Kornimate/medical-research-clean huggingface dataset:
effects of cognitive stimulation in older people with mild cognitive impairment

Conditions: Mild Cognitive Impairment; Older People

Summary: mild cognitive impairment is becoming one of the most common cynical manifestations that affect older people. that is why there is a need to investigate non-pharmacological interventions that help to improve or maintain this problem.

each week for 12 weeks, ge participants will attend three 60-minute sessions of cognitive exercises. each session is divided into 10 minutes of memory practice, which includes short-term and long-term memory; 10 minutes of language skills, including vocabulary, comprehension, reading and writing exercises; 10 minutes of calculation, in which arithmetic, similar and different operations are carried out; 10 minutes of praxis and gnosis where drawing and recognition and auditory, tactile, spatial, visual attention were promoted; 10 minutes of orientation where knowledge of space, person and place is developed; and 10 minutes of executive functions in which exercises of organization, planning and problem solving are worked.

Eligibility criteria:
inclusion criteria: * with or without dependency to move. * people who show mild cognitive impairment. * that they were able to carry out the different selected questionnaires. exclusion criteria: * people with visual deficit. * people already enrolled in a cognitive program. * score between 24 and 10 in the mini cognitive exam (mec).
efficacy of lotus leaves in management of plaque induced gingivitis

Conditions: Gingivitis

Summary: due to difficulties in maintenance of an effective mechanical oral hygiene regime, effective chemical adjunctive measures will likely significantly contribute to overall oral health, the function of which should be to augment mechanical plaque control. traditionally, in chinese medicine the lotus leaf has been used for treating gingival inflammation. an extract of lotus leaves have demonstrated significant antibacterial activity against some of the periodontopathogens.

the objective of the present research is to evaluate the efficacy of a lotus leaf mouth wash in management of plaque induced gingivitis. study design: 30 systemically healthy volunteers will be randomly allocated into two arms arm a: lotus leaf mouth wash (aqueous) group \[test group\] arm b: placebo mouth wash group \[control group\] all the volunteers are instructed to refrain from tooth brushing 24 hours before the examination. clinical parameters (plaque index, bleeding index and gingival index)will be measured and the plaque samples are collected from subjects from each group for microbiological analysis. all the participants will undergo scaling, and they were instructed to refrain from tooth cleaning procedures and were advised to use the prescribed mouth wash twice daily for 4 days. all volunteers were recalled on 5th day for clinical and microbiological analysis. statistical analysis and results are awaited

Eligibility criteria:
inclusion criteria: 1. subjects willing to comply with the study protocol \& instruction. 2. clinically diagnosed with chronic gingivitis. 3. no history of allergies to herbal formulations. 4. no history of periodontal therapy within the previous 6 months. 5. no history of antibiotic therapy within the previous 6 months. exclusion criteria: 1. any systemic diseases 2. use of tobacco or tobacco related products 3. pregnant woman and lactating mothers 4. subjects that had used any type of antibacterial mouthrinse within 4 weeks of recruitment in to the study.

Keywords: lotus leaf, mouthwash, gingivitis
long term follow-up study of aavanc80-hotof gene therapy

Conditions: Otoferlin Gene-mediated Hearing Loss

Summary: this multi-center, observational, post-intervention long term follow-up (ltfu) study will monitor for safety and efficacy of aavanc80-hotof in individuals with sensorineural hearing loss due to otoferlin gene mutations who have previously received intracochlear administration of aavanc80-hotof in the ak-otof-101 clinical trial.

after completing one year of initial safety and efficacy assessments following an intracochlear administration of aavanc80-hotof in ak-otof-101, participants will continue to be observed for an additional approximately four years of safety and efficacy follow-up in this ltfu study, for a total of approximately five years of safety and efficacy observations after vector administration. for each participant, evaluations in the ltfu study will occur at approximately one and a half years and two years after vector administration, followed by annual visits through year 5; the duration in this ltfu study is approximately four years, with the aim of understanding and mitigating any risks related to delayed adverse events, as well as characterizing the durability of effect of the aavanc80-hotof.

Eligibility criteria:
inclusion criteria: * individuals with otoferlin gene-mediated hearing loss who received intracochlear administration of aavanc80-hotof in the ak-otof-101 clinical trial * legally authorized representative and/or participant willingness to comply with all study requirements, as evidenced by successful completion of the informed consent process or permission and participant assent process (where appropriate) exclusion criteria: * any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and/or, in the opinion of the investigator, makes the potential participant unsuitable for the study

Keywords: otoferlin deafness, autosomal recessive 9 (dfnb9) hearing loss hearing loss, bilateral hearing loss, sensorineural auditory neuropathy (an)
cd30-directed chimeric antigen receptor t (cart30) therapy in relapsed and refractory cd30 positive lymphomas

Conditions: Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma

Summary: chimeric antigen receptor-modified t cells (cart) holds great promise for treatment of tumors. in this trial, cd30 positive hodgkin's lymphoma and non-hodgkin's lymphoma will be treated by cd30-specific cart cells (cart30).

when patients enroll on this trial, autologous cart-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (pb). during the term of cell preparation of cart30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. one day after completing conditioning regimen, the patient will be given infusions of cart30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days. extra blood will be drawn to measure the persistence of cart30 in vivo.

Eligibility criteria:
inclusion criteria: * male and female subjects with cd30+ hodgkin lymphoma and non-hodgkin lymphoma relapsing after autologous stem-cell transplantation (asct), or refractory to 2 multidrug regimens and/or anti-cd30 antibody treatment. * newly diagnosed cd30+ hodgkin lymphoma and non-hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy. * karnofsky or lansky score greater than 60%. * expected survival\>12 weeks. * creatinine\<2.5mg/dl. * alt (alanine aminotransferase)/ast (aspartate aminotransferase)\<3 fold normal. * bilirubin\<2.5mg/dl. * pulse oximetry of \>90% on room air. * adequate pulmonary function with fev1, fvc and dlco greater than or equal to 50% of expected corrected for hemoglobin. * available autologous t cells with 10% or more expression of cd30 car determined by flow-cytometry. * patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. patients or their guardians will be given a copy of the consent form. exclusion criteria: * active infection such as hepatitis b or c. * receive anti-cd30 antibody-based therapy within recent 6 weeks. * current use of systemic corticosteroids. * pregnant or lactating. * confirmed tumor in pulmonary and archenteric tissues.
impact of sympathetic renal denervation- a study in patients after renal transplantation

Conditions: Hypertension; Chronic Kidney Disease; Renal Transplantation; Sympathetic Activity

Summary: the study is aiming to document the safety and effectiveness of renal denervation in patients after renal transplantation with hypertension. catheter-based renal denervation will be performed using ce marked, percutaneous symplicity catheter.


Eligibility criteria:
inclusion criteria: * patient after renal transplantation (\> 6 month) without resection of native kidneys * systolic blood pressure \>=150 mmhg * on 3 or more antihypertensive medications * individual is 18 years of age * individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry. exclusion criteria: * secondary causes and a white coat hypertension * renal artery abnormalities * egfr \< 30ml/min (mdrd) * angina * severe aortic valve stenosis * individual is pregnant, nursing or planning to be pregnant * other
physical exercise and nutrition in functional gastrointestinal disorders in obese children

Conditions: Functional Gastrointestinal Disorders; Obesity, Childhood

Summary: a prospective observational case-control study evaluating the effect of a weight loss intervention program on functional gastrointestinal disorders among overweight and obese children.

the investigators intend to conduct a prospective observational case-control study of overweight and obese children, aged 6-18 years, followed in the child health and sport center at meir medical center, kfar-saba, israel. overweight and obese subjects, defined as body mass index (bmi) percentile ≥85%, will be offered to participate. healthy subjects with normal bmi percentile from other pediatric outpatient clinics as well as relatives and friends of physicians from the pediatric division will be enrolled and serve as the control group. study visits will be at enrollment and after 3 and 6 months of participation in the intervention program. during the visits the investigators will collect anthropometric measurements (height, weight, bmi, total body fat). participants (age 10y and above) or their parents (age 6-10y) will fill a validated questionnaire for diagnosis of fgid based on rome iv criteria. the investigators will also collect data from exercise capability testing and quality of life questionnaires performed regularly (and irrespective of this study) during the intervention program. the investigators will then compare between subjects who succeeded to those who failed in losing at least 5% of their initial body weight as well as to healthy controls with normal bmi percentile.

Eligibility criteria:
inclusion criteria: * obese / overweight children participating in the life style modification program at the child sport and health center exclusion criteria: * other known chronic non-functional gastrointestinal conditions (e.g. celiac disease, inflammatory bowel disease)

Keywords: obese overweight abdominal pain diarrhea
aat-app+: a novel brain-training app to reduce drinking

Conditions: Alcohol Use Disorder

Summary: this study will explore the feasibility, acceptability, and preliminary effectiveness of a smart phone delivered form of cognitive training intervention (approach bias modification (abm)) in a non-clinical community sample of middle to older adults (\>55 years) reporting hazardous alcohol use in a pilot randomised controlled trial (rct). this app is called aat-app+

alcohol use in older adults is of particular concern, with the 55-74 year old cohort most likely to exceed lifetime alcohol risk. approach bias modification (abm) is a form of computerised cognitive training that is an efficacious intervention for alcohol use disorder. previous studies are limited in that the stimuli are not personalised, nor are interventions readily accessible to non-treatment seeking problem drinkers. this has led to the development of a world-first, smart phone version of abm called aat-app+ the current study aims to explore the feasibility, acceptability, and preliminary effectiveness of aat-app+ in reducing alcohol consumption and cravings in a pilot rct with a non-clinical community sample of 100 older adults (aged 55+ years) reporting hazardous alcohol use (i.e. a score of 8+ on the audit), recruited via targeted advertising. participants in active training will upload (or select pre-selected) photos of beverages and meaningful activities, which will form the 'avoid' and 'approach' stimuli, respectively, then complete two training sessions per week for four weeks, with results compared to controls. aat-app+ holds promise as an innovate, cost-effective, and remotely accessible adjunctive support tool.

Eligibility criteria:
inclusion criteria: * adults aged 55+ years * score 8 or higher on the alcohol use disorders identification test (indicates 'hazardous' levels of alcohol use). * access to an android or apple smart phone and australian contact number * wish to reduce their drinking * live within the eastern health primary and secondary catchment (see map below) exclusion criteria: * under age 55 * not concerned about their drinking * do not wish to reduce their alcohol use in the next 4-6 weeks * do not reside with the appropriate catchment will be excluded. * experiencing severe alcohol problems likely to need professional treatment (i.e. presence of withdrawal symptoms in the past year)

Keywords: alcohol intervention cognitive bias modification mobile health intervention approach bias
monitoring in dialysis -- a prospective, multi-center, single-arm, non-randomized, observational study in patients who are undergoing hemodialysis.

Conditions: End Stage Renal Disease

Summary: the primary objective of this study is to estimate the proportion of hemodialysis patients experiencing clinically significant cardiac arrhythmias over a 6-month period using continuous cardiac monitoring with an implanted medtronic reveal insertable cardiac monitor (icm) device.


Eligibility criteria:
inclusion criteria: * 21 years of age or older and is willing to be implanted with the reveal icm * currently on hemodialysis at least three times per week or has an estimated glomerular filtration rate (egfr) of \< 15 ml/min/1.73m\^2 and is expected to begin hemodialysis within 2 months. * subject is willing and able to comply with the protocol exclusion criteria: * currently enrolled in an interventional study that may interfere with the monitoring in dialysis protocol * not suitable for reveal icm implantation * has an existing hemodialysis catheter that may interfere with the reveal icm implantation site * has a recent infection * is currently on hemodialysis with a hemoglobin \< 10 g/dl * has end-stage liver failure or has had thoracic surgery within the past 6 months * has an existing pacemaker, implantable cardioverter-defibrillator (icd) or cardiac resynchronization device * is scheduled for renal transplantation or will likely be transplanted within 6 months * is currently on home hemodialysis

Keywords: end stage renal disease, hemodialysis, arrhythmia, reveal icm
effects of aleurone-enriched products on cardiovascular risk factors

Conditions: Glucose and Lipid Metabolism; Incretin Hormones Plasma Levels; Inflammation, Oxidative Stress and Endothelial Function

Summary: very few studies have evaluated the effect of aleurone-enriched grains on cardiovascular risk factors. price et al.(2010) have shown that 4-week supplementation of aleurone-enriched products (27 g/day of aleurone) increased betaine concentration in plasma whereas reduced homocysteine and ldl-cholesterol levels. interestingly, aleurone had no effect on total antioxidant status or endothelial function, whereas an improvement of c-reactive protein was observed (price rk et al, 2012). it is not known whether consumption of more than 27g/day of aleurone-enriched products with higher ferulic acid biodisponibility and longer time of treatment could influence these parameters in individuals with metabolic syndrome. noteworthy, no studies have investigated the effect of aleurone-enriched products on fasting and postprandial glycemic homeostasis and lipid metabolism. in addition, mechanisms by which aleurone may act in vivo are still unknown. the aim of this study is to investigate whether 8 weeks supplementation with aleurone-enriched products may influence glucose and lipid metabolism, incretin hormones levels, satiety, inflammation, oxidative stress and endothelial function in overweight/obese subjects with high cardiovascular risk.


Eligibility criteria:
inclusion criteria: * overweight/obese subjects of both gender * age range between 20 and 70 years * high cardiovascular and metabolic risk profile will be enrolled in the study * waist circumference \> 102 cm for men, and \> 88 cm for women * at least one of the characteristics of the metabolic syndrome according to the ncep/atp iii criteria: * fasting triglycerides ≥150 mg/dl * high-density lipoprotein cholesterol \<40 mg/dl (men)/\<50 mg/dl (women) * blood pressure ≥ 130/85 mmhg * fasting glucose ≥100 mg/dl exclusion criteria: * age \ 70 years * fasting triglycerides ≥400 mg/dl * fasting cholesterol \>270 mg/dl * cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study; established diabetes mellitus or any chronic disease * renal and liver failure (creatinine \>1.7 mg/dl and alt/ast \>2 times than normal values, respectively) * anaemia (hb \<12 g /dl) * any chronic disease * people treated with antihypertensive drugs will have to keep the type and dosage of medication unchanged during the whole study period
gut microbiota in intestinal barrier damage in acute leukemia patients undergoing inpatient induction

Conditions: Chemotherapy-Induced Gut Barrier Damage; Acute Leukemia

Summary: this is an observational study to collect stool, blood, and urine from acute leukemia patients undergoing induction chemotherapy in order to generate preliminary data regarding the association between microbiota and chemotherapy-induced gut barrier damage. this study consists of inpatient collections of blood, urine, and stool while the patients are undergoing inpatient induction therapy. patients will not be scheduled for any additional procedures or testing beyond what is required for clinical care.


Eligibility criteria:
inclusion criteria: * adults (ages 18 - 99 years) undergoing inpatient induction chemotherapy for newly diagnosed or relapsed acute leukemia (myeloid or lymphoblastic). * any induction regimen (standard or experimental) with planned \~4 weeks of inpatient stay * able to provide written voluntary consent before performance of any study related procedure.

Keywords: al
a randomized post-market study to evaluate zip device compared to sutures for laceration repair in pediatrics and adults

Conditions: Laceration

Summary: the zip-009 clinical investigation will enroll 26 paediatric and adult subjects requiring laceration repair and fulfilling the eligibility criteria for the clinical investigation. the investigation is designed to evaluate the time and cost savings and the satisfaction and outcomes of the zip device compared to conventional sutures. the subjects will be randomly assigned at a 1:1 ratio to either the zip surgical skin closure device group or the standard of care sutures group. the investigation consists of one screening/baseline visits at day 0 where the subject will be treated with either the zip device or sutures, and thereafter two follow up telephone calls at day 10 and day 30. the zip device/sutures will be removed prior the first follow up call day 10. the duration of the investigation is estimated to 5 months, including a 4-month recruitment period and 1-month follow up period.


Eligibility criteria:
inclusion criteria: 1. between 4 and above at the time of laceration repair. 2. require suture closure as standard of care for simple straight wounds on trunk, extremities or face. 3. low tension laceration, e.g. skin can be easily approximated by pinching with fingers. 4. subject and legal representative(s) (if a pediatric subject) are willing and able to comply with the investigational device removal and meet the follow up requirements. 5. subject and legal representative(s) (if a pediatric subject) have been informed of the nature, the scope and the relevance of the study. 6. subject and legal representative(s) (if a pediatric subject) have voluntarily agreed to participation and have duly signed the informed consent form. exclusion criteria: 1. known personal or familial history of scar hypertrophy. 2. known or suspected allergies or hypersensitivity to non-latex skin adhesives. 3. atrophic skin deemed clinically prone to blistering. 4. wounds that are easily susceptible to infection as a result of exposure to unsanitary conditions ("dirty wounds"). 5. wounds that require deep dermal closure using sutures. 6. known or suspected mental problems and/or aggressiveness that indicates that the subject might try to remove the device during the treatment period. 7. ongoing treatment with cytostatic. 8. known or suspected diagnosis of severe anorexia. 9. participating in any other clinical investigation. 10. known health condition that would affect healing in the opinion of the investigator. 11. any subject that according to the declaration of helsinki is deemed unsuitable for study enrolment.
project options - the abc method

Conditions: Dermatology/Skin - Other; Health Behavior; Sunburn

Summary: the present study explores the ability of dermatologists to influence patients' behavior using a novel and brief (3 minute) behavioral intervention in the context of naturally occurring patient interactions and shows promise for long term sustainability. the incidence of invasive skin cancers, cutaneous melanoma in particular, has nearly tripled in the u.s. between 1975 and 2004, making it the fastest rising incidence rate for all cancers in the united states. dermatologists are in an ideal position to effect change in their patients. the present study will assess whether a brief intervention (the abc-addressing behavior change method) delivered to patients by dermatologists during a skin examination will increase the use of sun protection and reduce risk behaviors compared to patients who receive treatment as usual.

skin cancer is the most common malignancy in the u.s. and the incidence and mortality from skin cancer is on the rise. individuals can decrease their risk of skin cancer by engaging in protective behaviors such as limiting intentional and unintentional uv exposure, and wearing broad-spectrum sunscreens and protective clothing. despite knowing the risks and receiving dermatological care, many patients with and without a history of skin cancer frequently forget to use uv protection or fail to use it in an optimal manner to reduce their uv risk. to address these concerns, mallett and colleagues developed a 3-minute brief abc intervention - addressing behavior change. the abc intervention is designed to be delivered by dermatologists in the context of a routine office visit involving a skin examination. previous work by mallett and colleagues showed dermatologists were highly motivated to deliver the intervention, quickly learned the requisite skills, delivered the intervention with fidelity, and showed minimal decay in knowledge, motivation, and skills over a 6-month period. this study builds on a previous study by conducting an examination of the efficacy of the abc intervention on patients' motivations and behaviors utilizing a prospective longitudinal design.

Eligibility criteria:
inclusion criteria: * scheduled for a skin exam with participating dermatologists exclusion criteria: * psoriasis

Keywords: addressing behavior change (abc) addressing behavior change (abc) intervention addressing behavior change (abc) intervention method