Kornimate/medical-research-clean huggingface dataset:
remineralisation of white spot lesions by elmex® gelée in post-orthodontic patients

Conditions: Tooth; Lesion, White Spot Lesions

Summary: the aim of this study is to monitor the effect of intraoral topical high fluoride application on the development of white spot lesions (wsl) after orthodontic treatment with multibracket appliances and to compare it to a placebo.


Eligibility criteria:
inclusion criteria: * written informed consent * healthy volunteers (≥11 years) scheduled for bracket removal * ≥ 1 wsl with a modified score 1 or 2 (gorelick et al. 1982) on uft at debonding exclusion criteria: * known hypersensitivity or allergy to study products and standard toothpaste ingredients and/or dental material used in the present study * known hypersensitivity or allergy to placebo gel ingredients * alterations in the teeth's enamel, e.g. hypoplasia, fluorosis * any illness/condition potentially affecting the study outcome at investigator's discretion * known pregnancy or breast feeding during the course of the study

Keywords: white spot lesion initial caries fluoride amine fluoride orthodontics remineralization brackets
plasma and hemodynamic markers during hepatectomy

Conditions: Hepatorenal Syndrome, Liver Regeneration

Summary: introduction liver resection is considered the only curative treatment option for mcrc patients without extrahepatic disease and is accepted practice. despite substantial improvements in surgical techniques, postoperative morbidity and mortality remain an important concern after major resections. complications of liver resection, although rare, include liver failure and acute kidney injury as indicated by oliguria and increased serum creatinine. the underlying pathophysiological pathways of post-operative renal alteration following liver resection is an increase in portal venous pressure, based on observations in animal models or small cohorts. the corpus of data is derived from patients with liver cirrhosis and subsequent hepatorenal syndrome. these data are limited since cirrhosis cannot distinguish between metabolic changes, portal hypertension and impaired liver function in the elucidation of the pathogenesis of renal alterations. liver resection is therefore a potent model to evaluate the impact of portal hypertension on the kidney despite stable liver function. the most significant factor determining morbidity and mortality following hepatectomy is the ability of the remnant liver to regenerate. in this context, several growth factors were shown to regulate the highly orchestrated process of liver regeneration (lr). hypothesis the investigators will therefore test the hypothesis that liver resection leads to a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal impairment, correlating with the quantity of resected liver. furthermore, the investigators will examine the relationship between postoperative liver regeneration and circulating growth factor levels in patients undergoing hepatectomy. based on the preclinical data the investigators hypothesize that a circulating growth factor levels will be associated with delayed liver regeneration, an increased incidence of postoperative liver dysfunction and concomitant worse clinical outcome.


Eligibility criteria:
inclusion criteria: * patient with neoplastic liver tumors undergoing elective hepatectomy. exclusion criteria: * non elective hepatic surgery, preoperative hvpg \> 10 mmhg, preoperative renal failure

Keywords: hepatorenal syndrome, liver regeneration, liver dysfunction
nab-paclitaxel dose schedual for her-2 negative advanced breast cancer

Conditions: Breast Cancer

Summary: what is the best dosage of nab-paclitaxel for chinese? this study would divide patients into two dosage groups: 1) 125mg/m2, 30 minutes intravenous injection, d1, 8, 21 days for a cycle(clinical use); 2) 125mg/m2 d1, 8, 15, 30 minutes intravenous injection, 28 days for a cycle(guideline recommand). treatment to disease progression. the efficacy (cr, pr, sd, pd) is evaluated every 2-4 cycles.if the patient withdraws from the trial because he cannot tolerate the toxicity caused by one of the drugs, such as neurotoxicity or bone marrow toxicity, it is recommended to switch to other drugs and follow up to pfs and os.each group was planned to include 30 patients.


Eligibility criteria:
inclusion criteria * female, aged≥ 18 years old; * histopathologically confirmed her-2 negative (definition: immunohistochemical ihc 0, or 1+, or in situ hybridization ish, defined as the ratio of her2 gene copy number to cep17 signal number less than 2.0, or for single probe detection, her2 gene copy number less than 6) in patients with recurrent or metastatic breast cancer; * up to two previous lines of chemotherapy were permitted for recurrent and metastatic diseases. and for endocrine therapy, the number of treatment lines can be omitted; * with measurable lesions; * the physical condition score of the eastern american cancer collaboration group (ecog) was less than 1; * expected survival period\>3 months; exclusion criteria * new york heart association nyha scores identify patients with congestive heart failure at grade ii or above;uncontrolled brain metastasis; * patients with severe systemic infection;patients with peripheral nerve injury of degree ii or above, or known drug allergy or intolerance within 4 weeks before admission; * important organ disorders or diseases: liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis,etc;there is a history of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma); * patients who had received other antineoplastic treatments or other experimental drugs within one month before treatment; * patients who also participated in other clinical trials; * researchers believe that patients are not suitable for any medical condition to enter the study.

Keywords: nab-paclitaxel advanced breast cancer her2 negative dose
a study to evaluate the efficacy and safety of galantamine in patients with mild cognitive impairment

Conditions: Dementia; Alzheimer Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of galantamine treatment in patients with mild cognitive impairment.

this is an international, multicenter, double-blind, randomized, placebo-controlled trial. patients with mild cognitive impairment (mci) who are clinically at risk for development of alzheimer's disease will be treated for 24 months with either placebo or galantamine hydrobromide. memory and overall clinical improvement will be evaluated using the alzheimer's disease assessment scale with cognitive subscale adapted to mci (adas-cog/mci) and the clinical dementia rating sum of the boxes (cdr-sb). overall functional skills and the severity of dementia will be assessed with the clinical dementia rating sum of the boxes (cdr-sb) and the overall clinical dementia rating (cdr) score. additional assessments include the digit symbol substitution test (dsst) to measure attention. safety will be assessed using adverse event reports, vital signs, laboratory parameters, physical examination, and electrocardiogram. the study hypothesis is that treatment with galantamine will be well tolerated and, compared with placebo, will significantly improve the signs and symptoms associated with mild cognitive impairment in patients who are considered likely to develop alzheimer's disease. galantamine hydrobromide immediate-release tablets (4, 8, or 12 milligrams), taken by mouth 2 times daily: 8mg/day for 4 weeks, 16mg/day for 4 weeks, then increased to 24mg/day for the remainder of the 24-month trial. doses may be reduced at investigator's discretion after 12 weeks.

Eligibility criteria:
inclusion criteria: * clinical decline of cognitive ability consistent with mild cognitive impairment * delayed recall score \<= 10 on a new york university paragraph recall test * sufficient visual, hearing and communication capabilities and be willing to complete serial standard tests of cognitive function * have a consistent informant to accompany them on scheduled visits * be able to read, write and fully understand the language of the cognitive scales used in the study exclusion criteria: * neurodegenerative disorders such as parkinson's disease * cognitive impairment resulting from acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency states, infections such as meningitis or aids, or primary or metastatic cerebral neoplasia * epilepsy * significant psychiatric disease * peptic ulcer disease * clinically significant heart, lung, liver or kidney diseases * pregnant or nursing women or those without adequate contraception

Keywords: mild cognitive impairment galantamine hydrobromide memory disorders
a phase 1, first-in-human study of vx-634

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (pk) of vx-634 at various doses.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * participants of age between 18 to 55 years (inclusive) * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * a total body weight of more than (\>)50 kg * participants of non childbearing potential * non smoker or ex-smoker for at least 3 months before screening key exclusion criteria: * any condition possibly affecting drug absorption other protocol defined inclusion/exclusion criteria may apply.
post-market clinical study of the panoptix intraocular lens (iol) in a chinese population

Conditions: Aphakia; Presbyopia

Summary: the primary objective of this clinical study is to assess the clinical performance of the panoptix iol in a chinese population.

in this clinical study, subjects will be implanted with the panoptix iol in both eyes. the second eye surgery will occur 7-28 days after the first eye. a total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. the total expected duration of the subject's participation will be about 14 months. this study will be conducted in china.

Eligibility criteria:
key inclusion criteria: * able to comprehend and sign an informed consent form; * able to complete all study visits required in the protocol; * chinese; diagnosed with cataracts in both eyes; * planned bilateral cataract removal by routine phacoemulsification; * pre-operative regular corneal astigmatism of less than 1.0 diopter (d); * pre-operative best corrected distance visual acuity (bcdva) worse than or equal to 0.3 logmar in each eye; * potential postoperative best corrected distance visual acuity (bcdva) of 0.3 logmar or better in both eyes based on the investigator expert medical opinion. * other protocol-specified inclusion criteria may apply. key exclusion criteria: * glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve; * clinically significant corneal diseases; * clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion; * previous intraocular or corneal surgery; * pregnancy or lactation during study or planning to be pregnant/lactating; * systemic medications that, in the opinion of the investigator, may confound the outcome or increase the risk to the subject; * other planned ocular surgical procedures; * patients who desire monovision correction. * other protocol-specified exclusion criteria may apply.

Keywords: cataract intraocular lens
urine and ultrasound screening for kidney disease in children

Conditions: Kidney Diseases; Diagnostic Techniques; Ultrasound; Urinalysis; Child, Only

Summary: the aim of this study is to early detect kidney disease in the natural population cohort of children by urine and ultrasound screening, to assist in the precise prevention and treatment of children's kidney disease, and to establish a risk prediction system for children's kidney disease. about 10,000 children called kunqi cohort are born in jiangsu province(8,000 in kunshan and 2,000 in qidong) and about 3,000 born in shanghai. through the project, child who is found with abnormal urine or ultrasound result will be referred to children's hospital of fudan university to get further examination and treatment.

chronic kidney disease (ckd) often has an insidious onset. early detection of ckd and more aggressive treatment and monitoring of high-risk ckd patients at risk of progression are the consensus of current medical practice. however, there is currently no ckd risk prediction system for the chinese population, especially children. the main goal of this project is to establish a risk prediction system for children's kidney disease, and to assist in the precise prevention and treatment of children's kidney disease. the project is based on the "urine and ultrasound screening" strategy that has been carried out for more than ten years in shanghai, using a non-invasive and effective screening method in the natural population cohort of children, in order to detect kidney disease in the early stage.

Eligibility criteria:
inclusion criteria: * all consecutive live newborn infants(regardless of physical condition) * complete at least 3 years of follow-up exclusion criteria: * declining the screening * missing
shock wave lithotripsy versus visual cystolitholapaxy in the management of patients presenting with calcular acute urinary retention: a randomized controlled trial.

Conditions: Urinary Calculi

Summary: the aim of the study is to compare the safety and efficacy of eswl and visual cystolitholapaxy in management of calcular acute urine retention.

patients who present with acute urinary retention due to stone in the urethra or urinary bladder will be randomly assigned to receive treatment either by extracorporeal shock wave lithotripsy or by endoscopic visual cystolitholapaxy where patients and stone characteristics will be recorded and the outcome including the intraoperative and postoperative complications and the stone free rate will be also evaluated

Eligibility criteria:
inclusion criteria: 1. adult male patients presenting with acute urinary retention due to urethral or urinary bladder stones. 2. with a stone size not more than 2 centimeters in greatest diameter. 3. no more than 2 stones. exclusion criteria: 1. bladder cancer. 2. bladder replacement of any type. 3. infravesical obstruction, due to marked benign prostatic hyperplasia, prostate cancer, stricture urethra or external urethral meatal stenosis.

Keywords: urethral stones acute cacular urinary retention extracorporeal shock wave lithotripsy (eswl) visual lithotripsy bladder stone
intrabronchial airway pressures in intubated patients during bronchoscopy

Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury (ALI)

Summary: the purpose of this study is to examine changes in ventilation and airway pressures during conventional bronchoscopy of intubated patients.

mechanically ventilated patients often need bronchoscopy as a diagnostic procedure or for visually directed elimination of secretions. partial endotracheal tube occlusion by the bronchoscope increases airflow resistance. inhibition of inspiratory flow may be compensated for by augmented inspiratory pressure. reduced expiratory flow however, cannot be compensated for by most ventilators and could lead to higher airway - and intrathoracic pressures that are not detected by pressure transducers in the ventilator tubing. in this study we compare changes in ventilation, airway pressures, ventilator pressures and blood gases during bronchoscopy of intubated patients in both volume controlled and pressure controlled ventilation. our hypothesis are that 1) increased resistance in the tube during bronchoscopy leads to high intrabronchial airway pressures when the ventilator is in volume controlled mode, and 2) when the ventilator is in pressure controlled mode, increased resistance in the tube during bronchoscopy leads to reduced tidal volume and moderately increased paco2.

Eligibility criteria:
inclusion criteria: * ards/ali patients on mechanical ventilation * endotracheal tube size 7-9mm * age \> 18 years * therapeutic or diagnostic bronchoscopy requested by staff physician exclusion criteria: * spo2 \< 90% * unstable bp * pneumothorax * acute cardiovascular disease * cerebrovascular or other condition that requires stable bp and saturation
study of azd1222 for the prevention of covid-19 in japan

Conditions: COVID-19

Summary: the covid-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. currently, there are no licensed preventions available against covid-19 and accelerated vaccine development is urgently needed. a safe and effective vaccine for covid 19 prevention would have significant global public health impact.


Eligibility criteria:
inclusion criteria: * participants aged 18 to 55 years (cohort a and c), aged 56 to 69 years (subcohorts b1 and d1), or aged ≥ 70 years (subcohorts b2 and d2) exclusion criteria: 1. known past laboratory-confirmed sars-cov-2 infection 2. positive sars-cov-2 rt pcr test at screening 3. seropositivity to sars-cov-2 at screening. 4. significant infection or other illness, including fever \> 37.8°c on the day prior to or day randomization 5. history of guillain-barré syndrome 6. any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days) 7. history of allergy to any component of the vaccine 8. any history of angioedema 9. any history of anaphylaxis 10. current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ) 11. history of serious psychiatric condition likely to affect participation in the study 12. bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venepuncture 13. suspected or known current alcohol or drug dependency 14. any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data 15. severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)

Keywords: covid-19 vaccine
the natriuretic peptide response to saline infusion

Conditions: Obesity

Summary: the primary objective is to evaluate the overarching hypothesis that obese and black individuals have relatively lower circulating natriuretic peptide levels compared with lean and white individuals. conventional clinical assays for measurement of circulating natriuretic peptides display substantial overlap, precluding determination of the basis of the relative natriuretic peptide deficiency previously observed in these groups. we will study lean or obese, black or white, healthy adult subjects with intravenous (iv) saline infusion as a stimulus for natriuretic peptide production and release. we will measure circulating levels of natriuretic peptide isoforms using mass spectrometry that allows the specific identification of probnp 1-108 and its cleavage product bnp 1-32.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years; * bmi between 18 and 25 (lean) or 30 and 40 kg/m2 (obese); * self-reported race of either black or white; * otherwise healthy with no chronic comorbidities. exclusion criteria: * history of diabetes mellitus * currently pregnant * history of cardiac disorder including heart failure, cardiomyopathy, myocardial infarction, coronary revascularization, abnormal stress test, uncontrolled arrhythmia or arrhythmia requiring treatment, congenital heart disease, pericardial disease. * history of hypertension defined as taking anti-hypertensive medications or untreated hypertension with systolic blood pressure ≥ 140 mm hg or diastolic blood pressure ≥ 90 mm hg at most recent clinical visit or screening visit. * obstructive lung disease * history of chronic kidney disease * history of liver disease or cirrhosis * uncontrolled thyroid dysfunction * history of solid organ transplant * history of malignancy other than basal or squamous cell skin cancer * inability to lie flat for 6 hours
absorption of antibiotics with high oral bioavailability in short-bowel syndrome

Conditions: Short Bowel Syndrome; Infection, Bacterial

Summary: the purpose of this study is to assess the drug absorption of oral antibiotics in patients with short bowel syndrome.

when required, due to an infection, patients with short bowel syndrome will be treated with an intravenous antibiotic. the pharmacokinetic profile of that intravenous antibiotic will be determined. once the full treatment with the intravenous antibiotic is over, the patient will be orally administered the same antibiotic, with determination of the oral pharmacokinetic profile, and both profiles will be compared, assessing the bioavailability of the oral antibiotic.

Eligibility criteria:
inclusion criteria: * short bowel syndrome * treated for a documented infection with antibiogram by amoxicillin (+/- clavulanic acid)or ofloxacin or levofloxacin or sulfamethoxazole/trimethoprim * hospitalized in the nutritional assistant unit or the infectiology unit of the regional university hospital of nancy * affiliated to a social security system * having received an physical examination before entering study * having received full information regarding the study organization and having signed the informed consent exclusion criteria: * patient at risk of worsening their oral absorption abilities during study * patient requiring dialysis * women of childbearing age without efficient birth control * allergy to any of the drugs tested * person concerned by articles l. 1121-5, l. 1121-7 et l1121-8 of the code of public health * person deprived of liberty or person undergoing psychiatric care pursuant to articles l. 3212-1 et l. 3213-1