Kornimate/medical-research-clean huggingface dataset:
myeloperoxidase (mpo) inhibitor a_zeneca for heart failure with preserved ejection fraction (hfpef)

Conditions: Heart Failure

Summary: researchers are studying the effect of a single dose of oral myeloperoxidase on heart failure versus placebo.

enroll subjects with a normal ejection fraction referred to the catheterization laboratory for evaluation of breathlessness or shortness of breath. perform safety lab sampling, echocardiography, arterial tonometry for pulse wave analysis, and assessment of endothelial function prior to administration of study drug. during the catheterization researchers will perform blood draws, assess baseline exercise capacity at rest and during exercise. researchers will also do an echocardiogram to take measurements of the heart. subjects will be randomized to one of two groups, oral myeloperoxidase inhibitor or placebo group. study drug or placebo will be administered followed by a repeat of the baseline catheterization assessments. at the conclusion of the second exercise test the subject will be moved to a room and monitored overnight for safety. repeat blood draws, echocardiogram, endothelial function test, and heart monitoring will be completed. the subject will be asked to follow up with the researchers between 9-14 days after the study drug dosage. the subjects history and blood work will be completed at that visit.

Eligibility criteria:
inclusion criteria: 1. males and females of non-childbearing potential 2. age ≥ 30 years 3. symptoms of dyspnea (ii-iv) at the time of screening 4. ejection fraction (ef) ≥ 50% as determined on imaging study within 12 months of enrollment 5. catheterization documented elevated filling pressures at rest (pcwp ≥15) or with exercise (pcwp ≥25) exclusion criteria: 1. use of nitrates, phosphodiesterase 5 inhibitors or other no-providing therapy in the past 24 hours of screening 2. significant valvular disease (\>moderate left-sided regurgitation, \>mild stenosis) 3. requirement of intravenous heparin at the start of case 4. severe pulmonary parenchymal disease 5. acute coronary syndrome or coronary disease requiring revascularization in the judgement of investigators 6. resting systolic blood pressure \< 100 mmhg 7. constrictive pericarditis 8. infiltrative, restrictive, or hypertrophic obstructive cardiomyopathies 9. previous anaphylaxis to any drug 10. pregnancy or breastfeeding mothers 11. high output heart failure 12. active thyroid disease 13. treatment with a new chemical entity (defined as a compound which has not been approved for marketing) within the preceding 3 months 14. patients with any prior allergy to propylthiouracil

Keywords: heart failure ejection fraction preserved myeloperoxidase inhibitor exercise
correlation between changes in liver stiffness and preeclampsia as shown by fibroscan

Conditions: Pre-Eclampsia

Summary: compare the fibroscan results of preeclamptic women to normal controls and to find out if the changes are reversible after labor. materials and methods

the purpose of the study is to compare the fibroscan results of preeclamptic women to normal controls and to find out if the changes are reversible after labor. materials and methods this prospective observational case-control study will include 50 women admitted to the fetal-maternal unit at 24 - 41 weeks gestation and diagnosed with mild/severe preeclampsia. preeclampsia is diagnosed as a new onset of hypertension over 140/90, at least two measurements at least four hours apart, and proteinuria (≥+1 in dipstick or \>300 mg/24 hr) after 20 weeks of gestation in a previously normotensive woman. a control group will consist 100 normotensive women with normal pregnancy outcomes who were admitted to our fetal-maternal unit during the same period. demographic, clinical, laboratory and sonographic data for the women participating will be collected from their chart. all patients diagnosed with preeclampsia will undergo the following workup: sign and symptoms evaluation, blood pressure follow up, 24-hour protein excretion in grams per day, complete blood count, hepatic function test: ast, alt and coagulation study, hba1c, coagulation function test and fibrotest. the fibroscan test will be performed by a trained hepatologist, who was blind to the women diagnosis. the fibroscan test will be done during the admission after the diagnosis of preeclampsia, after delivery and 6 weeks post-partum. commonly used cutoffs are \>7 kpa for significant fibrosis. statistical analysis will be performed with spss using mann whitney test. continuous variables will be analyzed using the student's t test and categorical variables were analyzed using 2. statistical significance was set at a p value of \< 0.05. the local institutional review board approved this study.

Eligibility criteria:
inclusion criteria: - fetal-maternal unit at 24 - 41 weeks gestation and diagnosed with mild/severe preeclampsia exclusion criteria: * age less then 18 * fetal-maternal less then 24 weeks
antiparasitic treatment for returning travelers with chronic diarrhea

Conditions: Chronic Diarrhea; Abdominal Pain; Bloating

Summary: study hypotheses is that antiparasitic therapy in patients with chronic diarrhea after travel to a developing country, with a negative stool findings, will be significantly effective in eliminating diarrhea and other gastro-intestinal complaints compared to similar patients receiving placebo.

it is common to encounter travelers from developing countries who suffer from persistent diarrhea after returning home. in many cases repeated stool samples are negative for bacteria, parasites and helminthes and the cause of the diarrhea is not found. the main debate is whether this condition is a persistent parasitic infection (unidentified) or post-infectious irritable bowel syndrome.however, clinical experience suggests that some of these travelers respond to antiparasitic therapy. this study aims to answer the question whether antiparasitic treatment in these cases is beneficial.

Eligibility criteria:
inclusion criteria: * diarrhea (3 or more soft stools per day) for at least two weeks after a trip to a developing country in the past year * stool sample negative for bacteria, parasites and helminthes at least once * has not received, until now, antiparasitic or antihelminthic therapy exclusion criteria: * bloody diarrhea * fever during enrolment 5. allergy to the offered medication

Keywords: chronic diarrhea travelers parasites albendazole tinidazole
safety and efficacy of cariprazine as an adjunctive to antidepressant therapy in major depressive disorder

Conditions: Major Depressive Disorder

Summary: an outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (adt) in participants with major depressive disorder (mdd) who have an inadequate response to adt alone. this clinical study compared cariprazine + adt with placebo + adt in outpatients with a diagnosis of mdd and an inadequate response to adt. the study consisted of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.


Eligibility criteria:
inclusion criteria: * male or female outpatients 18 to 65 years of age, inclusive. * currently meet the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for moderate to severe major depressive disorder (mdd). * current major depressive episode of at least 8 weeks and not exceeding 24 months in duration. * ongoing inadequate response to protocol allowed antidepressant therapy (adt). exclusion criteria: * principal dsm-iv-tr-based diagnosis of an axis i disorder, other than mdd, * women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study. * history of meeting dsm-iv-tr criteria for: 1. depressive episode with psychotic or catatonic features. 2. manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode. 3. schizophrenia, schizoaffective, or other psychotic disorder. 4. obsessive-compulsive disorder. 5. bulimia or anorexia nervosa. 6. dementia, amnesic, or other cognitive disorder. 7. mental retardation. * participants considered a suicide risk.

Keywords: major depressive disorder depression
the effect of proximity on flu-shot participation

Conditions: Influenza; Human

Summary: using desk location information and employees' building entry/exit swipe card data from a company that offered a free 2-day worksite influenza vaccination clinic, we separately identify the vaccination effects of base proximity-the inverse of walking distance between one's desk and the clinic-and functional proximity-the likelihood of passing near the clinic during the course of a normal work day (ie, days when the clinic is not open).

we study the 2011 influenza vaccine uptake of employees at the headquarters of a health benefits administrator in the united states. these employees are generally not health care personnel. all of them have health insurance. of the company's total workforce (including those not based at the headquarters), 26% are african americans and 37% are racial minorities. there are 2 main buildings at the company headquarters. building one houses 520 employees and is the site of the vaccination clinic; building two houses 1281 employees. the 2 buildings are 131 meters apart and connected by an enclosed passageway. the clinic was located near the cafeteria in building one and adjacent to the passageway connecting the 2 buildings. the clinic was conducted from october 19 to 20, 2011, and it was advertised during the 3 weeks prior. the company requires employees to swipe a personalized electronic badge to open the external doors of its buildings, which include the doors to the passageway between the buildings. the company provided us data on the date and time of each swipe in september and october 2011. if an employee swipes her badge and holds the door open for another employee, we do not observe that other employee. the badge swipe data are therefore an incomplete measure of all movements between the buildings. the company also gave us data on employee characteristics and vaccination uptake, scaled architectural plans of the buildings, and employee desk maps.

Eligibility criteria:
inclusion criteria: * employee of express scripts. * eligible to receive a flu shot at express scripts. * over 18 years of age. exclusion criteria: * children * non express scripts employees

Keywords: influenza proximity
comparison of wound integrity for clear corneal cataract incisions

Conditions: Cataract

Summary: this is a randomized controlled trial to evaluate the safety and efficacy of two different closing methods for clear corneal cataract incisions

compared with other incision types , clear corneal incision has the advantages of simple operation, small incision and good healing. it has been widely used in recent decades and has become the most commonly used incision type in phacoemulsification cataract surgery.however, there is no unified standard for the closed method of the clear corneal incision, and some studies have shown that the wound integrity of clear corneal incision is not well.in the poorly closed incision, the risk of infection increased due to the leakage .especially in 2.2mm incision, the frequent entry and exit of the instrument reduces the corneal rebound ability at the incision so that the incision is hard to closed. ensuring wound integrity for clear corneal cataract incision is the key to the success of cataract surgery. clinically closed methods include stromal hydration and suture.the effectiveness of stromal hydration as one of the most commonly used methods has been validated, but also adds additional negative effects. additionally, the suture extends the operation time and improves the operation cost, and is also accompanied by some complications, which has been less used. exploring a safe and effective closed method will benefit for most cataract patients. this study intends to evaluate the safety and efficacy of a closed method that incision is pressed by a cotton swab.the investigators planned to select 130 cataract patients who met the inclusion criteria. the investigators will press the clear corneal incision with a cotton swab in experimental group, while the control group used stromal hydration to close the corneal incision. wound integrity, wound leakage, corneal thickness at the incision, keratometric value at the incision, anterior chamber depth and incidence of incision-related descemet membrane detachment were compared between the two groups.

Eligibility criteria:
inclusion criteria: 1. \> 18 years old; 2. nuclear grade is iii or iv; 3. visually significant cataract; 4. the patient is willing and able to complete all necessary follow-ups and examinations. exclusion criteria: 1. intraoperative or postoperative complications: such as intraoperative posterior capsule rupture, the rupture of zonule, secondary glaucoma, endophthalmitis, etc.; 2. combined with other eye diseases: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.; 3. history of intraocular surgery; 4. severe systemic diseases: such as severe hypertension, diabetes, heart disease, alzheimer's, parkinson, etc.; 5. any condition that the study physician considers to be an impediment to the clinical trial.
microbe-gut interaction in microscopic colitis and post-infectious irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome (IBS)

Summary: objective: this study aims elucidate the pathophysiological link between the environment in the colon (mainly the microbiota), the local immune system and activation of the enteric nervous system in patients with post-infectious ibs (pi-ibs) and microscopic colitis (mc) with special emphasis on microbial-mucosa interactions and evaluation of the effect on the immune activation/response as well as how afferent gut-brain signalling leads to abdominal discomfort. method: the project is based on data from three cohorts of patients, one with pi-ibs and one with mc as well as a gender- and age-matched cohort of healthy individuals. measurement of perceived sensitivity in the gut will be evaluated by pain-response under mechanical stress using a barostat. the hit (human intestinal tissue)-chip array will be used to characterize the diversity, stability and functionality of the intestinal microbiota on mucosa level, giving a clue to the interactions with the host and insight to changes leading to the development of the two diseases. immunohistochemistry and flowcytometry will be used to analyse the location, frequency and phenotype characteristics of lymphoid- and mast cells. functional analysis of mucosal lymphocytes activated in vitro by products from the intestinal microbiota will be examined by cytokine production using the luminextm system. the ussing chamber technique will allow investigation of the impact of the microbiota and its metabolites on intestinal barrier functions. in this method the sample has access to stressors under standard conditions.

we will make a characterization of lymphocytes, mast cells and gut microflora. depending on these results we will make stimulations of patient biopsies to find if tissue from patients react differently then patients from healthy.

Eligibility criteria:
inclusion criteria: * over 18 years * healthy and not eating any prescription medication except birth control in pill form exclusion criteria: * have or had a history of gastrointestinal disease that has required specialist medical care * being lactose intolerance * have high blood pressure requiring treatment * have premenstrual syndrome * lose weight * being pregnant or breast-feed
verification of the efficacy/safety of the intratympanic drug delivery for hearing loss

Conditions: Hearing Loss, Sudden; Hearing Loss, Ototoxic; Hearing Loss, Noise-Induced; Meniere Disease

Summary: this study is a prospective, randomized pilot study. to verify an efficacy and safety of the intratympanic drug delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. hearing test, endoscopy of tympanic membrane and ct scans will be conducted after intratympanic treatment for evaluation.


Eligibility criteria:
inclusion criteria: * sudden hearing loss, ototoxic hearing loss, noise-induced hearing loss, meniere's disease patients with 25db hl in pure tone audiometry * patients whose hearing has not been restored after standard treatment * patients do not participate in clinical trials within 6 months exclusion criteria: * patients with retrocochlear lesion * patients with history of hypersensitivity to the ingredients of this drug * patients with end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive palsy and progressive stroke, etc. severe brain disease or cancer.

Keywords: hearing loss drug delivery dexamethasone hyaluronic acid intratympanic injection
pancreaticoduodenectomy with or without braun enteroenterostomy: comparison of postoperative pancreatic fistula and delayed gastric emptying

Conditions: Postoperative Pancreatic Fistula; Delayed Gastric Emptying

Summary: the investigators plan to perform a prospective randomized, head-to-head trial to test the hypothesis that the addition of braun enteroenterostomy to standard pancreaticoduodenectomy (pd) reconstruction can decrease the rates of postoperative pancreatic fistula (popf) and/or delayed gastric emptying (dge).


Eligibility criteria:
inclusion criteria: * patients undergoing pancreaticoduodenectomy surgery at johns hopkins hospital exclusion criteria: * pregnant women * patients under the age of 18 * adults lacking ability to consent, * patients scheduled for laparoscopic whipple surgery * non-english-speakers, and * prisoners
prospective clinical evaluation of beta-d-glucan assay in blood and bal

Conditions: Invasive Fungal Infection; Hematological Malignancy; Receipt of Solid Organ Transplant

Summary: in patients with invasive fungal infection (ifi) rapid diagnosis is essential for early initiation of appropriate antifungal therapy and thereby survival. conventional culture is still the gold-standard for diagnosis of ifi. sensitivity of conventional culture, however, is low (50%) and time to results minimum 24 hours. therefore usage of serological tests detecting fungal antigens has increased dramatically over recent years. main advantages of this new methods are rapid results and higher sensitivity when compared to conventional culture. one of the most promising serological marker currently used is beta-d-glucan, which is a component of the fungal cell wall. ß-d-glucan has been detected in ifi caused by aspergillus, candida and fusarium spp. the fungitell assay (associates of cape code, inc.) was developed and validated for detection of ß-d-glucan in peripheral blood. up to date information about clinical performance of the fungitell assays in bronchoalveolar lavage fluid (bal) is limited. this study will therefore evaluate clinical and diagnostic performance of the fungitell assay in bal from patients with solid organ transplant or hematologic malignancy. in addition mn/a-mn, the lateral flow device test for aspergillosis, and galactomannan, as well as pcr will be determined and used as comparators for bdg performance.


Eligibility criteria:
inclusion criteria: * above 18 years of age * bronchoscopy performed in clinical routine due to suspicion of ifi * hematological malignancy or receipt of solid organ transplant/icu exclusion criteria: * below 18 years of age * no bronchoscopy performed * no hematological malignancy nor receipt of solid organ transplant/icu

Keywords: ifi
study of major cardiovascular events in patients with nonvalvular atrial fibrillation treated with rivaroxaban

Conditions: Atrial Fibrillation

Summary: evaluation of the performance of the 2mace index in a population of nonvalvular atrial fibrillation (nvaf) patients treated with rivaroxaban in spain


Eligibility criteria:
inclusion criteria: * adult patients aged 18 years or older. * patients with diagnosis of nvaf. * patients treated with rivaroxaban from at least six months prior to the study inclusion. * patients who have been given appropriate information about the study objectives and procedures and who have given their written informed consent. exclusion criteria: * patients participating in an investigational program with interventions outside of routine clinical practice. * patients who initiate treatment with rivaroxaban after the start of the study inclusion period. * prosthetic heart valves or the presence of any severe valvulopathies. * patients with severe cognitive impairment. * patients with chronic infections (hiv infection, hepatitis c virus, hepatitis b virus) or systemic autoimmune diseases. * patients with active cancer. * patients with liver insufficiency (eg. cirrhosis).
a study of the safety and efficacy of pimavanserin in patients with alzheimer's disease psychosis

Conditions: Alzheimer's Disease Psychosis

Summary: this study will evaluate the safety and efficacy of pimavanserin 40 mg compared to placebo in patients with alzheimer's disease psychosis.


Eligibility criteria:
inclusion criteria: * patient must be 50 years of age or older with nincds-adrda defined possible or probable ad * patient must have psychotic symptoms that developed after the diagnosis of ad was established. these symptoms must include visual and/or auditory hallucinations, and/or delusions * patient must have been a nursing home resident for ≥ 4 weeks prior to randomization, not bedridden and expected to remain in the facility throughout the study * patient must have actively experienced and verbally communicated psychotic symptoms during the month prior to the screening visit and weekly during the previous 2 weeks prior to baseline * if patient is on acetylcholinesterase inhibitor (achei) therapy and/or memantine, must be on stable doses for 3 months prior to the baseline visit and during the study * patient is willing and able to provide informed consent. if the subject is unable to provide written consent due to the severity of dementia, consent must be given by a legally authorized representative exclusion criteria: * patient has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of alzheimer's disease including, but not limited to, schizophrenia or bipolar disorder * patient is unable to communicate verbally * patient has current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study * patient has had a myocardial infarction in the last six months * patient has moderate to severe congestive heart failure * patient has any surgery planned during the screening, treatment, or follow-up periods that could interfere with participation in the study per the protocol assessments patients will be evaluated at screening to ensure that all criteria for study participation are met. these evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).