Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of bile salt stimulated lipase (bssl) as replacement therapy in infant formula for preterm infants

Conditions: Replacement Therapy in Preterm Infants

Summary: the purpose of this study is to evaluate the efficacy in preterm infants following treatment with bssl when administered in infant formula.

in this double-blind crossover study, patients will be randomized to receive infant formula including bssl or infant formula without bssl for the first 7 days. after a wash-out period of 2 days the patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. the primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.

Eligibility criteria:
inclusion criteria: * preterm infants * less than or equal to 32 weeks of gestational age * appropriate for gestational age * enterally fed with infant formula

Keywords: preterm infants replacement therapy infant formula bssl bssl is present in fresh mother's milk but not in infant formula.
emergency medicine cardiovascular risk assessment for lipid disorders trial

Conditions: Lipid Disorder; Hypercholesterolemia; Cardiovascular Diseases; Atherosclerosis

Summary: emergency medicine cardiovascular risk assessment for lipid disorders (emerald) is a protocolized intervention based on american college of cardiology/american heart association and us preventive services task force guidelines designed to initiate preventive cardiovascular care for emergency department patients being evaluated for acute coronary syndrome. the overarching goals of this proposal are to (1) determine the efficacy of emerald at lowering low-density lipoprotein cholesterol (ldl-c) and non high-density lipoprotein cholesterol (non-hdl-c) among at-risk emergency department (ed) patients who are not already receiving guideline-directed outpatient preventive care and (2) inform our understanding of patient adherence and determinants of implementation for ed-based cardiovascular disease prevention strategies.

emerald involves (1) ordering an ed lipid panel, (2) calculating 10-year atherosclerotic cardiovascular disease (ascvd) risk, (3) prescribing a moderate- or high-intensity statin, (4) providing healthy lifestyle counseling, and (5) bridging patients to ongoing outpatient preventive care (primary care or cardiology, depending on risk level). we hypothesize that emerald will be associated with lower ldl-c and non-hdl-c at 30- and 180-days vs. usual care. the primary outcome will be percent change in ldl-c at 30-days. secondary outcomes include percent change in ldl-c at 180-days and non-hdl-c at 30- and 180-days. we will randomize 130 ed patients with possible acute coronary syndrome 1:1 to emerald or usual care, which will provide 90% power with a two-sided alpha of 0.05 to demonstrate a 10% difference in percent change in ldl-c at 30-days between arms.

Eligibility criteria:
inclusion criteria 1. evaluation for acute coronary syndrome 2. age 40-75 years 3. 10-year atherosclerotic cardiovascular disease (ascvd) risk ≥7.5% or known diabetes or known ascvd: 1. myocardial infarction 2. unstable angina 3. percutaneous coronary intervention 4. coronary artery bypass graft 5. stroke 6. transient ischemic attack 7. peripheral artery disease exclusion criteria 1. st-segment elevation myocardial infarction (stemi) activation 2. st depression \>1 mm in contiguous leads 3. on a lipid lowering agent (statin, pcsk9 inhibitor, bempedoic acid, ezetimibe, inclisiran, etc.) 4. inability to return for 30-day follow-up 5. unstable vitals (systolic blood pressure \ 120 or \<50, oxygen saturation \<90%) 6. statin intolerance 7. any resulted high-sensitivity troponin i ≥100 ng/l 8. end-stage renal disease (esrd) and/or glomerular filtration rate (gfr) \<30 ml/min/1.73 m2 9. liver cirrhosis 10. pregnancy 11. anticipated hospitalization 12. life expectancy \<1 year 13. transfer from another hospital 14. prisoner 15. non-english speaking

Keywords: hyperlipidemia cardiovascular disease atherosclerotic cardiovascular disease
vac npwt kci dressing study

Conditions: Surgical Wound Infection

Summary: in this study, the investigators propose using negative pressure wound therapy (npwt) to aid in wound healing along the lines of closure for lower extremity amputation and complex abdominal wounds. this study is designed to be a prospective, randomized clinical trial to evaluate the effectiveness of npwt versus accepted standard surgical dressings on these wounds. study participants will be randomized to one of the two treatment groups (npwt vs. standard dressing) prior to surgery, and will be followed in the post operative period to monitor the effects on their surgical closures. the experimental group will consist of participants receiving npwt and will have a vacuum assisted closure (v.a.c., kci inc.) device placed intra-op along the line of closure. the control group will receive a standard surgical dry sterile dressing. the surgical closures will be assessed after three days of treatment as well as the first outpatient post-op visit and any subsequent visits through the following 6 months. by doing so, the investigators hope to demonstrate the utility of npwt on difficult, at risk surgical closures. additionally, the investigators hope to show a difference in clinical outcome of incisions treated by npwt over our current standard technique. all patients in the principal and co-investigators practice who are scheduled to undergo lower extremity amputation or complex abdominal closure will be eligible for enrollment in this prospective randomized study. there are no exclusion criteria. informed consent will be obtained pre-operatively. data collection will include basic demographic data, disease history, past medical and social history as well key data relating to wound healing (infection, wound dehiscence or breakdown) and hospital course (length of stay, operative complications). the investigators will use simple statistical methods (anova and chi-squared analysis) to compare surgical wound healing between the two populations. the only deviation from current standard of care in these populations includes utilizing a v.a.c. system on the closure line of the experimental group versus the standard dry sterile dressing.

no further description is desired

Eligibility criteria:
inclusion criteria: * patients presenting to wound center undergoing wound treatment with expected closure of wounds including: midfoot amputations, below knee amputations, knee disarticulations, above knee amputations, and trunk wounds * wounds must be closed primarily without the use of grafts exclusion criteria: * any patient \<18 years old * any patient whose wound is unable to be closed primarily

Keywords: wound healing negative pressure wound therapy v.a.c. incision
deb ( drug eluting balloon) in crural arteries and critical limb ischemia

Conditions: Peripheral Vascular Diseases

Summary: the purpose of this trial is to compare short- medium long-term results in treatment of pad (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study results will be defined as: limb salvage, event-free survival, freedom from tlr (target lesion revascularization), primary patency, clinical success, serious adverse events, and the patients will be followed-up for 1 years. primary endpoints: primary patency at 12 months, tlr (clinical driven), secondary endpoints: event free survival, clinical success at 6,12 months, technical success, serious adverse events,


Eligibility criteria:
inclusion criteria: * critical limb ischemia. rutherford class 4-6 * crural disease, long lesions, more than 2 cm. * life expectancy \> 1year * \> 18 years exclusion criteria: * pregnancy * patients disapproval * allergy to drug or contrast
a validated educational video intervention improves the quality of bowel preparation for colonoscopy

Conditions: Bowel Dysfunction

Summary: the investigators hypothesised that a video based patient education will help patients understand the process of colon cleansing prior to a colonoscopy procedure and hence will result in clean colons that will may help physician perform a better quality examination.

after obtaining consent over phone, the investigators randomly assigned assigned participants to receive either the standard paper based instructions or receive an educational video in addition to the standard paper based instruction. physicians performing the procedure were blinded to this assignment. the investigators obtained information relating to the cleanliness of the colon as noted during the colonoscopy examination. the investigators obtained this information from the colonoscopy reports. the investigators also obtained information regarding colon polyps,wanting to see if there is any difference in the number of patients in whom adenomatous polyps were detected. outcome measures: primary out come: 1.quality of bowel preparation secondary outcome: 1. adenoma detection rate 2. rate of incomplete procedures due to poor bowel prep.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. subjects who have the ability to give consent 3. subjects who are scheduled for colonoscopy as out patient 4. subjects consenting to participate in the study 5. subjects who are able to read and understand english exclusion criteria: 1. \< 18 years age 2. subjects from whom consent cannot be obtained for any reason. 3. subjects who are scheduled for colonoscopy as in patient 4. subjects who are scheduled for colonoscopy within a time period or a situation where the educational material cannot be properly delivered to the study participant. 5. subjects who are advised to undergo bowel prep for more than one day. 6. subjects undergoing bowel prep with medications other than colyte. 7. subjects who do not have access to equipment to watch the video (tv/cd player) 8. pregnant patients 9. prisoners 10. subjects who are not able to read or understand english. (j)subjects who had bowel resection surgery

Keywords: colonoscopy
hofh, the international clinical collaborators registry

Conditions: Homozygous Familial Hypercholesterolemia

Summary: homozygous familial hypercholesterolemia (hofh), a rare inherited disorder caused by bi-allelic mutations in the ldl receptor pathway, is characterized by extremely elevated levels of low-density lipoprotein cholesterol (ldl-c) from birth and premature atherosclerotic cardiovascular disease (ascvd). our current knowledge about hofh is disjointed and largely stems from relatively small case series and expert opinion. hicc (homozygous fh international clinical collaborators) is a global consortium of clinicians who are contributing de-identified data of patients diagnosed with hofh with the goal to advance our understanding of this rare disease.

the hicc registry is an observational, multicenter, international registry collecting de-identified clinical and genetic information from patients with homozygous familial hypercholesterolemia (hofh) worldwide. patients are eligible to be enrolled in the registry based on the diagnosis of hofh by the treating clinician, irrespective of how the diagnosis was made. to generate up-to-date data reflecting current rather than historic practice, patients who died or were lost to follow-up prior to 2010 are excluded. anonymized data on demographics, type of hofh diagnosis (clinical and/or based on the results of a genetic test), genetic results, (cardiovascular) medical history, relevant family history, physical examination, laboratory measurements, lipid lowering treatment and cardiovascular imaging are collected for 3 different time points: at diagnosis, at enrolment and at time of best lipid profile (if this is different from time at enrolment). data are collected using pre-definite electronic case report forms to ensure uniformity of data collected. primary analysis will be cross-sectional (e.g. based on country of residence, age, etc)

Eligibility criteria:
inclusion criteria: * diagnosis of homozygous familial hypercholesterolemia (hofh) clinically of genetically determined exclusion criteria: * no diagnosis of hofh

Keywords: homozygous familial hypercholesterolemia autosomal dominant hypercholesterolemia autosomal recessive hypercholesterolemia registry
regn7508 versus apixaban and enoxaparin for thromboprophylaxis after total knee arthroplasty in adults

Conditions: Venous Thromboembolism (VTE)

Summary: this study is researching an experimental drug called regn7508 (called "study drug"). the study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. the aim of the study is to see how effective the study drug is at preventing venous thromboembolism (vte) and other related diseases after total knee replacement surgery. the study is looking at several other research questions, including: * what side effects may happen from taking the study drug * how much study drug is in the blood at different times * whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)


Eligibility criteria:
key inclusion criteria: 1. is undergoing a primary elective unilateral tka 2. is in good health based on laboratory safety testing as described in the protocol 3. body weight \<130 kg at screening visit as described in the protocol key exclusion criteria: 1. any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation 2. history of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol 3. history of thromboembolic disease or thrombophilia 4. history of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization 5. has an estimated glomerular filtration rate (gfr) of \<30 ml/min/1.73 m2 at the screening visit as described in the protocol note: other protocol-defined inclusion/ exclusion criteria apply

Keywords: unilateral total knee arthroplasty (tka) factor xi (fxi)
to determine tolerability and efficacy of long-term oral lacosamide in patients with partial seizures

Conditions: Partial Epilepsies

Summary: the purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.


Eligibility criteria:
inclusion criteria: * completion of parent clinical trial for treatment of partial seizures. exclusion criteria: * receiving any study drug or experimental device other than lacosamide. * meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.
the effect of ischemic training on exercise endurance

Conditions: Heart Failure; Congestive Heart Failure; Cardiovascular Disease

Summary: the purpose of this study is to determine if reducing blood flow to an exercising muscle during exercise training will enhance the training effect on that muscle in people who have limited exercise because of congestive heart failure

the objective of this study is to determine whether reduction of blood flow during stair-stepping and cycling ergometer leg exercise will contribute to an improvement in whole body exercise capacity or submaximal exercise endurance in patients with mild congestive heart failure. two groups of 25 patients with mild to moderate chf, aged 30-70, will be trained for 12 weeks. the experimental group will train with pressure cuffs inflated on one thigh and lower leg during exercise. the cuff will be applied on alternate legs during training, such that each leg has the same duration of ischemic training. the control group will train for a similar duration and intensity without pressure cuffs on the legs. pre and post training measures will include vo2peak, exercise duration at 30% vo2peak, 6 minute walk test, minnesota living with heart failure questionnaire

Eligibility criteria:
inclusion criteria: * mild congestive heart failure * must be able to exercise exclusion criteria: * venous or arterial thrombus * lower extremity arthritis * blood clotting abnormalities * claudication * peripheral vascular disease * evidence of deep vein thrombosis on ultrasound

Keywords: exercise exercise therapy
timely reperfusion in acute st-segment myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the aim of the study is to monitor outcomes, especially time to reperfusion, in st-elevation acute myocardial infarction patients.

in the regional health trust of north norway, time to reperfusion in acute st-elevation myocardial infarction is below the national average and below recommendations. the aim of this study is to monitor outcomes, especially time to reperfusion, in st-elevation acute myocardial infarction patients. the study period is supposedly lasting for approximately 4 months, the time estimated to observe the clinical course of 100 patients. before and during the study period, clinical leaders are encouraged to improve guideline adherence and to closely monitor the results of their own and collaborating institutions.

Eligibility criteria:
inclusion criteria: * patient diagnosed with acute myocardial infarction with st-elevations within our regional health trust during nov 1st and for approx 4 months, and with an indication for reperfusion therapy (thrombolysis and/pr pci) exclusion criteria: * reperfusion therapy not indicated or contraindicated
vitamin d & levothyroxine combination versus levothyroxine on lipid profile in hypothyroidism

Conditions: Hypothyroidism Primary; Lipid Disorder; Dyslipidemias

Summary: the goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment. the main question it aims to answer is: • whether adding vitamin d to standard therapy has any additional benefits participants will be given vitamin d in replacement doses according to their pre-existing vitamin d level in addition to levothyroxine. researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them


Eligibility criteria:
inclusion criteria: * patients of all genders. * age more than 12 years * biochemically hypothyroid (overt \& subclinical) * vitamin d level between 10-70ng/ml * tc \<250mg/dl, ldl 70-144mg/dl, tgs 150-499mg/dl exclusion criteria: * known atherosclerotic cardiovascular disease * bmi\>35kg/m2 * history of alcoholism (\>14 units/day) * history of beta blocker intake * patient taking lipid lowering drugs

Keywords: levothyroxine vitamin d lipids hypothyroidism dyslipidemia
feasibility of the mindfulness-based stress reduction intervention for black women living with hiv

Conditions: HIV Infections; Health Behavior

Summary: the investigator propose to culturally adapt the mindfulness-based stress reduction (msbr) intervention for black/african american women living with hiv (wlwh) to reduce stress and enhance hiv self-care behaviors and viral load (vl) suppression, which has the potential to attenuate prominent racial and gender disparities experienced by black wlwh in the us. specifically, the investigator aims to 1) culturally adapt the mbsr intervention for black wlwh using adapt-itt; 2) pre-pilot the adapted intervention via an open non-randomized pilot study to further refine the culturally adapted intervention; and 3) conduct a 2-armed randomized pilot test of the behavioral intervention compared to standard of care to assess the feasibility and acceptability the adapted mbsr intervention for black wlwh. the investigator hypothesis that the adapted intervention will be feasible and acceptable to member of the target population.


Eligibility criteria:
inclusion criteria: * cisgender females * hiv seropositive * 18 years of age or older * english speaking * an active patient at the local hiv ambulatory clinic in alabama. exclusion criteria: * non-english speaking * appear temporarily impaired (e.g., intoxicated) * not willing to or legally unable to provide informed consent.
antibiotic susceptibility of conjunctival bacterial isolates from refractive surgery patients

Conditions: Bacterial Keratitis

Summary: the purpose of this study is to determine the in vitro antibiotic susceptibility patterns of conjunctival bacterial flora isolated preoperatively from patients undergoing refractive surgery.

laser in situ keratomileusis (lasik) is the most commonly performed refractive surgical procedure for the correction of ametropia worldwide. infectious keratitis, although rare, is a potentially devastating complication of lasik, and it can lead to horrifying outcomes. previous studies on antibiotic susceptibility of preoperative ocular bacterial flora focused primarily on intraocular surgeries with particular interests in endophthalmitis. this study was aimed at refractive surgeries with special interest in infectious keratitis after lasik. intraocular surgeries for cataract, glaucoma or retinal disease are performed mostly on aged patients at a large hospital on an inpatient or outpatient basis; however, most refractive surgeries are performed on young, healthy people in private clinics on an outpatient basis. the patient populations are therefore quite different between these two types of surgery. the aim of this study is to determine the in vitro antibiotic susceptibility patterns of conjunctival bacterial flora isolated preoperatively from patients undergoing refractive surgery at an outpatient laser surgery clinic. preoperative conjunctival swab samples are directly inoculated in culture media at the bedside before topical anesthetic or antibiotic application. blood agar, chocolate agar, thioglycolate broth, sabouraud dextrose agar, and ogawa media are used for bacterial, fungal and mycobacterial cultures. minimum inhibitory concentrations (mics) of ofloxacin (ofx), levofloxacin (lev), gatifloxacin (gat), moxifloxacin (mox), gemifloxacin (gem) and other commonly used antibiotics are determined using an e-test.

Eligibility criteria:
inclusion criteria: * myopia patients scheduled for refractive surgery exclusion criteria: * active keratitis * current treatment of antibiotics (systemic or topical)

Keywords: antibiotic susceptibility bacterial flora fluoroquinolone lasik refractive surgery
laparoscopic sleeve gastrectomy vs laparoscopic roux-en-y gastric bypass

Conditions: Laparoscopic Surgery

Summary: this is a retrospective work on 200 morbid obese patients randomized and categorized into 2 groups according to the treatment method: the laparoscopic sleeve gastrectomy (lsg) and lrygb groups, within the period from 2014 to 2019 and matched weight dissipation, complications, life quality, and negative events


Eligibility criteria:
inclusion criteria: * all patients of (body mass index) more than 40, with at least 1 comorbidity exclusion criteria: * all patients of (body mass index) less than 40, * no comorbidities * patients who refused the surgical procedures.
albanian versions and validation of visual analogue scale, back pain and autonomy questionnaires

Conditions: Back Pain; Pain, Acute; Disability Physical

Summary: a total of 200 participants are predicted to be enrolled for completing questionnaires in relation of visual analogue scale, back pain disability and autonomy in albania. a feasibility, validate, test-retest reliability and observational design is estimated.

this study consist of two parts, firstly translation and cross-cultural adaptation of pain and automaton questionnaires into albanian language and secondly psychometric evaluation of the questionnaires including test-retest reliability in albanian health care centers/ hospitals .

Eligibility criteria:
inclusion criteria: * back pain * orthopedic problems * albanian citizens * rehabilitation center patients exclusion criteria: * neurological patients * no native albanian language