Kornimate/medical-research-clean huggingface dataset:
local excision versus total mesorectal excision in pathological complete response (ypt0-1cn0) mid- or low-rectal cancer after neoadjuvant therapy

Conditions: Rectal Cancer; Surgery

Summary: patients with ct2-4an0-2m0 mid- or low-rectal cancer received neoadjuvant chemotherapy or combined chemoradiotherapy. good responders (ct0-1n0) patients received local excision 4-8 weeks after treatment. pathologically verified ypt0-1 patients are randomized to observation (local excision group) or complementary rectal excision (total mesorectal excision group). the composite end points include 3 year disease-free survival (dfs), overall survival (os), recurrence, major morbidity and quality of life.

total mesorectal excision is still the standard surgical treatment of mid-and low advanced rectal cancer after neoadjuvant treatment. this radical procedure inevitably has the risk of major short and long term morbidity and anorectal function impairment. additionally, abdominal perineal resection(apr) with permanent stoma is still applied to some low rectal cancer patients, even though major response had been achieved after neoadjuvant treatment. previous studies have proposed "wait and see" strategy in clinical complete response patients. the local recurrence rate is still high due to residue adenocarcinoma lesion. local excision is a conservative alternative approach associated with low mortality and morbidity and high quality of life. in this study, the investigators proposed local excision in good responders (ct0-1n0) 4-8 weeks after neoadjuvant treatment. patients with pathologically verified complete response (ypt0-1cn0) are randomized to observation (local excision group) or complementary rectal excision (total mesorectal excision group). the purpose of this prospective randomized controlled study is to compare local excision versus total mesorectal excision in pathological complete response (ypt0-1cn0) mid- or low-rectal cancer after neoadjuvant therapy.

Eligibility criteria:
inclusion criteria: * 1、willing and able to provide written informed consent. 2、histological or cytological documentation of adenocarcinoma of the rectum (≤8 cm from the anal verge). 3、ypt0-1cn0 after neoadjuvant therapy 4、no metastatic disease. 5、patient is at least 18 years of age. 6、eastern cooperative oncology group (ecog) performance status of 0 or 1. 7、non complicated primary tumor (obstruction, perforation, bleeding). exclusion criteria: * 1、t1, t4 tumour or anal sphincter invasion 2、metastatic disease (m1) 3、contra indication for radiotherapy and/or fluoropyrimidine use in chemotherapy 4、current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study 5、history of cancer
comparison of single intravitreal injection of triamcinolone or bevacizumab for the treatment of diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: the purpose of this study is to compare a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular edema.

comparison a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab regarding the ability of central macular thickness reduction. secondary objectives are analysis of visual outcomes and variations on intraocular pressure. the patients data were statistically analyzed if there was a 24 week follow up completed.

Eligibility criteria:
inclusion criteria: * diabetic macular edema with central foveal measurement over 300 micrometers exclusion criteria: * glaucoma * vitreoretinal surgery * cataract surgery less than 3 months prior inclusion * unilateral cataract surgery * uncontrolled glycosylated hemoglobin * previous intraocular injection * systemic corticosteroids less than 1 month prior inclusion * macular ischemia at fluorescein angiography * cataract precluding fundus examination * active proliferative diabetic retinopathy

Keywords: diabetic macular edema intravitreal injection pharmacological treatment
the effect of telephone and video counseling on weight loss and quality of life

Conditions: Weight Loss; Obesity

Summary: individuals with obesity are at higher risk for severe disease, hospitalizations, and death from the sars-cov-2 virus. social distancing guidelines intended to prevent viral spread during the covid-19 pandemic resulted in major changes to daily routines . several studies have demonstrated that individuals with overweight/obesity reported worsening mental health, poor eating habits , less physical activity (pa) since the onset of the covid-19 pandemic. because of these pandemic rules, the use of phone/video consultancy applications and online classes for body weight control and diet monitoring is increasing. therefore, in this study it is aimed to determine the effect of diet counseling via phone or video on weight loss and to compare it with the traditional follow-up method in the covid-19 pandemic.

the use of phone/video consultancy applications for body weight control and diet monitoring is increasing. one of the main reasons for this situation is that individuals care more about the social distance rule as a result of the increase in health concerns after the covid-19 (sars-cov-2) pandemic. in addition, due to the uncertainty of how long the pandemic will last, many people are adapting to online applications and programs quicly. however, it's unclear which method of phone/video-based diet counseling is more successful or preferable to traditional diet follow-up. based on the above-mentioned information; in this study, it is aimed to determine the effect of diet counseling via phone or video on weight loss and to compare it with the traditional follow-up method in the covid-19 pandemic. individuals who meet the research criteria will randomize according to their file numbers (with the ramdomizer program) and divide into 3 groups: telephone counseling (15), video counseling (15) and traditional follow-up group (figure 1.). food consumption records, anthropometric measurements and quality of life scale scores of all individuals will record at the beginning and end of the study (figure 2.). in order to prevent interaction between individuals, all diet programs will prepare at different times and individually.

Eligibility criteria:
inclusion criteria: * being between the ages of 20-65 * being obese (bmi≥30 kg/m2) * having a smartphone with internet access and being competent to use it * volunteering to participate in research exclusion criteria: * being pregnant/lactating * having a hearing problem * being on a followed diet program

Keywords: obesity weight loss covid-19 pandemic
efficacy of the administration of colloidal silicon dioxide in tablet dosage form in patients with acute diarrhea

Conditions: Diarrhoea;Acute

Summary: the purpose of the study is to demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet dosage form (carbowhite) in patients with acute diarrhea.

background: diarrhea is a medical condition characterized by frequent stool, more than 3 times (and more than 5-7 times in newborns) within the last 24 hours, and/or loose stool. the fecal matter is liquid, its daily mass exceeds 200 g per day, and water content reaches 95%. objectives: to demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet dosage form (carbowhite) in patients with acute diarrhea. methods: a randomized clinical trial, double-blind, placebo-controlled, multi-center.

Eligibility criteria:
inclusion criteria: * signed informed consent form for patient's study participation * male and female patients at the ages from 18 to 55 years * acute diarrhea (more than three episodes of liquid stool a day) within 48 hours or less in patients with usually normal stool * body temperature of ≤ 38 °c * patient's ability to adequately cooperate in the process of study exclusion criteria: * aged of \ 55 years; * blood or pus in stool; * body temperature of \>38 °c; * episodes of acute diarrhea for the last 30 days; * administration of antidiarrheal products for the last 24 hours; * salmonellosis (salmonella of any serotype different from s. typhi and s. paratyphi; icd-10: a02.0), dysentery (shigella dysenteriae, shigella flexneri, shigella boydii; icd-10: a03.0-a03.3), colibacillosis (escherichia coli; icd-10: a04.0-a04.4) which require administration of antimicrobial products; * pregnancy, lactation; * concomitant decompensated diseases or acute conditions which, according to an investigator, may affect study results * alcoholism and drug abuse; * participation in any other clinical study.

Keywords: diarrhoea carbowhite colloidal silicon dioxide
prehospital cerebral oxygenation during cardiopulmonary resuscitation (cpr)

Conditions: Cardiac Arrest

Summary: near infrared spectroscopy (nirs) is a technique that measures regional cerebral oxygenation in a non-invasive manner. through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. by applying the beer-lamber law, a numeric result can be calculated. during a cardiac arrest, there is no stroke volume, no cardiac output and no cerebral perfusion. by using cerebral nirs during out-of hospital cardiac arrest, low flow time and return of spontaneous circulation, this study wants to show the prognostic value of nirs as extra monitoring.


Eligibility criteria:
inclusion criteria: * \>16 year exclusion criteria: * dnr code

Keywords: cardiac arrest cerebral oxygenation pre-hospital
sensory assessment and regression rate of bilateral external oblique intercostal block and m-tapa block

Conditions: Pain, Postoperative; Pain, Acute; Pain

Summary: external oblique and m-tapa blocks are routinely performed on patients undergoing laparoscopic cholecystectomy in our clinic. in this study, sensory block and regression rates will be investigated in patients who underwent block.

external oblique block and m-tapa blocks may be the key to provide adequate analgesia in patients undergoing abdominal surgery by blocking the abdominal nerves. in this study, the sensory dermatome block area calculation and the regression rate of the blocks will be evaluated in patients who underwent eoib and m-tapa.

Eligibility criteria:
inclusion criteria: * patients undergoing l/s cholecystectomy exclusion criteria: * patients who do not want to participate

Keywords: cutaneous block sensory assessment regression rate
7 year follow-up study of the danrisk population

Conditions: Cardiovascular Disease; Coronary Artery Calcification; Atherosclerosis

Summary: objectives: to investigate the incidence of cardiovascular events as well as progression of coronary artery calcium (cac) in healthy middle-aged subjects over a period of 7 years, and the relation to traditional as well as new cardiovascular risk factors. methods: the danrisk cohort was established in 2009-2010 based on random retrieval from the danish national civil registry (n=1825). initially, distribution of gender, area of residence and year of birth (1949 or 1959) were equal among the 4 involved centres (ouh, svendborg, vejle and esbjerg). a total of 1257 subjects (69%) accepted the invitation to undergo cardiovascular risk evaluation including non-contrast enhanced cardiac ct-scan for cac estimation, and a total of 1227 subjects were found free of cardiovascular disease (cvd) and diabetes (dm), and was included in the study back then. in 2014-2015 the danrisk cohort was invited to a 5 year follow-up examination. the investigators examined a total of 1031 subjects (82%) in the investigators 4 regional centres. the follow-up examination included general health evaluation and estimation of cac by non-contrast enhanced cardiac ct-scan. information of death, cardiovascular events and medication usage was obtained from the danish national patient register, the danish register of causes of death and the danish national database of reimbursed prescriptions in 2016.


Eligibility criteria:
inclusion criteria: * born in either 1949 or 1959 * residence in/near one of the regional centres (esbjerg, svendborg, vejle, odense). exclusion criteria: * known cardiovascular disease
general anesthesia versus sedation during intra-arterial treatment for stroke

Conditions: Stroke

Summary: in france, the annual incidence rate of acute ischaemic stroke is around 150 000 patients, 65 % of whom keep long-term disability. several multicentric randomized controlled trials have shown the benefit of a mechanical thrombectomy in the acute phase of ischaemic stroke on functional disability, compared to a medical treatment alone (thrombolysis). the timeliness of revascularisation is an essential factor of good prognosis. this intra-arterial treatment, associated with thrombolysis if applicable, is the reference treatment of large-vessel occlusion. the stillness of the patient is required to control the safety of the recanalization. currently, either a general anesthesia or a sedation can be performed. several studies have shown a trend to superiority of the sedation but none was conducted with a high level of proof methodology. the aim of our multicentric randomized controlled trial is to compare sedation and general anesthesia during intra-arterial thrombectomy for an acute ischaemic stroke in the anterior cerebral circulation. the main outcome will be the efficacy on the functional neurological prognosis at 3 months.


Eligibility criteria:
inclusion criteria: * age \> 18 years * body mass index \< or equal to 35 kg/m² , * indication for thrombectomy, after multidisciplinary consultation, * proximal artery occlusion in the anterior circulation (internal carotid artery, m1, m2,...), confirmed on imaging (angioscan or angio-mri), * written informed consent of the patient or a close / trusted person when possible, or emergency procedure, * patient affiliated to or beneficiary of an health insurance non-inclusion criteria: * comorbidity committing short-term prognosis, * hemodynamic instability, * pregnant woman, * contra-indication to sedation: pre-existing swallowing impairment; restless patient, not able to stay lying down; glasgow score \< 8, * contra-indication to general anesthesia, * intubated patient at inclusion, * additional intracerebral hemorrhage, * sign of occlusion in a different cerebral territory, * known contra-indication to succinylcholine: hypersensitivity, hyperkaliemia, * known contra-indication to one of the anesthesic agents, * patient participating in another clinical trial, possibly interfering with the study procedures, * patient in a known situation of deprivation of freedom, guardianship or curatorship. exclusion criteria: * patients with deprivation of freedom will be excluded as soon as the investigator will have knowledge of the situation.

Keywords: ischemic stroke thrombectomy anesthesia sedation
ysgg application in periodontal treatment

Conditions: Periodontal Diseases

Summary: adjunctive use of er,cr:ysgg (erbium-chromium-yttrium-scandium-gallium-garnet) laser in combination with conventional, mechanical periodontal treatment may benefit in complete decontamination of the periodontal pocket leading to improved early healing and better long term clinical result. radial firing periodontal tip (rfpt) offered by the er,cr:ysgg system is devised to let irradiation primarily in radial pattern (85%) with lesser portion in straight manner (15%), meaning laser beams are effectively emitted to affected root surface and inner epithelium of periodontal pocket with simple tip management. therefore, using er,cr:ysgg laser with rfpt could be the best option for periodontal laser therapy. the aim of this study is to investigate adjunctive treatment effect using er,cr:ysgg laser and rfpt in moderate to severe periodontitis patients. study subjects are randomly allocated to either 'scaling and root planing (srp) only' or 'srp + laser therapy' group. periodontal parameters including probing pocket depth (ppd), clinical attachment level (cal), modified gingival index (mgi), and plaque index (pi) are recorded at baseline and 8 weeks after treatment. gingival crevicular fluid (gcf) samples are obtained using paper strips at baseline, 1w, 2w, 4w, and 8w post op. to determine laser-induced effect in early wound healing. cytokine levels are evaluated from the gcf samples taken.


Eligibility criteria:
inclusion criteria: 1. diagnosis of stage iii or iv periodontitis based on the 2017 periodontitis classification (tonetti, greenwell, \& kornman, 2018); 2. minimum of two teeth with probing depth (pd) ≥ 6 mm and radiographic bone loss in at least two quadrants of the whole dentition; 3. each quadrant with a minimum of four teeth; and 4. systemically healthy patients. exclusion criteria: 1. history of periodontal treatment in the previous six months; 2. antibiotic medication in recent three months; 3. under steroid therapy or taking any anti-inflammatory drugs in recent three months; 4. history of any systemic disease that may influence the periodontal condition and treatment outcome, including diabetes mellitus, cancer, metabolic diseases, cardiovascular disease, and rheumatoid arthritis; 5. pregnancy or breastfeeding; and 6. smoking habits.
impact of desflurane and sevoflurane on postoperative delirium in elderly patients

Conditions: Delirium; Postoperative Cognitive Dysfunction

Summary: advanced age is a consistent risk factor for the incidence of postoperative cognitive decline, which is associated with longer hospital stays, decreased quality of life, and increased mortality. anaesthetic drugs can also affect postoperative cognition, as their residual effects can alter central nervous system activity. desflurane and sevoflurane are widely used volatile anesthetics. choice anesthetics may influence the occurrence of postoperative delirium. however, evidence in this aspect is conflicting.

with increasing life expectancy, more and more patients aged 65 or older will receive general anesthesia. rapid recovery from anesthesia may reduce the incidence of many postoperative complications, such as postoperative delirium and cognitive dysfunction. using inhalational anesthetics is the mainstay of general anesthesia. since they pass readily into the brain, anesthetics are usually recognized as the important cause of postoperative cognitive dysfunction. studies have shown that inhalation anesthesia may increase the risk of postoperative delirium in elderly patients compared to propofol, but such studies mostly focus on isoflurane and sevoflurane. concentrations isoflurane caused aggregation of amyloid peptides in cell cultures, indicating that they brought cytotoxicity to the brain; sevoflurane also showed the same cytotoxic effect. however, some studies showed that inhalational anesthetics had a protective effect on postoperative cognitive function. desflurane is currently known to be the least biotransformation inhaled anesthetic, whose blood-gas partition coefficient is only 0.42. desflurane is increasingly used in elderly patients in clinical practice. however, it is not clear whether general anesthesia maintained mainly by desflurane reduces postoperative delirium and early cognitive dysfunction compared with sevoflurane-based general anesthesia

Eligibility criteria:
inclusion criteria: 1. age ≥ 65 years and \< 90 years; 2. scheduled to undergo non-cardiac or non-neurosurgery with an expected duration of 2 hours or more, under general anesthesia; 3. agree to participate, and give signed written informed consent. exclusion criteria: 1. preoperative history of schizophrenia, epilepsy, parkinsonism or any diseases of central nervous system; 2. inability to communicate in the preoperative period (coma, dementia, language barrier, impaired hearing or vision); 3. severe diseases in cardiovascular, respiratory, liver, kidney, or preoperative american society of anesthesiologists physical status classification ≥ iv; 4. alcoholism and drug dependence; 5. other reasons that are considered unsuitable for participation by the responsible surgeons or investigators (reasons must be recorded in the case report form).
dbt to enhance health behaviour change for adolescents living with obesity

Conditions: Prevention; Type2Diabetes

Summary: this research is being conducted to evaluate emotion-focused therapy that incorporates elements of mindfulness, distress tolerance, and relationship support. the investigators want to learn if this therapy, called dialectical behavioral therapy (dbt) will help improve quality of life and weight management in youth at risk for type 2 diabetes. individuals will be randomly assigned to weekly group based session in one of 3 intervention arms; lifestyle + dbt, lifestyle alone, or a control arm.


Eligibility criteria:
inclusion criteria: * 14-17 years old * bmi z-score \>1.6 * signs of mild-moderate depression (phq-9 score 5-19) * willing and able to comply with study procedures exclusion criteria: * more than one health co-morbidity * being treated with medication for obesity * taking steroids * currently being treated for atypical antipsychotics * have an orthopedic injury or chronic illness that would prevent them from performing the intervention * experienced weight loss or enrolled in weight loss program in the six months prior to the study * self reported history of alcoholism or drug abuse * history of self-harm or suicide attempts in the past 12 months * currently enrolled in psychotherapy or dbt * parents do not approve of you participating * unable/unwilling to give assent/consent
liposomal bupivacaine versus lidocaine for skin graft donor site pain

Conditions: Pain, Postoperative; Burns

Summary: donor site pain study comparing post-operative donor site pain and opioid consumption after use of lidocaine, liposomal bupivicaine or regional nerve block for split thickness skin graft harvesting in patients with less than 20% tbsa burn wounds and less than %5 deep partial or full thickness burn wounds.

the first phase of the study was a randomized controlled study. in the second phase, all subjects will receive fascia iliaca, lateral femoral cutaneous, or femoral nerve blocks based on the proposed donor site location and will be compared to historic controls from the first phase. in the first phase, the control group underwent split thickness autografting using the standard protocol, involving injection of lidocaine with epinephrine at the donor site. in the first phase, the experimental group underwent injection of liposomal bupivacaine (exparel) at the time of harvest of the skin graft. in the second phase, patients will undergo preoperative regional anesthesia with a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location rather than the standard protocol of lidocaine with epinephrine at the donor site. thus, in the second phase, group 3 (preoperative block group) will be compared to historic controls which received the standard of care in the first phase of this trial. baseline pain levels will be obtained for all subjects using a validated pain assessment scale, the visual analog pain scale. postoperatively, time to first opioid pain medication (excluding immediate postoperative recovery from anesthesia), total opioid consumption on a daily basis, and donor site interval pain scores using a validated pain assessment scale will be obtained. the experimental groups will then be individually compared to the control group to determine if there is a significant difference in pain levels, time to first opioid, and overall opioid consumption between the groups.

Eligibility criteria:
inclusion criteria: * spanish/english speaking * \<20%tbsa; \<5% tbsa deep partial or full thickness burns exclusion criteria: * chronic pain syndrome * \> 20% tbsa burn injury; \> 5% tbsa deep partial or full thickness burn * pregnant * allergy to lidocaine or other local anesthetics * burns to anterior thighs