Kornimate/medical-research-clean huggingface dataset:
the aric mri study

Conditions: Cardiovascular Diseases; Cerebrovascular Disorders; Cerebrovascular Accident

Summary: to perform a follow-up study of cerebrovascular disease in the atherosclerosis risk in communities (aric) magnetic resonance imaging subcohort.

background: although the clinical manifestations of cerebrovascular disease (cvd) typically appear acutely, the deleterious effects of cvd on brain structure and function likely begin in a presymptomatic fashion at a younger age than clinical strokes. in an effort to characterize the prevalence, risk factors, and cognitive correlates of subclinical cvd, the atherosclerosis risk in communities (aric) study funded by the national heart, lung, and blood institute performed cerebral magnetic resonance imaging (mri) and cognitive assessments on a large, bi-racial sample of middle-aged and young-elderly adults. results from the aric mri baseline study revealed a remarkably high prevalence of subclinical cvd including silent cerebral infarctions, white matter hyperintensities, and brain atrophy. moreover, these subclinical abnormalities were found to be associated with reduced cognitive functioning and with clinical cvd outcomes such as incident stroke. surprisingly little is known about risk factors related to the incidence or progression of subclinical cvd or how progression of these markers may relate to clinical outcomes such as stroke or neurocognitive decline. design narrative: this is a follow-up study of the aric mri cohort, with repeated semiquantitative mr imaging and cognitive assessments. the study will also take advantage of recent advances in mr imaging and obtain volumetric measurements of selected brain regions and expand upon the baseline cognitive assessment to further characterize neurocognitive functioning. the longitudinal design of the proposed study will fill salient gaps in current understanding of subclinical cvd. moreover, conducting this study within aric takes advantage of aric's baseline mri data, unique african american population, and extensive vascular risk factor data (including new genetic and biochemical factors as well as subclinical markers of both large and small vessel disease), making an efficient study to provide new insights into the incidence, progression, and outcomes associated with subclinical cvd.

Eligibility criteria:
participated in the baseline aric mri study.
the effect of body mass index on etonogestrel hormone levels in women using the single-rod contraceptive implant

Conditions: Contraception; Obesity

Summary: two-thirds of young women in the united states are overweight or obese. this excess weight may affect how their body metabolizes drugs such as different birth control methods. there is a not a lot of research about how excess weight could affect the hormone levels of the contraceptive implant. methods like the implant contain only progesterone, which is a hormone that does not increase a woman's risk of blood clot. these methods would be preferred for overweight and obese women because excess weight also increases a woman's risk of blood clot. the investigators propose a study comparing blood hormone levels of women using the implant for at least twelve months and in all weight categories. the investigators hope to show that all women, regardless of weight, will have hormone levels high enough to prevent pregnancy.

two-thirds of reproductive-age women in the united states are either overweight or obese. body composition may affect contraceptive hormone metabolism and possibly efficacy. phase iii studies to date included few women weighing more than 70 kilograms (134 of 923, 14.5%); there were no reported pregnancies in that group. data about pregnancy rates for women in higher body mass index (bmi) categories using the etonogestrel implant exists, but we know little about how weight affects the serum etonogestrel levels. progestin-only methods, such as the etonogestrel implant, may be preferred over combined methods including estrogens because obesity increases thrombosis risk. the investigators propose a prospective study to compare serum etonogestrel levels in the second and third years of implant use between women across body mass index categories. based on previous studies, the investigators expect a difference in etonogestrel levels based on body weight; however, the investigators hypothesize that etonogestrel levels will remain above the threshold for ovulation suppression through three years of implant use for women across bmi categories. the investigators will measure the serum levels of etonogestrel in normal weight (bmi \< 25kg/m2), overweight (bmi ≥ 25kg/m2 and \< 30kg/m2), and obese women (bmi ≥ 30kg/m2) using the single-rod contraceptive implant for at least twelve months. their primary objective is to compare the three groups and to evaluate whether etonogestrel levels fall below the critical level for contraceptive efficacy (90 pg/ml) (díaz 1991) in any group.

Eligibility criteria:
inclusion criteria: * woman using contraceptive implant for more than 12 months * english or spanish-speaking exclusion criteria: * none

Keywords: contraception implant obesity
establishment and evaluation of standardized clinical, biological and imaging parameters to assess the response of ldrt in heel spur with plantar fasciitis

Conditions: Calcaneal Spur

Summary: the clinical picture of calcaneal spur with plantar fasciitis is a debilitating disease that is difficult to treat with conservative and interventional measures. radiotherapy has shown very good therapeutic results in retrospective data, which need to be clinically confirmed both subjectively and in terms of image morphology in a prospective approach. primary objective of the study: to demonstrate a clinical benefit of ldrt: improvement of pain, functionality and quality of life after ldrt


Eligibility criteria:
inclusion criteria: * age \> 39 years * typical clinical picture of plantar fasciitis for at least 3 months without associated trauma, other musculoskeletal co-morbidities or degenerative joint disease * patients with first-time application of ldrt to the affected joint * willingness to cooperate and accessibility of patients, especially geographical proximity, for treatment and follow-up * patients for whom ldrt is indicated independently of the study * karnofsky index \>70% exclusion criteria: * achillodynia ("dorsal" calcaneal spur) * previous trauma to the foot (fracture, tendon rupture) * musculoskeletal comorbidities of the foot * acute infections/open wounds in the area of the tendon to be examined or other relevant damage to the tendon to be examined * local steroid injections into the tendon prior to the study * rheumatic or vascular diseases, lymphedema * patients with tumors * individuals of childbearing potential who do not use adequate contraceptive measures consistently during therapy * persistent drug, medication or alcohol abuse * patients who have already undergone radiotherapy for the treatment of cancer * patients with an increased risk of an mri examination, including the presence of metal implants, pacemakers or claustrophobia
pharmacokinetics and dialysability of cp-690,550 in subjects with end-stage renal disease

Conditions: End-Stage Renal Disease; Hemodialysis

Summary: there were 2 study periods in this study. in the period 1, cp-690,550 was to be administered approximately 1 to 2 hours following hemodialysis. if significant non-renal clearance of the drug occurred such that dialyzability of cp-690,550 could not be assessed in period 1, a second period (period 2) will be conducted. in period 2, a single dose of drug will be administered approximately 4 hours prior to hemodialysis.


Eligibility criteria:
inclusion criteria: * subjects with end-stage renal disease * subjects need hemodialysis 3 times weekly exclusion criteria: * subjects with evidence or history of clinically significant disease, excluding those common for subjects with end-stage renal disease (esrd). * subjects with any condition possibly affecting drug absorption. * subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin.

Keywords: cp-690 550 pharmacokinetics end-stage renal disease
quelling of excitotoxicity in acute stroke with ketamine

Conditions: Acute Ischemic Stroke

Summary: the investigators plan to undertake a phase ii study to investigate the efficacy and side effects of intravenous ketamine to reduce neuroexcitotoxicity, and thus provide neuroprotection in patients diagnosed with acute ischemic stroke.

after obtaining informed consent, patients enrolled in the 'study drug' arm of the trial will receive ketamine (1 mg/ml solution prepared in normal saline) infusion at a rate of 20 mg/h for a period of 24 hours. the infusion will start at a rate of 5 mg/h, and then gradually tapered up during the first 3 hours by 5 mg an hour. similarly, the infusion rate will be gradually tapered down at a rate of 5 mg/h during the last 3 hours of infusion. the patients randomized to the 'placebo arm' of the trial will receive normal saline infusion at the same rates. in order to prevent the psychogenic adverse effects associated with ketamine, the patients will be administered midazolam at a dose of 1 mg iv every 4 hours. midazolam will also be administered at the same rate to the patients randomized to the placebo arm. blood ketamine levels will be measured before starting the treatment, and daily while the infusion is on. while receiving treatment, the patients will be admitted to the telemetry floor in the hospital, on a monitored bed.

Eligibility criteria:
inclusion criteria: 1. all patients who are 18 years or older, presenting or admitted to the study site with acute ischemic stroke, up to 24 hours since their last known well time 2. an mri evidence of acute ischemic infarct on the diffusion-weighted imaging with adc correlate 3. pre-stroke modified rankin scale of 0-2 4. patient should be willing to participate in the study by providing a written consent himself/herself or through a proxy. exclusion criteria: 1. eligibility to receive iv alteplase or intra-arterial thrombectomy/embolectomy 2. longer than 24 hours since last known well time 3. pre-stroke modified rankin scale of 3 or above. 4. pregnant or lactating females 5. pre-existing psychiatric illness 6. intracranial hemorrhage of any type at presentation 7. seizure at onset of symptoms 8. sustained uncontrolled hypertension defined as systolic blood pressure greater than 185 mmhg or diastolic blood pressure greater than 110 mmhg, despite administration of antihypertensive medications 9. known hypersensitivity or adverse reaction to prior administration of ketamine 10. inability/refusal to provide consent by the patient or through a proxy

Keywords: stroke, neuroprotection, ketamine
effectiveness of thai northeastern folk musical therapy for blood pressure control in hypertensive patients

Conditions: Musical Therapy as a Complementary Treatment of Hypertension

Summary: a randomized controlled trial was conducted in a tertiary care hospital, khon kaen province, thailand. sixty participants were randomized to music listening group and control group. the music listening group was assigned to listen to 30-minute instrumental folk music everyday for one month. home bp and office bp were monitored and recorded.


Eligibility criteria:
inclusion criteria: * 40-80 years old * diagnosed stage-2 hypertension (ht) (defined by office systolic blood pressure \>= 140mm hg and/or diastolic blood pressure \>= 90 mm hg at first hospital visit) exclusion criteria: * pregnant women, white-coat ht, secondary ht and hearing loss or blind.

Keywords: music therapy hypertension asian stage-2 hypertension
first in human study to compare safety between intravenous bolus versus infusion of aptoll

Conditions: Stroke

Summary: the main objective of the study is to assess the tolerability and safety of aptoll administration when comparing intravenous infusion vs. bolus intravenous injection, in healthy volunteers. pharmacokinetic profile of aptoll will be also analysed as secondary objective of the study.


Eligibility criteria:
inclusion criteria: * male or female (with no possibility to become pregnant (hysterectomized or menopausal women)) subjects who give their written consent to participate in the study. * aged from 18 to 55. * no clinically significant organic or psychic conditions. * no clinically significant abnormalities in medical records and physical examination. * no clinically significant abnormalities in haematology, coagulation, biochemistry, serology and urinalysis . * no clinically significant abnormalities in vital signs and electrocardiogram. exclusion criteria: * subjects affected by an organic or psychic condition. * subjects who have received prescribed pharmacological treatment in the last 15 days or any kind of medication in the 48 hours prior to receiving the study medication * subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range. * history of sensitivity to any drug. * positive drug screening (for cannabis, opiates, cocaine and amphetamines). * smoker. * daily consumers of alcohol and/or acute alcohol poisoning in the last week. * having donated blood in the last month before start of the study. * participation in another study with administration of investigational drugs in the previous 3 months (if the study was conducted with drug substances marketed in spain, a period of at least 1 month or 5 half lives, what is longer, will be considered). * inability to follow the instructions or collaborate during the study.
educational program plus physiotherapy after prostatectomy

Conditions: Prostate Cancer; Side Effects

Summary: objective: to find out the effectiveness of therapeutic education program plus pelvic-perineal physical therapy in radical robotic prostatectomy men in terms of quality of life (qol), urinary incontinence (ui), erectile dysfunction (ed) and muscle strength. design: randomized, controlled and single blinded clinical trial. participants will be randomly assigned in two groups. experimental group: training pelvic-perineal physical therapy plus lifestyle education. control group: training in pelvic-perineal physical therapy only. in the 2 groups several physical therapy measurements will be undertaken: 1st before physical therapy treatment, 2nd, 3 th and 4th after 3, 6 and 12 months after initial measurement. study subjects: post radical robotic prostatectomy men, which have not been already treated with adjuvant treatment and pelvic-perineal physical therapy, and after reading, understanding and freely signing an informed consent form. sample size: 84 subjects will be included (42 subjects per group). to have a statistical power of 90% to detect an average difference of 10 points between two groups in the change of quality of life according to the questionnaire validated in spanish sf-12, assuming a standard deviation of the change of 20 points based on the study from hou et al, establishing an alpha risk of 0.05, in a bilateral contrast and assuming a 10% of drops outs. data analysis: separate analyzes of each variable collected in the two groups will be carried out. for continuous variables, means, medians, standard deviations and quartiles will be calculated, depending on the assumption or not, respectively, of the assumption of their normality previously determined with the shapiro wilk test (s-w). qualitative variables will be described with absolute and relative percentage frequencies. effectiveness will be evaluated by comparing between the two groups of the change in outcome variables between measurements.


Eligibility criteria:
inclusion criteria: * men had undergone radical robotic prostate surgery. * men reading, understanding and freely signing an informed consent form. exclusion criteria: * participants who had received adjuvant therapies (chemotherapy, radiotherapy) before pelvic-perineal physical therapy treatment. * men with a history of pelvic organ surgery. * men with chronic diseases that affects their quality of life. * participants with psychiatric or neurological problems. * postoperative men with cognitive limitations to understand information, respond to questionnaires, consent and / or participate in the study.
safety and efficacy of pbk-1701tc for bowel cleansing before colonoscopy

Conditions: Colonic Diseases; Intestinal Disease; Gastrointestinal Disease; Digestive System Disease

Summary: this study evaluates the efficacy, safety and tolerability of pbk-1701tc for bowel cleansing before colonoscopy. half the participants will receive pbk-1701tc and while the other will receive standard oral preparation.

this study is a prospective, randomized, single-blinded, parallel, 2-treatment, multi-center clinical trial. a total of 224 subjects will participate to this study and be assigned to the test group or the control group. the subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. subject will take the second dose early in the morning of the colonoscopy.

Eligibility criteria:
inclusion criteria: * patients who is informed and give a consent in voluntary * patients who is scheduled a colonoscopy * bmi 19≤and\<30 exclusion criteria: * patients who participate in other interventional study or had participated within 30 days before screening * pregnant or breast-feeding women who do not want to stop breast-feeding * women of childbearing potential who do not agree with appropriate contraception during this study * patients who had experienced any hypersensitivity study drug or ingredient * uncontrolled hypertension * arrhythmia with clinically significant findings from ekg * congestive heart failure; nyha functional class iii or iv; unstable coronary artery disease; myocardiac infarction history within 6 months * uncontrolled diabetes * active infection except acute upper respiratory infection or local skin infection; fever (38 °c and higher) within 1 week before study administration * hiv infection and/or chronic hepatitis b or c * patients who has a difficulty to participate because of severe nausea or vomiting * suspected or confirmed inflammatory bowel disease, toxic colon or toxic megacolon, or gastrointestinal obstruction or perforation; visible bleeding in colon * history of colon surgery and abdominal surgery within 6 month; need an emergency surgery * colonoscopy for the following use: treatment of bleeding from such lesions as vascular malformation, ulceration, neoplasia, and polypectomy site (e.g.,electrocoagulation, heater probe, laser or injection therapy); foreign body removal; decompression of acute nontoxic megacolon or sigmoid volvulus; balloon dilation of stenotic lesions (e.g., anastomotic strictures); palliative treatment of stenosing or bleeding neoplasms (e.g., laser, electrocoagulation, stenting) * fluid or electrolyte (na, k, ca, mg, chloride, bicarbonate) disturbance * severe dehydration risk (e.g., rhabdomyolysis, ascites) * history of hypersensitivity of drug or others * alcohol or drug abuse within 6 months * clinically significant underlying disease or medical history at investigator's discretion

Keywords: colonoscopy pbk-1701tc bowel cleansing
metabolic effects of oral sodium butyrate supplementation on overweight individuals

Conditions: Glucose Metabolism Disorders; Overweight or Obesity

Summary: numerous evidences suggest an important role of short-chain fatty acids, produced by the intestinal fermentation of dietary fibers by the intestinal microbiota, in the modulation of various biological functions relevant to human health. in particular, butyrate, in addition to its trophic action on enterocytes, could improve insulin sensitivity and increase glp-1 secretion, suggesting a possible role in the modulation of glucose metabolism. however, to date, very few randomized controlled trials (rcts) have observed a significant increase in plasma butyrate concentrations in humans after nutritional interventions with high-fiber diets or foods. butyrate occurs naturally in some foods, such as milk and dairy products, where it is often associated with sodium, becoming sodium butyrate. therefore, recent studies suggest the use of oral sodium butyrate supplements in order to obtain a significant increase in butyrate plasma concentrations able to exert the potential beneficial effects related to them. to date, few studies have investigated the effect of oral sodium butyrate supplementation on glucose metabolism in healthy or overweight individuals, individuals at high cardiometabolic risk, and individuals with type 2 diabetes. therefore, the purpose of this pilot study is to evaluate the effects of oral sodium butyrate supplementation, versus placebo, on glucose tolerance and insulin sensitivity in a group of overweight/obese individuals and the mechanisms underlying these effects.


Eligibility criteria:
inclusion criteria: * body mass index: 25-30 kg/m2 exclusion criteria: * type 2 diabetes, * treatment with antibiotics within the past 3 months * history of gastrointestinal diseases (inflammatory bowel disease, crohn's disease, malabsorption etc ) * cardiovascular events (myocardial infarction or stroke) during the 6-12 months prior to the study * thyroid disorders not controlled by drug therapy, * kidney (creatinine \>1.7 mg/dl or proteinuria) and liver diseases (alt/ast \>twice the upper limits) * anaemia (hb \<12 g /dl) * pregnancy or breastfeeding, * celiac disease, cancer or any other chronic disease

Keywords: butyrate sodium butyrate short chain fatty acids glucose insulin