Kornimate/medical-research-clean huggingface dataset:
effect of chewing a calcium supplement before fluoride rinse on salivary fluoride

Conditions: Dental Caries

Summary: the anticaries effect of fluoride is through the increase in fluoride presence and retention in the oral fluids, reducing dental demineralization and enhancing remineralization. previous studies showed that a preapplication of calcium (in a rinse) prior to administration of fluoride greatly enhances fluoride concentration in the mouth and the anticaries effect of fluoride. the hypothesis of this study is that the same can be achieved by chewing a calcium supplement prior to a fluoride rinse. the first goal is to determine if chewing these calcium supplements will increase calcium concentration in the oral fluids above baseline levels. secondly, the calcium supplement with the highest calcium release will be tested before a fluoride rinse to assess the increased retention of fluoride in the oral fluids when compared with the fluoride rinse alone. in both parts, healthy volunteers will participate and saliva will be collected to assess calcium and fluoride concentration.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * reported good general health * reported good oral health * having at least 20 teeth in the mouth, being at least 4 (natural or crowned) teeth in all four quadrants of the mouth * having normal salivary flow rate according to direct flow rate determination methods * agreement to adhere to the study protocol exclusion criteria: * unable to understand and/or follow study instructions * hyposalivation * active periodontitis, identified by frequent bleeding of the gums * oral pain * in need of urgent dental care
safety and efficacy therapy of gemcitabine and erbitux® to r0 or r1 resected pancreatic cancer

Conditions: Adenocarcinoma

Summary: this is an open-label, non-randomized phase ii study to evaluate immunochemotherapy in patients with r0 or r1-resected pancreatic cancer.

available study data indicated a possible benefit from adjuvant chemotherapy for patients with resected pancreatic cancer. the optimal therapy regimen has yet to be determined. based on the experiences with cetuximab (erbitux®)and gemcitabine in advanced pancreatic cancer and with gemcitabine as adjuvant therapy, the aim of this study was to evaluate the feasibility of the combined treatment of cetuximab and gemcitabine in patients with r0 or r1-resectable pancreatic cancer and to evaluate if the disease free survival can be increased by the addition of an egfr-targeted therapy.

Eligibility criteria:
inclusion criteria: * provided signed written informed consent. * men and woman age \> 18 years * histologically confirmed r0 or r1 resected ductal adenocarcinoma of the pancreas * life expectancy \>12 weeks * patients with performance status of ecog ≤ 2 * patients without metastasis exclusion criteria: * women of child bearing potential (wocp) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and follow-up to 4 weeks after the study. * women who are pregnant or breastfeeding. * women with a positive pregnancy test on enrollment or prior to study drug administration. * dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. * any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (patients with a previous malignancy but without evidence of disease for \> 5 years will be allowed to enter the trial). * inadequate hematologic function defined by an absolute neutrophils count (anc) \< 1,500/mm³, a platelet count \< 100,000/mm³ and a hemoglobin \< 9 g/dl. * inadequate hepatic function defined by the upper limit of normal (uln), ast and alt levels \> 5 times the uln. * serum bilirubin \> 1.5 times the uln. * inadequate renal function defined by a serum creatinine \> 1.5 times the uln. * prior cetuximab or other therapy that targets the egf pathway. * prior antibody therapy. * any known allergic reaction against cetuximab. * any concurrent chronic systemic immune therapy, radiation therapy, hormonal therapy (except for physiological replacement), or any other investigational agents. * hiv infection. * having participated in another clinical trial in the preceding 30 days.

Keywords: pancreatic cancer adjuvant chemotherapy phase 2 r0 or r1 resected adenocarcinoma of the pancreas
enhanced reality for hemiparetic arm in the stroke patients

Conditions: Stroke; Paresis; Mirror Movement

Summary: the researchers found that enhanced reality developed for the first time in the word by us had a synergistic or additive effect on brain plasticity in patients without central nervous system injury. the aim of this study is to determine the validity and feasibility of enhanced reality in hemiparetic arm in the stroke patients with central nervous system injury.

pre-interventional evaluation; within 1 day of initiation of the intervention; 10 days after initiation of the intervention; 30 days after termination of treatment.

Eligibility criteria:
inclusion criteria: * arm motor fugl-mayer scale; wrist/hand subscales ≥ 2-20 * 9-hole pegboard ; ≥ 25% of contra-lateral hand exclusion criteria: * alexander apraxia scale ≤2 * nih stroke scale question ia-c ≥1 * nottingham sensory scale; \<75% of contra-lateral hand * ashworth scale ≥3 * nih stroke scale question ix ≥2 * beck depression inventory ≥21 * significant upper extremity disease causing hand or below elbow dysfunction * visual disturbance * refusal of participation
gabapentin to reduce opioid use postoperatively (group) in children

Conditions: Pain, Postoperative

Summary: the primary objective of this study is to determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after thoracic surgery. we hypothesize that patients who are given gabapentin will need fewer morphine equivalents postoperatively than those who were not given gabapentin

this study is a double-blind, placebo controlled, randomized study to explore the effects of gabapentin peri and post operatively. physician and families will be blinded to the treatment. 60 subjects will be randomized in a 1:1 ratio to either: * gabapentin treatment group * placebo - control group we aim to understand the impact that gabapentin use peri and post operatively has on: 1. opioid use based of iv morphine 2. pain scores 3. opioid related complications such as withdrawal 4. effects on the level of sedation 5. possible adverse effects associated with use of gabapentin 6. time to extubating the duration of an individual subject's participation in the study will be 7 days or until the patient is discharged from uc davis hospital, whichever occurs first.

Eligibility criteria:
inclusion criteria: 1. age newborn to \< 18 years. 2. gestational age to be minimum 38 weeks. 3. undergo cardiac surgery via a sternotomy or thoracotomy. 4. any thoracic surgery 5. planned noncardiac surgery via a thoracotomy or video assisted thoracotomy (vats). 6. surgery will result in an inpatient stay of at least 48 hours. exclusion criteria: 1. use of opioids within 30 days prior to study entry. 2. renal failure as defined by rifle criteria. 3. history of seizures requiring active treatment. 4. history of chronic pain treated medically. 5. diagnosis of autism. 6. unable to tolerate enteral medications. 7. hematology/oncology patients. 8. parents/legal guardians unable to consent. 9. participation in another clinical study presently or within the last 30 days 10. pregnancy 11. prisoners

Keywords: thoracic surgery cardiac surgery via a sternotomy or thoracotomy
mechanism of action of electroconvulsive therapy

Conditions: Unipolar Depression; Bipolar Depression

Summary: this is an observational neuroimaging study assessing the effects of ect on the brains of patients with unipolar and bipolar depression.

this project aims to use functional connectivity magnetic resonance imaging (fcmri) to study patients with unipolar and bipolar depression receiving ect. patients will be scanned before and after a full course of ect and clinical measures for depression severity and memory will be obtained at the same times.the project has the following aims and hypothesis: (1) to determine the therapeutic antidepressant mechanism of action of ect at the circuit level (2) to determine the mechanism of action of iatrogenic amnesia caused by ect at the circuit level (3) to study the use of fcmri as a state biomarker for depression (4) to study the use of fcmri as a predictor of response for depression.

Eligibility criteria:
inclusion criteria: * males and females between ages of 18 and 65 * diagnosis of major depressive disorder without psychotic features or bipolar i/ii * requiring ect treatment as part of psychiatric care exclusion criteria: * comorbid diagnoses of major depressive disorder with psychotic features, schizoaffective disorder, schizophrenia or dementia * history of psychosis * substance use disorder (abuse or dependence) with active use within last 6 months * severe or unstable medical illness * medical contraindication to anesthesia or ect (e.g., recent myocardial infarction)

Keywords: electroconvulsive therapy magnetic resonance imaging
age of exposure and immunity to malaria in infants

Conditions: Malaria

Summary: the overall objective is to evaluate the effect of exposure to plasmodium (p.) falciparum erythrocytic stage antigens during different periods of infancy on the development of naturally acquired immunity (nai). hypothesis: exposure to p. falciparum prior to 5 months of age does not result in the development of nai, while exposure to p. falciparum after 5 months of age leads to the development of nai. the risks of clinical malaria and anaemia during the second year of life will be compared between cohorts, as well as their correlations with the type and quality of immune responses (antibodies to several p. falciparum antigens, cytokines), oxidative stress markers and host genetic factors. these results should shed light on the determinants of the development of anti-p. falciparum responses early in life and the potential constraints to early life immunisation.


Eligibility criteria:
inclusion criteria: inclusion criteria for pregnant women: * healthy hiv-negative pregnant females less than 50 years of age who attend the voluntary counseling and testing (vct) center at the maragra or manhiça antenatal clinic, * permanent residents of the manhiça area and expecting to be living in the area with their infant for at least 2 years. inclusion criteria for newborn infants: * healthy infants, weighing \>= 2 kg and having an alive mother. exclusion criteria: exclusion criteria for pregnant women: * plan to leave the area in less than 2 years from the start of the study; * women not willing to get tested for hiv infection at the vct center; * test positive for hiv; * not willing to provide informed consent; * cannot understand either portuguese or changana (consent forms are written in these languages). exclusion criteria for newborn infants: * any obvious congenital malformation; * any signs of cerebral asphyxia; * any obvious neonatal infection; * same gender twins; * low birth weight (\<2 kg).

Keywords: natural acquired immunity, clinical malaria, p. falciparum, age, exposure, neonatal immunology, infants
phase ii study using thalidomide for the treatment of als

Conditions: Amyotrophic Lateral Sclerosis; ALS

Summary: the use of thalidomide in patients with als who have disease progression.

phase ii open labeled trial testing the efficacy of thalidomide for als in the setting of disease progression.

Eligibility criteria:
inclusion criteria: * clinically proven als * disease duration less than or equal to 5 years * alsfrs-r score equal to or greater then 30 exclusion criteria: * patients with known deep venous thrombosis or hyper coagulable state will be excluded * patients with fvc less than 80%

Keywords: als
syn120 study to evaluate its safety, tolerability and efficacy in parkinson's disease dementia (synapse)

Conditions: Parkinson's Disease Dementia (PDD)

Summary: the purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of syn120 in patients with parkinson's disease dementia (pdd) already treated with a stable dose of a cholinesterase inhibitor.

this study includes a screening period of up to 6 weeks, a 16 week treatment period, and a 2 week safety follow up period. final eligibility will be determined at the baseline visit. eligible patients will be randomized to receive placebo or syn120 100 mg once a day (qd).

Eligibility criteria:
inclusion criteria: * parkinson's disease dementia * patient has a routine caregiver * taking a stable cholinesterase inhibitor. * patient has a montreal cognitive assessment (moca) 10-23 inclusive exclusion criteria: * history of any significant neurologic or psychiatric disease other than pd * any other condition or clinically significant abnormal findings that would make the patient unsuitable for the study * unpredictable motor fluctuations that would interfere with administering assessments

Keywords: pdd parkinson's disease dementia patients taking a cholinesterase inhibitor.
sleep patterns in children and adolescents with adhd

Conditions: Sleep Disorder; ADHD; Cognitive Change

Summary: this study is aimed to find out sleep profile differences in children and adolescents with and without adhd,relationship between sleep profile disturbance and adhd symptoms, impact of sleep disturbance on cognition functions and quality of life.

attention deficit hyperactivity disorder (adhd) is the most common neurodevelopmental disorder of childhood, affecting 3 -5% children \& adolescent worldwide . inattention, hyperactivity, and impulsiveness are the major adhd symptoms based on the diagnostic criteria of diagnostic and statistical manual of mental disorders (dsm), fifth edition . sleep has been referred to as a "window to the central nervous system", owing to its close associations with many other neurophysiological variables. children are highly vulnerable to sleep disruptions in early childhood, perhaps due to the complexity of the sleep process and children's reliance on caregivers for achieving and maintaining sleep . the relationship between sleep and adhd is a complex process and has gained renewed interest since clinicians and researchers observed that sleep-related problems and complaints are relatively common among children with adhd .previous studies have shown that about 25-50% of children and adolescents with adhd have sleep disorders , including nocturnal awakenings, phase delay, increased night time activity and insomnia. evaluation of sleep problems in child \&adolescent clinical settings is commonly lacking, often unrecognized and go untreated in clinical setting. so, untreated sleep disturbances and sleep disorders pose significant adverse daytime consequences and place children at considerable risk for poor health outcomes . sleep disturbances impair a child's cognitive functioning and contribute to problems with school attendance and performance .

Eligibility criteria:
inclusion criteria: * ages 6-17 years inclusive * males or females * intelligence quotient( iq) \> or equal 80 detected by wechsler intelligence scale for children . * willingness to comply with all study requirements inclusion criteria for adhd group only: • confirmed newly diagnosed adhd according to dsm-5 criteria. (american psychiatric association) exclusion criteria: * history of chronic/significant medical condition * history or current prescribed use of any psychotropics, including non-stimulant medications for adhd. * history or current substance abuse or dependence. * first degree relative with psychosis or bipolar disorder. exclusion for the adhd group only: • meets criteria for any other psychiatric comorbidity disorder besides adhd or oppositional defiant disorder (odd). exclusion for the healthy control group only: • meets criteria for any psychiatric disorders.

Keywords: sleep adhd children cognition
clinical and genetic characterization of individuals with achromatopsia

Conditions: Achromatopsia

Summary: the purpose of this study is to identify individuals with achromatopsia caused by mutations in the cngb3 gene and characterize their clinical condition using several tests of visual function every 6 months for up to 1.5 years.

individuals with a clinical diagnosis of achromatopsia will be asked to provide informed consent and will then have a single 5 ml blood sample drawn for dna sequence analysis of genes known to cause achromatopsia, including the cngb3 gene. all participants will be informed of the results of testing for these mutations. those with mutations in both alleles of the cngb3 gene will be evaluated every 6 months for up to 1.5 years by using a variety of non-invasive visual function tests to more fully characterize their clinical condition. this testing will include routine ophthalmic examination and tests of visual acuity, color vision, reading speed, perimetry, nystagmus, light sensitivity, optical coherence tomography, adaptive optics retinal imaging, electroretinography, fundus photography and completion of a quality of life questionnaire.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of achromatopsia (screening portion of study); 2. molecular confirmation of mutations in the cngb3 gene (main portion of study); 3. at least 6 years of age; 4. willing and able to perform study procedures; 5. signed informed consent(s) obtained (and child assent where applicable). exclusion criteria: 1. not able to have a blood sample drawn; 2. pre-existing eye conditions that would interfere with interpretation of study endpoints (e.g. glaucoma, corneal or lenticular opacities, diabetic retinopathy, history of retinal detachment); 3. participating in an interventional research study of drugs or devices for treatment of achromatopsia or other retinal diseases; 4. use of medications that may impair color vision (e.g. hydroxychloroquine); 5. any condition which leads the investigator to believe that the participant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for participation.

Keywords: achromatopsia, cngb3
clinical trial of rapid progressive central precocious puberty with integrative chinese and western medicine

Conditions: Idiopathic Precocious Puberty

Summary: our study used a randomized controlled trial to validate the clinical efficacy of a combination of traditional chinese and western medicine in the treatment of children with rapid progressive central precocious puberty.

in the research, 164 subjects diagnosed with rapid progressive idiopathic precocious puberty are randomly divided into group ziyinxiehuo granules and megestrol acetate tablet（82 cases）and group gonadotrophin ( 82 cases). patients in group ziyinxiehuo granules and megestrol acetate tablet are treated with ziyinxiehuo granules and megestrol acetate tablet , whereas the group gonadotrophin received with gonadotrophin releasing hormone agonist, and all the subjects in two groups are continuously treated for 6 months.

Eligibility criteria:
inclusion criteria: * girls are diagnosed as idiopathic central precocious puberty by gnrh （gonadotrophin releasing hormone）stimulation test, and their age of onset ≤8 years; * tanner stages of breast in female patients ≥ tanner iii stage，diameter of mammillary nucleus ≥ 3cm; * b-type ultrasonography: the volume of uterus≥3ml, the volume of ovary≥1.5ml, the diameter of follicle≥4mm; * bone age: compared the chronological age, the bone age is more than 1 year and the bone age \<11.5 years old; * it progresses rapidly, ratio of bone age difference to chronological age difference\> 1; * no gnrh analogs or sex hormones were administrated in the past; * all above are needed at the same time. exclusion criteria: * precocious precocity caused by the central nervous system organic diseases; * precocious precocity caused by congenital hypothyroidism, congenital adrenal hyperplasia, adrenal tumor and ovarian or testicular neoplasms as well as mccune-albright syndrome, etc; * precocious precocity with a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematous; * pseudo sexual precocity and partial precocious puberty.

Keywords: idiopathic precocious puberty rapid progressive integrative chinese and western medicine evidence-based medicine
mental health status and related factors among physical medicine & rehabilitation physicians in the covid-19 pandemic

Conditions: Anxiety; Depression; Insomnia; Covid19; Coronavirus

Summary: in december 2019, a highly infectious disease caused by a novel coronavirus (sars-cov-2) emerged in wuhan, china. on march 11th 2020, the world health organization (who) declared covid-19 a pandemic. facing this critical situation, health care workers on the front line are at risk of developing psychological distress and other mental health symptoms. physical medicine and rehabilitation (pm\&r) physicians works both in specialty outpateint/inpatient clinic and pandemic outpatient/inpatient clinics during the outbreak. accordingly, pm\&r physicians are expected to be mentally affected by covid-19 pandemic. in this study we aimed to evaluate mental health status of pm\&r physicians and related factors during covid-19 pandemic. this study is a cross-sectional survey which is conducted on an online platform. demographic data, working conditions of pm\&r physicians and factors that may be related to mental health status is questioned in the survey. the depression, anxiety and stress scale - 21 (dass-21) is used to measure the emotional states of depression, anxiety and stress.the insomnia severity index (isi) is used to assess the severity of both nighttime and daytime components of insomnia.


Eligibility criteria:
inclusion criteria: * being a physical medicine and rehabilitation physician * worked during covid-19 pandemic in specialty outpatient/inpatient clinic or pandemic outpatient/inpatient clinic. exclusion criteria: * being a specialist in a branch other than physical medicine and rehabilitation

Keywords: depression anxiety insomnia covid-19 coronavirus