Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of a natural health product in reducing cholesterol and triglyceride levels.

Conditions: LDL Cholesterol; Triglycerides

Summary: the purpose of this study is to assess the safety and efficacy of a natural health product among participants with elevated ldl cholesterol and triglyceride levels.

cardiovascular disease \[cvd\] is one of the primary causes of illness, disability and death in canada and in the united states. hypercholesterolemia and hypertriglyceridemia are significant risk factors for the development of cardiovascular disease. the investigational product used in this trial, has been specially formulated to help reduce elevated triglycerides and ldl cholesterol levels, and may provide a natural alternative in the prevention of cvd. this study is a prospective, 12 week study, where participants will be randomized to receive the treatment, placebo, or a comparator product for a period of 12 weeks. blood lipids will be analysed at baseline, week 6 and week 12.

Eligibility criteria:
inclusion criteria: * adults aged 30 - 70 years. * 10-year cad risk \<10% * elevated blood ldl cholesterol in the range of 3.0 to 5.0 mmol/l \[equivalent to 117-195 mg/dl\]. * have elevated tg levels \[1.5/l - 4.0mmol/l, or 134 mg/dl - 356 mg/dl\]. exclusion criteria: * adults aged less than 30, or more than 70 years of age * adults with a 10-year cad risk \>10% * individuals with a pre-existing disease or illness including: heart disease, diabetes, renal disease or cancer * individuals taking cyp3a4 inhibitors \[including cyclosporine and danazol\]. * individuals taking statin medications, including: atorvastatin \[brand names: lipitor®, caduet®\] * fluvastatin \[brand names: lescol®, lescol® xl\] * lovastatin \[brand names: advicor ®, altocor ®, altoprev ®, mevacor ®\] * pravastatin \[brand names: pravachol® , pravigard® pac\] * rosuvastatin \[brand name: crestor®\] * simvastatin \[brand names: vytorin®, zocor ®\] * individuals with an allergy to fish and/or fish oil, vitamin e, red yeast rice, coenzyme q10, soybean oil or any other ingredient in the investigational product \[i.e. capsule constituents\] * individuals who anticipate, or have planned surgery during the course of the trial * individuals who are taking any other natural health products, particularly those containing vitamin k, high levels of vitamin e or coenzyme q10 \[individuals on a 4-week wash-out of nhps will be permitted\] * individuals who have consumed fish oil or another type of omega-3 fatty acid supplement one-month prior-to and/or during the course of the study * women who are pregnant or breastfeeding * individuals with a history of migraines * individuals taking blood thinning, or blood pressure medications * individuals who have been diagnosed with statin-induced muscle damage (myopathy)

Keywords: hypercholesterolemia hypertriglyceridemia fish oil red yeast rice
outcomes of colonoscopy with non-anesthesiologist administered propofol

Conditions: Colo-rectal Cancer; Colon Adenoma; ADR

Summary: the efficacy and safety of non-anesthesiologist administered propofol (naap) for gastrointestinal endoscopy have been widely documented although there is not information which has evaluated the outcomes of colonoscopy it self when the endoscopist has to fulfill the additional task of supervising the sedation. objective: to determine the equivalence of adenoma detection rate (adr) in colorectal cancer (crc) screening colonoscopies performed with naap and performed with monitored anesthesia care (mac). method: single blind non-randomized controlled equivalence trial. patients: adults between 50 - 69 years old from national crc screening program (crcsp). intervention: the patients are blindly assigned to undergo either colonoscopy with naap or mac according to the arrival of fecal occult blood test, patient's suitability for colonoscopy date and availability of places at endoscopy schedule (with naap or mac).


Eligibility criteria:
inclusion criteria: healthy patients - exclusion criteria: patients with familial colorectal cancer history -

Keywords: adr with non-anesthesiologist administered propofol (naap)
demonstration of near zero antibiotic prescribing for acute bronchitis

Conditions: Bronchitis; Cough

Summary: studies show, guidelines state, and performance measures assert that antibiotic prescribing for uncomplicated acute bronchitis is inappropriate. however, clinicians prescribe antimicrobials in over 60% of the 22.5 million acute bronchitis visits in the united states each year. previous successful interventions have only reduced the antimicrobial prescribing rate to 40% or 50%. it is unknown if the antimicrobial prescribing rate for acute bronchitis can be brought to near zero percent in actual practice while maintaining patient safety and satisfaction. the goal of this study is to develop an electronic health record (ehr)-integrated algorithm for the diagnosis and treatment of adults with acute bronchitis with a goal of reducing the antibiotic prescribing rate to near zero percent.

we will use a multi-modal implementation - including computerized decision support, reporting tools, and clinician feedback - and quality improvement techniques to ensure adherence to the algorithm and reduce the antimicrobial prescribing rate to near zero percent. the duration of the intervention will be 4 years.

Eligibility criteria:
inclusion criteria: * first visit in 30 days, age 18-64, has a cough of less than 3 weeks duration exclusion criteria: * infiltrate on chest x-ray, has chronic lung disease

Keywords: antibiotic antimicrobial prescribing cough acute bronchitis
atrial fibrillation (af) and electrocardiogram (ekg) interpretation project echo

Conditions: Atrial Fibrillation

Summary: the goal of this study is to determine the effectiveness of a direct-to-provider virtual education program ("af and ekg interpretation project echo") for primary care providers who manage patients with atrial fibrillation (af). the main questions this study aims to answer are: 1. will participants have improvement in knowledge and confidence in managing patients with atrial fibrillation after program completion? 2. will quality and performance metrics improve at the patient level for program participants? participants will be asked to: * participate in 12 hours of virtual education sessions over twelve weeks via zoom. * complete a knowledge and confidence assessment online before the program starts and after its completion.


Eligibility criteria:
inclusion criteria: * primary care provider (physician, nurse practitioner, physician assistant) with primary practice in the state of north carolina * care for adult population exclusion criteria: * none

Keywords: atrial fibrillation
intravenous ancrod for the treatment of acute ischemic stroke within 6 hours after onset of symptoms

Conditions: Brain Infarction; Cerebral Ischemia; Acute Stroke

Summary: treatment of acute stroke is still difficult and the only specific drug approved (rtpa) can only be administered if treatment starts within 3 hours after onset of symptoms. this results in a still too small number of patients treated with rtpa ( \< 15% in best clinical care institutions ). ancrod is a differently acting biological drug which has been used for a long time but not for acute stroke treatment. stat was the first rct of medium size to show a significant benefit/risk ration if treatment starts within 3 hours. estat was designed closely related to stat but with a longer 6 hours window and specifically extended inclusion/exclusion criteria to avoid secondary complications possibly related to a longer time window.


Eligibility criteria:
inclusion criteria: * 18 years and above, both sexes * acute ischemic stroke with first symptoms within 6 hours of beginning * treatment after onset of symptoms * sss \< 40 at baseline ( consciousness necessary ) exclusion criteria: * clinical or ct evidence of brain hemorrhage or hemorrhagic transformation * ct evidence of major signs of developing infarction * coma * prior strokes within 6 weeks * severe hypertension (\> 220 systolic \> 120 mm hg diastolic) * baseline fibrinogen \< 100 mg/dl * recent use of thrombolytic agents * recent or anticipated surgery

Keywords: stroke vascular diseases
laparoscopic associating liver partition with portal vein ligation for staged hepatectomy (alpps) for colorectal liver metastases (crlm)

Conditions: Colorectal Liver Metastases

Summary: associating liver partition and portal vein ligation for staged hepatectomy (alpps) is a procedure used for patients with initially unresectable colorectal liver metastases (crlm). however, the procedure has been reported to be associated with high morbidity and mortality. laparoscopic alpps has recently been reported as a minimally invasive technique that reduces perioperative risks. this study aimed to assess the safety and feasibility of full laparoscopic alpps in patients with crlm.


Eligibility criteria:
inclusion criteria: 1. male or female subjects \> 18 years \< 75 of age. 2. ecog performance status 0-1. 3. histologically confirmed colorectal adenocarcinoma. 4. imaging (ct or mri) or pathological confirmation of liver metastasis. 5. child-pugh grade a liver function. 6. flr/stlv (standardized total liver volume) \< 30% (patients without underlying liver diseases)or \< 40% (patients with liver diseases, such as hepatic steatosis, cirrhosis, or liver damage after chemotherapy). 7. the indication of surgery is evaluated by a multidisciplinary team attended by hepatobiliary surgeons, oncologists, hepatologists and radiologists. exclusion criteria: 1. patients with unresectable extrahepatic metastatic disease (except potentially resectable lung metastases) or primary tumor. 2. patients with severe concomitant diseases who are intolerance of major liver surgery by the judgment of the surgeon. 3. diagnosis of other malignant tumors within the past 5 years. 4. intention to become pregnant during the course of the study. 5. inability to comply with the study protocol. 6. previous enrollment in the current study.

Keywords: colorectal liver metastases associating liver partition and portal vein ligation for staged hepatectomy laparoscopic surgery
cost-effectiveness, volar locking plate or non-operative treatment distal radius fracture

Conditions: Radius Fractures; Aged; Cost-Benefit Analysis; Wrist Fracture; Quality of Life; Wrist Injuries; Postoperative Complications; Health Care Utilization

Summary: a cost-utility analysis based on an earlier published rct comparing surgery with volar locking plate to non-operative treatment for the elderly with a displaced distal radius fracture.

study design: a cost-utility analysis of a patient population included in a previous published randomized controlled trial. patient population:140 patients 70 years of age or older with a displaced distal radius fracture that met the inclusion and no exclusion criteria at danderyd hospital or södersjukhuset hospital were randomized to volar locking plate or non-operative treatment with a cast. primary outcome: incremental cost-effectiveness ratio (icer) at 1 and 3 years. data collection: prospectively collected clinical data is available for 4, 12, weeks, 1 and 3 years. costs will be analysed regarding surgical equipment, inpatient stay, surgical time. prescriptions of analgesics and antibiotics as well as inpatient and outpatient consumption over a three years period after the injury will be retrieved from the swedish national board of health and welfare.the life expectancy adjusted life years (qalys) is calculated from prospectively collected results from eq-5d.

Eligibility criteria:
inclusion criteria * patient \>70 years * wrist radiograph \>20° dorsal tilt and/or +/-4 mm axial shortening exclusion criteria * former disability of either wrist * intra-articular fractures with a step-off of \>1 mm or a gap of \> 1 mm (at sodersjukhuset hospital) * high-energy trauma (sodersjukhuset hospital) * associated ulnar fracture * injury to ipsilateral upper extremity * rheumatoid arthritis or other severe joint disorders * dementia or pfeiffer score of \<5 at sodersjukhuset hospital and \<8 at danderyd hospital * drug or alcohol abuse or psychiatric disorder * dependency in activities of daily living * patient not a resident within the catchment area of the 2 centers * fracture diagnosed \>3 days from injury at sodersjukhuset hospital and \>6 days at danderyd hospital * patient not fit for surgery or american society of anesthesiologists class 4
an open-label, multinational, multicenter, follow-up study to evaluate the long-term safety and efficacy of brivaracetam

Conditions: Epilepsy

Summary: the sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. this study permits continued access to treatment for subjects who participated in a previous epilepsy study. the study will explore the long-term safety and efficacy of brivaracetam.


Eligibility criteria:
inclusion criteria: * subjects with epilepsy who participated in previous brivaracetam trials which allow access to the present trial. * subjects from whom the investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected. exclusion criteria: • severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.

Keywords: epilepsy monotherapy partial onset seizures
metformin in intrahepatic cholestasis of pregnancy

Conditions: Intrahepatic Cholestases; Pregnancy Complications

Summary: this is a pilot study aimed at comparing the effect of metformin versus ursodeoxycholic acid in women with intrahepatic cholestasis in pregnancy. the study will be conducted in three nhs hospital sites, over an 18 month period.

intrahepatic cholestasis is a condition that affects pregnant women. it is characterised by itching, usually in the third trimester of pregnancy and is associated with an increase in the liver enzymes and bile salts. this can be associated with maternal and neonatal morbidity, and rarely perinatal mortality. the investigators propose to assess and compare the effect of metformin versus ursodeoxycholic acid on lowering liver enzymes and bile salts, improving maternal morbidity and improving neonatal outcomes. this study is a pilot study that will be conducted at 3 nhs hospital sites where patients will randomly assigned to receive either metformin or ursodeoxycholic acid. there will be 20 patient in each arm. recruitment will commence in february 2017 and will run for an 18 month period.

Eligibility criteria:
inclusion criteria: 1. 20+0 to 40 weeks' gestation on day of randomisation 2. itching with a raised serum bile acid above the upper limit of normal 3. normal anomaly scan at 20 weeks 4. aged 18 years or over 5. able to give written informed consent 6. no known pre-existing liver disease exclusion criteria: 1. decision already made for delivery within the next 48 hours 2. known allergy to any component of the ursodeoxycholic acid or metformin tablets 3. patients already on metformin for other conditions

Keywords: metformin ursodeoxycholic acid outcomes
prospective cohort with hemopathy in languedoc-roussillon

Conditions: Hematologic Malignancy

Summary: prospective cohort study of clinical and laboratory data of patients with hemopathy.

prospective cohort study of clinical and laboratory data of patients with hemopathy in lr.

Eligibility criteria:
inclusion criteria: * age over 18 * consultant or hospitalized patient for suspected malignant hemopathy and justifying further exploration or patient with a diagnosis of malignant hemopathy less than 6 months old at the time of signing the consent * having signed an informed consent * affiliated with a social security scheme exclusion criteria: * minor or major protected * patients who have received treatment for hematological pathology

Keywords: lymphoma, leukemia, multiple myeloma, hodgkin disease
melatonin levels in smith magenis syndrome (sms)

Conditions: Chromosome Disorders

Summary: the goal of this pilot project is to determine whether melatonin levels are disordered in patients with smith-magenis syndrome (sms) and whether melatonin treatment can correct abnormal circadian rhythms in sms patients. in addition, the study investigates the effects of bright light in an elderly control population that exhibits low melatonin secretion.

participation involves 5 stages for sms patients. first, subjects will complete 4 sessions of 25-hour salivary or plasma sampling, with the last sampling occurring in front of a bright light box. second, subjects will enroll in the melatonin treatment phase, involving a daily dose (up to 3 mg) for up to one year, with frequent (every 2-4 weeks) of 25-hour salivary or plasma sampling. during this stage, the subject and/or caregiver may also be asked to wear an activity wrist monitor, complete a daily sleep diary and behavioral questionnaires. third, the subject may be asked to complete up to 3 25-hour sampling periods and take a melatonin pill on the same day to test how their body metabolizes the hormone, melatonin. the fourth stage is for subjects who are found to have an abnormal body rhythm. subjects will complete a 25-hour plasma sampling period under bedrest to test for a hormone, cortisol. the fifth stage is an optional 12-hour sleep analysis (polysomnography) to test for sleep disorders. control participants will complete an abbreviated protocol of the 3 baseline 25-hour sampling periods and 1 involving bright light exposure.

Eligibility criteria:
inclusion criteria: * control participants: * 30 individuals: ages 55-85, * healthy without significant active medical problems. * sms patients: * 20 individuals: ages 3-50, * with a clinical diagnosis of smith-magenis syndrome by a qualified medical geneticist, confirmed by cytogenetic analysis documenting deletion of chromosome band 17p11.2. exclusion criteria: * control participants: * a current axis i psychiatric or substance abuse disorder according to the dsm-iv manual, abnormal heart, liver or kidney function, diagnoses of neurodegenerative or cerebrovascular disease (alzheimer's disease, parkinson's disease, stroke, etc.), * cognitive impairment (mini-mental state score \< 23) but without a formal diagnosis of dementia, * active symptoms of depression (geriatric depression scale: 30 pt. version \> 10), * current diagnosis of cataracts, * macular degeneration or retinopathy based on eye exam by an optometrist or ophthalmologist within the past year.

Keywords: smith-magenis syndrome melatonin circadian rhythm sleep
carotid and vertebral magnetic resonance angiography (mra) study comparing dotarem and time of flight (tof)

Conditions: Cerebral Arterial Diseases

Summary: the study will evaluate the efficacy and safety of dotarem enhanced mra in patients suffering from carotid or vertebral arterial disease.

each subject will undergo a time of flight (tof) magnetic resonance angiography (mra) followed by a dotarem enhanced mra

Eligibility criteria:
inclusion criteria: * male or female, aged more than 18 years * strongly suspected of having carotid or vertebral arterial disease * scheduled (or to be scheduled) to undergo computed tomography angiography (cta) examination exclusion criteria: * known grade iv or v chronic kidney disease (gfr\<30 ml/min/1.73m²) * contraindication to mri * acute renal dysfunction within the 6 months preceding dotarem®-enhanced mra examination

Keywords: carotid or vertebral artery disease contrast agent mra
health information technology in heart failure care

Conditions: Heart Failure

Summary: the objective of this proposal is to develop, implement, and test the effectiveness of a computerized clinical decision support system for hospitalized patients with heart failure. aim 1: develop an electronic health record (ehr) based search method that uses both structured data and natural language processing of unstructured text to identify hospitalized patients with heart failure while they are still in the hospital. aim 2: develop and test the usability of an electronic health record (ehr) based clinical decision support system (cdss) to support delivery of evidence-based care to hospitalized heart failure patients using human computer interaction methods. aim 3: assess the effect of an electronic health record (ehr) based clinical decision support system (cdss) on processes of care for heart failure patients who are hospitalized for other causes. as part of the evaluation, we will test two implementation strategies, one of which will introduce the cdss as an interruptive alert to providers, the second of which will introduce the cdss as part of a provider checklist that exists on the side of the screen for each patient.


Eligibility criteria:
inclusion criteria: * patients hospitalized 2 years prior and 18 months after the time of implementation of the computerized clinical decision support systems (cdss) in the (electronic health record (ehr). exclusion criteria: * patients on the obstetrical service, who died during hospitalization, or on hospice care.
a comparison of tracheal intubation using the totaltrack vs the macintosh laryngoscope in obese patients

Conditions: Endotracheal Intubation; Obesity; Desaturation; Ventilation

Summary: airway management in obese patients has to consider that mask ventilation (dmv) risk is increased and difficult tracheal intubation (dti) risk may be increased too. in obese patients, is essential to prevent early arterial oxygen desaturation related to a reduced functional residual capacity (frc), atelectasis formation during anesthetic induction and after tracheal intubation, because oxygenation maintenance is the cornerstone of the airway management of the obese patient. endotracheal intubation is usually required to allow unrestricted surgical approach. the macintosh laryngoscope is the standard method. however, sometimes this technique is ineffective and poorly tolerated by the obese patient. the totaltrack™ (medcomflow s.a., barcelona, spain) is a hybrid device, between a supraglottic airway and a videolaryngoscope with an anatomically shaped blade. it allows fibreoptic visualization of the larynx for tracheal intubation and was developed to aid both ventilation and tracheal intubation, at the time of anticipated and unanticipated difficult airway management. however, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy in obese patients.


Eligibility criteria:
inclusion criteria: * bmi \> 30. * asa 1-3 * scheduled surgeries that require orotracheal intubation. * general anesthesia with neuromuscular relaxation before intubation. * patients who sign informed consent. exclusion criteria: * asa 4 * difficult airway already known. * alterations of airway documented, with previous tracheostomy or involve anatomical alterations. * general anesthesia that not require orotracheal intubation or neuromuscular relaxation. * symptomatic gastro-esophageal reflux. * lap-band carrier. * allergy medications to use. * urgent surgery.