Kornimate/medical-research-clean huggingface dataset:
effectiveness of sdf in arresting dental caries in preschool children

Conditions: Early Childhood Caries

Summary: background: tooth decay in children (early childhood caries, or ecc) is a common childhood disease. poor dentition significantly affects the nutrition, growth, development and general health of children. conventional dental care for ecc is neither affordable nor accessible, particularly for the disadvantaged communities. silver diamine fluoride (sdf) is a safe, cost-effective caries-arresting agent that appears to conform to the world health organization's millennium goals. sdf is commercially available at 38% and 12%, and topically used yearly or half-yearly to arrest ecc. the sdf regimens used for ecc treatment lack an evidence base. therefore it is necessary to find the most suitable sdf concentration and application interval to arrest ecc. the purpose of this randomised controlled trial is to compare the efficacy of two commercially available sdf solutions at pre-prepared concentrations of 38% and 12% when applied at yearly or half-yearly intervals over 36 months in arresting caries in primary teeth. methods / design: this double-blinded study has recruited 888 kindergarten children aged 3-4 years with caries. the sample size is sufficient for the appropriate statistical analyses. the children were classified into high and low caries rates and equally allocated into four groups for the caries treatment: group a - semi-annual application of 12% sdf; group b - annual application of 12% sdf; group c - semi-annual application of 38% sdf; group d - annual application of 38% sdf. the children will be followed for 36 months in their kindergartens until they enter primary school. clinical examinations at 6-month intervals will be conducted to assess whether the caries are arrested. information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and follow-ups. discussion: this study will help determine the most suitable sdf concentration and application interval to arrest caries in children. because sdf use for caries arrest is painless, simple, and low-cost, it can be widely recommended and promoted for caries control in young children or those with difficulty accessing and affording conventional dental care. the applicability of the findings and their impact on public health would be immense.


Eligibility criteria:
inclusion criteria: the children included in the study should 1. aged 3-4 years who have tooth decay and are attending the first year of kindergarten, 2. be generally healthy, 3. have parental consent, and 4. have at least 1 tooth with untreated caries that extends into the dentine. exclusion criteria: * children who are uncooperative and difficult to manage, have major systemic diseases, or are on long-term medication will be excluded.

Keywords: silver diamine fluoride randomized clinical trial caries children fluoride
safety and activity of imab362 in combination with zoledronic acid and interleukin-2 in cldn18.2-positive gastric cancer

Conditions: CLDN18.2-positive Gastric Adenocarcinoma; CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction; CLDN18.2-positive Adenocarcinoma of Esophagus

Summary: the purpose of the trial is to assess the immunological effects and their kinetics, the safety and activity of imab362 plus zoledronic acid with/without low to intermediate doses of interleukin-2 in subjects with advanced gastroesophageal cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction * inoperable locally advanced disease, resections with r0, r1 or r2 outcome or metastatic disease. * cldn18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample. * measurable and/or non-measurable disease as defined according to recist v1.1 * age ≥ 18 years * written informed consent * ecog performance status (ps) 0-1 * life expectancy \> 3 months exclusion criteria: * prior hypersensitivity reaction or intolerance to one of the compounds of the study treatment * known hiv infection or known symptomatic hepatitis (a, b, c) * clinical symptoms of cerebral metastases * pregnancy or breastfeeding * patients treated with any bisphosphonate-based therapeutic for any indication during the previous year * hypocalcemia that requires medication. corrected (adjusted for serum albumin) serum calcium \ 12 mg/dl (3.0 mmol/l)
erector spinae plane block as analgesia in patients for colectomy

Conditions: Colo-rectal Cancer

Summary: management of postoperative pain relief is largely inadequate. despite the recent advances in pain management, postoperative pain incidence has not decreased; most patients still experience severe pain after major surgery. poorly or inadequately controlled pain was reported to be linked to prolonged hospitalization, decreased patient satisfaction, the risk of readmission, and a higher incidence of postoperative complications.

in major abdominal surgeries, the gold standard for postoperative analgesia is thoracic epidural analgesia. nevertheless, there are many concerns regarding its side effects, including motor blockade and hypotension. moreover, many researchers interrogated its role as it may increase the risk of serious problems such as epidural hematoma and abscess. as an alternative, some surgeons proposed the transversus abdominis plane (tap); however, a recent meta-analysis established that tap block was of minimal effect. the erector spinae plane block (espb) is a fairly original paraspinal plane block that was first designated for thoracic analgesia. recently, some reports showed that it could offer effective and widespread somatic and visceral abdominal analgesia. bilateral continuous esp blockade represents a respected alternative to thoracic epidural analgesia. the local injection under the erector spinae muscle is carried out in this technique, which is estimated to spread a paravertebral of three vertebral levels cranially and four levels caudally. it was designated that the injected local anesthesia passes across the costotransverse foramina and blocks the ventral and dorsal rami of spinal nerves, causing a sensory blockade over the anterolateral thorax. the dermatomes enclosed by espb depend on the site of entry, the volume, and the concentration of the local anesthetic used. this rct aimed to assess the analgesic effectiveness of us-guided bilateral erector spinae plane block in patients undergoing elective colectomy. this randomized controlled trial was designed to assess the analgesic effectiveness of bilateral us-guided erector spinae plane blocks (espb) in patients undergoing elective colectomy surgery.

Eligibility criteria:
inclusion criteria: * patients of colorectal carcinoma scheduled for elective colectomy exclusion criteria: * patients with a body mass index (bmi) of 35 kg/m2 or above * patients with a history of hepatic or renal diseases * patients with second- or third-degree heart blocks * patients with coagulopathies * patients with history of hypersensitivity to local anesthetics

Keywords: erector spinae plane colectomy
planning your everyday life in virtual reality : a study in schizophrenia;

Conditions: Schizophrenia

Summary: patients with schizophrenia , who visit frenquently day-care or day-care activities clinics, often experience difficulties of daily living and cognitive deficits. living independently is a key for recovery. cognitive remediation is a therapy which reduces deficit and improves daily living. nowadays no program exists targeting neurocognitive functions in virtual reality which could mimic everyday life in a virtual town. hypotheses : * persons with schizophrenia experience difficulties in daily living and disabilities to plan in everyday life. plani-rev program, a serious game with a navigation in a virtual town, in a 15 weekly group sessions could reduce these difficulties compared to the initial assessment. this improvement could be maintained 6 months after the end of the program. * plani-rev could also improve prospective memory, attention, working memory, and visuospatial organization. * plani-rev could induce a clinical improvement, as well as better perception of self-efficiency, self esteem, quality of life, and conversation skills.


Eligibility criteria:
inclusion criteria: * age between 18 and 50 years old. * diagnostic of schizophrenia or schizoaffective disorder (dsm v), attested by the mini structured interview (shehan et al. 1998) * who visit for months or year, weekly or several times per week, a day care, or therapeutic activity units outpatients clinics and nursing homes * french mother tongue * consent of the legal representative caregiver for the patients under representative law (tutelle in french). * clinical stability - therapeutic stability for at least one month. * national healthcare assurance exclusion criteria: * central neurological or non stabilized somatic diseases. * treatments for somatic disease with putative psychotropic effect. * electroconvulsive therapy in the last six months * illetrism * iq\< 70 established with the f-nart. * substance misuse or dependence (except nicotine) or toxic for more than 5 years.
type 2 diabetes primary prevention for at risk girls

Conditions: Obesity; Diabetes Mellitus; Prediabetic State

Summary: purpose: to evaluate two approaches to prevent obesity and type 2 diabetes in young girls. the need: we are experiencing an epidemic of childhood obesity. rates of obesity have doubled to tripled in the past two decades, with the highest rates among poor and ethnic minority girls. type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in overweight children, and more children are manifesting precursors of heart disease and stroke. our two approaches: 1. a state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity. 2. after-school dance classes held five days per week all year long at school sites from the time school lets out until 6pm. dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance. participants: second, third and fourth grade girls and their families will be eligible to participate. all activities are free of charge. to be able to perform a valid evaluation, to be able to accommodate all girls at their own school, and to be fair about which girls receive which program, families who wish to participate will be randomly selected to participate in either one program or the other (nutrition education or dance classes). each family will participate for two years. evaluation: trained stanford staff will perform all evaluation procedures with participating families in their own homes at the beginning and every six months. families will be compensated for their participation.


Eligibility criteria:
second-, third- and fourth-grade girls, aged 7-10 years of age enrolled in one of the participating schools will be eligible. our goal is to be as inclusive as possible. however, girls will not be eligible to participate if they: * have been diagnosed with a chronic illness that affects their growth and/or weight (e.g., type 1 diabetes, hypothyroidism, inflammatory bowel disease) * are taking medications potentially affecting their growth and/or weight (e.g., methylphenidate hcl, systemic steroids) * have asthma (not exclusionary alone) but have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year * have a condition that limits their participation in physical activity enough that they are not able to participate in physical education at school (e.g., significant structural heart disease) * are pregnant * are unable to complete the informed consent process.

Keywords: exercise eating dance health education obesity prevention diabetes prevention children
intraoperative soft tissue balance in tka

Conditions: Osteoarthritis, Knee

Summary: the purpose of this evaluation is to evaluate the intraoperative soft tissue balance as assessed by the orthosensor device, to measure the perioperative gait and function with the muvr tracking device, and to correlate this soft tissue balance with early functional outcomes in the persona total knee system.

this is a single surgeon, prospective, controlled study consisting of 50 patients with a primary indication of oa who are eligible for primary total knee arthroplasty using the persona total knee system. the patients are equally divided in two groups; patients in group 1 will receive traditional, manual soft-tissue balancing during surgery. for the purpose of the study, the balance will be quantitatively assessed at the end of the case, by means of surgeon-blinded verasense measurements before and after cementation. for the patients in group 2, intra-operative sensor feedback will be used in creating a quantitatively balanced knee (verasense, orthosensor inc.). thereby, a quantitatively balanced knee is characterized by a mediolateral load differential below 15lbs at 10-45-90 degrees of flexion. post-operatively, the patients will be evaluated using the muvr device at the day of surgery, day of discharge and 2, 6, and 12 weeks, and 1 year postoperatively. this device will provide quantitative feedback on different gait metrics as well as function during activities of daily living such as stair climbing / stair descent, walking, and timed get up and go testing. during each post-operative visit, the following metrics will be recorded: * active and passive range of motion * implant alignment * patient reported outcomes by means of knee society score (kss), western ontario and mcmaster universities osteoarthritis index (womac) and forgotten joint score (fjs)

Eligibility criteria:
inclusion criteria: 1. patient has a primary indication of osteoarthritis and is eligible for primary total knee arthroplasty using the persona total knee system 2. patient is willing and able to provide written informed consent prior to study surgery 3. patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the informed consent form exclusion criteria: 1. patient does not have a primary indication of osteoarthritis 2. patient does not have access to internet or mobile device or understand how to use phone/app 3. patient is not eligible or will not receive the persona total knee system 4. patient has not provided written informed consent
study to characterize acute and chronic directional aspects of deep brain stimulation

Conditions: Parkinson Disease

Summary: the primary objective is to characterize the programming effects of boston scientific vercise™ pc system using the dbs directional lead for bilateral stn dbs for the treatment of parkinson's disease in acute and chronic settings.


Eligibility criteria:
key inclusion criteria: * diagnosis of bilateral idiopathic pd with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia. * updrs iii score of \>25 in the meds off condition * medication must improve pd symptoms by ≥30%, as measured by updrs subset iii score key exclusion criteria: * any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator * any current drug or alcohol abuse as determined by the investigator * any history of recurrent or unprovoked seizures * any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<12 months

Keywords: parkinson disease deep brain stimulation directional stimulation
post-neoadjuvant treatment mri based ai system to predict pcr for rectal cancer

Conditions: Rectal Cancer

Summary: in this study, investigators seek for a better way to identify the potential pathologic complete response (pcr) patients form non-pcr patients with locally advanced rectal cancer (larc), based on their post-neoadjuvant treatment magnetic resonance imaging (mri) data. previously, a post neoadjuvant treatment mri based radiomics ai model had been constructed and trained. here, the predictive power of this artificial intelligence system and expert radiologist to identify pcr patients from non-pcr larc patients will be compared in this prospective, multicenter, back-to-back clinical study

this is a multicenter, prospective, observational clinical study for seeking out a better way to predict the pathologic complete response (pcr) in patients with locally advanced rectal cancer (larc) based on the post-neoadjuvant treatment magnetic resonance imaging (mri) data. patients who have been pathologically diagnosed as rectal adenocarcinoma and defined as clinical ii-iii stage will be enrolled from the sixth affiliated hospital of sun yat-sen university, sir run run shaw hospital and the third affiliated hospital of kunming medical college. all participants should follow a standard treatment protocol, including neoadjuvant treatment, total mesorectum excision (tme) surgery. patients with larc who received neoadjuvant treatment will be enrolled and their post-neoadjuvant treatment mri images will be used to predict their pathologic response (pcr vs. non-pcr). the artificial intelligence prediction system and the expert radiologist will define the pathologic response as pcr or non-pcr, respectively. the pathologist will provide the final pathology report of tme surgery specimen (pcr or non-pcr) as a standard. the predictive efficacy of these two back-to-back approaches generated will be compared in this multicenter, prospective clinical study.

Eligibility criteria:
inclusion criteria: * pathologically diagnosed as rectal adenocarcinoma * defined as clinical ii-iii staging (≥t3, and/or positive nodal status) without distant metastasis * receive neoadjuvant chemoradiotherapy or chemotherapy * pre- and post-neoadjuvant treatment mri data obtained * receive total mesorectum excision (tme) surgery after neoadjuvant therapy and get the pathologic assessment of tumor response exclusion criteria: * with history of other cancer * insufficient imaging quality of mri to delineate tumor volume or obtain measurements (e.g., lack of sequence, motion artifacts) * not completing neoadjuvant chemotherapy or chemoradiotherapy * tumor recurrence or distant metastasis during neoadjuvant treatment * not undergoing surgery resulting in lack of pathologic assessment of tumor response

Keywords: radiomics features artificial intelligence model locally advanced rectal cancer pathologic complete response neoadjuvant treatment
to demonstrate the relative bioavailability of divalproex sodium 500 mg delayed release tablets under fasting conditions

Conditions: Epilepsy; Bipolar Disorder

Summary: to demonstrate the relative bioavailability of divalproex sodium 500 mg delayed release tablets under fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
mechanistic insights to weight loss maintenance through sglt2 inhibitors

Conditions: Obesity; Weight Loss

Summary: obesity increases the risk of cardiometabolic diseases such as hypertension and diabetes. weight loss interventions such as low-calorie diet and physical activity are effective for weight loss in the short term, but weight loss maintenance (wlm) with low-calorie diet and physical activity is challenging. weight loss is associated with a reduction in the amount of calories needed to maintain the body at rest, called the resting energy expenditure (ree), which may be a probable mechanism for this lack of wlm. most individuals are unable to adequately change their diet and increase their physical activity levels to overcome this decrease in ree which prevents wlm. therefore, techniques that increase ree may promote wlm in these individuals. pre-clinical studies for empagliflozin - sodium-glucose cotransporter-2 (sglt2) inhibitor have shown an increase in ree. thus, in addition to reducing the cardiovascular risk, sglt2 inhibitor may promote wlm by increasing ree. this study aims to promote wlm in obese individuals by increasing the ree using sglt2 inhibitor therapy.


Eligibility criteria:
inclusion criteria: * age more than or equal to 18 years * body mass index more than or equal to 30 kg/m2 who have lost ≥5% of body weight within the past 6 months without taking any pharmacotherapy for weight loss exclusion criteria: * age less than 18 years at screening. * untreated systolic bp \ 160 mmhg at baseline, or diastolic bp \ 100 mmhg at baseline * women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence) * taking pharmacotherapy indicated for weight loss, such as glp-1 agonists or with weight loss as an adverse event * history of type i diabetes * history of lung disease * have any past or present illness of cardiovascular disease, including myocardial infarction, angina, cardiac arrhythmia, diabetes, stroke, tia, or seizure * current or past (\<12 months) history of smoking * estimated glomerular filtration rate (gfr) \< 60 ml/min/1.73 m2 (ckd-epi equation) urine albumin creatinine ratio ≥30 mg/g * hepatic transaminase (ast and alt) levels \>3x the upper limit of normal * significant psychiatric illness * anemia (men, hct \< 38%; women, hct \<36%) * inability to exercise on a treadmill * consumption of more than 2 alcoholic drinks daily * any contraindications to empagliflozin
18f-fdg pet/ct and molecular tumor characterisation for staging and follow-up of colon cancer

Conditions: Colon Cancer

Summary: the investigators are investigating the usefulness of 18f-fluordeoxyglucose positron emission tomography/ computed tomography (18f-fdg pet/ct) for staging and follow-up of colon cancer. furthermore, the investigators combine 18f-fdg pet findings with clinical and histopathological features, circulating tumor cell (ctc) analyses, tumor gene expression and measurements of circulating cancer biomarkers supar, timp-1 and cea in order to predict tumor recurrence. the investigators hypothesis: the combination of functional imaging by 18f-fdg pet/ct and pre-existing and evolving molecular biomarkers will optimize tumor characterization, staging of disease and early detection of recurrence.


Eligibility criteria:
inclusion criteria: * clinical or histological diagnosis of malignant clonic neoplasm (distance of more than 15 cm from anal ring) * 18 years of age or older * written informed consent exclusion criteria: * diabetes * known malignant disease other than colon cancer * known metastatic disease * impairment of renal function * allergy to ct contrast agents * body weight of more than 150 kg * claustrophobia

Keywords: positron emission tomography computed tomography fluordeoxyglucose colon cancer cancer staging imaging