Kornimate/medical-research-clean huggingface dataset:
risk of malignancy index and assiut scoring model for adnexal malignancy

Conditions: Risk Malignant Index

Summary: the presence of an adnexal mass is a frequent reason for a woman to be referred to a gynaecologist. the discrimination between benign and malignant adnexal masses is central to decisions regarding clinical management and surgical planning in such patients. patients with malignant tumours should be referred to a gynaecological oncologist, as the quality of cytoreductive surgery and surgical staging/lymph node dissection are important prognostic factors in ovarian cancer. these specialized surgical procedures require the specific skills and experience provided by gynaecologic oncology surgeons. furthermore, appropriate and timely referral to a gynaecologic oncologist has been proven to increase survival in patients with ovarian cancer.conversely, patients believed to have a benign mass requiring surgery are able to have this performed by a general gynaecologist. a standardized method for preoperative identification of probable malignant masses would allow optimization of first-line treatment for women with ovarian cancer. a risk of malignancy index would be valuable for the selective referral of relevant patients to specialized oncology centres. currently, clinical examination, ultrasound assessment, and assays of tumour markers are part of the standard work-up for an adnexal mass. although none of these indicators alone is very sensitive or specific for detecting malignancy, an index developed by jacobs et al. incorporates information about the patient's menopausal status and serum cancer antigen a-125 levels, and ultrasound characteristics of the mass to predict the risk of malignancy with greater sensitivity and specificity than any one factor alone.some of the potential advantages of risk malignant index include rapid triage of patients through the referral system and fewer operations for benign masses being performed by gynaecologic oncologists.


Eligibility criteria:
inclusion criteria: 1. age at menarche to 60 years. 2. presence of ovarian mass clinically by vaginal or bimanual examination. 3. presence of sonographically diagnosed ovarian mass. 4. accepting and signing the informed written consent. exclusion criteria 1. known diagnosis of nature of mass by previous biopsy or ovarian malignancy scheduled for second look operation. 2. patient unfit for surgery or inoperable.
early flu shots in sot

Conditions: Influenza; Solid Organ Transplant

Summary: although time from transplant has been a factor in vaccine response, there is limited data on immunizations that occur in the first post-transplant year, and there are no data that suggest influenza vaccination early post-transplant may have any adverse effects on the graft. it is suggested that early vaccinations may lead to reduced immunogenicity due to induction immunosuppression. however, not vaccinating patients may leave them vulnerable to influenza infection for a period of time. this study is designed to look at the immunogenicity and side effects of the standard of care influenza vaccine in patients between 31 and 365 days post-transplant.

influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. influenza vaccine is effective in the prevention of influenza infection and is recommended by the canadian national advisory committee on immunization (naci). the annual influenza vaccine is suggested for transplant patients as the standard of care starting from 3 months post-transplant. most recent guidelines now suggest that it is reasonable to get a flu shot starting earlier at 1 month post-transplant. anti-rejection drugs are now tapered more quickly and it is possible that antibodies will be produced against the flu shot as early as 1 month post-transplant. the study hypothesizes that kidney and liver transplant recipients in the early post-transplant period (31-180 days) will have similar immunogenicity as those in the late post-transplant period (\>180 days).

Eligibility criteria:
inclusion criteria: * kidney, liver or pancreas transplant recipients on at least one immunosuppressive medication * age ≥ 18 * outpatient status * greater than 30 days post-transplant exclusion criteria: * has already received influenza vaccination for 2017-2018 season * egg allergy or allergy to previous influenza vaccine * febrile illness in the past one week * active cytomegalovirus viremia * use of rituximab in the past one year * ongoing or recent (in past 30 days) therapy for acute rejection * chronic kidney insufficiency (creatinine clearance ≤30ml/min or dialysis-dependent * previous life-threatening reaction to influenza vaccine (i.e., guillain barre syndrome) * receipt of intravenous immunoglobulin (ivig) in the past 30 days or planning to receive ivig in the next four weeks

Keywords: vaccine immunogenicity vaccine safety
zingiber and acmella against knee osteoarthritis

Conditions: Pain; Osteo Arthritis Knee

Summary: one-group pretest-posttest quasi-experimental design in which primary outcomes were: a) the evaluation of pain intensity, by a 30-days visual analogue scale (vas) and b) the assessment of knee function by western ontario and mcmaster universities arthritis index and by tegner lysholm knee scoring collected at baseline, at 15 and 30 days after treatment. secondary outcomes were the evaluation: c) of health-related quality of life, by the shortform36, d) of inflammation by c-reactive protein and erythrocyte sedimentation rate, and e) of body composition by dual-energy x-ray absorptiometry measured at baseline and 30 days after treatment.

to evaluate the safety and the efficacy on pain and inflammation of a new food-grade lecithin formulation of standardized extracts of zingiber officinale and acmella oleracea.

Eligibility criteria:
inclusion criteria: * established moderate knee oa (classification 1-3 according to kellgren and lawrence system for classification of knee oa) * lequesne index of 6-10; 3) body mass index (bmi) between 22 and 30 kg/m2 * aged 40-75 * no drugs for oa, such as nonsteroidal anti-inflammatory drugs (nsaids). exclusion criteria: * diabetes, metabolic disease, or neoplasia, as well as the patients with disabling diseases that could directly affect muscle weakness (such as neurological diseases, hip fractures, or amputations)
effects of anthocyans on cardiovascular and sympathetic function

Conditions: Hypertension

Summary: anthocyans modify cardiovascular and sympathetic function


Eligibility criteria:
inclusion criteria: * ages 35 to 50 years old * males * hypertension
tot and estrogen in postmenopausal females

Conditions: Stress Urinary Incontinence; Postmenopausal Disorder

Summary: to compare the subjective and objective outcomes of tvt-o procedure alone versus the same procedure followed by the use of premarin vaginal cream for 3 months in postmenopausal female with genuine stress incontinence.

a randomized controlled trial comparing the effect of using local estrogen cream after tot in postmenopausal female

Eligibility criteria:
inclusion criteria: -menopause patients included in group a should have: no history of breast cancer, ovarian cancer or uterine cancer no history of blood clots or thromboembolism no history of heart disease or stroke no history liver disease. endometrial thickness less than 5mm have a normal mammogram exclusion criteria: * presence of urge or mixed incontinence .

Keywords: post menopausal stress incontinence local estrogen
optimizing postoperative cognition the elderly

Conditions: Postoperative Cognitive Dysfunction; POCD

Summary: this study will recruit surgical patients more than 65 years old. patients who participate will wear a sticker on their forehead during surgery which monitors their brain waves (electroencephalogram, eeg) and participate in memory testing before and after surgery. brain wave patterns will be compared between patients who have problems with memory and thinking after surgery and those who do not. the hypothesis is that there will be characteristic brain wave patients for who will go on to have problems with memory and thinking after surgery.

eligible patients will be identified through the computerized scheduling system at the icahn school of medicine at mount sinai. after informed consent, patients will complete cognitive and tests at least one but not more than 30 days prior to surgery. in the recovery room the post anesthesia recovery scale (pqrs), and cam-icu delirium screening will be administered. immediate recovery will be recorded using the postoperative recovery scale (pqrs) on postoperative day 1 and 3, and 1 week. longterm functional recovery will be measured with the alzheimer's disease research center (adrc) instrumental activities for daily living (iadl-24). postsurgical complications will be recorded including unplanned icu admissions, postoperative myocardial infarction and stroke (risk less than 1 % in most cases), wound infection and reoperation. the full cognitive and functional battery will be repeated at 3 months and 1 year after surgery.

Eligibility criteria:
inclusion criteria: * 65 years of age and older * having major elective non-cardiac surgery requiring general anesthesia requiring at least a 2 day hospital stay exclusion criteria: * previous diagnosis of dementia, stroke, cardiac or intracranial surgery * inability to consent or communicate in english or spanish * major uncorrected hearing or vision deficit, parkinson's disease, or major psychiatric disease which will be determined by phone interview and computer medical records abstracted by the primary investigator.

Keywords: postoperative cognitive dysfunction elderly, geriatric anesthesia anesthetic depth bispectral index monitor function recovery after surgery surgery
study to estimate the point prevalence of peripheral intravenous catheter-related complications in brazil

Conditions: Infusion Site Injury

Summary: a multi-center, national prevalence study where: (1) baseline spivc therapy complications of hospitalized adult patients that meet the inclusion/exclusion criteria of the study and (2) the compliance of clinicians to the hospital's evidence based practice will be measured in brazil.

at each participating research site, select nurse clinicians who are experienced or experts in short peripheral i.v. catheter (spivc) therapy, will audit medical records and observe the spivc sites of adult patients in various hospital wards until a minimum total of 300 spivc sites are audited among 3 brazilian acute care hospitals. the wards audited will be selected by the investigator and will be audited during a specified time period until at least 100 spivcs are audited. the time to complete the study will depend on the size of the select wards, the number of nurse auditors and the number of monitoring visits required. there are no treatments. the short peripheral i.v. catheter-related medical devices (products) observed during the study are currently approved by brazil regulatory agencies, purchased by the hospital and available to the clinician at the time of the study.

Eligibility criteria:
inclusion criteria: * male or female subject, aged 18 years or older at the time of the study's audit of the ward; * subject admitted into one of the wards audited at the study site; * subject available for observation at the time of the audit; * subject with at least one inserted pivc; * subject that voluntarily signed and dated the informed consent form (icf) prior to study entry, if required by the study site's ethics committee. exclusion criteria: * subject under treatment at the study site's outpatient clinics; * subject admitted into a mental health ward, emergency ward or burn unit; * subject awaiting transfer to another facility.
food effect study for pf-06372865

Conditions: Healthy

Summary: this study has been designed to investigate the effect of high fat food on the pharmacokinetics of pf-06372865 when administered to healthy subjects as single oral doses.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs); exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * screening supine blood pressure \> 140 mm hg (systolic) or \>90 mm hg (diastolic), following at least 5 minutes of supine rest. * any condition possibly affecting drug absorption: current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecysectomy) which would be expected to influence the absorption of drugs.
study of abemaciclib in dedifferentiated liposarcoma

Conditions: Sarcoma; Dedifferentiated Liposarcoma

Summary: the purpose of this study is to test any good and bad effects of the study drug called abemaciclib. abemaciclib could shrink your cancer but it could also cause side effects. researchers hope to learn if the study drug will delay the growth of the cancer or shrink the cancer by at least one quarter compared to its present size. abemaciclib is not fda approved and has not been tested in liposarcoma, but it has shrunk tumors in patients with breast cancer, lymphoma, and lung cancer.


Eligibility criteria:
inclusion criteria: * a diagnosis of dedifferentiated liposarcoma confirmed at mskcc. * metastatic and/or locally advanced or locally recurrent disease that is not surgically resectable. * all patients must have measurable disease as defined by recist 1.1. patients must also have evidence of disease progression by recist 1.1 within 6 months of first dose of study drug. * any number of prior therapies (including none) is permitted. the last dose of systemic therapy (include targeted therapies) must have been given at least 2 4 weeks prior to initiation of therapy. patients receiving bcnu or mitomycin c must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy. * patients with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months are eligible. * age ≥ 18 years. * ecog performance status 0 or 1 * adequate organ and marrow function as defined below (uln indicates institutional upper limit of normal): * absolute neutrophil count ≥ 1.510\^9/l * hemoglobin ≥ 8.0 g/dl * wbc ≥ 3.0 x 10\^9/l * platelets ≥ 100 x 10\^9/l * total bilirubin ≤ 1.5 x uln except for patients with known gilbert syndrome * ast(sgot)/alt(sgpt) ≤ 3 x institutional uln * creatinine ≤ 1.5 x uln or creatinine clearance \> 50 ml/min (calculated by cockcroft-gault method) * patients must not have current evidence of another malignancy that requires treatment. * women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence). women must not breast feed while on study. * ability to understand and the willingness to sign a written informed consent document. * ability to swallow capsules exclusion criteria: * patients who have not recovered from adverse events of prior therapy to ≤ nci ctcaev4.0 grade 1. * patients receiving any other investigational agents. * patients who have received prior treatment with a selective cdk4 inhibitor * uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including hiv, active hepatitis b or c, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant women and women who are breast-feeding.

Keywords: abemaciclib i ly2835219 16-376
practicing self-control lowers the risk of smoking lapse

Conditions: Behavior, Addictive; Cigarette Smoking

Summary: the proposed study will investigate the role of self-control in smoking cessation and whether interventions that improve self-control can help reduce the risk of lapsing among smokers who wish to quit. our model predicts that the regular practice of self-control should lead to a building of strength and a general improvement in self-control performance. hence, smokers who practice self-control prior to quitting should be more likely to succeed in their cessation attempt than smokers who do not practice self-control


Eligibility criteria:
inclusion criteria: * smoked at least 10 cigarettes per day for at least two years * currently smoking exclusion criteria: * have at least an 8th grade education level * have a working touch-tone phone * report low motivation and efficacy to quit
exhit entre implementation trial of high intensity versus low intensity strategy

Conditions: Substance Use Disorders; Opioid Use Disorder, Severe; Opioid Use Disorder, Moderate

Summary: this study is a multi-site, cluster randomized, two group implementation trial comparing a low- versus high-intensity implementation strategy for supporting hospital-based opioid use disorder treatment (hbot) in community hospital settings where medication for opioid use disorder (moud) treatment has not been implemented.

the study will randomize approximately 24 community hospitals meeting defined eligibility requirements, including a desire to address oud among inpatients through the use of moud. community hospitals will be randomized 1:1 to implement a low- or high-intensity strategy. hospitals will be randomized with intervention implementation and oversight assigned to one of 3-4 geographically diverse hub academic medical centers with existing clinical and research expertise in hbot. the randomization will be stratified by site/hub. participants will be assessed for "engagement with moud", measured as the proportion of community hospital oud discharges engaged with moud within 34 days following hospital discharge during months 13-24 of the intervention. further outcomes will be assessed during the entire 4-year study period.

Eligibility criteria:
inclusion criteria: 1. be a community hospital deemed by the lead investigators to be in the region of a site/hub. region will usually be defined as state unless a compelling case can be made as to geographic feasibility of implementing the intervention and access to relevant medicaid data. 2. be willing to identify a site champion to promote and adopt change that can address oud in hospitalized patients. 3. have hospital personnel who state that their institution is interested in and would be willing to work to implement moud prior to hospital discharge. 4. commit to having buprenorphine-waivered prescribers willing and able to write prescriptions to bridge discharged patients to post-discharge oud treatment, or available direct entry into outpatient moud with methadone or buprenorphine. 5. have hospital staff who express willingness to engage with a site/hub team for training and for data collection. 6. be willing to be randomized to low-intensity or high-intensity implementation support. 7. provide inpatient general medical care. 8. have sufficient numbers of medicaid oud discharges (any listed diagnosis; sufficient is defined as at least enough such that when added to the other hospitals in the region there are on average 100 discharges per year). medicaid data must capture at least 3 discharge diagnoses, outpatient moud, and be available within no more than 12 months of discharge. exclusion criteria: 1. have an acs routinely prescribing moud at discharge. 2. have an existing, functioning hbot program or be imminently starting an hbot initiative, as confirmed by the investigator team. 3. be a veterans affairs hospital.

Keywords: hbot moud oud sud otp ed
lung bioavailability and total systemic exposure to beclomethasone17monopropionate and formoterol across two strengths of nexthaler inhalation powder

Conditions: Asthmatic

Summary: the study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to b17mp (active metabolite of bdp) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of chf 1535 nexthaler dpi at two dose strengths. at the same time, the study will assess if the lung deposition and the total systemic exposure to formoterol is affected by increasing doses of bdp.


Eligibility criteria:
inclusion criteria: * diagnosis of asthma as defined by global initiative for asthma (gina) 2011 * asthmatic patients already treated with low daily doses of inhaled corticosteroids (ics) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ics/long acting beta2 agonists (laba) fixed combinations. * patients with forced expiratory volume in 1 sec (fev1) \>= 70 % of predicted values * non or ex-smokers * body mass index (bmi) \>= 18.5 and \<= 32 kg/m2 exclusion criteria: * pregnant or lactating women unless using acceptable methods of contraception * diagnosis of chronic obstructive pulmonary disease (copd) * history of near fatal asthma * patients with abnormal qtcf at screening visit * hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period. * lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period. * history of drug addiction or excessive use of alcohol ; * diagnosis of restrictive lung disease. * patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids) * significant medical history or any laboratory abnormality indicative of a significant underlying condition

Keywords: patients adult