Kornimate/medical-research-clean huggingface dataset:
negative-pressure wound therapy on full-thickness skin grafts of the lower leg

Conditions: Skin Tumor

Summary: this randomized controlled non-sponsored trial on 60 patients evaluates if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications for skin-cancer surgeries below the knee.

annually, 12 000 skin cancers are diagnosed in finland. this randomized controlled non-sponsored trial evaluate if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications. 60 patients over 18 years of age are included and randomly assigned to either the negative pressure-treatment group or the conventional treatment group. at the control appointment one-week postsurgery, graft take is documented as a primary outcome and any complications (necrosis, infection, hematoma/seroma) and adverse events (pain, skin reactions) as secondary outcomes. adverse events are evaluated by a phone call 3 weeks postsurgery and based on medical records 3 months postsurgery.

Eligibility criteria:
inclusion criteria: * from referrals received by the unit, or from patients undergoing follow-up who have skin cancer (basal cell carcinoma, squamous cell carcinoma or melanoma) or suspected skin cancer below the knee exclusion criteria: * toe lesion, bleeding disorder, severe dementia, critical peripheralischemia, or skin disease that is expected to impair wound healing, such as pyoderma gangrenosum
omadacycline versus linezolid for the treatment of absssi (eudract #2013-003644-23)

Conditions: Bacterial Infections; Skin Structures and Soft Tissue Infections

Summary: the purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.


Eligibility criteria:
inclusion criteria: * patients, ages 18 years or older who have signed the informed consent * has a qualifying skin and skin structure infection * female patients must not be pregnant at the time of enrollment * must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug exclusion criteria: * infections where the outcome is strongly influenced by factors other than protocol-defined treatment and procedures, that require antibacterial treatment for greater than 14 days * evidence of significant immunological disease * severe sepsis or septic shock * has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid * has received an investigational drug within past 30 days * women who are pregnant or nursing
comparison of distraction methods for pain relief of trigger finger injection

Conditions: Trigger Finger

Summary: the purpose of this study is to evaluate the best distraction mechanism during trigger finger injection in the outpatient setting. temporary discomfort from the needle prick is highly feared by patients and is often accompanied by significant acute pain and distress during routine corticosteroid injection in the orthopedic outpatient setting. this study aims to examine 4 different distraction methods and their efficacy in reducing perceived pain, which will be evaluate using the vas (visual analog pain score.) the three distraction methods will be ethyl chloride spray, adjacent pinch, ethyl chloride spray and pinch, and "screen" or looking away method.


Eligibility criteria:
inclusion criteria: * diagnosis of trigger finger exclusion criteria: * allergies to lidocaine, betamethasone, infection, pregnancy, 3 prior injection to the digit
zinc and diabetes in patients with thalassemia: a pilot study

Conditions: Thalassemia

Summary: the primary aim of this study is to measure zinc status and related proteins in patients with thalassemia who have or do not have diabetes. the secondary aim will be to explore the effect of zinc supplementation on glucose metabolism in patients with thalassemia.

patients with thalassemia major (thal) require frequent blood transfusions and are at risk for iron overload. high tissue iron increases the risk of various endocrinopathies, including diabetes, as well as cardiovascular disease, and infections due to the formation of free radicals. this systemic condition of oxidative stress elicits an antioxidant response to reduce tissue damage. zinc is an important component of that response because it can compete with iron for multiple cellular binding sites and, therefore, reduce the redox-cycling of iron and minimize iron-mediated oxidation of lipids, proteins, and dna. in thal patients with chronic hepatic iron overload, tissue zinc redistribution is likely to be persistent. this could create an unbalanced tissue zinc distribution with excessive amounts in the liver and deficient levels in other tissues altering zinc-dependent functions, such as growth, skeletal development, immunity, and glucose regulation. there is a rich body of literature focused on the 'diabetogenic effects' of altered zinc status which will be reviewed herein. our group has recently shown that supplementation with 25 mg/d of zinc can improve bone density in patients with thal. this provides evidence for a functional zinc deficiency, which may also affect other whole body zinc functions, such as insulin secretion and glucose homeostasis. our hypothesis is that hepatic iron overload induces a sub-clinical inflammatory response that alters the expression of mt and zinc-transport proteins leading to hepatic zinc sequestration, and an associated zinc-depletion in other tissues. marginal zinc depletion in turn leads to increased oxidative stress, cellular apoptosis and altered glucose homeostasis and insulin secretion. this proposal will focus on cross-sectional differences in markers of glucose homeostasis and zinc status in diabetic and non-diabetic thal patients, combined with a short- term zinc supplementation to explore the effect on glucose and insulin homeostasis.

Eligibility criteria:
inclusion criteria: * patients diagnosed with transfusion dependent thalassemia * \> 12 years of age exclusion criteria (for both cross-sectional and interventional studies) * patients who are pregnant * patients who are on growth hormone therapy exclusion criteria (for intervention study only) * patients who currently have diabetes (therefore cannot have an oral glucose tolerance test)

Keywords: thalassemia diabetes zinc iron-overload
outcome of patients treated by iv rt-pa for cerebral ischaemia according to the ratio sc-tpa/tc-tpa

Conditions: Stroke, Acute; Drug Toxicity

Summary: intravenous rt-pa is effective to reduce the risk of death or dependency after ischaemic stroke. this effect is due to an early recanalization secondary to the lysis of the clot. however this effect may be counterbalanced by the increased risk of bleeding and also the neurotoxicity of rt-pa, which has been shown in animals to depend on the ratio single chain (sc) / double chain (tc) in the rt-pa administered. the main objective of ophelie is to determine whether the functional outcome after treatment by iv rt-pa depends on the ratio sc-rtpa / tc-rtpa. secondary objectives were to identify the influence on the risk of brain haemorrhage, and the influence of the cognitive state (ophelie-cog substudy).

ophelie is a multicenter study conducted in france in 25 centers where patients treated by iv rt-pa will be included. patients are treated according to the local protocol, without any modification specifically for this study. a sample of 2 drops of the rt-pa used for the treatment is stored for analysis, to determine the sc-tpa/tc-tpa ration (immunostaining). 700 patients are needed for the study assuming that a difference of 5% will be found in the primary outcome measure (modified rankin scale 0-1 at 3 months) with alpha and beta risks respectively of 5% and 20%. the participating clinical centres recruit altogether more than 500 patients per year for thrombolysis. assuming that 70% will be eligible, the recruitment should take less than 2 years.

Eligibility criteria:
inclusion criteria: * being treated by iv tpa for acute cerebral ischaemia exclusion criteria: * absence of reliable informant * no rtpa left in the syringe after treatment

Keywords: stroke ischemic stroke thrombolysis toxicity of t-pa
post market observational retrospective study of glycar bovine pericardial patch (cip-003)

Conditions: Cardiac Defect; Cardiac Anomaly; Pericardial Defect

Summary: the overall purpose of this observational post market clinical follow up (pmcf) study is to ensure continued acceptability of the benefit risk ratio by assessment of safety and performance, in patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available glycar pericardial patch.

to comply with medical device regulation (mdr) post market clinical follow up (pmcf) requirements through proactive ongoing assessment of the safety, efficacy, and performance of the commercially available glycar pericardial patch in patients undergoing cardiovascular repair or reconstruction surgery. this real-world evidence retrospective data collection single-arm multicentre, observational, non-interventional study will enrol up to a minimum of 50 consecutive participants who meet inclusion criteria, in 2-3 centres. the study is aimed at providing real-world evidence of the glycar pericardial patch. retrospective data analysis will include collected clinical data from consecutive participants with a minimum of 2 years follow up, meaning from 30 june 2020 and going back in time. the quality of medical history being recorded is believed to be more reliable and complete in the most recent years. therefore, it was decided to start enrolling consecutive participants in a reverse chronological order.

Eligibility criteria:
inclusion criteria: * if no waiver has been granted by the ethics committee: participants (all age) or legal guardian has signed the informed consent * participant has undergone a cardiac or vascular procedure which falls within the indications for use and required the use of glycar pericardial patch exclusion criteria: - there are no study specific exclusion criteria. participants have already been treated per standard clinical practice.
an open label, prospective, multicentre, non-interventional study of apatinib for chemotherapy-refractory advanced metastatic gastric cancer

Conditions: Metastatic Gastric Cancer

Summary: this is an open label, prospective, multicentre, non-interventional study of apatinib for chemotherapy-refractory advanced metastatic gastric cancer, the investigators opted to give patients for apatinib 850 mg once daily, 28 days for a cycle. to evaluate the safety and efficacy of apatinib for advanced metastatic gastric cancer in the real world.

in the last decade, front-line chemotherapy has been considered a standard therapeutic regimen for the extension of survival time in patients with metastatic gastric cancer (mgc). new evidence suggests that salvage chemo-therapies, as second-line treatments, may have a survival advantage when compared with best supportive care. after failure of second-line chemotherapy, the results of further treatment are poor, yielding response rates of 0% to 5% with no evidence of prolonged survival. apatinib is a small-molecule vegfr-2 tyrosine kinase inhibitor, had been approved by the cfda for the treatment of advanced gastric cancer, however, this study defines a variety of inclusion/exclusion criteria, efficacy and safety are not well reflect in the real world for the treatment of advanced gastric cancer. therefore, an open label, prospective, multicentre, non-interventional study could evaluate the safety and efficacy of apatinib for advanced metastatic gastric cancer in the real world.

Eligibility criteria:
inclusion criteria: * 》18 years old * advanced metastatic gastric cancer * the doctor evaluate that patients had benefit from treatment * the patients signed the written informed consent exclusion criteria: * apatinib has been confirmed for allergy sufferers * pregnant or lactating women * patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, iii-iv level cardiac insufficiency, severe liver and kidney dysfunction) * doctors think doesn't inclusion

Keywords: apatinib metastatic gastric cancer non-interventionalstudy
intra-operative monitoring of blood loss

Conditions: Undetected Intraoperative Blood Loss

Summary: certain types of surgery are associated with occult blood loss, which is hard to detect intraoperatively by intermittent conventional, invasive hb concentration measurements using the clinical standard of hb monitoring by satellite laboratory analysis (hbsatlab). the investigators want to see whether continuous non-invasive transcutaneous hb measurement using a finger sensor (sphb), (a) reduces the total time (area under the curve, auc) a patient's hb is below a predetermined transfusion threshold (hbauc) for administration of red blood cell concentrate (rbc), and (b) prevents a decrease in total oxygen delivery (do2) possibly associated with transfusion below a critical haemoglobin concentration. furthermore, the investigators want to study if sphb monitoring changes the timing of rbc administration and reduces the need for intra- and post-operative rbc transfusion.


Eligibility criteria:
inclusion criteria: * patients at the age of 18 years or older, planned for elective surgery at-risk for undetected blood loss. * american society of anesthesiologists (asa) classification i, ii, iii, iv exclusion criteria: * patient refusal * emergency surgery
first-in-human trial of a novel endoluminal robotic system for en-bloc resection of bladder tumours

Conditions: Bladder Cancer

Summary: this is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the zenith robotic system.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years 2. body mass index \<35 kg/m2 3. bladder tumour located \<3 cm in size; clinically non-muscle invasive bladder tumour 4. clinically indicated for en-bloc resection. 5. willingness to participate as demonstrated by giving informed consent exclusion criteria: 1. presence of endoscopic or imaging signs of detrusor muscle invasion 2. contraindication to general anaesthesia / spinal anaesthesia 3. asa \> 2 patients 4. severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention 5. untreated active infection 6. un-corrected coagulopathy 7. presence of another malignancy or distant metastasis 8. emergency surgery 9. vulnerable population (e.g. mentally disabled, pregnant)
risk factors for venous thromboembolism in the community

Conditions: Cardiovascular Diseases; Thromboembolism

Summary: to evaluate the trends in the incidence of venous thromboembolism, to determine the risk factors for venous thromboembolism in patients with medical and surgical illness, and to evaluate the efficacy of the anticoagulant therapy in reducing venous thromboembolism.

background: venous thromboembolism (vte) occurs frequently among patients hospitalized for major surgery or hospitalized for a medical illness primarily due to prolonged duration of immobilization. however, many patients undergo major surgery without any occurrence of vte. standard prophylactic therapy after surgery is heparin, which reduces the risk of vte. however, heparin is associated with bleeding complications. thus, it would be desirable to identify patients at high risk for vte who might benefit the most from heparin therapy. an important focus of the study is to look at genetic factors which might play an important role in vte incidence. design narrative: the study is a population based, retrospective case and case-control investigation of the genetic and environmental determinants of venous thromboembolism in the rochester minnesota olmsted county population. the first five years of the study had three specific aims. the first specific aim was to update the 1966-1995 inception cohort to include olmsted county residents with vte during the five year period, 1996-2000. the second aim was to extend the analysis of risk factors for vte by identifying two olmsted county residents (controls) without vte matched by age and gender to each definite or probable case within the 1996-2000 cohort, and to obtain plasma and genomic dna from all cases and controls and perform a case-control study. the third specific aim was to evaluate the efficacy of anticoagulant therapy to prevent vte recurrence. the study was extended through march, 2009 to investigate trends in the incidence of venous thromboembolism, new risk factors including lipid-lowering, beta-blocker, and ace-inhibitor therapies, and introduction of low molecular weight heparin (lmwh) therapy.

Eligibility criteria:
no eligibility criteria

Keywords: venous thromboembolism (vte) deep vein thrombosis (dvt) pulmonary embolism (pe)
prophylaxis of venous thromboembolism in advanced lung cancer (prove)

Conditions: Venous Thromboembolism; Lung Neoplasm

Summary: prospective randomized open multicenter trial with blinded adjudication of endpoints to assess the efficacy of six-month low-dose lmwh (low molecular weight heparin) for the prevention of symptomatic or incidental vte in patients with stage iv lung cancer and elevated d-dimer.

adult patients aged ≥ 18 years with stage iv lung cancer and elevated d-dimer will be randomized to the experimental or control group.patients in the control group will receive usual care, patients in the experimental group will receive subcutaneous tinzaparin once daily for six months. follow-up visit will take place in outpatient clinic at day 90, day 180 and day 360. blood sampling for biomarkers will be performed at inclusion visit and day 90.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * social security affiliation * written informed consent * histologically confirmed stage iv (m1a or m1b) non-small-cell lung cancer, including recurrent non-small-cell lung cancer after a period of complete remission * d-dimer \> 1,500 µg/l * first line of systemic cancer treatment (chemotherapy, immunotherapy or targeted therapy), or new line of systemic cancer treatment for cancer progression (chemotherapy, immunotherapy or targeted therapy), introduced during the month preceding inclusion or planned within one month after inclusion * ecog (eastern cooperative oncology group) score 0-2 * life expectancy \>3 months exclusion criteria: * hypersensitivity to heparin or to any excipients * septic endocarditis * history of heparin-induced thrombocytopenia * ongoing anticoagulant treatment at therapeutic dosage * vte at inclusion * creatinin clearance \<30 ml/min * active bleeding * platelet count \< 100 g/l at inclusion * severe hepatic insufficiency * cancer treated exclusively with supportive care * aspirin at daily dosage \> 160 mg * pregnancy * patient under tutorship or curatorship

Keywords: low-molecular-weight heparin tinzaparin
phase 1 study to evaluate the safety, pharmacokinetics and pharmacodynamics of h3b-6527 in participants with advanced hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma; Hepatocellular Carcinoma; Liver Cancer; Liver Neoplasms; Hepatic Cancer; Hepatic Carcinoma

Summary: the purpose of this study is to determine the maximum tolerated dose (mtd) and recommended phase 2 dose (rp2d) of h3b-6527, and to assess the safety, tolerability and pharmacokinetics of h3b-6527.


Eligibility criteria:
inclusion criteria: 1. participants with hepatocellular carcinoma. 2. must have had at least one prior standard-of-care therapy, unless contraindicated. 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. must be willing to undergo a biopsy up to 8 weeks before administration of h3b-6527 on cycle 1 day 1 for part 2 (dose expansion). 5. adequate bone marrow and organ function. exclusion criteria: 1. uncontrolled significant active infections, except hepatitis b virus (hbv) or hepatitis c virus (hcv). 2. known human immunodeficiency virus infection. 3. presence of gastric or esophageal varices requiring active treatment. 4. previous treatment with a selective fgf19-fgfr4 targeted therapy. 5. females of childbearing potential, or males who have not had a successful vasectomy, who are unable or unwilling to follow adequate contraceptive measures. 6. hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption.

Keywords: advanced hepatocellular carcinoma h3b-6527 fibroblast growth factor receptor 4 (fgfr4) fibroblast growth factor 19 (fgf19)
evaluate the efficacy and safety of ki1106 in patients whose tg level is not adequately controlled with atorvastatin calcium monotherapy while ldl-c is properly controlled

Conditions: Dyslipidemias

Summary: to examine variation rate of non-hdl with ki1106 comparison atorvastatin monotherapy.

randomly assigned to two groups (ki1106 or atorvastatin monotherapy) after 4 weeks run-in period and prescribed ki1106 or atorvastatin for 8 weeks.

Eligibility criteria:
inclusion criteria: * screening visit * age: 20-80 * high risk for cardiovascular disease according to ncep apt iii * tg≥300mg/dl and 160mg/dl\>ldl-c≥100mg/dl for subjects who were not taking statins for 4 weeks * 500mg/dl\>tg≥200mg/dl and ldl-c\<110mg/dl for subjects who were taking statins for 4 weeks * baseline visit * 500mg/dl\>tg≥200mg/dl * ldl-c\<110mg/dl * reduction of ldl-c comparing screening visit exclusion criteria: * the patient has histories of acute artery disease within 3 months * the patient has histories of operation revasculariation or aneurysm within 6 months * the patient has histories of unexplained myalgia or diagnosed myalgia or rhabdomyolysis * the patient has histories of effect able disease to the procedure and clinical trial result