Kornimate/medical-research-clean huggingface dataset:
effects of coffee on hepatic steatosis induced by a high fructose diet

Conditions: Hepatic Steatosis

Summary: this study will assess * whether coffee consumption protects against fructose-induced hepatic steatosis in healthy humans * whether the protective effect of coffee is dependent on it's antioxidant composition

epidemiological studies suggest that coffee consumption improves glucose homeostasis in insulin resistant subjects. an increase in intrahepatic lipids (hepatic steatosis) is highly prevalent in patients with the metabolic syndrome and may be used as a marker of altered hepatic lipid metabolism. such an increased hepatic lipids content can be experimentally produced in healthy humans by a 6-day high fructose diet. the purpose of this study is to evaluate whether coffee prevents hepatic lipid deposition in healthy male subjects fed a fructose-rich hypercaloric diet. both caffeine and antioxidants (yet unspecified) may be involved.. to sort out the role of caffeine and antioxidants, we will test 3 different soluble coffee, ie fully torrefied decaffeinated coffee , partially torrefied decaffeinated coffee, and partially torrefied caffeinated coffee.

Eligibility criteria:
inclusion criteria: * bmi between 19 and 15 kg/m2 * less than 30 min physical activity /day * habitual coffee consumption less than three cupy /day * consumption of caffeine-containing sodas less than 2 servings/day * non-smoker exclusion criteria: * consumption of alcohol more than 40g/day * presence of metallic foreign bodies * history of eye surgery * family history of diabetes mellitus * history of food intolerance * vegetarians

Keywords: hepatic steatosis coffee fructose lipids
assessment of serum interleukin10 level in patients with immune thrombocytopenic purpura at sohag university hospital

Conditions: Immune Thrombocytopenic Purpura

Summary: autoimmune diseases are characterized by various factors that contribute to a breakdown in self-tolerance, that is, the ability of the immune system to effectively distinguish self from non-self and to refrain from attacking self. autoimmune diseases include a broad spectrum of disorders, such as idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, and inflammatory bowel disease. although significant progress has been achieved in the development of approaches to the treatment of autoimmune diseases, the etiologies, and pathogenesis of autoimmune diseases remain obscure (tao et al., 2016) immune thrombocytopenia (itp) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/l (neunert et al., 2019). itp is classified based on course of disease into acute (3- \<12 months), and chronic (≥12 months) (provan et al., 2019). itp usually has a chronic course in adults (moulis et al., 2017) whereas approximately 8090% of children undergo spontaneous remission within weeks to months of disease onset (heitink et al., 2018). the main pathogenesis of itp is the loss of immune tolerance to platelet auto-antigens, which results in increased platelet destruction and impaired thrombopoiesis by autoantibodies and cytotoxic t lymphocytes (ctls) (adiua et al., 2017). among these abnormalities include the increased number of the t helper 1 (th1) cells (panitsas et al.,2004). the decreased number or defective suppressive function of regulatory t cells (tregs) (yu et al., 2008) , and the


Eligibility criteria:
inclusion criteria: * patients with platelet less than 100 × 109/l diagnosed as immune thrombocytopenia according to bone marrow findings . exclusion criteria: * other causes of thrombocytopenia as: * hypersplenism. * bone marrow diseases including : aplastic anemia, leukemia and myelodysplastic syndromes. * patients on chemotherapy and radiation therapy for cancer management
radiation therapy with or without temozolomide in treating women with brain metastases and breast cancer

Conditions: Breast Cancer; Metastatic Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. it is not yet known whether radiation therapy is more effective when given alone or together with temozolomide in treating brain metastases secondary to breast cancer. purpose: this randomized phase ii trial is studying how well radiation therapy given together with temozolomide works compared with radiation therapy given alone in treating women with brain metastases and breast cancer.

objectives: primary * compare the objective response rate at 6 weeks in women with brain metastases secondary to breast cancer treated with radiotherapy with vs without temozolomide. secondary * evaluate the tolerability. * compare the duration of response. * compare local progression-free survival. * compare overall survival. outline: this is a multicenter study. patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks. * arm ii: patients undergo radiotherapy as in arm i and receive oral temozolomide once daily for 2 weeks. after completion of study treatment, patients are followed at 3 and 6 months and then every 6 months for 2 years.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer * unresectable disease or patient refused surgery * must have brain metastases patient characteristics: * who performance status 0-2 * anc ≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * liver transaminases ≤ 1.5 times upper limit of normal (uln) * creatinine \< 1.5 times uln * not pregnant or nursing * fertile patients must use effective contraception * no carcinomatous meningitis * no history of cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix * no other serious concurrent disease that is, in the opinion of the investigator, likely to interfere with study evaluation and treatment * no contraindications to treatment with temozolomide * no psychological, familial, social, or geographic situations that preclude clinical follow up * no patient deprived of liberty or under guardianship prior concurrent therapy: * no prior brain radiotherapy * at least 10 days since prior chemotherapy

Keywords: tumors metastatic to brain stage iv breast cancer
efficacy and safety of baricitinib for the treatment of moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a randomized controlled study. baricitinib 4mg in one arm and baricitinib 2mg in another arm will be used. methotrexate 10mg per week in both arms will be used.

this open label randomized controlled clinical trial will be conducted in the department of rheumatology, bsmmu. the rheumatoid arthritis patients with moderate to severe disease activity (das 28 esr/crp\>3.2) despite treatment with methotrexate or other csdmards will be considered as primary entry criteria for this study. simple random sampling method will be applied. after a washout period of three weeks, group a will be put on baricitinib 2 mg once daily and group b will be put on baricitinib 4 mg once daily. methotrexate 10mg will be used on both groups in addition to barcitinib. nsaids and adjuvant analgesics will be used if needed. all the patients will go through baseline evaluation before treatment which include-disease activity score derivative for 28 joints (das 28esr/crp), clinical disease activity index (cdai), simplified disease activity index (sdai), health assessment questionnaire-disability index (haq-di) and laboratory tests like cbc, crp, sgpt, serum creatinine, ldh, rf, acpa, chest x-ray p/a view and tst or interferon gamma release assay (igra). follow up will be done at 4th, 12th and 24th week. response to treatment will be evaluated by das 28 esr/crp. primary endpoint for efficacy will be assessed at the end of 24th week by das 28 crp response. secondary endpoints will be determined by sdai, cdai and haq-di. adverse effects will be assessed by history, physical examinations and investigations

Eligibility criteria:
inclusion criteria: 1. age greater than 18 years 2. patients fulfill the acr/eular 2010 classification criteria for ra 3. das-28 crp more than 3.2 despite optimum dose of methotrexate exclusion criteria: 1. recent or concurrent infection including active or latent tuberculosis except patients with latent tuberculosis in whom treatment was commenced ≥ 4 weeks before randomization 2. hemoglobin (hb) \< 8 g/dl 3. white blood cell count \< 4000, neutrophil count \< 1000, platelet count \< 100000/mm3 4. live vaccines within 3 months prior to the first dose 5. serum creatinine \> upper limit of normal reference range 6. egfr \< 60 ml/minute/1.73 m2 7. alanine transaminase (alt) more than uln 8. pregnant or breast feeding females of child-bearing potential 9. evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ 10. new york heart association class iii and iv congestive heart failure 11. previous history of thromboembolism, deep venous thrombosis, diverticulitis

Keywords: baricitinib ra jaki
fl3x study: an adaptive intervention to improve outcomes for youth with type 1 diabetes (fl3x)

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to see if a behavioral intervention for adolescents with type 1 diabetes will improve adherence to t1d self-management activities and improve diabetes outcomes. we expect the intervention to improve diabetes outcomes when compared to usual care.

the fl3x adaptive intervention is designed to increase adherence to t1d self-management including medical management (blood sugar testing and insulin dosing), diet, and physical activity. fl3x relies on mi, and problem-solving skills training (psst) as the basis for the counseling strategy, and creates a coherent integration across three key components of 1) behavior family systems therapy focused on family communications and teamwork; 2) individualized diabetes education in response to knowledge gaps relevant to behavioral goal attainment; and 3) use of currently available communications technology to support behavioral goal attainment through participant-defined reminders and motivational boosters, and/or peer support. all fl3x intervention participants will receive "fl3x-basic", which is the initial 3-month intervention that includes 4 sessions (40-60 min), supplemented with short additional contacts (via text, email, or web-based communication) as needed. thereafter, applying principles of adaptive interventions, based on a decision rule using a1c values measured at defined intervals, participants are iteratively assigned to "fl3x-check-in" or "fl3x-regular", both of which continue with mi and psst for the underlying counseling strategy. in fl3x-check-in, participants who are doing well ("responders") will receive minimal ongoing support to reinforce successful strategies through brief monthly "touch-base" contacts. in fl3x-regular, those who are "regular-responders" will have a minimum of 3-4 in-person full-length sessions (40-60 min) over each 6-month interval, with additional brief contacts as needed (e.g., text, voice, or internet). fl3x participants randomized to the control group will receive usual care.

Eligibility criteria:
inclusion criteria: * type 1 diabetes with duration at least 12 months * between ages 12-16 years at registration * poor glycemic control (a1c 8.0-13.0%) * parent/guardian willing to also participate * not planning on moving in the following 18 months exclusion criteria: * pregnant (if female) * diabetes type 2 or gestational * pre-existing systemic chronic disease (drug abuse, cancer, certain psychiatric conditions)

Keywords: motivational interviewing problem solving skills training family communication social support adolescents
nocturnal transnasal insufflation (ntni)

Conditions: COPD; Hypercapnia

Summary: on the basis of different studies the long term oxygen treatment is deemed to be routine treatment in patients suffering from chronic obstructive pulmonary disease (copd) at appearance of hypoxaemia. non invasive ventilation (niv) is the treatment of choice in hypercapnic copd patients with respiratory acidosis at acute respiratory decompensation. several prospective randomized studies have shown a reduction of acute mortality as result. but everyday practice shows that copd patients with chronic hypercapnia hardly accustom oneself to nocturnal ventilation. reasons are not known yet, but substantial pulmonary overinflation or the appearance of depressions or rather anxiety disorders are possible causes. on the other hand patients may not notice any subjective improvement of symptoms and won't accept the burden of a tight fitting mask during the night. the aim of the present study is to determine the effect on gas exchange of a nocturnal transnasal application of an oxygen-enriched gaseous mixture via nasal cannula and the subjective acceptance. this is compared to a nocturnal transnasal application of oxygen alone in randomized order for at least 6 hours each night. thirty hypercapnic copd gold iv patients (pco2 \> 50 mmhg) will be included. the two night polysomnographies (psg) will be evaluated with special attention to nasal flow measurements, breathing effort, oxygen saturation and an additional transcutaneous pco2 measurement. at begin and end of each measurement night a capillary blood gas analysis is made.


Eligibility criteria:
inclusion criteria: * hypercapnia in routine blood gas analysis with \> 50 mmhg pco2 * clinically stable respiratory situation * treatment on normal ward possible exclusion criteria: * before known obstructive sleep apnea syndrome (osa) * a found osa during study means no exclusion * any other severe or acute physical illness which requires intensive medical care * acute hypercapnic decompensation with ph \< 7.30 in capillary blood gas analysis

Keywords: transnasal high flow therapy copd
the use of cinemri to evaluate botox in patients with medication refractory overactive bladder

Conditions: Overactive Bladder

Summary: with the goal of providing improved treatment to patients with overactive bladder symptoms (oab), the investigators seek to apply the new technology of time-resolved (cine) mri combined with urodynamics (uds) to understand the exact effect of intravesical botulinum toxin on bladder physiology. the investigators will specifically aim to assess the physiological mechanism by which intravesical botulinum alleviates urgency and urge incontinence symptoms in women with oab refractory to medical therapy.

overactive bladder (oab) is defined by the international continence society as urinary frequency and urgency, with or without urge urinary incontinence. the burden of oab on the american public is immense in both human and financial terms. despite this burden, there is a lack of effective diagnostic and treatment modalities for oab. other than two-dimensional video urodynamics, which has remained relatively unchanged for decades, there is a lack of diagnostic modalities that will allow investigators to characterize subtypes of oab and measure the effects of treatment on bladder physiology. newer imaging techniques are desperately needed to help guide treatment and predict and improve outcomes of different treatment modalities. intravesical botulinum toxin is a minimally invasive treatment for oab refractory to medical therapy. despite the widespread use of intravesical botulinum toxin injection for oab refractory to medical therapy, to date the optimal placement of the drug has not been determined. typically ten injections are given, either dispersed evenly across the bladder or in two rows of five injections. however, it remains unknown which injection method will optimize outcomes and reduce the risk of urinary retention after botox®. this lack of knowledge is a direct result of the fact that there has been no mechanism to study the effect of botox® on bladder filling and emptying in a three-dimensional fashion. cinemri-uds will provide this mechanism, and has the potential to significantly improve care and urologic education by enhancing the understanding of bladder physiology.

Eligibility criteria:
inclusion criteria: * female * age 21 years or older * overactive bladder symptoms exclusion criteria: * age less than 21 years * inability to give informed consent * claustrophobic
quality of life in food allergic families

Conditions: Food Allergy

Summary: food allergies are becoming more prevalent with more children being diagnosed with food allergies each year. food allergies place a tremendous burden not just on the patient but on his/her family as well. in an attempt to provide better care to the investigators patients, the investigators would like to determine if regular contact with our food allergy nurse has a positive effect on a family's perceived quality of life.

we intend to show a difference between the intervention group, who will receive a food allergy packet, along with three follow up phone calls from our trained allergy nurse, and the control group, will be given the food allergy packet only. we expect the intervention group to score higher on the quality of life survey, showing that the support and education of our allergy nurse has a positive effect on quality of life of our patients and their families.

Eligibility criteria:
inclusion criteria: * ige mediated food allergy * ages 0-17 * willing to participate exclusion criteria: * food sensitivities * unable to understand or read survey * unable to be available for follow up survey and nurse phone calls.
characteristics of the anosmic olfactory mucosa

Conditions: Anosmia; COVID-19; Head Injury

Summary: the present study aims to describe the structural tissue and cell characteristics of the olfactory mucosa in patients with persistent anosmia (≥2 years) due to covid-19 or head-trauma, in comparison to healthy individuals with intact olfactory function. in order to avoid possible age-related degenerative changes in the neuro-epithelium, both patients and controls are between 25 and 35 years of age.


Eligibility criteria:
inclusion criteria: * legally competent to vouch for their own study participation. * informed and written consent for participation in this study. * study group 1 (post-covid anosmia) 1. diagnosed with persistent anosmia for approximately two years concurring with positive sars-cov-2 pcr-test between 2019 and 2020. 2. sniffin'sticks test with a threshold-discrimination-identification-score(tdi)≤16 3. between 25 and 35 years of age. study group 2 (post-trauma anosmia) 1. diagnosed with persistent anosmia for approximately two years concurring with head trauma. 2. sniffin'sticks test with a threshold-discrimination-identification-score(tdi)≤16 3. between 25 and 35 years of age. study group 3 (controls): 1. between 25 and 35 years of age. 2. undergoing reposition of a nasal fracture in general anaesthesia exclusion criteria: * \<25 years of age. * \>35 years of age. * chronic rhinosinusitis with/without polyps. * nasal cancer. * presence of viral or bacterial rhinosinusitis. * uncontrolled allergic rhinosinusitis. * coagulation deficiencies, e.g. haemophilia. * use of anticoagulants. * not able to undergo general anaesthesia. * pregnancy. * any use of nasal detumescence drugs ≤2 weeks before biopsy. * any use of nasal steroids ≤3 months before biopsy. * use of nasal inhaled recreational drugs ≤3 month before biopsy. * participants not able to communicate in danish or english. * major depression inventory (mdi) score ≥27 \[49, 50\] * mini mental state examination (mmse) score ≤ 26 \[51\] * study group 1 (post-covid anosmia) 1. anosmia for less than two years or more than two and a half years. 2. no positive sars-cov-2 pcr-test concurring with olfactory dysfunction. 3. history of olfactory dysfunction before covid-19 infection. * study group 2 (post-trauma anosmia) 1. anosmia for less than two years or more than approximately two-three years. 2. anosmia without concurring with head trauma 3. history of prior olfactory dysfunction before head trauma. * study group 3 (controls) 1. known olfactory dysfunction.
a study to evaluate the efficacy and safety of co-administrated br1018b and br1018c

Conditions: Essential Hypertension; Primary Hypercholesterolemia

Summary: the purpose of this clinical trial is to evaluate the efficacy and safety of co-administrated br1018b and br1018c in patients with essential hypertension and primary hypercholesterolemia


Eligibility criteria:
\ screening visit (v1) * patients with essential hypertension and primary hypercholesterolemia * if patients are being treated with antihypertensive/antihyperlipidemic drugs at screening, they should be determined to be medically reasonable by investigator about discontinuing existing antihypertensive/antihyperlipidemic drugs during the clinical trial * patients under the following criteria at screening: * patients who meet a fasting triglyceride (tg) \< 400 mg/dl and ldl-c ≤ 250 mg/dl * patients who meet the following criteria, depending on whether antihypertensive drugs were administered within the last 4 weeks 1. naïve : 140 mmhg ≤ mssbp \< 180 mmhg and msdbp \< 110 mmhg 2. use antihypertensive drugs : 130 mmhg ≤ mssbp \< 180 mmhg and msdbp \< 110 mmhg baseline visit (v2) * patients who meet the following criteria of blood pressure measured in selected reference arm at baseline (according to the clinical situation of each subject, follow the blood pressure standards(refer to 2022 the korean society of hypertension guideline)) * 140 mmhg(or 130 mmhg) ≤ mssbp \< 180 mmhg * msdbp \< 110 mmhg * patients who meet fasting serum lipid profile test levels (ldl-c and tg) correspond to cardiovascular risk and risk factors at baseline (refer to 2022 korean guidelines for the management of dyslipidemia (the 5th edition)) \ * patients with a difference of sisbp ≥ 20 mmhg and sidbp ≥ 10 mmhg in blood pressure measured three times on both arms at screening(v1) * patients with blood pressure results showing mssbp ≥ 180 mmhg or msdbp ≥ 110 mmhg at screening(v1, both arms) and baseline(v2, selected reference arm) * patients with a history of secondary hypertension or suspected secondary hypertension; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, renal hypertension, pheochromocytoma, cushing's syndrome and polycystic kidney disease, etc.) * patients with a history of secondary hyperlipidemia or suspected hyperlipidemia; (e.g., chronic renal failure, nephrotic syndrome, dysproteinemia, obstructive liver disease, cushing's syndrome, hypothyroidism, etc.) * patients with hyportensive shock * patients with orthostatic hypotension accompanied by symptoms