Kornimate/medical-research-clean huggingface dataset:
multi-targeted cardiac risk intervention in type 2 diabetes

Conditions: Diabetes; Hypertension; Dyslipidemia

Summary: our study intends to test the efficacy of pharmacist-led group interventions on a weekly basis for 4-weeks, then on a monthly basis for 5 additional months to achieve concomitant reductions in hemoglobin a1c, lipids and blood pressure.

our project intends to study the 6-month efficacy of a pharmacist-led group intervention program that simultaneously target diabetes, hypertension and dyslipidemia. we hypothesize that pharmacist-led group interventions on a weekly basis for 4-weeks then on a monthly basis for 5 additional months may achieve concomitant reductions in hemoglobin a1c, lipids and blood pressure. we are proposing a pilot randomized controlled study to test the efficacy and feasibility of this approach.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus, * \>18 years old, * with a documented hba1c more than 7.0%, * an ldl cholesterol \>100 mg/dl and a blood pressure \>130/80 mm hg documented at least once in the medical records within the last 6 months, and * willing to comply with the study interventions will be eligible for the study. exclusion criteria: * pregnancy, * unable to attend the group sessions, * disease conditions such as psychiatric instability (acutely suicidal, psychotic) or organic brain injury that preclude them from performing diabetes self-care, * enrolled in the providence vamc's telehealth program

Keywords: group intervention pharmacotherapy behavioral modification diabetes
study on the effect of rosuvastatin treatment on the prevention of thrombosis in patients with previous thrombosis

Conditions: Venous Thrombosis; Pulmonary Embolism

Summary: this study evaluates whether treatment with rosuvastatin on top of standard anti-coagulant treatment will decrease the risk of recurrent venous thromboembolism and arterial thromboembolic events in patients with previous deep vein thrombosis or pulmonary embolism.


Eligibility criteria:
inclusion criteria: * signed informed consent. * patients with venous thromboembolism who are treated with anti-coagulant according to the current guidelines exclusion criteria: * patients in need of or already treated with lipid lowering drugs * active liver or kidney disease or dysfunction or muscle disorders * unstable medical or psychological condition that interferes with study participation * pregnant woman or woman with childbearing potential who are not willing to use contraception * history of statin-related muscular pain, or hypersensitivity to statins

Keywords: deep venous thrombosis pulmonary embolism rosuvastatin treatment
comparison of analgesic effects according to patient-controlled epidural analgesia modes in patients undergoing open gastrectomy

Conditions: Open Gastrectomy With Gastric Cancer

Summary: epidural pca (patient controlled analgesia) for post-operative pain management are effective analgesic method. it is widely used in the postoperative pain management for decades. pca pumps typically set a fixed basal infusion rate to infuse the analgesics at a constant rate per every hour (conventional mode). in contrast, the newly developed computer-integrated patient-controlled analgesia (cipca) mode increases or decreases the basal infusion rate with the use of the patient's bolus button. the cipca mode sets the basal infusion rate, the increase / decrease rate of basal rate, and the increment / decrement interval. if the patient presses the bolus button within the set time interval, the set infusion rate is increased because the analgesic is more required. if the bolus button is not pressed during the set time interval, the infusion rate is decreased. therefore, it can be said that it is an effective method to control the dose of analgesic agent more sensitively to changes in patient's needs and pain.


Eligibility criteria:
inclusion criteria: 1. elective open gastrectomy due to stomach cancer 2. asa classification ⅰ-ⅲ exclusion criteria: 1. hematologic clotting defect 2. sepsis 3. distance metastasis 4. pca drug (fentanyl, ropivacaine) allergy 5. patients who can not read the consent form or are not fluent in korean (illiterate, foreigner) 6. pregnant, lactating women
fetal ano-genital distance in 2d ultrasound.

Conditions: Urogenital Abnormalities; Prenatal Disorder; Sex Development Disorder

Summary: the purpose of this study is to determine a threshold value of fetal anogenital distance in 2d ultrasound to differentiate male fetuses from female fetuses, starting 18 weeks of gestation and until the due date. the study also evaluates the feasibility of the measure and its interobserver variability.

the anogenital distance of female newborns is shorter than that of male newborns. urogenital disorders, such as hypospadias and micro-penis, are associated with a shorter anogenital distance. anogenital distance is a good marker of fetal exposure to androgenic substances. prenatal anogenital distance ultrasound measure can help the diagnosis in case of doubt about fetal sexual phenotype or in case of urogenital disorder suspicion (hypospadias or micropenis). is the anogenital distance easy to make measure? can this procedure be reproduced? what are the threshold values to determine fetal sex at each term of pregnancy?

Eligibility criteria:
inclusion criteria: * pregnant woman * sonographic fetal follow up in brest hospital * term\>18 weeks of gestation exclusion criteria: * no datation between 11 weeks of gestation and 13 weeks of gestation and 6 days by crown-rump length measurement * minor * no consent * ultrasound performed by an operator without ultrasonography graduation

Keywords: anogenital distance prenatal sex determination androgen
the effect of vitamin d on urinary calcium excretion in kidney stone formers with high urinary calcium

Conditions: Vitamin D Deficiency; Nephrolithiasis

Summary: the investigators hypothesize that a 3 month course of vitamin d supplementation to treat 25(oh)d deficiency in stone formers with high levels of 24-hour urinary calcium will not increase urinary calcium excretion by greater than 10%.

we plan to conduct a clinic-based interventional study of 30 patients followed at brigham and women's hospital with history of nephrolithiasis, urinary calcium excretion between 200 and 400 mg/day, and 25-vitamin d deficiency (defined as serum level ≤ 25ng/ml). the intervention is oral ergocalciferol 50,000 iu per week for 8 weeks \[1\], and each participant will serve as his own control. the outcome is the change in urinary calcium excretion. the planned study duration is 3 months. we will have greater than 95% power to detect a 10% increase in 24-hour urinary calcium

Eligibility criteria:
inclusion criteria: * history of nephrolithiasis * 25(oh)d deficiency (defined as serum level ≤ 25ng/ml) within 3 months of enrollment * 24-hour urinary calcium excretion \> 199 mg/day and \< 400 mg/day (measured less than 6 months prior to study enrollment) exclusion criteria: * non-caucasian * women of child-bearing age (age \< 50) * known uric acid, cystine, or struvite stone disease * hypercalcemia (serum calcium \> 10.4 mg/dl within the past 12 months) * gross hematuria within the past 6 months * acute stone event within the past 2 months * recent stone intervention within the past 1 month * suspected or known secondary causes of hypercalciuria such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except non-melanoma skin cancer) * addition or dose change of medicines potentially affecting urinary calcium since enrollment 24-hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin d supplementation)

Keywords: vitamin d
effect of febuxostat on renal function in patients with gout and moderate to severe renal impairment

Conditions: Renal Impairment

Summary: the purpose of this study is to determine the effect of febuxostat, once daily (qd) or twice daily (bid), on renal function in gout patients with elevated serum urate levels and who have moderate to severe renal impairment.

gout is caused by high levels of uric acid in the body, and is associated with a broad range of conditions including heart disease, chronic kidney disease and high blood pressure. hyperuricemia, which is defined as an elevation in serum urate levels, develops into gout when urate crystals form in the body and settle in joints and other organs. approximately 40-60% of patients with hyperuricemia and gout have some degree of renal impairment. hyperuricemia has long been associated with renal disease, and chronic hyperuricemia as seen in gout can lead to deposition of urate crystals resulting in diminished renal function. this study will evaluate the effect of febuxostat on the renal function of patients with hyperuricemia and gout and moderate to severe renal impairment. all participants must have an average sitting blood pressure measurement less than 160 mmhg systolic and less than 95 mmhg diastolic. all participants must meet the american rheumatism association (ara) diagnostic criteria for gout (subjects with tophi were excluded). participants are expected to return to the site for approximately 10 visits.

Eligibility criteria:
inclusion criteria: * must have a serum urate greater than 7 mg/dl and a serum creatinine greater than or equal to 1.5 mg at day -21 * must have a history or presence of gout defined as having one or more of the american rheumatism association criteria for the diagnosis of gout (the criteria related to tophi have been excluded for the purpose of the study) * must have an estimated glomerular filtration rate (egfr) of 15 or greater, or less than or equal to 50 ml/min, and a serum creatinine greater than 1.5 mg/dl at screening visit day -21 exclusion criteria: * has secondary hyperuricemia (eg, due to myeloproliferative disorder, or organ transplant) * has tophaceous gout * has a history of xanthinuria * has received aspirin greater than 325 mg/day within 35 days prior to day 1/randomization visit * has known hypersensitivity or allergy to allopurinol or any component in its formulation * has known hypersensitivity to febuxostat or colchicine or any components in their formulation * has myocardial infarction or stroke within the 90 days prior to the screening visit * has alanine aminotransferase and/or aspartate aminotransferase values greater than 2.0 times the upper limit of normal * has end stage renal disease or is likely to be a candidate for dialysis over the 1 year study period * has a serum creatinine less than or equal to 1.5 mg/dl, or an estimated glomerular filtration rate at day -21 screening visit less than 15 ml/min or greater than 50 ml/min as calculated by the central laboratory * is required to take excluded medications

Keywords: gout physiology hyperuricemia uric acid drug therapy
g.i. pharmacokinetics of lmn-401 in individuals with ileostomies

Conditions: Travelers Diarrhea

Summary: the goal of this interventional study is to learn about the intraluminal pharmacokinetics (pk) of the investigational drug lmn-401 in adult healthy volunteers with ileostomies. lmn-401 is being developed as a potential new treatment for traveler's diarrhea. the study will also learn about the safety of the investigational drug lmn-401. the main questions it aims to answer are: * what is the timing and amount of components of investigational drug lmn-401 detected in the collected ileostomy material? * is lmn-401 safe and well tolerated in healthy volunteers taking the investigational drug? researchers will compare the timing and amount of investigational drug components detected in the ileostomy material in volunteers taking the investigational drug lmn-401 formulated into tablets with different properties. the impact of the study participant's fed or fasted state on the timing and amount of drug components detected in the ileostomy material will also be evaluated. each study participant will come into the research clinic for four study visits. study participants will receive the investigational product formulated into tablets with different properties. ileostomy material will be collected at baseline (pre-dose) and every two hours after investigational product dose administration for 10 hours.


Eligibility criteria:
inclusion criteria: * aged 19 years and above * medically stable * mature and stable ileostomy (no revisions in past 6 months) * willing and able to participate in all study visits * willing and able to provide informed consent exclusion criteria: * unable or unwilling to provide adequate informed consent * gastroparesis * using or planning to use anti-diarrheal medication * using or planning to use opioids * clinically significant disease * women who are pregnant, intending to become pregnant, or breastfeeding * non-english speakers
hypnosis in pain management, anxiety and depression in oncological patients

Conditions: Pain; Depression Anxiety Disorder

Summary: the aim of this trial is to compare and evaluate the effects of hypnosis in cancer patients, to reduce the level of pain, anxiety and depression. the comparison was made through the scores on the visual analogue scale (vas) and the hospital anxiety and depression scale (hads).

volunteers cancer patients of both gender, aged between 40 and 70 years, susceptible to hypnosis, with pain scores ≥ 3 measured by visual analogue scale (vas), will be randomized into two groups of 12 participants each. they might or might not present metastasis, whether or not performed cancer surgery, regardless of the location of the primary tumor, with or without concomitant surgical indication. it will be used the visual analogue scale (vas) and hospital anxiety and depression scale (hads) at 3 different times: at baseline, after 7 days and after 2 weeks of the first assessment. it will be done, in the hypnosis group, an hypnosis intervention. it consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression. then, it will be evaluated the intensity of the pain as well as depression and anxiety in both groups. finally, the results of both groups will be compared.

Eligibility criteria:
inclusion criteria: * patients of both sexes * aged 40-70 years susceptible to hypnosis * who have cancer of the digestive tract and pain resulting from this cancer treatment these may or may not have metastasis, have done or not cancer surgery, regardless of the location of the primary tumor or its presence,with or without concomitant surgical indication.this will include patients who have pain scores ≥ 3 in the visual analogue scale (vas). exclusion criteria: * patient not suggestible to hypnosis * psychotropic drug users, * patients with severe psychiatric disorder, except depression and anxiety ,- patient terminally ill cancer * patients with tumor or cancer metastasis in the central nervous system, _ deaf and people with mental disabilities and cognitive.

Keywords: behavioral hypnosis anxiety depression
effects of short term, high dose atorvastatin therapy on periprocedural myonecrosis and platelet inhibition after percutaneous coronary intervention (pci)

Conditions: Coronary Artery Disease

Summary: this research study plans to evaluate the use of atorvastatin in patients with coronary artery disease given immediately before pci and whether it will decrease the amount of heart damage after pci.


Eligibility criteria:
inclusion criteria: * patients undergoing revascularization for significant coronary artery disease * age range 21-85 years exclusion criteria: * non-stemi, stemi * cancer * renal failure with creatinine\>3.0mg/dl * liver cirrhosis * lymphoproliferative disorder * pregnancy * thrombocytopenia\<150'000 * coagulopathy (inr\>1.5) * abnormal liver function tests * illicit drug use * history of statin intolerance * history of rhabdomyolysis * planned use of glycoprotein iib/iiia inhibitors during pci * current therapy with atorvastatin, pravastatin, lovastatin, fluvastatin, or rosuvastatin

Keywords: atorvastatin clopidogrel percutaneous intervention periprocedural myonecrosis
chemoreflex and baroreflex alterations causing postural tachycardia syndrome with orthostatic hyperpnea and hypocapnia

Conditions: Postural Orthostatic Tachycardia Syndrome; Hypocapnia; Hyperventilation

Summary: postural tachycardia syndrome (pots) is the most common chronic cause of postural lightheadedness, and upright confusion afflicting many americans, mostly young women. many pots patients hyperventilate by increasing their depth of breathing that produces tachycardia, alters blood flow and blood pooling in the body and importantly reduces brain blood flow causing "brain fog". in this proposal the investigators will demonstrate in young women that abnormal repeated brief impairment of blood pressure and brain flow just after standing sensitizes the body's oxygen sensor in pots to respond as if it were in a low oxygen environment causing hyperventilation and its consequences. in this project the investigators will use various drugs that will help to understand the mechanisms that cause pots in this unique subset of pots patients who hyperventilate.

the investigators will compare results from female pots patients, free of known pulmonary or sleep disorders aged 15 to 39 years with, and without orthostatic hyperpneic hypocapnia, to healthy female volunteers with the following two (2) specific aims: 1. to test poikilocapnic (allowing carbon dioxide (co2) to vary) orthostatic cardiorespiratory responses to determine whether prolonged initial orthostatic hypotension (ioh) precedes upright hypocapnia in hyperpneic pots but not in controls or non-hyperpneic pots. subjects are instrumented for cerebral blood flow, respiratory and hemodynamic measurements, investigating splanchnic blood flow by indocyanine green infusion, and measuring changes of cbv, regional blood volumes, and cardiac output (co) by impedance plethysmography during a 10 min stand to quantify ioh, and a 10 min tilt test to 70⁰ to quantitate cardiorespiratory changes. these changes during tilt stratify hyperpneic and non-hyperpneic pots. 2. to test if chemoreflex sensitization of ventilation and sympathetic activity (by microneurography) are abnormal when supine and tilted upright at 45o and how that interacts with oxford measured cardiovagal and sympathetic baroreflexes under controlled gas conditions which are: isocapnic hypoxia and isocapnic hyperoxia to measure carotid body reflex; hyperoxic isocapnia and hyperoxic hypercapnia to measure central chemoreflexes. hyperoxia silences peripheral chemoreceptors and will normalize baroreflex and tilt responses.

Eligibility criteria:
inclusion criteria: * the investigators will recruit female pots cases (n=80) and healthy female control subjects (n=40) aged 15-39 years, matched for bmi. pots is a disease in which 80-90% are females. therefore, the investigators will only recruit female pots patients and controls. exclusion criteria: * any subjects with systemic disease or who cannot stop taking prescribed medications for at least 2 weeks prior to study.

Keywords: postural tachycardia syndrome (pots) young females tilt table testing initial orthostatic intolerance
a comparison of the flex-it® to the gliderite® stylet for glidescope® in simulated difficult intubations.

Conditions: Difficult Intubation

Summary: the purpose of this study is to determine if the flex-it® articulating stylet or the gliderite® rigid stylet is more effective and less traumatic in the context of difficult glidescope® intubations.

pre-operatively patient are approached and enrolled according to inclusion and exclusion criteria. demographic data is then recorded and afterwards the patient is randomized (randomization.com) but is blinded to the group. the patient is outfitted with a philadelphia® cervical collar and a bis® monitor before induction of anesthesia. the anesthetist is blinded to the randomization group. once asleep, the patient is intubated using the glidescope® with the single-use blade and one of the randomized intubation stylets by an operator. intubation and tube manipulation times, vital signs and bis level are recorded via a nurse or video camera. verbal cues are given for start of laryngoscopy, tube manipulation and confirmation of co2 which is recorded by the camera microphone. patient is questioned about hoarseness and sore throat when leaving the post anesthesia care unit according to our local protocol and 24hr after the surgical procedure. the data is then taken from the video and analyzed by a blinded operator.

Eligibility criteria:
inclusion criteria: * asa status 1-2 * bmi \< 35 * elective surgery * general anesthesia exclusion criteria: * difficult intubation * indication for rapid sequence intubation * contraindication for cervical collar

Keywords: glidescope® gliderite® flex-it® difficult intubation
the effect of iloprost on oxygenation during one-lung ventilation for lung surgery

Conditions: Lung Cancer

Summary: during one-lung ventilation in patients undergoing thoracic surgery, the persistent flow in the non-ventilated lung increases intrapulmonary shunt and decreases systemic arterial oxygenation. this prospective, randomized, double blind study was conducted to evaluate the effects of inhaled iloprost during one-lung ventilation on arterial oxygenation and shunt fraction during thoracic surgery.


Eligibility criteria:
inclusion criteria: * elective video-assisted thoracoscopic surgery (vats) lobectomy * 20 \< age \< 75 * american society of anesthesiologists (asa) classification i\~iii exclusion criteria: * asa classification iv * new york heart association (nyha) class iii\~iv * severe obstructive lung disease / restrictive lung disease * pulmonary hypertension * end-stage organ disease (i.e. hepatic failure, renal failure) * arrhythmia * previous history of thoracic surgery