Kornimate/medical-research-clean huggingface dataset:
a study of the efficacy and safety of dulaglutide (ly2189265) in participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus (t2dm) for at least 6 months * have been treated with stable metformin dose for at least 3 months * have hba1c ≥7.5% and ≤11.0% at study entry * have body mass index (bmi) ≥25 kilograms per meter squared (kg/m\^2) exclusion criteria: * have type 1 diabetes mellitus * have used any glucagon-like peptide-1 receptor agonist (glp-1 ra) or insulin, not including prior short term insulin use (≤14 days) * have been taking any other medicine for diabetes (other than metformin) during the last 3 months * have used in the last 3 months (or plan to use) prescription weight loss medications * have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss * current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes) * have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (nafld), or alanine transaminase (alt) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with nafld are eligible for participation in this trial * had chronic or acute pancreatitis any time prior to study entry * have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity * estimated glomerular filtration rate (egfr) \<30 milliliters/minute/1.73m\^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the chronic kidney disease-epidemiology (ckd-epi) equation, as determined by the central laboratory at study entry and confirmed at lead-in * have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2 * have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
semi-up right position study

Conditions: Obstructive Sleep Apnea

Summary: our main objective is to perform an explanatory, first stage proof of concept, randomized controlled trial to determine whether a semi-upright patient position versus a supine position while asleep in the postoperative period helps decrease the worsening of ahi in patients diagnosed with osa and compare this to usual care (i.e. supine patient positioning while asleep). the investigators will evaluate whether a semi-upright position reduces: worsening of ahi (as measured with a portable psg) on the second postoperative night (pod2); oxygen desaturation index (using a portable oxygen saturation monitor, oxygen desaturation defined as \>4% change below baseline lasting for 10 seconds); rem sleep related change in ahi at baseline and pod2.; major and minor perioperative complications on postoperative day pod1, pod2, at discharge and pod 30.; length of hospital stay and readmission within 30 days; and patient satisfaction score on pod30

the proposed study is to determine whether patient positioning in supine or semi-sitting position can effectively control the worsening of osa see in the postoperative period. the study patient will be randomized to semi-sitting position (45 degrees incline) group or supine (0 degrees incline) group. patients will undergo a portable sleep study on the first or second postoperative night. they will also be monitored with wristwatch oximeter pre and postoperatively according to the study protocol. patients will be managed according to the routine care determined by the health care team. there will be no change in the clinical management of patients.

Eligibility criteria:
inclusion criteria: * adult patients (18 years and above), * asa physical status i to iv, * undergoing elective inpatient surgery with obstructive sleep apnea (as determined by initial screening using stop-bang questionnaire and if at high risk (\>3 points), * confirmed by an apnea-hypopnea index (ahi) \>5 using a diagnostic home portable polysomnography) exclusion criteria: * patients previously diagnosed as osa and on continuous positive airway pressure (cpap) device; * known cervical, shoulder, spine abnormalities, and/or chronic pain predisposing to difficulty in maintaining a sitting position; or * previous intervention for osa (e.g., uvulopalatopharyngoplasty, bariatric surgery); where sitting position is contraindicated postoperatively such as hip or spine surgery, hemodynamic instability; ambulatory surgery i.e. planned discharge on the same day of surgery.
protective effect of pcsk9 inhibitor against negative inflammatory response and organ dysfunction after coronary artery bypass grafting (panda viii)

Conditions: Myocardial Ischaemic Syndrome; Coronary Heart Disease

Summary: this is a multi-center, randomized controlled study to investigate whether early offering pcsk9 inhibitor can protect against negative inflammatory response and organ dysfunction after coronary artery bypass grafting (cabg). subjects with myocardial ischaemic syndromes (mis) will be enrolled in this study after consent information. after randomization, the control group will receive standard therapy, while the experiment group will receive first pcsk9 inhibitor before cabg, then twice a month until 3 months later. six month after cabg, crp will be used to evaluate inflammation, and echocardiography and coronary cta will be used to evaluate cardiovascular function.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * patients with myocardial ischemic syndromes (with any of the following): * patients are ready to undergo coronary artery bypass grafting (cabg) with 1 month; * participate voluntarily and sign an informed consent exclusion criteria: i. pregnant and lactating women ii. during the study period and within 3 months of receiving the last dose of the study drug, women with fertility intentions and men unwilling to use effective contraceptive methods iii. have used pcsk9 inhibitors within 3 months before enrollment, or have a history of severe allergic reactions to pcsk9 inhibitors iv. severe infections requiring intravenous antibiotics v. hiv-positive or history of acquired immunodeficiency syndrome (aids) vi. with cognitive impairment or psychiatric illnesses

Keywords: inflammation cabg
diuretic effect of metolazone pre-dosing versus concurrent dosing

Conditions: Fluid Overload; Heart Failure Acute

Summary: the purpose of this study is to examine whether administering metolazone 60 minutes prior to furosemide increases urine output compared with administering metolazone and furosemide concomitantly. participants will have equal chance of being assigned to each group.

diuretic resistance is common among patients with acute decompensated heart failure, and one strategy for overcoming this phenomenon is sequential nephron blockade with loop plus thiazide-type diuretics. metolazone is an oral thiazide-type diuretic commonly used for this purpose. due to its delayed absorption, some clinicians suggest that metolazone be given 30-60 minutes prior to the loop diuretic. however, the efficacy and safety of such a strategy has not been investigated despite its added complexity. the purpose of this study is to investigate whether pre-dosing with metolazone confers a difference in efficacy and safety compared to administering it at the same time as furosemide.

Eligibility criteria:
inclusion criteria: * admission within 48 hours for acute decompensated heart failure with at least one symptom and one sign of volume overload * receipt of loop diuretic prior to admission * plan to administer furosemide 120 - 160 mg iv bolus twice daily over the next 24 hours with additional diuresis deemed necessary * if patient is concurrently administered intravenous vasodilator or inotrope, the dose of vasodilator or inotrope must be stable for 6 hours prior to enrollment with a plan to continue the same dose for the 24 hour duration of this study exclusion criteria: * metolazone prescribed prior to admission * receipt of continuous intravenous infusion of furosemide * cirrhosis or end stage renal disease * non-english speaking patients

Keywords: diuretic metolazone furosemide
a non-interventional study of mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on dialysis

Conditions: Anemia

Summary: this multicenter observational study will evaluate the efficacy and safety of mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on dialysis in routine clinical practice. eligible patients treated with mircera for chronic renal anemia according to the standard of care and in line with the current local label will be followed for 6 months.


Eligibility criteria:
inclusion criteria: * adult patients, 18 to 65 years of age inclusive * patients with chronic kidney disease stage iii-iv not on dialysis * hb \< 10 g/dl (for correction of anemia) or hb 10-12 g/dl and receiving any other esa (for maintenance of hb levels) * adequate iron status as judged by the treating physician exclusion criteria: * hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication * significant acute or chronic bleeding * hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) * active malignant disease during the last five years (except non-melanoma skin cancer) * uncontrolled or symptomatic secondary hyperparathyroidism * epileptic seizure during the last 6 months * poorly controlled hypertension (sitting blood pressure \> 170/100 mmhg) * myocardial infarction or stroke, or severe or unstable cad * severe liver disease during the previous 6 months * congestive heart failure nyha class iii-iv * diagnosis or suspicion of pure red cell aplasia (prca) * planned elective surgery during the study period (except cataract surgery and vascular access surgery) * transfusion of red blood cells during the previous 2 months * pregnant women * any contra-indications to mircera
accuracy of a rapid diagnostic test for cutaneous leishmaniasis in morocco

Conditions: Cutaneous Leishmaniasis; Skin Diseases, Parasitic; Neglected Diseases

Summary: the aim of this study is to estimate the accuracy of cl detect rapid test™ compared to a composite reference standard test (direct examination of skin smears + pcr test) in patients with clinically suspected cutaneous leishmaniasis disease in morocco.

study participants are recruited in nine health centers located in fourthree cl endemic provinces. the rdt under evaluation (index test) is the cl detect™ rapid test (inbios, usa); a membrane-based amastigote antigen (peroxidoxin) detection test. the reference standard consists of two tests: direct examination of skin smears and pcr. for each patient, the health professional takes one dental broach sample and four skin smear samples from a single lesion. the dental broach sample is used for the rdt, which is done once. the skin smear samples are sent to provincial laboratories for microscopy testing and to reference laboratories in morocco and belgium for pcr testing by its1 pcr, hsp70 genotyping and parasite load determination. readers of index and reference tests do not have access to clinical information or any other test results. the results of the test under evaluation (rdt) and the molecular tests (pcr) are not communicated to the patient or her/his physician, as case management has to follow current clinical guidelines.

Eligibility criteria:
inclusion criteria: * participants with suspected cutaneous leishmaniasis wound(s) in apparently healthy state * who is able to learn the information sheet and sign the informed consent form by them selves or by their parents with the presence or not of a witness (for illiterate people) * who satisfy the following criteria : * with an ulcerative lesion in any accessible part of the body to perform the dental broach and the scraping. * just one ulcerative lesion by patient could be selected (the newest and the less infected) * lesion should be less than 04 months of age exclusion criteria: * patients with only nodular, papular, macular or nodulo-papular suspected cl forms * patients with ulcerative lesions with a suspected bacteria origin which could disappear after a short course of antibiotic treatment. * patients who already received during the last two months, prior to signing the consent, a physical treatment (e.g. cryotherapy, thermotherapy, laser) or a traditional treatment (e.g. burn, acide, traditional scraping) * patients presenting other disease with the need to take anti-parasite treatments * patient with a acute or chronic disease needing hospitalization * patient who already received antimoniate treatment incomplete or complete duration and dose against cl * any situation that could engage the security of the patient or of the health professional (e.g. people with a psychiatric trouble or a mental handicap ) * for children less than 12 years old, the decision of participation is mainly based on the condition that their parents are able to learn and understand the information sheet and sign the informed consent form
the brain health study: a pragmatic, patient-centered trial

Conditions: Dementia; Alzheimer Disease

Summary: the eradar brain health study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.

eradar stands for "electronic health record (ehr) risk of alzheimer's and dementia assessment rule." it is a low-cost tool or algorithm that uses readily available ehr data elements to identify high-risk patients. we will conduct a pragmatic randomized controlled trial to assess the impact of implementing eradar as part of a supported outreach process on dementia detection rates. we will also explore the impact of eradar implementation on healthcare utilization and patient experience.

Eligibility criteria:
inclusion criteria: * no prior diagnosis of dementia (defined from ehr diagnosis codes) and not receiving medications for dementia * active patient at participating clinic * adequate data to calculate eradar score exclusion criteria: - currently receiving hospice care
randomized study of a hospice video educational tool for patients with advanced cancer and their caregivers

Conditions: Advanced Cancer

Summary: the purpose of this research study is to compare two ways to educate patients with cancer and their caregivers about hospice care services

the purpose of this research study is to compare two ways to educate patients with cancer and their caregivers about hospice care services - a video educational tool or a verbal narrative. the study will assess the effect of these methods on patients' and caregivers' knowledge about hospice care, as well as their perceptions and preferences for this service. using this research, the investigators hope to find out the best way to help patients and their loved ones better understand hospice care. the educational methods used in this study (the video educational tool or verbal narrative) are meant to serve as an introduction to hospice care. further details about hospice should be discussed directly with your care team. this study will enroll 150 patients with advanced cancer and up to 150 of their caregivers in this randomized clinical trial. the study will use questionnaires to measure the participant and the caregivers' knowledge of hospice care, as well as your perceptions and preferences for these services. study assessments will be completed before and after watching the video or hearing the verbal narrative in the hospital.

Eligibility criteria:
inclusion criteria: patients eligibility criteria: * adult patients (≥18 years) with a diagnosis of metastatic solid cancer. * a prognosis of 12 months or less based on the treating oncologist's assessment. * the ability to provide informed consent. * ability to comprehend and speak english. caregivers eligibility criteria: * adult caregivers (\>18 years) of patients who have agreed to participate in study. * a relative or a friend upon whom the patient relies for help and who will be likely to be present during hospitalization, or willing to participate by phone. * ability to comprehend and speak english. exclusion criteria: patients exclusion criteria: -significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures

Keywords: advanced cancer
person centered nurse led atrial fibrillation care

Conditions: Atrial Fibrillation

Summary: the aim of the study is to evaluate the effect of a person-centred nurse-led outpatient clinic on health related quality of life, for persons with af. secondary outcomes are effects on anxiety, depression, illness perception, symtom burden, life style and health economics.

the aim of the study is to evaluate the effect of a person-centred nurse-led outpatient clinic on health related quality of life, for persons with af. secondary outcomes are effects on anxiety, depression, illness perception, symtom burden, life style and health economics. we plan a randomized controlled trial comparing person centred nurse led care vs. standard care. a sample size of 100 persons per group will be recruited. data will be collected through questionnaires, medical records, interviews.

Eligibility criteria:
inclusion criteria: * patients aged \> 18 years with diagnosis of atrial fibrillation, referred for follow up after atrial fibrillation, able to provide informed consent and able and willing to fill in questionnaires. exclusion criteria: * atrial flutter diagnosis, severe heart failure (corresponding to nyha iiib and nyha iv), cardiac surgery \< 3 month prior to hospitalization for atrial fibrillation, planned surgical procedures (catheter ablation, cardiac surgery), atrial fibrillation in connection with acute coronary syndrome or infection, not able to fill in questionnaires.

Keywords: atrial fibrillation person centred care health related quality of life nurse led
cognition in the study of tamoxifen and raloxifene

Conditions: Cognition; Aging

Summary: the purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women.

recent reports indicate that hormone therapy (ht) may have a protective effect on the aging brain. although previous studies have examined the effects of ht on age-related cognitive changes, there is little information on the effect of a new class of estrogenic agents, selective estrogen receptor modulators (serms), on cognitive aging. the two most commonly prescribed serms are tamoxifen, for treatment and prevention of breast cancer, and raloxifene, for maintaining bone density. in the face of potential widespread use of serms in healthy women, information on the effects of these agents on memory and other cognitive functions is essential. the principal goals of co-star are to compare the effects of tamoxifen and raloxifene * on age-associated declines in measures of verbal and nonverbal memory in women over age 65 * other cognitive abilities and mood * with those resulting from more common forms of ht, specifically et (conjugated equine estrogen) and et plus progesterone co-star results will be compared to results from the women's health initiative study of cognitive aging (whisca), a study involving 6-year longitudinal assessment of cognitive outcomes in 2969 women randomly assigned to receive active treatment (premarin or premarin plus medroxyprogesterone acetate) or placebo. a comparison of the co-star treatment groups with the group of whisca participants receiving placebo will provide insights into the effects of serms relative to no treatment. a comparison of the co-star treatment groups with whisca treatment groups receiving et or et plus progesterone will provide insights into the effects of serms relative to common ht treatments. co-star participants will be recruited from the national cancer institute's (nci) study of tamoxifen and raloxifene (star) nct00003906, a multi-center, 5-year, randomized clinical trial among 22,000 women at increased risk for breast cancer, to compare the effects of tamoxifen and raloxifene on risk for breast cancer.

Eligibility criteria:
inclusion criteria: * women enrolled in star trial at a site participating in co-star * 65 years of age or older * have been randomized into star but have not started taking the study drug or enrolled in star for a minimum of one year * have not been diagnosed with dementia * have signed a separate consent document for the co-star study * previous diagnoses of chronic neurologic disease (parkinson's disease, stroke, epilepsy, multiple sclerosis), history of head injury, depression, alcohol addiction, drug addiction, and other neurologic or psychiatric conditions will be recorded but will not serve as exclusion factors for this study exclusion criteria: * not enrolled in the star trial * younger than 65 years of age * diagnosed with dementia

Keywords: breast cancer tamoxifen raloxifene hormone therapy
effectiveness of oral quinine and artemether-lumefantrine in the treatment of uncomplicated malaria in ugandan children

Conditions: Uncomplicated Malaria

Summary: we will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether lumefantrine in the treatment of uncomplicated malaria in children.

this study will be designed as an open randomized effectiveness study assessing the parasitological and clinical cure rates and adherence to oral quinine monotherapy in comparison to artemether-lumefantrine. we will also describe some of the adverse events to the two drugs.the measurements will include age, sex, weight, hemoglobin levels on days 0, 7, 14 and 28, parasite density on days 0, 7, 14 and 28 and clinical examination findings. adverse events will also be documented

Eligibility criteria:
inclusion criteria: 1. aged between 6 and 59 months of age seen at the assessment centre during the study period 2. with fever defined as axillary temperature ≥37.5 °c or history of fever in the past 24 h 3. with a microscopically confirmed monoinfection of plasmodium falciparum 4. able to tolerate oral therapy, 5. whose parents/guardians have provided written informed consent. exclusion criteria: 1. children with a history of allergy to quinine, artemether-lumefantrine or milk. 2. evidence of severe malaria. 3. residence at more than 20km from the health clinic. 4. evidence of a significant concomitant febrile illness that would require hospitalization or chronic medical illness

Keywords: effectiveness oral quinine coartem uncomplicated malaria children
effects of various modalities water immersion on veins

Conditions: Hydrotherapy

Summary: objectives in this study the investigators examined the changes in common femoral vein (cfv) and great saphenous vein (gsv) calibre during thermo neutral water immersion (tni), cold water immersion (cwi) and contrast water therapy (cwt). design ten professional handball players visited the laboratory on three occasions. at each visit, participants completed a 20-minutes procedure in an upright position: 4-minutes in air (baseline) and then 16-minutes lower limbs tni (\~35°c), cwi (\~12°c) or cwt (2:2minutes (\~12°c to \~35°c) ratio), selected randomly. methods cfv and gvs calibres were evaluated by echo doppler measures at baseline and at the end of 16 min immersion.


Eligibility criteria:
inclusion criteria: * free healthy voluntary exclusion criteria: * hypersensitivity to cold

Keywords: femoral vein saphenous vein hydrostatic pressure temperature recovery