Kornimate/medical-research-clean huggingface dataset:
comparison of two different flap methods in the treatment of pilonidal sinus disease

Conditions: Pilonidal Sinus

Summary: sacrococcygeal pilonidal sinus disease (psd) has been defined as a disease characterized by chronic inflammation and recurrent infections caused by the movement of hair toward the gluteal sulcus. this condition is especially seen in young men and negatively affects the quality of life of patients and prevents them from performing their work and school activities. the treatment options for psd range from the use of antibiotics alone to reconstructed excision with tissue flaps. although the optimal surgical treatment option remains controversial, expectations from the ideal surgical treatment include low recurrence and postoperative complication rates, early wound healing, short hospital stay, early return to work, and good cosmetic outcomes. the aim of this study was to compare the efficacy of the different flap techniques in the surgical treatment of psd and evaluate the long-term outcomes of patients.


Eligibility criteria:
inclusion criteria: * underwent surgery due to pilonidal sinus disease exclusion criteria: * patients with a history of previous pilonidal sinus surgery, * an acute pilonidal abscess, * immunodeficiency, * using immunosuppressive drugs, * refuse to participate in the study

Keywords: pilonidal sinus disease flap karydakis bilaterally parallel elliptic
effect of covid-19 lockdown on alcohol and tobacco use in two chilean universities

Conditions: SARS-CoV-2 Infection; COVID-19

Summary: this is a longitudinal study of participants from two university communities in chile. the primary objective is to examine the effect of a regional lockdown on alcohol and tobacco use, using a difference-in-difference analysis to obtain causal estimates of these covid-19 policies.

the covid-19 pandemic is spreading worldwide. countries have adopted public health and social measures that, together with a direct effect of the pandemic, can affect alcohol and tobacco use. the most stringent measures are lockdowns and curfews that include statutory restrictions on people's mobility. research to date has shown mixed effects of the covid-19 pandemic and lockdowns on alcohol and tobacco use. importantly, previous studies have not been able to differentiate the effects of the pandemic itself with those from lockdown and curfew policies. they have also been restricted to countries in europe, the united states, australia and new zealand. the study will advance prior knowledge by providing evidence from a country in latin america, one of the worst-hit regions worldwide. latin america accounts for 8.4% of the global population, but 20.3% of the total sars-cov2 cases and 30.2% of the covid-19 deaths to date. in addition, the study will exploit the variation in lockdown policies in two regions in chile to disentangle the effects of the covid-19 pandemic with those from a lockdown. the aim of the study is to examine the effect of a regional lockdown on alcohol use in two university populations in the araucanía and coquimbo regions in chile. the investigators will use a difference-in-difference analysis to obtain causal estimates of these covid-19 policies.

Eligibility criteria:
inclusion criteria: * people with study rights either at the undergraduate and postgraduate levels by july 27, 2020 at the universidad de la frontera or universidad católica del norte; or * workers with a full-time or part-time contract with either university, including academics, administrative and assistant personnel; and * having an email registered in the human resource office of each university exclusion criteria: * people without valid study rights at either university * people without a working contract with the university * not having an email registered at the human resource office

Keywords: alcohol drinking tobacco use sars-cov-2 covid-19 epidemiology cohort studies
inhibition of che-1/aatf as a new tool in multiple myeloma treatment

Conditions: Multiple Myeloma

Summary: multiple myeloma (mm) is a haematological malignancy characterized by the accumulation of proliferating antibody producing plasma cells in the bone marrow. in the last few years many studies have emphasized the biological complexity and heterogeneity of mm as a result of both genetic and epigenetic aberrations. che-1/aatf (che-1) is a transcriptional cofactor involved in cell cycle regulation, apoptosis, dna damage and stress response. it can be hypothesized that che-1 might contribute to the establishment of the mm malignant phenotype by sustaining global transcription through its ability to modulate chromatin accessibility. the prospective study on mm human samples aims to understand the involvement of che-1 in the transcriptional regulation and chromatin remodeling during the pathology. to this goal the main objectives are: * characterization of che-1's role in chromatin remodeling and global gene expression * study in vivo and in vitro of che-1 involvement in mm tumorigenesis * evaluation of che-1 as a possible therapeutic target


Eligibility criteria:
inclusion criteria: * mm patients exclusion criteria: * no exclusion criteria
observation of treatment patterns with lucentis in approved indications

Conditions: Neovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNV

Summary: a multicentre, open-label, non-interventional study to observe treatment patterns in patients with wet age-related macular degeneration (wamd), with visual impairment due to diabetic macular edema (dme), due to macular edema following retinal vein occlusion (rvo) or due to chorioidal neovascularization following pathologic myopia (mcnv) with repeated intravitreal injections of lucentis® (ranibizumab) including optional oct monitoring over a 24 months observational period under real life conditions.


Eligibility criteria:
inclusion criteria: * presence of * neovascular (wet) age-related macular degeneration (amd), * visual impairment due to diabetic macular oedema (dme), * visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo) or * visual impairment due to choroidal neovascularisation (cnv) secondary to pathologic myopia (pm) * patients for whom a therapy with lucentis® is medically indicated. * written patients informed consent. exclusion criteria: * as described in the smpc. * preceding intravitreal treatment of the study eye with anti-vegf drugs in the last three months before enrollment * preceding intravitreal treatment of the study eye with steroids
regional kale as source of lutein and zeaxanthin to improve vision of amd-patients

Conditions: Changes in Macular Pigment Optical Density

Summary: the age-related macular degeneration (amd) is an age-dependent, multi-factorial disease. in western industrial countries, it is the main cause of visual impairments. in germany, approximately 4.5 million people suffer from amd. genetic as well as nutritional aspects are mainly important in amd development. until now, amd-patients are advised to use supplements based on the carotenoids lutein and zeaxanthin, comprised in high doses and in isolated form. results showing the effects of food items (kale, spinach) rich in lutein on improvement of vision are scarce. and how much is needed within the diet? within the planned project, human intervention studies will investigate whether an oil-based kale extract or fresh kale can be used to improve vision of amd-patients and persons aged 50+ (without amd). the first study will use volunteers without amd (\>18 y) to investigate if there is a dose-dependent effect of lutein and zeaxanthin (out of a kale extract) on macular pigment optical density (mpod). this study will also compare the bioavailability of the carotenoids from the extract and from a supplement. a second study (also using volunteers without amd, \>18 y) will compare the bioavailability of lutein and zeaxanthin from the extract and from kale purée. the third study will investigate the effect of the oil-based kale extract on improvements of mpod and vision of amd-patients and of a control group (volunteers 50+ without amd). usually, the intestinal absorption of lutein and zeaxanthin is determined by analyzing changes in concentrations in blood plasma. a fast, non-invasive sampling will be evaluated to check the efficacy of an increased uptake of lutein. thus, the project will test the usability of buccal mucosa cells to detect metabolic changes after an uptake of carotenoids. besides, the determination of carotenoid contents in skin will be checked on its use as biomarker of carotenoids in plasma and macula. thus, the planned research project will evaluate two non-invasive markers of exposition on their usability as markers of absorption of lutein and zeaxanthin in blood and macula. in addition, the minimally needed dosage of lutein and zeaxanthin for amd prevention will be determined to reduce the possible risk of currently recommended doses of these compounds. the project will also present alternatives (kale extract, kale purée) for amd prevention and to improve vision to be used instead of currently used high-dose supplements.


Eligibility criteria:
inclusion criteria: * healthy, \> 18 years, written consent exclusion criteria: * uptake of dietary supplements, glaucoma
mechanisms and prognosis of stroke-heart syndrome

Conditions: Stroke; Myocardial Injury; Heart Failure; Acute Coronary Syndromes; Arrhythmia; Sudden Cardiac Death; Takotsubo Syndrome; Heart Rate Variability

Summary: the incidence of stroke-heart syndrome following acute stroke, which encompasses both acute ischemic stroke and acute intracerebral hemorrhage, is notably high and is strongly associated with increased mortality and poor outcomes in stroke patients. however, the underlying mechanisms remain unclear, and there are currently no effective prevention or treatment strategies. this study aims to elucidate the neuro-humoral mechanisms of stroke-heart syndrome through multimodal imaging and multi-omics blood analysis. additionally, it seeks to observe the progression of stroke-heart syndrome and its impact on functional outcomes, cognitive abilities, and emotional issues post-stroke. the research is expected to uncover novel blood biomarkers and brain network mechanisms associated with stroke-heart syndrome, providing potential targets and theoretical foundations for pharmacological treatments or physical interventions. furthermore, it aims to establish a risk early-warning system for major cardiovascular complications post-stroke, enabling early identification, early intervention, and integrated brain-heart management to improve clinical outcomes for stroke patients.


Eligibility criteria:
inclusion criteria: 1. patients admitted within 48 hours of onset, confirmed by ct/mri as having a stroke (including acute ischemic stroke and hemorrhagic stroke). 2. moderate-to-severe stroke with nihss ≥ 5. exclusion criteria: 1. previous focal brain injury (such as stroke, brain surgery, traumatic brain injury, etc.). 2. brain dysfunction caused by other major neurological disorders than stroke (such as brain tumors, epilepsy, parkinson's disease, etc.). 3. transient ischemic attack (tia) and subarachnoid hemorrhage (sah). 4. history of cardiac diseases (such as coronary heart disease, heart failure, severe arrhythmias, congenital heart disease, cardiac surgery, valvular heart disease, or undiagnosed significant cardiac symptoms). 5. concomitant systemic diseases such as renal failure (egfr \< 30), autoimmune disorders, severe infections, etc. 6. history of dementia, depression, or other psychiatric disorders. 7. poor compliance and inability to cooperate with follow-up.

Keywords: stroke-heart syndrome
burtvision™ for arm rehabilitation in chronic stroke survivors:

Conditions: Stroke

Summary: the focus of this study is to perform a preliminary assessment of the efficacy of the burtvision system. while the burt robotic-arm assists the patient's upper-limb in their movements, burtvision will allow the patient to perform unimanual and bimanual activities while leveraging augmented reality games. the investigators will compare clinical outcomes when the burtvisions ystem is used for training solely relying on unimanual tasks vs. when it is used for training relying on both unimanual and bimanual tasks.

the proposed study is a single-blinded randomized clinical trial to evaluate the effect of using the burtvistion on motor gains after robot-assisted upper-limb. study participants (stroke survivors) will be recruited at the spaulding rehabilitation hospital - boston. subjects will be randomly assigned to one of the two different groups: unimanual or unimanual + bimanual arm therapy using a block-randomized allocation procedure to ensure important covariates, such as baseline fugl-meyer assessment of the upper extremity (fma-ue) scores and chronicity, are balanced between groups.

Eligibility criteria:
inclusion criteria: 1. male or female, 18-80 years old; 2. unilateral ischemic or hemorrhagic stroke at least 6 months and no more than 5 years prior to study enrollment; 3. upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the fugl-meyer assessment (fma-ue) between 12 and 40; 4. some active pro-supination range of motion; 5. some active metacarpal-phalangeal joint in the hemiparetic hand; 6. intact cognitive function to understand the robotic therapy procedures (mmse\>23 and able to follow 3 step command) during initial evaluation visit; exclusion criteria: 1. undergoing upper-limb rehabilitation therapy during the period of the study. 2. severe spasticity (defined as a modified ashworth scale score of 3 or more) that would prevent safe use of the robotic system; 3. visual impairments as assessed by the nih stroke scale visual field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject's ability to play the interactive games (as assessed with the line bisection test); 4. severe proprioceptive deficits that impair the ability to process haptic or visual feedback, as assessed by physical examination during screening; 5. communication impairments such aphasia that impair the subject's ability of providing feedback (as reported by a physician in his/her medical record); 6. individuals with open wounds or recent fracture (\<3 months) in the upper extremity, fragile skin or active infection; 7. upper-extremity orthopedic injuries or severe pain resulting in movement limitations.
a long-term follow-up study evaluating intravenous injection of exg001-307 in patients with type 1 sma

Conditions: Spinal Muscular Atrophy

Summary: an open-label, long-term follow-up study to evaluate the safety and tolerability of gene therapy with exg001-307 in sma1 patients ,who joined the parent study (exg001-307-102)

this study plans to enroll type 1 sma patients who have previously received exg001-307 treatment in the parent trial exg001-307-102 to observe the long-term safety and efficacy of gene therapy with exg001-302. the first year of long-term follow-up will be conducted every 3 months ; in the second year, follow-up visits will be conducted every six months, with telephone follow ups at 15 and 21 months during this period; from 3 to 5 years after gene therapy, follow up by phone every six months and follow on on site once a year.

Eligibility criteria:
inclusion criteria: 1. previously received treatment with exg001-307 in trial exg001-307-102; 2. parents or guardians understand the research procedure and sign the icf; good compliance and willingness to follow research procedures. voluntarily participate in this clinical trial. exclusion criteria: 1. parents or guardians are unwilling or unable to participate in long-term follow-up studies.

Keywords: sma
multi-omics study and drug intervention study of spondyloarthritis

Conditions: Spondylarthritis

Summary: spondyloarthritis (spa) is a type of chronic inflammatory rheumatic disease that mainly affects the spine and peripheral joints, or joints, ligaments and tendons. this disease subtype has the same clinical and immunological features. further explore the pathogenesis of spondyloarthritis, explore the guiding significance of different imaging examinations for spondyloarthritis, and study the efficacy and mechanism of different drugs for spondyloarthritis.

1. clinical phenotype research. the clinical phenotype is the symptoms and signs of the disease and its evolution. through the clinical phenotype research of spondyloarthritis, it is helpful to realize the diagnosis and grading of spondyloarthritis and help to achieve individualization precise treatment. 2. transcriptomic research. the key genes and pathways involved in the pathogenesis of spondyloarthritis can be explored through transcriptomic research of spondyloarthritis, which can provide help for early diagnosis and seeking potential treatment methods. 3. microbiological research. through the microbiome research on spondyloarthritis, the composition and function of intestinal flora in patients with spondyloarthritis can be deeply analyzed to provide help for diagnosis and treatment. 4. radiomics research. through the radiomics research on spondyloarthritis, it is helpful to realize the diagnosis and grading of spondyloarthritis and the evaluation and prediction of treatment. 5. drug treatment research by studying the therapeutic effects of different drugs in patients with spondyloarthritis, it is helpful to explore the efficacy and mechanism of different drugs on spondyloarthritis, and to achieve precise and individualized treatment.

Eligibility criteria:
inclusion criteria: * the patient meets the revised as new york diagnostic criteria or asas axial spa classification criteria. exclusion criteria: * patients with rheumatoid arthritis, scleroderma, systemic lupus erythematosus and other immune system diseases; * patients who had received head and neck radiotherapy; * patients with history of antidepressants and parasympathetic stimulants; * patients known to be infected with human immunodeficiency virus (hiv) or hepatitis c virus; * patients with sarcoidosis or tuberculosis infection. * patients with inflammatory bowel disease or uveitis.
yoga in patients with fibrosing interstitial lung diseases

Conditions: Fibrosing Interstitial Lung Diseases; Idiopathic Pulmonary Fibrosis

Summary: fibrosing interstitial lung diseases are characterized by loss of lung function, which leads to a decrease in quality of life and physical capacity. several studies have shown an increase in quality of life and physical capacity after increasing physical activity in patients. there is evicence that yoga has a positive influence in patients with chronic obstructive pulmonary diseases, but so far, studies examining the effect of yoga in patients with fibrosing interstitial lung diseases are missing. study aims are to determine the feasibilty of this study, and to determine the effects of yoga to patients' quality of life and physical capacity. twenty patients with a fibrosing interstitial lung disease will be recruited and randomly assigned to the intervention or control group. several questionnaires regarding quality of life will be conducted. furthermore, the 6 minutes walking test, a lung function test and a biomarker analysis will be conducted at baseline and follow-up. the intervention group will participate in a 12 week yoga class, whereas the controll group will not participate. yoga classes will be offered to the control group after the study. in addition, focus group interviews will be conducted at baseline and follow-up with the intervention group.

patients with a fibrosing interstitial lung disease will be recruited. in total 20 patients will be recruited, 10 for the intervention group and 10 for the control group. the intervention group will participate in a 12 week yoga class with classes twice a week for about 1 hour. the control group will not participate in a yoga class. at baseline all patients will conduct a 6 minutes walking test, a lung function test, several surveys to measure health related quaility of life (king's brief interstitial lung disease questionnaire (k-bild), hospital anxiety and depression scale (hads), interstitial lung disease anxiety questionnaire), and some blood will be drawn for biomarker analysis. furthermore, participants in the intervention group will participate in two focus group interviews, one at baseline and the second one at 12 week follow-up.

Eligibility criteria:
inclusion criteria: * ability to understand study and study procedure * diagnosis of fibrosing interstitial lung disease * age: \> 18 years * ability to consent exclusion criteria: * forced vital capacity \< 50% * oxygen therapy * diagnosis of pulmonary hypertension * participant does not understand the study * pulmonary infection within the last 4 weeks * acute exacerbation within the last 4 weeks * other respiratory decline within the last 4 weeks * co-morbidities which make yoga training impossible

Keywords: fibrosing interstitial lung disease idiopathic pulmonary fibrosis yoga
comparison of multi-parametric and bi-parametric magnetic resonance imaging in men with suspicion of prostate cancer

Conditions: Prostatic Neoplasm

Summary: to compare the detection rate of biparametric (bp) magnetic resonance imaging (mri) for clinically significant prostate cancer (pca) with that of multiparametric (mp)-mri, in biopsy-naïve patients. today, bp-mri is not the standard diagnostic procedure, however preliminary studies showed its non-inferiority with respect to mp-mri. its implementation on a wide scale could significantly reduce examination costs (no iv contrast agent and no endorectal coil), and study time. secondary objectives will be: * to assess specificity of a blood test based on microrna (mir) score in biopsy-naïve patients, using pathological assessment after mr-guided biopsy as reference standard. if specificity of the mir score is higher than that of psa, then fewer patients will undergo unnecessary mri, thus increasing the efficiency of the diagnostic pipeline for pca; * to develop a clinical decision support system (cdss) based on mri and circulating mir evaluation, to stratify patients according to their risk of pca progression, using pathological assessment after prostatectomy as reference standard. patients will be stratified into two classes of risk: i) low-risk pca, in which patients may benefit from a conservative approach (i.e. active surveillance), and ii) medium/high-risk pca in which patients should undergo radical treatment (i.e. surgery or radiation therapy).

the trial is a prospective, randomized, two-arms study with a 2:1 ratio. subjects meeting the inclusion criteria will be randomized either into the bp-mri group (arm a), or the mp-mri one (arm b). all subjects will perform blood sampling in edta tubes before undergoing imaging session. plasma will be isolated within 1 hour from sampling, with a double round centrifugation, aliquoted and stored at -80°c before undergoing mir analysis. mri will be performed with a 1.5 t using axial t2w and diffusion-weighted imaging for subjects in arm a with no endorectal coil and no intravenous contrast agent. men randomized in arm b will undergo mri with t2w in the three acquisition planes, diffusion-weighted and dynamic contrast-enhanced imaging usign endorectal coil. random biopsy will be performed in subjects with no suspicious regions for pca found on mri. men with suspicious regions on mri will be invited to a targeted or in-bore biopsy.

Eligibility criteria:
inclusion criteria: * age \<= 75 years * psa \<= 15 ng/ml * no previous prostate biopsy * negative digital rectal examination * signed infomed conset exclusion criteria: * known prostate cancer diagnosis * previous prostate biopsy or surgery * contraindication to mri * non-cooperative subjects

Keywords: magnetic resonance imaging prostate biopsy microrna