Kornimate/medical-research-clean huggingface dataset:
diabetic kidney alarm (dka) study

Conditions: Type 1 Diabetes Mellitus; Diabetic Ketoacidosis

Summary: the overarching goals of this study are to determine whether tubular dysfunction (elevated urine sodium, bicarbonate and amino acids) and injury (elevated kidney injury molecule 1 \[kim-1\], neutrophil gelatinase-associated lipocalin \[ngal\] and matrix metallopeptidase 9 \[mmp9\]) exist in diabetic ketoacidosis (age 3-18), whether it is reversible and whether it is related to uricosuria and copeptin. the investigators propose to study a cohort of youth (ages 3-18, n=40) with t1d who have serum and urine collection at dka diagnosis and 3-month follow-up.

every year over 86,000 children (0-14 years) worldwide are diagnosed with type 1 diabetes (t1d) translating to a lifetime of exposure and risk for early death from cardiovascular disease (cvd) and diabetic kidney disease (dkd). dkd, which manifests in children and adolescents, remains the leading cause of renal failure and dialysis in the western world (4). while diabetic glomerulopathy has received significant attention from researchers, determinants of tubular injury in diabetes are less well examined. compared to glomerular injury, tubular injury is known to associate better with renal function. the majority of youth diagnosed with t1d in the us present with diabetic ketoacidosis (dka), a condition associated with risks factors for tubular injury including dehydration, metabolic acidosis and acute glycemia. it is unknown whether dka is associated with tubular injury. the investigators published the first report showing that youth with established t1d have more acidic urine and higher fractional excretion of uric acid (feua) than their non-diabetic peers, which may predispose to uua-mediated tubulopathy. furthermore, t1d is associated with vasopressin overactivity, and the investigators reported strong relationships between serum copeptin, a reliable surrogate marker for vasopressin, and dkd in t1d. the overarching goals of this study are to determine whether tubular dysfunction (elevated urine sodium, bicarbonate and amino acids) and injury (elevated kim-1, ngal and mmp9) exist in dka, whether it is reversible and whether it is related to uricosuria and copeptin. the investigators propose to study a cohort of youth (ages 3-18, n=40) with t1d who have serum and urine collection at dka diagnosis and 3-month follow-up.

Eligibility criteria:
inclusion criteria: * new onset t1d and known t1d * dka (mild, moderate and severe dka eligible) * 3-17 years of age * toilet trained * boys and girls * all ethnicities * initial presentation to children's hospital colorado (chco) main ed exclusion criteria: * non-t1d etiology * history of chronic kidney disease (egfr \<60ml/min/1.73m2) or dialysis dependent * history of tubulopathy (e.g. fanconi syndrome) * currently menstruating * patient visiting colorado with plan to establish diabetes care outside of colorado * on ace-inhibitors or angiotensin ii-receptor blockers (arb) * on sodium-glucose co-transporter 2 inhibitors (sglt2 inhibitors)
efficacy and safety of atacicept in iga nephropathy

Conditions: IgA Nephropathy

Summary: this main purpose of this study was to evaluate the safety, tolerability, dose response and efficacy of atacicept in participants with iga nephropathy and persistent proteinuria. the study hypothesis was that treatment with atacicept would reduce proteinuria compared to placebo.


Eligibility criteria:
inclusion criteria: * greater than or equal to (\>=)18 years of age * biopsy-proven immunoglobulin (iga) nephropathy * urine protein to creatinine ratio (upcr) \>= 0.75 and \<= 6 milligram per milligram (mg/mg) during screening * stable and optimal dose of angiotensin converting enzyme (ace) inhibitor and/or angiotensin ii receptor blockers (arb) at least 8 weeks prior to screening exclusion criteria: * concomitant significant renal disease other than iga nephropathy * iga nephropathy with significant glomerulosclerosis or cortical scarring * diagnosis of henoch-schonlein purpura * failure to meet estimated glomerular filtration rate (egfr) and biopsy requirement criteria * serum igg below 6 grams per liter (g/l) * use of cyclophosphamide ever or use of other immunosuppressants or systemic corticosteroids within 4 months * active infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks * history, or current diagnosis, of active tuberculosis (tb), or untreated latent tb infection * history of or positive hiv and/or positive for hepatitis b or hepatitis c at screening * history of malignancy * nursing or pregnancy * any condition, including any uncontrolled disease state other than iga nephropathy

Keywords: atacicept iga nephropathy berger´s disease glomerulonephritis proteinuria
significance of benign lymph node enlargement in colorectal cancer

Conditions: Colorectal Neoplasms Malignant

Summary: the objective of this observational study was to investigate the clinical significance of benign mesenteric lymph node （blne） enlargement in patients with colorectal cancer. the main questions it aims to answer are: do patients with benign mesenteric lymph node enlargement have a better prognosis? what are the clinical characteristics of benign mesenteric lymph node enlargement? as part of routine medical care for colorectal cancer, we will follow up with all participants over the course of the study.

from january 2015 to june 2023, 2,270 patients with colorectal cancer received surgical treatment at peking university third hospital. the clinical data of these patients were recorded retrospectively and the eligible patients were divided into two groups. according to the 9th edition of the tnm staging system published by the ajcc, the blne group included the mesenteric blne group, while the non-benign lymph node enlargement (nblne) group was the control group. inclusion criteria were :1) no regional lymph node metastasis or distant metastasis; 2) stage i and ii patients with ajcc staging system; 3) radical crc resection reached r0 status, no positive lymph nodes; colonoscopy confirmed a single malignant lesion. exclusion criteria :1) emergency surgery or preoperative complications such as intestinal obstruction and perforation; 2) positron emission tomography (pet-ct) suspected distant metastasis; 3) preoperative neoadjuvant therapy; 4) hereditary colorectal cancer such as familial adenomatous polyposis; microsatellite instability (msi) was confirmed by pathology. in early colorectal cancer, msi-h status is associated with a favorable prognosis and enhanced anti-tumor immune response. therefore, we excluded these patients to avoid their influence on prognosis. 6) lack of imaging data; 7) loss of follow-up.

Eligibility criteria:
inclusion criteria: * no regional lymph node metastasis or distant metastasis; * stage i and ii patients in the ajcc staging system; * radical crc resection achieving r0 status with no positive lymph nodes; * a single malignant lesion confirmed via colonoscopy exclusion criteria: * underwent emergency surgery or had preoperative complications such as intestinal obstruction or perforation; * had suspected distant metastasis on positron emission tomography (pet-ct); * received preoperative neoadjuvant therapy; * had hereditary crc such as familial adenomatous polyposis; * had microsatellite instability (msi) confirmed by pathology. * lacked imaging data; * were lost to follow-up.
study of the key techniques of prevention and treatment of osteoporotic refracture

Conditions: Osteoporotic Fractures

Summary: this project anchors osteoporotic fractures, conduct registration and follow-up studies, and conduct prospective treatment studies. by registering for follow-up studies on osteoporotic fractures, it is planned to obtain epidemiological data through registration and follow-up studies; a prospective treatment study for patients with osteoporotic fractures is planned to explore effective treatment strategies through randomized controlled trials; to study biomarkers for osteoporotic refractures, we plan to establish a biomarker warning model through multi omics research; to study imaging biomarkers for osteoporotic refractures, a new imaging technology is proposed to establish an imaging omics warning model.


Eligibility criteria:
inclusion criteria: 1. new brittle hip fractures; 2. new brittle vertebral fractures; 3. new other site fractures and/or total hip or neck of femur or l1-l4 t-value \&lt; -1.0; 4. men or postmenopausal women; 5. age 45-90 years old; 6. ability to move autonomously exclusion criteria: 1. bone metabolic diseases except for osteoporosis eg. a. (osteogenesis imperfecta, paget's disease, osteomalacia), b. cushing's syndrome, c.hyperprolactinemia; 2. having primary hyperparathyroidism or hypothyroidism; 3. had or have osteomyelitis of the jaw or necrosis of the jaw; 4. gfr\<30ml/min/1.73m2; 5. active infection that requires systematic treatment; 6. used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years; 7. used teriparatide and denosumab for osteoporosis within 6 months; 8. used glucocorticoids (equivalent to \&gt;5 mg/day prednisone) for more than 10 days within 6 weeks; 9. the time gap between the first time and the last time oral bisphosphonate for osteoporosis less than 1 year( if used within one year, but the cumulative use is ≤ 1 month, the subject can be enrolled) ; 10. patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment; 11. have hypocalcemia and hypercalcemia; 12. unexplained elevation of alkaline phosphatase; 13. a serious deficiency of vitamin d (25ohd \&lt;10ng/ml); 14. patients who have previously received external radiation or radiation therapy with bone implants; 15. uncontrolled comorbidities included heart failure above the new york cardiac function scale, glycosylated hemoglobin \&gt; 8.5%, and severe arrhythmias; 16. planned pregnancy and lactation at present or during the study period; 17. allergic to teriparatide and denosumab; 18. participating in clinical trials of other drugs at present; 19. subjects do not suitable for this study

Keywords: osteoporosis osteoporotic fractures bone turnover markers imaging biomarkers
an act-based physician-delivered weight loss intervention

Conditions: Overweight and Obesity; Eating Behavior

Summary: the purpose of the present study was to conduct a pilot rct to test the feasibility of a physician-delivered act-based intervention for emotional eaters with overweight/obesity against standard care at a network of weight loss clinics. participants were randomized to receive either standard care at the clinics or the act intervention.

the purpose of the present study was to conduct a pilot rct to test the feasibility of a physician-delivered act-based intervention for emotional eaters with overweight/obesity against standard care at a network of weight loss clinics. psychology clinical phd students trained physicians in the delivery of the brief manualized intervention and were available for regular consults. the intervention consisted of eight, 5-10 minute sessions that could be easily incorporated into the physician's current practice. over the duration of the act intervention, physicians met individually with patients to teach them various techniques to address and improve mindfulness, acceptance, and values clarification and commitment, all of which emotional eaters have been found to struggle with (forman \& butryn, 2014). the proven habit formation technique of if-then planning (gollwitzer, 1993) was used throughout these sessions in order to train emotional eaters to habitually use act techniques and to change the maladaptive habit of eating in response to negative emotions.

Eligibility criteria:
inclusion criteria: * only participants considered to be emotional eaters, as assessed by a score of 3.25 or higher on the dutch eating behavior questionnaire (debq), were recruited for the study (van strien, herman, anschutz, engels, \& de weerth, 2012). exclusion criteria: * not being an emotional eater. * participants who did not speak, write, and read in english fluently were excluded from the study, as well as those who were pregnant.

Keywords: emotional eating
histolog comparison to standard histology

Conditions: Margins of Excision; Breast Cancer

Summary: this is a clinical device trial to assess the accuracy of margin assessment for a confocal scanning device (histolog scanner) at assessing the margins of breast tissue following wide local excision surgery.

currently a 15-20% of breast cancer patients have cancer cells seen at the edge of the tissue removed following. these patient will need to undergo a second operation to ensure all the cancer cells are removed, which has psychological, cosmetic and cost implications. several technologies have been designed to allow the edges of tissue to be tested during surgery, with the most accurate being those that involve assessing the tissue edge at a cellular level. however, these techniques are time consuming which makes their use in routine work impractical. the histolog system uses pinhole (confocal) microscopy to capture cellular level images of the edge of tissue intra-operatively. the first generation of the device has been shown to be accurate for assessing breast tissue biopsies and skin cancer. the second generation of the device has an 8cm plate for scanning tissue and is ce marked for the assessment of tissue margins. this project is to show that the device is accurate for the assessment of margins, with further assessment in relation to the time for images to be captured and ease of interpretation to assess overall feasibility. the study would recruit at a single high volume breast cancer centre. the study will recruit patients with a diagnosis of breast cancer who are due to undergo breast conservation surgery (lumpectomy) with inclusion criteria of female patients over the age of 18 who are able to give informed consent. the study would involve the edges of removed tissue being imaged following surgery. these images would be reported by a consultant histopathologist and compared to the routine gold standard histology. there is no change to patient care and the device will not be used to change the surgery performed. there are no questionnaires or additional demands placed on the participants.

Eligibility criteria:
inclusion criteria: * patient capable of providing informed consent * female * have a diagnosis of invasive breast cancer or ductal carcinoma in-situ * have been discussed within the multidisciplinary meeting with a recommendation that the patient is suitable for breast conservation therapy * any localisation technique can be used of impalpable lesions (eg if the wire impairs the image quality, this will inform for full scale research) * patient undergoing breast conservation surgery * patient undergoing further breast conservation surgery for positive margins after previous surgery * patient's will be able to participate for a re-excision of margin, even if they did not participate for their initial operation exclusion criteria: patient undergoing mastectomy, including completion mastectomy due to involved margins * patients undergoing excision biopsies * male patients * patients under the age of 18 * unable to provide valid consent in english language
restless legs syndrome in hemodialysis patients

Conditions: Restless Leg Syndrome

Summary: restless legs syndrome (rls) is defined as the spontaneous movement of the limbs (mainly legs) associated with unpleasant - painful sensation which is relieved by moving the affected limb. it is a common disorder in hemodialysis patients that leads to insomnia, impaired daytime functioning and quality of life. symptoms of rls are estimated to affect up to 25% of patients on dialysis when the international rls diagnostic criteria are applied. various pharmacological and non-pharmacological interventions have been used to treat primary rls. however, the evidence for use of these interventions in people with end stage renal disease is not well established; and some have serious side effects. because high oxidative stress has been implicated in the pathogenesis of rls, investigators thought of evaluating the efficacy of vitamin c in reducing the severity of rls symptoms in hemodialysis patients in this randomized, double-blind, placebo-controlled, two arm parallel trial. to note that only two studies were done worldwide that proved the efficacy of vitamin c in those patients.

the investigators are proposing to carry out a clinical trial. around 100 stable hemodialysis adult patients at makassed general hospital dialysis center and around 150 patients at sahel general hospital and zahraa hospital will be assessed according to the international rls criteria. the data on individual, clinical and laboratory indices will be obtained from patients' recorded files and interviews. the investigators will compare the rls group versus the non rls group according to these factors to find the independently associated factors for rls in dialysis patients. those who fulfill all four diagnostic criteria for rls (confirmed independently by 2 neurologists) will be classified as "rls positive" and will be asked to answer 10 questions on the international rls study group (irlssg) rating scale. the irlssg rating scale was also used to evaluate the severity of rls symptoms. these patients will be randomly allocated to two parallel groups to receive vitamin c (200 mg) or placebo for eight weeks.

Eligibility criteria:
inclusion criteria: * patients under regular hemodialysis * with no acute illness * not hospitalized exclusion criteria: * patients receiving: * tricyclic antidepressants, * selective serotonin reuptake inhibitors, * dopamine antagonists, * dopamine blocking, * antiemetics, * lithium, * sedative antihistamines, * patients with a history of renal stones
prevention of amputation in diabetic foot ulcers using amniotic tissue

Conditions: Diabetic Foot Ulcer

Summary: the purpose of this study is to see whether the use of amnioexcel® improves healing and reduces the need to cut off all or part of a leg (amputation) in high-risk patients who have diabetes and foot sores (also sometimes called ulcers or wounds).

the purpose of this study is to demonstrate the effectiveness of comprehensive, interdisciplinary approach (usual care) in combination with early application of advanced therapy; dehydrated human amniotic membrane allografts (amnioexcel®, derma science, princeton, new jersey) in healing and preventing amputation in high risk patients with diabetic foot ulcers.

Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetes * ulcer anywhere on the foot * moderate to high risk for amputation according to prevention of amputation for veterans everywhere (pave) and the society for vascular surgery lower extremity threatened limb (svs wifi) classification system (wifi) criteria exclusion criteria: * inability or unwillingness to travel to boise va for clinic visits * enrolled in hospice * have known or expected malignancy of foot ulcer * are or planning to become pregnant * signs of progressive gangrene, limb-threatening infection

Keywords: foot ulcer, diabetic wound healing diabetic foot ulcer
prophylactic ethanol lock therapy (elt) in patients on home parenteral nutrition

Conditions: Catheter-related Bloodstream Infection (CRBSI) Nos; Bloodstream Infection Due to Central Venous Catheter; Bloodstream Infection Due to Hickman Catheter

Summary: this study is being implemented to identify the role of prophylactic use of ethanol lock in adult patients on home parenteral nutrition (hpn). central catheter related blood stream infection is a major complication in patients on hpn. the investigators hypothesize that the prophylactic use of elt will decrease the number of catheter related blood stream infections compared to the control group. the investigators further hypothesize that with the introduction of prophylactic elt, the number of infections will decrease.

catheter-related bloodstream infection (crbsi) is a serious complication for home parenteral nutrition (hpn) patients causing morbidity, mortality, and prolonged hospitalization. crbsis may also result in the need for central venous catheter (cvc) removal and replacement. current literature supports the use of antibiotics locks in patients with repeated crbsi. there is a growing concern about the increased risk of microbial resistance with the long term use antibiotic locks. ethanol lock therapy (elt) has broad spectrum coverage and includes gram negative bacteria, gram positive bacteria, atypical bacteria, and fungi. compared with antibiotic and other solution locks, which have limitations, elt has excellent broad-spectrum bactericidal and fungicidal killing action and poses no problems with development of resistance over time. there is a lack of a randomized controlled study to characterize the role of elt in adult patients on hpn.

Eligibility criteria:
inclusion criteria: * newly started on home parenteral nutrition and anticipated duration \>3 months. * not previously on home parenteral nutrition. * providing consent. * patients with non-medicare insurance. * patients with medicare insurance and a supplementary insurance. * patients with single lumen hickman® catheters. * no known alcohol addiction. exclusion criteria: * failure to provide consent * patients with medicare insurance and no other supplemental private insurance * patients with a catheter type other than a single lumen hickman® * patients who are on hpn for less than three months * pregnant patients * patients who have previous proven addiction and dependence to alcohol. * patients lacking capacity to provide consent * patients who are not be managed by hpn team at investigator's institution

Keywords: home parenteral nutrition infection prevention crbsi ethanol lock therapy
comparison of screening strategies for active tuberculosis (compass-tb)

Conditions: Active Tuberculosis; Latent Tuberculosis

Summary: the study is an evaluation of the diagnostic performance of different tests and their association in order to confirm or exclude active tuberculosis.

background : diagnostic methods to distinguish between latent tb infection (ltbi) and active tb disease remains challenging. data are scarce concerning the positive predictive value of current diagnostic approaches, including interferon-gamma release assay (igra) and chest radiography, which is often very low. computed tomography (ct) scanning, although not recommended by the world health organization (who) for tb diagnosis, may be of high interest in our high-income low-burden countries. this study assess the performance of the combination of ct scanning and igra to diagnose active pulmonary tb and identifies discriminatory ct scan features indicative of active disease. methods : a retrospective study was conducted on 580 patients clinically suspected of tb or in contact with bacteriologically confirmed cases (index cases). patients underwent igra testing, thoracic ct scans, and respiratory (or other organs) samples culture. ct scan findings were blindly analyzed, and a composite score combining significant radiological signs with igra results was constructed. diagnostic performance measures, including sensitivity, specificity, positive predictive value (ppv), and negative predictive value (npv), were calculated.

Eligibility criteria:
inclusion criteria: major patients who received the following examinations at the montpellier university hospital for tuberculosis screening (clinical suspicion and/or contact with a person with active tuberculosis): * chest x-ray and * chest ct scan and * mycobacteriology examination of respiratory or tissue sample (direct/culture/genxpert) and * igra test (quantiferon)

Keywords: active tuberculosis latent tuberculosis infection interferon-gamma release assay quantiferon chest ct scan chest x-ray