Kornimate/medical-research-clean huggingface dataset:
effect of epigallocatechin-3-gallate solution as a root canal irrigant on post-operative pain intensity and bacterial load reduction in necrotic tooth

Conditions: Necrotic Pulp

Summary: clinically compare the intensity of post-operative pain and the amount of bacterial load reduction after using 20% epigallocatechin-3-gallate solution during chemomechanical preparation, versus 2.5% naocl, in asymptomatic necrotic mandibular premolars treated in a single visit.

the patients will be randomly divided into 2 groups. intervention group (20% epigallocatechin-3-gallate solution root canal irrigant) and control group (2.5% sodium hypochlorite root canal irrigant). post-operative pain will be measured at 6, 12, 24 and 48 hours post-operatively. the pain will be recorded using the numerical rating scale (nrs). amount of bacterial load reduction the intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (cfus/ml) before and after root canal preparation.

Eligibility criteria:
the inclusion criteria: 1. systematically healthy patient (asa i, ii). 2. age between 18 and 45 years 3. male or female. 4. asymptomatic mandibular premolar teeth diagnosed with pulp necrosis. the exclusion criteria: 1. medically compromised patients having significant systemic disorders. (asa iii or iv). 2. teeth with: * immature roots * association with swelling or sinus tract. * acute peri-apical abscess or acute exacerbation of a chronic abscess. * mobility grade ii or iii * previously accessed or endodontically treated * deep periodontal pockets more than 4 mm * vertical root fractures, coronal perforation, calcification, and external or internal root resorptions. 3. patients who could not interpret the nrs.

Keywords: asymptomatic necrotic mandibular premolar
efficacy of parecoxib combined with paracetamol in mastectomy

Conditions: Post Operative Pain

Summary: patients undergoing breast cancer surgery experience persistent pain after surgery and subsequent development of chronic pain. parecoxib or paracetamol has been reported to reduce postoperative pain in mastectomy. the investigators aim to assess the effectiveness of the perioperative administration of parecoxib combined with paracetamol to reduce postoperative acute and subacute breast surgical pain.

patients with breast cancer undergoing mastectomy experience moderate postoperative pain which may persist for more than 3 months and may turn into chronic pain. this may interfere with the daily life of the patients. proper prophylaxis and management to control postoperative pain are essential. morphine is the most common drug to control postoperative pain. however, there are many serious side effects, e.g., nausea/vomiting, pruritus, ileus, constipation, sedation, and respiratory depression. multimodal analgesia comprises the use of a combination of drugs to provide the opioid-sparing effect. parecoxib, a selective cox-2 inhibitor, and intravenous paracetamol are reported to provide good postoperative analgesia. the investigators aim to apply a combination of parecoxib and paracetamol perioperatively to reduce postoperative morphine consumption.

Eligibility criteria:
inclusion criteria: * patients with breast cancer undergoing elective mastectomy * asa physical status 1-3 exclusion criteria: * allergy to parecoxib, paracetamol, or sulfonamide * history of opioid use * pregnant * renal or hepatic disease

Keywords: postoperative pain multimodal anagesia
standard dose continuous renal replacement therapy (crrt) versus low-dose crrt ( ketzerei )

Conditions: Critical Illness; Acute Kidney Injury

Summary: acute kidney injury (aki) is a well-recognized complication in critically ill patients, which often leads to the necessity of mechanical kidney support (crrt). in current therapeutic regimes, crrt is used to strictly prevent azotaemia. thus recent clinical observations, as well as data from animal testing suggest a link between controlled azotaemia and faster renal recovery in aki patients. the aim of the study is to improve renal recovery.


Eligibility criteria:
inclusion criteria: * adult patients (age ≥18 years) * critically ill patients with aki + in need of crrt * written informed consent exclusion criteria: * chronic dialysis dependency * chronic kidney disease with estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m² * severe liver cirrhosis (child-pugh c) * severe acidosis (ph \< 7,20 at study enrolment) * severe hyperkalaemia (\> 6mmol/l) * pregnancy or breastfeeding * persons held in an institution by legal or official order * dependency on the investigator or center

Keywords: continuous renal replacement therapy
evaluation of clinical results and imaging of anterior cruciate ligament reconstruction with orthopure xt

Conditions: ACL; ACL Injury

Summary: the purpose of this study is to evaluate subjective and objective clinical outcomes and imaging data of subjects undergoing reconstruction or revision of lca reconstruction using orthopure xt


Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 65 at the time of acl reconstruction surgery; * patients aged 35 to 65 at the time of primary acl reconstruction surgery; * male and female sex; * first injury of the acl with impossibility of use of autograft (patellar tendinopathy, quadriceps tendinopathy, goose leg tendinopathy) or refusal to use allograft (bank tendon); * recurrence of acl injury with impossibility of use of autograft (prior use/tendinopathy of the patellar, previous use/tendinopathy of the quadriceps, previous use/tendinopathy of the goose leg) or refusal to use allograft (tendon of bank); exclusion criteria: * patients who do not consent to be included in the study * presence of haematological, rheumatic or haemorrhagic disease time of assessment * acl primary reconstruction in subjects under 35 * allergies and/or reactions from hypersensitivity or religious objection to the use of porcine derivation * pregnant and/or breastfeeding women
renal resistive index and cardiac output changes during resuscitation predict the occurrence of acute kidney injury in septic shock patients

Conditions: Critically Ill; Acute Kidney Injury; Septic Shock

Summary: record the renal resistive index and hemodynamic parameters ( record the cardiac output and stroke volume if the patient's next to kin agree to undertake a picco monitoring ) before and after resuscitation for severe sepsis or septic shock patients, to determine whether the changes of resistive index or hemodynamic parameters, especially the cardiac output can be a better parameter to predict aki

* purpose: to examine whether the resuscitation-induced changes of renal resistive index or hemodynamic parameters has the superiority as a valid tool to evaluate the renal perfusion improvement and whether the changes can better predict aki occurrence in severe sepsis or septic shock patients. * methods: measure the renal resistive index and take record of hemodynamic parameters (use a picco monitoring to measure cardiac output if the patient's next to kin agree to undertake such a catheter ) before and after successful resuscitation for severe sepsis or septic shock patients, followup to determine the occurrence of aki and mortality. * hypothesis: the changes of resistive index or cardiac output during shock resuscitation may be a better parameter to evaluate renal perfusion and predict aki, and may have a better value to guide renal protective therapy in septic shock.

Eligibility criteria:
inclusion criteria: * ≥18 years, sex unlimited * arriving icu in 6 hours and diagnosed with severe sepsis or septic shock * physician in charge decide that an aggressive fluid resuscitation was in order exclusion criteria: * pregnancy, age \<18 years * ongoing recovery from aki * known end-stage renal disease or chronic kidney disease(glomerular filtration rate \<30ml/min/1.73m2) * known other causes of shock morbidly * conditions known to modify rri, such as renal-artery stenosis, intra-abdominal hypertension(\>35cmh2o)

Keywords: septic shock acute kidney injury renal resistive index
the role of emotional arousal in food preference and taste

Conditions: Obesity; Food Craving; Food Consumption

Summary: the purpose of this study is to examine the role of stress in food craving and food consumption in obesity. using experimentally validated guided imagery procedure, the investigators propose to examine the stress response using subjective, physiological and neurobiological measurements.

one hundred and fifty men and women will participate in three laboratory sessions to assess stress responses to personal stress imagery, food cue imagery, and to neutral-relaxing imagery. subjects will be distributed into 3 groups stratified by bmi category. subject recruitment, eligibility determination, baseline assessments and script development will be conducted at the yale stress center. subjects will complete a variety of diagnostic, cognitive and psychological assessments, a comprehensive physical examination and blood work and will be involved in development of imagery scripts from personal stress, food cue and neutral-relaxing situations. subjects will then be scheduled for three laboratory sessions at the yale stress center. subjects will also participate in an imagery and relaxation training session followed by three laboratory sessions. the three laboratory sessions will be conducted within a brief interval of days, when subjects will be exposed to a personal stress, a food cue and a neutral-relaxing imagery condition, one condition per day. the order of imagery conditions will be randomly assigned and counterbalanced across subjects in order to balance any influences due to order of imagery conditions.

Eligibility criteria:
inclusion criteria: * between ages 18-45 years * able to read and write * normal/lean bmi group: bmi 18.5-24.9 as calculated based on height and weight. * overweight bmi group: bmi 25.0 - 29.9 as calculated based on height and weight obese bmi group: bmi 30-35 as calculated based on height and weight. * do not meet criteria for any current axis i dsm-iv psychiatric diagnoses and provide negative urine toxicology screens during initial appointments and at admission for laboratory sessions. exclusion criteria: * meet current criteria for dependence on any psychoactive substance, including nicotine and caffeine * current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse * any psychotic disorder or current psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders * any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded * women on oral contraceptives, peri and post menopausal women, and those with hysterectomies * pregnant and lactating women will be excluded.

Keywords: stress food cues obesity
study to assess and monitor brain activity

Conditions: Delirium; Encephalopathy

Summary: a mainstay in the diagnosis and care of hospitalized patients is the assessment of mental status. changes in mental status can have broad clinical significance, and while some patients are admitted with mental status changes, nearly half of the patients who experience delirium in the hospital develop it after admission in a manner that is hard to predict on the level of individual patients. patients with altered mental status such as delirium have worse clinical outcomes, suggesting that early monitoring of mental status can identify important clinical populations who may benefit from targeted delirium prevention and intervention. delirium remains under-recognized in the hospital, in part due to its fluctuating nature. typically, mental status is assessed sporadically, perhaps once a day, through intermittent and subjective clinical interactions. as such, there is a clear clinical need for objective, continuous methods to monitor mental status. such methods could potentially improve detection of delirium, potentially even predicting it prior to clinical recognition, and therefore direct multimodal delirium prevention and intervention strategies when most effective-before delirium becomes fully manifest. in this proposal we plan on testing noninvasive, continuous monitors of mental status in the inpatient setting, primarily through the use of eeg.


Eligibility criteria:
inclusion criteria: * admitted to a general medical ward * expected stay of at least one night exclusion criteria: * patients who have any scalp incisions or head wound(s) that would prevent eeg attachment * non-english speakers

Keywords: eeg mental status
efavirenz 400mg in treatment-naïve chinese hiv-infected patients

Conditions: HIV-1-infection

Summary: evaluating the efficacy, pharmacodynamics, and safety of efavirenz 400mg in treatment-naïve chinese hiv-infected patients.

treatment-naive hiv-infected patients are designed to enroll and receive efavirenz 400mg combined with tenofovir (tdf) and lamivudine (3tc) as initial antiretroviral regimens, and monitoring for 48 weeks, to evaluate efavirenz concentration, t-cell subsets, hiv rna load, and neuropsychiatric tests with hamilton depression scale (hamd) and pittsburgh sleep quality index (psqi) at baseline, 4, 12, 24, 48 weeks.

Eligibility criteria:
inclusion criteria: * (1) hiv treatment-naïve, (2) age between 18 years or older, (3) be willing to complete the hamd and psqi scale and follow-up regularly, (5) not participating in other studies. exclusion criteria: * (1) acute hiv-1-infected patients, (2) an aids-defining illness such as pneumocystis pneumonia, tuberculosis within 2 weeks of entry, (3) transaminase and alkaline phosphatase levels beyond three times the upper limit of the normal range, bilirubin level more than 2.5 times the upper limit of the normal range, and serum creatinine level excess 1.5 times the upper limit of the normal range, (4) pregnancy or breast feeding

Keywords: efavirenz 400mg chinese hiv-infected patients
multi-institutional transgender & gender-diverse breast cancer study

Conditions: Breast Cancer; Breast Neoplasms; Breast Adenocarcinoma; Breast Cancer Stage; Breast Cancer Stage IV; Breast Cancer Invasive; Breast Cancer in Situ

Summary: there is no granular retrospective data on breast cancer in transgender and gender-diverse (tgd) persons from a contemporary and diverse american cohort. the purpose of this investigation is to aggregate data from multiple institutions to describe the risk, diagnosis, management, and outcomes of tgd persons with breast cancer in effort to identify opportunities for future intervention studies to eliminate breast cancer disparities for this population.


Eligibility criteria:
inclusion criteria: 1. age 18 years of age or older 2. breast cancer diagnosis (including dcis) 3. persons who identify as gender and/or sex that is different from the sex they were assigned at birth exclusion criteria: 1. age \<18 at time of breast cancer diagnosis 2. cis-gendered persons

Keywords: transgender breast cancer nonbinary gender diverse gender-affirming hormone therapy
pk study of n91115 in cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: this phase 1 study in f508del-cftr homozygous cf patients is being conducted to assess the pharmacokinetics and absorption dynamics of n91115 compared with healthy subjects in order to identify an initial starting dose for phase 2 trials.

this is an open-label pharmacokinetic (pk) study of twice daily doses of 50 mg of n91115 administered for 14 days in f508del-cftr homozygous cf patients. six patients are planned for enrollment. each patient will undergo screening (day 28 to day 3) and, if eligible, will return to the clinical site on day 1 or optionally on day 1. eligibility will be reconfirmed and the patient will be admitted to a clinical research unit (cru). patients will stay overnight from day 1 to day 2 and will be discharged on day 2 after all procedures and assessments are completed. patients will return to the cru as outpatients on days 4, 7, 11, 14, and 15 for pk sample collection and other assessments. they will receive an oral dose of investigational medicinal product (imp), n91115, twice daily on days 1 through 14 and will be followed for pk through day 15. telephone calls to assess safety and ensure compliance with dosing will be made on days that patients do not make clinic visits (days 3, 5, 6, 8, 9, 10, 12, and 13). follow-up safety calls will then be made on day 21 (adverse events) and day 28 (serious adverse events only). participation of an individual patient may last approximately 56 days from the time of screening until the end-of-study (day 28) follow-up call.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of cf, homozygous for the f508del-cftr mutation 2. weight ≥ 40 kg at screening 3. fev1 ≥ 40% of predicted normal for age, gender, and height (hankinson standards) pre or post-bronchodilator value, at screening 4. hematology, clinical chemistry, and urinalysis results with no clinically significant abnormalities that would interfere with the study assessments at screening exclusion criteria: 1. history of any illness or condition that in the opinion of the investigator could confound the results of the study or pose additional risk when administered imp 2. any acute infection, including acute upper or lower respiratory infections and pulmonary exacerbations that require treatment or hospitalizations within 4 weeks of study day 1 3. any change in chronic therapies for cf lung disease (e.g., ibuprofen, pulmozyme®, hypertonic saline, azithromycin, tobi®, cayston®) within 4 weeks of study day 1 4. history, including the screening assessment, of ventricular tachycardia or ventricular arrhythmias 5. history, including the screening assessment, of prolonged qt and/or qtcf (fridericia's correction) interval (\> 450 msec) 6. history of solid organ or hematological transplantation 7. history of alcohol abuse or drug addiction (including cannabis, cocaine, and opioids) in the year prior to screening 8. use of continuous (24 hr/day) or nocturnal supplemental oxygen

Keywords: cf f508del cavosonstat n91115
teas reduces remifentanil consumption

Conditions: Anesthesia; Pain

Summary: transcutaneous electrical acupoint stimulation (teas) has been shown to decrease the need of opioids including remifentanil during anaesthesia. however, it is not clear whether combination of two or more acupoints could induce stronger analgesia. moreover, evidence for the long-term effect of teas has been limited. the present study was to compare the short-term and long-term effect on pain of dual-acupoint and single-acupoint teas.


Eligibility criteria:
inclusion criteria: * 18 to 65 yrs * body mass index (bmi) of 18 to 30 kg/m2 * elective radical mastectomy under general anaesthesia exclusion criteria: * contradictions to teas * difficulties in communication * histories of general anaesthesia * drug or alcohol abuse or addiction * cardiac dysfunction or severe hypertension * confirmed hepatic dysfunction and renal impairment * the participants recruited into other clinical trials during last three months
pharmacogenetic study of antimitotic therapies involved in hepatic vod in children with nephroblastoma or all

Conditions: Hepatic Veno-Occlusive Disease; Nephroblastoma; Acute Lymphoblastic Leukemia

Summary: hepatic veno-occlusive diseases (vod) during cancer treatment in children are serious toxicities that have occurred with interruptions of chemotherapy and risk of relapse. in addition, these toxicities have a negative impact on the patient's quality of life, serious long-term sequelae and are potentially fatal in children. the risk factors associated with the occurrence of these complications are, to date, unknown, at the exception to the exposition to certain treatments (6-thioguanine, busulfan, actinomycin d, radiotherapy, etc.). to understand the effects of this toxicity and those of susceptibility to the disease becomes a major issue in the treatment of these children.

case-control study, nested in two french multicenter cohorts, on pharmacognenetic, biological and clinical susceptibility factors associated with the occurrence of hepatic veno-occlusive disease during the anticancer treatment for nephroblastoma or acute lymphoblastic leukemia, with centralized genetic analysis. after obtaining consent (patient or parents for minor patients), a blood sample is collected during the routine follow-up consultation and tubes are sent directly to paris for the pharmacogenetic analysis at the end of the study.

Eligibility criteria:
inclusion criteria: * children aged \< 18 years old at the time of cancer diagnosis * having been treated with a single line of treatment for nephroblastoma or all, in france between 2000 and 2018, and who did not receive allogeneic hematopoietic stem cell transplantation * weight greater than 5 kg at inclusion * informed consent dated and signed by the holder of the parental authority (if minor) or by the patient (if major) to take part in the study * affiliated to a social security scheme exclusion criteria: * unavaibility of constitutional dna * person who receive more than one treatment line for nephroblastoma or all in childhood or adolescence * pregnant, lactating or parturient women * person deprived of their liberty by judicial or administrative decision * person under psychiatric care under duress * person subject to legal protection * person unable to express their consent

Keywords: pharmacogenetics