Kornimate/medical-research-clean huggingface dataset:
in vitro study of the liquid biopsy test system of the diagnostic value, in women with various forms of breast cancer

Conditions: Breast Neoplasms

Summary: the study objective is to evaluate the diagnostic efficacy of the liquid biopsy system versus the gold standard mammography (or mri, or ultrasound) diagnosis in patients with suspected breast cancer.

women of the required age group, in case of suspicion of breast cancer, are sent to clarify the diagnosis for mammography or ultrasound of the mammary glands, or mri. based on the results of these studies, a biopsy is prescribed to make a final diagnosis. before a biopsy to diagnose the presence / absence of breast cancer, patients do the blood sampling one time. the blood is processed in the sponsor's laboratory. the test results are compared with the data obtained from the biopsy. the evaluation of the effectiveness of the method will be determined on the basis of the obtained data on the sensitivity and specificity of the test in relation to the reference method.

Eligibility criteria:
inclusion criteria: * availability of signed and dated informed consent. * women from 35 to 65 years old, who are generally healthy, with suspected breast cancer. or without suspicion of (control group) * presence of a documented referral diagnosis of "breast cancer" * presence of a documented biopsy referral * presence of mammography, ultrasound or mri of the mammary glands no later than three months. exclusion criteria: * pregnancy. * any other cancers diagnosed now or previously, with the exception of breast cancer. * therapy with cytostatics during the last three months. * chemotherapy within the past three months. * therapy with hormonal drugs, including all forms of contraceptive drugs. * therapy with other prohibited groups of drugs. * systolic blood pressure \> 180 mm hg. and / or diastolic blood pressure \> 120 mm hg. with repeated measurements. * simultaneous participation in another clinical study. * relative affiliation to the clinic, for example, the patient is a close relative of the researcher or a dependent person (for example, a clinic employee or student or a sponsor employee). * a clinically significant condition or laboratory result that, in the opinion of the investigator, threatens the safety of the test subject, may interfere with assessments, or prevent the completion of the study. * failure to cooperate to participate in planned procedures, including the following examples: lack of understanding of language, mental illness, inability to visit the clinic. * diseases or conditions that may affect the conduct of the study or the interpretation of the results. * history of organ transplantation. * blood transfusions within the last 6 months.
self-management of asthma by forced oscillation technique

Conditions: Asthma

Summary: self-management strategies for asthma, including patients engagement and adherence to personalised action plans with advice on recognizing and responding to deterioration in control with effective treatments can improve asthma outcomes and possibly reduce the risk of future exacerbations. however, the real-life evidence is that asthma control remains sub-optimal in the majority of cases, thus increasing the related socio-economic costs worldwide. because an increased variability of lung function remains a hallmark of poor asthma control and exacerbations, its assessment over time could contribute to the success of self-management plans. previous studies have shown the potential of forced oscillation technique (fot) as a tool for monitoring increased variability of airway obstruction and for identifying the onset of acute deterioration of airway function. the aim of this study is to test the hypothesis that a personalised self-management plan including fot improves asthma control and reduces number of days with increased symptoms compared to conventional asthma treatment.


Eligibility criteria:
inclusion criteria: * age: 6-65 years old * diagnosis of persistent asthma * treatment level at study entry: * for children 6-11 years: step2 or step3 of the gina document * for adolescents and adults 12-65 years: step2 under daily low-dose inhaled corticosteroids (ics), step 3 or step 4 of the gina document * uncontrolled asthma (acq-5 \> 1.5) that, according to the physician, does not warrant an immediate step-up of the treatment * history of moderate or severe exacerbations in the twelve (12) months prior to baseline visit exclusion criteria: * use of oral, rectal or parenteral glucocorticosteroids 30 days before enrolment * treatment with leukotriene receptor antagonist (ltra) * treatment with maintenance and reliever therapy (smart/mart) * smoking, current or previous with a history of 10 pack-years or more * documented copd or other concomitant clinically important diseases or cognitive impairment that, according to the physician, may interfere with the subject's ability or safety to participate in the study * obesity (for subjects 6-19 years: bmi ≥ 95th percentile; for adults 20-65 years: bmi ≥ 40kg⋅m-2 * for school-age children (6-11 years old): gestational age at birth \< 37 weeks or documented bronchopulmonary dysplasia (bpd) * prolonged absence from home during the monitoring period (i.e. at recruitment, expected ≥3 consecutive weeks for ≥2 times during the 9- month monitoring period) subject currently enrolled in other clinical trials related or involving the study of the respiratory system * history of near-fatal asthma * women who are pregnant, nursing or intending to become pregnant during the time of the study * absence of health insurance coverage (applies to french centres only)
the effects of mild sedation on motor function networks in patients with brian gliomas

Conditions: Brain Glioma; Midazolam; Dexmedetomidine

Summary: it has been shown through functional mri (magnetic resonance imaging) that patients with gliomas in eloquent areas have compensated neurological function by virtue of brain post-injury reorganization. our previous clinical research found that mild sedation could induce and/or exacerbate neurological deficits, especially in limb motor and ataxia function, in these patients presumably by impairing functional compensation,. nevertheless it is still very unclear how mild sedation affects sensorimotor networks in brains where reorganization may be present. since eloquent area glioma patients are frequently subjected to sedation, anesthetics, and neurological examinations perioperatively, it is important to investigate how mild sedation interacts with motor network reorganization and functional compensation. our research in patients with eloquent area gliomas will utilize neurological evaluations and multimodal mri to explore the changes in brain upper limb' motor network reorganization after mild sedation by different sedatives-anesthetics. the neurological evaluations include sensorimotor function scale and testing tool. multimodal mri consists of 3-dimentional structure, blood oxygen-level dependent for cortical activation and diffusion tensor imaging for subcortical conduction. the data from the clinical testing and functional mri will be processed and analyzed along with other relevant clinical information. this research will answer the question of how mild sedation affects upper limb motor function networks in brains with eloquent area gliomas. this new information will help optimize perioperative anesthetic and sedative choice for patients with eloquent area gliomas.


Eligibility criteria:
inclusion criteria: * age between 25 to 60 years old; * diagnosed as intracranial eloquent glioma by mri, or healthy volunteer without any intracranial disease; * without history of chronic diseases; * without internal and/external metal object; * right handedness exclusion criteria: * unable to cooperate the neurologic function evaluation; * neuropsychiatric disorders and/or taking antipsychotic medications; * drug and/or alcohol abuse; * receiving longterm sedatives and/or analgesics; * pregnant and/or lactation period patients; * present severe cardiovascular diseases; * having claustrophobia; * body mass index equal or more than 35 kg/m2; * anticipated difficult airway; * history of severe obstructive sleep apnea; * history of reflux

Keywords: functional mri sensory motor function midazolam mild sedation dexmedetomidine
the impact of an 8-week supported exercise program on fitness and symptoms in adolescents with down syndrome

Conditions: Down Syndrome

Summary: this study explores the effects of an eight-week exercise intervention for adolescents with down syndrome on home exercise compliance. as well, to observe changes in fitness including muscular strength, endurance and aerobic capacity. finally to observe any changes in mood, behavior and quality of life.

adolescents with down syndrome will participate in an eight-week, center-based exercise intervention. participants will undergo an hour of exercise intervention each week. during this time, participants will be working with a team consisting of a physician, physical therapy student volunteers, and clinical research coordinators. exercises will focus on strength and endurance of all major muscle groups, while ensuring proper technique and form is used. they will also receive instruction on how to continue the exercise program at home. prior to starting, and at the end of eight sessions, all exercise participants will undergo testing procedures for anthropometric, strength and flexibility measurements. this data will be collected as part of clinically evaluating the impact of the program on each participant. in addition to the exercise program (and clinical assessments of fitness), dsfit participants will complete study measures of behavioral functioning as well as scales of depression and anxiety. participants in the dsfit study will also complete a weekly exercise log during the intervention and for a follow-up period afterwards.

Eligibility criteria:
inclusion criteria: * males and females * 10 to 17 years old (until 18th birthday) * diagnosed with down syndrome by a physician * medically cleared to exercise exclusion criteria: * requires consistent one-on-one care * history of behavioral issues (outbursts, aggressive/self-injurious, bolting) * pre-existing cardiovascular, respiratory or orthopedic conditions that could place participant at risk for injury or illness resulting from exercise. for example: * untreated significant atlantoaxial instability * severe pulmonary hypertension

Keywords: exercise fitness overall wellbeing
tiotropium respimat versus handihaler on sao2 and sleep in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study was to compare the tiotropium respimat soft mist inhaler and the handihaler in terms of their effects on sleeping oxygen saturation (sao2) and sleep quality in patients with copd.

patients with chronic obstructive pulmonary disease (copd) have poor sleep quality as a result of various alterations in oxygenation parameters and sleep macro- and micro-architecture. we aimed to compare the tiotropium respimat soft mist inhaler and the handihaler in terms of their effects on sleeping oxygen saturation (sao2) and sleep quality in patients with copd. in a randomized, parallel-group trial involving 200 patients with mild to moderate copd (resting arterial oxygen tension \>60 mmhg while awake), we compared the effects of 6 months' treatment with the two devices on sleeping sao2 and sleep quality.

Eligibility criteria:
inclusion criteria: * male or female patients aged \>=40 years old * current or ex-smokers with a smoking history of at least 10 pack-years * mild to moderate stable copd (global initiative for chronic obstructive lung disease \[gold\] stage i and ii according to the 2010 gold guidelines (a post-bronchodilator forced expiratory volume in the first second (fev1) ≥80% of predicted for stage i and 50% ≤ fev1 \< 80% of predicted for stage ii, with a post-bronchodilator fev1/forced vital capacity (fvc) ratio \<0.70 at screening) * waking arterial oxygen tension (pao2) ≥60 mmhg exclusion criteria: * refusal to participate * respiratory tract infection within 4 weeks prior to screening * copd exacerbations requiring treatment with antibiotics and/or oral corticosteroids and/or hospitalization within 6 weeks prior to screening * concomitant pulmonary diseases other than copd * asthma * evidence of sleep apnea on baseline sleep studies * obesity hypoventilation syndrome * respiratory failure * congestive heart failure * a history of life-threatening arrhythmias * cardiomyopathy * long-qt syndrome or qtc \>450 ms at screening * diabetes * long-term oxygen therapy * symptomatic prostatic hyperplasia * bladder-neck obstruction * moderate/severe renal impairment * urinary retention * narrow-angle glaucoma * family or personal history of mental illness * drug or alcohol abuse * severe cognitive impairment * concurrent oncological diseases * history of narcolepsy or restless legs syndrome * known history of alpha-1 antitrypsin deficiency * participation in the active phase of a supervised pulmonary rehabilitation program * hypersensitivity to any of the test ingredients * history of adverse reactions to inhaled anticholinergics.

Keywords: chronic obstructive pulmonary disease sleeping oxygen saturation sleep quality
a clinical study to evaluated which number of passes of eus-fnb is better for culturing primary cells of pdac

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: the aim of this study is to investigate the amount of tissue required for the successful culture of primary cells from human-derived pancreatic ductal adenocarcinoma which obtained by endoscopic ultrasound-guided fine-needle biopsy wet suction technique

pancreatic cancer is one of the malignant tumors with the highest mortality rate in the world, with a 5-year survival rate of only 7.2%-9%. because some patients are resistant to multiple chemotherapy drugs, and there are differences in drug sensitivity between individuals, the current pancreatic ductal adenocarcinoma (pdac) chemotherapy effect is not satisfactory. in order to improve the efficacy of chemotherapy and achieve precise treatment, it is important to establish an accurate and individualized pdac research model. because most of patients with pdac have developed to advanced stage at the time of diagnosis, it is not suitable for surgery. that limits our ability to obtain tumor cells seriously. with the development of endoscopic ultrasound-guided fine-needle biopsy (eus-fnb) technique, it can be used not only to diagnose diseases, but also to provide specimens for molecular analysis and create valuable preclinical disease research models, so as to guide the selection of the most appropriate individualized treatment. eus-fnb can obtain lesions without any treatment. therefore, the preclinical disease research model established by eus-fnb is more representative of the original tumor. however, compared with surgical specimens, the specimens obtained by eus-fnb are smaller in size, which may affect the successful construction of research models in vitro. therefore, the investigators plan to use eus-fnb wet suction technique, a modified specimen acquisition method, to obtain pdac tissue, and use it for primary cell culture, to explore the amount of tissue required for the successful cultivation of human-derived pancreatic cancer primary cells, so as to provide a prerequisite for the successful establishment of human-derived preclinical disease research model.

Eligibility criteria:
inclusion criteria: 1. male or female, age≥18 2. imaging examination (us, mri, ct or pet-ct) of patients confirmed pancreatic lesions, and considered the possibility of pdac, eus-fnb was needed for auxiliary diagnosis 3. no chemotherapy, including neoadjuvant chemotherapy, postoperative adjuvant chemotherapy and palliative chemotherapy, has been performed on patients 4. agree to attend this study and signed informed consent exclusion criteria: 1. poor physical condition, including but not limited to hemoglobin ≤ 8.0g/dl, severe cardiopulmonary insufficiency, etc 2. coagulation dysfunction (platelet count \ 1.5), or inability to discontinue anticoagulation therapy 3. high risk for deep sedation 4. acute pancreatitis in the previous 2 weeks 5. pregnancy or lactation 6. any diseases leading to unreliable follow-up 7. absence of informed consent
microbiome and immunologic analysis - women with endometriosis

Conditions: Endometriosis

Summary: the primary goal of this study is to assess differences in the microbiome between women with and without endometriosis. a second goal of this study is to assess immunologic differences between the eutopic (within the uterus) and ectopic (outside of the uterus) endometrial tissue in women with endometriosis. in order to investigate these areas of interest, 25 women with endometriosis and 25 women without endometriosis will be enrolled. all women will be undergoing a previously scheduled surgical procedure at which time presence or absence of endometriosis will be confirmed and specimens will be obtained.

endometriosis is a chronic gynecologic condition where implants of endometrial glands and stroma are present outside of the uterus. it occurs in 6-10% of women of reproductive age and is characterized by dysmenorrhea, chronic pelvic pain, dyspareunia, or infertility. in addition to symptom burden, there are significant direct costs related to diagnosis and treatment of disease, as well as indirect costs related to absenteeism from school and work, loss of productivity, and unemployment. the estimated national economic burden in the united states related to these costs is approximately 78 billion dollars per year. while clinical signs and symptoms may be suggestive of endometriosis, the gold standard for diagnosis requires surgical confirmation of disease. the pathogenesis of endometriosis is complex and likely multifactorial with genetic, epigenetic, environmental, and immunologic factors. an increasing number of studies have also suggested the role of the microbiome in human health and development of disease. this study aims to investigate possible differences in the microbiome and immunologic factors that could contribute to pathogenesis of this disease. findings from this study could potentially contribute to the development of of a less invasive, non-surgical diagnostic test for endometriosis.

Eligibility criteria:
inclusion criteria: * females, age 18 years or older * undergoing laparoscopy (conventional or robotic) with or without hysterectomy for non-cancer indications and including women from two groups: * suspected endometriosis * elective salpingectomy or tubal ligation or abnormal uterine bleeding * understands study procedures * willing and able to provide signed informed consent exclusion criteria: * postmenopausal * currently pregnant or lactating * prior hysterectomy or oophorectomy * undergoing hysterectomy via vaginal or abdominal approach * undergoing hysterectomy or laparoscopy for suspected malignancy * use of antibiotics within 2 weeks prior to surgery * use of hormone therapy for endometriosis or contraception within 4 weeks prior to surgery * diagnosis or treatment of vaginitis during the past 6 months prior to surgery * personal history of autoimmune or inflammatory disease
stellate ganglion block (sgb) for covid-19 acute respiratory distress syndrome (ards)

Conditions: Acute Respiratory Distress Syndrome; COVID-19

Summary: the purpose of this study is to understand if it is safe and useful to perform sgb (stellate ganglion block) in patients who have severe lung injury acute respiratory distress syndrome (ards) due to covid-19 infection.

primary aim: • to determine safety of stellate ganglion block (sgb) in ards secondary aim: * to determine efficacy of sgb in slowing the progression of ards

Eligibility criteria:
inclusion criteria: * subjects age 18 to 80 * subjects with pcr documented diagnosis of covid-19 ards requiring critical care and transfer to intensive care unit * bilateral opacities consistent with pulmonary edema must be present and may be detected on ct or chest radiograph exclusion criteria: * subjects with pre-existing cardiac failure * hemodynamic instability * subject on extracorporeal membrane oxygenation (ecmo) * anatomical inability to do a stellate block

Keywords: acute respiratory distress syndrome covid-19 autonomic nervous system stellate ganglion
achieving a better outcome through limiting the glioblastoma clinical target volume

Conditions: Glioblastoma; Radiotherapy Side Effect

Summary: the objective of the belgica trial is to evaluate if radiotherapy could be given in a more focused manner in patients with glioblastoma in order to reduce side effects and improve quality of life. the glioblastoma (gbm) is the most common and aggressive tumour originating from the brain, affecting approximately 600 patients per year in belgium. the treatment consists in surgical resection of the tumour (when feasible), followed by a combination of radiotherapy and chemotherapy. despite multimodal treatment (surgery, radiotherapy, and chemotherapy), the life expectancy of patients with gbm remains limited, with an average survival of 12-18 months and only 5% of patients surviving more than 5 years. in addition to limited survival, most patients with gbm experience impaired quality of life, both because of the disease and treatments. radiotherapy is a treatment where radiation is used to kill cancer cells. in gbm, radiotherapy is targeted at the tumour (or tumour bed if the tumour was resected) with a safety margin around it (the "clinical target volume" or ctv) to account for potential microscopic spread of the tumour. the downside of this safety margin is that a substantial amount of brain tissue is irradiated, which can lead to treatment toxicity. reducing the ctv margin would enable to decrease the volume of brain being irradiated and could thereby allow to reduce the side effects of brain irradiation. the belgica trial (achieving a better outcome through limiting the glioblastoma clinical target volume) is a national multicentre trial which will evaluate if reducing the irradiation volume in glioblastoma is safe and allows for lowering side effects and improving quality of life.


Eligibility criteria:
inclusion criteria: * participants capable of giving informed consent * age \>= 18 y.o. * who performance status 0-2 * newly diagnosed glioblastoma (histologically proven glioblastoma per who 2021 classification based on biopsy or resection ) * indication of chemoradiotherapy confirmed by multidisciplinary tumour board exclusion criteria: * participation in a competing trial * known contraindication to undergo mri scans