Kornimate/medical-research-clean huggingface dataset:
chemotherapy, radiation therapy and immunotherapy prior to surgery in operable esophageal cancer

Conditions: Esophageal Cancer

Summary: the purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-fu, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer. side effects (toxicity) information will also be collected.

surgical removal has been the standard treatment for operable esophageal cancer. however, recent studies have shown improved results when patients receive a short course of chemotherapy and radiation therapy prior to surgery. prior to surgery study treatment will be given over a 6 weeks (days 1-42) period. beginning day 1 and continuing through day 35 patients will receive a continuous infusion of 5-fu by vein. a small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. on day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. erlotinib is given by mouth beginning on day 1 and continuing through day 45. patients will receive radiation therapy daily, monday through friday, beginning day 1-35 (approximately 5 weeks). surgery will be performed approximately 12-14 weeks after beginning this combined treatment.

Eligibility criteria:
inclusion criteria: * clinically confirmed esophageal or gastroesophageal junction cancer stage i, ii or iii * no prior treatment for esophageal cancer * must be surgical candidate based on stage and location of disease * measurable or evaluable disease * able to be up and perform self care * adequate liver, renal function and bone marrow function * patients will have to have a central venous access device placed * able to give written informed consent. * age 18 or older exclusion criteria: * stage iv disease * prior cancer treatment for advanced cancer in the last 5 years * pregnant or lactating women * history of stroke, transient ischemic attacks, or acute mi within the past 6 months or any other serious cardiovascular disease * history of neurological disease * recent history of blood in the sputum or vomitus * non-healing wounds, ulcer or long bone fractures * history of bleeding problems or coagulation problems * history of abdominal fistula, gi perforation or intrabdominal abscess within 6 months * history of uncontrolled hypertension please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have. you can then decide if you wish to participate.
evaluation of new specifications (2.25mm) of firehawktm in the treatment of coronary heart disease ( firehawk_2.25 )

Conditions: Coronary Heart Disease

Summary: the purpose of this study is to evalute the clinical safety and effectiveness of released specification (2.25mm) of firehawktm sirolimus target-eluting coronary stent system.


Eligibility criteria:
inclusion criteria: 1. 18-80 years of age, males or non-pregnant women; 2. evidence of silent ischemia, stability or in patients with old myocardial infarction or unstable angina; 3. primary target lesion, in situ coronary artery disease; 4. target lesion length ≤ 60mm, target lesion diameter 2.25mm (visual method); 5. the target lesion diameter stenosis ≥ 70% (visual method); 6. each target lesion implantation the same stent (firehawk stent); 7. with indications for coronary artery bypass surgery; 8. to understand the purpose of testing, voluntary and informed consent, patients agreed to achieve invasive imaging and clinical follow-up. exclusion criteria: 1. within 72h of any acute myocardial infarction; 2. unprotected left main coronary artery disease, triple vessel lesions which need treated all; bifurcation lesions and vascular lesions of the bridge; 3. severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery; 4. artery and/or vein bypass graft lesions; 5. intracoronary implantation of any branding stents within 1 year; 6. severe congestive heart failure (nyha class iii and above), or left ventricular ejection fraction \<35% (ultrasound or left ventricular angiography); 7. preoperative renal function serum creatinine \>2.0mg/dl; 8. bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy; 9. aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies; 10. the patient's life expectancy is less than 12 months; 11. top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame; 12. researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements; 13. heart transplantation patients.
remote monitoring system for patients, who had myocardial infarction

Conditions: Myocardial Infarction; Adherence, Patient

Summary: one-centered, open, prospective, non-randomized, controlled clinical study will be aimed at creating remote monitoring system for patients' condition and the development of methodological approaches and its usage for conducting patients, who had myocardial infraction and who has a very high risk of developing an unfavorable outcome.

the research will involve patients, who had myocardial infraction and who has the high level of potential adherence to treatment, which will be determined by the usage of russian generic questionnaire for evaluation of compliance to drug therapy. at the end of a 12 month observation with the registration of unfavorable cardiovascular occasions (death from cardiovascular reasons, nonfatal myocardial infraction, cerebral stroke, necessity for repeated revascularization of the coronary arteries) based on the analysis of non-genetic and genetic factors (polymorphism of genes thr174met and met235thr in gene angiotensinogen, arg389gly and ser49gly in gene adrenoceptor beta 1, ser447ter in gene lipoprotein lipase and leu28pro in gene apolipoprotein e, trp212ter and g681a in gene cytochrome p450 family 2 subfamily c member 19) factors of unfavorable prognosis will be identified and considering which group of patients requires the use of remote monitoring system will be formed. from one group of patients we will form two comparable groups, one group will use this remote monitoring system and another will not. the effectiveness of the remote monitoring system will be evaluated after 6-month's observation based on the registration of the unfavorable cardiovascular occasions (death from cardiovascular reasons, nonfatal myocardial infraction, cerebral stroke, necessity for repeated revascularization of the coronary arteries, frequency of hospitalizations).

Eligibility criteria:
inclusion criteria: 1. a significant diagnosis of myocardial infraction, confirmed by the level of biomarkers of myocardial necrosis in blood examination (troponin, creatine kinase-mv), electrocardiographic criteria, typical clinical presentation. 2. the high level of adherence to treatment 3. signed informed agreement exclusion criteria: 1. active cancer or remission period less than 5 years; 2. absolute contradictions to the prescription of beta-adrenergic blocking agents, angiotensin converting enzyme inhibitors, statins, antiaggregants. 3. mental illnesses. 4. alcohol and drug abuse 5. patient's noncompliance, according to the researchers

Keywords: myocardial infraction the high level of potential adherence to treatment polymorphism of genes remote monitoring, prognosis
back pain prevalence in wheelchair users and associated risk factors

Conditions: Back Pain

Summary: the primary purpose of this study is to determine the prevalence of back pain in permanent wheelchair users (excludes transitory users) in different regions of spain. another study objective is the identification of risk factors for back pain in this population. data collection will be by means of a structured questionnaire which will be validated in a previous pilot study.


Eligibility criteria:
inclusion criteria: * adults with established disability; * permanent wheelchair users; * having physical and intellectual ability to answer questionnaire. exclusion criteria: * transitory wheelchair users; * diagnosis of inflammatory rheumatic disease, cancer, systemic infection; * red flags for systemic disease.

Keywords: wheelchair users back pain prevalence risk factors
effectiveness, safety, adherence, and health-related quality of life in hiv-1 infected adults receiving bictegravir/ emtricitabine/tenofovir alafenamide

Conditions: HIV-1-infection

Summary: the primary objective of this study is to evaluate hiv-1 rna suppression, defined as hiv-1 rna \<50 copies/ml, at 12 months after initiating or switching to bictegravir/ emtricitabine/tenofovir alafenamide (b/f/taf).


Eligibility criteria:
inclusion criteria: * hiv-1 infection * signed informed consent * initiating treatment with b/f/taf in accordance with the product monograph exclusion criteria: participation in any other observational or interventional clinical trial without prior approval from the medical monitor

Keywords: observational
study of topical calcitriol or oral calcitriol in patients with psoriasis

Conditions: Psoriasis

Summary: objectives: i. evaluate the long term safety and efficacy of orally administered calcitriol in patients with at least 5% of their body covered with psoriasis. ii. evaluate the long term safety and efficacy of topically administered calcitriol in patients with at least 5% of their body covered with psoriasis. iii. compare the topical calcitriol treatment to the oral calcitriol treatment in these patients.

protocol outline: this is a part placebo-controlled (arm i) study. patients either apply topical petrolatum (vaseline) with calcitriol (vitamin d3) on a psoriatic lesion daily and petrolatum only on an other similar lesion daily to serve as a control (arm i) or receive oral calcitriol nightly (arm ii). arm i patients continue treatment for at least 2 months. at the end of 2 months of topical treatment, one biopsy is taken of the lesion treated with calcitriol, one biopsy of the lesion treated with petrolatum alone, and one biopsy of skin unaffected by psoriasis. lesions are also photographed prior to therapy, 2-4 weeks during therapy for the first two months, then once every 1-3 months, and then once at end of treatment. arm ii patients increase dosage of oral calcitriol every 2 weeks up to a maximum dosage daily in the absence of adverse effects (high urinary calcium or serum calcium levels). patients continue treatment for at least 1 month. lesions are photographed prior to therapy, 2-4 weeks during therapy, and then once at end of treatment.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- psoriasis covering at least 5% of body --prior/concurrent therapy-- at least 30 days since prior systemic therapy for psoriasis at least 14 days since prior topical therapy for psoriasis no other concurrent treatment for psoriasis for the first 2-4 months of study no calcium supplement greater than 1,000 mg per day --patient characteristics-- no hypercalcemia no hypercalciuria not pregnant effective contraception required of all fertile patients

Keywords: dermatologic disorders psoriasis rare disease
effect of an informative anxiety and stress in patients requiring an oral biopsy

Conditions: Anxiety ; Dental

Summary: in clinical practice, patients scheduled for biopsy often suffer substantial stress before, during or after the procedure. in particular, most patients feel uncomfortable both with the procedure itself and with the idea of the results of the biopsy. providing adequate information is crucial, though there is no agreement as to which is the best way to present such information. although verbal information provided by the professional is the most common scenario, the use of written information in the form of explanatory leaflets, as well as audio recordings or videos, has also been proposed the present study was carried out at the dental school of universidad de san carlos (guatemala) to evaluate the hypothesis that an audiovisual intervention providing information on oral biopsy is able to reduce patient anxiety and stress.

a prospective, randomized clinical trial was carried out involving. a total of 120 patients were therefore finally randomized, following the consort statement guidelines, with the definition of two groups: a control group (n = 60) that received standard verbal information, and an experimental group (n = 60) that received information in the form of a video

Eligibility criteria:
inclusion criteria: * the inclusion criteria were a patient age of over 18 years and the presence of an oral lesion/s requiring biopsy. exclusion criteria: * patients with decompensated systemic disorders, poor general condition, a history of psychiatric disease or psychoactive drug use were excluded, as were pregnant women and individuals failing to sign the informed consent document.
diagnostic efficiency of artificial intelligence for surgical neuropathology

Conditions: Central Nervous System Neoplasms

Summary: this is a multi-center, prospective, self-controlled, diagnostic accuracy comparative study of artificial intelligence diagnostic system for surgical neuropathology. the investigators will compare the diagnostic efficiency of artificial intelligence with that of practicing pathologists, and suppose that the diagnostic efficiency of artificial intelligence in prospective clinical data is no less than that of pathologists.

in this study, 141 patients will be recruited. after being enrolled, the patients will accept surgery and specimens for pathological analysis will be taken according to the routine treatment process. the histopathologic slides will then be digitized by a whole-slide scanner. the images will be reviewed by gold standard committee for evaluation of ground truth. and then be separately diagnosed by artificial intelligence diagnostic system and practicing pathologists. so the investigators can compare the diagnostic efficiency of artificial intelligence with that of pathologists, thus understand the gap between artificial intelligence and actual clinical practice.

Eligibility criteria:
inclusion criteria: 1. patients or their guardians understand the research process, agree to use their data, and sign the informed consent form; 2. aged \>=18 years; 3. mri shows intracranial spaceoccupying lesions; 4. the clinical diagnosis is glioma, metastasis or lymphoma thus requiring surgical treatment; 5. the patient is willing to accept the surgery. exclusion criteria: 1. the patient has serious underlying diseases thus is not suitable for surgery; 2. after further clinical evaluation, surgical treatment was not the best choice; 3. the patient participate in clinical research of other drugs or devices; 4. the researchers believe that there are other factors that will make the patients unable to complete the study.

Keywords: artificial intelligence cns tumor surgical pathology diagnostic accuracy study
efficacy of dexmedetomidine vs magnesium sulphate with bupivacaine in erector spinae block for thoracotomy pain

Conditions: Analgesia

Summary: postoperative pain management is considered an integral part of perioperative care in patients undergoing thoracotomy. in order to reduce these complications, multiple regional techniques have been developed for thoracotomy including intercostal nerve block, erectospinae plane block and serratus block. multiple adjuvants have been used in regional analgesia including adrenaline,clonidine,magnesium sulphate,dexmedatomidine and opoids.


Eligibility criteria:
inclusion criteria: * age from 18 to 65 years. * male and female sexes. * asa i-ii.,iii * cancer patients undergoing thoracotomy incisions * body mass index (bmi) from 18.5 to 30 kg/m2 exclusion criteria: * patient refusal * known allergy to any of the used drugs * low platelet count, any coagulation defect
effect of exenatide on glucose homeostasis determinants in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine in type 2 diabetic patients in secondary failure to combined oral therapy whether, besides improvement in glycemic control, addition of exenatide, a new drug introduced to treat diabetes before addition of insulin to current therapy, over 6 months is associated with improvement in beta-cell function, insulin sensitivity following 24-hours discontinuation of the drug.


Eligibility criteria:
inclusion criteria: * type 2 diabetes subjects * 40 to 80 years * body mass index (bmi) between 25 and 40 kg/m² * baseline glycated haemoglobin (hba1c) \> 7.0 %, despite a maximally-tolerated combined oral therapy with a bcf stimulant (sulfonylurea or repaglinide) plus metformin exclusion criteria: * previous or current use of glitazone * previous use of systemic glucocorticoids, weight-reducing drug(s) such as sibutramine * previous exposure to glp-1 receptor agonist or dpp-4 inhibitors

Keywords: t2dm exenatide hba1c weight waist circumference insulin sensitivity beta-cell function
comparative assessment of effectiveness and safety of methods for skin and hair care in severe intensive care unit patients

Conditions: Pressure Ulcer

Summary: skin care for seriously ill patients in the intensive care unit (icu) is one of the key components in the prevention of serious complications that affect the treatment outcome. bed rest, prolonged skin contact with biological secretions (urine, faeces, etc.) containing active irritating metabolic products (urea, faecal proteases, lipase, bile salts), and the use of diapers (disposable or otherwise) result in patient skin damage. skin microbiota metabolizes urine that leads to alteration of skin ph, and promotes the propagation of opportunistic microorganisms causing infectious complications of skin and soft tissues. additional factors, such as pressure on soft tissues, friction, or soft tissue displacement, lead to the formation of pressure sores which seriously worsens clinical results, patients' life quality, and significantly increases treatment costs. statistics on the incidence of pressure sores in russian medical institutions are rather scarce. it was reported that the incidence of pressure sores in hospice patients is up to 22.4%, and when assessing skin and soft tissues infections in icu patients, the incidence of pressure sores is 28.9%. a meta-analysis of foreign studies on the prevalence of pressure sores in icu showed an incidence range of 7.8%-54% in studies using the methodology of the european pressure ulcer advisory panel, 6-22% in studies applying the methodology of the national pressure ulcer advisory panel, and 4.94% for a study that used the torrance system. the probable range of the prevalence of pressure sores worldwide in intensive care facilities is from 6% to 18.5%. a recent uk randomized study found the development of new pressure sores or progression of existing ones in 15% of icu patients with an expected stay in the ward for at least 36 hours. unfortunately, premorbid skin conditions that contribute to the formation of trophic disorders are largely overlooked, which results in the absence of a proper risk management system. use of the traditional method of skin care in patients including liquid soap, napkins, and diapers can disrupt the skin barrier function and increase the risk of bedsores. this treatment method contributes to probable damage of the hydrolipid skin layer, the formation of skin microcracks, and the chemical irritation of skin, which is aggravated by frequent washing. the current trend is the use of methods that allow frequent skin washing without compromising its barrier function.


Eligibility criteria:
inclusion criteria: 1. estimated length of stay in icu - 3 days or more. 2. signed informed consent form. exclusion criteria: 1. the presence of trophic skin changes (bedsores, maceration, intertrigo). 2. allergy to any component of the investigated products for skin and hair care.

Keywords: hygienic gloves icu nosocomial infections patient skin care pressure sores skin lesions critical care nursing
leo 22811 - a phase 1, double-blind, placebo-controlled, single and multiple oral dose study in healthy subjects

Conditions: Psoriasis Vulgaris

Summary: the purpose of this first-in-man trial is to determine the safety and tolerability of ascending single and multiple doses of leo 22811 in healthy male subjects as well as to determine the safety and tolerability of single oral doses of leo 22811 in healthy female subjects. the trial will be performed in two parts. in part 1, single doses of leo 22811 will be administered to healthy male and female subjects. in part 2, multiple doses of leo 22811 will be administered to healthy male subjects.


Eligibility criteria:
inclusion criteria: (in summary) * subjects will be caucasian males or females of non-child bearing potential between 18 and 65 years of age * subjects will have given their written informed consent to participate in the study and to abide by the study restrictions exclusion criteria: (in summary) * women of childbearing potential * subjects with an infectious illness within 3 days prior to dosing * subjects with a history of tuberculosis * subjects who have received any prescribed systemic or topical medication (including natural/herbal medicines) within 14 days of the first dose administration * subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration * in part 2, subjects who have received or been exposed to cloroquine products, endoxan, or any immunomodulating agent (e.g. azathioprin) within one month prior to the start of dosing * subjects who are participating in a clinical study * subjects with a significant history of drug allergy or with a known or suspected hypersensitivity to any of the components of leo 22811 as determined by the investigator * subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the investigator * subjects who have a supine blood pressure and supine pulse rate at screening higher than 150/90 mmhg and 100 beats per minute (bpm), respectively, or lower than 90/40 mmhg and 50 bpm, respectively * subjects who have pr interval \>= 200 ms, qtc(b) interval \>450 ms (males) or \> 470 ms (females), or who exhibit u waves of atrio-ventricular blocks at screening, based on 12-lead ecgs * subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse * subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day * subjects with a significant cardiac history (e.g. heart failure, hypokalemia, long qt syndrome) * subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the investigator * subjects who, in the opinion of their general practitioner (gp) or the investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol