Kornimate/medical-research-clean huggingface dataset:
histocompatibility leukocyte antigen (hla)-a*0201 restricted peptide vaccine therapy in patients with colorectal cancer

Conditions: Colorectal Cancer; Colon Cancer; Rectal Cancer

Summary: the purpose of this study is to evaluate the safety and time to progression of hla-a\*0201 restricted epitope peptides vegfr1 and vegfr2 emulsified with montanide isa 51 in combination with tegafur/uracil/folinate chemotherapy.

vegf receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific ctl response in vitro and vivo. according to these findings, in this trial, we evaluate the safety, clinical and immunological response of those peptides. patients will be vaccinated twice a week for 8 weeks. on each vaccination day, vegfr1 peptide (1mg) and vegfr2 peptide (1mg) mixed with montanide isa 51 will be administered by subcutaneous injection. the patients will also receive oral chemotherapy (tegafur/uracil/folinate) simultaneously. repeated cycles of the vaccine and the chemotherapy will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. in the phase i study, we evaluate the safety and tolerability of these peptide vaccine. in the following phase ii study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility criteria:
inclusion criteria: * advanced or recurrent colorectal cancer * resistant against chemotherapy including cpt-11, l-ohp、+/- 5-fu +/- bevacizumab or difficult to continue the chemotherapy due to intolerable side effect(s) * ecog performance status 0-2 * life expectancy \> 3 months * hla-a\*0201 * laboratory values as follows * 2000/mm3\<wbc\<15000/mm3 * platelet count\>100000/mm3 * bilirubin \< 3.0mg/dl * asparate transaminase \< 150iu/l * alanine transaminase \< 150iu/l * creatinine \< 3.0mg/dl * able to receive oral tegafur/uracil/folinate therapy * able and willing to give valid written informed consent exclusion criteria: * pregnancy(woman of childbearing potential:refusal or inability to use effective means of contraception) * breastfeeding * active or uncontrolled infection * unhealed external wound * concurrent treatment with steroids or immunosuppressing agent * prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks * uncontrolled brain and/or intraspinal lesion(s) * history of allergy to tegafur, uracil, and/or folinate * decision of unsuitableness by principal investigator or physician-in-charge

Keywords: hla-a*0201 peptide vaccine vegfr1 vegfr2
nasal packing as a drug delivery system postoperatively in chronic sinusitis with polyposis

Conditions: Chronic Sinusitis; Polyposis

Summary: that high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.


Eligibility criteria:
inclusion criteria: * hyposmia and nasal obstruction for \>12 weeks * bilateral nasal polyposis * candidate for surgery exclusion criteria: * immunocompromised * non-english speaking * prisoner * pregnant/lactating * will not attend follow up appointments
family based interpersonal psychotherapy (fb-ipt) for depressed preadolescents

Conditions: Depressive Disorders

Summary: the investigators proposed a preliminary randomized control trial of family based interpersonal psychotherapy (fb-ipt), a family-based adaptation of interpersonal psychotherapy for depressed adolescents (ipt-a; mufson et al., 2000). forty-five preadolescent children (ages 8-12) diagnosed with a depressive disorder will be randomized to receive a 14-week course of fb-ipt or client centered therapy (cct), a supportive nondirective psychotherapy that closely approximates treatment at usual in community mental health clinics. in addition to assessing the feasibility and acceptability of randomization and each of the treatment conditions, this project will evaluate the effects of fb-ipt and cct across multiple domains, including symptomatology and psychosocial functioning. preadolescents will be assessed prior to treatment, during treatment (weeks 3, 7, 11), one week post-treatment, and at 3 and 6 months post-treatment to compare changes in depressive symptoms, global, social, and family functioning. data on psychosocial risk factors associated with onset and recurrence of preadolescent depression will be collected prior to treatment and at specified intervals post-treatment in order to conduct exploratory analyses on correlates of positive and negative treatment outcomes for family based ipt. this data will be used to generate future hypotheses about potential mediators and moderators that will be incorporated into an r01 application for an efficacy study of family based ipt.


Eligibility criteria:
inclusion criteria: * current depressive disorder * one parent must be willing to participate in treatment exclusion criteria: * bipolar disorder * ptsd * recent abuse * developmental delay * autism spectrum disorder
neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for resectable locally advanced esophageal cancer (hchtog1903)

Conditions: Esophageal Squamous Cell Carcinoma

Summary: multimodal treatment combining surgery with chemotherapy and/or radiotherapy is necessary to improve the chances of survival in patients with locally advanced thoracic esophageal cancer. however, there is no consensus about the neoadjuvant treatment for resectable locally advanced esophageal squamous cell carcinoma. the aim of current randomized controlled clinical trail is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiation therapy plus surgery on overall survival for patients with resectable locally advanced esophageal squamous cell carcinoma. the investigators plan to enroll 456 patients with locally advanced esophageal squamous cell carcinoma in 3 years. eligible patients will be randomized into neoadjuvant chemotherapy group (paclitaxel 175mg/m2 plus cisplatin 75mg/m2, q21d, 2 cycles) or neoadjuvant chemoradiation group (41.4gy, 1.8gy\*23d plus paclitaxel 50mg/m2 plus carboplatin auc=2, q1w, 5 cycles). the primary endpoint is 5 year overall survival and the secondary endpoints include 5 year disease-free survival, adverse events, pathologic complete response, postoperative complications, quality of life. the biomarkers predicting the sensitivity of neoadjuvant therapy will be explored.


Eligibility criteria:
inclusion criteria: * ct2-t4an+m0 or ct3-4an0m0 (8th tnm staging system) thoracic esophageal squamous cell carcinoma * no metastatic cervical lymph node * no anti-cancer treatment * no contraindication for esophagectomy * no contraindication for chemotherapy or chemoradiation therapy * ps score 0-1 * written consent is obtained exclusion criteria: * previous cancer treatment history * concurrent cancer disease in other site * tumor length ≥8cm * tumor width ≥5cm * need continuous steroid treatment * cardiac infarction in 6 months * psychotic patient * can not achieve r0 resection * gastric tube can not be used for reconstruction after esophagectomy * pregnant woman

Keywords: esophageal squamous cell carcinoma neoadjuvant chemotherapy neoadjuvant chemoradiation therapy randomized controlled survival
skin health in young adults - preventing indoor tanning and promoting sun protection

Conditions: Skin Neoplasms

Summary: this is a pilot randomized controlled trial of an internet-based skin cancer prevention intervention as compared to a standard of care control in 80 non-hispanic white females ages 20-30.


Eligibility criteria:
inclusion criteria: * tanned indoors in past 12 months * able to communicate well in english * reliable internet access exclusion criteria: * history of skin cancer (self-report)
long-term extension study of sm-13496 (lurasidone hcl) in patients with schizophrenia

Conditions: Schizophrenia

Summary: the study evaluates the long term safety and efficacy of sm-13496 in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * patients who are considered by the investigator eligible for the present study with no significant safety concerns * patients who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study exclusion criteria: * patients who are planning pregnancy for the expected duration of the study * patients who are otherwise considered ineligible for the study by the investigator
campania registry on peripheral artery disease

Conditions: Peripheral Artery Disease

Summary: the campania registry on peripheral artery disease (care-pad) is a single-center observational study which has the purpose to collect clinical, laboratory, instrumental, procedural and follow-up data and to evaluate the outcome of peripheral artery disease (pad) patients.

pad patients had widespread atherosclerosis and show a worse prognosis than patients with coronary artery disease alone. the campania registry on peripheral artery disease (care-pad) is a single center observational study conducted at the department of advanced biomedical sciences of the federico ii university of naples which aims to collect clinical, laboratory, instrumental, procedural and follow-up data and to evaluate short, medium and long term outcome of pad patients. patients with established diagnosis of peripheral arterial disease according to current international guidelines will be included in the observational study. the overall duration of the study will be 10 years. the presence of pad will be confirmed based on clinical and instrumental criteria: * intermittent claudication and/or critical limb ischemia with presence of haemodynamically significant stenosis/occlusion of the lower limb arteries detected by ultrasound and/or other imaging methods or with ankle/brachial index (abi) ≤ 0.90. * carotid stenosis of at least 50% at ultrasound and/or at other imaging methods * abdominal aortic aneurysm (≥3 cm) found at ultrasound and/or other imaging methods. * history of peripheral/carotid revascularization or of aortic aneurysm treatment. all patients will be managed according to current guidelines and will receive maximal antiatherosclerotic medical therapy to improve cardiovascular prognosis and, if clinically indicated, could undergo peripheral revascularization procedures to improve symptoms and/or limb prognosis. the choice of the revascularization procedure will be based on careful individual evaluation and will take into account, in accordance with current guidelines, several variables such as clinical characteristics, comorbidities, individual surgical risk and feasibility of the percutaneous peripheral revascularization procedure.

Eligibility criteria:
inclusion criteria: confirmed diagnosis of peripheral artery disease as follows (one or more of the following): * intermittent claudication with presence of hemodynamically significant stenosis/occlusion of lower limb arteries or pathological abi (≤ 0.90); * critical limb ischemia with presence of hemodynamically significant stenosis/occlusion of lower limb arteries or pathological abi (≤ 0.90); * presence of carotid stenosis of at least 50%; * presence abdominal aortic aneurysm (≥ 3 cm); * history of peripheral/carotid revascularization or of aortic aneurysm treatment. exclusion criteria: refusal to sign the informed consent

Keywords: outcome peripheral revascularization
clinical and healthcare economic outcomes from real-world use in europe of an ai software during af ablation

Conditions: Atrial Fibrillation; Atrial Arrhythmia; Arrhythmias, Cardiac

Summary: the goal of this observational prospective multi-center study is to observe the acute and long-term safety and performance outcomes after spatiotemporal dispersion-based af/at ablation utilizing the volta medical ai software in "real-life" clinical practice, without any imposed clinical workflow. moreover, this study will allow to collect medico-economic data related to the tailored ablation strategy guided by the volta medical ai software.

all patients enrolled are treated for atrial fibrillation/tachycardia via a catheter ablation procedure using volta medical ai software during the mapping phase to identify areas of interest specific to the patient. the ablation approach is free and chosen by the operator according to standard practice. intraoperative and postoperative follow-up will be performed as in routine clinical practice during af ablation procedures: hospitalization for ablation procedure and standard postoperative quarterly visits (at 3 months, at 6 months and/or 9 months as per the study investigator's standard of care) then annual visits up to 24 months post-ablation. adverse events, recurrences of atrial arrhythmia and af related symptoms (ehra score) are collected from the patient's enrollment until the patient's study termination. a quality-of-life questionnaire related to general health (eq-5d-3l) is collected during the preoperative visit and at least during annual follow-up visits. the patient's study-termination corresponds to the last annual visit at 24 months post-ablation index.

Eligibility criteria:
inclusion criteria: 1. patient aged 18 years or older. 2. patient candidate for catheter ablation to treat paroxysmal or persistent atrial fibrillation, atrial tachycardia, de novo or after one or several previous ablation procedures, and for which the investigator considers using vx1 or volta af-xplorer or volta af-xplorer ii. 3. patient able and willing to provide written informed consent to participate in the study. 4. only for france: patient affiliated to the french social security system. exclusion criteria: 1. contraindication to af/at catheter ablation. 2. patient who is or could potentially be pregnant. 3. person deprived of liberty or under guardianship. 4. person unable to undergo a medical monitoring for geographical, social or psychological reasons. 5. patient\&#39;s refusal to participate in the study. 6. enrollment in an investigational study evaluating another device, biologic, or drug.

Keywords: artificial intelligence cardiac ablation medical device software volta medical atrial arrhythmia vx1 volta af-xplorer volta af-xplorer ii
antibiogram and biofilm formation of bacteria causing prosthetic joint infections isolated from assiut university hospital

Conditions: Prosthetic Joint Infection

Summary: 1. setting of antibiogram in orthopedic department 2. evaluate the production of biofilm in bacteria isolated from specimens phenotypically and genotypically.

increased use of total joint arthroplasties will naturally result in a related increase in the number of prosthetic joint infections (pjis). pji is a disastrous complication of orthopedic surgery, frequently leading to prolonged morbidity and increased mortality. moreover, therapy for pji is associated with enormous costs. pji results from numerous factors that lead to inability of periprosthetic immune cells to protect implant surfaces and tissues from bacterial colonization. the most destabilizing factor is the ability of bacteria to adhere to and survive on virtually all natural and synthetic surfaces. once firmly attached to the surface of an implant, the microorganisms initiate "biofilm" formation, which is a complex of microbial cells embedded in an extracellular matrix composed of proteins, extracellular dna, and exopolysaccharides, providing protection for bacteria and making them extremely resistant to the immune system and antibiotic. an ineffective empiric antibiotic regimen can be harmful to patients while unnecessary broad-spectrum antibiotics lead to increased resistance. however, healthcare providers often select an antibiotic regimen before bacterial antibiotic sensitivities are available. the clinical and laboratory of standards institute publishes the m39 analysis and presentation of cumulative antimicrobial susceptibility test data; approved guideline, which is a referenced guideline on how to create antibiograms. the antibiogram has multiple uses, including providing guidance for empiric antibiotic therapy, monitoring changes in resistance over time, assisting in formulary decisions and supports antimicrobial stewardship programs to reduce multidrug resistant organisms and the risks of adverse drug events.

Eligibility criteria:
1. inclusion criteria: * age above 18 years old * no intraarticular surgery of the respective joint prior to the index surgery. 2. exclusion criteria: * age below 18 years old * if the patient had any intraarticular surgery prior to the primary arthroplasty in the respective joint.
a study of enterorenal syndrome assessed by gastrointestinal ultrasound combined with renal artery resistance index

Conditions: Sepsis; Urinary Tract Infections

Summary: in this study, the patients with sepsis caused by abdominal infection were divided into survival group and death group by ultrasound examination of gastrointestinal function, superior mesenteric artery blood flow, and renal artery resistance index. the cross-sectional area of gastric antrum, average time flow rate of superior mesenteric artery, colon diameter, colon peristalsis frequency, and renal artery resistance index of the two groups were compared to determine the progression of entero-renal syndrome as soon as possible. to provide reliable objective basis for clinical decision-making, in order to improve the success rate of rescue.

adult patients admitted to eicu of our hospital who met the diagnostic criteria for sepsis were included in the study. patients with intra-abdominal sepsis were divided into survival group and death group for case control. exclusion criteria: open chest and abdomen injury, advanced tumor, uremia, pregnancy. the primary endpoint was survival. extraction time: icu (0h), icu (6h, that is, after fluid resuscitation), icu (24h), icu (48h, 08:00 a.m.), icu (72h, 08:00 a.m.), icu (120h, 08:00 a.m.); monitoring indicators: antral cross-section area, colon diameter, colon peristalsis frequency, renal artery resistance index, cvp, scvo2, il6, blood lactic acid, blood creatinine, fluid intake, bladder pressure. the primary endpoint of the study was survival rate, and statistical analysis was performed to evaluate the progression of enterorenal syndrome, provide reliable objective basis for subsequent clinical decision-making, and improve the success rate of rescue.

Eligibility criteria:
inclusion criteria: * patients diagnosed with intra-abdominal infections * patients with sepsis or septic shock exclusion criteria: * patients with open chest or abdominal injury * patients with advanced tumor * patients with uremia * pregnant women
calcaneal neck lengthening osteotomy in children with artificial bone graft

Conditions: Pes Plano Valgus; Flatfeet

Summary: in a group of children with severe and painful flatfeet lengthening procedures of calcaneus can be indicated. in this study the investigators use an artificial bone graft technique to avoid removing bone graft from the iliac crest.

the aim is to study the clinical and radiological effects of calcaneal lengthening with either autogen bonegraft or a ha-βtcp graft material in a group of children with planovalgus. the hypothesis is that it is possible to achieve a stabile osteotomy with ha-βtcp graft material equal to the use of autogen bonegraft thus avoiding the need to obtaining iliac crest graft material at growing children.

Eligibility criteria:
inclusion criteria: * pain * gait disturbance exclusion criteria: * post traumatic conditions

Keywords: artificial bone graft hydroxyapatite children osteotomy pes plano valgus flatfeet
efficacy and safety of 5% lidocaine patch with placebo patch in subjects with herpes zoster associated pain

Conditions: Herpes Zoster Pain

Summary: this is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of 5% lidocaine patch, following placebo or active patch applications in placebo insensitive subjects.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 18 to 85 years of age. 2. subjects must have herpes zoster associated pain present for ≥1 months after healing of the acute herpes zoster skin rash and not located on the face, scalp; the diagnosis will be based on physical examination and review of available medical records confirming an episode of herpes zoster. 3. herpes zoster associated pain must be of at least moderate severity, defined as the average pain level ≥40 mm on a 100 mm visual analog scale (vas slide ruler) exclusion criteria: 1. subjects with signs of cord or brainstem injury from herpes zoster. 2. presence of another pain problem of greater severity than their herpes zoster associated pain. 3. subjects who have undergone neurolytic nerve blocks or ablative neurosurgical procedures for control of herpes zoster associated pain
lupus interval monitoring to manage disease flare and enable treatment optimization

Conditions: Systemic Lupus Erythematosus; Lupus; Lupus Erythematosus; Lupus Erythematosus, Systemic

Summary: to develop a test to characterize and monitor sle disease activity status from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.

systemic lupus erythematosus (sle or lupus) is a chronic inflammatory autoimmune disorder of poorly understood etiology associated with a wide range of symptoms and physical findings. many patients have incompletely controlled disease progressing to end-stage organ involvement. recognizing and predicting flares and under associated organ damage would facilitate better treatment timing and selection. recent improvements in care have dramatically enhanced the survival of lupus patients but increased mortality remains a major concern and current treatments for lupus remain inadequate. development of novel therapies to manage lupus has been hampered by several challenges, including poorly understood pathogenesis, the heterogeneity of disease activity across and within patient populations, and difficulties conducting interventional studies. there remains a need for reliable and timely monitoring of disease activity and degree of organ damage to adequately evaluate response to treatments and long-term outcome. it is also important to differentiate genuine lupus activity and flares from another intercurrent disease such as infection. to fill this gap, panels of reliable biomarkers that can classify patients with lupus into more homogenous subsets that are linked to disease activity are needed. such a panel can be developed from signatures found in lupus patients' transcriptome sequencing data. dxterity's proprietary dxcollect® microcollector device (mcd) is intended to facilitate the collection, stabilization, and shipping of a microsample (about 150μl) of blood. this microsample provides sufficient amounts of quality rna to perform transcriptome sequencing, allowing identification and validation of candidate biomarker signatures. a rapid blood test to monitor and predict disease activity and treatment response would be an innovative diagnostic product. it could bring significant clinical benefits by enabling the individualized lupus monitoring and treatment to better control the disease and slow organ damage. this may assist with unburdening healthcare costs, help identify flares before they happen, and dramatically improve the management of lupus. the study will collect participant self-collected blood samples from a fingerstick collection kit that can be done from home and self-reported information from up to 2500 participants for analysis.

Eligibility criteria:
inclusion criteria: 1. male and female patients age 18 or older 2. have a permanent address in the united states for the duration of the study 3. have an email address and access to the internet for the duration of the study 4. able to provide informed consent 5. self-reported diagnosis of lupus exclusion criteria: 1. none

Keywords: lupus sle systemic lupus erythematosus