Kornimate/medical-research-clean huggingface dataset:
elaboration of new generation snacks

Conditions: Snack Food

Summary: it is a blind randomized clinical trial of nutritional intervention in humans with a snack (seaweeds and carob), compared to a control snack without the bioactive ingredients studied but of similar nutritional composition, to evaluate the effect on the lipid profile, glycemia and insulin resistance.

the design will consist of a double-blind randomized study in adult subjects with metabolic syndrome, who will consume snack (enriched in seaweeds and carob) (50 g / day) vs. conventional snack for 8 weeks. all the next parameters will be measured/calculated at basal time and after 8 weeks of intervention. the next biochemical parameters will be measured: total cholesterol, ldl cholesterol, hdl, triglycerides will be analyzed using an enzyme-colorimetric method (roche diagnostics , mannheim, germany). glucose will be determined by the method of glucose oxidase (glucose analyzer 2, beckman instruments, fullerton, california), insulin will be determined by elisa (elisa diagnostic corporation, los angeles, ca) and homa will be calculated by the formula matthew et al. , 1985 (homa = (glucose \* insulin) / 22.5). body weight and fat mass by bioimpedance will be measured, too. blood pressure (systolic and diastolic blood pressure) will be measured, too. a diet records for 3 days and a satiety scale will be performed at the beginning and end of the intervention period.

Eligibility criteria:
inclusion criteria: * presence of metabolic syndrome by (adult treatment panel iii) criteria exclusion criteria: * consume supplements (vitamins, minerals or other dietary components), * non-restrictive diet * known chronic disease (eg diabetes, cardiovascular disease, inflammatory diseases). * active cancer

Keywords: carob seaweed snack food obese subjects
study of the efficacy and safety of etanercept treatment in patients with sapho syndrome

Conditions: SAPHO Syndrome

Summary: the study includes adult patients with sapho syndrome (orpha: 793), meeting the modified classification criteria according to kahn (2003), with the ineffectiveness of standard treatment (patient's global assessment of the disease on the vas scale greater than or equal to 4 cm with accompanying pain on the vas scale greater than or equal to 4 cm) treated with non-steroidal anti-inflammatory drugs in a stable dose for at least 4 weeks and/or classical disease-modifying antirheumatic drugs in stable doses for at least 12 weeks.


Eligibility criteria:
inclusion criteria: 1. diagnosis of sapho syndrome according to modified kahn criteria from 2003. 2. age over 18. 3. patient overall disease and pain assessment on vas both ≥ 4 cm. 4. expressing informed consent to participate in the study. exclusion criteria: 1. according to the summary of product characteristics (smpc) for enbrel. 2. pregnancy, breastfeeding, inability to use effective contraception during the examination. 3. change in the dose of nsaids treatment in the last 4 weeks. 4. dose modification of disease-modifying antirheumatic drugs (dmards) over the past 12 weeks. 5. use of biological drugs / synthetic targeted drugs in the last 12 weeks. 6. use of corticosteroids (orally or local injections), bisphosphonates and/or antibiotics in the last 4 weeks. 7. any medical condition that the investigator judges to contraindicate etanercept treatment.
intravenous fluids in hospitalised children

Conditions: Hypokalemia; Hyponatremia; Hypernatremia; Dehydration

Summary: the main objective of the trial is to evaluate the risk of hypokalemia following administration of a isotonic solution compared to a hypotonic solution in acutely ill hospitalised children, who need intravenous fluid therapy.

the main objective of the trial is to evaluate the risk of hypokalemia (low plasma potassium concentration) following administration of a plasmalyte glucos 50 mg/ml solution compared to a 0.45% saline in 5% dextrose solution in acutely ill hospitalised children, who need intravenous fluid therapy. the secondary objective of the trial is to evaluate the risk of hyponatremia (low plasma sodium concentration) and the risk of hypernatremia (high plasma sodium concentration) following administration of isotonic solution compared to hypotonic solution.

Eligibility criteria:
inclusion criteria: * acutely ill hospitalised children * need for intravenous fluid therapy exclusion criteria: * an initial plasma sodium concentration of lower than 130 mmol/l * an initial plasma sodium concentration of higher than 150 mmol/l * an initial plasma potassium concentration of lower than 3.0 mmol/l * need for 10% glucose solution * diabetes * diabetes insipidus * diabetic ketoacidosis * renal disease that needs dialysis * protocol-determined chemotherapy hydration * severe liver disease * inborn errors of metabolism that need protocol-determined fluid therapy

Keywords: isotonic hypotonic intravenous fluids
endoscopic tri-modal imaging in patients with barrett's esophagus

Conditions: Barretts Esophagus; High Grade Dysplasia; Early Esophageal Adenocarcinoma

Summary: this study is being done to determine if a new endoscope will help doctors identify pre-cancer or early cancer lesions in patients who have barrett's esophagus. this new endoscope allows the doctor to look at the lining of the esophagus in 3 different ways by modifying light.

patients with barrett's esophagus are advised to undergo periodic endoscopic surveillance with random biopsies in an attempt to identify high-grade dysplasia (hgd) or early adenocarcinoma (aca) at a time when intervention can be curative. this approach, however, can be time-consuming and is hindered by low sampling yield and random sampling error. endoscopic tri-modal imaging (etmi) is a novel diagnostic modality that encompasses three advanced imaging features in one system: high-resolution endoscopy (hre), autofluorescence imaging (afi) and narrow-band imaging (nbi). hre and afi provide a bird's-eye view of 'red flag' areas which are then assessed by nbi for focused and more specific tissue characterization. the aim of this prospective, multi-center study is to compare the diagnostic performance of etmi with that of standard white-light endoscopy (wle) for identifying high-grade dysplasia (hgd) and early adenocarcinoma (aca) in be. a total of 84 be patients will be recruited for the study and they will undergo both etmi and wle examinations in a randomized, crossover fashion. standard surveillance biopsies and etmi-targeted biopsies will be performed. the primary outcome will compare the number of patients and lesions with hgd or early aca detected with wle and etmi. it is anticipated that etmi will enhance the detection of high-grade barrett's lesions relative to wle.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. prior diagnosis of be, defined as the presence of columnar-lined epithelium in the distal tubular esophagus with specialised intestinal metaplasia on histological investigation 3. prior diagnosis of hgd or early aca that was endoscopically inconspicuous according to the referring source 4. a minimum barrett's length of c\>2m\>2 or c\ 4 according to the prague c\&m classification for the endoscopic appearance of be 5. ability to provide written informed consent exclusion criteria: 1. description of a visibly suspicious lesion within the barrett's segment according to the referring source 2. presence of a type 0-i or type 0-iii lesion, or a lesion that, according to the discretion of the endoscopist, does not allow delay in intervention for a period of 6 weeks (minimum interval between the two crossover endoscopies) 3. prior endoscopic therapy for barrett's lesions, such as photodynamic therapy or endoscopic mucosal resection (emr) 4. presence of esophagitis \> los angeles grade a classification 5. presence of conditions precluding histological sampling of the esophagus (e.g., esophageal varices, coagulation disorders, anticoagulant therapy) 6. pregnancy

Keywords: barrett's esophagus esophageal cancer high grade dysplasia
a prospective study evaluating the impact of conservative management on retained products of conception and emv

Conditions: Retained Products of Conception; Miscarriage; Conservative Management

Summary: the goal of this observational study is to learn about the therapeutic effects of the conservative treatment approach on pepole with retained products of conception (rpoc) and enhanced myometrial vascularity (emv). the main question it aims to answer is: is it possible to achieve the natural resolution of rpoc by combining it with emv through conservative treatment？ participants will receive conservative treatment (such as mifepristone, gnrh-a, or expectant management) following the initial diagnosis of rpoc and emv, and the therapeutic efficacy of the conservative approach will be assessed after the completion of two menstrual cycles.


Eligibility criteria:
inclusion criteria: * recent history of miscarriage or delivery (within the past 8 weeks) * strong willingness to undergo conservative management * hemodynamically stable * signed informed consent form exclusion criteria: * heavy vaginal bleeding (requiring immediate surgical intervention) * active pelvic or systemic infection (e.g., fever \>38°c, elevated crp/wbc) * severe dysfunction of vital organs (heart, liver, or kidney) * known drug allergies or contraindications to proposed medications (e.g., misoprostol intolerance) * suspected ectopic pregnancy or gestational trophoblastic disease (confirmed by ultrasound or β-hcg levels) * placenta accreta spectrum disorders diagnosed during current pregnancy * history of uterine artery embolization
ultrasonography as a biomarker in early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a prospective, observational study designed to look at ultrasound images of the joint at baseline and over time, and investigate whether there is a correlation between ultrasound images and progression of disease. the researchers wish also to see if ultrasound can be used as a tool to predict progression of rheumatoid arthritis in patients with early disease who have not taken biologics therapy. in addition, the researchers wish to investigate whether peripheral blood "biomarkers"can be identified that predict the progression of erosive disease in early rheumatoid arthritis, with the intention of testing the most promising biomarkers in future clinical trials.


Eligibility criteria:
inclusion criteria: 1. male and female adults aged 18 years or greater. 2. the subject has a diagnosis of ra according to the revised 1987 criteria of the american college of rheumatology (acr) with onset of symptomatology of less than 3 years. 3. the patient is seropositive for rheumatoid factor (igm rf measured by agglutination assay) and / or anti-cyclic citrullinated peptides (measured by elisa). 4. the subject has provided signed and dated written informed consent prior to admission to the study 5. the subject is able to understand and comply with protocol requirements, instructions and restrictions. exclusion criteria: 1. past or present disease, which as judged by the investigator, may affect both the subject's participation in the study or outcome of the study. these diseases include but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. 2. current or prior use of biologic drugs ( anti- tumour necrosis factor alpha drugs or rituximab) 3. as a result of the medical interview, physical examination or screening investigations, the physician responsible considers the subject unfit for the study. 4. the subject's ra does not have a clearly recordable time of onset (within a 6 month period) as determined by either the notes or from the history taken from the patient by the physician responsible

Keywords: early rheumatoid arthritis biomarkers ultrasound
effect of zoledronic acid treatment on bone-related events in breast cancer patients with bone metastases: a prospective, multicenter, real-world study

Conditions: Histologically Confirmed Breast Cancer ,Diagnosis of Bone Metastasis

Summary: non-intervention、real world study； effect of timing and regular treatment of zoledronic acid on the incidence of sres in breast cancer patients

(1) main purpose: to observe the clinical efficacy of zoledronic acid regularly in the prevention of sres in breast cancer patients with bone metastasis (2) secondary objectives: 1. to observe whether zoledronic acid prolonged the time of first sres in patients with bone metastasis; 2. the clinical efficacy and influencing factors of zoledronic acid in different subgroups were observed by subgroup analysis of population baseline, clinical characteristics (such as different types of breast cancer), past history and complications. 3. to observe the clinical distribution, characteristics, timing and compliance of zoledronic acid administration in chinese breast cancer patients with first bone metastasis.

Eligibility criteria:
inclusion criteria: * 1. age ≥18 years 2. histologically confirmed breast cancer 3. initial diagnosis of bone metastasis by mri or ct and treatment with zoledronic acid 4. serum creatinine ≤265mol/l or 3.0mg/dl 5. crcl ≥ 30 ml/min 6. serum ca2+ concentration 2.0-3.0 mmonl/l 7.ecog score ≤2 voluntary research, informed consent exclusion criteria: * 1. pregnant and lactating women 2. severe liver insufficiency (alt and/or ast higher than 3 times the upper limit of normal) 3. patients with osteoarthritis or other bone related diseases need bone targeted therapy 4. patients with uncontrolled dental problems or planned jaw surgery
rct of air insufflation versus water infusion colonoscopy

Conditions: Colorectal Cancer

Summary: compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.

background: a novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy. aim: to perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients. hypothesis: compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy. setting: outpatient colonoscopy in a single va hospital methods: after informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of fentanyl (25 μg) and 0.5 increment of versed (1 mg) plus 50 mg diphenhydramine. the conventional and the study method for colonoscopy were implemented as previously described. additional pain medications were administered at the patients' request. outcome measures: increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy. limitations: single va site, older male population

Eligibility criteria:
inclusion criteria: * healthy individual 50 years or older * eligible for colorectal cancer screening or surveillance exclusion criteria: * patients who do not understand or failed to sign informed consent

Keywords: colorectal cancer screening optical colonoscopy water method sedation
effect of smoking on pain and atherosclerosis in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Atherosclerosis; Pain

Summary: primary aim: examine a possible connection between cigarette smoking, disease activity and perceived pain in patients with rheumatoid arthritis. secondary aim: evaluate cardiovascular risk in patients with rheumatoid arthritis.

the study will recruit patients with rheumatoid arthritis (age 20-60 years) at rheumatology clinics in västra götaland. all patients meeting the inclusion criteria will be informed of the study in a letter and later contacted by the study coordinator and if interested booked for a study visit at the rheumatology clinic. at the study visit the patients will meet with rheumatologist for clinical examination of their joints and tenderpoints. an algometer is used for objective quantification of the patients pain sensitivity. questionnaire regarding medical treatment, other diseases, smoking habits, subjective pain, fatigue, anxiety and depression, ability to work and ability to perform everyday activities are filled out by the patient. height, weight, blood pressure, blood, urine and fat biopsy will be collected for analyse.

Eligibility criteria:
inclusion criteria: * patients aged 20-60 years diagnosed with rheumatoid arthritis exclusion criteria: * other serious physical or mental illness, lack of knowledge in swedish language making answering the questionnaires impossible
observational study of denosumab (prolia®) in postmenopausal women with osteoporosis

Conditions: Postmenopausal Osteoporosis

Summary: the main objective of this observational study was to describe medication-taking behavior of patients treated with denosumab for postmenopausal osteoporosis (pmo) at 12 and 24 months.

the decision to treat patients with denosumab was made independent of and before their enrolment in the study. no study drug was administered as part of the study.

Eligibility criteria:
inclusion criteria: * indicated for treatment of osteoporosis in postmenopausal women at increased risk of fractures according to the approved regional prescribing information (eg, eu smpc in germany, austria, greece and belgium). * enrolled into the study within 4 weeks of receiving their first injection of prolia® according to the approved regional prescribing information (eg, eu smpc in germany, austria, greece and belgium). * appropriate written informed consent has been obtained (as required per local country regulations). exclusion criteria: * patient is currently enrolled in or has been enrolled within the prior 6 months in a study involving any investigational procedure, device or drug. * contraindicated for treatment with prolia® according to the approved regional prescribing information (eg, eu smpc in germany, austria, greece and belgium). * participation in ongoing or previous denosumab clinical trials. * patient has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the patient to give written informed consent.
prognosis assessment of the increase of gadd34 gene expression for patient suffering from systemic lupus erythematosus

Conditions: Lupus Erythematosus

Summary: given that gadd34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in sle patients, this study aim to prove that the gadd34 rna level in mononuclear blood cells can be used as a prognostic marker to assess the risk of sle flare.

systemic lupus erythematosus (sle) has a prevalence estimated between 1 and 6 per 10000 individuals and concerns over 30 000 patients in france for example. as of today, there isn't any reliable specific blood analysis that can be used to assess the prognosis of sle, that means predict a sle flare. the discovery of such a blood test could allow a better patients' monitoring in order to help doctors to better adapt treatments (lowering background treatments when they are not needed and increase them ahead of a potential flare when the risk assessment raises). in sle patients, a recent study shows elevated levels of gadd34 rna in mononuclear blood cells : higher than twice the control levels for 36 of the 60 sle patients and ten times higher than the control levels for 13 of the 60 sle patients. given that gadd34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in sle patients, this study aim to prove that the gadd34 rna level in mononuclear blood cells can be used as a prognostic marker to assess the risk of sle flare.

Eligibility criteria:
* inclusion criteria: * man and women over 18 years old. * suffering from sle (american college of rheumatology criteria). * without sle flare for 3 months. * with a signed consent and social security affiliation (required in france). * exclusion criteria: * viral infection within 15 days. * other chronic inflammatory disease. * people with special protection (defined in articles : l1121- §5-8 et articles l3212-§1-3 of french health care law).

Keywords: flare therapeutic adjustments biological marker immunologic marker prognosis
accelerated intermittent theta burst stimulation for depressed patients during the covid-19 pandemic

Conditions: Treatment Resistant Depression

Summary: repetitive transcranial magnetic stimulation (rtms) using intermittent theta burst stimulation (itbs) has been found to be a non inferior protocol to standard rtms for the treatment of major depressive disorder. an accelerated course is of particular interest given the safety profile of the procedure and the potential to treat people more quickly making the treatment more accessible. this study aims to assess the feasibility and clinical outcomes of a high dose itbs protocol in patients with depression in the context of unipolar or bipolar ii disorder who are waiting for electroconvulsive therapy (ect) or rtms due to degree of treatment resistance or severity of symptoms. this is a prospective, open-label, interventional pilot study wherein patients who have been diagnosed with major depressive disorder and referred to brain stimulation clinic, will be recruited for the treatment. patients will be administered eight questionnaires before and after the treatment to assess the change in clinical outcomes.

participants will receive same stimulation protocol, however they will be given 6 times per day instead of once per day. each treatment will consist of a single itbs treatment delivering 600 puses of itbs (bursts of 3 pulses at 50 hz, bursts repeated at 5 hz, with a duy cycle of 2 seconds on, 8 seconds off, over 60 cycles and it takes about 3 minutes at a target of 90 to 120% of the subject's resting motor threshold. treatment will be given through the device that is usually used, which is magpro by magventure, b70 fluid-cooled coil .

Eligibility criteria:
inclusion criteria: * 18 years and older * unipolar depression or bipolar ii depression based on the mini - no psychotic features * pass the tms safety screen on the brain stimulation consultation template voluntary and competent to consent to treatment exclusion criteria: * have a mini confirmed diagnosis of a substance use disorder within the last month * have a concomitant major unstable medical illness, cardiac pacemaker or implanted mediation pump * have a lifetime mini diagnosis of bipolar i, or schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder. * have any significant neurological disorder or insult including but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ect, or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, or significant head trauma with loss of consciousness for greater than 5 minutes * have an intracranial implant (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head (excluding the mouth) that cannot be safely removed. * currently taking more than lorazepam 2mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rtms efficacy.