Kornimate/medical-research-clean huggingface dataset:
alirocumab and reverse cholesterol transport

Conditions: Atherosclerosis; Coronary Heart Disease

Summary: alirocumab is an injectable treatment for elevated blood cholesterol. the hypothesis of this study is that it also increases cholesterol excretion from the body into the stool, a process sometimes called reverse cholesterol transport. a cholesterol metabolic study will be done before and after 6 weeks of alirocumab treatment. if alirocumab increases reverse cholesterol transport, it is possible that this action provides additional protection from cardiovascular disease.

this study is a single-site, randomized, placebo-controlled clinical trial in which about 24 subjects are expected to complete an 8-week study period. the performance site is washington university school of medicine. even though alirocumab is an approved drug, the investigators consider this to be a phase i trial because it is a physiological study in which the primary endpoint is change in fecal cholesterol excretion and measures of reverse cholesterol transport. it is not a treatment protocol and uses healthy subjects. subjects with greater than ideal cholesterol but not taking cholesterol lowering drugs will be studied. all receive whole body cholesterol metabolism tests before and after treatment for 6 weeks with either alirocumab or placebo. each test takes 2 weeks. on the first day the subjects receive about 35 mg cholesterol-d7 intravenously and blood samples are obtained in order to measure cholesterol turnover rate, pool size, esterification rate, transfer from hdl to ldl and removal from the plasma compartment. fecal cholesterol excretion and related parameters are measured on days 13 and 14 after a relative steady-state is obtained. during this time the subjects consume a metabolic kitchen diet controlled in cholesterol and phytosterol content and consume oral tracer capsules consisting of cholesterol-d5 and sitostanol-d4. plasma and stool samples are analyzed by gas chromatography/tandem mass spectrometry to determine daily percent cholesterol excretion from rapidly-mixing body cholesterol pools, fecal cholesterol mass and percent cholesterol absorption. the cholesterol metabolic test is repeated on day 43 and final measurements are made on day 57. treatment effect, defined as the difference between active and placebo treatments is then calculated. based on animal data it is expected that alirocumab will increase the efficiency of cholesterol excretion from body pools and the rate of removal of cholesterol ester from plasma.

Eligibility criteria:
inclusion criteria: * healthy or with stable medical or surgical illnesses * ldl\>100 mg/dl. exclusion criteria: * triglycerides\>250 * taking drugs affecting lipid metabolism * elevated liver function tests * diabetes mellitus * a1c 6.5% or greater * pregnant * breastfeeding * desire for conception in either sex.
3d visualization system in highly myopic cataract operation

Conditions: Cataract; High Myopia

Summary: this study aims to investigate the impact of depth of field differences between the use of the 3d imaging system (ngenuity® 3d visualization system, alcon, tx, usa) and conventional optical microscope in cataract surgery for highly myopic patients on intraoperative parameters and outcomes.

the objective of this study is to compare the surgical outcomes and parameters between cataract surgeries performed using the ngenuity® 3d visualization system (alcon, tx, usa), a 3d imaging system, and the current standard binocular microscope in highly myopic patients. the focus is on evaluating the differences in depth of field and their impact on intraoperative parameters and outcomes. this prospective randomized controlled trial aims to enroll patients with both high myopia and cataracts requiring surgical intervention. participants will be randomly assigned to undergo cataract surgery using the current standard binocular microscope (control group) or the ngenuity® 3d visualization system (alcon, tx, usa) (study group). the study will compare intraoperative parameters, surgical outcomes, and the incidence of potential complications, including the frequency of microscope adjustments during surgery, total distance of adjustments during surgery, distance needed to achieve clear focus from the corneal surface to the posterior capsule, surgical duration, cumulative ultrasound energy during surgery, and occurrence of surgical complications.

Eligibility criteria:
inclusion criteria: 1. high myopia (axial length of 26 millimeters or more). 2. presence of clinically significant age-related nuclear cataract requiring surgery, assessed using the international classification system for cataract (lens opacities classification system iii, loc iii), with a graded score indicating nuclear cataract (loc iii nc/no grade 3-5). 3. participants must be 20 years of age or older. exclusion criteria: 1. the target eye has undergone vitrectomy surgery. 2. the target eye has undergone corneal refractive surgery. 3. presence of corneal diseases such as corneal dystrophy, corneal trauma, corneal scarring, corneal ulcers, or clinically significant corneal softening that significantly affects the clarity of cataract surgery. 4. complicated cataracts with features such as extreme hardness, complex composition, zonular laxity, lens dislocation, extensive capsular fibrosis, or those falling under the international cataract classification standards lociii no/nc6 or c4-c5 or p4-p5. 5. presence of other non-myopia-related eye diseases significantly affecting the complexity of surgery, such as adhesive uveitis causing adhesions, corneal damage due to trauma or lens dislocation, structural changes and adhesions due to intraocular inflammation, or severe uncorrected strabismus affecting eye alignment.

Keywords: cataract high myopia digital 3d system depth of field
intracervical catheters for induction of labour in women with prelabour rupture of membranes at term

Conditions: Fetal Membranes, Premature Rupture; Induced Labor

Summary: the purpose of this study is to examine the feasibility of using intracervical balloon catheters for cervical ripening as part of labour induction in healthy, gbs-negative women with prelabour rupture of membranes at term.

this is a randomized controlled trial comparing two methods of induction of labour for pregnant, gbs-negative women presenting with prelabour rupture of membranes at term. the intervention consists of the insertion of a double-balloon intracervical catheter at the time of induction, followed immediately by oxytocin infusion. the control consists of standard therapy: oxytocin induction. our primary outcome is feasibility, and our secondary outcomes are length of first and second stages of labour, rate of vaginal delivery, intrapartum fever, chorioamnionitis, nicu admission, suspected or proven neonatal sepsis, or serious neonatal complication.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * 37.0 and 41.0 gestational age * confirmed rupture of membranes * group b streptococcus negative * cephalic presentation * absence of contractions for at least 60 minutes following rupture * absence of contractions at time of enrolment exclusion criteria: * contraindication to vaginal delivery * previous uterine surgery, including caesarean section * previous cerclage, cone biopsy, leep, or cervical surgery * documented history of cervical incompetence * high grade intraepithelial lesion, adenocarcinoma in situ, or invasive cervical cancer. * immunosuppressed state * active vaginal infection
effects of high dose atorvastatin in patients with surgical aortic stenosis

Conditions: Aortic Valve Stenosis; Ventricular Hypertrophy

Summary: the purpose of the study is to see if statin therapy will optimize myocardial response to cardiopulmonary bypass during aortic valve replacement (avr) for aortic valve stenosis (avs) (phase i) and optimize left ventricular reverse remodeling following avr (phase ii). preliminary evidence indicates that perioperative statin therapy reduce mortality and morbidity following cardiac surgery. pleiotropic effects of statins may induce myocardial preconditioning and optimize myocardial and systemic responses to cardiopulmonary bypass during avr. furthermore statin therapy after avr may contribute to an optimal left ventricular reverse remodeling.


Eligibility criteria:
inclusion criteria: * age \> or = 70 years and \< 80 years * severe aortic valve stenosis * indication for aortic valve replacement by bioprothesis * ejection fraction \> or = 50% * without treatment with statin- no renal failure * informed consent signed exclusion criteria: * ischemic heart disaese * concomitant surgery to aortic valve replacement * emergency surgery- known intolerance for statin * pregnant woman

Keywords: left ventricular hypertrophy aortic valve stenosis aortic valve replacement cardiopulmonary bypass statins myocardial preconditioning left ventricular reverse remodeling
comparison of the efficacy of diclofenac sodium and subcutaneous 5% dextrose injection in low back pain.

Conditions: Low Back Pain, Mechanical

Summary: the aim was to compare the effectiveness of intramuscular diclofenac sodium and subcutaneous 5% dextrose injection in patients presenting to the emergency department with low back pain using the visual analog scale (vas).

the aim was to compare the effectiveness of intramuscular diclofenac sodium and subcutaneous 5% dextrose injection in patients presenting to the emergency department with low back pain using the visual analog scale (vas). the study is planned to include 150 volunteer patients with low back pain who applied to the emergency department of aksaray university education and research hospital. the patients will be randomly divided into two groups. the first group will receive subcutaneous 5% dextroseprolotherapy (approximately 75 patients), and the second group will receive intramuscular 75 mg diclofenac sodium injection (approximately 75 patients). in all patients, pain intensity will be measured and recorded using the vas immediately before the injection (baseline), 30 minutes, 1 hour, 2 hours, 12 hours and 24 hours after the injection, and evaluations will be made.

Eligibility criteria:
* applying to emergency clinics * having isolated low back pain * being between the ages of 18-55 exclusion criteria: * patients under 18 and over 55 years of age, * intolerance to nsaids or allergy to diclofenac sodium, * history of gastrointestinal bleeding, * pregnancy * patients with red flags for bp (trauma history, recent lumbar surgery, stenosis, spondylolisthesis, lumbar spondylosis with myelopathy) * documented symptoms as red flags (new leg/foot weakness, new loss of -balance or walking ability, new fever, new night sweats, new urinary retention, new loss of bowel/bladder control) * known cancer * long-term steroid use * patients requiring rescue treatment during the study

Keywords: low back pain neuroprolotherapy , diclofenac sodium, emergency department
prevalence of musculoskeletal pain and its impact on quality of life and functional exercise capacity in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: prevalence of musculoskeletal pain and its impact of quality of life and functional exercise capacity will be evaluated in patients with pulmonary arterial hypertension.

although main symptoms of pulmonary arterial hypertension (pah) include shortness of breath and exercise intolerance, patients may also experience symptoms related to musculoskeletal system such as muscle fatigue or pain. due to insufficient cardiac output and chronic arterial hypoxemia, oxygen cannot be delivered to skeletal muscles sufficiently, especially during exertion. in addition, inflammation, which is thought to play an important role in pulmonary vascular remodeling and disease pathophysiology in these patients, affects skeletal muscles as well. increased sympathetic tone in pah restricts the perfusion of skeletal muscle by increasing peripheral vascular resistance. with the addition of physical inactivity to all these factors, skeletal muscle metabolism is further impaired. furthermore, drugs used for the treatment of pah may induce musculoskeletal pain as a side effect. musculoskeletal pain is one of the most important factors impairing individual's quality of life, regardless of whether there is an underlying disease. our aim in this study is to evaluate pain prevalence in the musculoskeletal system over 9 body regions, to compare the pain prevalence of patients using different types of pah drugs and to examine impact of musculoskeletal pain on quality of life and functional capacity in patients with pah.

Eligibility criteria:
inclusion criteria: * diagnosis of pulmonary arterial hypertension exclusion criteria: * diagnosis of heart failure or any chronic respiratory disease * recent coronary bypass surgery * recent acute myocardial infarction * having a pacemaker * having any orthopedic or neurologic diseases which may impede walking or exercising
using systemchange™ to enhance medication adherence in older adult stroke survivors

Conditions: Stroke, Ischemic

Summary: this study evaluated the feasibility and acceptability of using a systemchange intervention in older adult stroke survivors to improve medication adherence. half the participants will receive the systemchange intervention, while the other half will receive the attention-control education intervention.


Eligibility criteria:
inclusion criteria: * age ≥50 years old * receives post-stroke care with saint luke's neurological consultants * prescribed at least 1, once a day, antithrombotic medication * able to provide informed consent * able to open an electronic cap * able to self-administer medications * has or has access to a telephone * has no cognitive impairment as determined by a score of 4 or greater on the six- item screener (sis). exclusion criteria: -

Keywords: medication adherence self-management antithrombotic
quality initiative in rectal cancer (qirc) trial

Conditions: Rectal Cancer

Summary: the quality initiative in rectal cancer (qirc) trial will test if a strategy designed to positively influence surgeon practice can decrease hospital rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients.

approximately 5000 canadians are annually diagnosed with rectal cancer. for patients undergoing rectal cancer surgery two unfortunate outcomes are permanent colostomy and local tumor recurrence. research demonstrates that in ontario, canada and other parts of the world the standard of care for rectal cancer surgery leaves room for improvement. this is a multi-center trial that will test if a set of interventions designed to positively influence surgeon practice, titled the quality initiative in rectal cancer (qirc) strategy, can improve rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients. secondary outcomes to be assessed include sexual, bowel, and bladder function, and quality of life. the qirc strategy consists of a workshop to discuss quality issues in rectal cancer, operative demonstration to demonstrate optimal surgical techniques, the use of opinion leaders, and a postoperative questionnaire designed to prompt surgeons to re-examine their key operative steps. the qirc strategy is largely designed to teach total mesorectal excision, a new gold standard for rectal cancer surgery that has been shown in non-randomized studies to lower patient rates of permanent colostomy and local tumour recurrence. sixteen hospitals across the province of ontario were allocated by cluster randomization to the qirc strategy (experimental arm) versus minimal intervention (control arm). all hospitals are high-volume centres - an annual rectal cancer procedure volume of 15 or greater. hospitals in the control arm represent the normal practice environment. approximately 700 patients will be assessed. in addition to measuring rates of permanent colostomy and local recurrence of tumour, the study will examine bowel, bladder and sexual function, and overall quality of life among patients. a positive trial - better results in hospitals that receive the intervention - may suggest that to effectively influence surgeon practice, resource intense approaches are necessary along with active buy-in from the surgical community.

Eligibility criteria:
inclusion criteria: hospital inclusion criteria: 1. an ontario hospital with a procedure volume of 15 or more major rectal cancer resections per year for fiscal years 1996 to 1998. patient inclusion criteria: 1. consecutive patients at each participating site who underwent major rectal cancer surgery. 2. tumor located within 15 cm of anal verge by rigid sigmoidoscopy, or, at or below the level of the sacral promontory at the time of surgery. exclusion criteria: -

Keywords: rectal cancer surgery physician behaviour knowledge translation
diet patterns in ibd in central texas

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Summary: the purpose of the study is to understand the diet patterns, preferences, and impact of diet on daily living in our patients with ibd in central texas.


Eligibility criteria:
inclusion criteria: * any patient 18years of age or older with inflammatory bowel disease exclusion criteria: * unwilling to participate * diagnosis of ibd unable to be verified
effects of thrombophilia on the outcomes of assisted reproduction technologies

Conditions: Birth Rate; Embryo Implantation; Reproductive Techniques; Thrombophilia

Summary: both hereditary and acquired thrombophilia have been associated with recurrent miscarriage and pregnancy complications. thrombophilia could favor the development of thrombosis of the maternal vasculature and obstacle placentation. some studies have suggested a role of thrombophilia in the failure of assisted reproductive techniques although this association has been recently questioned. the scope of this study is to evaluate the effect of thrombophilia on the implantation rate and live birth rate in women undergoing art. design: prospective, observational study primary end-point: live birth rate. secondary end-points: implantation rate, venous thromboembolic events during art up to 6 weeks post-partum


Eligibility criteria:
inclusion criteria: * women undergoing art * age 18 years or older exclusion criteria: * ongoing anticoagulant therapy * previous venous thromboembolism * no informed consent
comparison of sclerotherapy agents used for rectal prolapse treatment in children

Conditions: Rectal Prolapse

Summary: introduction patients with rectal prolapse are treated with injection sclerotherapy, which is the most often used first-line surgical technique. injection sclerotherapy has a success rate of 90-100% in youngsters, according to certain studies. objective to compare the outcome of injection sclerotherapy using 5% phenol in almond oil, 15% hypertonic saline and 50% dextrose water in the treatment of rectal prolapse in children.

materials and methods study design: randomized control trial. setting: paediatric surgery department, king edward medical university, mayo hospital lahore. duration: twelve months after approval of synopsis. data collection procedure: after ethical approval, all the patients with rectal prolapse fulfilling inclusion criteria admitted. routine history, thorough clinical examination and routine preoperative investigations was done. patients were randomly allocated to group a, b or c using the lottery method. group a patients were given injection sclerotherapy with 5% phenol in almond oil; group b patients were given injection sclerotherapy with 15% hypertonic saline and group c patients were given injection sclerotherapy with 50% dextrose water solution. under general anesthesia and patient in lithotomy position, 2-3 ml of sclerosing agent was injected into the submucosa at 3 sites around the circumference preferably at 3,6 and 9'o' clock positions about 2-3 cm above dentate line. the injection was performed under vision, using a speculum while lp needle was passed through the perianal skin. all patients were kept under observation during the hospital stay and discharged on same day and followed on week 1 and after 3 months for recurrence of rectal prolapse, fecal incontinence, perianal abscess and anal stenosis according to the operational definition.

Eligibility criteria:
inclusion criteria: • patients with partial or complete rectal prolapse of either gender presenting to paediatric surgery department, mayo hospital lahore, under 13 years of age. exclusion criteria: * patients of rectal prolapse due to ulcerative colitis and crohn's disease documented in medical record. * patients with previous history of surgery on pelvic floor documented in medical record. * caudaequina syndrome, neural tube defects, sacrococcygeal teratoma, hirschsprung,s disease, congenitalmega colon and rectal polyps documented in medical record. -

Keywords: injection sclerotherapy 5% phenol in almond oil 15%hypertonic saline 50% dextrose water rectal prolapse
fasted evening exercise: performance and compensatory eating

Conditions: Obesity

Summary: this study will compare the appetite, energy intake, and exercise performance responses to a bout of exercise completed in the evening after an extended period of fasting with a similar bout of exercise completed in the evening and the morning, after consuming a carbohydrate-containing meal.

regular exercise is known to be a successful strategy for improving several facets of health and maintaining body weight. however, many people are not engaging in enough exercise, and some may not be achieving maximum benefits from the exercise that they already do. performing exercise in the overnight fasted state has been shown to reduce energy intake over the course of a single day, without any compensatory reductions in free-living energy expenditure. despite these promising findings, it is likely that not every member of the population is logistically able to perform exercise in the morning due to various work, family and social commitments, and exercise in the evening may be a logical alternative for these individuals. whether the beneficial effects of overnight fasted exercise can be observed at an alternative time of the day (i.e. the evening) is unknown. therefore, the investigators are interested in examining the compensatory appetite and energy intake responses following a bout of evening exercise performed after an extended (7 hour) period of fasting. exercise performance will also be assessed as a marker of voluntary energy expenditure, which if reduced, has the potential to compensate for the reduced energy balance induced by fasted exercise.

Eligibility criteria:
inclusion criteria: * non-smokers. * have maintained a stable weight for 6 months (self-reported). * no history of gastric, digestive, cardiovascular or renal disease (self-reported). * female specific: must be using a monophasic, low dose combined ocp (containing less than 50μg oestradiol and a synthetic progestin) or females with regular menstrual cycles (self-reported). exclusion criteria: * have an unusual eating pattern (i.e., extended fasting periods \>8h other than overnight - self-reported). * severe food allergies, dislike or intolerance of study foods or drinks. * currently undergoing a lifestyle intervention (structured diet or exercise) * diagnosis of a condition or currently undergoing treatment therapy known to affect glucose or lipid metabolism (e.g., type-2 diabetes, taking statins), or contraindications to exercise. * use of medication or supplements that may affect hormone concentrations. * excessive alcohol consumption (\>14 units/week). * intensive training schedule (\>10 hours/week). * having received a positive covid-19 test in the 6-month period prior to participation. * female specific: currently pregnant or breastfeeding, the use of any hormonal contraception, and the self-reporting of short (\ 35 d), or irregular menstrual cycles.

Keywords: fasted exercise energy intake energy balance appetite exercise performance