Kornimate/medical-research-clean huggingface dataset:
effect of interleukin 6 receptor antagonists in sars-cov-2 patients

Conditions: Corona Virus Infection

Summary: 1. investigate the possible effects of interleukin-6 receptor antagonists such as tocilizumab and sarilumab on the levels of il-6, inflammtory and anti-inflammtory markers and cytokines before and after treatment in critically ill corona virus disease-19 patients. 2. correlate between il-6 levels with other inflammatory markers as ferritin and c-reactive protein. 3. investigate the possible changes on the levels of other inflammatory, anti-inflammatory markers and cytokines such as il-10 and ip-10, before and after treatment.

an outbreak of a mutated respiratory virus that belongs to the coronavirus family was reported in mid-december 2019, in wuhan, china. the virus was named as severe acute respiratory syndrome coronavirus (sars-cov-2) and the disease was named as coronavirus disease-19 (covid-19) by the who. the infection spread pandemically and by the end of october 2021,the number of confirmed cases of covid-19 reached 244,897,472, including 4,970,435 deaths, reported by who. viral genome was sequenced and published by public health information on 10th of january. covid-19 uses the same cell entry receptor {angiotensin converting enzyme ii} (ace2) as sars-cov . recent studies have shown that il-6 level increased in severe cases of covid-19. il-6 is one of the major pro-inflammatory factors that contribute to the formation of cytokine storm.therefore, the il-6 monoclonal antibody (mab) directed covid-19 therapy has been used in clinical trial in china. the main conclusion they reached was that the treatment with the il-6 receptor antagonists ( tocilizumab (tcz), sarilumab, sirukumab, olamkicept and levilimab) improved outcomes, including survival. tcz is a humanized antibody that blocks both soluble and membrane-bound forms of il-6 receptor. sarilumab is a fully human antibody against the il-6 receptor that binds to both soluble and membrane-bound il-6 receptors and has the approval of the food and drug administration (fda) for rheumatoid arthritis (ra) treatment. additionally, these drugs have been considered for off-label use in the treatment of covid-19.

Eligibility criteria:
inclusion criteria: * must be critically ill coronavirus disease-19 exclusion criteria: * patients receiving corticosteroids * pregnancy * active tb * bacterial infection * fungal infection * co-infection with other hepatitis viruses.

Keywords: interleukin-6 receptor antagonists corona virus disease sarilumab interferon gamma inducible protein-10
pharmakokinetik of caffeine in epiretinal membranes after oral intake: a pilot study

Conditions: Epiretinal Membrane

Summary: caffeine concentrations in the vitreous body and exzised epiretinal membranes are measured by gas-chromatography/mass spectrometry.

caffeine concentrations in the vitreous body and exzised epiretinal membranes are measured by gas-chromatography/mass spectrometry. one hour before surgery patients in the caffeine group will receive 180mg of caffeine. in all patients vitrectomy with membrane peeling will be performed, due to epiretinal membranes

Eligibility criteria:
inclusion criteria: * epiretinale membrane exclusion criteria: * none
correlation of metabolic imaging with immune markers in nsclc candidate to immunotherapy.

Conditions: Carcinoma, Non-Small-Cell Lung; Positron-Emission Tomography; Immunotherapy

Summary: the purpose of the present study is to prospectively investigate the correlation between the metabolic parameters on fdg-pet before and during immunotherapy treatment with the immune infiltrate and other tissue or circulating markers in a nsclc patients candidate to immunotherapy.

this is an interventional prospective study without medication lasting 36 months, including an estimated period of 18 months for the enrolment and max 18 months of follow-up. all consecutive patients affected by nsclc and referred for immunotherapy with the anti-pd-1 agent nivolumab, or other checkpoint inhibitors that may become available in the future, will be prospectively enrolled. the study cohort will consist of 40 patients. all patients will undergo the following steps: 1) selection based on eligibility criteria and informed consent; 2) baseline examinations (cect and 18f-fdg pet/ct); 3) tumor biopsy and blood sampling; 4) immunotherapy with check-point inhibitors; 5) response evaluation after 8 weeks of treatment (cect and 18f-fdg pet/ct) and second blood sampling; 6) follow up.

Eligibility criteria:
inclusion criteria: * patients with pathological diagnosis of nsclc eligible for immunotherapy; * obtained informed consent. exclusion criteria: * age \<18 years; * pregnancy or breast-feeding.
immunohistology in usdd and correlation between bacterial flora and phlogosis

Conditions: Diverticular Disease

Summary: diverticulosis of the colon is a frequent condition in adults in western countries and a significant number of patients experience clinical symptoms even when the diverticulosis is not complicated by diverticulitis. both central and mucosal immunity are altered in uncomplicated symptomatic diverticular disease (usdd) and rifaximin ameliorate clinical symptoms and normalize the immunological abnormalities. the study protocol is verify the modifications in the immunological pattern induced by reducing bacteria related activation of immunity by rifaximin treatment.


Eligibility criteria:
inclusion criteria: * male and female * age 18 or more * radiologic or endoscopic diagnosis of diverticular disease located in sigma or colon descendent * informed consent * patients willing to participate in to the study exclusion criteria: * other colon diseases * inflammatory bowel diseases * signs or symptoms of inflammation * consumption of : antibiotics, anti-inflammatory drugs ( fans and 5-asa), prebiotics, proton pump inhibitors, corticosteroids, fiber within three months * pregnancy and breast feeding * acute diverticulitis characterized by: * moderate/sever pain in left iliac fossa * fever \> 38°c * abdominal pain * haematochezia * leukocytosis (20% more than the normal range) * remote acute diverticulitis * rifaximin hypersensitivity * neoplastic diseases * immunodeficiencies * poor physical conditions * leaver deficiencies (child c), kidney (creatinine\>2,2 mg/dl), heart (nyha 3-4) * major psychiatric illness * drugs abuses and alcoholism * participations in other clinical trials within 4 weeks * patients unwillingness certificate

Keywords: uncomplicated symptomatic
an extension study of belcesiran in patients with alpha-1 antitrypsin deficiency associated liver disease (aatld)

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: this is a phase 2, multicenter, open-label extension of study dcr-a1at-201, designed to evaluate the long-term safety and further characterize the pharmacodynamics (pd) of belcesiran in adult patients with pizz aatld.


Eligibility criteria:
inclusion criteria: 1. must be 18 to 75 years of age inclusive, at the time of signing the informed consent form (icf). 2. documented diagnosis of pizz-type alpha-1 antitrypsin deficiency (aatd), confirmed by genotyping. 3. lung, renal and liver function within acceptable limits. 4. capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the icf and in this protocol. exclusion criteria: 1. any condition that, in the opinion of the investigator, would make the participant unsuitable for enrollment or could interfere with participation in or completion of the study 2. routine use of acetaminophen/paracetamol 3. use of systemically acting steroids in the month prior to screening and throughout the study period. 4. positive sars-cov-2 virus test at screening 5. any other safety laboratory test result considered clinically significant and unacceptable by the investigator 6. inability or unwillingness to comply with the specified study procedures, including lifestyle considerations
apremilast pediatric study in children with active oral ulcers associated with behçet's disease

Conditions: Behçet Disease

Summary: the aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to \< 18 years of age with oral ulcers associated with behçet's disease (bd) through week 12.


Eligibility criteria:
key inclusion criteria * male or female participants 2 to \< 18 years of age at randomization. * diagnosed with behçet's disease (bd) meeting the international study group for behçet disease (isgbd) criteria at any time prior to the screening visit. * oral ulcers that occurred ≥ 3 times within the 12-month period prior to the screening visit. * participant must have ≥ 2 oral ulcers at both the screening visit and on day 1. * participant has had prior treatment with ≥ 1 non-biologic bd therapy, such as, but not limited to, topical corticosteroids or systemic treatment. key exclusion criteria * behcet's disease-related active major organ involvement - pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), and central nervous system (cns) (eg, meningoencephalitis) manifestations, and ocular lesions (eg, uveitis) requiring immunosuppressive therapy; however: * previous major organ involvement is allowed if it occurred ≥1 year prior to the screening visit and is not active at time of enrollment * participants with mild bd-related ocular lesions not requiring systemic immunosuppressive therapy are allowed * participants with bd-related arthritis and bd-skin manifestations are also allowed. * previous exposure to biologic therapies for the treatment of bd oral ulcers, previous biologic exposure is allowed for other indications (including other manifestations of bd).

Keywords: behçet's disease oral ulcers apremilast
immune response to influenza vaccine in islet cell transplant recipients

Conditions: Transplant

Summary: influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. although the annual influenza vaccine is recommended for organ transplant patients, studies have shown that the standard inactivated influenza vaccine has poor immunogenicity in this population. the investigators plan to test the humoral response to vaccination and look at hla upregulation

objective and hypothesis * to test the specific humoral response of the influenza vaccine after islet cell transplantation * to test the production of hla alloantibodies after vaccination.

Eligibility criteria:
inclusion criteria: * adult islet cell transplant recipients * able to provide informed consent exclusion criteria: * egg allergy * previous life-threatening reaction to influenza vaccine (ie guillain barre syndrome) * febrile illness in the past two weeks * unable to provide informed consent

Keywords: flu shot islet cell transplant recipients
the effects of light on glucose metabolism

Conditions: Diabetes Mellitus, Type 2; Glucose Intolerance; Prediabetic State

Summary: this study evaluates the effect of bright light on postprandial blood glucose metabolism in obese subjects with impaired fasting glucose and/or impaired glucose tolerance.

light has a major influence on the biological clock and several studies suggest that bright light during the day and dim light in the evening are beneficial for the circadian timing system. nowadays, large parts of the population spend 90% of their time indoors and are thereby exposed to artificial lighting instead of daylight. the artificial light levels are relatively low during the day and continue relatively late in the evening. the lack of a clear natural light-dark cycle could results in delayed timing of the biological clock relative to the behaviour. optimizing the lighting conditions under controlled laboratory settings might lead to better alignment of the biological clock, which in turn could improve metabolic parameters such as glucose control.

Eligibility criteria:
inclusion criteria: * caucasian * bmi 25-35 kg/m2 * stable weight (+/- 3 kg in the last 3 months) * one of the four criteria for prediabetes: * impaired fasting glucose (6.1 mm to 6.9 mm) * blood glucose values 7.8 - 11.1 mm 2h after glucose drink consumption during the oral glucose tolerance test (ogtt) in screening * insulin resistance: glucose clearance rate ≤ 360 ml/kg/min, as determined using the oral glucose insulin sensitivity (ogis120) index * hba1c of 5.7 - 6.4%. exclusion criteria: * fasting plasma glucose ≥7.0 mm * blood donation one month prior to study and three months after finishing study. * participants with extreme chronotypes (going to bed extremely late/early).

Keywords: circadian rhythm
haplo-hsct for myelofibrosis

Conditions: Myelofibrosis

Summary: myelofibrosis (mf) is a myeloproliferative neoplasm causing bone marrow failure and high risk of leukemia transformation. jak2 inhibitors improve symptoms but do not cure mf. allogeneic stem cell transplantation (allo-hsct) is the only potential cure, though limited donor availability restricts access. haploidentical transplantation shows promise but associated with higher graft failure and treatment related mortality. we recently developed a novel regimen of haplo-sct for mf. this study aims to investigate this novel protocol in a prospective trial to improve mf outcomes.

myelofibrosis (mf) is a myeloproliferative neoplasm characterized by clonal proliferation of hematopoietic stem cells, reactive hyperplasia of bone marrow stromal cells, and secondary inflammation and fibrosis, leading to progressive bone marrow failure and a high risk of acute myeloid leukemia transformation, with a median survival of about 6 years. while jak2 inhibitors like ruxolitinib have been approved to improve symptoms and survival in mf patients, they do not provide a cure. allogeneic stem cell transplantation (allo-hsct) remains the only potential cure, but limited availability of matched sibling and unrelated donors often prevents patients from receiving this treatment. haploidentical stem cell transplantation has shown good efficacy in leukemia but is less studied in mf, possibly due to concerns about graft failure, complications, and high transplant-related mortality. our team has applied a novel haploidentical transplantation protocol for treating mf, which has shown promising results in preliminary observations. this study aims to further validate the effectiveness of this protocol through a prospective clinical trial, potentially establishing an effective approach for hsct in mf and improving overall transplant outcomes.

Eligibility criteria:
inclusion criteria: * primary disease type: myelofibrosis (including primary myelofibrosis and myelofibrosis secondary to polycythemia vera or essential thrombocythemia). * no matched sibling donor or unrelated donor, with the availability of a haploidentical donor. * signed informed consent. exclusion criteria: 1. active infection 2. very poor performance status (ecog score \> 2) 3. estimated survival time \< 30 days 4. patient or family unable to cooperate 5. considered unsuitable after discussion

Keywords: haplo-hsct myelofibrosis mf
a repeated study of krn23 in adults with x-linked hypophosphatemia

Conditions: X-linked Hypophosphatemia

Summary: the primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (sc) injections of krn23 in adult subjects with x-linked hypophosphatemia (xlh). a bone substudy will evaluate the effects of single-blind krn23 versus placebo on bone mineral density and bone quality.


Eligibility criteria:
main inclusion criteria: 1. 18 years or older 2. clinical diagnosis of xlh 3. tmp/gfr \< 2.0 mg/dl 4. gfr ≥60 ml/min 5. corrected ca \<10.8 mg/dl 6. a willingness to utilize adequate contraception and not become pregnant\[or to have their partner(s) become pregnant\] during the study 7. additional inclusion criteria apply main exclusion criteria: 1. have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within 3-weeks of screening 2. history of known immunodeficiency 3. pregnant or lactating females subjects or female planning to be become pregnant during the study 4. receipt of a live (attenuated) vaccine (except for influenza vaccines) within 3-months of screening, and/or during the study 5. use of pharmacologic vitamin d metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10-days prior to screening and/or dosing 6. use of any supplement containing phosphate, calcium and/or vitamin d within 10-days prior to screening and/or dosing 7. condition which could present a concern for either the subject's safety or difficulty with data interpretation 8. additional exclusion criteria apply

Keywords: xlh
observational study on non-steroid anti-inflammatory drugs (nsaids) treated patients with arthritic disorder

Conditions: Osteoarthritis; Rheumatoid Arthritis; Ankylosing Spondylitis

Summary: the aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving nsaid-therapy are treated and managed by their doctor in usual clinical practice, how patients comply with their treatment and how satisfied they are with their treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis) * already receiving nsaid treatment at enrolment visit exclusion criteria: * inability to complete the study related questionnaires * current participation in any interventional study

Keywords: nsaid-treated patients gastrointestinal events non-steroid anti-inflammatory drug (nsaid) gastrointestinal events (gi events) proton pump inhibitors (ppi)
an efficacy study of morab-009 (amatuximab) in subjects with pleural mesothelioma

Conditions: Malignant Pleural Mesothelioma

Summary: this research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called morab-009 in patients with malignant pleural mesothelioma.


Eligibility criteria:
primary inclusion criteria: * confirmed diagnosis of malignant pleural mesothelioma (mpm) with the following characteristics: unresectable disease (or otherwise not a candidate for curative surgery); epithelial type or biphasic (mixed) type with low sarcomatous content. * measurable disease at screening by computed tomography (ct)(or magnetic resonance imaging \[mri\]). * kps of greater than or equal to 70% at screening. * life expectancy of at least 3 months primary exclusion criteria: * sarcomatous type of mesothelioma * prior systemic therapy or radiotherapy for mpm; local radiotherapy for symptom control (ie, non-curative intent) is permitted. * confirmed presence of cns tumor involvement. * evidence of other active malignancy requiring treatment.
abdominal drainage, postoperative antibiotico-prophylaxis and cme with d3 lyphadenectomy effect on gastrointestinal function in laparoscopic right hemicolectomy with intracorporeal anastomosis for right colon cancer

Conditions: Colon Cancer

Summary: monocentric, two-level factorial, parallel-arm, pilot randomized clinical trial, conducted comparing patients undergoing laparoscopic right hemicolectomy with ica for right colon cancer in a single unit of a teaching hospital: minimally invasive surgery unit, department of surgical sciences, policlinico tor vergata, rome, italy.


Eligibility criteria:
inclusion criteria: * right colon cancer * intracorporeal anastomosis * laparoscopic surgery * elective surgery * informed consent signed exclusion criteria: * below 18 years old * ibd * asa iv * t4b * metastatic disease * preoperative steroids * conversion to open surgery * emergency surgery * concomitant major operation * preoperative infective status * benign disease

Keywords: intracorporeal anastomosis right hemicoletomy colon cancer
using ctdna to detect minimal residual disease after lung cancer resection

Conditions: Non Small Cell Lung Cancer

Summary: ctdnalung-detect is an investigator-initiated single arm, multi-institution study designed to assess the ctdna detection rate and its association with relapse free survival (rfs) in operable stage t1-t4 (t3,t4 multifocal) n0m0 non-small cell lung cancer (nsclc) patients.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. ability to provide written informed consent; 3. eastern cooperative oncology group (ecog) performance status of 0 or 1; 4. t1-t4 (t3,t4 multifocal) n0m0 nsclc who are planned for complete surgical resection; 5. tumour size must be at least 1 cm (unidimensional) and have at least some solid component on imaging; 6. surgical tumour formalin-fixed, paraffin-embedded (ffpe) specimens for ctdna studies are required. exclusion criteria: 1. prior radiation, surgery or chemotherapy for the current diagnosis of nsclc is not permitted. 2. incomplete surgical resection. participants who had pre-operative ctdna samples taken but subsequently do not have a complete surgical resection would not qualify for post-operative ctdna testing. 3. concurrent enrolment in a therapeutic study using drug or radiation therapy. enrolment in observational, diagnostic or studies of novel surgical techniques will be allowed. 4. concurrent active malignancy or other invasive malignancy within previous 2 years. non-invasive malignancies (i.e., cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition. 5. pregnancy.
characterization of endothelial dysfunction as a function of hyperaemia of the brachial artery during cardiac surgery

Conditions: Capillary Leak Syndrome

Summary: the glycocalyx is a layer of proteins and complex sugars covering the endothelium of vessels. its role as capillary filtration control is important. in case of alteration of the glycocalyx, experimental models and some clinical studies show an increased capillary leak responsible for interstitial edema. the analysis of glycocalyx in routine care is important to guide volume expansion. indeed, the literature provides evidence about the poor prognosis of excess water and its impact on organ. this analysis challenge is to justify filling solution of choice according to the characteristic of this capillary leakage.

extra corporeal circulation and aortic clamp induce ischemia-reperfusion damages. vascular damages are represented by first glycocalyx, a layer of endovascular vessel proteoglycans, responsible for fluid permeability and secondly by nitro oxygen liberation responsible for vascular tonus. the investigators suppose that both functions are impaired after cardiac surgery.

Eligibility criteria:
inclusion criteria: * cardiac surgery exclusion criteria: * auricular fibrillation * endocarditis * aortic dissection * end stage chronic renal disease

Keywords: glycocalyx capillary leak syndrome