Kornimate/medical-research-clean huggingface dataset:
serum and saliva sirtuin 6, lipoxin a4, caspase8 levels in correlation with periodontal status in severe periodontitis

Conditions: Periodontitis; Diagnose Disease

Summary: it has been stated that sirtuin-6 (sirt6) play a important role in regulation of inflammation, energy metabolism, homeostasis and apoptosis, and sirt6 may be assosiciated with many diseases. the aim of this study was to evaluate saliva and serum sirt6, lipoxin a4 (lxa4) and caspase-8 (casp8) levels in correlation with periodontal clinical status in patients with periodontitis and healthy subjects

20 patients with stage iii grade b periodontitis (p) and 20 periodontally healthy individuals (control;c) were included in this study. clinical periodontal parameters were measured. saliva and serum levels of sirt6, lxa4 and casp8 were analyzed by enzyme-linked immunosorbent assay.

Eligibility criteria:
inclusion criteria: * systemically healthy * clinical diagnosis of periodontitis * clinical diagnosis of periodontal health exclusion criteria: * history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months) * nonsurgical periodontal treatment (previous 6 months) * surgical periodontal treatment (previous 12 months) * presence of\<10 teeth * current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy) * diabetes * diagnosis of rheumatoid arthritis * pregnancy * lactating * smoking * excessive alcohol consumption.

Keywords: inflammation resolution periodontitis cell apoptosis
breath analysis in asthma

Conditions: Asthma; Exhaled Breath; Mass Spectrometry

Summary: the purpose of this study is to answer the question whether a disease-specific profile of breath in patients with asthma can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.


Eligibility criteria:
inclusion criteria: 1. confirmed asthma. diagnosis of asthma is made with episodic chest symptoms and a documented reversibility of at least 12% and/or 200 ml in fev1 after 200 ug of inhaled salbutamol or airway hyperresponsiveness in the case of normal lung function testing (pc20 methacholine \< 4mg/ml) at the time of diagnosis. 2. age between 18 and 80 years at study entry. 3. healthy controls: never-smokers, normal spirometry (baseline fev1 \> 85% predicted and fev1/fvc greater than 0.7). exclusion criteria: 1. asthma exacerbation within the last 6 weeks, defined as worsening of asthma symptoms requiring a change in therapy by a physician or a change in regular asthma therapy (including short course of oral corticosteroids) 2. any lung disease other than asthma. 3. acute inflammatory disease (e.g. common cold) within the last 4 weeks. 4. regular intake of oral steroids. 5. active smoking habits / positive history of smoking. 6. acute or chronic hepatic disease. 7. renal failure or renal replacement therapy. 8. pregnancy.
talking time: telephone support groups for informal caregivers of people with dementia

Conditions: Caregivers of People With Dementia

Summary: caring for people with dementia (pwd) at home requires an enormous amount of time, organization and commitment. therefore, informal caregivers (ics), mainly relatives, of pwd often feel a high burden. even though support groups on-site have shown positive effects on the subjective well-being and on the perceived social support of ics, relatives either have no time or opportunity to leave the pwd alone or there are no support groups in the vicinity. the talking time project therefore aims to close this supply gap by providing structured telephone-based support groups in germany for the first time. international studies have shown resulting benefits for ics. methods/design: the project will be evaluated in a cluster adjusted randomized controlled trial. the effects of the 3-months talking time intervention will be compared to a normal care group. outcomes will be measured at two different times (baseline = t0, after 3 months =t1). the control group will receive the talking time intervention after t1. ics are eligible if they are 18 or older, have cared for the pwd for at least four hours on four days per week in the last six months. exclusion criteria are psychiatric disorders of the ic. primary outcome of the effectiveness elevation is the subjective well-being of the relatives measured by the mental component of the sf-12. secondary outcomes are the physical component summary of the sf-12, the perceived social support caregiver scale, the caregiver reaction scale and the neuropsychiatric inventory. for the process evaluation different quantitative and qualitative data sources will be collected addressing reach, fidelity, and dosage.


Eligibility criteria:
inclusion criteria: * medical icd-10 dementia diagnosis available for the patient (f00.-\*: alzheimer disease or related disorders, f01.-: vascular dementia, f03.-:unspecified dementia) * living with or sharing cooking facilities with the care recipient or providing care for a relative with diagnosed alzheimer disease or related disorders for at least 4 hours on at least 4 days of a week for at least the past 6 months, respectively * access to a telephone connection to be able to participate in the talking time intervention and the telephone- based interviews for the evaluation exclusion criteria: * lack of knowledge of german language of informal caregiver * risk of suicide in the informal caregiver * actual psychiatric diagnosis of mental illness of the caregiver * icd-10-diagnosis of dementia in other diseases classified elsewhere (f02.-\*), except dementia in primary parkinson disease (f02.3\*) and lewy body disease (f02.8/g31.82)
a comprehensive evaluation of tobacco-flavored vs. non-tobacco flavored e-cigarettes on smoking behavior

Conditions: Cigarette Smoking-Related Carcinoma

Summary: this clinical trial compares the use of tobacco flavored electronic cigarettes (ecs) vs. non-tobacco flavored ecs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ecs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. by comparing participants' preferred flavor ecs (pec) to tobacco flavor ecs (tec) to nrt, researchers hope to determine the effect of ec flavors on appeal and use and learn how ecs affect smoking behaviors and health.

primary objectives: i. determine pec versus vs. tec vs. nicotine replacement therapy (nrt) on tobacco use patterns including product switching, abstinence from cigarettes, and number of cigarettes smoked. ii. examine pec vs. tec vs. nrt on cigarette craving, withdrawal symptoms, and perceived nicotine dependence. iii. examine pec vs. tec on product appeal and uptake, including initial trial, days used during period of product provision, and purchase and continued use after 12 weeks. outline: participants are randomized to 1 of 3 arms. arm i: participants receive pec for 14 weeks, including a 2-week pre-switch period to become familiar with usage. arm ii: participants receive tec for 14 weeks, including a 2-week pre-switch period to become familiar with usage. arm iii: participants receive nrt (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage. participants in all arms participate in discussions throughout the trial. surveillance phase: participants in all arms are followed for 12-weeks after completion of study procedures.

Eligibility criteria:
inclusion criteria: * \>= 21 years old * smoke \>= 5 cigarettes per day for the past year * willing to use either an ec or nrt * read and speak english * have a smartphone exclusion criteria: * report currently using smoking cessation medications, nrt, or actively seeking treatment for smoking cessation * current use of an ec \> 4 days a month * diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (copd) * unmanaged (unmedicated and/or without counseling) diagnosis of schizophrenia * history of cardiac event or distress within the past 3 months * currently pregnant, planning to become pregnant within 6 months, or breastfeeding * high blood pressure not controlled by medications * serious angina pectoris or chest pain * stroke within the past three months * known allergy to propylene glycol or vegetable glycerin * serious underlying arrhythmias, irregular heartbeat or abnormal heart rhythm * live in same household as another study participant
hepatitis a vaccine, inactivated and measles, mumps, rubella and varicella virus vaccine live safety study (v251-066)(completed)

Conditions: Hepatitis A; Measles; Mumps; Rubella; Chickenpox

Summary: two doses each of hepatitis a vaccine, inactivated and measles, mumps, rubella and varicella \[oka/merck\] virus vaccine live will be given concomitantly or non-concomitantly. safety data will be collected following each vaccination.


Eligibility criteria:
inclusion criteria: * negative clinical history of hepatitis a, measles, mumps, rubella, varicella (chickenpox), and/or zoster * no other vaccinations scheduled to be administered at the time of the first or second doses of vaqta(tm) and proquad(tm) exclusion criteria: * previously vaccinated with any hepatitis a vaccine, measles, mumps, rubella, and/or varicella vaccine either alone or in any combination * history of allergy to any vaccine component * history of seizure disorder * immunosuppressed including congenial and acquired conditions and immunosuppressive therapy * known severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injections * recent (\ 100.3 degrees f \[\>37.9 degrees c\] oral equivalent) prior to study vaccination.
evaluation of the immunogenicity and safety of ad26.cov2.s's covid-19 vaccine

Conditions: COVID-19; Vaccine Reaction; SARS CoV 2 Infection; Vaccine Adverse Reaction

Summary: phase ii, non-randomized, open-label, comparative, national, multicenter trial in mali, aimed to assess the humoral vaccine immune response induced by ad26.cov2.s vaccine in 200 adults one month after receiving the complete vaccination schedule of sars-cov-2 vaccine.

the main objective of this phase ii trial is to evaluate the humoral immune response induced by the ad26.cov2.s vaccine in adults one month after complete vaccination regimen against sars-cov-2, compared younger (up to 45 years old) and elderly (55+ years old) populations. 200 participants will be included, 200 participants for each vacine. the age categories are 18 - 45 years, 55 - 64 years and 65+ years. the number of participants per age group will be distributed as follows 1:1:0,5. there will be no comparison between population on different vaccines. ad26.cov2 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants participants in ad26.cov2 arm receive intramuscularly as a single dose of 0.5ml. humoral vaccine immune responses, induced by ad26.cov2.s vaccine, will be measured by elisa at d0, m1, m2, m6, m12 and m24.

Eligibility criteria:
inclusion criteria: * age between 18 and 45 years old or 55 years and older * be eligible to receive one of the study vaccines as part of the trial * understand and agree to comply with study procedures (visits, telephone calls) * agree not to participate in any other vaccine study during the time of the study * give written informed consent prior to any examination performed as part of the trial exclusion criteria: * positive sars-cov-2 antigenic test * positive sars-cov-2 polymerase chain reaction (pcr) results less than 48 hours old * history of infection by sars-cov-2 confirmed by antigenic test or pcr within 3 months prior to inclusion * symptoms compatible with infection to sars-cov-2: sick or febrile participants (body temperature ≥ 38.0°c) * pregnant or breastfeeding woman * known chronic disease impacting the participant's immune response (uncured cancer, human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv) infection) * anti-coagulant treatment * immunosuppressive treatment * contraindication to the proposed vaccine (according to rcp) * previously received at least one injection of a sars-cov-2 vaccine * patient having received immunoglobulin or another blood product within 3 months prior to inclusion * a history of serious adverse vaccine reactions (anaphylaxis and associated symptoms such as rash, breathing difficulties, laryngeal edema, or a history of allergic reaction that may be exacerbated by a component of the sars-cov-2 vaccine) * any condition that, in the opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study

Keywords: ad26.cov2.s
a study to evaluate the treatment of previously untreated b-cell chronic lymphocytic leukemia (b-cll)

Conditions: B-Cell Chronic Lymphocytic Leukemia

Summary: this is a multi-center, open-label, single arm phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of id-klh with gm-csf in patients with previously untreated b-cll. the length of the controlled portion of the study is two years. the study will be conducted at investigative sites in the united states.


Eligibility criteria:
inclusion criteria: * have signed a written informed consent * b-cll diagnosis * rai stage 0, i, or ii * previously untreated * be able to watch and wait for approximately 8 months following submission of blood (or tissue) while id-klh is being manufactured exclusion criteria: * anti-leukemia treatment prior to beginning immunization * anti-leukemia treatment other than id-klh during immunizations * prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ) * pregnant or lactating * patients with known autoimmune disease (including previously treated autoimmune hemolytic anemia or immune thrombocytopenia) * participation in any other clinical trial in which an investigational agent is administered

Keywords: b-cll
the neuro-protective effects of exercise in children with brain tumors

Conditions: Brain Tumor

Summary: the objectives of our proposed study are to (a) evaluate the feasibility of conducting a structured exercise program in children treated with cranial radiation for brain tumors, (b) test whether exercise results in improved thinking skills and emotional function, and (c) examine potential mechanisms of improved outcome, particularly recovery of white matter and grey matter.

brain tumors are the leading cause of death and disability from childhood disease in developed countries. with treatment advances over the last 25 years, survival rates have improved dramatically. however, survival is often achieved at considerable cost. cranial radiation is frequently required for effective tumor control, and is associated with significant neuro-toxicity, including white matter damage and cognitive morbidity. in order to achieve the best possible outcome for survivors, and ultimately conquer the long-term consequences of this disease, new interventions must be developed to ameliorate the neuro-toxic effects experienced by children. radiation injury can now be used to guide the development of interventions designed to rescue neural tissue. furthermore, various new agents and activities with potential to stimulate neuro-recovery are now available. the potential value of exercise for rescuing the brain from neuro-toxic effects, for instance, has recently been reported. next, neuro-cognitive processes that are particularly sensitive to the effects of cranial radiation have been identified and can serve as behavioral assays to test the effectiveness of these new interventions. finally, novel neuro-imaging tools are available to perform in vivo evaluations in order to delineate potential mechanisms of neuro-recovery. we intend to integrate these new research findings to develop and evaluate a physical exercise-based intervention targeted at rescuing brain tissue of children with brain tumors from the neuro-toxic impact of cranial radiation.

Eligibility criteria:
inclusion criteria: * survivors will be included if they are between 7 and 17 years of age. * survivors will be included if they either declare english as their native language or have had at least two years of schooling in english at the time of their first assessment. * survivors must have been diagnosed with a hemispheric or posterior fossa tumor and been treated with cranial spinal radiation. * survivors no more than 10 years may have elapsed between diagnosis and time of study. * survivors with a shunt will be included in the study, but will need to be identified prior to study on-set to discuss any specific considerations for imaging and physical activity. exclusion criteria: * are younger than 7 years (the delivery of an intervention program to young children carries challenges that make it difficult to include in an initial feasibility grant) or older than 17 years * require sedation for mri imaging * is claustrophobic * have severe neurological/motor dysfunction that would preclude safe participation in an exercise program.

Keywords: pediatrics brain tumor neuro-radiation exercise
moderate alcohol consumption, glucose metabolism and gastric emptying

Conditions: Lean; Obese

Summary: moderate alcohol consumption is associated with a decreased risk of type ii diabetes mellitus. in a recent study of greenfield et al. it was observed that moderate alcohol consumption significantly improved postprandial glucose concentrations. similar observations were made in our previous study. one of the mechanisms by which this may occur is delayed gastric emptying after alcohol consumption.

purpose: the primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage. secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied. these effects will be studied in apparently healthy, lean or overweight young men. design: randomized, partially diet-controlled, placebo controlled cross-over design. subjects: healthy male lean and obese volunteers aged between 18 and 40 years (n=18). intervention: during 2 periods of 21 days either white wine or white grape juice has to be consumed with the evening meal. the last 7 days of each period will be fully dietary controlled. treatment a: 375 ml of white wine (35 g alcohol) per day treatment b: 375 ml of white grape juice per day measures: * glucose metabolism: glucose uptake and peripheral glucose storage (measurement of isotopic enriched plasma glucose levels. * gastric emptying and postprandial wellness. * postprandial glycemic response and related factors (glucose, insulin, lactate, ffa, glucagon, ghrelin, cck, gip, glp-1, pyy, triglycerides, total cholesterol, hdl cholesterol, ldl cholesterol, paracetamol (absorption test)

Eligibility criteria:
inclusion criteria: * healthy as assessed by the: * physical examination * results of the pre-study laboratory tests * males aged between 18 and 40 years at day 01 of the study (including 18 and 40) * lean subjects and overweight/obese subjects: bmi 18.5-35 kg/m2 * alcohol consumption between 7 and 28 units/week (including 7 and 28) * non restrained eater, defined as a score ≤ 2.5 on the dutch restrained eating questionnaire exclusion criteria: * smoking * not willing or able to change habitual alcohol consumption during the study according to protocol * having an allergy for paracetamol

Keywords: glucose insulin sensitivity glucose metabolism appetite satiety
single leg squat performance in physically and non-physically active individuals

Conditions: Single Leg Squat Performance; Athletic Injuries

Summary: single-leg squat (sls) is a functional test visually rated by clinicians for assessing lower limb function as a preventive injury strategy. sls clinical rating is a qualitative evaluation and it does not count objective outcomes as kinematics data and surface electromyography (semg) assessment. based on the sls rating, the aims of this study were (i) to determine the clinical rating agreement among six raters and (ii) to assess kinematic and semg predictors of good sls performance in physically and non-physically active individuals.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.5-25.5, * age between 18-35 years old, * written informed consent to participate, exclusion criteria: - musculoskeletal pain or history of lower extremity injuries lasting more than three months

Keywords: reproducibility of results clinical assessment
the effect of buzzy and puppet on pain and fear

Conditions: Pain; Fear; Nurse's Role

Summary: summary aim: this study was conducted to evaluate the effects of the use of bee buzzy, external vibrating cold application, and the use of puppets on pain and fear in children aged 3 to 6 years during phlebotomy. method: this study is a randomized controlled trial. the study was conducted with 105 children aged 3-6 years who came to the pediatric phlebotomy unit of a university hospital. the sample of children (n=105) was divided into groups (group 1, bee buzzy; group 2, puppet; group 3, control) by block randomization. children's pain and fear scores were evaluated using the wong-baker pain scale and child fear scale, as well as the investigator's report, after phlebotomy, their parents, and the nurse who attempted phlebotomy.


Eligibility criteria:
inclusion criteria: * participants whose child and parents agreed to participate in the study * children who had successful phlebotomy on the first attempt exclusion criteria: * children with chronic disease, mental disability, or mental retardation * children who had taken analgesics in the last 24 hours * children who were hospitalized * children who had undergone a surgical procedure * children who did not have successful phlebotomy on the first attempt

Keywords: pain fear external cold and vibration pediatrics puppet