Kornimate/medical-research-clean huggingface dataset:
long-term pleiotropic effect of statins in patients with peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to determine the long-term effects of statins, atorvastatin, upon nitric oxide, as an endothelial function assessment, and c-reactive protein, an inflammatory marker, levels in patients with peripheral arterial disease. these long-term biological pleiotropic effects of statins will offer information on the role of endothelial function and systemic inflammation in the etiopathogenesis of pad.


Eligibility criteria:
inclusion criteria: * patients at the time of diagnosis of fontaine grade ii peripheral arterial disease (pad), confirmed by hemodynamic evaluation (doppler ultrasound) * over 18 years old exclusion criteria: * patients had previously undergone revascularization * patients were receiving treatment with statins * patients with contraindications to statin use. * patients with coexistence of chronic inflammatory diseases or steroidal medication
acute oral ketones or carbohydrate supplement modify heart function in heart failure?

Conditions: Heart Failure

Summary: does oral intake of exogenous ketone salt improve heart function measured by cardiac mri in heart failure compared to oral intake of a carbohydrate placebo?

this study will help to quantify heart and kidney ketone uptake with or without an exogenous ketone salt in heart failure condition. participants will have 2 different cardiac mri to perform: 1. fasting with exogenous ketone salt supplement 2. fasting with exogenous carbohydrate supplement

Eligibility criteria:
inclusion criteria: * patients with heart failure with left ventricle ejection fraction of 40% * heart failure of ischemic or dilated etiology * ambulatory patient with a nyha functional class of ii-iii; * stable symptoms and no change in medical therapy in the last month. exclusion criteria: * diabetes * patients treated with any sglt2i; * chronic kidney disease * acute coronary syndrome in the last 3 months; * use of parenteral inotropic agents; * persistent or permanent atrial fibrillation or atrial flutter; * presence of pacemaker or defibrillator; * medical condition that causes malabsorption of the test material; * under ketogenic diet, or using exogenous ketone supplements * use of nicotinamide adenine dinucleotide (nad) precursor supplements

Keywords: ketones heart
usg-guided m-tapa vs ostap block in patients undergoing laparoscopic cholecystectomy

Conditions: Laparoscopic Cholecystectomy

Summary: in this study, the postoperative analgesic effect of ultrasound-guided modified thoracoabdominal nerves blocks through perichondrial approach (m-tapa) and oblique subcostal transversus abdominis plane block(ostap) will be searched in patients recruiting for laparoscopic cholecystectomy (lc) and the two groups will be compared in terms postoperative opioid consumption. the primary aim of this study is to compare the effects of ultrasound-guided (m-tapa) and ostap blocks on opioid consumption after lc surgery. it is hypothesized that m-tapa will reduce opioid consumption of the patients more than the ostap block.

laparoscopy is a minimally invasive procedure, but postoperative pain is still the most common symptom after laparoscopic cholecystectomy (lc). oblique subcostal transversus abdominis plane (ostap) block is a regional anesthesia technique defined for abdominal surgeries. previously, several studies have reported that ultrasound-guided ostap blocks reduce postoperative pain scores after lc. m-tapa block is performed by applying local anesthetic to the lower surface of the chondrium. this technique provides effective analgesia in the abdominal wall. this study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. after randomization, m-tapa and ostap blocks will be performed under ultrasound guidance after administering general anesthesia and prior to the skin incision. an anesthesiologist who performed blocks will not involve in the data collection. other health care workers who will involve in the evaluation of postoperative pain scores, vital parameters, nausea and vomiting, antiemetic, opioid consumption, and quality of recovery score will be blinded to group assignment.

Eligibility criteria:
inclusion criteria: * patients' age between 18 and 70 years with american society of anesthesiology (asa) physical status i-ii, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study exclusion criteria: * presence of coagulation disorder * infection at the injection site of the block * known allergy to local anesthetics * advanced hepatic or renal failure * can not communicate in turkish * history of abdominal surgery or trauma * conversion of laparoscopic to open surgery * consumption of any pain killers within the 24 h before the operation * chronic opioid consumption * pregnancy * alcohol or drug abuse * body mass index (bmi) ≥ 35 kg m-2.

Keywords: modified-thoracoabdominal nerves block oblique subcostal transversus abdominis plane block postoperative pain
improving childhood obesity-related behavior change through better risk communication

Conditions: Obesity, Childhood

Summary: one-third of american children are overweight or obese, leading to an increased risk for cardiovascular disease (cvd), early mortality, and other risks throughout their lifespan relative to normal weight children. in our pilot work, we found that 67-83% of parents underestimate a child's long-term risk of developing cardiovascular disease in adulthood and that parents thought their own child's risks were 13-15% lower than those of a typical child in their community, even controlling for family health and demographic characteristics. parents were 40 times less likely to predict that their child, rather than a typical child in their community, would be overweight or obese in adulthood. these findings suggest that parents suffer from optimism bias, the tendency to overestimate one's chances of experiencing unlikely positive events. belief that a child is at increased risk for adverse health outcomes in adulthood could be an important motivator for a family to initiate behavior changes and vice versa. the overall goal of this research is to develop provider-based risk communication approaches to motivate parents of obese children to engage in behavior change to protect their children from cvd and other obesity-related co-morbidities later in life. specifically, the investigators will: 1. develop risk communication methods that providers can use to better convey accurate information about a child's health behaviors, obesity status, and future health risks to parents. 2. using an online experiment, we will evaluate the impact of new risk communication methods on parental engagement in behavior change. 3. pilot test the feasibility, acceptability, and impact of new risk communication approaches in pediatric primary care clinics. this work will give pediatricians novel tools to effectively discuss the long-term consequences of childhood obesity with parents. the findings from this work will inform an interventional trial that will assess the impact of improved risk communication techniques on child behavior change and health outcomes.


Eligibility criteria:
inclusion criteria: * must be a parent of a 5-12 year old child * child must be a patient at university of washington medical center * child must have bmi at or above 95th percentile for age and sex * parent must have home or mobile internet access exclusion criteria: * none

Keywords: risk communication
immediate breast reconstruction following mastectomy (irma)

Conditions: Breast Cancer Female

Summary: based on data from the us surveillance, epidemiology and end result program (seer), the rates of nipple-sparing mastectomy (nsm) have risen 202% since 2009. in spite of the increasing popularity of irma, limited research has been done to identify complications in patients undergoing these procedures. of particular importance is to assess the effects of combining the procedure with radiotherapy, and undergoing a one- versus two-step surgical procedure. active monitoring and periodic assessment of irma patients are needed to establish the safety of these different techniques in terms of complications and recurrence rates. identifying an optimal strategy for irma may lead to the development of clinical guidelines, which are currently lacking.

this is a multicenter observational, cohort study. the study is designed to serve a similar purpose as a disease registry. the only study-specific intervention will be the completion of the breast-q quality-of-life (qol) form. only quantitative data will be collected. the rationale for this study design is to identify and describe the type and frequency of complications related to irma. no hypothesis is being tested. although group comparisons based on surgical techniques will be made, conclusions based on these findings will be limited by the observational nature of the design. data from patients will be collected using a series of pseudonymized case report forms, including the validated quality-of-life questionnaire: breast-q. these data will be entered into the web-based data collection system, secutrial. a precise description of the surgical procedure will be required, as specified on the case report forms (e.g., implantation of a mesh, resection margins), to allow for subsequent multivariate analyses. during the first year of follow-up, data from routine clinical assessments and the qol forms will be gathered at baseline (within 90 days after mastectomy), 6 and 12 months. thereafter, data will be collected from annual clinical assessments and completion of the qol form will be done for an additional four years (24, 36, 48 and 60 months postoperatively). consequently, a total of five years of postoperative follow-up data will be collected to allow sufficient time for the development of the majority of foreseeable complications.

Eligibility criteria:
inclusion criteria: * any women ≥ 18 years of age undergoing irma (nsm or ssm) at any participating breast center may be included in the study. * women undergoing irma for either prophylactic or oncologic purposes * enrolment is possible up to 90 days after mastectomy * a patient who has had the mastectomy at a non-participating institution, but has subsequently sought treatment at one of the study centers, may be eligible for enrolment up to 90 days following mastectomy exclusion criteria: * unwillingness to have follow-up assessments at the participating breast centers * limited ability to understand study-specific procedures, which includes language difficulties.
compounded pain preparation absorption study

Conditions: Pain

Summary: single center, prospective, observational study to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications from medimix specialty pharmacy.

single center, prospective, observational, open-label, cohort study of participants that receive a combination topical pain medication from medimix specialty pharmacy with no comparator group designed to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications.

Eligibility criteria:
inclusion criteria: * participants must apply and consistently use the supplied cream for 1 month at a prescribed * participants must be ≥ 30 and \<65 years of age * participants must be able to provide sound written and verbal informed consent * participants must be diagnosed with an icd9 code indicative of chronic pain exclusion criteria: * participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription * participants must not be pregnant or breastfeeding * participants must not have used any study drug greater than 180 days from the day of screening * participants must not be utilizing medications that may interact with those being used in the topical formulation as determined by the pi * participants must not be using any systemic medications that may influence drug serum concentrations of ingredients being used in the topical compound. these include medications from the same class of studied drugs or drugs that may falsely increase or decrease serum levels of the study drugs
improving stroke motor control with non-invasive brain stimulation and functional electrical stimulation

Conditions: Stroke; Rehabilitation; Hand

Summary: this pilot study for stroke patients with chronic upper limb hemiplegia will examine the effects of non-invasive brain stimulation and neuromuscular electrical stimulation on hand motor control and corticospinal excitability. specifically, this study will investigate the effects of timing and delivery of tdcs in conjunction with contralaterally controlled functional electrical stimulation.


Eligibility criteria:
inclusion criteria: 1. age ≥ 21 2. ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke 3. able to follow 3-stage commands and remember 2 of 3 items after 30 minutes 4. full volitional elbow extension/flexion and hand opening/closing of unaffected limb 5. adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice 6. patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment 7. medically stable 8. ≥ 10° finger extension 9. unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the manual muscle test and a score of ≥1 and ≤ 11/14 on the hand section of the upper extremity fugl-meyer assessment 10. skin intact on hemiparetic arm, hand and scalp 11. while relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain. 12. no significant visual or hearing impairment exclusion criteria: 1. co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, parkinson's disease, spinal cord injury, traumatic brain injury, multiple sclerosis). 2. uncontrolled seizure disorder 3. use of seizure lowering threshold medications at the discretion of the study physician (dr. rich wilson) 4. cardiac pacemaker or other implanted electronic device and/or stent 5. pregnant 6. intramuscular botox injections in any upper extremity muscle in the last 3 months 7. insensate arm, forearm, or hand 8. severely impaired cognition and communication 9. uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) 10. severe shoulder or hand pain (unable to position hand in the workspace without pain) 11. metal implant in the head
pharmacokinetic study of min-101 in healthy subjects

Conditions: Schizophrenia

Summary: the aim of the study is to assess how min-101 is taken up by the body when given in different amounts and in different formulations. the drug will be given as a single dose in part 1 of the study and during part 2 of the study as multiple dose, once daily for 7 days. the ultimate aim is to find an optimal formulation which can be developed as a once daily dose for the treatment of schizophrenia.


Eligibility criteria:
inclusion criteria: * healthy males (part 1 and part 2) or non-pregnant, non-lactating healthy females (part 2 only) * body mass index (bmi) of 18.0 to 30.0 kg/m2 * must be cyp2d6 extensive metabolizer * must be willing and able to communicate and participate in the whole study * must provide written informed consent * must agree to use an adequate method of contraception key exclusion criteria: * subjects who have qtc \> 430 in male, \> 450 in female confirmed by a repeat ecg * any family history of sudden cardiac death and torsade de points * no personal or family history of unexplained presyncope, syncope or orthostatic hypotension * history of any drug or alcohol abuse in the past 2 years * history or evidence of any medically diagnosed clinically significant psychiatric disorders * suicidal tendencies or history of suicidal attempts * regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 ml of 40% spirit or a 125 ml glass of wine) * current smokers and those who have smoked within the last 12 months. a breath carbon monoxide reading of greater than 10 ppm at screening * females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission) * clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator * positive drugs of abuse test result * positive hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv ab) or human immunodeficiency virus (hiv) results

Keywords: modified release formulation pharmacokinetics
prenatal screening of intestinal malrotation with a higher risk of volvulus.

Conditions: Postnatal Complication; Mesenteric Pregnancy

Summary: digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. this requires emergency surgery with a risk of digestive resection. visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication. the aim of the study is to study the neonatal outcome of fetus confirm to have an abnormal positionning of mesenteric vessels


Eligibility criteria:
inclusion criteria: * pregnant women attending for 2nd trimester ultrasound * abnormal positionning of mesenteric vessels * no other foetal malformation * singleton pregnancy * age \>18 years exclusion criteria: * chromosomal abnormality * polymalformative syndrom * foetal malformation changing intestine disposition (gastroschisis, diaphragmatic hernia, heterotaxis...)

Keywords: pregnant women 2nd trimester ultrasound examination mesenteric vessels positionning pediatric follow up +/- treatment postnatal confirmation evolution and complication
oral health awareness and oral hygiene in insulin dependent diabetes mellitus

Conditions: Health Attitude; Diabetes type1

Summary: this study is designed to evaluate the effect of oral health educational program on the awareness and oral health status of children with insulin dependent diabetes mellitus.

first visit: (baseline) 1. awareness questionnaire is given to parent or caregiver to fill. 2. child information will be recorded in the diagnosis chart of pediatric dentistry and public health department 3. intra-oral and extra-oral examination to all children included and recording oral hygiene index simplified. 4. intervention group will receive: * supra-gingival scaling * oral health educational program through life demonstration of tooth brushing on a model, power point presentation and a poster. * package containing tooth brush, tooth paste, poster and follow-up chart. second and third visits: (every month) 1. oral hygiene index simplified will be recorded for both groups. 2. follow-up chart is collected from intervention group. forth visit: (final visit) 1. awareness questionnaire is given for parents of both groups. 2. oral hygiene index simplified is recorded for both groups. 3. follow up charts is collected from intervention 4. control group will receive the same program after collection all data. number of visits \& follow up period: * four visits, time interval between each visit is one month and the follow up period is three months

Eligibility criteria:
inclusion criteria: 1. children aged 6-8 years old. 2. cooperative children. 3. both genders. 4. insulin dependent diabetes mellitus children exclusion criteria: 1. children with any other medical condition. 2. children undergoing orthodontic treatment. 3. parents unable to give informed consent

Keywords: oral-health-awareness, diabetes
effect of homocysteine-lowering therapy with folic acid, vitamin b12, and vitamin b6 on endothelium-dependent vasodilatation of forearm resistance vessels in patients with coronary heart disease

Conditions: Cardiovascular Disease; Endothelial Dysfunction

Summary: endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (cad) and peripheral artery disease (pad). statin-therapy has been shown to improve endothelial function in pts with cad or pad by reducing ldl-cholesterol and inflammatory markers. b-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. therefore, we want to compare the effect of rosuvastatin and b-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.

study design: 36 pts with cad or pad are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin b12 0.4mg and b6 10mg/d for 6 weeks in a double-blinded design. after 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.

Eligibility criteria:
inclusion criteria: * cad or pad (\>50% luminal stenosis), previous myocardial infarction or bypass surgery \>3 month ago * history of percutaneous coronary intervention (ptca or stenting) * confirmed consent exclusion criteria: * myocardial infarction or acute coronary syndrome or bypass surgery \<3 month ago * ongoing treatment with statins * ongoing vitamin supplementation with folic acid and b vitamins * \<18 years * active smokers * uncontrolled arterial hypertension * renal insufficiency * atrial fibrillation * liver disease * nyha class \>2 * familial hypercholesterolemia

Keywords: endothelial function flow mediated dilatation rosuvastatin folic acid b vitamins
use of hrv measuring hearing-aid device to detect acute stress

Conditions: Stress

Summary: validation of in-ear device to measure acute mental stress in comparison with a polar h10 chest band. stress is measured on the basis of heart rate variability.


Eligibility criteria:
inclusion criteria: * dutch speaking and understanding * evidence of a personally signed and dated informed consent, indicating that the subject (or a legally recognized representative) has been informed of all pertinent aspects of the study * age ≥ 50 years * no contra-indications for the use of the receiver in-the-ear device (biometric sr 26uaa01gf), and smartwatch and chest strap heartrate monitor exclusion criteria: * • smokers * obese patients (bmi \>30 kg/m2) * presence of a pacemaker * supraventricular tachycardias: atrial fibrillation, atrial flutter, frequent supraventricular extrasystole or frequent ventricular extrasystole * otologic contraindications determined by licensed otolaryngologist
acupuncture for the treatment of vulvodynia

Conditions: Vulvodynia; Vulvar Vestibulitis; Pain; Dyspareunia; Female Sexual Dysfunction Due to Physical Condition

Summary: a randomized controlled pilot study was conducted to evaluate the effect of an acupuncture protocol for the treatment of vulvodynia. hypotheses: 1. acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia. 2. acupuncture increases sexual function in women with vulvodynia.


Eligibility criteria:
inclusion criteria: * previously diagnosed with either generalized vulvodynia, localized vestibulodynia, or both * provoked vulvodynia * unprovoked vulvodynia * women between 18 years of age and menopause exclusion criteria: * pregnancy * menopause * interstitial cystitis * irritable bowel syndrome * untreated vaginitis * cervicitis * pelvic inflammatory disease * diagnosed with other pelvic pathology causing pain * concomitantly receiving physical therapy * concomitantly receiving biofeedback, * concomitantly receiving massage * concomitantly receiving additional acupuncture.

Keywords: vulvodynia acupuncture provoked vestibulodynia vulvar vestibulitis vulvar pain dyspareunia female sexual function