Kornimate/medical-research-clean huggingface dataset:
rosuvastatin in visceral adiposity

Conditions: Abdominal Obesity

Summary: the purpose of this study is to investigate whether 6 months treatment with the cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged men.

the accumulation of intra-abdominal fat has been suggested to be of primary importance in the development of the metabolic syndrome and associated metabolic disturbances and it has been hypothesized that a selective reduction of visceral fat tissue would improve the symptoms of the metabolic syndrome. treatment with statins decrease levels of ldl-cholesterol and reduce coronary artery disease (cad) events. although it is widely accepted that the majority of benefit obtained with statins is a direct result of their lipid-lowering properties, they also demonstrate additional cholesterol-independent or pleiotropic effects. the results of experimental studies have now shown that statins decrease fat mass in the visceral region in an animal model. in the present study, we will investigate whether statins can decrease visceral obesity in humans.

Eligibility criteria:
inclusion criteria: * male patients between 40 and 65 years of age. * abdominal obesity * dyslipidemia * written informed consent. exclusion criteria: * uncontrolled hypertension * diabetes mellitus * severe liver disease * severely reduced renal function * uncontrolled endocrine disorders * history of or ongoing malignant disease * patients with known myopathic disease * recent alcohol or drug abuse * weight loss or weight gain during the three months prior to screening. * ongoing treatment with statins * ongoing treatment with calcineurin-inhibitors * ongoing treatment with anti-inflammatory drugs * received an investigational drug within 30 days prior to screening. * strong clinical indication for statin treatment * in the principal investigator's opinion, the patient has other clinically significant cardiac, oncologic, neurologic or psychiatric disease that could be adversely affected by study participation. * for any reason the patient is considered by the principal investigator to be an unsuitable candidate to participate in the study.
evaluating the influence of apnea on cardiac function using cardiac magnetic resonance imaging.

Conditions: Physiological Changes in Deliberate Apnea

Summary: former studies revealed a distinct pattern of changes in circulation during deliberate apnea. blood pressure rises significantly often accompanied by bradycardia. further studies confirmed a massive increase of total vascular resistance as it also happens in shock to maintain perfusion of heart, lung and brain. this study is to determine the exact alterations of the cardiac function during this reaction, show the redistribution of blood volume in apnea and evaluate possible longterm effects on the central nervous system caused by repeated apnea via magnetic resonance imaging.


Eligibility criteria:
inclusion criteria: * being able to hold breath deliberately at least 4,5 minutes exclusion criteria: -
cognitive behavioral therapy (cbt) for nightmares in operation enduring freedom/operation iraqi freedom (oef/oif) veterans

Conditions: Posttraumatic Stress Disorder; Sleep Disorders; Nightmares

Summary: the purpose of this study is to compare the effectiveness of two talk therapies for oef/oif veterans at the michael j. crescenz and the west haven va medical centers. participants will randomly receive one of two individual treatments intended to improve the sleep disturbance and nightmares of returning veterans.

this is a dismantling study with the objective of determining whether imagery rehearsal is essential to the efficacy of imagery rehearsal + cbt-i for improving the sleep and nightmare disturbance in veterans with ptsd and recurrent nightmares.

Eligibility criteria:
inclusion criteria: * currently enrolled in treatment in the michael j. crescenz va medical center or va connecticut healthcare system mental health clinic * meets dsm-iv-r criteria for current ptsd (within the past month) * repetitive, military-related nightmares (at least 1 every 2 weeks, for at least 6 months) * a global sleep disturbance, as indicated by a score of five or greater on the pittsburgh sleep quality index * ability to read and speak english * a concurrent anxiety disorder or depressive disorder diagnosis will be allowed * dementia related to head injury and amnestic disorder related to head injury will be allowed exclusion criteria: * current substance dependence * bipolar disorder * delirium * dementia that is not related to head injury * amnestic disorder that is not related to head injury * schizophrenia and other psychotic disorders * severe traumatic brain injury, as indicated by self-report (loss of consciousness or alteration of mental status greater than 24 hours, or peri-traumatic memory loss, or any posttraumatic amnesia greater than 7 days) * the presence of diagnosed sleep disorders other than insomnia: narcolepsy, circadian rhythm sleep disorders, and periodic limb movement disorder. participants in treatment for sleep apnea, or who have not benefited from or declined available treatment may be included.

Keywords: posttraumatic stress nightmares sleep psychotherapy imagery rehearsal insomnia behavioral treatment veterans operation iraqi freedom operation enduring freedom
changes in cerebral oxygenation and cognitive functions

Conditions: Hypotension; Controlled; Cognitive Dysfunction

Summary: the present study aimed to assess the influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by using near-infrared spectroscopy and postoperative cognitive function in patients undergoing nasal surgery.


Eligibility criteria:
inclusion criteria: * written informed consent * patients with asa physical status of i-ii * aged 18-65 years exclusion criteria: * age under 18 or above 65 * asa \> ii * coagulation disorders * history of cardiovascular and cerebrovascular disease * poor blood pressure control * anemia, pregnancy, addiction to opioids * body mass index (bmi) \> 35 * intraoperative systolic bp \< 65 mmhg * surgical duration less than 30 minutes or more than 160 minutes * need for an intraoperative sympathomimetic drug and the use of other hypotensive drugs * preoperative mini-mental state examination (mmse) score of 23 or less.

Keywords: cerebral oxygenation cognitive function esmolol nitroglycerine
contrast-enhanced spectral mammography (cesm) breast cancer screening

Conditions: Mammographic Breast Density; Mammography

Summary: the purpose of this study is to evaluate how well women may adopt a contrast-enhanced spectral mammography (cesm) as their yearly breast screening test compared to the standard 2-d or 3-d mammogram.

contrast-enhanced spectral mammography (cesm) is an fda approved tool for breast cancer detection. however, adoption into clinical practice has been slow. in this study, we will explore patient issues related to the use of cesm for breast cancer screening. for this study, 210 women with heterogeneous or dense breast tissue reported on a previous mammogram, will be recruited to undergo a screening contrast-enhanced spectral mammography (cesm). the cesm will serve as the subject's annual screening breast exam for clinical care. a survey will be administered before and after the examination that evaluates the patient experience. women will not be at high risk for breast cancer (\<20% lifetime risk). all abnormal findings will be acted upon independently. results of the general screening population survey will be compared with those of women who choose to undergo the cesm examination in order to evaluate the influence of age, education, and lifetime risk on decision making about advanced screening.

Eligibility criteria:
inclusion criteria: * • female * 40 to 69 years * previous normal mammogram (bi-rads 1 or 2) showing heterogeneous or extremely dense breast tissue within last 24 months * scheduled for screening mammogram as part of the patient's clinical care exclusion criteria: * • no mammogram within last 24 months * fatty or scattered fibroglandular tissue on last mammogram * history of allergy to iodinated contrast * history of renal disease or renal function abnormalities * pregnant women * history of diabetes * history of paraproteinemia syndromes such as multiple myeloma * history of collagen vascular disease * history of vascular disease (coronary artery disease, myocardial infarction, carotid disease, peripheral vascular disease, or known visceral artery disease) * previously identified as high risk for breast cancer (\>20% lifetime risk) * asthma * sickle cell anemia * currently on dialysis
fluid resuscitation for pediatric diabetic ketoacidosis

Conditions: Diabetes

Summary: randomized trial to determine if the volume of fluid administration in pediatric patients with dka impacts the rate of normalization of serum bicarbonate, ph as well as the length of treatment

a randomized trial of two initial volumes of ivf and subsequent administration rates. group i received 10 ml/kg of ns intravenous bolus over the first hour followed by ¾ ns with potassium replacement at 1.25 times maintenance and group ii received 20 ml/kg of ns intravenous bolus over the first hour followed by ¾ ns with potassium replacement at 1.5 times maintenance. the specific variables measured included demographics (age, gender, and race/ethnicity) and routine laboratory values (ph, pco2, plasma glucose, electrolytes, bicarbonate, sodium, chloride, bun. length of treatment was defined as a time of the hospital stay after the start of ivf infusion.

Eligibility criteria:
inclusion criteria: * 1 day to 18 years of age * type 1 diabetes * presence of dka, as defined by glucose \>250 mg/dl, accumulation of ketone bodies in the blood, and metabolic acidosis (venous ph \< 7.30 or serum bicarbonate \< 15 mmol/l.) exclusion criteria: * requirement for additional fluid resuscitation for hemodynamic instability * weight greater than 70 kilograms

Keywords: ketoacidosis fluids
association between light spectrum and survival after cataract surgery

Conditions: Cataract; Age-related Cataract; Circadian Rhythm Disorders; Glaucoma; Age Related Macular Degeneration

Summary: this study was a retrospective observational cohort analysis of subjects aged 65 years and older, who underwent bilateral cataract surgery within a single (15 hospital) healthcare system, to determine the association between type (conventional or blue-light filtering) of implanted intraocular lens and survival.


Eligibility criteria:
inclusion criteria: * the study population consisted of all adult patients (at least 65 years) who underwent bilateral cataract surgery between january 01, 2012 and january 01, 2018 within the university of pittsburgh medical center (upmc) healthcare system. to be considered bilateral and concomitant, cataract surgery had to be performed on both the left and the right eye within a 365-day period. exclusion criteria: * we excluded patients undergoing unilateral cataract surgery, surgery to replace or repair a previously implanted iol, or bilateral implantation with one blue-iol and one natural-iol (i.e., mixed iol transmission properties).

Keywords: circadian cataracts blue light survival
phase 4 study of greenlight xps laser versus bivap saline vaporization of the prostate in men with symptomatic benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia (BPH)

Summary: this is a phase 4, prospective, open-label, randomized study of greenlight xps laser versus bivap saline vaporization of the prostate in men with symptomatic benign prostatic hyperplasia (bph). the study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.


Eligibility criteria:
inclusion criteria: * male over the age of 18 years * present with symptomatic/ obstructive symptoms secondary to pbh requiring surgical intervention * subjects must read, understand and sign the informed consent * aua ≥ 15 * qmax \< 15ml/sec * stopped bph medication. alpha blockers 15 days 5-α-reductase 3 months * prostate volume ≥ 30g exclusion criteria: * pvr \> 300ml * current urine retention * previous surgical or invasive treatments (turp, tumt, tuna) * psa ≥ 4 (must have negative biopsy within last 12 months) * neurogenic bladder * obstruction due to urethral stricture * any disorder or condition of the subject that the investigator believes will counter indicate their inclusion in the study

Keywords: enlarged prostate
to evaluate the efficacy and safety of liztox in subjects with benign masseteric hypertrophy

Conditions: Benign Masseteric Hypertrophy

Summary: a double-blind, randomized, placebo-controlled, multi-center, phase iii study to evaluate the efficacy and safety of liztox in subjects with benign masseteric hypertrophy


Eligibility criteria:
inclusion criteria: * male or female subject over 19 years of age and written informed consent is obtained. * subject who has bilaterally symmetrical of masseter at visual and palpable assessment. * subject who average masseter muscle thickness of at least 14mm on each side in males and 12mm in females at maximum clenching by ultrasonography. * subject who has a masseter muscle hypertrophy scale of 4(marked) or more as determined by investigator. * subject who fully understands this clinical trial and voluntarily writes icf in the clinical trial. exclusion criteria: * subject who had previously received botulinum toxin within 12 weeks prior to the study entry. * subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in masseter muscle area within 48 weeks prior to the study entry. * subject who has a disease(e.g. temporo mandibular joint disorder, etc.) * subject who were diagnosed myasthenia gravis, lambert-eaton syndrome, amyotrophic lateral sclerosis, or any other condition that might influence with neuromuscular function. * subject who had taken medication(e.g. muscle relaxant, polypeptide antibiotics, aminoglycoside antibiotics, etc.) within 4 weeks prior to the study entry. * subject who are hypersensitive to investigational drug components (botulinum toxin, serum albumin, etc.) * subject who are pregnant or lactating or planing pregnancy or disagreed to avoid pregnancy during study period. * subject who participate other clinical trials within 4 weeks prior to the study entry. * subject who are not eligible for this study at the discretion of the investigator.

Keywords: bmh
intradermal, fractional dose of hpv vaccines:

Conditions: HPV Infection; HPV Vaccine

Summary: this randomized phase iv trial compares fractional dose of bivalent hpv vaccine to fractional dose of nonavalent hpv vaccine among men and women aged 27-45 years in seattle, washington. participants will have immune response assessed at baseline, 4 weeks, 6 months, 12 months, and 24 months.


Eligibility criteria:
inclusion criteria: * age 27-45 years at enrollment * not intending to receive the hpv vaccine series for the duration of the study participation * willing and able to provide written informed consent, undergo clinical evaluation, and adhere to follow-up schedule exclusion criteria: * prior immunization with hpv-vaccine (cervarix, gardasil-4, gardasil-9) * currently pregnant or breastfeeding * immune deficiency or other immune disorder * hiv infection or continued high risk for hiv; patients at risk for hiv who do not have a negative hiv test in the last 6 months will be excluded * cancer or chemotherapy (current, within 6 months, or anticipated in the future) except for fully excised non-melanoma skin cancer) * unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes, * known allergy to vaccine components * prior history of hpv-associated cancer
mitigating toxic impact: the role of coenzyme q10 in post-exposure protection

Conditions: Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities

Summary: this research study is being conducted to see if coenzyme q10 (a nutritional supplement) might help to prevent and/or alleviate symptoms and health consequences and help to improve quality of life and physical function in residents affected by the february 2023 east palestine, ohio train derailment. this is a pilot study that is not powered to achieve benefit but seek to examine effect size and variance to aid in power calculations for a potential future better powered study.


Eligibility criteria:
inclusion criteria: * on feb. 3, 2023, lived within 10 miles of the east palestine, oh train derailment (closer in will receive preference). others who were in the area for toxin mitigation and other reasons and show compatible symptoms will also be eligible. * meets kansas symptom criteria for multi-symptom illness - originally defined for gulf war illness (has persistent symptoms, lasting greater than six months, that are of \>mild severity in at least three of the six domains of fatigue/sleep, pain, neurological/cognitive/mood, gastrointestinal, respiratory and dermatologic). at least some symptoms must be new or worsened since the derailment. * access to internet and smart phone or computer for remote qualtrics survey participation. * willing to perform the stipulated study elements. * took ≥80% of run-in soft gels. exclusion criteria: * anticipated move from the area or other anticipated obstacle to participating for study duration. * participating in another clinical trial. * has a pre-existing health condition expected to produce significant and variable fluctuating symptoms (e.g. chronic infection and/or active cancer other than non-melanoma skin cancer). * contraindications to coq10, such as use of coumadin (although an interaction with coq10 is controversial).

Keywords: mixed toxic chemicals chronic multisymptom illness train derailment
a multicenter, randomized, double-blind, placebo-controlled study of the combination therapy of t-614 and methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the efficacy and safety of t-614 versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis


Eligibility criteria:
inclusion criteria: * subjects who have a diagnosis of rheumatoid arthritis by the acr criteria * age greater or 20 years and less than 70 years old exclusion criteria: * subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study * women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant
validation of a microrna-based fecal (mirfec) test for colorectal cancer screening, surveillance and diagnosis

Conditions: Colorectal Cancer

Summary: the present study aims to compare effectiveness and cost-effectiveness of the mirfec test with respect to fecal immunochemical test (fit) for the detection of advanced colorectal neoplasm among individuals participating in colorectal cancer (crc) screening, surveillance and diagnosis.

the mirfec test -a gradient boosting machine-generated algorithm that includes two fecal mirnas (mir-421 and mir-27a-3p) and fecal hemoglobin concentration, along with age and gender- is more effective and cost-effective than fit for the identification of patients with advanced colorectal neoplasm (i.e. colorectal cancer, advanced adenomas or advanced serrated lesions) among individuals participating in colorectal cancer screening and surveillance programs, and diagnosis.

Eligibility criteria:
inclusion criteria: * male or female aged 50 to 75 (average-risk) referred to colonoscopy-based crc screening. * male or female aged 30 to 80 with family history of crc (moderate-risk) referred to colonoscopy-based crc screening. * male and female aged 18 or older with personal history of colorectal polyps referred to colonoscopy surveillance. * male and female aged 18 or older with personal history of crc referred to colonoscopy surveillance. * male and female aged 18 or older with colorectal symptoms referred to diagnostic colonoscopy. exclusion criteria: * lack of informed consent to participate * personal history of lynch syndrome * personal history of adenomatous or hamartomatous polyposis * personal history of serrated polyposis syndrome * personal history of inflammatory bowel disease * personal history of total colectomy for any reason * family history of lynch syndrome * family history of adenomatous or hamartomatous polyposis * family history of serrated polyposis syndrome
rehabilitation team functioning and patient outcomes

Conditions: Stroke

Summary: the purpose of the study is to determine if 1. rehabilitation staff can be trained to work better together as a team; and 2. better team work improves patient outcomes.

the benefits of team treatment are widely accepted. prior research has shown that how rehabilitation teams go about their work makes a difference in the patients they treat. however, there is little information about what, specifically, the team does that results in patients who are able to do more for themselves. the objectives of this clinical trial was to test whether a team training intervention in stroke rehabilitation was associated with improved patient outcomes. we conducted a cluster randomized trial of 31 rehabilitation units comparing stroke outcomes between intervention and control groups. in thirty-one va medical centers with 237 clinical staff on 16 control teams and 227 staff on 15 intervention teams. there were 487 stroke patients treated by these teams before and after the intervention. the intervention consisted of a multiphase, staff training program delivered over six months, including: an off-site workshop emphasizing team dynamics, problem solving, and the use of performance feedback data; and action plans for process improvement; and telephone and videoconference consultations. control and intervention teams received site- specific team performance profiles with recommendations to use this information to modify team process. the main outcomes measures consisted of three patient outcomes: functional improvement as measured by the change in motor items of function independence measure (fim), community discharge, and length of stay (los). for both the primary (stroke only) and secondary analyses (all patients), there was a significant difference in improvement of functional outcome between the two groups, with the percentage of stroke patients gaining more than a median fim gain of 23 points increasing significantly more in the intervention group (difference in increase = 13.6%, p=0.032). there was no significant difference on los or rates of community discharge. stroke patients treated by staff who participated in a team training program were more likely to make functional gains than those treated by staff receiving information only. this study is a randomized cluster trial which tested used workshops to train rehabilitation staff. patients treated by trained teams were compared with patients treated by teams that did not have workshop training. stroke patients

Eligibility criteria:
inclusion criteria: * randomized, controlled subjects were va inpatient rehabilitation teams. secondary data included telephone surveys from discharged patients treated by the rehabilitation teams. exclusion criteria: * va sites which did not submit data to the va-fsod - the national functional outcomes database

Keywords: patient care team rehabilitation outcomes treatment outcomes