Kornimate/medical-research-clean huggingface dataset:
effectiveness of non-surgical periodontal treatment on hba1c levels in a patient with type 2 diabetes mellitus

Conditions: Chronic Periodontitis; Diabetes Mellitus, Type 2

Summary: this study evaluates the effectiveness of an intervention, non-surgical periodontal treatment (spr), in patients with poorly controlled type 2 diabetes mellitus and moderate-severe periodontal disease aimed at reducing hba1c levels at 12 months compared with the usual practice in primary health care.

design: pragmatic cluster randomized clinical trial with 12 months follow-up. unit of randomization: dentist. setting: primary health care centers in one spanish region (madrid) population: patients ≥ 35 years of age with moderate-severe periodontal disease and diagnosed with type 2 diabetes with por control (hba1c \> 7,5). n=288 patients (144 in each arm) will be recruited by dentist before randomization. intervention: both groups will receive education on oral hygiene measures. the experimental group will receive the non-surgical periodontal treatment at the beginning of the study and the control group at the end of the study.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes (code ciap-2 t90) * with at least one determination of hba1c in the last 3 months hba1c\> 7.5% * no changes in hypoglycemic or insulin treatment in the last 3 months. * with generalized moderate-severe chronic periodontal disease. * presence of at least 16 natural teeth. * informed consent. exclusion criteria: * patients with basic systemic diseases with oral involvement (autoimmune diseases of oral involvement: oral lichen planus, lupus, pemphigus, pemphigoid) * limited life expectancy. * urgent diabetic complications in the 30 days prior to the study. * they need extensive oral treatment: fistulous trajectories, cellulitis, pulpitis or other oral infections. * pregnant, with desire for pregnancy in the 12 months of study or breastfeeding. * that they have received periodontal treatment in the last 6 months. * that they have received antibiotic and / or anti-inflammatory regimen continued at least in the last 4 weeks prior to the study (except low doses of acetylsalicylic acid). * in treatment with corticosteroids or immunosuppressive drugs. * on dialysis or risk of bleeding (anticoagulant treatment). * dependent on alcohol. * patients who require antibiotic prophylaxis for the realization of spr. * patients with uncontrolled systemic diseases (with the exception of diabetes): cardiovascular, lung, liver, kidney disease in advanced stages or neoplasms.

Keywords: dentist primary health care chronic periodontitis diabetes mellitus, type 2 root planing dental scaling
fast troponin as a biomarker to assess exercise-induced muscle damage in muscle diseases

Conditions: Becker Muscular Dystrophy; McArdle Disease; Limb-Girdle Muscular Dystrophy Type 2

Summary: the purpose of the study is to explore the biomarker fast troponins response to exercise in patients with becker muscular dystrophy, limb-girdle muscular dystrophy and mcardle disease


Eligibility criteria:
inclusion criteria: * the ability to cycle * no concurrent medical condition that could interfere with interpretation of the results * molecular diagnosis of the specific condition in specified patient groups or healthy control * no active muscle injury on the test day (caused by recent exercise, seizures, trauma, etc.) exclusion criteria: * competing conditions at risk of compromising the results of the study * cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise * veins that are too difficult to puncture for blood sampling, evaluated by the investigator * severe muscle weakness, that prevents the subject completing the exercise test, evaluated by the investigator
phase i/ii cancer caregiver interventions to improve quality of life and prevent burnout

Conditions: Cancer Care Recipient

Summary: this study defines cancer caregivers as unpaid individuals who provide physical, practical, and/or emotional care and support to the cancer patient in the home setting. they may participate in this study if care recipients and the caregiver are both adults (18 years or older), with the patient having been diagnosed with cancer.the 8 intervention sessions will target the five domains of quality of life (emotional, physical, social, cognitive, and spiritual well-being), be provided in group settings, and be delivered in two 45-minute sessions each week over a 4-week period.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent. * ability to speak, read, write and understand english language * has cancer caregiver status defined as an unpaid individual who provides physical, practical, and/or emotional care and support to a cancer care recipient in the home or other healthcare setting. * has a care recipient: * ≥ 18 years of age who * has a malignancy (either solid tumor or hematologic) diagnosis. * who has signed a research authorization form * who is undergoing or in the last 6 months has undergone cancer treatment * ability to use and access to a computer, tablet or other device with internet access and video capabilities exclusion criteria: * diagnosis within the past 12 months of active substance abuse (alcohol or drugs) * diagnosis within the past 12 months of active mental health condition that has required psychiatric hospitalization * diagnosis within the past 12 months of suicidal thoughts or attempt * care recipient is currently participating in another psychosocial clinical trial
effect of platelet inhibition and / or lipid lowering in non-acs-patients with positive troponin

Conditions: Acute Chest Syndrome

Summary: the study evaluates the effect of platelet inhibition and / or lipid lowering in non-acs-patients with symptoms suggestive for acs, and elevated high-sensitivity troponin values

current databases show, that high-/ ultra sensitive (hs)/ (us) troponin levels above the 99th percentile in patients presenting with chest pain are indicative for future cardiovascular events, even when acute coronary syndrome (acs) was ruled out. most of these non-acs-patients are discharged without specific/ preventive therapy (anti-platelet or anti-lipid), although "positive" troponin values (any value at any time during hospitalisation above the 99th percentile) seem to clearly indicate underlying myocardial ischemia. in summary, there is an unmet need and huge potential to reduce mortality and morbidity in chest pain unit patients by specific therapy. the investigators propose that platelet inhibition by aspirin or lipid lowering by atorvastatin will prevent plaque rupture and superimposition of thrombosis to coronary atherosclerosis in this population. it is planned to conduct a controlled clinical trial: 3,000 troponin positive patients presenting at emergency room (er)/ cpu with symptoms suggestive for acs, but an acs was ruled out, will be assigned randomly to aspirin 100 mg and/ or atorvastatin 20 mg versus placebo (2x2 factorial design).

Eligibility criteria:
inclusion criteria: * patient with symptoms suggestive for acs presenting within 48 hours after onset in the er/ chest pain unit (cpu) * patient has at least one elevated high-sensitivity troponin i or t value * chest pain is classified as non-acs, despite elevated hstn (e.g. because of missing troponin dynamics) * at least 50 years of age exclusion criteria: * indication for antiplatelet therapy (e.g transient ischemic attack, or stable coronary artery diseases -cad) or anticoagulation therapy (such as atrial fibrillation) * indication for anti-lipid therapy * any evidence of an acute myocardial necrosis (e.g imaging evidence of new regional wall motion abnormality, or significant st-segment-t wave (st-t) changes in ecg) * untreated clinically significant cad requiring revascularization * hemoglobin value below 8 mg/d, and/or creatinine kinase ≥3 times uln, and/or ast or alt ≥3 times uln * active malignancy of any organ system, treated or untreated. subjects have to be in remission for at least 36 months to be eligible.

Keywords: aspirin atorvastatin troponin
blood pressure lowering effect of supplementation with korea red ginseng associated with reductions in circulating lp-pla2 activity and lysophospatidylcholines and an increase in dihydrobiopterin in prehypertensive subjects

Conditions: Prehypertension

Summary: this study evaluated effects of red ginseng consumption on blood pressure (bp) and fasting plasma metabolomes.

a randomized, double-blind, placebo-controlled study was conducted on nonobese, nondiabetic and prehypertensive subjects. over a 12 week test period, the red ginseng group (n=31) consumed 10 capsules (total 5g) daily containing red ginseng, while the placebo group (n=31) consumed the same product without red ginseng. fasting plasma metabolomes were profiled using uplc-ltq-orbitrap mass spectrometry.

Eligibility criteria:
inclusion criteria: * nondiabetic, nonobese and prehypertensive subjects with blood pressures ranging 120 - 139 mmhg (systolic) or 80-89 mmhg (diastolic) were enrolled in this study. exclusion criteria: * exclusion criteria included previous diagnosed clinical hypertension * self-reported use of antihypertensive medication * abnormal liver or renal function * history of cardiovascular disease * kidney disease * cancer * thyroid or pituitary disease or any other serious life-threatening illness that required regular medical treatment * we also excluded women who were pregnant, breast feeding or intending to become pregnant during the time of study.
ssvep evaluation of brain function (pro)

Conditions: Mild Traumatic Brain Injury

Summary: the investigational device used in this clinical investigation, the nurochek pro system (ncpro), is a portable electroencephalogram (eeg) headset which delivers a visual stimulus and measures a vep. the visual stimulus is delivered to the subjects' eyes via light-emitting diodes, and the eeg measures the user's visual-evoked potential. this headset communicates with an application on a computer, which processes the signals and transmits them to a secure cloud server for analysis and storage of the data. nurochek pro is a development of the previously fda cleared nurochek system. the primary objective of this clinical investigation was to evaluate the performance of the investigational device (ncpro) against clinical diagnosis of detection of mild traumatic brain injury (mtbi). the primary endpoint outlined for this study was set at the collection of 100 valid investigational device readings from individuals with concussion and 500 valid investigational device readings from healthy individuals who have had a plausible mechanism of sustaining a concussion, but do not have one. additionally, readings from healthy individuals are also to be acquired. the aim of this study was to collect data from 100 readings from individuals with concussion. the initial assumption was that sites would provide players pre-season and make players available for testing post-concussion. in practice, some sites provided player data only post-concussion event (such as medical clinics). participants were acquired from sporting clubs, medical clinicals and schools.


Eligibility criteria:
inclusion criteria: * individuals aged 12 years and older, participating in sport-related activities. exclusion criteria: * individuals are excluded if they have a history of seizures, history of epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights.

Keywords: mild traumatic brain injury concussion steady state visual evoked potential electroencephalography sports concussion sports medicine
a multicenter study of nb-001 in the treatment of recurrent herpes labialis (sharcs)

Conditions: Recurrent Herpes Labialis

Summary: the purpose of this study is to demonstrate the safety and efficacy of nb-001 in subjects with recurrent herpes labialis (rhl).

this is a randomized, double-blind, two arm, parallel-group, vehicle-controlled, multi-center study of nb-001. the study is designed to demonstrate the safety and efficacy of nb-001 in subjects with rhl. approximately 850 subjects who meet all eligibility criteria will be randomized in the study. subjects will begin treatment as soon as they experience the onset of cold sore symptoms. treatment will be applied 5 times daily, approximately 3-4 hours apart while awake. treatment will continue until the investigator assesses the primary lesion complex as healed or a maximum of 4 days. clinic visits will occur on a daily basis until the investigator determines that the primary lesion complex has healed or a maximum of 15 clinic visits. at daily clinic visits, the investigator will make efficacy assessments of the primary lesion complex; safety and tolerability assessments of nb-001 following topical administration will also be assessed daily. subjects will make daily assessments of therapy. at the end of study, the investigator will make a global assessment of therapy. the subject will make global assessments of therapy and social impact.

Eligibility criteria:
inclusion criteria: * a healthy man or woman 18 years of age or older. women who are pregnant, lactating or may become pregnant may (at the investigator's discretion) be included in the study. * have recurrent herpes labialis as defined by a history of three (3) or more cold sore recurrences on the lips and/or skin surrounding the lips in the previous 12 months; * have the majority of their cold sore recurrences preceded by a well defined history of prodromal symptoms. exclusion criteria: * subjects with severe chronic illness * received (within the last 6 months) or receiving chemotherapy; * significant skin disease on the face * previously received herpes vaccine; * active alcohol or drug abuse; * prior randomization into any nanobio study; * known allergies to topical creams, ointments or other topical medications.
energy expenditure in chronic kidney disease

Conditions: Kidney Diseases; Chronic Kidney Diseases

Summary: patients with kidney disease need accurate advice on their diet. researchers know very little about energy needs and nutritional requirements in kidney patients. simple tools are needed to calculate calorie requirements so that good bed-side advice can be given to patients, and to allow cost-effective research. this study aimed to measur energy requirements in kidney disease using a gold-standard safe and very accurate method called the "doubly labelled water technique". the study has compared measurements with less costly measurements obtained using a device which measures oxygen content of air breathed out. the study has also measured physical activity levels with questionnaires.

background the function of the kidneys is to remove waste products of metabolism, and despite advances in treatment of ckd little is known about metabolic rate in renal disease. increased knowledge about metabolic rate would have numerous potential benefits. little is known of the effects of metabolic rate on kidney disease. this study was designed to define the relationship of metabolic rate with degree of kidney function. study design and methods in an observational cohort study, the investigators studied total energy expenditure in 80 patients with ckd stage 1-5 using the doubly-labelled water technique over a 14 day period. the group was divided such that half had stage 1-3 ckd and half stage 4-5. all subjects performed a comprehensive metabolic analysis including measurement of resting energy expenditure using indirect calorimetry, bioimpedance, and body size measures. physical activity was assessed using a stanford 7 day recall questionnaire. data analysis the data analysed will include determining the relationship between level of kidney disease as measured by egfr and energy expenditure measured as resting energy expenditure and doubly-labelled water total energy expenditure. this will be determined by regression analysis. additionally, comparison will be made between subjects with early-moderate (ckd stage 1-3) and advanced (ckd stage 4-5) ckd.

Eligibility criteria:
inclusion criteria: 1. ckd stages 1-5 according to the mdrd equation egfr 2. age \>18 exclusion criteria: 1. abnormal thyroid stimulating hormone level or previous thyroid disorder 2. active malignancy 3. pregnancy 4. intercurrent illness or infection 5. hospital admission in month prior to enrolment 6. surgery in 4 weeks prior to enrolment 7. hiv, hepatitis b, hepatitis c positive status 8. tuberculosis in the 12 months prior to enrolment. 9. active vasculitis or connective tissue disorder 10. organ transplantation. 11. treatment with immunosuppression, except low dose corticosteroids (\<10mg/day prednisolone).

Keywords: chronic kidney disease energy expenditure metabolic rate
glasgow-blatschford score validation in digestive hemorrhage

Conditions: Gastrointestinal Hemorrhage

Summary: the purpose of this study is to validate the glasgow-blatchford score for the stratification of patients with upper gastro-intestinal hemorrhage. this score is easy to calculate. it is mainly based on the hemoglobin, blood pressure and blood urea. if the score is zero, the bleeding is very low risk and the gastrointestinal endoscopy may be delayed and performed as an outpatient.


Eligibility criteria:
inclusion criteria: * to be admitted in the university hospital for a gastrointestinal hemorrhage (vomiting of red or black blood or melena) exclusion criteria: * age under 18 * pregnancy * hemorrhage during hospitalisation * red rectal bleeding * no consent signed
internet-based self-help intervention for social anxiety symptoms

Conditions: Mental Health Issue

Summary: this study is a randomized-controlled trial in which the assumed superiority of the module internet-based cognitive behavioral therapy intervention for social anxiety disorder is evaluated compared to a waitlist control group. participants will be assigned to one of two groups, treatment which have web-based intervention (guided), and waitlist. the intervention program will be offered to treatment group participants (guided) through the website https://kendikendineyardim.org, the unique online self-help platform in turkey. participants in the web-based treatment group will receive feedback message within 24 hours after each completed module from the guides.

this study is a randomized-controlled trial in which the assumed superiority of the module internet-based cognitive behavioral therapy intervention for social anxiety disorder is evaluated compared to a waitlist control group. participants will be assigned to one of two groups, treatment which have web-based intervention (guided), and waitlist. the intervention program will be offered to treatment group participants (guided) through the website https://kendikendineyardim.org, the unique online self-help platform in turkey. participants in the web-based treatment group will receive feedback message within 24 hours after each completed module from the guides. the intervention program consists of five modules. each module can be completed in 30-40 minutes. each module starts with the evaluation of the exercises given at the end of the previous module and ends with a between-module exercise. the module includes text, interactive forms, animated videos, audio recordings, and images. the duration of the program will be approximately five to seven weeks. however, participants will be allowed to follow the program at their own speed. no limitations will be imposed other than the completion of no more than one module per day. users can use the system with their e-mail addresses and passwords. the data will be compared with suitable statistical techniques.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study; * having a valid e-mail address; * having internet access (computer, laptop, tablet, or mobile device); * being aged 18 or older; * score of 25 or above on both anxiety and avoidance subscales of the liebowitz social anxiety scale turkish form exclusion criteria: * receiving any psychological help (i.e., medication or psychotherapy/counseling) during the research period

Keywords: cognitive behavioral therapy web-based intervention procrastation
activity trackers for improving bp

Conditions: Hypertension; Cardiovascular Risk Factor; Physical Activity; Chronic Kidney Diseases

Summary: the study aims to determine if use of physical activity trackers coupled with provider feedback will increase awareness of young adults of their physical fitness and improve blood pressure levels. the goal of this pilot study is feasibility, with a secondary goal of examining potential effect sizes for planning purposes for a larger randomized controlled trial.

increasing physical activity levels may improve cardiovascular health and bp levels in young individuals, especially if such strategies promote healthy lifestyles. physical activity is currently recommended for adults cv health, but physical activity levels are known to be low in populations with diabetes or chronic kidney disease. one prior study of the use of pedometers (not associated with wireless technology or provider feedback) in children with ckd did not significantly improve physical activity levels. supervised walking appeared to provide some benefit in individuals with type ii diabetes, but overall compliance was poor. interview of adolescents and young adults with chronic illnesses has shown preference for the use of electronic devices and online tools for disease management.thus, use of sophisticated electronic devices such as fitbits© (wireless pedometers worn on the wrist that sync with cell phones) may improve disease control by engaging young patients in self-monitoring of their own health and lifestyle behaviors. this pilot study aims to determine if use of fitbits© coupled with provider feedback will increase awareness of young adults of their physical fitness and improve blood pressure levels.

Eligibility criteria:
inclusion criteria: * ages 8-30 receiving anti-hypertensive therapy at the time of recruitment. * diabetes, non-dialysis requiring chronic kidney disease, kidney transplant, or other etiologies of hypertension * have phones compatible for wireless device (fitbits©) data transmission exclusion criteria: * history of decompensated congestive heart failure * pregnant * cognitive impairment * unable to perform physical activity * bp \>180/110 mm hg * prisoners * contraindication to use or wear of home activity tracker (such as allergy to activity tracker band) * presence of any co-morbidity that would preclude physical activity * actively using physical activity tracking devices prior to the study will be excluded.