Kornimate/medical-research-clean huggingface dataset:
biomarkers in the evaluation of chronic lung disease

Conditions: Pulmonary Hypertension; Pulmonary Arterial Hypertension; Interstitial Lung Disease

Summary: we hypothesize that hypoxia-induced pulmonary vascular remodeling is mediated by macrophage migration inhibitory factor (mif), that remodeling is in fact the reflection of a chronic inflammatory process, and that mif may be a useful biomarker of the severity and progression of both ild and ph.

we hypothesize that hypoxia-induced pulmonary vascular remodeling is mediated by macrophage migration inhibitory factor (mif), that remodeling is in fact the reflection of a chronic inflammatory process, and that mif may be a useful biomarker of the severity and progression of both ild and ph. to study this hypothesis, we have two specific aims: 1. to evaluate plasma mif concentration as a marker of severity in ild and ph and 2. to determine the utility of breathe condensate analysis in the evaluation of ild and ph. if we are successful in identifying mif as a biomarker, it may identify mif as a useful therapeutic target, as we have shown in other inflammatory disorders.

Eligibility criteria:
inclusion criteria: * subject are at least 18 years of age * subject has confirmed pulmonary hypertension and interstitial lung disease * subject are able to complete study procedures, such as spirometry, and pulmonary exercise test. exclusion criteria: * subject are pregnant * subject is unable to perform tasks associated with study

Keywords: pulmonary hypertension pulmonary arterial hypertension interstitial lung disease mif
the use of pedometers as an adjunctive tool in a school-based pediatric weight management program

Conditions: Obesity

Summary: the purpose of this study is: * to validate the use of pedometers in assessing the level of physical activity in middle school children. * to evaluate whether setting a step goal through the use of pedometers could increase physical activity and prevent weight gain in middle school children.


Eligibility criteria:
inclusion criteria: * all healthy 8th grade students at the springboard academy of the milton hershey school willing to participate in the study and whose parents give consent. exclusion criteria: * any medical condition that prevents the child from walking during the 12 week study period. * non-english speaking student.

Keywords: obesity physical activity pedometers children
feasibility study to determine the optimal calibration method for glucose sensors

Conditions: Diabetes

Summary: two new glucose sensors (ir-glucose reader (joanneum research, austria), ir-cgm (imm, germany)) will be investigated to determine the optimal calibration method in patients with type 1 diabetes

the subjects (type 1 diabetes) will stay at the clinical research centre for the whole period of the investigation (12 hours). continuous blood glucose monitoring will be performed using the ir-glucose reader system and/or the ir-cgm system based on microdialysis. in parallel blood glucose measurements will be performed every 15 min as reference. the measurements of the sensors will be calibrated with different schemes and the difference between the calibrated glucose readings and the reference blood glucose values will be determined.

Eligibility criteria:
inclusion criteria: * informed consent obtained after being advised of the nature of the study * male or female aged 18 to 75 years (both inclusive) * the subject has type 1 diabetes (as defined by who) for at least 24 months * body mass index (bmi) \<= 35 kg/m2 exclusion criteria: * subject is actively enrolled in another clinical trial or took part in a study within 30 days * experienced recurrent severe hypoglycaemic unawareness (as judged by the investigator) * a history of drug or alcohol dependence * positive result for hiv antibodies * positive result for hepatitis b antigen or hepatitis c antibodies * any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator * patient is pregnant, or breast feeding during the period of the study * patient donated blood in the last 3 months
1 year trial telmisartan 80 mg versus valsartan 160 mg in hypertensive type 2 diabetic patients with overt nephropathy

Conditions: Diabetic Nephropathies; Hypertension

Summary: the general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure beyond the target of 130/80 mmhg after one year of treatment. the primary objective of this study is to show that telmisartan 80 mg is at least as effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment.

this is a randomised, double-blind, double-dummy, forced titration, multicentre, parallel group trial in patients with essential hypertension, diabetes mellitus type 2 and diabetic nephropathy. after a 4-6 week run-in period, patients are randomised to one of the treatment groups and receive either telmisartan 40 - 80 mg or valsartan 80 - 160 mg. the treatment regimen is a forced titration with the lower dose given for 2 weeks and the higher dose given for the rest of the treatment period summing up to 52 weeks of treatment. during the treatment period, 8 visits to the investigator are scheduled in order to control blood pressure, renal function parameters and safety. in addition, parameters of endothelial function and oxidative stress are measured at baseline, 6 months and after one year of treatment. study hypothesis: non-inferiority of telmisartan 80 mg compared to valsartan 160 mg will be tested using the following set of hypotheses: null hypothesis: the overall mean change from baseline in uper (24 hour urinary protein excretion rate) for telmisartan 80 mg is inferior to that for valsartan 160 mg by 0.5 g/day or more. alternative hypothesis: the overall mean change from baseline in uper (24 hour urinary protein excretion rate) for telmisartan 80 mg is less than 0.5 g/day worse than that for valsartan 160 mg. comparison(s): in order to test the non-inferiority hypothesis, analysis of covariance with treatment and centre as main effects and baseline as a covariate will be performed. time-to-event data will be analysed using the log-rank test.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes mellitus 2. aged 30-70 years of age 3. hypertension at screening defined as: * an average cuff systolic blood pressure \> 130 mmhg and/or diastolic blood pressure \>80 mmhg in untreated patients or * patients receiving antihypertensive therapy (i.e., medications specifically prescribed to treat hypertension) 4. overt nephropathy defined by 24 hour proteinuria \>= 900 mg and by serum creatinine below 265 mol/l (3.0 mg/dl) exclusion criteria: none
a trial to compare the pk and pd of insulin lispro administered into different tissues in subjects with diabetes mellitus type 1

Conditions: Diabetes Mellitus

Summary: the aim of this trial is to compare the pharmacokinetics and pharmacodynamics of insulin lispro injection into either lipohypertrophic lesions or normal tissue, utilizing both state-of-the-art euglycaemic clamp and mixed meal tolerance testing. the magnitude of insulin efficacy after injection into these different areas is still unclear. the results from this study may expand the knowledge on the severity of this issue and may provide evidence for future treatment recommendations regarding injection sites for insulin administration.


Eligibility criteria:
inclusion criteria: * aucins.0-4h and aucgir.0-4h during treatment period 1 exclusion criteria: * aucins.0-4h and aucbg.0-4h during treatment period 2, intra-subject variability of aucins.0-4h and aucgir.0-4h during treatment period 1
diagnosing acute onset insufficient intestinal blood flow (bowel ischemia) with a novel ct technique called dual-energy ct (dect). this observational study seeks to evaluate whether dect can improve the diagnosis of bowel ischemia and how the dect findings correlate with intraoperative findings

Conditions: Bowel Ischemia; Acute Bowel Ischemia / Infarction

Summary: the aim of this study is to evaluate the performance of dual-energy ct (dect) in the diagnosis of acute bowel ischemia (abi). abi is a condition characterised by inadequate blood supply to portions of the intestine. abi is a relatively rare condition, but is associated with a high mortality rate. dect is an emerging field within radiology. few reports have reported an increased conspicuity for abi using dect compared with conventional ct, which is the current preoperative golden standard. the investigators hypothesize that dect increases conspicuity of abi compared with conventional ct and that dect image findings correlate with the intraoperative findings.


Eligibility criteria:
inclusion criteria: * referred on the suspicion of acute bowel ischemia exclusion criteria: * patient not scanned with dect * patient does not undergo abdominal surgery

Keywords: dual-energy ct
optimizing care for challenging people living with hiv

Conditions: Adherence, Medication; HIV Infections; Social Media

Summary: conduct an intervention combining social and behavioral health models with digital health technologies to improve their adherence to their medication schedules. the success of the intervention is assessed by comparing adherence rates before and after its implementation to see if there's a notable enhancement in how well patients follow their antiretroviral therapy.

this is an intervention strategy for hiv-infected individuals based on their viral load measurements and medication adherence rates, measured by the proportion of days covered (pdc) for the past 365 days. a specific pdc threshold identifies individuals with less than 90% viral suppression at under 200 copies/ml. an intervention approach integrating social and behavioral models with electronic health (ehealth) technology is implemented for cases with a pdc below this threshold. the intervention aims to enhance the patient's adherence to their medication regimen. the effectiveness of this intervention is evaluated by comparing indicators before and after its application to determine if there are significant improvements in the participants' compliance with their antiretroviral therapy.

Eligibility criteria:
inclusion criteria: 1. plwh with adherence below the specific proportion of days covered (pdc), which is defined as the specific level that corresponds to 90% at viral suppression (\< 200 copies/ml). exclusion criteria: 1. under 18 years of age. 2. illiterate. 3. non-consenting individuals. 4. less than 365 days from the initial use of antiretroviral drugs to the assessment for inclusion in the study. 5. inability to obtain complete medication records for the 365 days prior to inclusion. 6. lack of a smart phone. 7. no willingness to return for follow-up at the participating hospital.

Keywords: hiv adherence social media platform
feasibility of combined genomics/transcriptomics for patients with lymphoma

Conditions: Lymphoma

Summary: to learn more about the usefulness of molecular testing with the molecular functional (mf) portrait (a commercial test conducted by the sponsor of this study, bostongene) in guiding lymphoma care.

primary objective: • to determine the feasibility and turnaround of clinical wes and transcriptome sequencing secondary objectives: * to determine the frequency of actionable dna and rna alterations * to determine the concordance of dna and rna alterations * to determine the frequency of molecularly matched therapy * to determine the feasibility of identifying mechanism(s) of acquired resistance with genomic profiling * to determine the feasibility of molecularly matched therapy to acquired resistance alterations exploratory objectives: * to determine the feasibility of prioritizing targets with precision analytics * to determine clinical outcomes in patients receiving molecularly matched therapy * to determine the role of additional emerging diagnostic technologies

Eligibility criteria:
patient eligibility: inclusion criteria: 1. male/female patients who are at least 18 years of age on the day of informed consent signing. 2. patients must have a histologically documented diffuse large b-cell lymphoma requiring therapy. 3. provision of written informed consent for the study. exclusion criteria: 1. none
one-month clinical evaluation of oté sensation multi-purpose solution care system

Conditions: Myopia; Hyperopia

Summary: the purpose of this study is to evaluate the clinical performance of the contact lens care product oté sensation in a representative population of soft contact lens wearers. for comparison, a widely used fda approved soft lens multipurpose solution will be used as a control. this control product has been tested in previous clinical trials.

this will be a 1-month, 200-subject, double-masked (care product), bilateral, randomized, comparative study. subjects will be clinically evaluated at the initial baseline visit (visit 1), then after 1 week and 1 month of lens wear having been randomly assigned to use one of six lens types and to either the test or control solutions.

Eligibility criteria:
inclusion criteria: * be a currently adapted soft contact lens wearer (\>1 month of lens wear). * be at least 18 years of age. * refractive astigmatism \<0.75 d in both eyes. * have clear corneas and be free of any anterior segment disorders. * be correctable through spherocylindrical refraction to 6/12 (20/40) (0.30 logmar) or better in each eye. * contact lens sphere requirement between +4.00 dioptre and -8.00 d (inclusive). * require visual correction in both eyes (monovision allowed, no monofit). * have normal eyes with no evidence of abnormality or disease. for the purposes of this study a normal eye is defined as one having: 1. no amblyopia 2. no strabismus 3. no evidence of lid abnormality or infection 4. no conjunctival abnormality or infection that would contraindicate contact lens wear 5. no clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities) 6. no other active ocular disease. exclusion criteria: * require toric or multifocal contact lenses. * previously shown a sensitivity to any of the study solution components. * any systemic or ocular disease or allergies affecting ocular health. * using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance. * clinically significant (\>grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear. * any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea. * keratoconus or other corneal irregularity. * aphakia or amblyopia. * have undergone corneal refractive surgery or any anterior segment surgery. * abnormal lacrimal secretions. * has diabetes. * known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., hiv). * history of chronic eye disease (e.g. glaucoma). * pregnant or lactating or planning a pregnancy at the time of enrolment. * participation in any concurrent clinical trial or in last 30 days.

Keywords: multipurpose contact lens care system
four-arm randomized control trial of brief mi versus couples-based hiv/sti prevention in south africa

Conditions: HIV Prevention

Summary: this study is a randomized controlled trial (rct) of integrated and cognitive behavioral therapy for hiv prevention in pretoria, south africa. the rct will evaluate the efficacy of a brief motivational interview (bmi) and a cognitive-behavioral couples' (ifcbt) intervention alone and in combination against a comparison condition to reduce new cases of hiv and sexually transmitted infections and increase condom use and decrease sexual risk behavior, drug use, and intimate partner violence among young female drug users in pretoria, south africa and their primary intimate partners. in the rct, 384 couples comprised of young female drug users who do (n = 192) and do not (n = 192) trade sex and their primary intimate heterosexual partners will be randomly assigned to one-of-four conditions: (1) testing and counseling; (2) brief motivational interview (bmi); (3) cognitive-behavioral couples' intervention (ifcbt); or (4) bmi and ifcbt combined. eligibility criteria for couples include an hiv-negative drug using female aged 18 to 40 and their primary intimate partner or spouse who is also hiv negative. each partner of each couple will be administered assessments with a rapid test for hiv and urine tests for chlamydia, gonorrhea, trichomoniasis, and drug use at baseline and 3-month, 6-month, and 12-month follow-up.


Eligibility criteria:
inclusion criteria: * live in the pretoria, south africa region * 18-40 years of age * in a steady, intimate relationship for 6 months or longer * used illicit drugs in the past 6 months exclusion criteria: * acute suicidality/homicidality

Keywords: hiv prevention intervention
results of endoscopic sinus surgery in management of ophthalmological complications of chronic rhino sinusitis

Conditions: Chronic Sinusitis

Summary: investigate the clinical features of orbital complications of sinusitis in the egyptian population, and observed that certain ophthalmological manifestations and outcomes were significantly associated with disease stage

retrospectively review of the medical records of all patients with orbital complications of paranasal sinusitis hospitalized at the orl-hns department at the university of tanta between 2010 and 2020. sex, age, symptoms, history, ophthalmological findings, laboratory and imaging findings, treatments, and outcomes were analyzed by staging. the data that will be retrieved from the medical records including: 1. history taking including personal present and previous medical history. 2. general examination 3. oto-rhinolaryngological clinical examination 4. routine preoperative laboratory investigations (e.g. complete total and differential blood count, blood sugar, coagulation profile, and renal and liver function) 5. diagnostic nasal endoscopy with zero and/or a 30-degree telescope. 6. ct paranasal sinuses with contrast, fine cuts in coronal axial, and sagittal planes. 7. the type of intervention whether medical or surgical. 8- culture results, treatments, hospital stay durations, and outcomes. ophthalmology data collection: 1. visual acuity (onset of decrease) (unilateral or bilateral) ant its improvement after sinus surgery 2. presence or absence of double vision (diplopia) 3. ocular motility and if its associated with pain 4. proptosis (present or absent) and calculate the degree and direction 5. ptosis (present or absent) 6. pupil reactivity 7. fundus examination to exclude optic nerve neuropathy 8. association between ocular pain and headache and its improvement after surgery 9. ct data collection (ct orbit, mri of sinus and head) 10. fundus photography after surgery to see improvement of optic nerve neuropathy if present

Eligibility criteria:
inclusion criteria: * patient presented with preseptal/orbital inflammation secondary to acute (\ 3 months) of bacterial, fungal or unidentified pathogens exclusion criteria: * patients with chronic rhinosinusitis without orbital complication, systemic diseases that affect the paranasal sinuses and the orbit e.g autoimmune diseases, lymphoma, leukaemia, sinus or orbital malignancy, data is missed from the charts
oral rivaroxaban in children with venous thrombosis

Conditions: Venous Thrombosis

Summary: the purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. there will also be a check for bleeding and worsening of blood clots.


Eligibility criteria:
inclusion criteria: * children aged 6 to \< 18 years with documented symptomatic or asymptomatic venous thrombosis treated for at least 2 months or, in case of catheter related thrombosis, treated for at least 6 weeks with lmwh (low molecular weight heparin), , fondaparinux and/or vka (vitamin k antagonist). * informed consent provided and, if applicable, child assent provided exclusion criteria: * active bleeding or high risk for bleeding contraindicating anticoagulant therapy * symptomatic progression of venous thrombosis during preceding anticoagulant treatment * planned invasive procedures, including lumbar puncture and removal of non peripherally placed central lines during study treatment * an estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m2 * hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk or alt \> 5x upper level of normal (uln) or total bilirubin \> 2x uln with direct bilirubin \> 20% of the total * platelet count \< 50 x 10\^9/l * hypertension defined as \> 95th age percentile * life expectancy \< 3 months * concomitant use of strong inhibitors of both cytochrome p450 isoenzyme 3a4 (cyp3a4) and p-glycoprotein (p-gp), i.e. all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically * concomitant use of strong inducers of cyp3a4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
distinguishing retroperitoneal fibrosis and sarcoma from other retroperitoneal diseases via radiomics

Conditions: Retroperitoneal Sarcoma; Retroperitoneal Fibrosis

Summary: a retrospective study utilizing archived ct scans of patients diagnosed with retroperitoneal fibrosis, sarcoma or other malignancies (i.e. lymphoma, germ cell tumors, metastasis, infections, ganglioneuromas) in order to implement a radiomics algorithm which is able to differentiate between these malignancies.

the aim of this project is to develop a radiomics algorithm that can reliably identify retroperitoneal fibrosis (ormond's disease) and retroperitoneal sarcomas, automatically segment them and differentiate them from other retroperitoneal diseases. radiomics is a technique that uses artificial intelligence to extract characteristics from radiological image data that are not visible to humans and to identify image morphological patterns of diseases. as it is difficult to differentiate between diseases using image data alone, clinical data such as symptoms and laboratory values are to be correlated with the image data and utilized by the algorithm. among other things, this should increase the sensitivity, accuracy and specificity of image-based diagnostics in order to enable faster, non-invasive diagnosis.

Eligibility criteria:
inclusion criteria: * patients of any age or gender. * ct scans confirming the presence of a retroperitoneal mass. * confirmed diagnosis of retroperitoneal fibrosis, sarcoma or other malignancies (i.e. lymphoma, germ cell tumors, metastasis, infections, ganglioneuromas) through pathology reports or clinical follow-up. exclusion criteria: * poor quality ct scans where the region of interest is not clearly visible. * previous treatments or surgeries that might alter the radiomic features of the tumors.

Keywords: radiomics auto-segmentation