Kornimate/medical-research-clean huggingface dataset:
octreotide acetate in microspheres in patients with diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: the most common ocular disease in patients with diabetes, diabetic retinopathy, is present in approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening diabetic retinopathy. although intensive control of blood glucose has been shown to reduce the development and progression of diabetic retinopathy, intensive control of glucose is usually not achieved in clinical practice.


Eligibility criteria:
inclusion criteria: * males and females with type 1 and type 2 diabetes mellitus * moderately severe or severe npdr or mild pdr in at least one eye: * with an early treatment diabetic retinopathy study (etdrs) visual score of \> 35 letters; and * not previously treated with scatter photocoagulation. * hba1c \< 13% at study entry exclusion criteria: * condition which could interfere with the assessment of retinopathy progression * history of symptomatic gallstones without cholecystectomy * brittle diabetes or history of severe hypoglycemia unawareness * previous treatment with a somatostatin analogue

Keywords: diabetic retinopathy,octreotide acetate in microspheres
mis refresh: robotic vs. freehand minimally invasive spinal surgeries

Conditions: Degenerative Spine Disease; Spondylolisthesis; Spondylosis

Summary: to quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery (mis) for adult patients with lower back degeneration, in comparison a matching group of control patients operated in a minimally invasive approach whether freehand or with image guidance or navigation techniques.


Eligibility criteria:
inclusion criteria: 1. adult patients (age over 21 years), undergoing short (4 or less consecutive vertebrae) lumbar or lumbosacral percutaneous/mis spinal fixation surgery. 2. may include surgeries involving iliac screws, although these screws will not be included in the data analysis. 3. primary fusion surgery 4. patient capable of complying with study requirements 5. signed informed consent by patient exclusion criteria: 1. pregnancy 2. revision surgery (prior laminectomy or discectomy is not excluded). 3. infection or malignancy 4. primary abnormalities of bones (e.g. osteogenesis imperfecta) 5. primary muscle diseases, such as muscular dystrophy 6. neurologic diseases (e.g. charcot-marie tooth, guillain-barre syndrome, cerebral palsy, spina bifida or neurofibroma) 7. spinal cord abnormalities with any neurologic symptoms or signs 8. spinal cord lesions requiring neurosurgical interventions, such as hydromyelia 9. paraplegia 10. patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery 11. patients requiring anterior release or instrumentation 12. any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study. 13. patient cannot follow study protocol, for any reason 14. patient cannot or will not sign informed consent

Keywords: robotic-guided surgery minimally invasive spinal surgery spinal fusion pedicle screws
usability study of a self-test prototype for human immunodeficiency virus (hiv) screening

Conditions: Mass Screening

Summary: it concerns a study to evaluate the usability of an hiv self-test prototype developed from tr dpp® hiv - 1/2 oral fluid. the study followed the recommendations of technical note no. 20/2016 / gevit / ggtps / anvisa.

it concerns a study with a mixed method approach to evaluate the usability of a prototype of hiv self-test among lay users. data collection techniques were performed through observation through videos of lay users conducting self-testing without supervision, a qualitative checklist by participant observation, pre-test and post-test interviews, and closure form. there was no randomization in this study. the study was conducted by four clinical research sites, distributed in four different states of brazil in other to obtain a geographic representation: unidade de ensaios clínicos para imunobiológicos (ueci) at rio de janeiro; centro de ciências da saúde da universidade federal da paraíba (ufpb) at paraíba, faculdade de medicina de botucatu (unesp) at são paulo and centro de ciências biológicas e da saúde da universidade estadual do pará (uepa) at pará.

Eligibility criteria:
inclusion criteria: * individuals aged ≥ 18 years, of both sexes, who agree to participate in the study, after reading, understanding and signing the icf; * individuals who authorized filming during the test. exclusion criteria: * illiterates; * participants who have already performed any other hiv self-test; * health professionals with complete higher education; * colorblind individuals.

Keywords: usability hiv self-test prototype
human factors study of ultrasound navigation software for cardiac imaging

Conditions: Cardiac Disease

Summary: the product is a machine learning software, that utilizes ai to provide real-time guidance to acquire diagnostic-quality ultrasound views of the heart.

participants are healthcare professionals, who are not performing echocardiography on a routine basis. participants attend a short training session to learn the software, then have a memory-decay period, followed by an individual simulated-use scanning session, lasting up to 60 minutes with a moderator at the heart institute.

Eligibility criteria:
inclusion criteria: * age 18 and older * novice users or medical professionals who do not perform echocardiographs as part of their routine job responsibilities. * have the capacity to understand study risks and consent to be in the study * be available and willing to participate in the study * not be employed by the sponsor or another medical device or pharmaceutical company exclusion criteria: -
the effectiveness of individualized imagery scripts on sleep, psychosis, and suicidality among inpatients with psychosis

Conditions: Psychosis

Summary: the purpose of this study is to see how feasible is the use of compact eeg and paired audio technology to administer sleep interventions for inpatients with psychosis, to see if individuals that receive individualized technology-based sleep interventions experience improvements in sleep quality and to see if individuals that receive individualized technology-based sleep interventions experience improvements in symptomatology


Eligibility criteria:
inclusion criteria: * primary diagnoses of schizophrenia spectrum disorder or mood disorder with psychotic features, as determined by the treatment team or record review * capacity to consent to the study as determined by licensed psychologists ( or the primary attending psychiatrist * reported sleep dysfunction which will be determined by a subthreshold or more severe score ≥ 8 on the insomnia severity index (isi), and/or report experiencing nightmares at least once a week. exclusion criteria: * primary substance- or medical-induced psychosis * intellectual and developmental disabilities * neurodegenerative cognitive disorders * implanted devices (e.g., pacemakers) * on one-to-one supervision or 15-minute safety checks for suicidality or aggression * patients with roommates that are on 15-minute checks to minimize impact on study participants' awakenings

Keywords: sleep therapy suicidality psychosis
efficacy of rtms treatment after spinal cord injury

Conditions: Spinal Cord Injuries; Myelopathy

Summary: there is accumulating evidence that neuromodulation by repetitive transcranial magnetic stimulation (rtms) of the motor cortex holds promise as a treatment for rehabilitation of motor function following a spinal cord injury. this study is designed to assess the clinical potential of non-invasive stimulation of the primary motor cortex to improve motor functions.the results will help to evaluate the clinical relevance of motor cortex stimulation for motor functions in patients with spinal cord injury. the outcomes of this study could potentially support the initiation of a larger clinical trial and the development of a new routine treatment.

the investigators will recruit 20 patients with low cervical or thoracic asia c or d spinal cord injuries based on specific inclusion and exclusion criteria. the patients will be randomized into 2 groups. each group will receive either the theta burst stimulation or the placebo stimulation. rtms will be delivered using a figure-of-eight coil positioned on the patient's head, targeting the leg area of the primary motor cortex. after the motor threshold (mt) is determined patients will receive a unilateral 90% subthreshold theta burst stimulation for 3 minutes the protocol includes 15 stimulation sessions over a 3-week period. the 12-week follow up consist of a series of electrophysiological and functional tests to assess upper and lower limb function bilaterally. secondary outcomes include pain using the nrs scale, and self-reported evaluation of autonomic functions before, during, and after the treatment.

Eligibility criteria:
inclusion criteria: * age over 18 years and less than 80 years * chronic patients with an incomplete cervical and/or thoracic spinal cord injury (traumatic and non-traumatic) affecting upper and/or lower extremities (i.e., c4-t12 and classified as asia c or d) (figure 138). * capable and willing to provide informed consent and able to adhere to the treatment schedule * patients who can be followed for the whole duration of the study 6.3 exclusion criteria * contraindication to rtms: * past severe head trauma * history of epilepsy or ongoing epilepsy * active cerebral tumor * intracranial hypertension * implanted ferromagnetic devices such as cardiac pacemaker and neurostimulator and cochlear implants * pregnancy or lactation. * any clinically significant or unstable medical or psychiatric disorder * other ongoing research protocol or recent past protocol within two months before the inclusion * history of treatment with deep brain stimulation (dbs) * subjects protected by law (guardianship or tutelage measure) * history of substance abuse (alcohol, drugs) * pending litigation * impossibility to understand the protocol or to fill out the forms * chronic use of sedative medication * participation in another clinical trial evaluating spinal cord injury

Keywords: rtms rehabilitation spinal cord injury motor cortex stimulation
surveillance for early liver injuries caused by xianlin gubao capsule.

Conditions: Drug-Induced Liver Injury

Summary: this is a prospective registry study to surveil early liver injuries caused by xianlin gubao capsule (xlgb capsule) through a non-intervention observational way. and attempt to establish a predictive model to screen susceptibilities to xlgb capsule.

the primary objectives of this study include: (i) the detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of xlgb capsule; (ii) the record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) the specimen collection of surveiled individuals. (iv) the attempt to establish a predictive model to screen susceptibilities to xlgb capsule.

Eligibility criteria:
inclusion criteria: 1. individuals in accordance with indications for xlgb capsule, including osteoarthritis, and lumbar muscle strain; 2. the age range of 18 to 70 years； 3. individuals taking xlgb capsule over 2 weeks; 4. abnormalities of serum liver biochemistry achieving one of the criteria as follows: (i) alanine aminotransaminase (alt) or aspartate transaminase (ast) ≥2 folds of upper limit of normal (uln); (ii) total bilirubin (tbil) ≥ 2 uln; (iii) alkaline phosphatase (alp) ≥ 2 uln; 5. individuals can provide informed consent form. exclusion criteria: 1. individuals without indications for xlgb capsule; 2. unconformity to the xlgb capsule drug label; 3. individual taking xlgb capsule less than 2 weeks; 4. individuals taking other hepatotoxic drugs combined with xlgb capsule, simultaneously; 5. unconformity to the diagnostic standard for herb-induced liver injury (the guideline for diagnosis and treatment of herb-induced liver injury, rpgip-2016cn003）.

Keywords: drug-induced liver injury
indocyanine green test for evaluation of perfusion of staple line of the stomach during laparoscopic sleeve gastrectomy

Conditions: Obesity, Morbid; Diabete Type 2; Cardiac Disease; Vascular Diseases

Summary: the investigators present the case of a 40-year-old female underwent laparoscopic sleeve gastrectomy. intraoperative indocyanine green test was performed


Eligibility criteria:
inclusion criteria: * bmi \>40 kg/m2 exclusion criteria: * non-obese patients

Keywords: laparoscopic sleeve gastrectomy bariatric surgery indocyanine greene test gastric fistula
pharmacogenomic research in korean patients with hepatitis c

Conditions: Chronic Hepatitis C

Summary: the aim of this study is to investigate the relationships between drug response and the host genetic factors, viral factors and clinical factors in chronic hepatitis c patients (hcv). and thus, the investigators are trying to develop the pharmacogenomic guideline in the korean patients with hcv.


Eligibility criteria:
inclusion criteria: * hepatitis c virus infected patients exclusion criteria: * patients who infected hepatitis b virus or human immunodeficiency virus * hcv infected patients previously treated with antiviral drugs * patients had a history of autoimmune hemolytic anemia

Keywords: chronic hepatitis c pharmacogenomics il28b itpa
anatomical and functional results of surgery of the tympanic membrane perforation of the child

Conditions: Tympanic Membrane Perforation; Tempanoplasty

Summary: this study is a retrospective cohort of patients minors during the operation of cartilage tympanoplasty for tympanic membrane perforation

the investigators hypothesis is that the cartilage tympanoplastie lead to a closure of the tympanic membrane in 95% of cases. but the investigators believe that certain risk factors may influence the anatomical and functional results of tympanoplastie of the child and that their inclusion could improve these results. for example, young age is not clear so far as a potential risk factor in the few studies analyzing this factor independently. a recommendation of the french society of ent surgery tympanic membrane perforation of the child in 2006 recommended a minimum age of 6 years. however, the level of evidence of articles analyzed was small (it was basically a consensus of experts) and the investigators feel it necessary to study this factor by age (\ 14 years) on a large cohort to determine the real influence of age on the anatomical and functional results as this may lead to changes in practice. similarly, whatever the influence of age in the general population, it could be a key criterion in children who have a particular field leading to prolonged tubal dysfunction (vélopalatines slots and craniofacial malformations), leading to raising the age of surgery tympanic closure: the investigators have for example in 1000 tympanoplasties for perforation, expected recruitment numbers in this study, 50 patients with craniofacial malformation or vélopalatine slot. the purpose of this study is to investigate the factors influencing the anatomic outcome at one year of cartilage tympanoplastie child.

Eligibility criteria:
inclusion criteria: * patient minors during the operation of cartilage tympanoplasty for tympanic membrane perforation (tympanoplasty for this first ear) * patient operated between early 1998 and late 2012 * postoperative audiometry and otoscopy available between 9 and 18 months after surgery exclusion criteria: * history of tympanoplasty ipsilateral, tympanic membrane perforation associated with épidermose or cholesteatoma * the holders of the parent or the patient has reached majority informed the doctor of their refusal to data collection.

Keywords: childrens tempanoplasty tympanic membrane perforation retrospective cohort
a post-marketing study to assess the safety of abatacept in sweden using the swedish rheumatology quality register (srq) register

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis

Summary: the purpose of this study is to collect real-world data in order to estimate the frequency of overall malignancies, melanoma, basal cell carcinoma, and squamous cell carcinoma in participants with rheumatoid arthritis (ra) or psoriatic arthritis (psa) enrolled in the srq register in sweden.


Eligibility criteria:
inclusion criteria: * diagnosis of ra or psa * ≥18 years at index treatment initiation * participants starting treatment with: * abatacept * non-targeted dmards * targeted dmard exclusion criteria: - not applicable

Keywords: abatacept orencia malignancies long-term safety follow-up
height loss, kyphosis indicators, bone mineral density and vertebral fractures in chinese postmenopausal women

Conditions: Osteoporosis Fracture

Summary: this is an observational and cross-sectional study on the height loss, kyphosis indicators, bone mineral density and vertebral fractures in chinese postmenopausal women

postmenopausal women (n=255) aged ≥50 years were randomly selected from community centers in changsha city, hunan province, china in september 2017. menopause was defined as the absence of menstrual cycles for at least one year. all subjects were noninstitutionalized and in good health.the criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs all participants were interviewed using a standard questionnaire. body weight and height were measured to the closest 0.1 kg and 0.5 cm, respectively, with subjects wearing light clothing and no shoes. current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. all subjects provided basic information, including current age, age at the start of menopause, years since menopause (ysm), weight, and their tallest recalled height. the current measured height subtracted from the tallest recalled height was subjects' hhl.the rpd, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. for the kyphosis assessment, subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. the wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. the distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance (c7wd) , and wall-tragus-distance (wtd) was defined as the horizontal distance from the participant's tragus to the wall . all rpd and anthropometric indicators of kyphosis were measured in increments of 0.1 cm by two trained physicians.bmd of the lumbar spine, left femoral neck, and total hip were measured using dual energy x-ray absorptiometry. vfs were assessed using lateral spine imaging from t4 to l4 on x-ray.

Eligibility criteria:
inclusion criteria: postmenopausal women aged ≥50 years (menopause was defined as the absence of menstrual cycles for at least one year) exclusion criteria: morphological abnormalities or skeletal distortions

Keywords: height loss, kyphosis osteoporosis, vertebral fracture postmenopausal women
external hypofractionated radiotherapy with simultaneous integrated boost in early breast cancer patients

Conditions: Breast Neoplasms; Breast Cancer

Summary: this is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer

patients enrolled for the study, according to eligibility criteria, undergo breast conserving surgery followed by adjuvant 10-fraction whole breast irradiation with a risk adapted simultaneous-integrated boost dose at the level of the tumour bed according to clinical and pathological risk factors.

Eligibility criteria:
inclusion criteria: * histologically proven invasive or in situ unifocal adenocarcinoma of the breast * breast conserving surgery * pathological ptis g3, pt1-2 any grade, pn0 or pn0(sn) (isolated tumor cells \[i+\] allowed) pn1mic, m0 stage * postoperative negative (no ink) final surgical margins * patient requires a whole breast radiotherapy plus a tumor bed boost * female patients aged ≥ 18 years of any menopausal status * ecog performance status 0-2 exclusion criteria: * past history of malignancy except basal cell skin cancer and cin cervix uteri or non-breast malignancy allowed if treated with curative intent and at least 5 years' disease free * mastectomy * concomitant chemotherapy (primary or sequential chemotherapy allowed) (chemotherapy and radiotherapy must be separated by a minimum of 2 weeks). (patients receiving neo-adjuvant chemotherapy are not excluded) * known disorders associated with a higher risk for complications following radiotherapy such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma * any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. example include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder * pregnant or lactating patients * presence of ipsilateral breast implant * prior breast or thoracic radiotherapy for any condition

Keywords: breast cancer simultaneous integrated boost hypofractionated radiotherapy whole breast radiotherapy
mani real-life perspective observatory

Conditions: Asthma; Mild Asthma; Moderate Asthma

Summary: the purpose of this registry aims is to collect a large number of patients with mild and moderate asthma in a real-word conditions for a perspective observation of epidemiological evolution of the disease in relation to the therapeutic interventions available currently and in the near future.

to represent real-world mild moderate italian asthmatics, all adults with diagnosed asthma by specialist, according gina (global initiative for asthma) document, attending respiratory or allergy clinic for a scheduled visit are eligible for study enrollment. if inclusion/exclusion criteria are satisfied, a written consent to participate in the study will be obtained and an informative leaflet for the patient and his/her general practitioners will be delivered. subjects follow up will be scheduled according with gina document and center plan (6 or 12 months follow up visit).

Eligibility criteria:
inclusion criteria: * adult patients * asthma diagnosis according gina 2020 algorithm (annex 1) * patients enrolled in other previous or ongoing observational studies exclusion criteria: * severe asthma patients according international ers/ats guidelines on definition, evaluation and treatment of severe asthma. \[chung kf et al. european respiratory journal feb 2014, 43 (2) 343-373; doi: 10.1183/09031936.00202013 (annex 2)\] * subjects are excluded from this cohort if they exhibit interstitial lung diseases, pulmonary neoplasms, current lung infections, immunological disorders leading to the use of immunosuppressants or continuous treatment with oral steroids.

Keywords: asthma adult cluster cohort study italy prospective