Kornimate/medical-research-clean huggingface dataset:
feasibility of obtaining adrcs from discarded thermal burn eschar tissue using investigational celution® system

Conditions: Thermal Burn

Summary: the objective of the study is to assess the logistical and biological feasibility of preparing adrcs from adipose tissue excised during standard-of-care burn wound excision using the celution® system for autologous, same-day application to the burn wound.

this study is a non-interventional clinical study. adipose tissue excised as part of usual care of burn wound that would otherwise be discarded will be collected for processing and analysis. target population includes patients with a burn injury that requires surgery in which fat excision of approximately 100 g (or more) is anticipated. the scope of the study includes: * fat tissue collected from tangential or fascial excision will be manually prepared for processing within the investigational celution® system * adipose tissue will be processed using the investigational celution® system. adrc yield and viability will be evaluated using a nucleocounter® device * age, gender, weight, height, location/severity/%tbsa of burn, time/date of burn injury, current stage of health will be collected * operational details such as start and stop time of tissue excision, adipose tissue preparation and celution® processing, cell counting and dose preparation will be collected. in addition, weight of excised tissue prior to and after preparation, weight of adipose tissue processed by celution device and adrc yield and viability will be recorded. * several samples will be collected and sent to a central microbiology laboratory for microbiological testing.

Eligibility criteria:
inclusion criteria 1. males or females ≤ 80 years of age 2. admission to hospital for acute burn injury 3. planned escharectomy anticipated to yield at least 100 g adipose tissue according to the treating surgeon's clinical judgment. exclusion criteria 1. known history of hiv infection, or has active hepatitis b or active hepatitis c infection 2. pre-existing condition requiring current use of immunosuppressive medication or systemic steroids 3. cancer requiring chemotherapy or radiation within previous 12 months
conservative treatment of trigger finger

Conditions: Hand Injuries; Trigger Finger

Summary: this study is to analyze the effectiveness of a nighttime extension orthosis after receiving a cortisone injection for the treatment of trigger finger to improve pain and restore functional outcomes. the investigators hypothesize that the extension orthosis will improve pain and functional outcomes compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.

the purpose of the research is to analyze the effectiveness of a proximal interphalangeal joint (pipj) extension night orthosis status-post cortisone injection of the first annular pulley for the treatment of trigger finger to improve pain and restore functional outcomes. the investigators hypothesize that the extension orthosis will improve pain and functional outcomes (quick dash score) compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.

Eligibility criteria:
inclusion criteria: * individuals 18 years old or older are included * patients with trigger finger, aka stenosing flexor tenosynovitis * status post receiving cortisone injection of the affected digit(s) exclusion criteria: * any records flagged with break the glass or research opt out * patients with rheumatoid arthritis * patients with a history of traumatic injury to the hand * cognitive or behavioral problems which would preclude informed consent * unable to speak and understand english
liver transplantation for unresectable perihilar cholangiocarcinoma

Conditions: Perihilar Cholangiocarcinoma; Klatskin Tumor

Summary: this is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging/disease control of unresectable perihilar cholangiocarcinoma using chemotherapy +/- immunotherapy and stereotactic body radiation therapy (sbrt).

patients with unresectable pcca who fit within inclusion criteria will be enrolled in the study. they will undergo staging laparoscopy with nodal sampling at the hepatic hilum. in case of negative staging (no peritoneal carcinomatosis, no positive hilar lymph nodes, negative peritoneal washing), they will receive downstaging with gemcitabine-cisplatin +/- durvalumab for 2 cycles, followed by sbrt, followed by at least 4 other cycles of gemcitabine-cisplatin +/- durvalumab. after downstaging, they will undergo disease restaging and, if at least disease stability is confirmed, they will undergo transplant screening and listing. treatment with gemcitabine-cisplatin + durvalumab will continue until liver transplant, progression or unacceptable toxicity. during listing, restaging will be performed every two months with ct scan and/or mri, molecular markers and fdg-pet. the target interval between listing and transplant should be less than 90 days.

Eligibility criteria:
inclusion criteria: * diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by: * transcatheter biopsy or brush cytology * ca-19.9 \> 100 mg/ml and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography * biliary ploidy by fish with a malignant appearing stricture on cholangiography * age between 18 years and 70 years * absence of intra- and extrahepatic metastases * absence of lymph-nodal metastases at any site * biliary stenting of all liver districts * no contraindications to liver transplantation * no concomitant malignancies or history of other malignancies in the previous 5 years * written informed consent exclusion criteria: * intrahepatic cholangiocarcinoma * uncontrolled infection * concomitant malignancies or history of other malignancies in the previous 5 years

Keywords: liver transplantation stereotactic body radiation therapy downstaging
scandinavian cohort study for optimal use of portal vein embolization

Conditions: Hepatic Neoplasm

Summary: several aspects on the use of portal vein embolization (pve) are poorly studied and todays recommendations are based on low-grade evidence. in this scandinavian multicenter cohort study we will study some of the controversial aspects on the use of pve to try to provide clearer answers on its optimal use. six tertiary university hospital hepatobiliary units in sweden, norway and denmark participate and contribute with all pve procedures performed at their units during the study period. we will then study several aspects pve technique in relation to induced hypertrophy and surgical outcome.


Eligibility criteria:
inclusion criteria: * right-sided pve exclusion criteria: * left-sided pve
sildenafil for early pulmonary vascular disease in scleroderma

Conditions: Scleroderma; Mildly Elevated Pulmonary Pressures

Summary: this is a phase ii randomized, double-blind, placebo-controlled trial of sildenafil in men and women with scleroderma with mildly elevated pulmonary pressures (ssc-mep) to determine whether sildenafil may be an effective treatment for ssc-mep.

data shows that sildenafil (sil) is an effective therapy in ssc-pah. sil has been safely used in many patients with various vascular and cardiovascular diseases over the past three decades. randomized controlled trial data for sil shows improvement in 6mwd, hemodynamics, and even evidence of cardiac remodeling in pah and ssc-pah patients. based upon these data, sil may be an effective therapy in ssc-mep. this study will help determine whether sildenafil could be a good treatment for patients with scleroderma that have mildly elevated pulmonary pressures.

Eligibility criteria:
inclusion criteria: * previous documentation of mean pulmonary artery pressure between 21 and 24 mm hg with a pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) ≤ 15 mm hg within six months before study entry. * diagnosis of ssc according to 2013 american college of rheumatology/ european league against rheumatism (acr/eular) classification criteria. * pulmonary function tests with forced expiratory volume in one second/forced vital capacity (fev1/fvc) \>50% and either a) total lung capacity (tlc) or forced vital capacity (fvc) \> 70% predicted or b) tlc or fvc between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest on studies obtained within 6 months of enrollment. * ventilation perfusion scan or computed tomography with intravenous contrast (ct angiogram) without evidence of chronic thromboembolism at anytime before study entry. * ability to perform six minute walk testing without significant limitations in musculoskeletal function or coordination. * informed consent. exclusion criteria: * world health organization (who) class iv functional status. * systolic blood pressure less than 90 mmhg at screening visit prior to enrollment. * clinically significant untreated sleep apnea. * left-sided valvular disease (more than moderate mitral valve stenosis or insufficiency or aortic stenosis or insufficiency), pulmonary artery or valve stenosis, or ejection fraction \< 45% on most recent echocardiography (within 1 year). * use of pulmonary arterial hypertension (pah) therapy (prostacyclin analogues, endothelin-1 receptor antagonists,phosphodiesterase-5 inhibitors, riociguat, selexipag) within the past 3 months. * hospitalized or acutely ill. * renal failure (creatinine above 2.0) at screening visit. * enrollment in a clinical trial or concurrent use of another investigational drug (non fda approved) or device therapy within 30 days of screening visit. * age \< 18. * currently pregnant. * current use of nitrates.

Keywords: ssc-mep
the initial management in patients with differentiated thyroid cancer in the real world in china

Conditions: Differentiated Thyroid Cancer

Summary: * to find out the gap between real-world clinical practice and guideline recommendations in initial management of dtc patients * to observe the characteristics of patients who achieved and did not achieve tsh target value after five year follow-up * to assess response to initial therapy in patients who undergo total or neartotal thyroidectomy and rai remnant ablation after five year follow-up (according to an modified dynamic risk stratification system) * to observe the recurrence status after five year follow-up

the dtcc 2nd will follow dtcc 1st and observe the long-term efficacy of initial management including surgery treatment, 131i therapy and tsh suppression therapy. it will involve nine hospitals which have participated in the first stage, and continually to observe the dtc patients who were recruited. the patients with more than 5 years long-term follow-up from the date of signing the informed consent form (icf) in dtcc 1st to signing icf in dtcc 2nd will be collected data retrospectively. for those follow-up less than 5 years, in addition to the retrospective data collection, one prospective visit will be conducted. primary endpoint(s) 1.five-year accumulated recurrence rate secondary endpoint(s) 1. disease-free survival (dfs) 2. overall survival (os) 3. response to therapy 4. re-operation rate 5. time weighted tsh level (tw-tsh) 6. adverse events related to l-t4 therapy (adrs) 7. median follow-up years

Eligibility criteria:
inclusion criteria: - patients who had been recruited into dtcc 1st study will be enrolled. exclusion criteria: * other malignant tumors; * severe organ damage such as heart failure of new york heart association classes iii-iv, liver failure, respiratory failure, renal failure, etc.; * medical or psychological condition that would not permit the patient to complete the study or sign the informed consent; ④ legal incapacity or limited legal capacity; ⑤ unwilling to be followed up

Keywords: differentiated thyroid cancer
point-of-care echocardiography to assess impact of dynamic cardiac function, renal and cardiac biomarkers in cirrhosis with hepatorenal syndrome-acute kidney injury

Conditions: Hepatorenal Syndrome; Cirrhosis, Liver; Acute-On-Chronic Liver Failure; AKI; Refractory Ascites

Summary: point-of-care echocardiography (poc-echo) is used to determine left ventricular systolic and diastolic dysfunction (lvdd), inferior vena cava (ivc) dynamics and volume status in cirrhosis and acute-on-chronic liver failure aclf accurately. we will assess ivc dynamics, lv systolic function \[lv ejection fraction (ef) \& cardiac output (co)\], and diastolic dysfunction (e/e', e' and e/a ratio) and urinary biomarkers (cystatin c and ngal) in patients with cirrhosis and aclf with hepatorenal syndrome-acute kidney injury (hrs-aki).


Eligibility criteria:
inclusion criteria: * cirrhosis of any etiology * patient with acute kidney injury meeting hrs-aki criteria exclusion criteria: * hepatocellular carcinoma * patients with active variceal bleeding * hiv or severe immunocompromised state * chronic kidney disease (ckd) on renal replacement therapy (rrt), * previous transjugular intra hepatic portosystemic shunt (tips) * porto-pulmonary hypertension, * coronary artery disease * congenital or valvular heart disease * prosthetic cardiac valves
tcf7l2 gene polymorphism and ages in diabetic nephropathy

Conditions: Diabetic Nephropathies

Summary: 1. to study genotypic distribution of the tcf7l2 gene polymorphism in diabetic nephropathy. 2. to assess level of ages and insulin in patients with diabetic nephropathy. 3. to study correlation between polymorphism of the tcf7l2 gene, ages, insulin and clinical characteristics in patients with diabetic nephropathy

diabetic nephropathy is one of microvascular complications of diabetes mellitus. dn is a multifactorial disorder that occurs in one third of patients with long standing dm. dn is one of the most serious complications that being a major contributing factor to end-stage renal disease and death in diabetic patients. the earliest clinical indication of dn is the appearance of microalbuminuria. detection of diabetic nephropathy as early as possible, is the best chance of delaying progression to esrd. thus, screening for microalbuminuria is recommended annually immediately after a diagnosis of diabetes. transcription factor 7-like 2 is a highly variable transcription factor, which is a key component of the wnt-signaling pathway and plays a role in the regulation of insulin secretion by pancreatic beta cells and the maintenance of glucose homeostasis. tcf7l2 rs7903146 polymorphism is more associated with t2dm which mediated by decreased insulin secretion associated with defects in insulin processing, reduced effects of glucagon-like peptide-1, increased hepatic glucose production and insulin resistance. the mutant tt genotype and the t allele frequency was associated with diabetic patients who developed nephropathy. advanced glycation end products are generated by the non-enzymatic reaction of amino groups in dna and proteins with reducing sugars. ages accumulate in glomerular basement membrane. the ages-rage interaction is a causative factor for dn through activating a series of intracellular signal-cascade pathways which induce the generation of further signalling factors, such as vascular endothelial growth factor, transforming growth factor b, nuclear factor-κβ. those signalling factors cause mesangial expansion and glomerulosclerosis.

Eligibility criteria:
inclusion criteria: * diabetic nephropathy * clinical diagnosis of prediabetes * type 2 diabetic patients exclusion criteria: * cardiovascular disease * diabetic neuropathy * diabetic retinopathy
vaccine therapy in treating patients with stage iii or stage iv ovarian epithelial cancer

Conditions: Ovarian Cancer

Summary: rationale: vaccines made from tumor tissue may make the body build an immune response and kill tumor cells. purpose: phase ii trial to study the effectiveness of vaccine therapy in treating patients who have stage iii or stage iv ovarian epithelial cancer.

objectives: i. determine whether patients with surgically debulked ovarian epithelial cancer develop delayed-type hypersensitivity to dinitrophenyl-modified autologous tumor vaccine. ii. assess the toxic effects of this regimen in these patients. iii. determine the feasibility of conducting a group wide vaccine study. outline: patients undergo a standard debulking procedure with the tumor tissue being sent to thomas jefferson university. patients then receive six courses of combination chemotherapy consisting of either paclitaxel and cisplatin or paclitaxel and carboplatin. vaccine therapy must commence within 4-12 weeks of completion of chemotherapy. patients are tested for delayed-type hypersensitivity (dth) on day -7. cyclophosphamide iv is administered on day 0. dinitrophenyl (dnp)-modified autologous ovarian epithelial cell vaccine and bcg adjuvant are injected once a week beginning on day 3 and continuing for 6 weeks. dth testing is repeated at week 8. booster vaccine injections are administered at 6 and 12 months if patient is disease free. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: approximately 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: surgically debulked stage iii or iv ovarian epithelial cancer must be able to obtain adequate number of viable cells from excised tumor mass must have received 6 courses of combination chemotherapy comprised of either paclitaxel and cisplatin or paclitaxel and carboplatin must be clinically tumor free following completion of chemotherapy (i.e., no metastasis by physical examination and ct of the abdomen and pelvis and serum ca-125 less than 35 iu/l) not on a phase iii gog protocol patient characteristics: age: 18 and over performance status: gog 0 or 1 hematopoietic: hematocrit at least 25% wbc at least 3,000/mm3 hepatic: not specified renal: not specified other: not pregnant or nursing no active infections hiv negative hepatitis b surface antigen negative hepatitis c antibody negative no active autoimmune disease no prior invasive malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics 4-12 weeks since prior chemotherapy endocrine therapy: no concurrent systemic corticosteroids radiotherapy: at least 6 months since prior major field radiotherapy surgery: see disease characteristics

Keywords: stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer
fam (follower, action plan, and remote monitoring) intervention to reduce severe hyperglycemia in adults with type 1 diabetes mellitus at risk for diabetic ketoacidosis

Conditions: Type 1 Diabetes

Summary: diabetic ketoacidosis (dka) results in significant morbidity and healthcare utilization and is the main contributor to loss of life expectancy in people with diabetes mellitus type 1 (t1dm) \<50 years old. this suggests the need to develop interventions to reduce dka events. innovative features of newer continuous glucose monitoring devices offer opportunities for novel strategies to reduce dka. designating a family member, friend, or caregiver as a follower was associated with reduction in hba1c, increased time in range, and improvement in quality of life metrics in people with t1dm. however, the previously published studies are limited as they were either retrospective, survey-based, or do not overlap with our proposed cohort involving adults ages 18-65 with t1dm (prior prospective studies involved either pregnant women with t1dm or adults ≥60 years of age with t1dm). this study is a randomized controlled trial pilot study to evaluate an intervention (fam) using a follower, action plan, and remote monitoring of glucose data to reduce severe hyperglycemia, a modifiable risk factor for dka, in adults with t1dm at high risk for dka. the intervention uses real-time glucose data sharing with a follower (family member, friend, or caregiver) and personalized diabetes education provided to the dyad (person with t1dm and their chosen follower). the overall hypothesis is that the fam intervention will improve glycemia with the primary outcome studied in this preliminary pilot study being percentage of time spent with glucose ≥250 mg/dl.


Eligibility criteria:
inclusion criteria: * people with t1dm for ≥1 year ages 18 - 65 * hba1c ≥7.5.0% - 14.0% * if the person with t1dm uses a cgm, the cgm must have the capability of real-time data sharing including glycemic alerts with a follower (including but not limited to dexcom g6 or g7 or freestyle libre 2 or 3, or medtronic guardian sensor 3) * follower (family member or friend ages 18 years and older) willing to participate in the study and "follow" glucose data and who was no self-reported cognitive impairment * ability of the dyad (participant and follower) to communicate and provide consent in english * cgm users: ≥50% personal cgm use and ≥50% dexcom g6 pro cgm use during the pre-intervention period (days -14 to -1) * non cgm users: ≥50% dexcom g6 pro cgm use and average ≥2 bgm readings/day during the pre-intervention period (days -14 to -1) exclusion criteria: * prisoner * active treatment with a sodium-glucose cotransporter-2 inhibitor or planning to start a sodium-glucose cotransporter-2 inhibitor in the next 6 months * active malignancy with the exception of non-melanoma skin cancer * hospice * skin conditions that inhibit wearing a cgm sensor and known severe allergy to adhesives
an exploratory investigation of the effects of single use vs. reuse catheters in intermittent catheterization

Conditions: Urinary Incontinence

Summary: the overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.

throughout the investigation, the impact of switch from single use to multiple reuse catheters will be observed and compared with respect to health-related quality of life (hr-qol), satisfaction, perception, and preference in female and male catheter-users, who use clean intermittent catheterization (cic) for bladder management. furthermore, the investigation intends to identify microbial contamination of reused catheters and compare proportions to a control single use catheter.

Eligibility criteria:
inclusion criteria: 1. ≥18 years of age and has full legal capacity 2. signed informed consent form 3. use clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusion 4. ability (assessed by the investigator) and willingness to participate in a 4-week study period with at least three catheterizations a day using the investigational test product 5. self-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusion exclusion criteria: 1. participation in any other clinical intervention study during this investigation 2. previous participation in this investigation 3. any known allergies towards ingredients in the investigational device 4. symptoms of uti at time of inclusion, as judged by the investigator 5. antibiotic treatment within 2 weeks prior to the baseline visit (v1) 6. pregnancy 7. breastfeeding