.5 µg/kg/h, while midazolam will be started at 1 mg.h-1 (3 ml.hr-1) and adjusted by 1 mg.h-1 to a maximum of 5 mg.h-1 (15 ml.h-1). all infusions will be adjusted by increments of 3 ml/hr-1. patients in either group not adequately sedated by study drug titration will receive a bolus dose of fentanyl 0.5-1 µg.kg. assessment of rass score will be performed every 2 hours and prior to any dose of rescue therapy. the study drugs will be infused for 24 hours and after that the choice of sedation will be determined according to preference of attending physician.

Eligibility criteria:
inclusion criteria: * age more than 18 years old * all mechanically ventilated patients who will be clinically suspected of having septic shock defined by infusion of at least one vasopressor and lactate \> 2.0 mmol/l (5) exclusion criteria: * age \< 18 years old * pregnant patient * source of sepsis not controlled * acute hepatitis or severe liver disease (child-pugh class c) * left ventricular ejection fraction less than 30% * heart rate less than 50 beats/min * second or third degree heart block * systolic pressure \< 90 mmhg despite of infusion of 2 vasopressors. * psychological illness or severe cognitive dysfunction * patients who are allergic to dexmedetomidine
the effects of cannabis on visual functions in healthy and retinitis pigmentosa patients

Conditions: Retinitis Pigmentosa; Retinal Degeneration; Cannabis

Summary: medical marijuana is used widely, and its effects on the visual system and the function of the retina have not been investigated thoroughly. some evidence suggests that cannabinoids may be beneficial in certain degenerative diseases of the retina. the purpose of the study is 1. to determine whether cannabis derivatives affect the visual functions in healthy adults 2. to examine the effect of cannabis derivatives on the retina of retinitis pigmentosa patients

twenty five healthy subjects and 25 retinitis pigmentosa patients will be recruited and will sign an informed consent form. an initial eye exam will include visual acuity and stereo vision, eye movements and eye movement recording, a full slit lamp eye exam, intra-ocular pressure measurement, visual field, oct and electrophysiology. the subjects will receive a single sublingual dose of cannabis (thc:cbd 1:1, thc 5 mg, or the:cbd 1:40, thc 5 mg), and will undergo the above examination again. subjects will be monitored for 5 hours after the administration of cannabis.

Eligibility criteria:
inclusion criteria: * consenting adults * generally healthy with or without retinitis pigmentosa exclusion criteria: * chronic or acute disease other than retinitis pigmentosa * use of medication * congestive heart failure * recent use of illicit drugs (past month) * history of drug dependency * history of psychiatric disorder in subject or immediate relatives * pregnancy

Keywords: retinitis pigmentosa retinal degeneration cannabis thc cbd electrophysiology visual functions eye retina
the gut microbiome in type 1 diabetes and mechanism of metformin action

Conditions: Type 1 Diabetes; Obesity

Summary: obesity prevalence in persons with t1d has increased, which further complicates management and risk for complications. the proposed study is relevant to public health because it helps us understand the role of the gut microbiome in disease pathophysiology in t1d youth with obesity as well as potential mechanisms to modify disease.


Eligibility criteria:
inclusion criteria: 1. obese youth 11-18 years of age with t1d at time of enrollment. 2. lean youth 11-18 years of age with t1d at time of enrollment. exclusion criteria: 1. known monogenic forms of diabetes or type 2 diabetes (confirmed clinically and by genetic/antibody testing). 2. history of ongoing infection or antibiotic treatment within the past month; 3. history of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months. 4. history of chronic gastrointestinal disease, possible or confirmed celiac disease; 5. participation in any research intervention trials within the past 3 months. 6. history of treatment or use of metformin, a type 2 diabetes medication.
effect of glutamine on urinary incontinence

Conditions: Urinary Incontinence

Summary: the objective of this study is to determine to effect of additional oral glutamine to kegel exercises on pelvic floor strength and clinical parameters of urinary incontinence in females with either urinary incontinence (stress and/or urgency) and pelvic prolapse.

urinary incontinence is a prevalent and costly condition that affects approximately 38% of older community-dwelling women (age\>60 years). incontinence predisposes patients to other health problems, contributes to depression and social isolation, is a significant source of dependency among the elderly, and is widely cited as a factor in nursing home admissions. sarcopenia is age-related and is characterized by loss of muscle mass, strength and endurance. there is not only a decrease in the number of muscle fibers, but also atrophy in the remaining ones. several studies indicate glutamine supplementations lead to better muscle performance by stimulate muscle producing in extremities. similarly, we assume glutamine supplementation could increase pelvic muscle mass and improve the pelvic floor strength. from this point, using glutamine supplementation may effect positively on stress, urge or mixed incontinence, and pelvic prolapse.

Eligibility criteria:
inclusion criteria: * presence of urinary incontinence and/or pelvic prolapse and/or decreased vaginal muscle strength in gynaecological examination exclusion criteria: * uncontrolled diabetes * cognitive dysfunction hampering participation in exercise or assessment
early diagnostic of sepsis and potential impact on antibiotic management based on serial.pancreatic stone protein (psp) measured using the abioscope.

Conditions: Sepsis

Summary: the main purpose of this study is to compare the early detection of sepsis and the decision, by the investigator to start or not, or to change, antibiotics in intensive care unit (icu) patients at high risk of sepsis, based on standard of care (clinical, laboratory and imaging data but not on psp values), as well as timing of antibiotic de-escalation versus the the retrospective assessment (i.e., at the end of the study) of a first endpoint adjudication committee (eac) which is aware of the clinical data and of the psp values but not of the investigator's decision(s), and of the retrospective assessment of a second endpoint adjudication committee which is only aware of the psp values. this study will follow the site's routine clinical practice for the diagnostic, assessment and treatment of the enrolled patients, with the exception of daily blood samples which will be taken for the psp measurement using the abioscope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to c-reactive protein \[crp\] and procalcitonin \[pct\]).


Eligibility criteria:
inclusion criteria: 1. adult patients (age ≥ 18 years) 2. requiring icu management 3. at high risk of sepsis (septic patients are excluded) 4. expected icu stay for more than 4 days 5. have provided written informed consent or consent is given by the patient's legally designated representative. exclusion criteria: 1. patient expected to die within 48 hours of admission to icu 2. patient suffering from or known acute or chronic pancreatitis, pancreatic cancer or admitted after pancreatectomy, but if a patient develops any pancreatic disease during the iuc stay he/she will remain in the study.

Keywords: sepsis, psp, abionic