Kornimate/medical-research-clean huggingface dataset:
special drug use surveillance of leuplin pro for injection kit 22.5 mg for "prostate cancer"

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.

the drug being tested in this study is called leuprorelin acetate (leuplin pro for injection kit 22.5 mg). leuprorelin acetate is being tested to treat people who have prostate cancer. this study will look at the safety in patients with prostate cancer receiving the drug in the routine clinical setting. the study will enroll approximately 300 patients. • leuprorelin acetate this multi-center trial will be conducted in japan.

Eligibility criteria:
inclusion criteria: * participants with prostate cancer will be included. exclusion criteria: * participants with previous history of hypersensitivity to any of the ingredients of the drug or synthetic lh-rh or lh-rh derivatives
hysteroscopic suture fixation of mirena in the treatment of adenomyosis

Conditions: Adenomyosis; Hysteroscopy

Summary: the purpose of this study was to evaluate the efficacy and safety of hysteroscopic mirena fixation in patients with adenomyosis with enlarged uterus, compared with simple mirena placement under hysteroscopy. whether the curative effect is not inferior to and reduces the incidence of mirena expulsion.

this study was a multicenter, randomized (1:1 allocation to each group), double-blind, parallel controlled trial.

Eligibility criteria:
inclusion criteria: * pain due to adenomyosis (lower abdominal pain and low back pain) visual analogue scale (vas) ≥40mm or menstrual volume score (pbac) ≥100; * adenomyosis was confirmed by ultrasound or magnetic resonance imaging (mri); * the uterine volume measured by transvaginal gynecological three-dimensional ultrasound was more than 150cm3 and less than 280cm3 (the volume was about 280cm3 at 10 weeks of pregnancy); ④ a strong desire to preserve the uterus; ⑤ no fertility requirements within nearly one year; * premenopausal women aged ≥18 years old; ⑦ willing and able to abide by the study protocol, and have the ability to clearly judge the amount of menstruation and the degree of pain. exclusion criteria: * presence of contraindications to mirena (known or suspected pregnancy, current pelvic inflammatory disease or recurrent pelvic inflammatory disease, lower genital tract infection, postpartum endometritis, infectious abortion within the past 3 months, cervicitis, cervical dysplasia, uterine or cervical malignant lesions, progestin-dependent tumors, abnormal uterine bleeding of unknown cause, congenital or acquired uterine abnormalities, these include fibroids that deform the cervix, conditions that increase susceptibility to infections, acute liver diseases or tumours, allergy to active ingredients or excipient); * malignant tumors (including reproductive system and other systems); * acute stage of heart, liver and kidney failure or other patients who cannot tolerate operation; * the history of mirena displacement or expulsion; * ultrasound showed the presence of ovarian chocolate cyst; ⑥ the presence of deep endometrial nodules by gynecological examination; * the presence of intramural or subserous myoma ≥3cm or any size of uterine submucosal myoma (type 0, 1, 2); ⑧ patients who are unwilling to participate in the study or who were considered by the investigators to be unsuitable for the study.

Keywords: suture fixation expulsion mirena adenomyosis
immune checkpoint inhibitor associated cardiovascular adverse events in patients with cancer

Conditions: Cardiovascular Diseases; Arterial Thrombosis; Myocardial Infarction; Stroke; Coronary Artery Disease; Atherosclerosis; Cancer

Summary: immune checkpoint inhibitors (ici) have revolutionized cancer treatment and are now approved for various types of cancer. the most common side effects of ici are immune-related adverse events which can affect any organ or system in the body. recently, concerns have also risen about cardiovascular effects of ici. retrospective studies showed an 4-5 times increased risk of developing an arterial thromboembolic event. the mechanisms driving the ici-associated risks of arterial thromboembolic events such as myocardial infarction and stroke, are unclear. since the risk of a thromboembolism appears to be increased already during the first months after initiation of ici, immune-related hypercoagulability or (autoimmune) antiphospholipid antibodies may play a role, but data to support this are lacking. the longer-term risk of arterial thromboembolism may be predominantly driven by (accelerated) atherosclerosis, a chronic low-grade inflammatory disease of the larger arteries. therefore, this study evaluates the effect of ici on progression of coronary non-calcifid plaque volume by using computed tomography angiography (ccta).


Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of the following tumor types, any stage: esophageal, gastric or junction cancer, colorectal cancer, non-small cell lung carcinoma, melanoma, renal cell carcinoma * prior to start of new therapy (i.e. immune checkpoint inhibitor, chemotherapy or follow-up in case of esophageal cancer) * age ≥ 50 years exclusion criteria: * ici therapy in previous 12 months * suspected or confirmed viral, fungal, or bacterial infectious disease * use of immunosuppressive therapy prior to ici start * estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m2 * known allergy to iodinated contrast agents * atrial fibrillation

Keywords: immune checkpoint inhibitors cardiovascular disease atherosclerosis
a new prenatal blood test for down syndrome

Conditions: Down Syndrome; Trisomy 21

Summary: the study will examine the sensitivity and specificity of a circulating cell-free nucleic acid test (dna/rna) to identify down syndrome between about 10 weeks and 21 weeks 6 days gestation. in addition, the new test may be used to identify trisomy 13 and 18 as part of a more complete laboratory developed test. we hypothesize that the new circulating cell-free fetal na-based test will accurately and precisely measure specific fetal markers in maternal circulation and that measurement will lead to the ability to noninvasively identify with high sensitivity and specificity, fetal chromosome abnormalities, such as down syndrome.

the rna study is an observational trial whose primary aim is to document the performance (sensitivity and specificity) of one or more laboratory developed test (ldt) using circulating cell-free fetal nucleic acids from maternal plasma to identify down syndrome. multiple test modalities are being pursued, including massively parallel sequencing and those utilizing differential methylation. the population being studied is women already having a diagnostic test (e.g., amniocentesis, cvs) between 10 weeks and 21 weeks 6 days gestation, and whose pregnancy is at high risk for having down syndrome. the women provide informed consent. the karyotype will provide the gold standard against which the ldt test is judged. samples and karyotypes will be collected from up to 25 prenatal diagnostic centers around the world and tested in several laboratories in the united states. the secondary aim is to develop a nucleic acid sample bank to allow documentation of subsequent improvements or new methodologies to identify fetal aneuploidy using circulating cell-free fetal nucleic acids.

Eligibility criteria:
inclusion criteria: * pregnant women between about 10 weeks and 21 weeks 6 days gestation who are undergoing a diagnostic procedure (i.e., chorionic villus sampling or amniocentesis) for karyotype analysis who have, on average, a high prevalence of down syndrome (about 1:30 to 1:50). * three main sources are pregnancies screen positive for: 1. the combined test at 10 to 13 weeks (nt, papp-a and hcg) 2. the second trimester quadruple test at 15 to 18 weeks gestation 3. integrated screening (papp-a and the quadruple test, with or without nt). * variations of the integrated test such as sequential testing will also be acceptable. * other, less common high risk groups would be women having diagnostic testing because of maternal age of 38 years or older at delivery, pregnancies with an abnormal ultrasound highly suggestive of a chromosome abnormality (e.g., major heart defect, clenched fist), and women with an inherited form of down syndrome (robertsonian translocation). exclusion criteria: * nonpregnant women and women at relatively low risk for a down syndrome baby.

Keywords: down syndrome trisomy 21 prenatal testing pregnant women
a comparison of measurements of ketone body flux versus ketone body concentration as a pharmacodynamic marker of hepatic fatty acid oxidation (0000-110)

Conditions: Diabetes

Summary: this study will compare two approaches to the measurement of fatty acid oxidation (ketone body flux and ketone body concentration) and determine which method demonstrates superior sensitivity and variability in the detection of moderate increases in ketogenesis rates.


Eligibility criteria:
inclusion criteria: * subject has a body mass index of 18-25 kg/m2 or 29-40 kg/m2 * subject has been a nonsmoker or has not used nicotine for the past 6 months exclusion criteria: * subject has a history of diabetes mellitus * subject has a history of stroke, chronic seizures, or other neurological disorder * subject has a history of cancer, except certain skin cancers * subject consumes more than 3 alcoholic beverages per day * subject consumes more than 6 servings of caffeinated beverages per day * subject has multiple and/or severe allergies to food or drugs * subject has allergy or sensitivity to eggs or soy * subject regularly uses illicit drugs or has a history of drug or alcohol abuse
a study of participants undergoing radial head replacement using the depuy synthes radial head replacement system for partial replacement of the elbow joint

Conditions: Radial Head Fractures

Summary: the purpose of this study is to establish survivorship defined by the cumulative incidence of revision over the first 6 months post-implantation.


Eligibility criteria:
inclusion criteria: * male or female - skeletally mature adult (aged 22 or older) * participant, who in the opinion of the investigator, is able to understand the purpose of the study and is willing to return for all the required post-operative standard of care follow-up visits and have their data collected * participant who is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the sponsor any one of below: * primary replacement after fracture of the radial head * participant needing a partial radial head replacement for degenerative or post-traumatic conditions presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: i) joint destruction and/or subluxation visible on x-ray and/or ii. resistance to conservative treatment * symptomatic sequelae after radial head resection * revision following failed radial head arthroplasty exclusion criteria: * dislocations of radius on ulna that would not allow a radio-humeral articulation * rheumatoid arthritis * infection, sepsis, and osteomyelitis * uncooperative participant or participant with neurologic disorders who is incapable of following directions, osteoporosis, metabolic disorders which may impair bone formation, osteomalacia, distant foci of infections which may spread to the implant site, rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * participants with limited life expectancy due to significant medical co-morbidity * presence of major vascular or major nerve injury (radial, ulnar, medial, musculocutaneous) * women who are pregnant or lactating * unable to comply with study requirements example, with maintaining follow-up * individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims * individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months * demented or unable to provide informed consent * individuals, in the opinion of the investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete participant reported questionnaires or be compliant with follow-up requirements

Keywords: radial head replacement radial head prosthesis depuy synthes, partial elbow replacement device survivorship
blue-blocking iols in combined surgery

Conditions: Epiretinal Membranes; Macular Holes; Cataract

Summary: although commonly used in cataract surgery, the use of the blue light-filter iols in vitrectomy combined with cataract surgery has not been reported yet. a prospective controlled clinical trial was designed to evaluate the effect of the blue light-filter iol on the surgeon's ability to perform specific vitreoretinal procedures and on the patients' outcome.

sixty patients were randomly assigned to receive a uv-filter iol (transparent iol group) or a blue light-filter iol (yellow iol group) combined with a vitreoretinal procedure. outcome measures were intraoperative conditions for the surgeon, complication rates, the functional outcome and vitreoretinal diagnoses.

Eligibility criteria:
inclusion criteria: * diagnosis vitreoretinal pathology (diabetic vitreous hemorrhage, macular hole, epiretinal membrane or persisting macula edema) * coexisting significant cataract * the need for combined surgery ( pars plana vitrectomy, phacoemulsification and iol implantation) * age over 50 years. exclusion criteria: * pseudophakia on the non-study eye * the need for silicone oil tamponade * optic atrophy.

Keywords: combined surgery, cataract surgery, vitrectomy, blue light-filter iols
misago® rx self-expanding peripheral stent for common and/or external iliac artery

Conditions: Iliac Artery Stenosis

Summary: this is a multi-center, single arm, non-randomized, prospective clinical study using the misago® rx self-expanding peripheral stent for treatment of de novo, restenotic, and/or occlusive lesion(s) of the common and/or external iliac artery.


Eligibility criteria:
inclusion criteria: 1. is ≥ 18 years old and of legal consent. 2. is willing to comply with all follow-up evaluations at the specified times. 3. subject or subject's legal representative has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. 4. has a rutherford clinical category score of 2, 3 or 4. 5. radiographic evidence of ≥ 50% stenosis or restenosis (from pta or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s) in the common iliac artery and/or external iliac artery. exclusion criteria: 1. has had previous stent or stent-graft implantation in the target lesion(s). 2. has a contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug used during the study according to the protocol. 3. has known hypersensitivity to contrast material that cannot be adequately pretreated. 4. has known hypersensitivity to nickel-titanium (nitinol).
clinical evaluation for sarcoma originated from bone

Conditions: Sensitivity; Specificity; Histological Response; Survival

Summary: response evaluation criteria in solid tumors (recist) are insensitive in evaluating primary sarcoma originated from bone treated with chemotherapy or targeted therapy, which did not have the definition of measurement methods either. this study evaluates whether clinical imaging findings of sarcoma after preoperative chemotherapy correlate with tumor responses by pathological evaluation by huvos classifications and develops reliable, quantitative, clinical response criteria.

a total of 1570 lesions were evaluated by clinical imaging including x-ray, computed tomography, magnetic resonance imaging and bone scan or pet/ct preoperatively treated with chemotherapy. all patients had surgery in our center and get pathological evaluation by tumor necrosis rate. statistical diversity analysis was performed by different pathological groups and receiver operating characteristic curves，roc were done to find the dividing clinical parameters (cut-off values) to distinguish different pathological groups.the cut-off values of change rate of maximum diameters of tumor located in extremities were 86%, 50.7% and 0.02% for huvos ⅳ,ⅲ,ⅱandⅰgroups. the differentiation was not obvious using bone scan to distinguish different pathological responses. and the cut-off value for suvmax value for huvos ⅲ,ⅱandⅰgroups were 60.7% and 31.4%.after multidisciplinary discussion in multiple sites of china, we finally designed a evaluation system based on our data. this study is desgined to prospectively compare the sensitivity and specificity of this clinical evaluation of primary sarcoma originated from bone with other clinical evaluation system,such as recist 1.1, choi and percist.

Eligibility criteria:
inclusion criteria: * 1) histologically confirmed high-grade osteosarcoma; * 2) initially treated in musculoskeletal tumor center of peking university people's hospital, xijing hospital or the second hospital affiliated to zhejiang hospital; * 3) imaging evaluation should be available; * 4) completed neo-adjuvant chemotherapy and at least 8 cycles of adjuvant chemotherapy; * 5) expected to live longer than 3 months with eastern cooperative oncology group performance status of 0 or 1; * 6) acceptable hematologic, hepatic, and renal function. exclusion criteria: * 1) patients who could not complete neo-adjuvant chemotherapy or at least 4-month adjuvant chemotherapy; * 2) lost to follow-up.

Keywords: cesofb clinical evaluation recist histological response survival osteosarcoma ewing sarcoma
alpha1-antitrypsin deficiency registry

Conditions: Lung Diseases; Emphysema; Alpha-1 Antitrypsin Deficiency; Chronic Obstructive Pulmonary Disease

Summary: to collect data from the 37 participating clinical centers on patients with alpha1-antitrypsin deficiency, including those who received replacement therapy with an intravenous preparation of alpha1-proteinase inhibitor (a1pi) concentrate.

background: severe congenital deficiency for alpha1-antitrypsin is associated with the early onset of emphysema, usually by the third decade of life. one approach to correct this deficiency is though replacement with alpha1-antitrypsin (referred to as alpha1-proteinase (a1pi) inhibitor in its purified form). an intravenous preparation of a1pi concentrate was produced from human plasma by cutter biological, a division of miles, inc., berkeley, california. this preparation had been evaluated in a clinical study for its safety and biochemical efficacy. based on the augmentation of its levels in the lung upon intravenous administration, the a1pi preparation was licensed by the food and drug administration for replacement therapy to treat individuals with severe congenital deficiency and impaired lung function. when the registry began in 1988, clinical efficacy was plausible, but unproven and there was no data base for estimating the degree of clinical benefit, if any. slow progression of emphysema and lack of an adequate control group have made it difficult to evaluate the proteinase inhibitor through a controlled clinical trial. a patient registry was an alternative method to collect data on the effect of long-term replacement therapy with a1pi on rate of decline of lung function. the registry also included individuals who did not receive the replacement therapy in order to obtain a better knowledge of the rate of decline of lung function associated with the congenital deficiency for alpha1-antitrypsin. design narrative: the registry consisted of a clinical coordinating center, 37 participating clinical centers that contributed patient data to the registry, a steering committee, and a data analysis and policy board, both appointed by the national heart, lung, and blood institute. data collected on all patients included a clinical history, laboratory evaluations such as chest x-ray, lung function studies of vital capacity, total lung capacity, forced expiratory volume in one second (fev1) and blood studies. in addition, patients receiving replacement therapy had baseline lung function tests, spirometry every six months following initiation of replacement therapy, and measurements of serum alpha1-antitrypsin level pre- and post-infusion, once every six months. the recruitment phase ended in september 1990. support for the registry ended in june, 1998.

Eligibility criteria:
no eligibility criteria
diagnosis of hcm with ai-ecg

Conditions: Hypertrophic Cardiomyopathy

Summary: the study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram.


Eligibility criteria:
inclusion criteria: * diagnosed with hcm exclusion criteria: * patients with ventricular pacing
efficacy of gadoterate meglumine in diagnosis of vascular diseases using mra mra

Conditions: Vascular Diseases

Summary: the purpose of this study is to compare magnetic resonance angiography (mra) using gadoterate meglumine to clinically obtained mra using gadobutrol. the specific aims are to show: 1. carotid, chest, and abdomenal mra with gadoterate meglumine has a comparable image quality and diagnostic confidence to mra using gadobutrol. 2. carotid, chest, and abdomenal mra with gadoterate meglumine has a comparable accuracy for vascular lesion and stenosis detection compared to mra using gadobutrol.

in this study, we will assess the image quality and accuracy of mra studies acquired using these two contrast agents. in the cases where digital subtraction angiography (dsa) or ct angiography images are available, the results of the study using both contrast agents will be compared to the dsa or cta findings. all mra images will be assessed independently by two readers. the readers will be blinded to the clinical symptoms, contrast agent and dsa/cta results. a five-level system rating for image quality of each arterial segment will be used (1 = non-diagnostic images, 2 = poor image quality, significant blurring/artefacts, diagnosis suspected but not established, 3 = fair quality with established diagnosis, 4=good quality with definite diagnosis, minimal blurring/artefacts, 5 = sharply defined borders, excellent quality image information). vascular lesions will also be graded on a 1-5 scale. vessel segment stenoses will be graded using a five-point grading scale as follows: (1) normal; (2) mild (\<50% diameter stenosis); (3) moderate (50% to 74%), severe (75% to 99%); and (5) total occlusion. grades 1 and 2 will be considered insignificant, while grades 3 to 5 will be interpreted as significant for diagnostic accuracy testing.

Eligibility criteria:
inclusion criteria: * male or female subjects 18-89 years of age * suspected or diagnosed vascular disease * standard of care carotid, chest, or * willingness to undergo 1 research mra with up to double dose gadoterate meglumine * able to complete the mr safety questionnaire * able to comprehend and provide informed consent in english exclusion criteria: * • allergy to gadolinium-containing contrast media * chronic, severe kidney disease * egfr \< 60ml/min/1.73m2 * acute kidney injury * kidney or liver transplant within 8 weeks * contraindication to mri (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions) * pregnant or breastfeeding women * adults unable to consent * individual who are not yet adults * prisoners