Kornimate/medical-research-clean huggingface dataset:
swallowing function, oral health, and food intake in old age

Conditions: Dysphagia; Deglutition Disorders; Swallowing Disorders; Quality of Life

Summary: the purpose of this study is to determine whether a specific rehabilitation program with oral screen used in an elderly population with dysphagia can improve elderly's swallowing capacity.

the present study aims to investigate the effects on swallowing function of a specific rehabilitation program with oral screen in the elderly population included. the present study is a part of an on-going cross-sectional, descriptive project called sofia where approximately 400 elderly individuals, admitted to short-term care (from the five regions/county dalarna, gävleborg, örebro, värmland and västerbotten in sweden), will be included. the purpose of the overall project is to gain a broader understanding of aspects of dysphagia, eating, oral health, and quality of life and care among elderly people in short-term care facilities. in the present study, 35 elderly individuals identified with dysphagia in the overall project (swallowing capacity \<10ml/sec) and without known dementia will be offered to participate and to undergo oral screen training for 5 weeks. the participants' status regarding swallowing, eating, quality of life and oral health will be assessed before and immediately after the intervention and 6-months post-intervention. a control group (35 people in short-term accommodation included in the overall project, identified with dysphagia but not offered the intervention) will undergo the same assessments (at start, after 5 weeks, and 6-month post-intervention) as the intervention group regarding swallowing, eating, quality of life and oral health status. cluster randomisation of short-term accommodation facilities will be made for those patients participating from the five regions/county to either intervention group or control group. participants will be recruited consecutively to either the intervention- or the control group, depending on which short-term care facility they are staying at. the investigators hypothesize that oral screen rehabilitation for elderly individuals with dysphagia and with different diagnoses treated in short-term care results in improved swallowing capacity.

Eligibility criteria:
inclusion criteria: * age ≥ 65 * admitted to short-term care facility ≥ 3 days * included in the overall project sofia and with a swallowing capacity \<10ml/sec exclusion criteria: * incapable of making decisions

Keywords: dysphagia oral screen intervention oral health food intake quality of life elderly short-term care facilities
pediatric cohort study

Conditions: Narcolepsy in Children

Summary: narcolepsy is a rare disease that affects 0.05% of the general population. it is characterized by a dysregulation of the sleep wake regulation that leads to uncontrolled sleep episode during day and a disorganized sleep during night. these symptoms are due to a loss of hypocretin neurons in the brain leading to an inability to maintain wake properly. the physiopathology of this rare disease still needs investigations. since we are a reference center for this disease, we propose to use patients files to better describe and document the sleep characteristics of these children, the cognitive performances, the effects of narcolepsy treatments on sleep architecture and the metabolic status of these children.


Eligibility criteria:
inclusion criteria: * patients between 0 and 18 years old * patients diagnosed with primary or secondary narcolepsy * from both gender exclusion criteria: * patients diagnosed with another sleep disorder * healthy patients * patients older than 18 years old
a survey on consumer use of over-the-counter (otc) nicotine patches

Conditions: Nicotine Dependence; Tobacco Use Disorder

Summary: since 1996, the nicotine patch has been re-classified from prescription to over-the-counter (otc) status in the united states. little is known about how the public uses the otc nicotine patch due to lack of monitoring. the purpose of this observational study is to describe the characteristics of consumers who purchase otc nicotine patches from community pharmacies and to determine the factors associated with the appropriate use of nicotine patches.

the nicotine patch is an effective aid for smoking cessation. since 1996, the nicotine patch has been re-classified from prescription to over-the-counter (otc) status in the united states. unlike prescription medications, post-marketing surveillance does not exist for otc medications. the purpose of this study is to describe the characteristics of consumers who purchase otc nicotine patches from community pharmacies and to determine the factors associated with appropriate use of nicotine patches. this prospective, cross-sectional, observational study will include a survey of 600 consumers who purchase otc nicotine patches at a random sample of 30 community retail pharmacies. consumers will be recruited by an ad located in the pharmacy next to the nicotine patch product. participants will fill out a self-administered, anonymous questionnaire at the time of otc nicotine patch purchase at the pharmacy counter. the questionnaire will gather information about demographics, medical history, smoking history, attitudes toward the nicotine patch, and motivation to quit smoking. no study visits will be required for this study.

Eligibility criteria:
inclusion criteria: * purchased otc nicotine patch (nicoderm cq step i, ii, iii or sav-on nicotine patch) for personal use exclusion criteria: * purchased otc nicotine patch for someone other than self (e.g., friend or family member)
a center based study of pivotal response treatment for preschoolers with autism

Conditions: Autism Spectrum Disorder; Autism

Summary: the purpose of this study is to examine the effectiveness of pivotal response training (prt) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (asd).

the purpose of this study is to examine the effectiveness of pivotal response training (prt) in an intensive center-based preschool environment to treat social communication deficits in children with autism spectrum disorder (asd). the study will compare pivotal response treatment (prt) to a delayed treatment group (dtg). prt is a naturalistic behavioral intervention based on the principles of applied behavior analysis which has shown to be effective in treating the core deficits in children with asd. the study will compare the combination of parent training with intensive center-based prt (prt-c) to a dtg and will include 44 children ages 2 to 3.11 years with asd and social communication deficits.

Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder (asd) based on clinical interview and diagnostic and statistical manual, 5th edition (dsm-5) and confirmed using the autism diagnostic interview revised (adi-r) and autism diagnostic observation schedule, 2nd edition (ados-2) or childhood autism rating scale (cars-2); diagnostic and statistical manual, 5th edition (dsm-5), and expert clinical opinion * boys and girls between 2 years and 3 years and 11 months * ability to participate in the testing procedures to the extent that valid standard scores can be obtained * stable treatment (e.g., applied behavior analysis (aba), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation * developmentally delayed with mullen scales of early learning (msel) or developmental profile (dp-4) composite score below 85 (1 standard deviation below the mean) * availability of at least one english-speaking parent who can consistently participate in parent training and research measures. exclusion criteria: * current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.) * presence of active medical problem (e.g., unstable seizure disorder or heart disease) * child primary language other than english * previous adequate trial of pivotal response treatment * more than 15 hours per week of in-home applied behavior analysis (aba).

Keywords: pivotal response treatment
therapeutic use of intravenous vitamin c in allogeneic stem cell transplant recipients

Conditions: Lymphoid Leukemia; Myeloid Leukemia; Monocytic Leukemia; Myelodysplasia

Summary: this phase 2 trial studies the effect of intravenous (iv) vitamin c repletion after myeloablative allogeneic stem cell transplant.

vitamin c is a nutritional supplement that can help fight inflammation. most patients who have a stem cell transplant have lower than normal levels of vitamin c in their blood. patients will receive intravenous vitamin c the day after transplant for two weeks, followed by oral vitamin c until six months after transplant. the effect of the vitamin c on non-relapse mortality (nrm), time to engraftment, rate of acute graft-versus-host disease and to characterize the safety and tolerability of the vitamin c regimen.

Eligibility criteria:
inclusion criteria: a patient must meet all of the following inclusion criteria to be eligible to participate in the study: 1. any of the following hematological malignancies: * acute lymphoblastic leukemia * acute myelogenous leukemia * chronic myelogenous leukemia * myelodysplasia 2. candidate for hematopoietic cell transplant (hct) note: patients with or without previous myeloablative autologous transplant are eligible. 3. human leukocyte antigen (hla) matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated (8/8 or 7/8 loci matched) 4. stem cell graft from either bone marrow or peripheral blood 5. negative serology for hiv 6. age ≥ 18 to \< 78 years of age 7. karnofsky performance status of 70-100% 8. women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test per standard massey cancer center- virginia commonwealth university health system (mcc-vcuhs) bone marrow transplant (bmt) program guidelines 9. ability to understand and the willingness to sign a written informed consent document. note: the consent form must be signed and dated prior to initiation of stem cell transplant (sct) preparative treatments. exclusion criteria: * a patient who meets any of the following exclusion criteria is ineligible to participate in the study. 1. known allergy to vitamin c 2. inability to swallow oral medication 3. known or suspected malabsorption condition or obstruction 4. g6pdh deficiency 5. uncontrolled viral, fungal, or bacterial infection 6. active meningeal or central nervous system disease 7. alternative hematopoietic cell transplant (hct) including haplo-identical and umbilical cord transplants 8. non-myeloablative conditioning defined as total body irradiation (tbi) \< 2 centigray (cgy) 9. pregnancy or breastfeeding 10. medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Keywords: vitamin c hematopoietic cell transplant (hct) non-relapse mortality graft versus host disease (gvhd)
frailty and postoperative shock

Conditions: Frailty; Elderly

Summary: to find an objective, affordable and manageable way to measure frailty in elderly patients and to examine relationship between peri-operative metabolism of frail older people and outcome after hip surgery.


Eligibility criteria:
inclusion criteria: * hospitalized in st-luc hospital (belgium) for hip surgery between 2013 and 2015 exclusion criteria: * non-traumatic hip fracture * refusal

Keywords: hip surgery frail older people
optimizing the management of acute diarrhoeal disease

Conditions: Acute Gastroenteritis

Summary: many children admitted to hospital in botswana without bloody diarrhoea are presumed to have viral gastroenteritis and so not treated with antibiotics - but they may indeed have a treatable cause for their illness. the investigators will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. the investigators will also be randomizing children to lactobacillus reuteri dsm (daughter strain) 17938 therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. the proposed study is a large multi-centre trial following the previous pilot trial.


Eligibility criteria:
inclusion criteria: * acute diarrhoeal illness (\>= 3 stools in 24 hour period) exclusion criteria: * diarrhoeal illness \>=14 days * bloody stool * known inflammatory bowel disease, cystic fibrosis, or malignancy * live in a household with someone else documented to have a bacterial or parasitic enteric infection of defined aetiology * live outside catchment areas * no permanent address * no access to mobile phone * previous participation in this study * nosocomial diarrhoea

Keywords: diarrhoea gastroenteritis rapid diagnostics probiotics
cognitive inhibition, psychosocial interactions and suicide attempt in elderly

Conditions: Suicide

Summary: the study aims to determine the correlation between the cognitive inhibition impairment and the history of suicide attempt in elderly depressed patients.

2 groups of patients will be studied: in the first group, depressed patients with a history of suicide attempt will be included whereas in the second group, depressed patients without a history of suicide attempt will be included. for each group, the cognitive inhibition will be assessed trough an eye tracker task (antisaccade). both groups will also be compared on their neuropsychological characteristics and the quality of social interactions of participants.

Eligibility criteria:
inclusion criteria: * major depressive disorder according to diagnostic ans statistical manual (dsm) v * group 1: with a history of suicide attempt * group 2: without a history of suicide attempt exclusion criteria: * other psychiatric disease * guardianship

Keywords: cognitive inhibition elderly suicide attempt depression
the effects of omega-3 fatty acid (omacor) on the low-density lipoprotein (ldl) sub-fraction in type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2; Hypercholesterolemia; Hypertriglyceridemia

Summary: the purpose of this study is to verify the possible effects of omacor(omega-3 fatty acid) on the percentage change of small dense ldl fraction in type 2 diabetic patients with combined hyperlipidemia, we perform open-label prospective randomized multi-institutional phase iv study.

the main cause of mortality in type 2 diabetes mellitus is a cardiovascular disease. among the many risk factors of atherosclerosis in diabetic patients, ldl(low density lipoprotein) cholesterol is now being regarded as one of the most important modifiable one. recent researches have revealed that the plasma ldl could be sub-divided according to the size of the particles into large buoyant ldl and small dense ldl. small dense ldl is very atherogenic. increased plasma triglyceride and the presence of insulin resistance are proved to be positively correlated well with the amount of small dense ldl in diabetic patients. we would like to see omega-3 acid(omacor) which is now widely used in clinical practice to decrease plasma triglyceride could change the amount of plasma small dense ldl in type 2 diabetic patients with combined hyperlipidemia. this trial is consisted of 6 weeks of wash out for the patients already taking statin. after that, daily 4 grams of omega-3 acid(omacor) will be administered for 10 weeks. before and after the administration of study drug, we will measure the change of the amount of plasma small dense ldl via ultracentrifuge/non-denaturing polyacrylamide gel electrophoresis followed by oil red o and coomassie blue staining. as a secondary outcome measure, we will also assess the change of hdl(high density lipoprotein) cholesterol sub-type by the same method.

Eligibility criteria:
inclusion criteria: * agreed for informed consent * age between 40-70 years old * type 2 diabetes mellitus * combined hyperlipidemia * serum triglyceride level between 200-500(mg/dl) * no sudden change of glucose lowering therapies during trial, anticipated exclusion criteria: * hypersensitivity to omacor(omega-3 fatty acid) * alcoholics * pregnancy * proliferative diabetic retinopathy * patients already taking fibrates * enrolled in other clinical trials during the recent 3 months * severe ischemic heart disease, liver disease, neurological disease * ast/alt level 2 folds above the normal reference level * psychiatric disorder not adequately controlled * serum creatinine over 2.0 (mg/dl) * previous pancreatic surgery * patients who can not maintain regular diet

Keywords: diabetes mellitus combined hyperlipidemia omacor small dense ldl hdl subfraction
promoting maternal mental health and wellbeing in neonatal intensive care

Conditions: Depressive Symptoms; Anxiety; Post-traumatic Stress Symptoms

Summary: this small randomized pilot study will evaluate feasibility and preliminary outcomes of an audio-delivered mindfulness program to reduce psychological distress for mothers with an infant in neonatal intensive care, as compared with an active control condition.

an estimated 400,000-480,000 infants in the u.s. with serious medical conditions are cared for in neonatal intensive care units (nicus) each year. maternal stress exposure related to infants' nicu stays is an under-appreciated public health problem with negative implications for maternal and child health and wellbeing. flexible, effective intervention strategies have potential to improve maternal mental health and parenting, promoting positive emotional and behavioral outcomes for both mothers and infants. in the investigators' successful pilot research, the investigators developed an audio-delivered mindfulness program to help nicu mothers reduce rumination and worry, cultivate a state of calm awareness, and promote self care. in this small randomized pilot study, the investigators will randomly assign mothers with an infant in the neonatal intensive care unit (nicu) to receive either the mindfulness intervention or an active control program (audio-delivered education on infant care and development). this study will evaluate feasibility of all key research aspects, including recruitment, randomization, intervention and control conditions, and assessments, in preparation for a future larger-scale study. this study will also assess preliminary intervention outcomes to identify potential program benefits.

Eligibility criteria:
inclusion criteria: * female * 18 to 50 years old * mother of an infant currently being treated in the johns hopkins hospital or johns hopkins bayview medical center nicu * able to speak english exclusion criteria: * known to have serious psychopathology * infant medically unstable/ progress is poor

Keywords: mindfulness maternal depression
interferon alpha-2b (intron a) for metastatic or unresectable clear cell renal carcinoma

Conditions: Renal Cancer

Summary: this study will determine the response rate of daily low dose interferon-alpha-2b in patients with metastatic or unresectable clear cell renal cell carcinoma.

rationale: interferon has long been used as a therapy for renal cell carcinoma. however, optimal dosing schedules have not been identified and patients have been relegated to receiving the highest possible doses for prolonged periods of time. this high-dose approach often leads to serious adverse effects from toxicity that limits the usefulness and patient tolerance of this treatment. no formal study has determined the relationship if any between the maximal tolerated dose (mtd) and the biological effective dose of interferon alpha-2b. the current study seeks to fill that gap by gathering research information about different doses of interferon alpha-2b and correlating with measurements of jak/stat in the blood. validation of correlative studies to determine optimum biologic dosing are needed so that therapy may be adjusted appropriately rather then the current approach of maximizing dose. in addition, a trial of low dose daily administered interferon-2b has not been carried out in the current era with refined histologic classification and modern ct imaging scanning. as this therapy potentially has wide applicability, definite response rates need to be documented. purpose: the purpose of this study is to assess the response rate of daily low dose interferon-2b in patients with metastatic or unresectable clear cell renal carcinoma. the duration of the response and overall survival will be determined in study participants. this study will also evaluate jak/stat, two types of kinases or enzymes involved in an intracellular signaling process associated with cancer growth, in peripheral blood mononuclear cells over the course of interferon alpha-2b dose escalation. researchers will examine in a preliminary manner the correlation between clinical response, toxicity, and jak/stat signal transduction. progression free survival and rate of stable disease will also be determined in a preliminary manner. treatment: study participants will receive interferon alpha-2b. this drug will be self-administered daily through injections into the skin. the dose level of interferon alpha-2b will be increased each week into study treatments. for the first three weeks and approximately monthly thereafter, patients will have blood drawn three hours following interferon alpha-2b administration to measure jak/stat. toxicity from study treatments will be closely monitored in patients during clinics visits. supportive care therapies will be given throughout the study. treatments will be discontinued due to disease growth or unacceptable side effects.

Eligibility criteria:
inclusion criteria: * metastatic or unresectable clear cell renal cell carcinoma * measurable disease exclusion criteria: * prior interferon therapy * more than 3 prior therapy regimens

Keywords: metastatic
the coastal exposome: a study of sea air inhalation and possible links to health

Conditions: Immune Suppression; Exposure

Summary: the research aims to understand oceans as crucial contributors to human health in coastal environments. oceans produce marine spray aerosols that contain a mixture of microbiota and natural biological molecules (biogenics).

the primary outcome envisioned consists of 2 goals. 1. in this study, the first objective is to determine whether the microbiota and biogenic molecules found in sea air are also found in the nasal swabs of the participants. in this way, the investigators will gain an understanding of which sea air components are inhaled by humans and how this changes over time. 2. second, the investigators want to get an idea of whether these inhaled sea air components have an effect on certain pathways in the human body. in the in vitro study with cell lines, effects were already seen of sea air exposure on certain pathways in the body. now the second goal of this study, is to see if changes in immunity biomarkers (il-6, tnf-alpha, il-10) are seen in vivo in humans. the investigators will do this by taking vams blood samples from the participants.

Eligibility criteria:
inclusion criteria: * health participants between 18 and 50 years old exclusion criteria: * people with a medical condition * people younger than 18 and older than 50

Keywords: oceans and human health