Kornimate/medical-research-clean huggingface dataset:
dario™ blood glucose monitoring system - user performance evaluation

Conditions: Diabetes

Summary: the study is performed to evaluate the accuracy of blood glucose level results obtained from fingertip using labstyle dario blood glucose monitoring system (bgms) compared to reference equipment (ysi 2300 statplus) and to evaluate the ease of use of the dario device by the lay-person. the participants will review the dario user manual and guide and will be requested to operate the dario bgms and perform their own glucose blood test, after which they will be asked to complete a questionnaire. as reference the participants will be tested by professional caregivers both using the dario bgms and by ysi 2003.

device accuracy will be assessed based on the acceptance criteria of iso 15197:2003 which states: "the minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dl of the results of reference method at glucose concentrations ≥ 4,2 mmol/l (≥ 75 mg/dl)".

Eligibility criteria:
inclusion criteria: * male or female between the age 18 and 80 * type 1 and type 2 diabetes exclusion criteria: * drug and alcohol abuse * investigator discretion
a qualitative study on csii in children and adolescents having type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: using qualitative method; a qualitative case study using semi-structured interviews to explore patients' experiences. study population of insulin pump patients aged 11-18 years old will be recruited from pediatrics with t1d at dasman diabetes institute; who started using csii at least one year ago and their parents. semi-structured interviews will be recorded and then transcribed word by word. data analysis will be performed using an inductive thematic approach.

specific aims 1. to explore the experiences of adolescents and their parents and parents ofi children with type 1 diabetes in kuwait about the use of insulin pump therapy (ipt) in the context of their quality of life. 2. to gain in-depth understanding of the perceptions of adolescents and their parents and parents of children with type 1 diabetes in kuwait with t1dm about ipt and its use for diabetes management. design a qualitative case study methodology will be adopted using semi-structured interviews for data gathering. interviews will be conducted with a purposive sample including adolescents and their parents and parents of children with type 1 diabetes in kuwait with t1d, who are on csii therapy at least 12 months, along with their parents.

Eligibility criteria:
inclusion criteria: * diagnosis of t1 d in kuwait as specified by their consultant and in line with the kuwait clinical guidelines diagnosis of t1d (2006) criteria * adolescents between the age of 11 and 18 or children between 2 and 10 years old * kuwaiti or expats * duration of csii (insulin pump therapy) at least 12 months. * prior to starting insulin pump therapy must have been on mdi for a minimum of 12 months * attend the insulin pump clinic at ddi exclusion criteria: * non-english \& non-arabic speakers * presence of a learning disability * diagnosis of any diabetes complication before starting the csii therapy * diagnosis of psychological problem

Keywords: children adolescents parents insulin pump therapy
early safety and clinical efficacy of mitral allograft in tricuspid surgery

Conditions: Allografts; Tricuspid Valve Insufficiency

Summary: the aim of the study is to evaluate early safety and clinical efficacy of mitral allografts in tricuspid valve replacement for primary tricuspid valve diseases.

early safety (morbidity, mortality rate, freedom from any valve related complication) along with mid-term clinical efficacy ( mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication ) is going to be evaluated.

Eligibility criteria:
inclusion criteria: * patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention. * intraoperative findings suggested for tricuspid valve replacement rather than repair. exclusion criteria: * pregnancy * confirmed active drug addiction * progressive hiv-infection * hiv-infected patients with cd4-cells count less than 250 * patients with secondary tricuspid valve pathology (left-sided valve disease) * lv ejection fraction less than 50%
phase 2 trial of afatinib plus prednisone for advanced squamous nsclc

Conditions: Advanced Squamous Non Small Cell Lung Cancer

Summary: to determine the efficacy of combined afatinib and prednisone in previously treated advanced squamous nsclc

this two-stage phase 2 study will determine the safety, tolerability, recommended phase 2 dose/maximum tolerated dose, preliminary efficacy and predictive/pharmacodynamic biomarkers of combined egfr inhibition (afatinib) and tnf inhibition (prednisone) in previously treated nsclc.

Eligibility criteria:
inclusion criteria: * written informed consent in accordance with federal, local, and institutional guidelines. the patient must provide informed consent prior to the first screening procedure. * previously treated (up to three prior lines of therapy), histologically proven advanced squamous nsclc. * no prior treatment with egfr inhibitors, imids (eg, thalidomide, lenalidomide), or anti-tnf antibodies. * no treatment with systemic glucocorticoids within 3 weeks of initiation of study therapy (topical and inhaled glucocorticoids are permitted). * age ≥ 18 years. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate organ and marrow function as defined below: * absolute neutrophil count ≥ 1,000/μl * platelets ≥ 50,000/μl * total bilirubin within normal institutional limits * ast(sgot)/alt(spgt) ≤ 2.5 x institutional upper limit of normal * crcl ≥ 45 ml/min * for both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment. * adequate archival tissue (5-10 slides) for correlative studies. * subject must have measurable disease per recist 1.1 exclusion criteria: * chemotherapy, radiotherapy, or other cancer therapy within two weeks prior to starting study treatment. subjects must have recovered from prior treatment-related to toxicities to grade 1 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment). * subjects may not be receiving any other investigational agents for the treatment of the cancer under study. * symptomatic brain metastases or brain metastases requiring escalating doses of corticosteroids * history of hypersensitivity or allergic reactions attributed to afatinib or prednisone. * uncontrolled intercurrent illness including but not limited to poorly controlled diabetes (which may worsen in setting of chronic prednisone therapy), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements. * subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
exploratory study to evaluate the efficacy of ruti® against sars-cov-2 infection (covid-19) in healthcare workers

Conditions: Covid-19

Summary: the aim of this study is to explore potential for reduction of incidence and/or morbidity of sars-cov-2 infection in healthcare personnel. the study will include a comparison between placebo and ruti® vaccine in a 2:1 design.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent before initiating the selection procedures. 2. population: 1. healthcare system workers working in contact with subjects potentially infected with sars-cov-2 2. people between 18 years and 59 years 3. willingness to meet the requirements of the protocol. 4. negative rapid serological test of sars-cov-2 5. the participant must agree to use effective contraceptive methods during the study period, in case of childbearing age. exclusion criteria: 1. previous sars-cov-2 infection 2. pregnancy. pregnancy test will be performed in case of doubt. 3. breastfeeding. 4. suspected of active viral or bacterial infection. 5. symptoms compatible with covid-19, despite a negative polymerase chain reaction (pcr) test. 6. vaccination in the last 4 weeks or planned vaccination during the study period, except for influenza vaccine. 7. participation in a research that requires experimental intervention (does not include observational studies) in the previous month before signing the consent or during the study. 8. severely immunocompromised people. this exclusion category includes: * subjects with human immunodeficiency virus (hiv-1). * neutropenic subjects with less than 500 neutrophils / mm3. * subjects with solid organ transplantation. * subjects with bone marrow transplantation. * subjects undergoing chemotherapy. * subjects with primary immunodeficiency. * severe lymphopenia with less than 400 lymphocytes / mm3. 9. malignancy, or active solid or non-solid lymphoma from the previous two years. 10. soy allergy. 11. direct involvement in the design or execution of the ruticovid19 clinical trial. 12. retirement, transfer, long-term leave (\> 1 month) due to scheduled surgery or any other event that makes it impossible to work in person at your health center during the months following the recruitment to the study. 13. do not have a smartphone. 14. detection by the researcher of lack of knowledge or willingness to participate and comply with all requirements of the protocol. 16. any other findings that, at the discretion of the researcher, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of the vaccine.
effect of liraglutide on neural responses to high fructose corn syrup in individuals with obesity.

Conditions: Obesity, Childhood; Neural Development

Summary: to study the effects of liraglutide on neural responses to high fructose corn syrup (hfcs) in individuals with obesity.

adolescents are the highest consumers of sugar sweetened beverages (ssb) potentially because their developing brains are most susceptible to the rewarding neural effects of sugar consumption. thus, we specifically target this population (adolescents) to understand neural mechanisms involved in excess sugar consumption which predisposes to the development of obesity, prediabetes, and type 2 diabetes. upon results entry, the data elements in protocol section of this record were updated to reflect the appropriate study phase and primary purpose that was inadvertently mischaracterized at the time of registration. one of the secondary outcomes was removed because it was a duplicate of the second primary outcome.

Eligibility criteria:
inclusion criteria: 1. 18-39 years old 2. lean (bmi 18.5-24.9 kg/m2) with normoglycemia 3. obese (bmi 30-45 kg/m2) with or without prediabetes 4. weight stable 5. right handed 6. able to read and write in english 7. able to provide written and verbal informed consent exclusion criteria: 1. current active participation in a weight loss program or weight loss of \>=10% of total body weight during the previous 6 months 2. prior bariatric surgery or current gastric balloon 3. weight \>440lbs or waist circumference \>142cm 4. following a vegetarian/vegan diet or dieting/restricting food 5. significant medical condition 6. current use of weight-loss medications or supplements, psychiatric medications or anti- hyperglycemic medications 7. history of or family history of multiple endocrine neoplasia type 1 (men-i) or medullary thyroid cancer, alcoholism, or previous history of pancreatitis 8. females who are pregnant or lactating, or who are unwilling to use proper contraception or remain abstinent, 9. claustrophobia that would interfere with mri or metal in their body that would pose a risk in the mri.
surveillance study of patients with newly diagnosed osteosarcoma

Conditions: Osteosarcoma

Summary: this study is an observational safety surveillance study designed to prospectively assess patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice


Eligibility criteria:
inclusion criteria each patient must meet all of the following inclusion criteria to be enrolled in the study: * male or female aged 2 to 40 years * confirmed pathological diagnosis of newly-diagnosed, nonmetastatic, resectable, primary, high-grade osteosarcoma * have completed definitive surgery (or other local ablation technique) * have a treatment regimen that includes mifamurtide and a minimum of 2 recognized chemotherapy agents in the treatment of osteosarcoma (cisplatin, doxorubicin, high-dose methotrexate or ifosfamide) * organ function deemed satisfactory to receive planned chemotherapy containing at minimum 2 of the recognized chemotherapy agents in the treatment of osteosarcoma * voluntary written consent exclusion criteria patients meeting any of the following exclusion criteria are not to be enrolled in the study: * female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period * history of pericarditis or pleuritis * have low-grade osteosarcoma or parosteal or periosteal sarcoma * have osteosarcoma associated with paget's disease * current treatment with any anticancer investigational products at the time of enrollment in this study
neuropathic foot and ankle in rheumatoid arthritis : ultrasound and nerve conduction study

Conditions: Rheumatoid Arthritis

Summary: 1. to measure the prevalence of neuropathic pain in rheumatoid arthritis patients with ankle and foot pain 2. to evaluate the role of neuromuscular ultra sound (nmus) and nerve conduction study (ncs) in assessment of neuropathic foot and ankle in rheumatoid arthritis patients

rheumatoid arthritis (ra) is a common chronic systemic autoimmune disease that primarily affects the lining of the synovial joints which symmetrically involves the small joints, can cause cartilage and bone damage and associated with progressive disability, premature deaths, and socioeconomic burdens . in ra, neuropathic pain "which is defined as pain caused by a lesion or a disease of the somatosensory system" , could be suggested by :nerve compression, associated comorbidities and vascuilitis . despite the recent advancement in ra treatment, neuropathic pain remains a cause of persistent pain even in controlled disease activity. the prevalence of clinical neuropathy varies from 0.5% to 85% in patients with ra, which can cause functional disability . foot and ankle pain is highly prevalent in ra with peripheral neuropathy is a common contributor to it . in previous studies , it was found that the most foot neuropathies are of tarsal tunnel syndrome, peroneal nerve entrapment and pure sensory axonal neuropathy. for evaluation of neuropathic foot and ankle in ra , electrophysiological and imaging techniques can be very useful. nerve conduction study (ncs) is the electrodiagnostic evaluation of the function of peripheral nerves ,it can provide information regarding the presence, severity and location of a lesion, symmetricity of neuropathy, mononeuropathy or disorders affecting the neuromuscular junctions. also, the functional modality most involved (sensory or motor) and the predominant pattern of pathology (e.g., axonal, demyelinating, or both. neuromascular ultrasond(nmus) is a new modality of diagnosis developed in the past 20 years , and it can assess anatomical abnormalities that can't be evaluated by ncs nmus being noninvasive and inexpensive diagnostic modality , it has been introduced as a complement to ncs for diagnosis of nerve conditions.

Eligibility criteria:
inclusion criteria: 1. adults aged ≥ 18 years. 2. ra patients who fulfilled the 2010 acr/european league against rheumatism(eular) criteria for the classification of ra 3. ra patients complaining of foot and ankle pain exclusion criteria: 1. presence of other autoimmune disorders 2. presence of any comorbidities causing neuropathy as diabetes mellitus, disc prolapse
endoscopic partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of symptoms

Conditions: Adenoidal Hypertrophy

Summary: efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.


Eligibility criteria:
inclusion criteria: * .all patients with adenoid hypertrophy causing airway obstruction. exclusion criteria: * 1. chlidren known to have cleft palate ,submucous cleft palate or other medical problems causing velopharyngeal insufficiency. * 2 . systemic medical problems interfering with surgery. * 3 . refusal of parents to participate. * 4. craniofacial abnormalities. * 5. down syndrome.
valutazione all'ingresso del rischio nutrizionale in pazienti ricoverati nel reparto di medicina interna (amido)

Conditions: Malnutrition; Hospitalized Patient

Summary: the aim of this study is to identify the risk of malnutrition in patients admitted to the internal medicine departments using the must screening tool. additional aspects are to evaluate malnourished patients' characteristics and effectiveness of an early nutritional programme started during hospitalization.

malnutrition is defined as a nutritional state characterized by an excess or deficient intake of nutrients. this condition may result in a change in body composition and in organic disfunctions. malnutrition in hospitalized patients is a condition prevalent worldwide affecting between 20% and 50% of patients at admission, with further increase expected during hospitalization. patients hospitalized in internal medicine departments are frequently older with multimorbidity and polypharmacy, so very likely to be malnourished, but the prevalence and determinants of malnutrition remain unclear. in amido study, all patients with must 1 and 2 will be sent to the a dietitian. the clinician will act on the patient's characteristics by providing different dietary therapies, such as oral nutritional supports (ons), extra nutritional cares, diet changes without supplements and artificial nutrition.

Eligibility criteria:
inclusion criteria: * patients admitted from 1st january 2023 to 31th may 2023 at the internal medicine department of the monsignor giovanni galliano hospital in acqui terme of the alessandria asl. exclusion criteria: * none
diagnostic study of tumor characteristics in patients with ewing's sarcoma

Conditions: Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Summary: diagnostic trial to study genetic differences in patients who have ewing's sarcoma. genetic testing may help predict how cancer will respond to treatment and allow doctors to plan more effective therapy.

primary objectives: i. to develop a mechanism to collect and distribute tumor specimens to various investigators, and a system to prioritize and develop quality-control measures for central data reporting of studies undertaken. ii. to determine the prognostic significance of translocation subtype in ewing sarcoma; to determine the prognostic significance of translocation negative ewing sarcoma. iii. to determine the prognostic significance of mrd detection in bone marrow specimens by rt-pcr determination of ews-ets fusion genes. iv. to determine whether serum levels of igf1, igfbp3 are of significance in the outcome of patients with ewing sarcoma. v. to determine whether rna expression profiles performed on diagnostic specimens will allow for the identification of newer prognostic categories and potentially new molecular targets for treatment in ewing sarcoma. vi. to identify new treatment targets for therapy. further testing of these potential targets will be carried out in hopes of expediting translation of these findings to the clinic. vii. to establish a bank of ewing sarcoma xenografts in scid/beige mice. viii. to establish clinical proteomics as a resource for investigations of altered signaling molecules in the pathogenesis of ewing sarcoma. outline: this is a multicenter study. patients undergo various specimen collections, including bone marrow aspirate, paraffin-embedded blocks of tumor tissue or slides of tumor tissue, and blood specimens. these specimens are collected before, during, and after any chemotherapy regimens, during follow-up, and at time of recurrence. translocation studies are performed on specimens to identify fusion genes, specifically ews-ets. serum igf1 and ifgbp3 levels are determined. bone marrow is assessed for minimal residual disease using reverse-transcriptase polymerase chain reaction.

Eligibility criteria:
inclusion criteria: * newly diagnosed or recurrent ewing's sarcoma * availability of the following specimens: * paraffin-embedded block or 20 unstained slides and 1-3 thick (50 micron) sections from initial biopsy * pretreatment serum and whole blood * concurrent therapy is not required
a safety and efficacy of ccrt with paclitaxel/carboplatin as adjuvant therapy to post-operative cervical cancer patients

Conditions: Cervical Cancer

Summary: the purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel/carboplatin is effective and safe in the treatment of high risk cervical cancer patients.

stage ib to iia cervical cancer can be treated effectively with either radioterapy or radical hysterectomy plus pelvic lymph node dissection. however, several pathological risk factors have been identified to compromise the treatment outcome. they include lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion. in these patients, postoperative rt is commonly recommended and has been demonstrated to improve the local control, but not survival rate. recently, it is reported that the additon of concurrent chemotherapy to postoperative rt reduced pelvic failures and enhanced progression free survival. in addition, paclitaxel/platinum combination chemotherapy was demonstrated to have superior progression-free survical over single agent platinum in a primary treatment of stage iv or recurrent cervical cancer. based on this obseration, we evaluated the efficacy and safety of ccrt with paclitaxel/carboplatin in patients with postoperative high risk factors.

Eligibility criteria:
inclusion criteria: * patients undertaken radical hysterectomy with diagnosis of invasive cervical cancer ib-iia (non-small cell type) * patients must have at least one of the following risk factors; pelvic lymph node involvemet, involvement of vaginal resection margin,parametrial invasion. * patients must have a gog performance of 0, 1, or 2. * patients must have expected life span over 6 months. exclusion criteria: * patients with peripheral neurotoxicity over grade 2 in ctc criteria. * patients with history of chemotherapy or radiation treatment. * patients with histologicallly proven or highly suspected metastasis to paraaortic lymph node. * patients with history of hypersensitive reaction to platinum agent.

Keywords: concurrent chemoradiation paclitaxel carboplatin