Kornimate/medical-research-clean huggingface dataset:
av-node stimulation clinical download study to reduce ventricular rate during af

Conditions: Atrial Fibrillation

Summary: the aim of this multi-center research study is to evaluate the performance (primary purpose) and safety of a new algorithm aimed at controlling ventricular rate (vr) during rapidly conducted atrial fibrillation (af) by delivering av node stimulation (avns) from the atrial lead placed at a septal position, and designed with the purpose of reducing inappropriate shocks. additional purposes include the assessment of a possible application of avns aimed at allowing prolonged control of vr during af and reducing af symptoms, and evaluation of implantation data on selective placement of the atrial lead in postero-septal right atrium. about 37 patients will be followed for half a year.

the aim of this multi-center research study is to evaluate the performance (primary purpose) and safety of a new algorithm aimed at controlling vr during rapidly conducted af by delivering avns from the atrial lead placed at a septal position, and designed with the purpose of reducing inappropriate shocks. additional purposes include the assessment of a possible application of avns aimed at allowing prolonged control of vr during af and reducing af symptoms, and evaluation of implantation data on selective placement of the atrial lead in postero-septal right atrium. about 37 patients will be followed for half a year.

Eligibility criteria:
inclusion criteria: * patients with a documented history of paroxysmal or persistent af are eligible to be enrolled in the study if one of the following criteria is met: * indication for crt implant according to current guidelines (heart failure, nyha iii-iv class, symptomatic despite optimal stable medical therapy, left ventricular (lv) ejection fraction ≤35% and qrs≥120ms); or * indication for upgrading to crt-d from a single chamber device; or * indication for upgrading to crt-d from a dual chamber device with septal atrial lead or a dislodged atrial lead; or * indication for device replacement or surgical revision in patients already implanted with a crt-d device and an atrial lead in the septal position or a dislodged atrial lead; or * patients already implanted with a consultatm device and an atrial lead in the septal position, requiring electrical cardioversion. exclusion criteria: * if any of the following criteria are met, patient cannot be enrolled in the study: * permanent atrial fibrillation; * patients who are not on anti-coagulant therapy; * advanced av block (ii-iii degree av block); * patients previously submitted to valvular surgery; * patients previously submitted to av or af ablative procedures; * age \< 18 years; * patient not disposed to sign the informed consent; * participation in other studies which could potentially conflict with this study;

Keywords: atrial fibrillation inappropriate shock av-node stimulation ventricular arrhythmia
statin and paf in patients with pacemaker

Conditions: Paroxysmal Atrial Fibrillation

Summary: statin could decrease af burden

statin could decrease af burden in patients with paf.

Eligibility criteria:
inclusion criteria: * patients with pacemaker exclusion criteria: * patients with hepatic dysfunction
aprepitant in the management of biological therapies-related severe pruritus

Conditions: ITCH

Summary: itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine kinase inhibitors. investigators designed a pilot single-center phase ii study evaluating the effects of aprepitant, a neurokinin receptor inhibitor, in managing biological therapy-induced pruritus.

investigators enroll patients affected by solid tumors which present itch refractory to standard treatment ("refractory group") and patients who did not receive any treatment for pruritus ("naïve group"). the intensity of itch will be evaluated with visual analogue scale (vas) score. in the refractory group aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) will be administered after at least 1 week of standard systemic treatment. in the naïve group, aprepitant will be administered after the first onset of severe pruritus. the primary end point is to evaluate the effect of aprepitant in managing pruritus both in naive and refractory group.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of solid tumor * treatment with anti-egfr antibodies or tkis * first onset of severe pruritus during treatment (≥7 on visual analogue scale (vas) score) exclusion criteria: * oral treatment with antimycotics during 4 weeks preceding enrolment * topical treatment during the previous 2 weeks * concomitant,chronic renal or hepatic insufficiency , skin infection or dermatitis.

Keywords: itch
clinical trial to evaluate the efficacy and safety of a thoracic and abdominal endoscopic surgical system

Conditions: Pathologic Stage I Gastric Cancer AJCC v8; Colorectal Cancer; Esophageal Cancer; Hepatectomy; Radical Hysterectomy

Summary: evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by shenzhen cornerstone robotics technology co., ltd. for use in general, gynaecological and thoracic surgical procedures.

the trial was designed using a prospective, multi-centre, single-group target value approach. for subjects who intend to undergo general surgery, gynaecological surgery and thoracic surgery assisted by the thoracic and abdominal endoscopic surgical system. to use the thoracic and abdominal endoscopic surgical system developed by shenzhen cornerstone robotics technology co., ltd. to perform surgery in the above three disciplines, and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment of the above three disciplines.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 80 years; * body mass height index (bmi) 18\<bmi\<30kg/㎡; * patients identified by the investigator as suitable for general, gynaecological and thoracic surgery; * written informed consent. exclusion criteria: * need for emergency surgery (e.g. gastric cancer, colorectal cancer combined with perforation, bleeding, obstruction, etc.); * with other malignancies or a previous history of other malignancies. * preoperative imaging suggests that the tumour has distant metastases. * the patient has a history of relevant surgery or previous history of other malignancy and is judged by the investigator to be unsuitable for enrolment. * severe bleeding tendencies or coagulopathic disorders. * with long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders. * significant immunodeficiency due to underlying illness (e.g. hiv/aids) and/or medication (e.g. systemic corticosteroids). * women who are pregnant or nursing an infant. * with severe allergies and suspected or established alcohol, drug or substance addiction. * other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.

Keywords: distal gastric cancer radical surgery colorectal cancer oesophageal cancer hepatectomy radical hysterectomy
characteristics and mechanism of denosumab-treated giant cell tumor of bone

Conditions: Giant Cell Tumor of Bone

Summary: giant cell tumor of bone (gctb) is a primary, osteolytic, benign tumor of the bone. surgery is the commonly used treatment. discovery of rankl and its human monoclonal antibody, denosumab, led to use of denosumab for treatment of gct. the aim of this study was to evaluate clinical and pathological results of treatment of relapsed or refractoriness gct with denosumab and to assess adverse effect profile and recurrence rate.

giant cell tumor of bone (gctb) is an aggressive, benign bone tumor. gctb, which was first defined by cooper and travers, can produce pulmonary metastasis, albeit rarely (1-6%). gctb constitutes 5% of primary bone tumors and 20% of benign bone tumors. histologically, the tumour consists of a proliferation of mononuclear cells, accompanied by a population of non-neoplastic osteoclast-like giant cells and mononuclear osteoclast precursors. currently, it is thought that proliferating neoplastic cells produce a number of cytokines and mediators, including the receptor activator of nuclear factor κ-b-ligand (rank-rankl) system, that recruit osteoclast precursors and induce their maturation into multinucleated osteoclast. the standard management of gctb is based on surgery with several local adjuvant treatments like methacrylate cement, phenol or cryotherapy to reduce the risk of recurrence, while bisphosphonates are used in some cases to decrease bone resorption and for pain relief in inoperable tumours or metastatic disease. in the last 5 years the use of denosumab, a fully human monoclonal antibody already licensed for postmenopausal osteoporosis and prevention of skeletal related events in bone metastases from solid tumours, has been introduced in the treatment strategy of gctb. in this study we examined the clinical, radiological, histological and underlying mechanism features of a series of gctb, before and after denosumab administration, comparing baseline and resection specimens. moreover, we examined the safety of the drug and on the angiogenesis through the determination of microvascular density (mvd).

Eligibility criteria:
inclusion criteria: * giant cell tumor of bone patients confirmed by clinical, medical imaging and pathology. exclusion criteria: * (1) less than 14 patients; 2) pregnant patients; 3) a patient who receives other medications during treatment.

Keywords: giant cell tumor of bone denousmab pathologic clinical mechansim
morphology of advanced symptomatic cerebral plaques with high embolic potential

Conditions: Ischemic Stroke; Atheroscleroses, Cerebral

Summary: the study is to attain early recognition of the unstable plaques which have an imminent embolic risk in patients with intracranial atherosclerotic disease (iad).

potential candidates will undergo a cranial mri and mr angiography. patients who are found signal void in a relevant intracranial internal carotid artery or middle cerebral artery will proceed to a 30-minute tcd monitoring for mes an angiograms will be analyzed by investigators blind to subjects' clinical information. all recruited patients will receive standard medical therapy throughout the investigation period.

Eligibility criteria:
inclusion criteria: * inclusion criteria for the symptomatic group: 1. patient is 30 to 85 years of age, inclusive. 2. patients who have an acute infarct in diffusion-weighted mri compatible with artery-to-artery thrombo-embolism, a relevant intracranial atherosclerotic stenosis ≥60%, and mes detected by tcd. 3. patient who has no contra-indication for the proposed imaging tests. 4. patient understands the purpose and requirements of the study, and has provided an informed consent. * inclusion criteria for the asymptomatic group: 1. patient is 30 to 85 years of age, inclusive. 2. patient who has a high-grade (\>60%) intracranial stenosis (signal void in mr angiography) but without infarct in the corresponding vascular territory in dwi or t2-weighted sequence. 3. patient has no mes detected on tcd examination. 4. patient who has no contra-indication for the proposed imaging tests. 5. patient understands the purpose and requirements of the study, and has provided an informed consent. exclusion criteria: subject who meets one or more of the following criteria cannot be recruited in the study: 1. stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, moyamoya disease, small vessel disease, etc. 2. a tandem stenosis \>50% at proximal internal carotid artery. 3. bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia (platelets \ 1.5). 4. a medical condition that would not allow the patient to adhere to the protocol or complete the study.

Keywords: ischemic stroke atherosclerosis plaque morphology dsa/3dra
mechanisms for restoration of hypoglycemia awareness

Conditions: Type1 Diabetes Mellitus

Summary: to assess if using the hypoglycemic clamp and functional magnetic resonance imaging (fmri) scanning in hypoglycemia unaware and aware t1dm patients and healthy controls have showed distinct differences in patterns of brain responses. in particular, t1dm patients who are aware of hypoglycemia (t1dm-aware) have greater activity in sensory integration brain regions (e.g. parietal lobe and caudate nucleus) in response to hypoglycemia, whereas hypoglycemia unaware t1dm patients (t1dm-unaware) show no detectable changes in brain reward regions during hypoglycemia.

to assess the following: 1) if these differences are driven purely by recurrent hypoglycemia or by other closely linked factors (e.g. glycemic variability); 2) the molecular and metabolic mechanisms by which unawareness leads to the suppression of central nervous system (cns) activity in the context of hypoglycemia; and 3) whether hypoglycemia avoidance using continuous glucose monitor restores central nervous system (cns) activation and metabolism toward normal levels and offers a therapeutic approach to more effectively combat neurocognitive dysfunction associated with intensive treatment of t1dm patients.

Eligibility criteria:
inclusion criteria: * ages \> 18 years * healthy, non-diabetic control or t1dm * bmi \> 18.0 exclusion criteria: * creatinine \> 1.5 mg/dl * hct \< 35% for females, \< 39% for males * alt \> 2.5 x uln * untreated thyroid disease * uncontrolled hypertension * neurologic disorders * untreated depression or change in antidepressant regimen in last 3 months * use of any anxiolytic medications (benzodiazepine) or antipsychotic medications * greater than 5% change in weight in last 3 months * malignancy * current or recent steroid use in last 3 months * illicit drug use * significant complications related to diabetes (peripheral neuropathy, proliferative retinopathy) * inability to enter mri (per standard mri safety guidelines) * for women: pregnancy or breastfeeding
efficacy and safety of letrozole vs. letrozole plus zoledronic acid as endocrine therapy before surgery in postmenopausal patients with breast cancer

Conditions: Breast Neoplasms

Summary: this study will evaluate the safety/efficacy of zoledronic acid when given by intravenous infusion every 4 weeks in addition to letrozole as endocrine therapy in postmenopausal patients with hormone responsive breast cancer

open-label, multicenter, randomized phase ii trial over approx 6.5 months of neoadjuvant treatment with letrozole with or without zoledronic acid in postmenopausal patients with primary breast cancer. a total of approximately 850 patients were originally planned to be enrolled; primary study endpoint was the objective response rate (according to modified recist criteria) after 6 months of treatment. after the core study, patients willing to participate were followed-up for further 5 years.

Eligibility criteria:
inclusion criteria: * postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (er) and / or progesterone (pgr) positive * clinical stage t1c (size ≥ 1.5 cm), t2, t3, t4a, b, c, n0 or n1, m0 (tnm classification). according to the modified recist criteria, tumors of size ≥ 1.5 cm are considered measurable by mammography and can be determined as target lesions). * tumor measurable by mammography, sonography and clinical examination. * adequate bone marrow, renal and hepatic function * good health status (ecog performance status of 0, 1 or 2) exclusion criteria: * prior treatment with letrozole or bisphosphonates. prior and concomitant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers (brm's), endocrine therapy other than letrozole (including steroids), and radiotherapy. patients who have received hormone replacement therapy (hrt) will not be excluded, provided that hrt is discontinued at least 2 weeks prior to entry into the study. * patients with unstable angina, or uncontrolled cardiac disease (e.g. class iii and iv new york heart association's functional classification, see appendix 9) or uncontrolled endocrine disorders. * evidence of inflammatory breast cancer or distant metastasis. * current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures. recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants). * history of diseases with influence on bone metabolism, such as paget's disease, osteogenesis imperfecta, and primary or secondary hyperthyroidism within the 12 months prior to study entry other protocol-defined inclusion/exclusion criteria may apply

Keywords: breast cancer anti tumor potential letrozole zoledronic acid neoadjuvant treatment hormone responsive breast cancer
comparison of two basal insulins for patients with type 2 diabetes on anti-hyperglycemic medications (iope)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ilps) as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus for at least 1 year. * are greater than or equal to 18 years old. * have been receiving oral antihyperglycemic medications (oams), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following oams for the 6 weeks prior to visit 1: metformin- sulfonylureas-dipeptidyl peptidase-iv (dpp-iv) inhibitors-thiazolidinediones (tzds) * have a hemoglobin a1c (hba1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before visit 2. * body mass index (bmi) greater than or equal to 25 and less than or equal to 45 kg/meter squared. exclusion criteria: * have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks. * have taken any glucose-lowering medications not included in inclusion criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before visit 1. * have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness. * have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months. * are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.

Keywords: diabetes type 2
rheumatological manifestations in inflammatory bowel diseases

Conditions: Inflammatory Bowel Diseases

Summary: ibd-related arthropathy is one of a group of inflammatory arthritides considered as seronegative spondyloarthropathies, a group of disorders that also includes ankylosing spondylitis, psoriatic arthritis, reactive arthritis, and undifferentiated spa. ibd-related spa is mainly characterized by axial involvement but may also be associated with peripheral symptoms, such as synovitis, dactylitis, or enthesitis


Eligibility criteria:
inclusion criteria: * any patient with inflammatory bowel diseases complaining of rheumatological manifestations exclusion criteria: * chronic hepatitis (c) patients * rheumatoid factor positive patients * psoriatic patients. * systemic lupus.
pigment dispersion syndrome with and without glaucoma

Conditions: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension

Summary: to compare patients having pds without and with oh or gl by documenting and following the clinical features and course of their disease and evaluating the patient's performance on a variety of diagnostic tests.

pigment dispersion syndrome (pds) is not an uncommon ocular condition and is frequently associated with myopia. there is loss of pigment from the posterior iris, seen clinically in most cases as iris transillumination with pigment deposited on the corneal endothelium, iris surface and on the angle structures overlying schlemm's canal. in a subset of patients ocular hypertension or glaucoma may develop. ocular hypertension is defined as 3 separate measurements of the intraocular pressure greater than 22 mm/hg in the absence of visual field loss. glaucoma is defined as the presence of a characteristic field defect (bjerrum scotoma, nasal step or arcuate scotomas) with intraocular pressures greater than 22 mm/hg measured sometime during a diurnal curve testing. the etiology of this condition is not known. hypotheses include developmental abnormalities of the iris dilator muscle or mechanical rubbing of zonules against the iris, resulting in pigment dispersion in the anterior chamber and pressure elevation. pds is then viewed as a variant of primary open-angle glaucoma or may be secondary to pigment deposited in the angle structures with secondary damage to the trabecular meshwork. a hereditary component does appear to play a role in the pds syndrome and may also predispose to the development of glaucoma. the purpose of this study is to evaluate and determine the risk factors that differentiate patients with pds, pds+oh, or pds+gl by documenting the ophthalmic findings and following their clinical course. in order to do this, diagnostic tests including intraocular pressure and visual fields will be performed. this data may make it possible to determine the risk of patients having pds of developing oh, gl or other possibly associated findings such as retinal detachment or cataract. in addition, patients with "pigmentary glaucoma (pg)" will be compared to those with the known characteristics of primary open-angle glaucoma (poag) to determine whether pg is different than or a variant of poag. when possible, family members will be examined to investigate the inheritance pattern of this syndrome and its relationship to poag.

Eligibility criteria:
entrance into the study will depend upon clinical evidence of black pigment deposition on trabecular meshwork at the site of schlemm's canal and at least one of the following: kruckenberg spindle, pigment deposition on iris surface, or mid-stromal iris transillumination. no patients with other ocular disease or disorders (uveitis, trauma, pseudoexfoliation, ice syndrome, etc.)

Keywords: aqueous humor dynamics glaucoma ocular hypertension pigment dispersion syndrome primary open angle glaucoma pseudo-exfoliation of the lens capsule
comparison between pre and intraoperative ercp in treatment of common bile duct stones

Conditions: Common Bile Duct Stones.

Summary: ercp plays an important role in management of common bile duct stones. herein the investigators compare preoperative against intraoperative ercp. 210 were included but only 198 patients were randomly divided into two groups; pes/lc (100 patients) and lc/ioes (98 patients). the total hospital stay were significantly shorter in the group of lc/ioes


Eligibility criteria:
inclusion criteria: * patients with gallstones and common bile duct stones exclusion criteria: * contraindications to ercp contraindication to laparoscopy biliary pancreatitis refusal to participate

Keywords: choledocholithias common bile duct stones endoscopic retrograde cholangiopancreatography endoscopic sphincterotomy preoperative intraoperative laparoscopic common bile duct exploration