Kornimate/medical-research-clean huggingface dataset:
the significance of deviation in time from the 12-hour standard serum-clozapine monitoring.

Conditions: Schizophrenia

Summary: the role of therapeutic drug monitoring (tdm) in clozapine dose adjustment have been debated. blood samples for s-clozapine monitoring should be drawn 12 hours post dose. the scope of this trial is to describe changes of s-clozapine and s-n-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine .

several factors can influence s-clozapine and thereby the occurence of dose-related adverse reactions and level of treatment response. the role of therapeutic drug monitoring (tdm) in clozapine dose adjustment have been debated. blood samples for s-clozapine monitoring are recommended to be drawn 12 hours post dose. uncertainty regarding the timing of blood sampling and the individual pharmakokinetics for clozapine +/- 2 hours from the 12-hour timepoint, leads to uncertainty regarding the comparability of serum concentrations and the information hold within them. the scope of this trial is to describe changes of s-clozapine and s-n-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine . in addition we want to investigate if any of the following covariates might affect the change of s-clozapine and s-n-desmethyl-clozapine: sex, age, bmi, co-medications, signs of infection, caffeine intake and smoking.

Eligibility criteria:
inclusion criteria: * age 18 \< 65 * diagnosed with schizophrenia according to the criteria of icd10 (international classification of diseases, world health organization) or the dsm-iv (diagnostic and statistical manual of mental disorders, fourth edition, the american psychiatric association) * unchanged dose of clozapine for the last 30 days * usual time of clozapine evening-dose administration between 9 and 12 pm. exclusion criteria: * significant drug or alcohol abuse that affects participation in this trial * non- or partial compliance of clozapine the day before the trial (assessed by interview) * unresponsive by telephone the evening before the trial * consumption of clozapine in the morning on the day of the trial * significant change in smoking habits within the last 30 days (assessed by interview) * significant change of caffeine intake within the last 7 days (assessed by interview) * modified use of other antipsychotics within the last 30 days * within the last 30 days (7 days for hormone based contraceptives) changes in the use of other medications that can affect s- clozapine during the trial : ( fluvoxamine, ciprofloxacin, hormone based contraceptives, carbamazepine , phenytoin , rifampicin, omeprazole ) * females who are pregnant or breast-feeding

Keywords: schizophrenia, clozapine, tdm, serum concentration
parent's knowledge, attitude and practices towards oral health of their children with primary dentition: a cross-sectional study

Conditions: Oral Health Knowledge

Summary: study aims to assess parents knowledge, attitude and practices towards oral health of their children with primary teeth.

dental caries is a chronic slowly progressing localized destruction of dental hard tissues by the acidic products formed as result of carbohydrates fermentation by bacteria due to disturbance in equilibrium between tooth minerals and plaque products through time. (trindade et al., 2014) it's a worldwide disease affecting all ages both sexes with different socioeconomic levels. dental caries commonly affects children and adversely affects their quality of life and so their weight and growth if left untreated (gokhale and nuvvula, 2015). the environmental factor is a very valuable factor affecting dental caries especially the mother and the family as whole, the family habits are directly influencing their children (suma g and anisha p, 2017). as parents are the primary decision makers for children and their first role models, their oral health knowledge, attitude and practice as well as habits influence their children (dikshit et al., 2018). there is lack of data about parent's oral health knowledge, attitude and practice and their implications on their children in egypt. acquiring information about oral health knowledge of parents, will help identifying those children who are at risk of dental caries consequently it will be possible to offer the proper preventive and curative measures for them. so, we need to know the effect of oral health knowledge, attitude and practice (kap) of parents on caries prevalence of their children.

Eligibility criteria:
inclusion criteria: * healthy children and their parents. * children with primary dentition. exclusion criteria: * parents refuse to participate.
inter-pathologist reader study

Conditions: Nevi, Dysplastic

Summary: this is a post study histology analysis from previously obtained pathology slides.

this is a post study histology analysis. pathologists will use digital histology slide scans of suspicious nevus/nevi obtained from previously conducted studies to provide histopathology gradations of histological features as outlined in the orlucent histology atlas (lbl0713 histopathology atlas for grading of dysplastic nevi and def0713-1 histopathology definitions for lbl0713).

Eligibility criteria:
inclusion criteria: 1. histology scans must have been obtained from previous consented subjects that allows post study ad hoc analyses. 2. histology scans must be available from the data collected from the orlucent oms002, sfi001 or sfi003 studies and are of good quality. exclusion criteria: * na
comparison between amalgam and hall technique in treatment of carious primary teeth

Conditions: Dental Caries in Children

Summary: compare between amalgam restoration and hall technique for treatment of decayed primary molars and intervention treatment for decayed primary molars in children, age 3-5 years using split mouth technique in the same child, conventional amalgam restoration and use stainless steel crown in other side

this study wiii be conducted on 30 chiidren: the moiars wiii be treated by spiit mouth technique. (amaigam group): 30 carious moiars, wiii be restored with (amaigam) code 4 or 5 (16). ( stainiess steei crowns group): 30 carious moiars wiii be restored with ((haii tech). - ciinicai assessment: during follow up periods if: * pain * redness, and * sweiiing wiii be assessed for presence or absence(18). * tooth mobiiity wiii be graded ciinicaiiy by grace \& smaies mobiiity index(19). * restoration effecincy. * gingival index gingival index (gi) radiographic examination ( parallel periapicai radiograph) : the radiographs will taken using the parallel periapical technique, will be taken immediately on the first visit post operatively, to act as base line for radiographic evaluation. the following criteria of radiographic assessment will include: 1. externai or internai root resorption. 2. inter-radicuiar bone resorption. 3. widening of the periodontai iigament space. 4. periapicai radioiucency. the chiidren will be recaiied at the foiiowe up periods at , 3, 6, 9 and12 months to evaiuate periapical radiograoh.

Eligibility criteria:
inclusion criteria: 1. apparently healthy children aged from 3-5 years old of both sexes. 2. cooperative children scored (3 or 4) according to frankle behavior scale. 3. informed consent were obtained from parents or care givers. 4. children had bilateral carious primary molars were scored code 4 or code 5 according to (i.c.d.a.s.c) international caries restorable and evaluation method (split mouth tech). exclusion criteria: 1. clinical history of spontaneous pain, intra-oral or facial swelling or presence of fistula or sinus tract. 2. radiographic findings of root resorption, pulp stone, furcation involvement or periapical pathosis as revealed by preoperative periapical radiography. 3. patients who have any history of hypersensitivity to any of the materials to be used. 4. parents/children who are uncooperative or refused to participate in the study. -

Keywords: caries hall technique amalgam primary molars
innovative "scoring system" in breast cancer post neoadiuvant chemotherapy

Conditions: Early Breast Cancer

Summary: our aim is to create a scoring system (ss) able of guaranteeing radical oncology by completely removing cancer and aesthetic outcomes in line with the needs or expectations of the patients that helps surgeons to decide the type of surgery in patients undergoing nact. secondary outcome is to assess the ability of the score to avoid neoplastic relapses by evaluating: * loco-regional disease free-survival (lr-dfs): months between start of nact and date of a neoplastic recurrence in residual mammary gland, in ipsilateral chest wall or in ipsilateral axilla. * distant disease-free survival (ddfs): months between start of nact and date of onset of visceral or skeletal metastases. * overall survival (os): months from the start of nact to death or last follow-up.


Eligibility criteria:
inclusion criteria: * patients undergoing neoadjuvant chemotherapy * surgery: breast conservative surgery; oncoplastic surgery type ii; conservative mastactomy (nipple sparing - nsm or skin sparing - ssm) exclusion criteria: * lack of initial staging or restaging; * previous or synchronous history of systemic malignant neoplasms. * history of homo-or contralateral breast cancer. * initial evidence of metastatic pathology or development of metastases during noeadjuvant chemotherapy (stage iv) * indication to modified radical mastectomy (mrm) without delayed reconstruction
non-pharmacological prevention of postoperative delirium by occupational therapy teams

Conditions: Postoperative Delirium; Aging Disorder

Summary: in the world, 230 million surgeries are performed every year and us data indicates that more than a third of patients who undergo surgery are older than 65 years, in which between 10 and 70% develop postoperative delirium (pod). patients who develop pod have poor outcomes, such as a longer hospital stay, a deterioration in functional and cognitive status, high mortality rates, and an increase in health costs. delirium is an entity that in a significant percentage is preventable, thus preventing the development of pod is fundamental. in fact, in older adults hospitalized in the no surgical ward, the implementation of non-pharmacological prevention measures of delirium has consistently shown to significantly prevent the development of this condition. however, limited information is available about the usefulness of non-pharmacological intervention protocols applied in the perioperative context to prevent pod. the main aim of this project is to determine whether the application of non-pharmacological measures during the perioperative period prevents pod in elderly patients undergoing highly complex elective surgeries. the hypothesis is that the application of these measures decreases the incidence of delirium in this population.

to determine whether non-pharmacological measures decrease the incidence of pod during the perioperative period in elderly patients undergoing highly complex elective surgeries, it will be performed a randomized clinical trial, where two groups of patients older than 75 years undergoing highly complex elective surgeries will be compared: 1. the first group will receive a protocol of non-pharmacological interventions implemented by occupational therapy teams to prevent delirium plus standard non-pharmacological prevention interventions. 2. the second group will only receive standard non-pharmacological prevention interventions. this study will be carried out in the surgical units of the hospital clinico de la universidad de chile (hcuch) and in the hospital san jose (hsj). the expected result is to demonstrate that the interventions carried out by occupational therapists decrease the incidence of dpo in a significant way in comparison with standard prevention intervention.

Eligibility criteria:
inclusion criteria: * hospital admission for highly complex elective surgery exclusion criteria: * history of cognitive impairment. * a low score in mini-mental state examination (mmse): \<23 points if the patient has 6 or more years of schooling, and \<18 points if the patient has \<6 years of schooling. * severe communication disorder and cultural language limitation (language other than spanish). * delirium on admission or prior to the start of the intervention (measured with cam). * patient enrolled in another study

Keywords: postoperative delirium prevention measure non-pharmacological subsyndromal delirium
baby formula and health

Conditions: Pancreas Disease

Summary: the purpose of this study is to learn about how different types of carbohydrates used in infant formula may affect a baby's intestines and pancreas.


Eligibility criteria:
inclusion criteria: * mothers ≥ 19 years of age * singleton birth * healthy infants * infant between 3-6 months at the time of visit and exclusively fed one of the formulas for a minimum of 3 months exclusion criteria: * delivery before 35 weeks * infant birth weight \<2500g * infants exhibiting growth faltering (loss of more than 25 percentile points) between 1 month to the time of study visit for either weight or length. * infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns. * infant consumption of more than two servings of complementary foods per day before the study visit.
comparative effectiveness of operative versus non-operative treatments for rotator cuff tears

Conditions: Rotator Cuff Tear

Summary: rotator cuff tears are one of the most common causes of shoulder pain. evidence-based guidance on optimal diagnostic and treatment strategies for rotator cuff tears is lacking. our proposed study aims to fill these gaps by identifying the prognostic factors which will predict better outcomes of rotator cuff tears, based on both operative and non-operative treatment. the investigators will also compare outcomes of operative and non-operative treatment of rotator cuff tears and report on the best way to diagnose rotator cuff tears.

rotator cuff tears account for over one quarter million surgeries annually. they are a leading cause of shoulder pain and disability. patients with rotator cuff tears present with shoulder pain and/or limitation in range of motion. fourteen special physical exam tests have been described for diagnosis of rotator cuff tears. prior literature describing sensitivity and specificity of these tests in diagnosing cuff tears is limited by retrospective design, small sample sizes, samples restricted to patients undergoing surgery, and failure to differentiate between partial and full thickness tears. as a result, there is little evidence to help clinicians interpret the diagnostic value of the clinical exam. consequently, clinicians rely heavily on magnetic resonance imaging (mri) for diagnosing cuff tears, adding considerable expense in the diagnostic process. the treatment options for rotator cuff tears are operative and non-operative. there is currently little consensus on indications and timing of rotator cuff surgery or non-operative treatment. furthermore, there is lack of evidence-based guidance on factors associated with outcomes of operative versus non-operative treatment for cuff tears. we are enrolling patients in a prospective cohort study to assess comparative-effectiveness of operative versus non-operative treatment of rotator cuff tears and understand prognostic factors for better outcomes after surgery and non-operative treatments.

Eligibility criteria:
inclusion criteria: * age 45 or older * symptoms for at least 4 weeks of shoulder pain and/or limitation in range of motion of shoulder exclusion criteria: * history of humeral fractures * prior surgery on the same shoulder * contraindications to mri (prior surgical hardware, pacemakers, defibrillators, and claustrophobia) * unable or unwilling to give informed consent * unable or unwilling to be followed up * non-english speaking (as questionnaires have only been validated in english)
the difference of follow-up methods of neonatal jaundice

Conditions: Neonatal Jaundice

Summary: the goal of this observational study is to compare the effectiveness and efficiency for precaution of severe hyperbilirubinemia in neonate by different follow-up methods of neonatal jaundice. there are two kinds of follow-up methods in the investigators clinical practice. the one is internet plus follow-up model, the other is conventional clinic follow-up method. parents of the participant neonates can choose one by themselves. after parents of the participant signed informed consent, the investigators recorded several information including severe hyperbilirubinemia, length of phototherapy, follow-up times, et al. then the investigators analysed these data in order to know what kind of follow-up method is better to prevent severe hyperbilirubinemia and more easy to be accepted.


Eligibility criteria:
inclusion criteria: 1. gestational age ≥ 28 weeks, corrected gestational age ≤ 44 weeks; 2. presence of skin yellowing, percutaneous measurement of jaundice or serum bilirubin concentration less than the phototherapy warning value for the same gestational age and day age group; 3. the vital signs are stable and meet the discharge requirements; 4. agree to participate in this project and sign an informed consent form; 5. parents have a certain understanding ability to cooperate in this study; exclusion criteria: 1. direct bilirubin ≥34mmol/l; 2. increased hepatic enzyme level more than twice of normal value; 3. those infants who have developed bilirubin encephalopathy or neurological damage due to other reasons before follow-up; 4. unable to continue follow-up due to other diseases.

Keywords: neonatal jaundice follow-up internet plus model severe hyperbilirubinemia
vasctrac peripheral arterial disease (pad) study

Conditions: Peripheral Artery Disease; Intermittent Claudication

Summary: vasctrac is a mobile medical application that tracks users' physical activity levels in order to predict endovascular failure of patients with peripheral artery disease.

vasctrac uses open-source software from apple's researchkit to passively track physical activity levels of users who sign up. the goal is to predict post-intervention endovascular failure before it occurs. currently, physicians have no way of knowing when procedures such as angioplasties fail; with vasctrac, researchers hope to find downward trends in physical activity that will predict and indicate endovascular failure. all users are assigned numbers and their medical data is securely coded, decreasing the risk of promulgation of personal information.

Eligibility criteria:
inclusion criteria: * adult, has iphone 5s, can read english exclusion criteria: * under 18 years

Keywords: pad
registry of irreversible electroporation for the ablation of prostate cancer with use of nanoknife device

Conditions: Prostate Cancer

Summary: the aim of this registry is to assess the recurrence of prostate cancer at 1 and 5 years, as well as the change in functional outcomes (e.g. incontinence or erectile function) from baseline. secondary objectives are to establish which indications lead to treatment with ire nanoknife® setting and safety assessment measured by number of complications and adverse events.

this is an international prospective observational multi-center study in which data on consecutive patients for 5 years with prostate cancer who undergo ire are collected. data from each patient will be collected at participating centers over a 5-year period. patients' data at baseline visit (pre-ire), peri-operative data and follow up for 5 years will be recorded. follow up data will be collected according to the following schedule: 1 - 2 weeks after surgery 1. st year: every 3 months 2. nd year: every three months 3. rd year: every 6 months 4. th and 5th year: once a year. data from participating centers will be collected through electronic case report forms (ecrfs), with use of an online data management system (dms), which is located and maintained at the croes office. the data collection or patient participation in this study does not interfere with the choice of treatment, sample collection, procedures and the treatment itself, which should entirely follow standard hospital practices, including the follow up.

Eligibility criteria:
inclusion criteria: * is diagnosed with histologically confirmed prostate cancer * is scheduled for ire nanoknife® * has signed informed consent form exclusion criteria: * no specific exclusion criteria are defined.
pilot study of infrared imaging of cutaneous melanoma

Conditions: Melanoma

Summary: design: this is a pilot study of infrared imaging of cutaneous lesions in patients and volunteers with and without clinically detectable melanoma, and with one or more palpable cutaneous lesions eligible for this imaging study. participants will be evaluated with infrared camera imaging at cutaneous sites with known melanoma deposits, suspected melanoma deposits that are to be biopsied, or at cutaneous sites with other lesions, including other skin cancers, benign inflammatory lesions, benign neoplastic lesions (lipomas, epidermal cysts, dermatofibromas, scar, healing wound, etc.).


Eligibility criteria:
inclusion criteria: * patients or volunteers with or without a history of melanoma. * one or more palpable skin or subcutaneous lesions for which at least one of the following is true: * a tissue diagnosis has been made for the lesion(s) in question, by prior cytologic or histologic evaluation (category a1). * a tissue diagnosis will be obtained for the lesion(s) in question by cytologic or histologic evaluation (category a2). * a tissue diagnosis is not available, but a clinical diagnosis of melanoma or benign lesion is available with a high degree of confidence. examples are hemangiomas, skin tags, seborrheic keratoses, dermatofibromas, lipomas, or growing pigmented skin lesions that are comparable to other cutaneous metastases of melanoma in the same patient (category b). * all patients must have the ability and willingness to give informed consent and must be age 18 years or older at the time of study entry. exclusion criteria: * known or suspected allergy to the adhesive skin markers or water-soluble ink used for the labeling of lesions. * very fragile skin that may be susceptible to injury from adhesive markers. * patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.

Keywords: melanoma cutaneous imaging