Kornimate/medical-research-clean huggingface dataset:
efficacy trial of mysmilebuddy

Conditions: Tooth Decay

Summary: this study seeks to evaluate the best way to encourage a healthy diet and proper fluoride use in children at greatest risk for tooth decay. to do so, this study will evaluate whether or not a family focused intervention, mysmilebuddy, is able to reduce tooth decay progression in hispanic preschoolers at high risk of this disease.

tooth decay in young children has traditionally been treated through surgical dental repair, an approach that does not address the oral hygiene and dietary behaviors that cause the disease. professionals agree that behavioral strategies to prevent tooth decay are needed, but they have not been well studied in hispanic children in the united states that have disproportionately high rates of this disease. use of fluoridated toothpaste twice a day and consumption of a healthy diet can both prevent tooth decay and stop it from progressing.

Eligibility criteria:
inclusion criteria: * children aged 24 to 71 months of age, have a minimum of 12 teeth present, and have early childhood caries (ecc) * will reside in the new york city (nyc) metropolitan for the following 12 months * parents must be 18 years or older and must report having a cell phone with texting capabilities exclusion criteria: * children with developmental delays or medical conditions that would impede oral dietary intake, at-home oral hygiene practices, or receipt of oral exams * children with parents who are under the age of 18 years of age, do not report having a mobile phone, do not plan to reside in the new york city (nyc) metropolitan area for the following 12 months * children of parents who do not provide consent to participate.

Keywords: oral hygiene decay decay progression
fluid status in valvular heart disease

Conditions: Valvular Heart Disease; Fluid Overload; Cardiovascular Risk Factor

Summary: by bioelectrical impedance spectroscopy (bis) association of fluid status in patients with valvular heart disease and cardiovascular outcome will be assessed.

volume overload and abnormal fluid distribution are hallmarks in the syndromes of acute and chronic heart failure (hf) as well as valvular heart disease (vhd). most patients, at some point in their disease progression, present acutely to an emergency department, where they will typically show symptoms of progressive volume overload. most patients respond well to standard diuretic therapy, usually at the costs of impaired renal function. based on the assumption that clinically overt fluid overload is the result of progressive fluid accumulation, current european society of cardiology (esc) and american college of cardiology foundation/american heart association (accf/aha) guidelines recommend a correction of volume status using diuretics, to reduce the total fluid volume. however there is no consensus on how to define fluid overload quantitavely. in patients undergoing dialysis, bioelectrical impedance spectroscopy / body composition monitoring (bcm) is a well established tool to assess fluid status, allowing quantitative measurement. this study aims to 1. establish a database reflecting the fluid status assessed by bcm of patients presenting with valvular heart disease according to current guidelines 2. monitor fluid status assessed by bcm during increased diuretic treatment in patients presenting with cardiac decompensation due to valvular heart disease 3. assess the association between severity of valvular heart disease assessed by echocardiography and/or cardiac magnetic resonance imaging, fluid status assessed by bcm, and clinical as well as laboratory parameters assessed during clinical routine 4. assess the relationship between fluid status assessed by bcm and cardiovascular outcome

Eligibility criteria:
inclusion criteria: * valvular stenosis and/or regurgitation of all severities as defined by current recommendations * informed consent * willingness to perform follow up visit exclusion criteria: * \<18 years old * pregnancy * unwillingness to paricipate
intranasal ketamine for suicidal ideation in veterans

Conditions: Suicidal Ideation

Summary: the objective of the current study is to investigate the safety, efficacy, and feasibility of multiple doses of intranasal (in) ketamine for suicidal ideation veterans.

to address the significant need for effective treatment of suicidal ideation in veterans, this trial is designed as an open label pilot study of intranasal ketamine in 15 people.

Eligibility criteria:
inclusion criteria: 1. male or female patients, 21-70 years of age 2. female individuals who are not of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year) or using a medically accepted reliable means of contraception. women using oral contraceptive medication for birth control must also be using a barrier contraceptive. women of childbearing potential must also have a negative pregnancy test at screening and at pre-administration 3. any non-psychotic disorder diagnosis 4. score \>4 on the suicide item of the montgomery-asberg depression rating scale (madrs-si; range 0-6)for clinically significant suicidal ideation or past suicide attempts 5. each participant must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document 6. each participant must agree to avoid future enrollment in ketamine trials. exclusion criteria: 1. current psychotic symptoms or lifetime history of primary psychotic disorder 2. active substance use in the preceding two weeks or needing medical attention for withdrawal 3. neurodevelopmental disorder (e.g., asd) 4. major neurocognitive disorder (e.g., alzheimer's type dementia) 5. serious cardiac disease 6. suicide attempt precipitating current admission requiring medical stabilization 7. lifetime histories of autism, mental retardation, pervasive developmental disorders, or tourette's syndrome 8. women who are either pregnant or nursing 9. hypertension (systolic bp \>160 mm hg or diastolic bp \>90 mm hg) at screening or immediately prior to treatment with study drug 10. previously received ketamine for refractory depression.

Keywords: ketamine veteran suicide suicidal ideation
detrol long acting (la) vs estrace vaginal cream for the treatment of overactive bladder symptoms

Conditions: Overactive Bladder

Summary: the purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of overactive bladder syndrome at 12 weeks post-treatment initiation. the hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of overactive bladder symptoms. secondary outcomes were to assess if the addition of the other therapy to the treatment regimen conferred benefit at 24 weeks and 52 weeks.

lower urinary tract bladder storage symptoms include urinary frequency, urinary urgency, nocturia and urge incontinence. overactive bladder (oab)syndrome is a condition in which urgency is the predominant symptom with or without urge incontinence and is usually accompanied by frequency and nocturia. the mainstay of treatment of women with oab syndrome is treatment with anticholinergic medication as well as behavioral therapy. this method of treatment has demonstrated a 60% response rate as reported in the cochrane database of systemic reviews. in addition to anticholinergic therapy, vaginal atrophy is often corrected as part of a pharmacologic treatment plan. vaginal atrophy is a condition this is vastly prevalent in post-menopausal women. it is thought to affect up to 48% of post-menopausal women. many women with this condition experience vaginal dryness, irritation, painful intercourse, as well as urinary symptoms including dysuria, urgency, frequency, nocturia, incontinence and recurrent urinary tract infections. comparison: tolterodine la compared to low dose intra-vaginal estrogen cream for the treatment of oab symptoms

Eligibility criteria:
inclusion criteria: * irritative voiding symptoms to include sensory urgency, frequency, urge incontinence, nocturia * postmenopausal women with a prior oophorectomy or 1 year from last menstrual period * women age 40-90 * women with hysterectomy with preserved ovaries must be age 55 or greater or have a documented follicle-stimulating hormone (fsh)\>40 to ensure post-menopausal status * community dwelling * ambulatory * ability to participate in a 12 month study exclusion criteria: * post-void residual volume\>150ml * glaucoma without ophthalmologist clearance * hormone replacement therapy in the past 6 months * current anticholinergic treatment * breast cancer * impaired mental status * undiagnosed vaginal bleeding in the past 12 months * endometrial thickness on pelvic ultrasound \>5mm * history of thromboembolic event * gynecologic cancer * untreated urinary tract infection (would be eligible after treatment) * stage iii pelvic organ prolapse or greater * recent diuretic medication changes (one month from change) * neurologic condition affecting bladder function (multiple sclerosis, parkinsons, spinal cord injury, spina bifida) * congestive heart failure * prior pelvic irradiation * interstitial cystitis

Keywords: overactive bladder urge leakage nightime urination incontinence urinary frequency
floatation experience in nurses and physicians

Conditions: Burnout, Professional; Negative Affect; Positive Affect; Wellbeing; Burnout; Psychological

Summary: the goal of this observational study is to monitor the floatation experience and continue the program as long as deemed important. the main question it aims to answer is: will inventory wellbeing scores increase according to the number of floatation sessions accrued? nurses (registered, practitioner, and anesthetist) and physicians, employed at st. elizabeth youngstown trauma center, mercy health, will be welcomed to participate in the floatation experience. participants will be given an option to complete the wellbeing inventory survey prior to each floatation session.

the floatation program is a mercy health enterprise sponsored by the mercy health mahoning valley foundation.the goal of this study is to monitor the floatation experience and continue the program as long as deemed important. the investigators hypothesize that inventory wellbeing scores will increase according to the number of floatation sessions accrued. nurses (registered, practitioner, and anesthetist) and physicians, employed at st. elizabeth youngstown trauma center, mercy health, will be welcomed to participate in the optional floatation program in warren, ohio at no financial cost to them. they will become aware of floatation options through the mercy health be well wellness program. floatation monitoring will include assessments of wellbeing, nonstress, and positive affect scores. participants will be given an option to complete the wellbeing inventory survey prior to each floatation session. this will be a self-reporting anonymous process. the investigator will never know the identity of the participant.

Eligibility criteria:
inclusion criteria: * nurses and physicians exclusion criteria: * any person that is not a physician or nurse at st. elizabeth youngstown hospital

Keywords: floatation anxiety attention awareness burnout relaxation therapy self-concept wellbeing
open label study of long term safety evaluation of alirocumab

Conditions: Hypercholesterolemia

Summary: primary objective: to assess the long-term safety of alirocumab (sar236553/regn727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (hefh) who had completed efc12492 (nct01623115), r727-cl-1112 (nct01709500), efc12732 (nct01617655) and lts11717 (nct01507831). secondary objectives: * to evaluate the long-term efficacy of alirocumab on lipid parameters. * to evaluate the long-term immunogenicity of alirocumab.

the maximum study duration will be 176 weeks per participant.

Eligibility criteria:
inclusion criteria: participants with hefh who had completed one of the four parent studies (efc12492, r727-cl-1112, efc12732 and lts11717). exclusion criteria: significant protocol deviation in the parent study; any permanent treatment discontinuation from the parent study. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
treatment with topical eflornithin after laser treatment in women with facial hirsutism

Conditions: Hirsutism

Summary: split-face investigation of the efficacy of applying eflornithin cream twice daily for six months after a period with six laser treatments for hair removal.

background: unwanted facial hair growth is a serious problem for 5-15% of all women winch affects their quality of life. in denmark patients are offered six laser treatments covered by the public health insurance. there is a lack of good follow-up treatments to this regime that can extent the efficacy of the laser treatment. eflornithin cream is an approved treatment for reduction of facial hair growth which has proved to give an additional efficiency when used in combination with laser treatments.the efficacy when used after laser hair removal is not known. aim: to investigate whether an extended efficacy of laser hair removal can be achieved with application of eflornithin cream twice daily for six months after completion of laser treatments. method: in a split-face trial to apply eflornithin cream twice daily for six months. outcome measures are investigator evaluation, blinded on-site evaluation, patient's assessment score and clinical photos.

Eligibility criteria:
inclusion criteria: * 18 years or older * habile, understands danish * moderate to severe hirsutism prior to laser treatments * succeeded minimum five laser treatments * intact skin with no severe adverse events to laser treatments * record of current medication and androgen hormone blood profile available * use of safe anti-conception (fertile women) exclusion criteria: * pregnant or lactating * allergy toward the content of eflornithin cream * concomitant use of immunosuppressive therapy * dementia, psychiatric disease, alcoholic

Keywords: unwanted facial hair growth
a study to assess efficacy and safety of asp1941 in diabetic patients with renal impairment

Conditions: Type 2 Diabetes Mellitus

Summary: this study is to assess the effect of renal function on the efficacy and safety of asp1941 in type 2 diabetic patients with mild to moderate renal impairment.

this study will be conducted in patients with type 2 diabetes mellitus and mild to moderate renal impairment who have inadequate glycemic control on an exercise program and stable diet, or one oral hypoglycemic agent. the severity of the reduction in renal function in each subject will be classified according to the glomerular filtration rate (gfr) estimated using the japanese gfr estimation equation. subjects will start with a screening period, followed by a single-blind placebo run-in period, and will be randomized to the asp1941 groups or the placebo group at a ratio of 2:1. for randomization, subjects will be stratified according to the severity of the reduction in renal function. in a treatment period, subject will receive study drug or placebo for 24 weeks under double-blind conditions. at 24 week, subjects who are willing to continue participation in the study will receive study drug for another 28 weeks in an open label condition. asp1941 can be increased. after completion of the study drug administration, a follow-up period will be provided.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patient * subject has been on an exercise program and stable diet, or one oral hypoglycemic agent (alpha-glucosidase inhibitor, sulfonylurea agent and pioglitazone) * estimated gfr value based on the japanese gfr estimation equation of ≥ 30 ml/min/1.73 m2 and \< 90 ml/min/1.73 m2 * hba1c value between 6.5 and 8.5% * body mass index (bmi) 29.0 - 45.0 kg/m2 exclusion criteria: * type 1 diabetes mellitus patients * proliferative diabetic retinopathy * subject has received insulin within 12 weeks before the study * subject has a chronic disease which requires the continuous use of adrenocortical steroids, immunosuppressant, and loop diuretic * serum creatinine \> upper limit of normal * proteinuria (albumin/creatinine ratio \> 300mg/g) * dysuria and/or urinary tract infection, genital infection * significant renal, hepatic or cardiovascular diseases * severe gastrointestinal diseases

Keywords: pharmacokinetics asp1941 renal impairment
an observational study on respiratory complications after gastrointestinal endoscopy assisted with anesthesia

Conditions: Pneumonia, Aspiration

Summary: the purpose of this study is to investigate the incidence of respiratory complications after gastroenteroscopy, and establish a logistic regression model to analyze the related risk factors of respiratory complications.

gastrointestinal endoscopy is currently the most widely used and reliable technique for diagnosing digestive tract diseases.with the increasing need for pain relief and the improvement of anesthesiology technology, more and more patients prefer to undergo gastroenteroscopy under sedation or anesthesia.the painless technique of gastroenteroscopy is an anesthetic method , and like other anesthesia techniques, it brings risks as well as comfort.however, current studies mainly focus on respiratory and circulation-related adverse events during the examination , while little attention is paid to delayed respiratory complications after examination.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old; 2. qualified gastrointestinal tract preparation in strict accordance with the preparation requirements related to gastroenteroscopy; exclusion criteria: 1. patients with respiratory system symptoms or history before surgery; 2. patients in need of a tracheal intubation; 3. refuse follow-up;

Keywords: gastrointestinal endoscopy respiratory complications sedation
a feasibility study to assess pre admission status and six month outcomes after major trauma

Conditions: Multiple Trauma

Summary: this study aims to assess the feasibility of obtaining details about a patients previous level of function from the patient of friend/relative, after they have been admitted an intensive care unit (icu). it will also assess the feasibility of re-assessing level of function at 6 months after the patient has been discharged from icu.

currently there is no standardised way of obtaining details about a patients pre-admission level of function. the process of gaining this history is often done by several different people with no standard questions asked. there is also a need to be able to measure what happens to patients after they leave icu, and compare their abilities to preadmission status. this feasibility study will aim to investigate: * the time taken to train the physiotherapy team in the use of the outcome measure * the ability to obtain pre admission functional status from patients/friend/relative on admission to icu * the ability to follow patients up at 6 months post discharge with re-assessment of the outcome measure

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study * participants relative or friend (consultee) is willing and able to give informed consent for participation in the study (where the patient is unable to give informed consent) * male or female, aged 18 years or above * injury severity score greater than 9 * admitted as an emergency to aicu * experienced at least 24 hours level three care during their admission exclusion criteria: * non uk resident (due to potential loss to follow up) * unwilling to consent * no gp details available * patients with a palliative diagnosis or established on a palliative treatment pathway
clinical validation of an immunocytochemistry method using mars1

Conditions: Bile Duct Obstruction, Extrahepatic

Summary: the sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. the aim of this study was to validate the clinical usefulness of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer-related protein expressed only in bile duct cancer.

hypothesis: the statistical significance of new staining method using aminoacyl-trna synthetases (arss) group in normal bile duct cells and the bile duct cancer cells collected by endoscopic retrograde pancreaticoduodenoscopy (ercp) will be compared to prove the usefulness of the new staining method. clinical study design: the bile duct cytology will be obtained by brushing cytology using ercp in patients with biliary stenosis. the expression of arss in the brushing cytology will be evaluated by a new staining method and compare with the results of the conventional cytology staining method including papanicolaou staining. immunofluorescence or immunocytochemistry staining will be performed to differentiate the presence of the tumor. the sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.

Eligibility criteria:
inclusion criteria: * patients with biliary cancer confirmed by imaging (ct, mri, positron emission tomography) * patients with bile duct cancer diagnosed using brushing cytology by endoscopic retrograde pancreaticoduodenoscopy * patients who underwent surgical treatment with biliary cancer * patients with bile duct stenosis exclusion criteria: * minors under the age of 19, vulnerable subjects such as illiteracy * necrotic specimens * samples with non-diagnostic cytology results and insufficient cells for further evaluation * samples classified as neoplastic (benign or other) * patient with cholangitis in the bile duct

Keywords: bile duct obstruction, extrahepatic cytology aminoacyl-trna synthetases