Kornimate/medical-research-clean huggingface dataset:
evaluation and medico-economic study of fibroscan in patients with viral hepatitis

Conditions: Hepatitis, Viral, Human

Summary: a new approach to the evaluation of liver fibrosis has been proposed using pulsometry. the objective is to evaluate the diagnostic performances of the fibroscan technique, together with non-invasive techniques, and to determine how it is able to predict the histological fibrosis score, defined by the metavir score. this transversal study aims to compare the evaluation of hepatic fibrosis obtained by fibroscan and histology (metavir score) in 2550 consecutive patients taken in charge for a liver biopsy. the results of the study will compare the respective performances of these techniques in the prediction of the metavir score, and help in the recommendation of the care of patients with viral hepatitis b and c; these methods will undergo a medico-economic study.

the gold standard for the evaluation of fibrosis is considered as the metavir score by the clinicians. the results of this score are currently used for clinical decisions and description of the evolution of the disease. fibroscan would be interesting in avoiding liver biopsies, if it was able to predict accurately the metavir score obtained if a liver biopsy was performed. the data available on diagnostic performances of fibroscan are incomplete, the number of patients studied and the methods selection (blindness of the results of other techniques) are not precise in some of them. the main objective of this study is therefore to evaluate the performance of fibroscan in the prediction of metavir score \> 2 (vs f0 or f1). an ancillary study will try to evaluate the diagnostic performance of fibroscan in the global prediction of metavir score. a statistical method will be tested using the reference method as an ordinal polytropic variable. half of the sample (1250 patients) will be used to determine the best thershold of fibroscan in each of the clinical subgroups of patients, in order to obtain a high sensibility. the second half will be used as the validation sample, and the threshold will be used to estimate the sensibility, specificity and other diagnostic parameters of the fibroscan. the secondary objectives are: 1. to evaluate the performance of fibroscan in the prediction of metavir score in adjacent classes of fibrosis (f0-f1, f1-f2, f2-f3, f3-f4), and 2. to study the association between elastometry and fibrosis surface obtained by morphometry (considered as the best evaluation of global liver fibrosis). this technique will be applied to a restricted number of biopsies (consecutive biopsies \> 2cm).

Eligibility criteria:
inclusion criteria: * chronic hepatitis b or c * with liver biopsy indication * patient information exclusion criteria: * drug hepatitis * metabolic hepatology * steatosis or non-alcoholic steatohepatitis * autoimmune hepatopathy * non-contraindication to liver biopsy * non-contraindication to fibroscan examination * ascites * obesity

Keywords: biopsy fibroscan
research study to look at how well semaglutide is at lowering weight when taken together with an intensive lifestyle program

Conditions: Overweight; Obesity

Summary: this study will look at the change in participant's body weight from the start to the end of the study. this is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. together with the medicine, the participant will also be part of an intensive lifestyle program where the participant will have talks with study staff about healthy food choices, what the participant can do to lose weight and be more physically active. the participant will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. the participant will need to take 1 injection once a week. the study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. for the first 2 months the participant will be on a low calorie diet. the diet is made up of bars, shakes and 1 low calorie pre-prepared meal for each day. the study will last for about 1.5 years. the participant will have 32 clinic visits with the study doctor.


Eligibility criteria:
inclusion criteria: * male or female, age more than or equal to 18 years at the time of signing informed consent * body mass index more than or equal to 30 kg/m\^2 or more than or equal to 27 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease * history of at least one self-reported unsuccessful dietary effort to lose body weight exclusion criteria: * hemoglobin a1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening * a self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
a randomized controlled trial of trauma-awareness training for early childhood educators

Conditions: Burnout, Professional

Summary: background. to increase school readiness, pre-k programs for low-income children must be responsive to the role of trauma in the lives of children, families, and staff. in 2017-2018, the school district of philadelphia's (sdp) office of early childhood education will help pre-k teachers support children's social-emotional and behavioral health, which is essential for early learning, by offering teachers a professional development course called enhancing trauma awareness (eta). purpose. to determine whether teachers who take eta will have: 1) better work functioning; 2) more trusting work relationships; and 3) better health. population. pre-k classroom teachers (n=128) working in centers under sdp auspice that serve exclusively low-income (≤300 % of poverty) children. intervention. a 12-week professional development course-enhancing trauma awareness-will delivered by lakeside global institute in 6 group sessions, with 16 teachers per group and each session lasting 2.5 hours. design. consenting teachers will be randomly assigned by classroom (lead teacher and/or assistant teacher) to receive the eta course in either fall 2017 (intervention groups) or spring 2018 (wait-list control groups). data collection and analysis. an external evaluation team (temple university) will administer a confidential, online survey to all 128 teachers in fall 2017 (before fall course), winter 2017 (after fall course), and spring 2018 (after spring course). teacher-children relationship quality will be the a priori primary outcome, and secondary outcomes will be assessed across the domains of work functioning, trust, and health.


Eligibility criteria:
inclusion criteria:preschool classroom teacher who works in a center that is under the auspice of the school district of philadelphia and serves exclusively low-income (≤300 % of poverty) children.
extension study, pilot, compassionate use of azacitidine 300 mg film coated tablets for acute myeloid leukaemia (aml) patients

Conditions: Acute Myeloid Leukemia

Summary: extension study, pilot, single-arm, compassionate use of hikma azacitidine 300 mg film coated tablets test product for the acute myeloid leukaemia (aml) patients who completed hikma bioequivalence study with protocol number: hik-aza-2023-01


Eligibility criteria:
inclusion criteria: 1. patients with aml who completed hikma bioequivalence study of the same hikma generic oral azacitidine test product with protocol number: hik-aza-2023-01, and who consent to participate in the study. 2. patients who understand and voluntarily sign a written informed consent document prior to any study related assessment/procedures are conducted. exclusion criteria: 1. female patients who are pregnant or nursing (lactating). 2. patients with medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition of the study. 3. patients with experience in any investigational drug in a clinical study within 6 months prior to study (except for patients who were enrolled in the hikma azacitidine bioequivalence study with protocol number: hik-aza-2023-01).

Keywords: oral azacitidine azacitidine acute myeloid leukaemia
effect and mechanism of brain stimulation for parkinson's disease with cognitive impairment

Conditions: Parkinson Disease; Cognitive Impairment

Summary: this study intends to apply structural and functional brain network neuroimaging techniques combined with image post-processing methods to explore the differences in brain network changes in pd patients with cognitive impairment after dbs or tms.

a variety of post-processing methods (vbm, spm, cat, lead-dbs, etc.) were used to analyze structural brain network images (smri, dti) and functional brain network images (rs-fmri, pet) based on connectomics, and combined with the changes of clinical symptoms before and after treatment. to study the mechanism of the influence of neural regulation on brain network, and further analyze how dbs and tms improve the cognitive symptoms of pd patients from the perspective of brain connectomics, so as to explore the occurrence and development of parkinson's disease with cognitive impairment and the possible improvement mechanism.according to the individual differences in clinical symptoms of different pd patients, better stimulation sites and the best brain network are sought to further guide the surgical plan, so as to obtain the best clinical treatment effect.

Eligibility criteria:
inclusion criteria: 1. the clinical diagnosis of pd is consistent with the united kingdom parkinson's disease society brain bank criteria, with disease duration over 5 years, acute levodopa motor response ≥30%, and indication for stn-dbs. exclusion criteria: exclusion criteria included patients with severe cognitive impairment, severe psychiatric disorders, acute levodopa motor response less than 30%, atypical parkinsonism, and contraindications to surgery.

Keywords: parkinson disease cognitive impairment deep brain stimulation transcranial magnetic stimulation
evaluation of the consumption of lupins in brine on metabolic markers in healthy individuals

Conditions: Lipid Disorder; Systemic Inflammatory Response

Summary: the aim of the project was the evaluation of the effects of the consumption of different amounts of lupins in brine on lipid, glucose, inflammatory, oxidative stress, gut microbiota profile and (epi)genetic markers in healthy volunteers, by means of a 4-week 2-arm parallel randomized controlled trial.

epidemiological and intervention studies confirm a tight relationship between lifestyle - and particularly dietary choices - and human health. among the dietary patterns, it has been showed that the adherence to a plant-based diet, i.e. mediterranean diet, may have a pivotal role in promoting a health longevity and counteracting cardiovascular, neurological and cancer-related diseases. in fact, the abundant consumption of fruit, vegetables, cereals and pulses leads to a high intake of vegetable proteins, unsaturated fatty acids, minerals, vitamins, fibre and bioactive compounds which may have anti-inflammatory, antioxidant, anti-atherosclerotic, hypocholesterolemic and antimicrobial activities. in particular, there is a growing interest for valorization of pulses, among which lupins represent a good alternative as healthy snack but also as serving to be used during the principal meal. lupins are traditional legumes of the mediterranean basin, and they represent a good source of bioactive peptides, soluble fibre and minerals. different trials evaluated the health effects of the consumption lupin derived products in humans concluding that it may lead to a decrease of blood pressure, reduction of blood glucose, cholesterol, triglycerides and uric acid. nevertheless, there is still a lack of information regarding the effects of the consumption of whole lupins, and in particular in one of the most sold forms, as in brine. in this parallel randomized controlled trial, 60 healthy volunteers were randomly allocated for a 4-week consumption of: * active comparator arm: 30 grams per week of lupins in brine; * experimental arm: 600 grams per week of lupins in brine and the suggestion of reduction of at least two servings per week of meat, processed meat and/or cheese; at baseline and after 4 weeks of dietary intervention, subjects were visited in medical facility and asked to provide blood, urine, saliva, feces for the evaluation of: * anthropometric and blood pressure parameters; * blood lipid and carbohydrate profile; * blood transaminase parameters; * blood and urine inflammation markers; * leucocyte and saliva dna genetic and epigenetic markers; * fecal profile of gut microbiota. in addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.

Eligibility criteria:
inclusion criteria: * bmi included between 18.5 and 29.9 kg/m2; * omnivorous diet; * consumption of more than 6 servings of meat, processed meat and/or cheese; exclusion criteria: * antibiotic treatment within 3 months prior the dietary intervention; * chronic diseases * surgeries * dieting * pregnant or lactating

Keywords: lupins blood lipids inflammation
microwave ablation in the treatment of early-stage unifocal invasive breast cancer

Conditions: Breast Cancer

Summary: microwave ablative (mwa) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . however, the optimal indications for mwa in the treatment of breast cancer is unknown. this prospective, open-label, single-arm phase ii clinical study was conducted to evaluate the efficacy and safety of mwa in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect.


Eligibility criteria:
inclusion criteria: 1. female patients aged 18-70 years; 2. patients with newly diagnosed invasive breast cancer confirmed by core needle biopsy; 3. the tumor smaller than 2cm in greatest diameter confirmed by us (ultrasonography), breast x-ray and breast mri (contrast-enhanced magnetic resonance image ) were performed at the same time, and the difference of the largest diameter between breast us and mri was less than 0.5 cm; 4. the single tumor without other suspicious lesions (bi-rads (the breast imaging recording and data system) score ≥4) evaluated by breast us, x-ray and mri; 5. the tumor without adhesion to chest wall, nipple or skin; 6. patients without distant metastasis; 7. karnofsky performance status greater than 70%. exclusion criteria: 1. multicentric or multifocal breast tumor; 2. the tumor located on nipple and areola area; 3. signs of extensive intraductal carcinoma on imaging examination (diffuse malignant calcification on breast x-ray or segmental distribution, non-mass enhancement, ductal or linear enhancement \> 2.5 cm on mri); 4. extensive intraductal component in invasive cancer (more than 50% of the tumor volume) confirmed by pathology; 5. invasive lobular carcinoma, metaplastic carcinoma or carcinoma with sclerosing adenosis; 6. patients who were pregnant or breastfeeding; 7. patients with evidence of coagulopathy, chronic liver diseases or renal failure; 8. patients with previous treatment including chemotherapy, targeted drug therapy, or local radiation therapy, etc; 9. patients with substance abuse, or mental or psychological disorders that may interfere with study compliance; 10. any condition that is unstable or likely to compromise the patient's safety and compliance; 11. patients enrolled in other clinical trials; 12. diseases or symptoms that other investigators consider unsuitable for participation.

Keywords: ablation
analgesic effect of different combinations of dexketoprofen trometamol with tramadol hydrochloride in a model of moderate to severe pain

Conditions: Pain

Summary: the purpose of this study is to evaluate the analgesic efficacy of dexketoprofen trometamol and tramadol hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. ibuprofen will be used as an active control to validate the pain model.

the aim of this study is to develop a combination of dexketoprofen trometamol (dkp.tris) and tramadol hydrochloride (tram.hcl) for the treatment of acute moderate to severe pain, based on the rationale that more than one drug is necessary in most patients suffering of acute and chronic pain, particularly of moderate to severe intensity. dkp.tris and tram.hcl have different mechanisms of action, therefore their combination is expect to result in an additive or synergistic analgesia, thus allowing a decrease in the required doses of the individual agents, and consequently a reduced risk of adverse events in this study, patients who present moderate to severe pain after impacted third mandibular molar tooth extraction will be randomised to a total of 10 treatment arms including 4 combinations of dkp.tris + tram.hcl, the four corresponding single treatments, placebo and ibuprofen. treatment administration will be followed by a 24-hour pain and analgesic effect assessment.

Eligibility criteria:
inclusion criteria: patients meeting all the following criteria will be eligible for entry into the study: * male or female patients aged 18 to 70 years old. females participating in the study must be either: of non-childbearing potential, or willing to use a highly effective contraceptive method. * scheduled for outpatient surgical extraction -under local anaesthesia- of third mandibular molar teeth, with at least one of which is fully or partially impacted in the mandible requiring bone manipulation. * normal physical examination or without clinically relevant abnormalities. at randomisation (after surgery): no intake of analgesics (including prescription and over the counter drugs) within 24h prior to the surgery. * no complication during the surgery, duration of surgery \< 1 hour and not requiring re-anaesthesia. * patients experiencing pain of moderate or higher intensity in the first four hours after the end of surgery. exclusion criteria: * history of allergy or hypersensitivity to nsaids, opioids or acetyl salicylic acid. * history of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic oedema. * history of peptic ulcer, gastrointestinal disorders by nsaids, gastrointestinal bleeding or other active bleedings.

Keywords: moderate to severe pain postoperative pain analgesics dexketoprofen tramadol
the clinical application of infrared thermal imaging detecting venous thromboembolism

Conditions: Deep Venous Thrombosis

Summary: the purpose of this study is to determine the effectiveness of infrared thermal imaging in adjunctive diagnostic screening for lower limb deep venous thrombosis (dvt).


Eligibility criteria:
inclusion criteria: 1. willing to participate in the trial and sign the informed consent form, 2. aged: 18-75 years. they had been definitively diagnosed with venous thromboembolism, 3. the bed-rest immobilization time should be more than 72 hours, 4. planing to gynecology operation, 5. the d dimer should be more than500 g • l-1, 6. there is no obvious symptoms of systemic infection two weeks before the test, 7. there is no trauma, infection, biopsy or puncture, hemorrhage and tumor in the corresponding detection site (chest and lower limbs), 8. there is no skin disease, heart, liver, kidney, gastrointestinal tract, hematopoietic system and mental, neurological has no serious diseases. exclusion criteria: 1. patients can not be good partners, 2. doctors believe that there is any inappropriate situations.

Keywords: infrared thermal imaging deep venous thrombosis
a clinical trial of tq05105 tablets in the treatment of chronic graft-versus-host disease

Conditions: Chronic Graft Versus Host Disease

Summary: this is an open, multi-center clinical study designed to evaluate the efficacy and safety of tq05105 tablets in patients with chronic graft-versus-host disease


Eligibility criteria:
inclusion criteria: * voluntary and signed informed consent, good compliance; * age 18-70 years old; karnofsky performance scale (kps) ≥60 points; life expectancy ≥ 6months. * received allogeneic hematopoietic stem cell transplantation; * diagnosis of moderate-to-severe chronic graft-versus-host disease (cgvhd) * received systemic therapies for cgvhd; * stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening; * absolute neutrophil count (anc) ≥ 1.0×10 9/l ；platelet count (plt) ≥30×10 9 /l; hemoglobin ≥80g/l; there were no obvious abnormalities in liver and kidney function and coagulation function; * men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study exclusion criteria: * currently present or occured other malignancies within 3 years prior to first administration; * known or suspected active acute graft versus host disease (agvhd); * presence of infection requiring treatment within 7 days prior to randomization; * failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants; * use of janus-activated kinase (jak) inhibitors, bruton's tyrosine kinase (btk) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization; * has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc; * those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder; * have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment; * have any severe or uncontrolled serious illness, including but not limited to，uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment; * those who are allergic to the study drug or its components; * participation in other clinical trials or major surgery within 4 weeks prior to the first dose; * subjects judged by the investigator to be unsuitable for enrollment;