Kornimate/medical-research-clean huggingface dataset:
efficacy of topical insuline in corneal epithelial healing post prk

Conditions: Corneal Epithelial Wound Healing

Summary: a prospective randomized double-blind controlled trial will be conducted. the informed consent of each patient will be obtained prior to the procedure. all patients will undergo a classic prk procedure patients will be instructed to use eye drops blindly in both eyes at a frequency of six times daily: * in one eye: insulin drops formulated by combining regular human insulin with artificial tears containing polyethylene glycol (peg 400) 0,25% at a concentration of 1 unit per milliliter. * in the other eye: placebo drops containing only artificial tears. for the double-blind trial, two identical vials will be provided to each patient: one labeled r (for the right eye) and one labeled l (for the left eye). using the bloc randomization method, the pharmacy will be the only entity aware of the composition of each vial, ensuring that 50% of patients use insulin drops in the right eye and 50% in the left eye. every week the drops will be prepared one day prior to the prk procedure and will be stored in a refrigerator, to be used within one week of their preparation date. patients will be examined by two ophthalmology residents on days 2 and 4 post-operatively. the size of the epithelial defect in both eyes will be measured using the imagej software. thus, the primary outcome of the study is the ulceration closure rate: the smaller the defect, the faster the epithelial healing is. additionally, a comparison of subjective symptoms reported by the patient in each eye will be recorded.


Eligibility criteria:
inclusion criteria: * myopic or astigmatic patient undergoing excimer laser prk exclusion criteria: * diabetes mellitus prior ocular surgery ocular surface disease (including dry eye disease, history of herpetic keratitis) previous ocular trauma use of systemic corticosteroids
study to evaluate the safety & performance of the xpert(tm) stent in treating below-the-knee lesions in patients undergoing percutaneous intervention for chronic cli.

Conditions: Chronic Critical Limb Ischemia; Peripheral Vascular Diseases

Summary: the purpose of this study is to evaluate the safety and performance of the xpert(tm) self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in patients undergoing percutaneous intervention for the treatment of documented chronic critical limb ischemia (cli).

peripheral arterial disease (pad) of the lower extremities affects roughly 25 million americans annually. the diabetic population is particularly prone to the most severe clinical problems associated with pad and the amputation rate amongst such patients is elevated five-fold. it has been shown that patients who undergo amputation for pad/cli have a much higher mortality rate in the months that follow. despite medical advances in the fields of pharmacology and wound care, the vast majority of patients who present with cli will ultimately require amputation in the absence of improved blood flow. recently, much attention has been directed towards less invasive endovascular solutions for treating patients with cli. this study will evaluate approximately 140 subjects with rutherford class iv-vi pad in a multi-center study in order to accurately estimate limb salvage rates for this treatment.

Eligibility criteria:
inclusion criteria: * patient has documented wound care greater than or equal to 2 weeks prior to enrollment * subject understands the duration of the study and its follow up visit requirements * female subjects of childbearing potential have a negative pregnancy test less than 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation * subject has documented chronic critical limb ischemia in the target limb for two weeks with rutherford category 4, 5 or 6 * subject must have one of 5 approved non-invasive test results of the target limb within two weeks of enrollment. exclusion criteria: * life expectancy of less than 12 months * cerebrovascular accident (cva) or myocardial infarction (mi) within 3 months prior to enrollment * inability to walk (with assistance is accepted) * previous bypass surgery to target limb less than 30 days prior to study procedure * acute thrombus at the lesion site(s)

Keywords: cli critical limb ischemia
the clinical investigation of a zinc based toothpaste in reducing plaque and gingivitis

Conditions: Dental Plaque and Gingivitis

Summary: this is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.


Eligibility criteria:
inclusion criteria 1. subjects, ages 18-70, inclusive. 2. availability for the six-month duration of the clinical research study. 3. good general health. 4. minimum of 20 uncrowned permanent natural teeth (excluding third molars). 5. initial gingivitis index of at least 1.0 as determined by the use of the loe and silness gingival index. 6. initial plaque index of at least 1.5 as determined by the use of the quigley and hein plaque index (turesky modification). 7. signed informed consent form. exclusion criteria 1. presence of orthodontic bands. 2. presence of partial removable dentures. 3. tumor(s) of the soft or hard tissues of the oral cavity. 4. advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). 5. five or more carious lesions requiring immediate restorative treatment. 6. antibiotic use any time during the one-month period prior to entry into the study. 7. participation in any other clinical study or test panel within the one month prior to entry into the study. 8. dental prophylaxis during the past two weeks prior to baseline examinations. 9. history of allergies to oral care/personal care consumer products or their ingredients. 10. on any prescription medicines that might interfere with the study outcome. 11. an existing medical condition that prohibits eating or drinking for periods up to 4 hours. 12. history of alcohol or drug abuse. 13. pregnant or lactating subjects.
urinary human papilloma virus test in the general population in brittany

Conditions: Neoplasms,Ovarian

Summary: this is a population-based, prospective, multicenter and open-label study. 12,500 female non-respondents to the uterine cervix smear from 30 to 65 years of age in the context of the organized cervical cancer screening of the uterus, in the 4 breton departments, will be proposed after stratification by age and socio-economic level at the revival of the cervical cancer of the uterus screening by the structure of management of rennes, an invitation to the human papilloma virus urine test thanks to the sampling kit sent to the home. it is planned a revival by simple mail after 4 months in one woman out of two who did not respond to this invitation to assess the impact of a recovery. this group represents about 5% of the eligible population in brittany. the specimen will be sent by post with the signed consent and a questionnaire to the hospital of brest in virology laboratory for the detection of human papilloma virus dna (qpcr) in the urine (hpu test) and typing (lipa). in the case of a positive human papilloma virus test, the woman being tested has a strong incentive to do the cervical cancer of the uterus with her doctor or midwife. in the case of abnormal smear, follow-up continues according to national recommendations to a gynecologist. all the data is collected on a software from the links company, with the networking of the 4 breton centers, the virology laboratory, and the anatomy-cytology-pathology laboratories in brittany; this collection will allow after extraction, a statistical analysis of the data. the analysis of the participation rate in this new screening, for each level of the socio-economic level, will allow a comparison with the participation in smear's revival of organized screening, between women's groups according to the socio-economic level of their residential place. the project will take place over 24 months in 3 phases: 1. d0-m6: pre-inclusion phase with implementation of the protocol (regulatory procedures, production of newsletters, consent, questionnaire, preparation of urine collection kits, postal validation). 2. m6-m18: inclusion phase with start of the study, sending invitations and inclusion, human papillomavirus urinary testing and uterine cervix smear monitoring. 3. m18-m24: post-inclusion phase with assessment of the inclusions on the 4 breton departments, verification and analysis of the data according to the socio-economic level, recovery of the uterine cervix smear stimulus data, realization of the statistical analyzes and budget impact analysis, communications and publications.


Eligibility criteria:
inclusion criteria: * women from 30 to 65 years old who did not do uterine cervix smear and who live in brittany exclusion criteria: * women under 30 years or over 65 years * women of 30-65 years who have responded to the uterine cervix smear invitation * women who have had an uterine cervix smear raise * women who have already had an uterine cervix smear within 3 years * women who had a total hysterectomy
pulmonary embolism registry

Conditions: Pulmonary Embolism

Summary: acute pulmonary embolism (pe) is the most serious clinical presentation of venous thromboembolism (vte), a leading cause of cardiovascular mortality, exceeded only by stroke and myocardial infarction. chronic thromboembolic pulmonary hypertension (cteph) is the most severe chronic form of cted and it occurs in 2-4% of patients after acute pe. in portugal little is known about pe epidemiology and its outcomes, including complications like cted. the main goal of this study is, therefore, to understand pe epidemiology and complications in the northern region of portugal. this information can enable the organization of a structured health care network that can potentially benefit all pe patients.


Eligibility criteria:
inclusion criteria: * acute symptomatic or asymptomatic pe, * age \>18 years, * availability of a minimum data set for pe and a minimum of 3-months follow-up for the primary objective and 36-months for the secondary one. except for patients who died prior to the 3 or 36 months follow-up. exclusion criteria: * enrolment of the patient in any treatment trial in a blinded fashion, * lack or withdrawal of patient´s consent.

Keywords: pulmonary embolism, venous thromboembolism, chronic thromboembolic disease
evaluation of dopaminergic denervation by datscan brain scintigraphy using a new multipurpose czt system

Conditions: Parkinson Disease

Summary: datscan is an important tool in the diagnosis and clinical management of parkinson's syndromes. new cadmium-zinc-telluride (czt) systems allow time and/or dose reduction. this can be interesting in datscan acquisitions as those are long-lasting, often on difficult patients. this study will evaluate the diagnostic performances of a new 3d-ring czt camera in datscan spect.

datscan is an important tool in the diagnosis and clinical management of parkinson's syndromes, particularly for the diagnosis of parkinson's disease or in the exploration of dementia-type neurodegenerative diseases. the acquisition of tomoscintigraphic images is performed 3 hours after injection and lasts approximately 30 minutes on a conventional gamma camera. recently, the introduction of systems equipped with cadmium-zinc-telluride (czt) technology has made it possible to reduce acquisition times and/or injected doses. among these systems, some new 3d-ring czt cameras allow tomoscintigraphic acquisitions to be carried out from the outset for the exploration of different organs. patients included in this study will be double scanned both on a conventional camera and on the new multipurpose czt system, with ct. the primary objective is to evaluate the diagnostic concordance between the datscan brain scintigraphy images from the new czt spect/ct system and those from the conventional spect camera, when visually interpreted blindly by experienced observers (nuclear medicine physicians), according to a diagnostic scale. striatal binding ratios (sbr) will also be compared. time reduction will also be evaluated on datscan spect data from the new multi-purpose czt system.

Eligibility criteria:
inclusion criteria: * patients referred to our nuclear medicine department for datscan scintigraphy. exclusion criteria: * under 18 years-old patients. * pregnant women or at risk of pregnancy. * breast feeding. * painful patients. * patients under guardianship. * patients in whom a standard examination is not feasible (agitation).

Keywords: datscan multipurpose czt camera
understanding covid-19

Conditions: SARS-CoV-2 Viral Kinetics and Host Immune Responses

Summary: this single-center prospective observational study will examine immune responses to to sars-cov-2 and how they correlate with its virological characteristics and clinical manifestations in infected patients. household contacts will also be included so that early immune responses and viral kinetics can be captured. patients and contacts will be followed for 8 and 2 weeks, respectively. the study will include a maximum of 250 participants.

the primary aim of this single-center prospective observational study is to establish how immune responses to sars-cov-2 or to cross-reactive viruses correlate with the virological and clinical characteristics of sars- cov-2-infected patients and their exposed household contacts. through iterative sampling, the viral kinetics of at least 50 infected patients will be evaluated in relation to symptom severity and innate and adaptive immune responses, while their household contacts will be observed for viral detection and immune responses. patients and contacts will be followed for 8 and 2 weeks, respectively. the study will include a maximum of 250 participants.

Eligibility criteria:
inclusion criteria: the following persons may be included: * a patient of any age meeting the european centre for disease control and prevention's confirmed case definition: "a person with laboratory confirmation of virus causing covid-19, irrespective of clinical signs and symptoms" (and/or high suspicion/actively being treated as covid+ cases pending test confirmation) * household contacts (defined as those sleeping in the same apartment/house as an infected patient) of a patient with laboratory-confirmed covid-19 (and/or high suspicion/actively being treated as covid+ cases pending test confirmation), whether symptomatic or not, and whether testing positive or not during a period of 14 days exclusion criterion: * long-term incapacity leading to the inability to provide informed consent while not having a patient representative with the ability to provide informed consent
effectiveness of medical coaching in enhancing periodontal health and lifestyle

Conditions: Periodontitis

Summary: periodontitis is a chronic inflammatory disease that adversely influences the supporting tissues of the teeth. it is primarily characterized by the accumulation of bacterial plaque and the host immune response. traditional periodontal therapy emphasizes the central roles of both oral hygiene education and risk factor management; however, maintaining a long-term optimal behavioral compliance remains challenging. the purpose of this randomized controlled trial is to assess how effective is medical coaching on oral health (mcoh) in improving plaque control (pcr) and gingival health (gbi) in patients with periodontitis after one month, in comparison to traditional oral hygiene instructions (ohi).

the baseline assessments included periodontal status, pcr, gbi (describe the achronym) and a systematic questionnaire on lifestyle factors (smoking, alcohol, food, exercise, sleep, and stress). the intervention group received tailored mcoh sessions that comprised goal-setting, emotional hurdle assessment and action planning, whereas the control group received conventional ohi.

Eligibility criteria:
inclusion criteria: * periodontitis patients exclusion criteria: * patients who do not wish to participate in the study.

Keywords: medical coaching periodontitis stress gingival health
a retrospective study of c-kit mutation status in asian patients with advanced gastro-intestinal stromal tumors (gist) treated with imatinib.

Conditions: Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib

Summary: imatinib is the current standard treatment for advanced gist. previous studies have shown that gist genotype was associated with treatment outcomes with exon 11 having superior outcome compared with exon 9 or wt.10, 11 in patients with exon 9 kit mutation, the response rate was higher at when imatinib was given at 800mg daily compared with the standard dose of 400mg daily. although the data linking tyrosine kinase mutation status and imatinib response in metastatic gists is intriguing, more information is needed before mutation testing is adopted as part of the routine analysis of high-risk or overtly malignant kit-expressing gists.25 despite the fact that exon 9 mutations are associated with a lower response rate, overall survival does not appear to be better with high-dose therapy. the investigators propose to conduct a retrospective analysis of mutational analysis on patients with gist and determine the relationship between patient response and imatinib dose.


Eligibility criteria:
inclusion criteria: 1. histologic diagnosis of advanced stage or metastatic gist 2. asian patient (as defined by the investigator) 3. first line treatment with imatinib 4. availability of tumor samples for kit mutation analysis 5. availability of tumor response rate and or time to progression data exclusion criteria: -

Keywords: advanced gastro-intestinal stromal tumors
effect of fresh gas flow differences on postoperative nausea and vomiting

Conditions: Nausea and Vomiting, Postoperative; Septoplasty/Septorhinoplasty

Summary: the aim of this study is to investigate the effect of fresh gas flow applied during general anesthesia on the incidence of postoperative nausea and vomiting in patients undergoing septorhinoplasty surgery. patients who agree to participate in the study will be divided into three groups according to the fresh gas flow applied: low flow (0.5 lt/min) (group l), medium flow (2 lt/min) (group m) and high flow (4 lt/min) (group h), and the postoperative nausea and vomiting data of the groups will be compared.

preoperative demographic characteristics and apfel score (smoking history, gender, postoperative opioid use, pob history) of the patients will be recorded. general anesthesia will be applied to all patients with standard asa monitoring. in general anesthesia induction, 2 mg/kg propofol, 1 mcg/kg remifentanil, 0.6 mg/kg rocuronium will be used for all patients. sevoflurane (minimum alveolar concentration of 1) will be used as a volatile agent and remifentanil (0.1 mcg-1 mcg/kg/h) will be used as an analgesic agent for anesthesia maintenance. after endotracheal intubation, fresh gas flow will be applied at 4 lt/min for 8 minutes, reduced to 0.5 lt/min in group l, 2 lt/min in group m, and maintained at 4 lt/min in group h. after extubation, patients will be monitored in the recovery unit for at least 30 minutes, and at postoperative 0th minute (when first seen in the recovery room), 30th minute, 1st hour, 6th hour, 12th hour and 24th hour, the nausea score of the patients will be evaluated using the numerical rating scale (nrs) with a score between 0 and 10. if vomiting is present, the number of times the patient vomited will be questioned and recorded. the patients' postoperative vas scores, the amount of antiemetics used, the amount of opioids used intraoperatively and postoperatively will be recorded, and comparisons will be made between the groups and evaluated.

Eligibility criteria:
inclusion criteria: * patients who agreed to participate in the study * 18-65 years of age * asa i-ii risk group patients exclusion criteria: * patient does not accept the study * presence of psychiatric disorder and patient's inability to cooperate * cognitive dysfunction * hearing problems * history of alcohol or drug addiction * presence of a serious pre-existing medical condition that limits objective assessment * complications developed during surgery * presence of any life-threatening condition after surgery * patient's classification is asa iii-iv

Keywords: fresh gas flow low flow anesthesia postoperative nausea vomiting
rectal short chain fatty acids combinations and substrate and energy metabolism

Conditions: Obesity; Type 2 Diabetes

Summary: gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. the role of gut-derived short-chain fatty acids (scfa), the formation of which is enhanced by microbial fermentation of fiber, is still controversial. one study found that an increase in the formation of scfa stimulated energy extraction from diet, with subsequent weight gain. in contrast, supplementation of non-fermentable carbohydrates, which lead to an increase in scfa formation, had beneficial effects on body weight control and insulin sensitivity. of note, a study showed that butyrate supplementation in mice prevented diet-induced obesity and insulin resistance. at the present time, our understanding of the effects of scfa on human metabolism (in gut or systemically) is still limited. yet, in light of the health claims of certain dietary fibers (prebiotics), a detailed picture of the physiology of human scfa metabolism and its interaction with the microbiome is of pivotal importance. we hypothesize that the differential availability of scfa impacts human metabolism differently. to determine whether rectal administration of scfa is a good model for studying the metabolic effects of scfa we first have performed a pilot study (metc 11-3-079). in this pilot study we have determined if rectal administration of sodium acetate has the same effects on substrate and energy metabolism compared to proximal administration. our results indicate that the primary outcome parameter fat oxidation was significantly changed during post-absorptive conditions, when sodium acetate in a concentration of 180mm was administered in the distal part of the colon. in contrast, no effect on energy expenditure or substrate oxidation was seen when sodium acetate was administered in the proximal colon. consequently, the distal part of the colon seems to be a good model to determine effects of gut-derived scfa on the human substrate and energy metabolism. therefore, we will administer in this study the scfa rectally by using enemas. we will administer different combinations of scfa to healthy, overweight male volunteers and examine effects on metabolism. this study is an important part of a gastrointestinal health tifn project (gh003 wp 1.2), which will provide more insight in how increased availability of a beneficial scfa mixture might serve as a basis for rational nutritional strategies in the prevention and treatment of obesity and type 2 diabetes mellitus. to obtain rational nutritional strategies, a next step in this tifn project will be focusing on dietary ingredients modulating intestinal microbiota and subsequent scfa production.


Eligibility criteria:
inclusion criteria: * overweight * obese men exclusion criteria: * athletes * diabetes mellitus