Kornimate/medical-research-clean huggingface dataset:
promoting healthy development with the recipe 4 success intervention

Conditions: Obesity; Poverty

Summary: 10-session home visit intervention conducted within early head start and designed to reduce low-income toddler's obesity risk and improve their self-regulation skills and parents' sensitivity.

recipe 4 success, the product of a university-community engagement collaboration, uses 10 tightly sequenced, structured, and scripted food preparation lessons, delivered as part of early head start home visits, to help low-income parents learn to sensitively scaffold their toddler's self-regulation skills and establish more healthy eating habits. the intervention relies on an active coaching therapeutic approach to deliver content. recipe 4 success is focused on parents because their feeding practices influence children's diet, and interventions to prevent childhood obesity are most likely to have long-term effects when they emphasize positive parenting practices. parents' sensitivity and constructive scaffolding behaviors are related to children's self-regulation skills, which are robust predictors of healthy eating habits and body mass index (bmi). for example, children who have difficulty with self-regulation by age 3 have a higher bmi through age 12. importantly, these relations may be causal: adults who are taught self-regulation skills appear more successful in maintaining healthy eating habits over time. as a preventive intervention, recipe 4 success is implemented when children are 2, the point at which deliberate self-regulation skills are starting to emerge and develop rapidly and taste preferences are being formed. recipe 4 success is designed for families living in poverty because parents are less likely to provide sensitive scaffolding and children are less likely to display well-developed self-regulation skills and healthy eating habits under conditions of economic adversity. finally, recipe 4 success was created to be integrated into early head start to expedite wide-spread dissemination and easy sustainability and to enhance the efficacy of this nation-wide home visit program. if successful, this will be one of the first preventive interventions to improve either toddler's self-regulation skills or their healthy eating habits and bmi.

Eligibility criteria:
inclusion criteria: * family lives in york, allentown, williamsport/lock haven pennsylvania * family enrolled in early head start home visit program * target child 18-36 months old at beginning of study exclusion criteria: * family considered "in crisis" by home visitor (i.e., not able to focus on new intervention lessons because of child custody, family violence, mental health, or housing issues that currently demand parents' full attention)
depressive and anxiety disorders in patients with chronic liver diseases

Conditions: Depression, Anxiety

Summary: the aim of this observational study is to learn about the prevalence of depressive and anxiety disorders among patients with chronic liver diseases

major depressive disorder (mdd), or clinical depression, is a psychiatric disorder characterized by 2 or more weeks of persistently depressed mood accompanied by symptoms such as feelings of worthlessness, guilt, hopelessness, helplessness, loss of self-esteem, sleep disturbance, changes in oral intake, anhedonia, loss of interest, and suicidality. the american psychiatric association, on the definition of anxiety, describes anxiety as the anticipated anticipation of a future danger or negative event, accompanied by feelings of dysphoria or physical symptoms of tension. the elements exposed to risk may belong both to the internal world and to the external world. depression is highly prevalent globally and is a leading cause of disability. the global burden of disease study found depression to be a leading cause of disability among all illnesses. liver cirrhosis is one of the diseases commonly associated with depression.chronic liver disease is the progressive destruction and regeneration of the liver parenchyma leading to fibrosis and cirrhosis (normally lasts 6 months). the etiologic agents of cld include hepatotropic viruses (hbv and hcv), fatty liver, alcohol, autoimmune hepatitis, etc. the mortality of cld patients remains high not only due to irreversible cirrhosis, but also multiple complications such as hcc and mental disease, especially depression. the progressive nature of this disease results in high rates of hospitalization, extensive exposure to medications, increased financial burden, frequent need for invasive procedures, changes in body image, and an increase in morbidity and mortality. all these factors contribute to the physical and psychological stress that mediates the development of depressive symptom high rates of depression have been documented in patients with decompensated liver disease and in those anticipating liver transplantation.

Eligibility criteria:
inclusion criteria: 1. patients admitted or attending at rajhi university hospital with chronic liver disease including: viral (hepatitis b and c), autoimmune (primary biliary cirrhosis, primary sclerosing cholangitis and autoimmune hepatitis), non-alcoholic steatohepatitis, morbus wilson and cryptogenic cld. 2. age group above 18 years old. exclusion criteria: 1. patients with chronic liver disease with other psychiatric disorders other than depression and anxiety. 2. patients with acute complication of chronic liver disease. 3. patients with chronic liver disease who underwent liver transplation. 4. patients with chronic liver disease under antiviral therapy.

Keywords: depression anxiety liver
nutrition throughout the treatment course - expanding care from hospital to home

Conditions: Head and Neck Cancer

Summary: patients with cancer have increased risk of malnutrition due to the disease itself and the treatment regimen they undergo. this is particularly relevant for patients with head and neck cancer (hnc), where 74%-95% are malnourished. hnc is a heterogenous group of cancers, including oral cavity, larynx, pharynx and salivary glands. the present project will study the effectiveness and implementation of remote patient monitoring of nutrition and tailored nutrition support throughout the treatment course in patients with head and neck cancer. the implementation will be evaluated in a randomized controlled trial (rct), and the aim of the project is to reduce the prevalence of malnutrition and increase the quality of life among patients with hnc.


Eligibility criteria:
inclusion criteria: * head and neck cancer * older than 18 years exclusion criteria: * patients admitted with the classification of malignant tumors (tnm) stage 4 * terminal condition (life expectancy \< 6 months) * patients who do not understand the norwegian language.
post marketing surveillance to collect and evaluate the safety and efficacy information of korean mds patients treated with vidaza®, after approval of marketing authorization for new drug in korea

Conditions: Myelodysplastic Syndrome

Summary: the main purpose of vidaza® due (drug use examination) is to collect and evaluate the safety information of korean mds patients treated with vidaza®(sc or iv) according to the approved package insert, after approval of marketing authorization for new drug in korea. in addition, the efficacy information of vidaza® in clinical practice is collected and evaluated. this due is a prospective, multi-centre, observational, non-interventional, post-marketing surveillance. at least 600 patients' data that is eligible for safety assessment will be collected. vidaza® due is to investigate frequency and change of adverse events(aes) /adverse drug reactions(adrs), serious adverse events(saes)/serious adverse drug reactions(sadrs), unexpected ae/adr and unexpected sae/sadr, and to scrutinize factors influencing safety \& efficacy of the drug. it is necessary to examine patients' demographics and baseline characteristics, medical history, status of vidaza treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.


Eligibility criteria:
inclusion criteria: * korean male or female myelodysplastic syndrome patients treated with vidaza®(subcutaneous or intravenous) according to the approved package insert exclusion criteria: * there's no exclusion criteria

Keywords: myelodysplastic syndromes vidaza observational study korea
characterization of dyschromic hypertrophic scar

Conditions: Burn Scar; Hypertrophic Scar; Hyperpigmentation; Hypopigmented Scar

Summary: currently, there are limited prevention or treatments available for dyschromia in burn hypertrophic scars (htss). the limited available techniques involve transferring melanocytes from unaffected areas to the scar to adjust pigment. these techniques involve the creation of a donor site and do not utilize the cells that may already be present in scars. this study aims to confirm melanocyte presence in regions of hypo- and hyper- pigmented hts. if melanocytes can be found in regions of hypopigmentation, these scars may be able to be treated in the future by pigmentation stimulators without the need for surgery. additionally, if pigmentation specific molecules of interest can be found to be up-regulated in hyperpigmented scar, these may be able to be altered by a pharmacotherapy.

subjects with burn scars that are lighter and/or darker than their normal skin will be asked to participate in this study. it is being done to obtain more information about why some people develop scars that are different in color to their normal skin after trauma to the skin such as a burn. participants who wish to participate will have scar measured with a ruler, and study sites identified and photographed. additionally the following procedures will be done: non-invasive measurements: each area of scar will have multiple non-invasive measurements done. these include: * scar scales - subjective measures of color, itching, pain, height, etc. * elasticity - a probe is briefly placed on top of the skin to measure its ability to stretch * induration - a probe is briefly placed on top of the skin to measure how firm it is * color - a skin probe in briefly placed on top of the skin to measure its color biopsies: based on the measurement of the scars, several small 3mm punch biopsies will be done. subjects with light colored scars and total scar greater than 500cm2 are eligible to participate in an optional sub-study. for this sub-study, an additional excisional biopsy 1 cm by 2 cm in the shape of an oval will be obtained from the lighter colored scar. blood collection: blood will be collected for correlating blood characteristics to scar outcome. approximately 20 ml of blood will be collected, which is less than 2 tablespoons. a portion of this blood might be used in the future for genome sequencing of pigmentation or hypertrophic scar-related gene sequences. whole genome sequencing will not be performed. interview: personal information, medical history, health behaviors, and scar history will be reviewed. data collection: information about initial burn injury, hospitalization, and outpatient visits will be requested from the medical record.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * skin trauma resulting in a dyschromic scar exclusion criteria: * dyschromic scar dole to face, genitals, fingers, or toes * known lidocaine allergy * pregnancy * prisoner status

Keywords: burn scar hypertrophic scar dyspigmentation dyschromic scar
bipolar versus mono-polar needlescopic en bloc tur-bt

Conditions: Bladder Cancer; Bladder Neoplasm

Summary: non-muscle invasive bladder cancers (nmibc) compose about 80% of bladder tumors. the stranded treatment of these tumors is turbt. en bloc resection of nmibc yields better mascularis propria with better oncological outcomes


Eligibility criteria:
inclusion criteria: * confirmed primary nmibc (ta, tis, t1) * age \> 18 years exclusion criteria: * mibc * anterior located mass ( difficult or non visualized)

Keywords: nmibc turbt en bloc resection
further psychometric data for the reliability and the diagnostic validity of crs-r

Conditions: Minimally Conscious State; Vegetative State

Summary: this study aims to provide, in a large sample, further psychometric data as regards the internal consistency, the test-retest reliability and the diagnostic validity of the coma recovery scale-revised (crs-r).

recently, a report of the american congress of rehabilitation medicine aiming to provide a systematic review of behavioral assessment scales for doc has indicated that, when compared to other scales, the crs-r meets the highest psychometric standards for the evaluation of severely brain-injured patients and may be used to assess doc with minor reservations. however, that report mentions few evidences or studies with small sample sizes for some aspects of its reliability and validity such as its internal consistency and its test-retest reliability.the report also states that the diagnostic validity of the crs-r remains unproven. in this study, the investigators will therefore aim to provide further psychometric data as regards those variables in a large sample of patients with doc

Eligibility criteria:
inclusion criteria: * age above 18 years old * any etiology * pre-screening performed by the referent physician comforting the presence of a disorder of consciousness in accordance with international diagnostic criteria for vs, mcs or emergence from mcs (emcs) exclusion criteria: * neuromuscular blocking agents or sedative drugs administered within the prior 24 hours * no documented history of a prior coma * critical illness or unstable medical condition

Keywords: disorders of consciousness vegetative state minimally conscious state emergence from mcs coma recovery scale-revised
bevacizumab for primary pterygium treatment

Conditions: Pterygium

Summary: the aim of this study was to investigate the efficacy and safety of subconjunctival bevacizumab application as an adjuvant therapy for primary pterygium.


Eligibility criteria:
inclusion criteria: * patients with primary pterygium exclusion criteria: * patients with diabetes mellitus * collagenopathies, * previous ocular surgeries, * pregnant or lactating patients

Keywords: pterygium bevacizumab autoconjunctival graft
comparison between efficacy of music therapy and intravenous midazolam 0.02 mg/kgbw in reducing preoperative anxiety

Conditions: Cancer

Summary: this study aimed to compare the efficacy of music therapy and midazolam 0,02 mg/kgbw in reducing preoperative anxiety on patients undergoing brachytherapy with spinal anesthesia

approval from ethical committee of faculty of medicine universitas indonesia was acquired prior conducting the study. subjects were given informed consent before enrolling the study. intravenous (iv) cannula had been set and the amsterdam preoperative anxiety and information (apais) score questionnaire was filled by the subject. blood pressure, pulse rate, and mean arterial pressure were recorded. subjects were then randomized into two groups (music therapy and midazolam). in music therapy group, subjects listened to music using headphone attached to music player for 30 minutes. music player has been filled with variety of slow beat songs (60 - 80 bpm), including instrumental, pop, jazz, classical, and so forth. in midazolam group, subjects was given intravenous midazolam 0,02 mg/kgbw injection without listening to music. after injection, subjects are allowed to rest or sleep for 30 minutes. after intervention, apais score was filled by subjects with blood pressure, pulse rate, and mean arterial pressure recorded again. subjects then were moved to brachytherapy room.

Eligibility criteria:
inclusion criteria: * woman aged 18-65 years old * undergoing one day care brachtherapy with spinal anesthesia * american society of anesthesiologist (asa) physical status of i-iii * agreed to participate in this study and signed informed consent * able to read, write, and speak in indonesian language. exclusion criteria: * subjects with severe hearing impairment * subjects with cognitive/mental impairment based on medical record * subjects with previous routine use of antipsychotic and benzodiazepine drug * subjects with prior heart disease or uncontrolled hypertension.
effects of a postural education multicomponent intervention in primary school children.

Conditions: Physical Activity; Back Pain Lower Back

Summary: the present study, named pepe project, aims to study the effects of a 9-month postural educational multicomponent intervention on back health in schoolchildren. as well as, this project aims to examine the effectiveness of the intervention on teachers. total of 2000 children aged 10 to 12 and 20 schools will be randomized into an intervention group (n=1000 children, n=10 schools) and a control group (n=1000 children, n=10 schools). a 9-months intervention program will be implemented. participants will be evaluated three times: before the intervention (baseline, month 0), after the intervention (post-test, month 9) and 6 months after the intervention finished (follow-up, month 15). the intervention will consist on: (1) nine oral presentations delivered at school, (2) multisubject teaching unit, (3) information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.), and (4) the back-care day at school. the effectiveness of the intervention will be evaluated by means of primary outcomes which include the back-care knowledge of schoolchildren. as well as, a set of secondary outcomes such as daily postural habits, use of a backpack, and lbp prevalence in schoolchildren and among teachers involved will be studied. this intervention will provide new insights into the prevention of childhood lbp which may lead to a better management of this health problem throughout an individuals lifetime.


Eligibility criteria:
inclusion criteria: * children aged between 10 and 12 years, who belonged to the fifth and sixth grades of primary school. exclusion criteria: * children with some type of medical condition that may affect the results of the measurements or that present some limitation of their abilities that prevents the intervention program from developing normally.
a study of aln-aat02 in healthy participants and participants with zz type alpha-1 antitrypsin deficiency liver disease

Conditions: ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease

Summary: the purpose of this study is to evaluate the safety and tolerability of single or multiple doses of aln-aat02. the study will be conducted in 2 sequential phases in which part a will be a single-ascending dose (sad) phase in healthy participants, and part b will be a multiple-ascending dose (mad) phase in participants with zz type alpha-1 antitrypsin deficiency (pizz) and biopsy-proven alpha-1 antitrypsin (aat) deficiency-associated liver disease.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 to 65 years, inclusive; * has normal 12-lead electrocardiogram (ecg); * has body mass index (bmi) between 18 and 30 kg/m\^2, inclusive; * has been a nonsmoker for at least 5 years before screening; * part a only: has alpha-1 antitrypsin (aat) levels within normal limits; * part a only: has adequate forced expiratory volume in 1 second (fev1) and adequate fev1/forced vital capacity ratio; * part b only: has documented zz type aat by genotype; * part b only: has liver biopsy within 90 days of the first dose of study drug demonstrating zz type alpha-1 antitrypsin deficiency (pizz aatd) liver disease; * part b only: has adequate post-bronchodilator fev1 and adequate diffusing capacity of the lung for carbon monoxide; * part b only: if on any maintenance medication, is likely to be able to remain on a stable medication regimen for the duration of the study (no new medications within 30 days prior to first dose of study drug). exclusion criteria: * has known human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis b virus (hbv) infection; * has clinically significant abnormal laboratory results; * received an experimental drug within 30 days of dosing; * has a history of multiple drug allergies or history of allergic reaction to an oligonucleotide or n-acetylgalactosamine (galnac); * part a only: has estimated glomerular filtration equal to or below 60 ml/min/1.73 m\^2 at screening; * part a only: has a history of asthma or recurrent or chronic lung disease, excluding resolved childhood asthma; * part a only: has a history of chronic liver disease; * part b only: has estimated glomerular filtration equal to or below 45 ml/min/1.73 m\^2 at screening; * part b only: received an augmentation therapy for aat deficiency within 8 weeks of first dose of study drug; * part b only: has a history of chronic liver disease from any known cause other than zz type aat deficiency; * part b only: has a history of hepatic encephalopathy; * part b only: has a history of gastrointestinal bleeding or ascites.
assessment of csf shunt flow in an outpatient setting with a thermal measurement device

Conditions: Hydrocephalus

Summary: this study collects exploratory data using a non-invasive device for assessing csf shunt flow using thermal anisotropy measurements. patients with an existing implanted ventricular csf shunt will be enrolled into either a prospective (study device) or retrospective (no study device) cohort to gather data on health resource utilization, quality-of-life, and study device measurements.


Eligibility criteria:
inclusion criteria 1. existing ventricular cerebrospinal fluid shunt 2. signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 3. subject available for 2 week follow-up 4. region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device (cohort a only) exclusion criteria 1. presence of more than one distal shunt catheter in the study device measurement region 2. presence of an interfering open wound or edema in the study device measurement region 3. subject-reported history of serious adverse skin reactions to silicone-based adhesives 4. participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject