Kornimate/medical-research-clean huggingface dataset:
role of aspirin in placental and maternal endothelial cell regulation in pre-eclampsia

Conditions: Pre-Eclampsia

Summary: endothelial dysfunction and defective placental vascularization are hypothesized to be significant causes of preeclampsia. in preeclampsia, due to vascular endothelial dysfunction, vasoconstriction and platelet activation can result in severe features which alter pregnancy outcomes. however, studies have shown that acetylsalicylic acid (aspirin) can decrease endothelial dysfunction leading to decreased platelet aggregation which reduces adverse outcomes. the objective of our study is to determine if aspirin has a dose-dependent response for modifying biomarkers reflective of maternal endothelial dysfunction when indicated for preeclampsia prevention in a cohort of women identified at risk for developing preeclampsia. pregnant women who are at risk for preeclampsia will be randomized to receive either 81mg aspirin or 162mg aspirin daily starting from 11-16 weeks of gestation until 36 weeks of gestation. a third, control group of women at low risk for preeclampsia will not receive aspirin. all women will be assessed with uterine artery doppler studies and mean arterial blood pressures at three time points during pregnancy. blood, urine, and cord blood samples will also be collected.

eligible women will be identified in the late first or early second trimesters. once recruited, women will be randomly assigned to either 81 mg or 162 mg per day dosing schedules. the randomization scheme will vary based on the body mass index (bmi) with separate schemes for women \ 30 kg/m2. ultrasonographic assessment of biophysical biomarkers will be obtained at 11-16 weeks, 18-22 weeks, and 28-32 weeks gestation. biologic samples of serum and urine will be obtained at the 11-16 week and 28-32 week visit. upon delivery, cord blood and a placental specimen will also be obtained. medication treatment will continue until 36 weeks gestation. pregnancy and neonatal outcome data will be recorded.

Eligibility criteria:
inclusion criteria (control) • no risk factors for preeclampsia inclusion criteria (pre-eclampsia) * history of preterm preeclampsia * chronic hypertension * type 1 and type 2 diabetes * renal diseases * autoimmune disease exclusion criteria * pregnant women younger than 18 years or older than 45 years * multiple gestations * history of allergy (urticaria or anaphylaxis) to aspirin or aspirin-related products asthma that worsens after aspirin use * patients with gastrointestinal or genitourinary bleeding * patients with peptic ulcer disease * patients with severe liver dysfunction * patients who have undergone bypass surgery * patients on anticoagulant medication(s) * women with anomalous fetus

Keywords: aspirin pulsatility index doppler uterine acetylsalicylic acid preeclampsia blood pressure
an evaluation of exenatide and rosiglitazone in subjects with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.


Eligibility criteria:
inclusion criteria: * hba1c of 6.8% to 10.0%, inclusive. * body mass index (bmi) of 25 kg/m\^2 to 40 kg/m\^2, inclusive. exclusion criteria: * have participated in this study previously, or have received exenatide, pramlintide acetate, glp-1 analogs, or dipeptidyl peptidase-iv (dpp-iv) inhibitors * have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start. this criterion includes drugs that have not received regulatory approval for any indication at the time of study start. * treated with any of the following medications: * thiazolidinedione within 5 months of screening; * sulfonylurea within 3 months of screening; * metformin/sulfonylurea combination therapy within 3 months of screening; * alpha-glucosidase inhibitor within 3 months of screening; * meglitinide within 3 months of screening; * insulin for more than 1 week within the 3 months prior to screening. * symlin (pramlintide acetate) injection or byetta (exenatide) injection at any time * chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a drug that directly affects gastrointestinal motility * are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start * regular use of a medication with addictive potential such as an opiate, narcotic, or tranquilizer * systemic antineoplastic agent * systemic transplantation medication * drugs for weight loss, including over-the-counter medications, within the 4 months prior to study start

Keywords: diabetes exenatide rosiglitazone amylin lilly
objective evaluation of shoulder pathology and surgery

Conditions: Glenohumeral Osteoarthritis; Rotator Cuff Disease

Summary: the goal of this study was to clinically validate a new device for the objective outcome evaluation of adult patients undergoing shoulder surgery for glenohumeral osteoarthritis and rotator cuff disease, using the activities of daily living described in the simple shoulder test (sst) as a reference. the study was set up as a clinical trial including patients over an observation period of one year and a control group of subjects. clinical evaluations will be made at baseline, 3 months, 6 months and 1 year after surgery by two independent observers. miniature sensors each containing three 3d gyroscopes and three 3d accelerometers will allow computing new kinematic scores. they will be compared to the regular sst, dash, ases and constant scores.


Eligibility criteria:
inclusion criteria: * at least 18 years old * patients with a unilateral rotator cuff disease implying a transfixiant supraspinatus rupture of at least 1 cm2, as determined by magnetic resonance imaging (mri), or a unilateral glenohumeral osteoarthritis stage ii or iii according the radiologic criteria published by koss * informed and signed consent exclusion criteria: * patients who had a previous shoulder surgery (open or arthroscopic) * patients who had a contralateral shoulder pathology
critical time intervention for individuals with hoarding disorder

Conditions: Hoarding Disorder

Summary: the purpose of this study is to investigate whether a well-established case management model called critical time intervention (cti) can help individuals with hoarding disorder who are concerned about the risk of eviction. each individual with hoarding disorder will be assigned to work with a cti specialist for 9 months, who will provide referrals for mental health treatment, legal consultations, and registration for entitlements. all participants will be offered a facilitated group intervention called the buried in treasures workshop. the cti specialist will also facilitate reconnecting the individual with supportive family/friends and will monitor and support the de-cluttering of the patient's home.


Eligibility criteria:
inclusion criteria: * primary hoarding disorder * age 18 or over * individuals concerned with the threat of eviction due to clutter * patient must be physically healthy * willing and able to understand and complete consent procedure * english speaking exclusion criteria: * not primary hoarding disorder * severly depressed patients; hamilton depression rating scale greater than 30 or judged clinically to be at risk of suicide with columbia suicide severity rating scale
multicentre retrospective study to understand anti-thrombotic treatment patterns and outcomes of acute coronary syndrome (acs) patients

Conditions: Acute Coronary Syndrome

Summary: trace is a multicentre retrospective study planned to gather follow up data for a period of 1 year in order to understand anti-thrombotic management patterns and outcomes of acute coronary syndrome patients in india. this retrospective study is designed to provide a rapid and quick analysis of the existing database of acs patients. so as to ensure quality check in the study, a pilot study will be conducted with around 500 patients at 10 centres across india and based on the meaningful results of the pilot study, full retrospective multi-centric study will be initiated at various selected centres across india. this study will use available registry data from a defined time period of jan 2007-dec 2009.


Eligibility criteria:
inclusion criteria: * patients of the age of 18 years or older and hospitalized for acs within the previous 3 years. * diagnosis of stemi, nstemi or ua using standard and universal definition of myocardial infarction exclusion criteria: * ua, stemi and nstemi precipitated by or as a complication of surgery, trauma, or gi bleeding or post-pci. * ua, stemi and nstemi occurring in patients already hospitalized for other reasons

Keywords: acs: acute coronary syndrome retrospective registry
cupping and serkangabin versus conventional migraine treatment

Conditions: Migraine Headache

Summary: migraine is the most common recurrent headache. current therapy of migraine headache consists of multiple drug groups for control of attack and prophylaxis against recurrent attacks. emerging alternative medicine worldwide led investigators to evaluate the efficacy of cupping therapy plus serkangabin syrup in treatment of migraine headache. severity, duration and frequency of attacks of migraine headache evaluated in two groups during six months from presentation.

in a randomized controlled trial investigators randomly assigned 76 patients with migraine to cupping therapy plus serkangabin or to receive conventional medical treatment. the use of cam in migraine is a growing phenomenon. migraine patients seek and explore both conventional and cam approaches. wet cupping is an ancient medical technique still used in several contemporary societies. it is being used in management of hypertension, diabetes mellitus, and headaches, renal and biliary stones and for maintaining health. little experimental study has been devoted to test its efficacy to treat migraine headache. investigators planned this study for evaluation of therapeutic efficacy of wet cupping and an iranian traditional medicine preparation, serkangabin in treatment of migraine headache compared with current medicine protocols. serkangabin is a preparation of honey, vinegar and distilled mint water that in traditional iranian medicine is believed to have therapeutic effects in many diseases (diabetes mellitus, hypertension, hyperlipidemia, osteoarthritis, chronic obstructive airway disease, interstitial lung disease, hepatitis, fatty liver, ischemic heart disease, migraine, cerebrovascular diseases)

Eligibility criteria:
inclusion criteria: * migraine headache with or without aura exclusion criteria: * uncontrolled hypertension * ischemic heart disease * cardiac arrhythmia or symptomatic wolff-parkinson-white syndrome * previous stroke or transient ischemic attack * severe liver or renal impairment * any other severe or disabling medical condition * history of alcohol or analgesic or psychotropic drug abuse * contraindication to or known hypersensitivity to study drugs * current use or use in the previous 2 weeks of mao-inhibitors * a pain disorder other than migraine as the primary presenting problem * current psychological treatment, psychiatric disorder needing immediate or priority treatment * current or planned breast feeding or pregnancy or unwillingness to use an established contraceptive method * non compliance of patients * not presenting at times determined for treatment and evaluation

Keywords: migraine prophylactic treatment cupping serkangabin
real-world study on dapagliflozin usage in patients with heart failure (hf) in germany

Conditions: Heart Diseases; Cardiovascular Diseases; Heart Failure

Summary: heart failure (hf) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. despite advancements in treatment, a hf diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (hrqol). dapagliflozin was recently granted approval for heart failure by the european commission, regardless of ejection fraction and whether the patient has diabetes. real-world observational data are necessary to describe dapagliflozin use in real-world settings in order to assess treatment patterns, hf symptoms and their impact on physical limitation, hrqol and work productivity, as well as health care utilization of patients treated with dapagliflozin in this setting under local treatment standard conditions in germany.


Eligibility criteria:
inclusion criteria: * age ≥18 years as of study index date; the study index date is date of initiation of treatment with dapagliflozin * patient received/receiving treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure (hf) and at timepoint of dapagliflozin initiation with: * preserved ejection fraction (hfpef; ef≥50%) or mildly reduced ejection fraction (hfmref; ef 41-49%) * or reduced ejection fraction (hfref ef ≤40%) * patient is enrolled within 14 to 90 days following initiation of dapagliflozin * signed and dated informed consent prior to enrolment in the study exclusion criteria: * patient should not be enrolled if he/she is less than 14 days or more than 90 days following initiation of dapagliflozin * prior treatment with dapagliflozin or other sglt2i treatment * initiation of dapagliflozin outside of the local hf label * diagnosis of type 1 diabetes prior to enrolment * current or planned participation in a clinical trial using an investigational medical product for treating hf * patient is involved in the planning and/or conduction of the study * hypersensitivity to dapagliflozin or to any of the excipients listed in the smpc

Keywords: heart failure with preserved ejection fraction (hfpef) heart failure with mildly reduced ejection fraction (hfmref) heart failure with reduced ejection fraction (hfref) dapagliflozin real-world
longitudinal assessment of gut hormone secretion following upper gastrointestinal surgery for cancer

Conditions: Esophageal Neoplasms; Stomach Neoplasms; Weight Loss; Malnutrition

Summary: surgery is the cornerstone of treatment for patients with oesophageal or gastric cancer, but while surgical removal of the tumour (oesophagectomy or gastrectomy) may offer the best chance of cure, these are major operations associated with specific long term complications. weight loss and poor nutrition are relatively common problems among patients who attain long-term cancer remission and cure after surgery. the mechanisms underlying these problems are not well understood and therefore treatment options are limited. the investigators research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone upper gastrointestinal surgery. these chemical messengers play a role in signalling the feeling of fullness during and after a meal (satiety). understanding the mechanisms involved in increased gut hormone secretion after these operations may allow us to use certain medications to block gut hormone release and hence reduce satiety allowing patients to eat more, regain weight and prevent nutritional complications after surgery. exaggerated post-prandial satiety gut hormone responses following oesophagectomy have, however, only been established cross-sectionally and therefore the time course for development of increased gut hormone secretion is unknown. data collected from this study will provide important information about optimal timing of therapeutic intervention in this patient group, while offering mechanistic insights with regard to the pathophysiologic process underlying post-operative early satiety.


Eligibility criteria:
inclusion criteria: * patients scheduled to undergo two-stage, three-stage or transhiatal oesophagectomy with gastric conduit reconstruction or total gastrectomy with roux-en-y reconstruction exclusion criteria: 1. significant and persistent chemoradiotherapy complication 2. other previous upper gastrointestinal surgery 3. unwell or unable to eat 4. other disease or medications which may affect satiety gut hormone responses 5. active and significant psychiatric illness including substance misuse 6. cognitive or communication issues or any factors affecting capacity to consent to participation 7. history of significant food allergy, certain dietary restrictions 8. confirmed or suspected residual or recurrent disease after surgery, synchronous or metachronous malignancy 9. significant surgical complication, aspiration risk or deterioration in performance

Keywords: longitudinal studies esophagectomy gastrectomy hunger appetite glucagon-like peptide 1 peptide yy ghrelin satiety response feeding behavior meals postprandial period
levosimendan in acute kidney injury study

Conditions: Acute Kidney Injury

Summary: we hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.

the purpose of this trial is to evaluate whether the use of levosimendan is able to improve renal function.

Eligibility criteria:
inclusion criteria: * clinically diagnosed adult patients with aki exclusion criteria: * failure to obtain written consent to participate from patient or legal representative (by deferred consent) * patients entering the icu for post-operative observation with an estimated length of stay less than 24 hrs. * moribund patients * patients under the age of 18 * pregnancy * patients suffering from pre-existing renal failure (elevated ngal values without apparent rise in creatinine values) * renal replacement therapy initiated before admission due to chronic kidney disease * hypersensitivity to levosimendan experienced by previous treatments * severe hypotension and tachycardia * significant mechanical obstruction affecting ventricular filling or outflow or both. * severe hepatic impairment (alat/asat\>400u/l) * patients will be excluded if the treating physician judges that study participation is undesirable for medical, medical-ethical or other reasons * known history of torsades de pointes

Keywords: renal acute kidney injury aki levosimendan simdax renal perfusion mortality renal flow
postoperative pain control & relief in neonates

Conditions: Pain, Postoperative; Premature Infant; Opioid Use

Summary: pain control for newborns has made significant improvements over the last 30 years. the use of narcotics remains the standard of care for neonates undergoing minor and major surgeries. narcotics, however, are associated with adverse effects such as respiratory depression, prolonged intubation and withdrawal symptoms. acetaminophen (tylenol©) has been proposed as an adjunct to reduce narcotic use but current evidence from well designed studies in newborns and premature infants is limited. this study will randomly assign neonates undergoing a surgery to either morphine plus acetaminophen or morphine alone for pain control. the subjects will be followed for 72 hours after the operation and evaluate the benefits of acetaminophen for pain control.


Eligibility criteria:
inclusion criteria: * all neonates ≥ 28 weeks of gestation and \<44 weeks of gestation undergoing general surgery procedures (below) and managed postoperatively in the neonatal intensive care unit (nicu). minor procedures inguinal hernia repair laparoscopic or open gastrostomy tube placement peritoneal drain placement for spontaneous intestinal perforation gastroschisis bedside patch closure major procedures laparoscopic or open nissen fundoplication, duodenal atresia repair, hirschsprung pull through, ladd's procedure or excision of abdominal cyst thoracoscopy or thoracotomy procedure enterostomy or colostomy creation exploratory laparotomy revision or closure of enterostomy or colostomy any gastroschisis or omphalocele repair in operating room repair or staged repair of congenital anorectal malformations resection of sacrococcygeal teratoma exclusion criteria: * any infant admitted with preoperative diagnosis of neonatal abstinence syndrome (nas) or known intrauterine opiate exposure * any diagnosis of hepatitis exclusive of tpn-related biliary cholestasis * renal disease with creatinine \>2.0 mg/dl at enrollment * intraventricular hemorrhage grade 3 or greater, or cerebellar hemorrhage * any patient with myotonic dystrophy or other congenital disease limiting validity of pain scoring * opiate exposure within 14 days of operative procedure * non-english-speaking parents/guardians
strategy training and pets to promote stroke survivor's cognitive performance and community participation

Conditions: Stroke

Summary: the study will administer an intervention called strategy training to adult stroke survivors living in the community who do and do not have pets, and will examine the role of a pet in promoting cognitive performance and community participation outcomes.


Eligibility criteria:
stroke survivors with pets inclusion criteria: 1. primary diagnosis of acute stroke 2. at least 3 months after the stroke onset 3. living in a community residence with a pet 4. cognitive impairment as indicated by an executive interview score of 3 or higher 5. participation restrictions as indicated by an activity card sort (\<80% of pre-stroke activities) 6. willing to participate in a 6-week program with 2 intervention sessions per week at home exclusion criteria: 1. dementia as indicated by montreal cognitive assessment score of 18 or lower 2. severe aphasia as indicated by the boston diagnostic aphasia examination severity score of 0 or 1 3. self-report of a central nervous system disorder other than stroke 4. recent drug or alcohol addiction/abuse within 3 months prior to the mini-neuropsychiatric interview 5. severe mental illness as indicated by the prime-md 6. prior exposure to strategy training 7. currently participate in rehabilitation therapy programs stroke survivors without pets inclusion criteria: 1. primary diagnosis of acute stroke 2. at least 3 months after the stroke onset 3. living in a community residence 4. cognitive impairment as indicated by an executive interview score of 3 or higher 5. participation restrictions as indicated by an activity card sort (\<80% of pre-stroke activities) 6. willing to participate in a 6-week program with 2 intervention sessions per week at home exclusion criteria: 1. dementia as indicated by montreal cognitive assessment score of 18 or lower 2. severe aphasia as indicated by the boston diagnostic aphasia examination severity score of 0 or 1 3. self-report of a central nervous system disorder other than stroke 4. recent drug or alcohol addiction/abuse within 3 months prior to the mini-neuropsychiatric interview 5. severe mental illness as indicated by the prime-md 6. prior exposure to strategy training 7. currently participate in rehabilitation therapy programs