Kornimate/medical-research-clean huggingface dataset:
single-centre propensity score-matched comparison of laparoscopic versus open pancreatoduodenectomy

Conditions: Pancreatic Neoplasms

Summary: minimally invasive pancreatoduodenectomy is increasingly performed. however, technical challenges and a perceived higher risk of complications has hindered wide adoption of a minimally invasive approach. this is a retrospective comparison of a prospectively kept database. the investigators compared surgical outcomes and survival after laparoscopic (lpd) versus open pancreatoduodenectomy (opd). in order to reduce the effect of bias and confounding, baseline characteristics of both groups were matched using propensity score matching.

all pancreatoduodenectomies were retrieved from a prospectively kept database and retrospectively analysed. all procedures were performed in a single supra-regional belgian centre. the primary endpoint was the major complication rate, defined by a clavien-dindo morbidity classification grade iiia or higher \[11\]. secondary endpoints were 90-day mortality rate, length of hospital stay, operative time, blood loss, transfusion requirements and specific pancreatic complications (pancreatic fistula, haemorrhage, and delayed gastric emptying). in addition, overall survival (os) and disease-free survival (dfs) were analysed in the subgroups of cancer patients.

Eligibility criteria:
inclusion criteria: * diagnosis of lesion of pancreatic head or peri-ampullary organs exclusion criteria: * \< 18 years old

Keywords: pancreatoduodenectomy minimally-invasive surgery pancreatic cancer chronic pancreatitis
efficacy of tak-085 in participants with hypertriglyceridemia

Conditions: Hypertriglyceridemia

Summary: the purpose of this study was to determine the efficacy and safety of tak-085, once daily (qd) or twice daily (bid), compared to ethyl eicosapentaenoate (epa-e), three times daily (tid) in participants with hypertriglyceridemia undergoing lifestyle modification.

tak-085 is an oral capsule medicine licensed to takeda pharmaceutical company ltd. tak-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (epa-e) and ethyl docosahexaenoic acid (dha-e)). this is a phase 3, double-blind, randomized study to evaluate the efficacy and safety of tak-085 compared to epa-e in participants with hypertriglyceridemia who are undergoing lifestyle modification. the study period is a total of 20 weeks, comprised of an 8- week screening period and 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: 1. participants with values of fasting triglyceride level at visit 2 (week -4) and visit 3 (week -2) are 150 mg/dl or higher and less than 750 mg/dl, and the difference between these 2 values is within 30% of the higher one. 2. participants with differences between 2 values of fasting low density lipoprotein - cholesterol level measured at visit 2 (week -4) and visit 3 (week -2) are within 25% of the higher one. exclusion criteria: 1. participants who have coronary artery diseases (eg, confirmed myocardial infarction and angina pectoris) within 6 months prior to visit 1 (week -8) or participants with a history of revascularization. 2. participants who received aortic aneurysmectomy or is complicated with aortic aneurysm within 6 months prior to visit 1 (week -8). 3. participants who have a history or complication of a clinically significant hemorrhagic disease (eg, hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous haemorrhage and so forth) within 6 months prior to visit 1 (week -8). 4. participants who have been diagnosed with pancreatitis. 5. participants who have been diagnosed with lipoprotein lipase (lpl) deficiency, apolipoprotein c-ii deficiency or type iii familial hyperlipidemia. 6. participants with complication of cushing's syndrome, uremia, systemic lupus erythematosus (sle) or serum dysproteinemia.

Keywords: drug therapy
head-us scoring system: assessment of the real-world impact of ultrasound

Conditions: Moderate and Severe Haemophilia

Summary: ultrasound represents a promising technique for the assessment of joint health in persons with haemophilia (pwh) by non-imaging specialists. the haemophilia early arthropathy detection with ultrasound (head-us) programme has been developed with the aim of integrating joint ultrasound in the routine assessment of pwh through the use of a simplified scoring system. the inter-operator reliability of the technique among european haemophilia treaters has been validated and described elsewhere. further work is needed to assess the real-world impact of ultrasound on disease management and treatment decision-making.

patients are seen routinely in clinic by specialist haemophilia physiotherapists who assess the patients using the haemophilia joint health score tool (hjhs). trial participants will be seen during their routine clinic visits and will be seen by a clinician and the physiotherapist who will carry out the routine assessment along with the head-us scan. patients will be seen a maximum of 4 times throughout the year from registration of the first patient, according to their visit schedule, but will only be scanned at the first visit. results will be analysed to determine if the treatment decision-making is influenced by the results of the scan

Eligibility criteria:
inclusion criteria: * moderate (fviii/fix:c 1-5%) and severe (fviii/fix: c \<1%) patients with haemophilia a or b aged ≥ 6 years * on demand or prophylaxis treatment regimen exclusion criteria: * joints with a previous history of surgery * joints with damage as a result of causes other than haemophilia-related bleeding
efficacy and safety evaluation of monoblue dual view and monoblue ilm view vital stains

Conditions: Macular Holes; Macular Pucker; Vitreomacular Traction

Summary: in this study, the investigators aim to collect data regarding the efficiency and safety of two dyes used intraoperatively in vitrectomy to stain intraocular tissues. these products have the necessary approvals to use during such operation,these are not experimental products.

to determine efficacy and safety of monoblue dual view and monoblue ilm view (study products) vital stains during vitrectomy surgery. both study products are ce-marked and legally marketed in europe. the data collection will serve as post-marketing clinical follow-up according mdr provisions. retrospective data will also be collected for the two reference products: ilm blue® (dorc) and membrane blue dual® (dorc) to serve as control. for this purpose, patient data will be used that were collected in studies s61408 (comparative study 23g vs 27g vitrectomy), s63610 (comparative study 27g vitrectomy vs larger gauge surgery) and s64913 (eva nexus field observation study). the expected effect of the study products is to provide the retinal surgeon with adequate aid in visualizing the membranes involved in the retinal pathology to treat, thanks to their staining capabilities. the performance of the study products is related to the visualization of retinal tissues (ilm and/or erm) during the vitrectomy procedure, when these tissues cannot be distinguished accurately enough without staining. their use allows for better identification of these tissues and facilitates their removal by the surgeon. the clinical benefit of using ophthalmic dyes is to increase the patient's ability to recover anatomically and functionally by allowing more precise surgery with an effective visualization tool. along with collecting post-marketing clinical follow-up data on the subject products, the outcomes of the present study results may be used at the uzleuven hospital to decide to use monoblue ilm view and/or monoblue dual view as standard-of-care, replacing membrane blue dual and ilm blue.

Eligibility criteria:
inclusion criteria: adult patients who underwent for vitrectomy surgery where ilm and/or erm removal is required: * macular holes (ilm staining) * macular pucker (ilm and erm staining) * vitreomacular traction (ilm staining) exclusion criteria: * children aged \<18 years * vitrectomy for other indication than mentioned in 3.1 * patients that have concomitant eye disease that may influence the outcome of the surgery, e.g. terminal glaucoma * patients that did to comply to the postoperative examination visit 6-10 weeks after the surgery
prostate artery embolization (pae) for treatment of benign prostatic hyperplasia

Conditions: Prostatic Hyperplasia; Benign Prostatic Hyperplasia (BPH); Prostatism; Lower Urinary Tract Symptoms (LUTS); Prostatic Hypertrophy; Hyperplasia; Male Urogenital Diseases; Genital Diseases, Male

Summary: the purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (pae) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (luts) due to benign prostatic hyperplasia (bph).

this pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. fifty adult male subjects will be enrolled and treated in this study. patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the interventional radiology department at the university of virginia. after performing an angiogram to identify the prostatic arteries, tiny particles known as embozene microspheres will be injected into the prostatic artery. injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. by shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to bph. subjects will be followed for 2 years as part of their participation in this study.

Eligibility criteria:
inclusion criteria: * patients between ages 45-80 years * diagnosis of lower urinary tract symptoms from benign prostatic hypertrophy for a minimum of 6 months * ipss score at initial evaluation should be greater than 7, and uroflowmetry (qmax) of \<12ml/s (milliliters per second) . * all prostate volumes will be at least 40gm and no more than 400gm based on dre, trus, or cross sectional imaging exclusion criteria: * patients with urinary tract infections (\> 2/year), prostatitis, or interstitial cystitis * cases of biopsy proven prostate cancer or urethral cancer. * patients on long-term narcotic analgesia, androgen therapy, or gnrh (gonadotropin-releasing hormone) analogue therapy within 2 months of study. * patients who are classified as new york heart association class iii (moderate), or higher. * patients with history of prior pelvic irradiation. * hypersensitivity reactions to contrast material not manageable with prophylaxis. * patients with serum creatinine values \>1.7mg/dl or glomerular filtration rates less than 50.

Keywords: prostate artery embolization (pae) benign prostatic hyperplasia (bph) lower urinary tract symptoms (luts) bph pae luts prostatic artery embolization
diagnostic yeld of ultrathin bronchoscopy in peripheral pulmonary lesions

Conditions: Lung Cancer; Lung; Node; Lung Diseases; Lung TB; Lung Adenocarcinoma; Lung Transplant Rejection

Summary: the use of an ultrathin bronchoscope (ub) has recently been introduced in the diagnosis of peripheral lung lesions. the use of the ub can be supported by navigation systems such as fluoroscopy, ultrasound guidance, electromagnetic navigation, or other technologies, which have complementary potential. further navigation techniques are still under study. the use of ultrathin instrumentation has already been shown to significantly reduce procedural times compared to traditional instrumentation. the purpose of the study is to prospectively evaluate the institutional experience of different third-level hospital centers with the use of a ub (mp190f; olympus medical systems, tokyo, japan) for sampling peripheral lung lesions by means of transbronchial needle aspiration (tbna) or transbronchial biopsy (tbb), performed after fluoroscopic navigation and simultaneous radial probe-endobronchial ultrasound (rp-ebus) assessment. design: multicentric, observational study.


Eligibility criteria:
inclusion criteria: * candidate for a diagnostic procedure for a new peripheral lung lesion or re-biopsy; * tissue sampling of the peripheral lesion performed only with ub; * the patient's ability to understand the individual characteristics and consequences of the clinical study; * males and females of any ethnicity; * subjects who have given their informed consent to use their clinical data for research purposes. exclusion criteria: * inability to give informed consent or understand its contents; * unavailability of tomographic imaging; * failure to use rp-ebus or fluoroscopic guidance during the procedure; * failure to use r.o.s.e. by the pulmonologist or pathologist during the procedure; * tissue sampling on the same peripheral lesion using an instrument of a different caliber in replacement or in association; * any other significant illness or disorder that, in the investigator's opinion, may put the patient at risk due to study participation.

Keywords: nsclc lung nodule
quality of life and health perception after surgery of varicose veins

Conditions: Quality of Life; Varicose Veins

Summary: the aim of this study is to analyze changes in health perception and quality of life in patients after surgery for varicose veins using clinical score vcss and qol scores sf12 as general health questionary and veines qol/sym as disease specific questionary.


Eligibility criteria:
inclusion criteria: * patients with reflux in saphenous vein exclusion criteria: * no reflux in saphenous vein
a study to investigate safety with risankizumab in psoriatic arthritis subjects who have completed week 24 visit of study m16-002 (nct02719171)

Conditions: Psoriatic Arthritis

Summary: this is an open-label extension (ole) study to assess the efficacy, safety and tolerability of risankizumab in participants with psoriatic arthritis (psa).

participants who had completed all doses of study drug and the week 24 visit of m16-002 (nct02719171; the lead-in study) were eligible to enroll in m16-244 (this study). participants were allowed to either finish the week 24 visit of the lead-in study and take the first dose of study drug for this study on the same day, or delay the start of this study up to 8 weeks if needed.

Eligibility criteria:
inclusion criteria: * participants who have completed all doses of study drug and week 24 visit of the lead-in study. * women of childbearing potential who are sexually active, must agree to use at least one accepted method of contraception throughout the study, including 20 weeks after last dose of study drug is given. * women of childbearing potential must have a negative urine pregnancy test at baseline (week 0/v1). * participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (iec)/institutional review board (irb), prior to the initiation of any study specific procedures. * participant is judged to be in good health as determined by the investigator. exclusion criteria: * female participant who is pregnant, breastfeeding or is considering becoming pregnant during study participation, including 20 weeks after the last dose of study drug is given. * premature discontinuation of the study drug in the lead-in study for any reason. * use of a biologic treatment other than risankizumab since first dose of study drug in the lead-in study. * time elapsed is \> 8 weeks since the week 24 visit in the lead-in study. * active systemic infections during the last 2 weeks (exception: common cold) prior to the first dose, as assessed by the investigator.

Keywords: risankizumab abbv-066 bi655066
the efficacy and safety of disposable balloon uterine stent in patients with asherman syndrome

Conditions: Intrauterine Adhesion

Summary: asherman's syndrome is characterized by the presence of intrauterine adhesions (iua) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. the gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. the recurrence of intrauterine adhesions is a major challenge in clinical practice. the isolation of barriers in the uterine cavity may be a measure to reduce postoperative re adhesion, but the effect of different devices is different. therefore, this study was conducted.

the foley catheter is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 5-7th day after surgery. several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

Eligibility criteria:
inclusion criteria: * age 20-40 years; * moderate to severe intrauterine adhesion (afs score ≥5）; * complains of menstruation disorder and reproductive dysfunction * agreement to have second-look hysteroscopy * informed consent exclusion criteria: * ovarian failure * patients who did not proceed to second-look hysteroscopy within the specified time frame * contraindication of hormone

Keywords: asherman syndrome disposable balloon uterine stent hysteroscopy foley catheter
vardenafil treatment of erectile dysfunction in depressive and non-depressive men

Conditions: Erectile Dysfunction

Summary: the primary aim of this open, uncontrolled, prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of levitra in routine treatment of erectile dysfunction. the secondary aim of this study is to assess the influence of the treatment with levitra on self-esteem (depressive symptomology) in men with ed.


Eligibility criteria:
inclusion criteria: * age over 18 * erectile dysfunction untreated or ineffectively treated with other than vardenafil pde5 inhibitors exclusion criteria: * treatment with nitrates * allergy to vardenafil or other tablets ingredients * treatment with cyp3a4 inhibitors (e.g. indinavir, ritonavir, ketoconazole, itraconazole, erythromycin) * cardiovascular status excluding any sexual activity
folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy

Conditions: Mucositis; Stomatitis

Summary: fastercc: folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy. a randomized, double-blind trial from the danish renal cancer group (darenca study-4)

mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to tki, immunotherapy or mtor inhibitor treatment in mrcc patients. the present trial will assess whether 12 weeks complementary treatment with folic acid in mrcc-patients receiving tki- or mtor inhibitor treatment or immunotherapy and displaying ctcae mucositis grade ≥2 can reduce the degree of mucositis, compared to placebo. this is a randomized, double-blind, placebo-controlled phase ii trial of the effectiveness of folic acid supplement for 12 weeks on mucositis. both arms will receive best supportive care. no crossover is allowed. the investigators anticipate a 96-month accrual period. the power calculation indicates a total of 50 patients per group are required. block randomization based on received tki/ mtor inhibitor/it-treatment will be performed.

Eligibility criteria:
target population: patients with inoperable, locally advanced, or metastatic renal cell carcinoma. inclusion criteria: 1. patients displaying ctcae ≥2 mucositis during tki, mtor inhibitor or immunotherapy treatment. 2. signed written informed consent obtained prior to any study specific procedures. 3. patient must be willing and able to comply with the protocol. 4. age ≥ 18. 5. biopsy proven locally advanced or metastatic renal cell carcinoma. 6. females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating. 7. fertile women of childbearing potential (\<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization). 8. karnofsky performance status ≥ 60%. exclusion criteria: 1. known hypersensitivity to folic acid. 2. use of prednisolone more than 10 mg daily.
convalescent plasma treatment in severe 2009 h1n1 infection

Conditions: Influenza A

Summary: treatment of severe 2009 h1n1 infection with convalescent plasma will reduce mortality.

patients presented with severe 2009 h1n1 infection responded poorly to antiviral agents. meta-analysis of reports from 1918 h1n1 pandemic suggested that convalescent plasma might be an effective treatment option for patients with severe 2009 h1n1 infection.

Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years old with written informed consent given by patient or next-of-kin * laboratory confirmatory diagnosis of 2009 h1n1 infection by positive rt-pcr from respiratory specimens * required intensive care within 7 days of onset of symptoms exclusion criteria: * age 18 years old or below * known hypersensitivity to immune globulin * known iga deficiency

Keywords: influenza a convalescent plasma death
central cervical dissection for clinical node negative papillary thyroid carcinoma

Conditions: Lymph Node Metastases

Summary: this study is divided into three stages. in the first stage, the investigators try to explore the objective clinical imaging standard of cn0ptc on the basis of previous studies, formulate the "clinical imaging standard of cn0ptc", and randomly enroll 2000 patients under the premise of meeting the standard to establish the "predictive model of cn0-pn+ptc". in the second stage, 2000 patients will be enrolled to test and improve the evaluation efficiency of "cn0-pn+ptc prediction model". in the third stage, 2 000 patients without lymph node metastasis assessed by "cno-pn+ ptc prediction model" will be randomly divided into experimental group and control group. the experimental group will be treated with pcnd, while the experimental group will be treated without pcnd. the central lymph node metastasis probability, the number and size of metastatic lymph nodes in the control group will be observed after operation. the two groups will be followed up for 5, 10, 15 and 20 years to observe the rfs and os, so as to further evaluate the "cn0-pn+ptc prediction model" scientifically.


Eligibility criteria:
inclusion criteria: * phase i and ii: 1. aged 18 to 80 years old; 2. the primary treatment of patients with unilateral or bilateral ptc; 3. ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm; 4. ultrasonography of cervical vi lymph nodes: the shortest diameter \< 4 mm, no calcification, no cystic change, no local or global echo enhancement; 5. ct scan of cervical vi lymph nodes: the shortest diameter \< 4 mm, no calcification, no cystic change, no enhancement (ct value 40hu or not higher than banded muscle level), no cluster distribution; 6. patients will voluntarily enter the study after informed consent; phase iii: 1. aged from 18 to 80 years old; 2. ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm; 3. unilateral or bilateral ptc without lymph node metastasis assessed by "cno-pn+ ptc prediction model"; 4. patients will voluntarily enter the study after informed consent. exclusion criteria: * (1) patients refused to participate in the study; (2) non first operation patients; (3) lateral cervical lymph nodes or distant metastasis; (4) hashimoto's disease; (5) history of neck trauma.