Kornimate/medical-research-clean huggingface dataset:
pmcf study for coseal® in gynecologic surgery

Conditions: Adhesion

Summary: the study is a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart, when necessary. the population will consist of patients who underwent an index gynecologic surgery (performed at least 2 years prior to the start of the study) during which coseal was used as an adjunct to good surgical technique to reduce the incidence, severity, and extent of post-surgical adhesion formation. the purpose of the study is to detect the incidence of adhesion-related morbidities as measured by the proportion of adhesion-related readmissions, including reoperations in these patients. patient charts will be reviewed to collect the data on readmissions related to adhesions, if the patient chart has no record of adhesion related readmission within approximately 2 years of the index surgery, then a patient questionnaire will be sent. a questionnaire may still be sent if a patient chart has a record of adhesion related readmission within approximately 2 years of the index surgery and further clarification is needed. the questionnaire will collect information regarding readmission or reoperation directly or possibly related to adhesions following the index gynecologic surgical procedure at a hospital or outpatient clinic other than that of the index surgery.


Eligibility criteria:
inclusion criteria: 1. adult female patients who, at the time of surgery, were ≥18 years of age and who have undergone an index gynecologic surgery at least 2 years prior to the start of the study. 2. patients in whom coseal was used for the reduction of post-surgical adhesion formation exclusion criteria: 1. patients who had frank infection in the abdominopelvic cavity at the time of the surgery

Keywords: gynecological surgery, adhesion related morbidities
using counter attitudinal advocacy to change drinking behavior

Conditions: Alcohol Drinking; Alcohol Abuse

Summary: high volume drinking by young adults has proven resistant to change, so new approaches are needed. we adapt a theory-based attitude change strategy for use in alcohol prevention. this research tests the impact of brief writing and advocacy activities on subsequent drinking and negative consequences.

the persistence of risky drinking among young adults in college calls for continued efforts to prevent harms related to alcohol. many prevention interventions rely on a primary mechanism of change: correcting exaggerated drinking norms. we propose to test a novel prevention strategy targeting another mechanism of change: creating attitude-behavior dissonance. to date, attitude change activities have not been harnessed as a behavior change strategy for alcohol abuse prevention, so this study adapts counter-attitudinal advocacy (caa) to the alcohol prevention context. the goals of the proposed research are to demonstrate (a) the utility of caa to change high volume drinking and related consequences, (b) that attitude change and attitude-behavior dissonance mediates the caa manipulation effect, and (c) that caa-induced risk reduction is not inferior to an established intervention based on personalized normative feedback (pnf). a pair of studies will be implemented across two sites. first surveys to document peer behaviors and normative perceptions (n = 500 at each site) will be conducted, in order to deliver accurate, campus-specific pnf. the next study consists of a randomized controlled trial (rct) with 2 experimental conditions (caa and pnf) and a 3rd assessment only control condition to determine the impact of caa on alcohol outcomes. for the rct, a total of 600 heavy drinking students who have endorsed alcohol-related negative consequences will be recruited. alcohol outcomes will be assessed at 1-, 3-, and 6-month follow-ups to test hypotheses that, relative to assessment only control, the caa manipulation will decrease alcohol consumption and consequences. we will also test the hypothesis that caa condition will be no less efficacious than (i.e., not inferior to) the pnf condition. the rct also allows tests of hypotheses about effect moderators and mediators. this study will demonstrate the generalizability of caa activities to the alcohol prevention context, as well as their generalizability across demographically different settings. implications for the public health include establishing the efficacy of a new approach for reducing high volume drinking and related consequences among young adults.

Eligibility criteria:
inclusion criteria: * age 18-26 * male or female student at brown university or university of houston * past month heavy episodic drinking (for men, \>5 drinks in one day, for women \>4 drinks in one day) * at least two self-reported negative consequences from drinking in the past month exclusion criteria: * status as a second semester senior

Keywords: brief intervention college students
safety and efficacy of vancomycin plus beta-lactams

Conditions: Critical Illness

Summary: the combination of vancomycin and piperacillin-tazobactam has been associated with an increased risk of acute kidney injury (aki) in non-critically ill patient populations, but it is still unknown if this association exists in critically ill patients. the objective of this study is to compare aki and efficacy of vancomycin plus piperacillin-tazobactam or beta-lactams.

the combination of vancomycin and piperacillin-tazobactam has been associated with an increased risk of acute kidney injury (aki) in non-critically ill patient populations, but limited data regarding this association exists in critically ill patients. the objective of this study is to compare aki and efficacy of vancomycin plus piperacillin-tazobactam or beta-lactams. this is a multicenter, retrospective cohort study. patients from the retrospective cohort will be divided into 2 groups based on the combination regimen received . patients who meet the inclusion and exclusion criteria will be included in our registry. as a non-intervention study, these information as below will be collected: basic demographics, diagnosis, concomitant nephrotoxic and other antibiotic medications, serum creatine levels, vancomycin concentrations, and indication for antibiotics.

Eligibility criteria:
inclusion criteria: * 18 years or older, * admitted to intensive care unit * received the combination of vancomycin and beta-lactams for at least 48 hours * had a serum creatinine level measured within 24-hour hospital admission * had at least one van level drawn while receiving a combination of study antibiotics exclusion criteria: * pregnancy or lactating patients * admission to the intensive care unit during administration or within 72 hours of completing the antibiotics * had end-stage renal disease * died within 48 hours of combination antibiotic therapy initiation
rct on the treatment of menopausal syndrome with chinese medicine

Conditions: Menopause

Summary: this is a double-blinded, randomized, placebo-controlled clinical trial. subjects will be randomly assigned to the treatment group (modified guizhi fuling granules) or placebo group (placebo granules) for 8 weeks. outcomes will be measured at week 8 and week 12.

menopausal syndrome is a series of symptoms caused by ovarian follicles degeneration that occurs before or after menopause. these symptoms include central nervous system-related disorders (such as hot flashes, insomnia, depression, anxiety, etc.); metabolic, weight, cardiovascular and musculoskeletal changes; urogenital and skin atrophy; and sexual dysfunction. some previous studies have investigated the possibilities of using traditional chinese medicine (tcm) for the treatment of menopausal syndrome. however, due to the limitations of previous clinical research, more evidence is required to support the efficacy of tcm treatment. therefore, we propose to conduct a randomized, double-blinded, placebo-controlled clinical trial here, with the hope of objectively assessing the efficacy and safety of using tcm to treat menopausal syndrome.

Eligibility criteria:
inclusion criteria: * female subjects with age between 40 and 60 years old; * for those who have symptoms of primary menopause (irregular menstruation lasting for more than 6 months, or absence of menstrual periods for more than 3 months) * the score of the physical symptoms in greene climacteric symptom score (gcs) is 6 or above (average level); * have moderate level (affecting certain level of daily activity) or severe (cannot carry out daily activity) hot flashes, defined as transient sensations of heat, sweating, flushing, anxiety and chills lasting for 1-5 minutes; * diagnosed deficiency of kidney essence and static blood in lower jiao by chinese medicine practitioner * agreed to receive chinese medication or placebo for 2 months upon randomization. exclusion criteria: * the menopausal syndrome caused by surgical operations or medications (such as chemotherapy, gonadotropin-releasing hormone agonists, etc.). * have received estrogen treatment in the past 2 months; * have received any medication for treating menopause in the past month, including herbs, non-prescribed drugs, supplements, or change of diet to consume more legumes; * known serious emotional, mental or psychological disorders that may affect the study; * during pregnancy, pre-pregnancy period, or lactation period; * known history of allergy to any traditional chinese medicine; * have received anticoagulant or antiplatelet drugs in the past month; * known history of some certain serious medical disease, such as cardiovascular disease, liver or renal dysfunction, diabetes, cerebrovascular disease, blood disorders, with unstable conditions; * chinese medicine pattern combined with damp phlegm or damp heat, or only deficiency of yin blood or absence of static blood pattern.

Keywords: traditional chinese medicine
brain mri in stroke patients with intracardiac thrombus

Conditions: Stroke; Intracardiac Thrombus

Summary: acute infarction patterns have been described in cardioembolic stroke, mainly with atrial fibrillation (af) or patent foramen ovale. we aimed to analyse acute infarction mri characteristics in stroke patients with intracardiac thrombus (ict) compared with stroke patients with af.


Eligibility criteria:
inclusion criteria: * consecutive patients presenting with acute symptomatic cardioembolic infarction associated with ict, recruited and registered in the stroke database between june 2018 and november 2019 of our centre (nîmes university hospital, france). these patients were compared with consecutive cardioembolic stroke patients with known or newly discovered af (in the absence of ict on echocardiography), recruited during the same time period. * brain mri (including diffusion-weighted imaging \[dwi\]) performed within one week of symptom onset; complete etiological work-up including intracranial (time-of-flight \[tof\], gadolinium-enhanced magnetic resonance angiography \[mra\], or computed tomographic angiography \[cta\]) and extracranial (gadolinium-enhanced mra, cta, or duplex ultrasound) vessel imaging; transthoracic or transoesophageal echocardiography; and ≥24h ecg monitoring (acute stroke unit monitoring and/or holter ecg monitoring). exclusion criteria: * opt-out patient

Keywords: brain mri
video-supervised motor and awareness training in writer's cramp

Conditions: Writer's Cramp

Summary: writer's cramp is the most common task-specific dystonia. it is characterized by involuntary co-contraction of antagonistic muscles during writing. this disabling condition may force patients to give up their occupation. in this study the efficacy of a twelve months long-term training in patients with writer's cramp will be investigated. two different programs will be offered: the first one will consist of a sensorimotor, the second one of an awareness training. all patients will benefit from video-based supervision with the aim to establish a practice-oriented therapeutic approach that will be available to all patients independently of their home location. the treatment effect will be measured primary with the patient-centered canadian occupational performance measure (copm) and secondary with clinical scales to assess the clinical efficacy and everyday constraints. writing will be assessed with a computer-based kinematic writing analysis. to evaluate the influence on the brain network, several functional magnetic resonance imaging (fmri) evaluations will be performed. this project is of minimal risk without negative side effects from the training. the risks for the mri experiment are equal to a non-contrast standard mri investigation.


Eligibility criteria:
inclusion criteria: * right handed idiopathic wc according to standardized criteria (simple and complex wc, any dystonic posture (including flexion, extension, pronation, supination)) * able to participate in video-calls exclusion criteria: * additional neurological or psychiatric diseases * left-handed patients * last botulinum toxin treatment \<3 months, remaining weakness from the last injection * concomitant use of anticholinergics or sedating medication exclusion criteria for mri: * cardiac pacemaker, electronic or metal implants * pregnancy or suspected pregnancy * severe ametropia, anxiety in small rooms

Keywords: dystonia training kinematic writing analysis copm functional magnetic resonance imaging
supplementary vitamin b12 effects on elevated homocysteine levels of vegetarians - clinical trial

Conditions: Vitamin B12 Deficiency

Summary: vegetarians are known to be deficient in vitamin b12, due to a lack or absence of dietary animal produce, which can elevate homocysteine. there is strong evidence indicating that elevated plasma total homocysteine (thcy) is a contributor to chronic conditions, such as primary cardiovascular disease (cvd). the study hypothesis is: there will be a significant decrease in plasma thcy of vegetarians following the intervention by supplementary vitamin b12 (of the methylcobalamin type) and this will lead to a reduction of the risk of cvd.


Eligibility criteria:
inclusion criteria: * having a plasma thcy \>10 micromol/l * not suffering from conditions as described in exclusion criteria. * vegetarian for at least one year. * not participating in a weight reducing diet. * not consuming regularly vitamin b12 supplements. * give written consent to participate in clinical trial and be fluent in english language. exclusion criteria: * having a plasma thcy less or equal to 10 micromol/l. * suffering from pernicious anemia or other vitamin b12 deficiency disease. * undergone bowel surgery or suffer from gastrointestinal disease. * pregnant, lactating or trying to conceive. * smoker. * alcohol intake regularly greater than official recommended daily units (i.e. 2 units female, 3 units male). * consume large amounts of caffeine (regular consumption of \>4 cups of strong tea or coffee per day). * use of medications known to influence nutritional status. * have genetic metabolic disease. * suffer from renal failure, diabetes, thyroid disease, cardiovascular disease, dementia or cancer. * have a known blood-borne infection (e.g. hepatitis or hiv).

Keywords: hyperhomocysteinemia methylcobalamin cardiovascular disease plasma total homocysteine vegetarians
evaluation of silver nanoparticles for the prevention of covid-19

Conditions: Coronavirus Disease 2019 (COVID-19)

Summary: in this research, silver nanoparticles (agnps) were tested in vitro and shown to have an inhibitory effect on sars-cov-2 infection in cultured cells. subsequently, the investigators assessed the effects of mouthwash and nose rinse with argovit® silver nanoparticles (agnps), in the prevention of sars-cov-2 contagion in health workers consider as high-risk group of acquiring the infection in the general tijuana hospital, mexico, a hospital for the exclusive recruitment of patients diagnosed with covid-19.

sars-cov-2 infection in hospital areas is of a particular concern, since the close interaction between health care personnel and patients diagnosed with covid-19, which allows virus to be easily spread between them and subsequently to their families and communities. preventing sars-cov-2 infection among healthcare personnel is essential to reduce the frequency of infections and outbreaks during the pandemic. in a first step, silver nanoparticles (agnps) were tested in vitro to determine an inhibitory effect on sars-cov-2 infection in cultured cells. subsequently, the investigators assess the effects of mouthwash and nose rinse with argovit® silver nanoparticles (agnps), in the prevention of sars-cov-2 contagion in health workers consider as high-risk group of acquiring the infection in the general tijuana hospital, mexico, a hospital for the exclusive recruitment of patients diagnosed with covid-19. the investigators present a prospective randomized study of 231 participants that was carried out for 9 weeks (during the declaration of a pandemic). the "experimental" group was instructed to do mouthwash and nose rinse with the agnps solution; the "control" group was instructed to do mouthwashes and nose rinse in a conventional way.

Eligibility criteria:
inclusion criteria: * men and women health workers in the general tijuana hospital, mexico who works in high-risk areas with direct contact with patients infected and diagnosed with covid-19. exclusion criteria: * persons with history of hypersensitivity to silver (rashes and other contraindications), * a history of sars-cov-2 infection in the three months prior to the start of the study, any respiratory distress, * and refusal to sign the informed consent.

Keywords: silver nanoparticles sars-cov-2 covid-19 infection control
fragility and programmed cardiovascular surgery (ecosarco)

Conditions: Fragility; Intensive Care Unit Syndrome

Summary: objectives: to characterize textural ultrasonographic biomarkers of the brachial biceps musculature, wrist flexors, quadriceps and anterior tibial muscle that allow the recognition of the muscular and functional status of patients undergoing programmed cardiovascular surgery and relate them to mortality, hospital stay and functionality results after the intervention. design: a first phase of cross-sectional observational study and a second phase of longitudinal observational prospective study. participants: patients with programmed cardiovascular surgery to aortic valve replacement outcomes: sociodemographic and anthropometric variables, severity and clinical risk scales, disability, fragility and quality of life scales, nutritional status and textural muscular biomarkers with ultrasonography. expected results: strong association between ultrasound muscle biomarkers and icu and hospital stay, disability, fragility and quality of life after the surgery.


Eligibility criteria:
inclusion criteria: * waiting list patients with cardiovascular surgery scheduled for aortic valve refill exclusion criteria: * urgency while waiting list * patients with no evaluation by presurgery committee * previous diagnosis of neuropathies, radiculopathy, polyneuropathy congenital or acquired or pathologies with muscular affectation

Keywords: imaging biomarkers ultrasonography fragility intensive care unit
safety evaluation of dasatinib in subjects with scleroderma pulmonary fibrosis

Conditions: Scleroderma

Summary: the purpose of this study was to evaluate the safety of dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis.


Eligibility criteria:
inclusion criteria: target population * meet american college of rheumatology (acr) criteria for scleroderma * have clinical evidence of active skin disease with a skin score of ≥15 * have had the onset of their first non-raynaud phenomenon feature of ssc no more than 3 years prior to screening * have evidence of fibrosing alveolitis (active pulmonary fibrosis) manifested by a forced vital capacity (fvc) between 45% and 80% of predicted normal and/or diffusing capacity (dlco) between 30% and 70% of predicted normal values * have an abnormal high resolution computed tomography (ct) scan of the chest/lungs demonstrating typical ground glass changes of alveolitis with background fibrosis * have adequate renal function- no evidence of renal crisis in the 2 months prior to enrollment and serum creatinine \< 3 mg/dl * for both sexes, must use an acceptable form of birth control * age ≥ 18 exclusion criteria: * clinically significant pleural or pericardial effusion in the previous 12 months: grade 3 or 4. patients with recent grade i or ii effusions or peripheral edema will be permitted to enter the study * clinically significant cardiac disease (new york heart association class iii or iv) including preexisting arrhythmia, (such as ventricular tachycardia, ventricular fibrillation, or "torsade de pointes"), myocardial infarction, uncontrolled angina within 6 months, congestive heart failure, cardiomyopathy, or pericardial disease * clinically-significant coagulation or platelet function disorder (eg, known von willebrand's disease) * abnormal qtcf interval prolonged (\> 450 msec) after electrolytes have been corrected on baseline electrocardiogram laboratory test findings * hgb \< 10 g/dl; platelet count \< 100,000/dl; wbc \< 3,000/dl; pmn \< 1,000/dl; or lymphocytes \< 350/dl * the presence of any of the following laboratory findings at screening: positive for antibodies to hepatitis c virus; positive for antibodies to hepatitis b surface antigen (hbsag); serum bilirubin 2 times normal, alanine aminotransferase (alt), or aspartate aminotransferase (ast)\> 2.5 times upper limit of normal prohibited treatments and/or therapies * use of other immunosuppressive therapies must be discontinued at enrollment, eg methotrexate, azathioprine, cyclophosphamide, mycophenolic acid, mycophenolate mofetil, cyclosporine * treatment with any other experimental or investigational drug(s) concurrently or less than 12 weeks prior to study enrollment * use of anti-fibrotic agents must be discontinued at enrollment, eg colchicine, d-penicillamine, minocycline or type 1 oral collagen
needle-free monitoring for ivf patient cycles

Conditions: Infertility

Summary: salivary diagnostic testing is emerging as a less invasive, inexpensive alternative to serum analyte measurements with proven diagnostic accuracy in clinical settings. this study aims to continue analyzing aspects of the performance of salivary hormone competitive immunoassays for monitoring patient's reproductive hormone profiles in the reproductive cycle. hormone levels will be monitored during treatment cycles for infertility.

this study will be a prospective study to measure salivary and serum estrogen and progesterone levels in subject's voluntarily undergoing monitored infertility treatment cycles including controlled ovarian stimulation (cos) with oral agents or gonadotropins and controlled ovarian hyperstimulation (coh) for in vitro fertilization (ivf). ultimately, the potential applicability and reliability of salivary steroid monitoring in ivf cycles will be assessed.

Eligibility criteria:
inclusion criteria: * diagnosis of infertility. * cycle start age of 25 -43 years. * undergoing controlled ovarian stimulation for ivf. * all monitoring scheduled at the participating ivf facility. exclusion criteria: -prior cancelled cycle due to hyperstimulation.

Keywords: infertility in vitro fertilization estradiol progesterone