Kornimate/medical-research-clean huggingface dataset:
a randomized phase iii study comparing pof with sox/capox/folfox as a postoperative adjuvant chemotherapy for curatively resected stage iii gastric cancer

Conditions: Gastric Cancer Stage III

Summary: fnf-014 is a randomised, open-label, multicentre, parallel-group, phase 3 study in china to prove superiority of pof over s-1/docetaxel in postoperative adjuvant setting for pstage iii gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction).


Eligibility criteria:
inclusion criteria: * age 18 to 70 years. * histologically proven in gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) of stage iiia, iiib, iiic with no evidence of metastatic disease. * subjects must be able to take orally. * r0 resection with d2 lymph-node dissection with al least 15 lymph nodes were examined to ensure adequate disease classification. * previously untreated except for the initial gastric resection for the primary lesion. * ecog performance status ≦ 1. * able to start chemotherapy with 42 days after gastrectomy. * hgb ≧ 9 g/dl, wbc 4000-12000/mm3, platelets ≧ 100,000/mm3 * creatine ≦ upper normal limit (unl) * total bilirubin ≦ 1.5 x unl * ast, alt and alp ≦ 2.5 x unl * life expectancy estimated than 3 months * written informed consent exclusion criteria: * active double cancer * gastrointestinal bleeding * pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant * definite contraindications for the use of corticosteroids * any subject judged by the investigator to be unfit for any reason to participate in the study
observational safety study for kalbitor (ecallantide) in the treatment of acute attacks of hereditary angioedema

Conditions: Hereditary Angioedema (HAE)

Summary: the objective of this study is to evaluate the formation of antibodies, the occurence of allergic reactions, and the risk of hypercoagulability and hypocoagulability in patients treated with kalbitor (ecallantide).

the objective of this study is to evaluate immunogenicity and hypersensitivity upon exposure to kalbitor, in particular: 1. determine the rate of anaphylaxis and type i hypersensitivity reactions upon exposure to kalbitor. 2. determine the rate of seroconversion to anti-ecallantide antibodies upon exposure to kalbitor. 3. determine the rate of adverse events related to disordered coagulation (hypercoagulability and hypocoagulability) upon exposure to kalbitor.

Eligibility criteria:
inclusion criteria: * patients indicated per the approved product label for kalbitor * patient or guardian is able to understand and sign the informed consent form * patient is willing and able to undergo a skin test procedure at screening (baseline) exclusion criteria: * patient contraindicated per the approved product label for kalbitor * patient confirmed pregnancy or active breastfeeding * any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study

Keywords: hae
protective behavioral strategies and brief alcohol interventions

Conditions: Alcohol Consumption

Summary: excessive college student drinking represents an important public health problem for both the students themselves and those with whom they interact. the objective of this research is to better understand how to reduce such high-risk drinking by improving prevention and treatment programs, which will provide an overall public health benefit. subjects in the study will be randomized to one of two brief intervention conditions or an education-only control condition. it is hypothesized that those in the intervention conditions will report greater reductions in alcohol use and alcohol-related problems than those in the control condition.

the primary objective of this project is to examine factors that are associated with the effectiveness of intervention programs designed to reduce high-risk drinking among heavy drinking college students. previous research has found similar effect sizes for different types of multi-component, brief interventions among college students, but little research has assessed the degree to which specific components of such interventions are associated with intervention outcomes. one common component of motivational enhancing interventions among college students involves providing cognitive-behavioral self-control strategies designed to reduce one's use of alcohol, which we term "protective behavioral strategies" (pbs). however, there are two important factors that limit our understanding of the effects of pbs on client outcomes. first, the use of these strategies in motivational enhancing programs has generally not been assessed in a systematic manner, due in part to the fact that until recently a standardized measure of such strategies did not exist. second, researchers have yet to conduct studies that dismantle the specific effects associated with the pbs component on client outcomes. that is, studies have not tested interventions with and without assessment and feedback regarding a client's use of pbs. participants in this project will be "at-risk" college student drinkers who will be assigned to one of three conditions: a brief intervention that includes a focus on pbs, a brief intervention that does not include this focus, and an education-only control condition. participant will complete self-report measures of alcohol-related variables at baseline, 30-day, and 6-month follow-ups. mixed-model analyses will be used to determine the effectiveness of the intervention programs, and structural equation modeling will be used to determine if increases in pbs result in reductions in alcohol use/alcohol-related problems.

Eligibility criteria:
inclusion criteria: * at least one binge drinking episode in the preceding month exclusion criteria: * at-risk for alcohol dependence or major depressive disorder
the use of transcutaneous electrical nerve stimulation (tens) for chronic pain of predominantly peripheral neuropathic origin

Conditions: Neuropathic Pain

Summary: the aim of this study is to investigate the effectiveness of tens in addition to routine care in patients with chronic pain of predominantly neuropathic origin, compared to treatment with routine care alone." hypothesis: an eventually neuropathic pain component is needed to be identified and alleviated in chronic pain patients to improve the quality of rehabilitation. 0-hypothesis: * tens is not better than than placebo, medication or standard rehabilitation program. * a neuropathic pain component does not demand special considerations in rehabilitation of chronic pain patients.

setting: skogli helse- og rehabiliteringssenter, lillehammer, norway. center of rehabilitation for chronic pain patients, rheumatic diseases and orthopedic postoperative patients. duration: until 18 months of intervention + 6 months of follow up and preparation. intervention: use of tens during 3-4 weeks of hospitalization connected to multimodal rehabilitation (short-term efficacy). tens or placebo-tens is added to routine care. follow-up: if patients want to continue the use of tens/placebo-tens at home, they will be offered to borrow equipment for 4 months. questionnaires will be send at 2 and 4 months, both for the active group, the placebo group and for the group of patients who discontinued the use of tens/placebo-tens (long-term efficacy).

Eligibility criteria:
inclusion criteria: * adult patients with chronic pain of predominantly neuropathic origin exclusion criteria: * pain less than 3 months * surgery or lesion within 3 months * central neuropathic pain * fibromyalgia * primary headaches * primary psychiatric diagnosis * patients with pacemaker * formerly treated with tens

Keywords: transcutaneous electrical nerve stimulation chronic pain neuropathic pain short-term efficacy long-term efficacy
symetis acurate neo™ valve implantation savi tf registry

Conditions: Aortic Stenosis

Summary: post-market registry aimed at further evaluating the safety and performance of the acurate neo™ aortic bioprosthesis and acurate tf™ transfemoral delivery system in patients with severe aortic stenosis treated with the commercialized device

the savi tf is s single arm, multicenter, non-randomized and open registry. the purpose of this registry is to collect and monitor ongoing safety and performance data from commercial use of the acurate neo™ aortic bioprosthesis and acurate tf™ transfemoral delivery system. the acurate neo™ and its transfemoral delivery system are intended for use in minimally invasive, transcatheter aortic valve replacement (tavr) using transfemoral access in patients presenting with severe aortic valve stenosis. the primary objective is to further evaluate the safety and performance of the acurate neo™ aortic bioprosthesis and acurate tf™ transfemoral delivery system in the first 1000 consecutive patients with severe aortic stenosis treated with the newly marketed device. the secondary objective is to evaluate adverse events and device performance of the newly marketed device.

Eligibility criteria:
inclusion criteria: 1. patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the acurate neo™ aortic bioprosthesis and acurate tf™ transfemoral delivery system as per the instructions for use 2. patient is willing to participate in the study, provides signed informed consent/data authorization form and authorizes the sharing of data in the registry 3. the subject and treating physician agree the subject will return for all required post-procedure follow-up visits exclusion criteria: 1. patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the acurate neo™ aortic bioprosthesis and acurate tf™ transfemoral delivery system as per the instructions for use.

Keywords: tavi aortic stenosis transcatheter aortic valve replacement transcatheter aortic valve implantation transfemoral access
pilot study of a homeopathic therapy in combination with cyclosporin (restasis) in the treatment of dry eye disease

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to determine whether a homeopathic therapy in combination with cyclosporin (restasis) is more effective than cyclosporin (restasis) alone in the treatment of dry eye disease.

dry eye disease affects millions of people world-wide, and presents with symptoms of blurred vision, discharge from the eyes, eye discomfort, burning, redness, sandy and gritty feeling in the eyes, and sensitivity to light. topical eye drops for eye lubrication (i.e., artificial tear solutions) and controlling ocular inflammation through the use of topical immunomodulatory agents (i.e., cyclosporine \[restasis\]) have been shown to be effective for treating dry eye syndrome, but are not curative. recently, we have evaluated a few patients who had discontinued using restasis as they had obtained better relief of their dry eye symptoms with a homeopathic therapy. potential participants will undergo an eye examination consisting of medical history and physical examination (i.e., visual acuity, pupillary exam, examination of the lids, slit-lamp examination of the conjunctiva, cornea, anterior chamber, iris, and lens, and funduscopic examination). participants qualifying for the study will then stop all eye medications and will use a common artificial tear solution for 2 weeks prior to the baseline examination. we will evaluate 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film to break-up; 2) staining of the cornea by fluorescein stain; 3) measurement of tear production over 5 minutes by schirmer's test; and 4) the ocular surface disease index (osdi).

Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe dry eye syndrome with or without sjögren's syndrome * receiving treatment with topical cyclosporine (restasis) * experience one or more moderate dry eye-related symptoms, including dryness, foreign body sensation, burning, blurred vision, photophobia, and soreness or pain exclusion criteria: * history of ocular disorder including non-dry eye ocular inflammation, glaucoma, contact lens use * trauma or surgery, including punctal plug insertion within the prior 3 months * any uncontrolled systemic disease or significant illness * use of topical ophthalmic medications that could affect dry eye syndrome * pregnancy, lactation, or considering a pregnancy

Keywords: dry eye syndromes lacrimal apparatus diseases
healthy foods and education to treat diabetes

Conditions: Diabetes Mellitus

Summary: the investigators will study a program that delivers weekly community-supported agriculture shares to patients of east baltimore medical center in order to increase access to healthy foods. the investigators will provide adult patients with uncontrolled diabetes with healthy foods including fresh vegetables and shelf-stable pantry items (e.g., canned beans) every week over the course of 6 weeks. the investigators will also collect demographic data and food insecurity status of participants via survey. this program will also conduct weekly cooking and nutrition classes at east baltimore medical center. the investigators will conduct a survey of participants' experiences each time participants pick up a vegetable bag and at the end of the cooking classes. in addition, a focus group of participants will be held to gather qualitative data regarding the vegetable initiative.


Eligibility criteria:
inclusion criteria: * patients with uncontrolled diabetes mellitus (defined as a glycosylated hemoglobin \>8%) * 18 years age of and over * living within the geographical region of east baltimore medical campus exclusion criteria: * current participation in five plus nuts and beans study or other program that provides diet-based food * non-english speaking * on hospice or palliative care * acute or chronic psychosis * active substance or alcohol use disorder * another active medical disorder that would preclude participation in weekly food pick-up or classes including: active treatment of cancer, steroid dependent asthma/chronic obstructive pulmonary disease/emphysema, steroid dependent colitis; chronic kidney disease with an estimated glomerular filtration rate less than 30mg/mmol, venous thromboembolic disease with current treatment with vitamin k antagonist, celiac disease, cirrhosis or steroid dependent arthritis
factors of steroid dependency in idiopathic nephrotic syndrome

Conditions: Idiopathic Nephrotic Syndrome

Summary: the primary purpose of the study is to identify the factors of steroid dependency in childhood idiopathic nephrotic syndrome. the steroid dependency is defined by a relapse of nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the first manifestation. different clinical and biological factors will be analyzed: age of first manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization in the parisian area, genoprevalence of herpes viruses and polymorphisms in the genes involved in the response to steroid therapy.

patients with a steroid dependent nephrotic syndrome will be compared to those with a non steroid dependent form of nephrotic syndrome at the end of the first manifestation. an additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease. genetics factors will be checked using a dna chips devoted to the response to steroid therapy and viral genome of ebv, cmv, hhv7 will be searched for using pcr reaction in total blood dna extract.

Eligibility criteria:
inclusion criteria: * children below 16 years * first manifestation of nephrotic syndrome * steroid sensitivity according to the recommendations of the french "pediatric society nephrology" exclusion criteria: * patients who don't stay in paris during the study

Keywords: proteinuria idiopathic nephrotic syndrome herpesvirus epidemiology immune response interferon steroid dependency nephrotic disease: idiopathic nephrotic syndrome
a post-approval, single-arm study of the synergy stent system in china

Conditions: Cardiovascular Diseases

Summary: a prospective, observational, single-arm, open-label, multicenter, post-approval study. to compile real-world clinical outcomes data for the synergytm monorailtm everolimus-eluting platinum chromium coronary stent system (synergytm stent system) in real-world clinical practice in china.

this prospective, open-label, multi-center study is designed to provide post-market surveillance information on the synergy stent system. the study will evaluate clinical outcomes of subjects receiving the synergy™ stents over 5 years in a real world setting according to post approval requirements by china government.

Eligibility criteria:
inclusion criteria: * • subject must be at least 18 years of age * subject understands and provides written informed consent * subject who is clinically indicated and will have an attempt of at least one synergytm stent or subject who is clinically indicated and was implanted with at least one synergytm stent * subject is willing to comply with all protocol-required follow-up evaluation exclusion criteria: * exclusion criteria are not required in this study which is an "all comers" study.
defining the quality of intraoperatively salvaged blood for deformity surgery

Conditions: Spinal Deformity

Summary: the actual quality of red blood cells (rbcs) salvaged during spinal deformity surgery has never been rigorously evaluated. to characterize the usefulness of intraoperatively salvaged rbcs in spinal deformity surgery. the study team hopes to answer the following questions: 1) what is the quality of rbcs salvaged during spine surgery? 2) does intraoperatively transfused rbc salvage impact clinical outcomes?


Eligibility criteria:
inclusion criteria: * any/all patients undergoing spine surgery who utilizes cell saver and has blood to be given back. * this will include pediatric patients 0-17 as well as adults of any age who have been indicated for surgery. * only patients with the capacity to consent will be included. exclusion criteria: * patients indicated for spinal surgery without the use of cell saver.

Keywords: red blood cells
gingival displacement by polytetrafluoroethylene & conventional retraction cord

Conditions: Gingival Pocket

Summary: to achieve harmony between restoration and surrounding periodontium, soft tissue management plays a pivotal role. various gingival displacement techniques show varying results in achieving the goals of displacement. the most preferred method of displacement by dental practitioners is through conventional retraction cord made up of cotton, which besides its advantages, poses certain drawbacks, including low tear strength, high friction, and fiber remnants within the sulcus. polytetrafluoroethylene (ptfe) retraction cord, is a fluoropolymer, known for its high tear strength, low friction, and bio-compatibility. this study aims to determine the difference of horizontal gingival displacement between ptfe and conventional retraction cord. participants inducted in this study will be assessed for eligibility. qualifying subjects will receive crown preparation for porcelain-fused to-metal crown. subjects will then be randomly allocated to either of the two arms of intervention. after making a pre-displacement impression, retraction cord will be applied for 3 minutes, then removed to record post-displacement impression. the difference in pre and post-displacement mean gingival sulcus width will be assessed by a stereomicroscope using image analysis software.


Eligibility criteria:
inclusion criteria: * indication of full veneer crown * age group: 18-60 years * probing depth 2-3mm and no bleeding on probing * no signs of gingival/periodontal disease exclusion criteria: * indication of subgingival margin location * developmental anomaly (anatomical) affecting abutment tooth * bleeding disorder * pregnancy

Keywords: polytetrafluoroethylene retraction soft tissue management retraction cord
predictive value of inflammatory indexes and cha2ds2-vasc score for lvt in ant-mi with left ventricular dysfunction

Conditions: Left Ventricular Thrombus; Acute Anterior Myocardial Infarction; Left Ventricular Dysfunction

Summary: to investigate the predictive value of inflammatory indexes and cha2ds2-vasc score for anterior myocardial infarction (ant-mi) with left ventricular thrombus(lvt) (lvt).

the clinical data were collected from 371consecutive patients with ant-mi in our hospital from january 2014 to january 2021.as a result,totally 62 patients with lvt were selected as the experimental group and 186 patients with non-lvt as the control group .the observation indexes included baseline data, coronary angiography, disease course, laboratory examination and auxiliary examination.patients with severe organic disease and having previous history of left ventricular aneurysm( lva) and lvt were excluded.data was analyzed by software spss 22.0 for statistical analysis,and the logistic regression model was established.a p\<0.05 was considered statistically significant, and the risk factors of lvt formation were retrospectively analyzed.

Eligibility criteria:
inclusion criteria: acute anterior myocardial infarction with left ventricular dysfunction exclusion criteria: end-stage organic disease, thrombotic hematological disorders, previous anticoagulant use, and poor echogenicity

Keywords: left ventricular thrombus;anterior myocardial infarction risk factors
efficacy and safety of aspirin and clopidogrel in the atrial fibrillation with low or moderate stroke risk

Conditions: Atrial Fibrillation

Summary: this study was designed in order to evaluate and compare the efficacy and safety between aspirin and clopidogrel in the patient with low stroke risk atrial fibrillation (af).

efficacy outcome will be evaluated the major cerebro-cardiovascular event including stroke, cardiovascular death, and myocardial infarction during 1 year-medication period. in addition, safety outcome will be evaluated the gastrointestinal responses including peptic ulcer and upper gastrointestinal bleeding events to both study drugs by repeated gastroenteroscopic examinations before and after medication by gi specialist.

Eligibility criteria:
inclusion criteria: 1. man or women \> 20 years old 2. newly detected af (cha2ds2vasc index score: 1) 3. patient who needs antiplatelet therapy using aspirin clopidogrel for stroke prevention 4. volunteer only 5. childbearing aged women who takes proper oral contraceptive exclusion criteria: 1. no specific contraindication or any history of hypersensitivity of clopidogrel or aspirin 2. patient with active gi bleeding or bleeding tendency or major bleeding history 3. less than 1 year of residual expected life 4. pregnant or breast-feeding women 5. other causes, determined by charged physician 6. patient with definite gerd who needs special treatment 7. patient who needs to take nsaid (non-steroidal anti-inflammatory drug) for more than 2 weeks
survival and success rates of 6mm implants with a micro-rough surface after 4.5 - 18.2 years in function

Conditions: Jaw, Edentulous, Partially; Dental Implant Failed; Implant Complication

Summary: in this retrospective study, approximately 60 patients treated with 6mm short implants (straumann, sla (sandblasted, large-grit, acid-etched surface), slactive (sandblasted, large-grit, acid-etched, hydrophilic surface), 4.1 or 4.8 mm in diameter) will be followed for 4.5-18.2 years. clinical and radiographic parameters will be assessed in a follow-up examination.


Eligibility criteria:
inclusion criteria: * partially or fully edentulous jaw * written informed consent exclusion criteria: * pregnant women/lactating women

Keywords: short dental implant partially edentulous jaw