Kornimate/medical-research-clean huggingface dataset:
trial to evaluate the safety and efficacy of keppra after conversion to mono-therapy in subjects with partial epilepsy

Conditions: Epilepsy

Summary: a cohort of patients who became seizure-free during add-on treatment to one standard aed with keppra in a previous trial (n01031) were followed to assess whether seizure freedom was maintained. tolerability was documented.


Eligibility criteria:
inclusion criteria: * diagnosis of epilepsy with partial seizures; * having completed the trial n01031 of keppra as adjunctive therapy (skate); * seizure-free over the last 3 months prior to protocol visit 1; * 1 concomitant marketed aed at the time of trial entry and throughout the previous trial n01031; * on the clinical judgment of the investigator, progressive withdrawal of the concomitant aed and conversion to monotherapy with keppra can be attempted. exclusion criteria: * history of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous 5 years; * presence of known pseudoseizures within the last year; * presence or history of allergy to the components of keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives; * felbamate with less than 18 months exposure; * vigabatrin, without visual field assessment as per recommendation of the manufacturer, i.e., every 6 months; * uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.

Keywords: levetiracetam keppra
artificial intelligence-enhanced electrocardiogram diagnoses and predicts future regurgitant valvular heart diseases

Conditions: Electrocardiogram, Valvular Heart Disease

Summary: this is a retrospective study to establish models for the prediction of future valvular heart diseases with artificial intelligence-enhanced electrocardiogram (ecg).


Eligibility criteria:
inclusion criteria: * subjects that received ecg and echocardiography tests during a date frame. exclusion criteria: * subjects who is younger than 18 years of age.
etiology of community acquired pneumonia

Conditions: Streptococcus Pneumonia; Haemophilus Influencae; Mycoplasma Pneumonia; Chlamydia Pneumonia

Summary: the proposed study aims to provide current information, etiology and outcome of community-acquired pneumonia (cap), risk factors for for cap in isolates of streptococcus pneumoniae and haemophilus influencae, mycoplasma pneumoniae, chlamydia pneumoniae and legionella. risk factors, including patient demographics, comorbid illnesses, setting of presentation, causative organisms, antibiotic history, and resistance profiles will be assessed and outcome will be recorded.

the following information will be collected: age, sex, occupation, hospital location at the time of positive culture (er, medical ward, icu etc), date of positive culture, prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, co-morbid illnesses, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history. we will collect information retrospectively.

Eligibility criteria:
inclusion criteria: * all patients with streptococcus pneumoniae, haemophilus influencae, mycoplasma pneumoniae, chlamydia pneumoniae and legionella species infections during the time period the study will be reviewed. a community-associated pneumonia isolate will be defined as one which was recovered from a clinical culture from a patient at upmc who had no established risk factors for infection with an antibiotic resistant organism. established risk factors are defined as: isolation of the organism two or more days after admission for hospitalization or history of hospitalization, surgery, dialysis, or residence in a long-term care facility within one year before the culture date or the presence of an indwelling catheter or percutaneous medical device (eg, tracheostomy tube, gastrostomy tube, or foley catheter) at the time of the culture or previous isolation of an antibiotic resistant organism. exclusion criteria: * does not meet entry criteria

Keywords: pnuemonia influenca
continuous spinal anesthesia with hypobaric bupivacaine to preserve hemodynamics in elderly

Conditions: Hip Fracture; Hypotension

Summary: the study evaluates the potential beneficial effects on hemodynamics when hypobaric bupivacaine is used instead of isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture in elderly patients. half of the patients will receive hypobaric bupivacaine and the over half will reveive isobaric bupivacaine and hemodynamic data will be compared.

anesthesia for surgical repair of hip fracture is still controversial. large retrospective studies and systematic reviews failed to demonstrate the superiority of either general or regional anesthesia. however, continuous spinal anesthesia has been shown to preserve hemodynamics better than general and single shoot spinal anesthesia. however, hypotension still occurs with continuous spinal anesthesia. unilateral spinal anesthesia may be achieved by hypobaric bupivacaine when patients are in the lateral position. unilateral spinal anesthesia is more effective in preserving hemodynamics by limiting the spread of the sympathetic blockade to the operated side. our goal is to show that the use of hypobaric rather than isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture reduces incidence of hypotension.

Eligibility criteria:
inclusion criteria: * patients aged more than 65 years and scheduled for a surgical repair of a hip fracture. exclusion criteria: * contraindication to spinal anesthesia or peripheral nerve blocks including hemostasis anomalies, local infection, allergic reaction to local anesthetics. * dementia. * consent refusal.

Keywords: hip fracture elderly continous spinal anesthesia hypobaric bupivacaine isobaric bupivacaine hypotension
influence of cerebral oedema in intracerebral haemorrhage

Conditions: Stroke; Intra Cerebral Hemorrhage

Summary: in 2020, intracerebral haemorraghe (ich) remains the most devastating type of stroke. besides stroke unit care, no specific treatment has been proven effective yet. perihaematomal oedema (pho) could be a promising therapeutic target. however, the mechanisms, the natural history as well as the clinical impact of this pho remain unclear. the copitch study has been designed to answer these questions


Eligibility criteria:
inclusion criteria: * with a spontaneous ich, i.e. non traumatic * admitted within 12 hours of stroke onset. for wake-up strokes, time of last seen well will be considered as stroke onset * patient insured under the french social security * consent form signed exclusion criteria: * pure intraventricular haemorrhages * "secondary" ich: ich resulting from intracranial vascular malformation, intracranial venous thrombosis, head trauma or tumour; haemorrhagic transformation within an infarct * pre-admission modified rankin score of 4 or 5 * life expectancy of less than 1 year related to comorbidities (end stage cancer, end stage organ failure) * pregnancy or breastfeeding or women of childbearing age without effective contraception (a pregnancy test will be done) * adults who are deprived of their liberty by judicial or administrative decision * referral from other hospitals * contra-indication to mri : claustrophobia, ocular metallic foreign bodies (accidental or other) or in a risk area (nervous or vascular system);irremovable implanted medical device (pacemaker, neurostimulator, cochlear implants and others);metallic heart valve (mainly old heart valves) or vascular clips previously implanted on cranial aneurysms; gadolinium allergy * no consent form

Keywords: intra cerebral hemorrhage perihaematomal oedema mri outcome
p16 staining as prognostic biomarker in serous papillary endometrial cancer

Conditions: Serous Papillary Endometrial Cancer

Summary: p16 is a tumor suppressor protein implicated in serous papillary endometrial carcinoma. evidence from previous trials indicates that it may be used as a diagnostic biomarker distinguishing this disease from endometrioid endometrial cancer. additional evidence points to its prognostic value. the current study will evaluate p16 both as a diagnostic tool for serous papillary endometrial cancer and as a prognostic biomarker. following anonymization, histology blocks will be microtomed and stained for p16 and p53 proteins. blocks from endometrioid endometrial cancer will be used as a control group.


Eligibility criteria:
inclusion criteria: * diagnosis of endometrial cancer * histology block exists in hospital's library exclusion criteria: * none

Keywords: serous papillary endometrial cancer endometrioid endometrial cancer biomarkers p16 p53 prognosis
decision counseling program in increasing shared decision making and clinical trial participation in patients with stage 0-iv lung cancer (free to breathe)

Conditions: Lung Cancer

Summary: this clinical trial studies how well the decision counseling program works in increasing patient-physician shared decision making and participation in clinical trials for lung cancer patients. decision aids help provide patients with information that may help them select a course of action related to their cancer care when more than one alternative is available. it also encourages shared decision making allowing patients and their providers to make health decisions together. determining how patients make decisions about participating in a clinical trial may help doctors facilitate patient decision making and improve participation in lung cancer clinical trials.

primary objectives: i. facilitate patient deliberation about participation in a lung cancer clinical trial using the decision counseling program (dcp). secondary objectives: i. document the extent to which patient values and preferences are incorporated into physician-patient shared decision making (sdm) about cancer clinical trials. ii. assess changes in patient knowledge, anxiety, and decisional conflict related to clinical trial participation. iii. characterize patient and physician experience with intervention exposure.

Eligibility criteria:
inclusion criteria: * patients diagnosed with lung cancer (stages 0, 1, 2, 3, 4) * lung cancer patients for which there is an available interventional clinical trial open at jefferson kimmel cancer center * patients being treated by a lung medical oncologist on the center city campus of thomas jefferson university * able to provide informed consent * english-speaking exclusion criteria: * inability to communicate in english * unable to provide informed consent * not eligible for an open, actively accruing interventional trial at jefferson
laparascopy versus laparatomy in the management of ruptured ectopic pregnancy

Conditions: Ruptured Ectopic Pregnancy

Summary: standard management for patients with ruptured ectopic pregnancies at our institution is treatment by laparotomy. this trail will investigate the feasibility of treatment with laparoscopy and will look at outcomes such as hospital stay and pain experienced the hypothesis is that laparoscopy is a feasible treatment option associated with shorter hospital stay and less pain

laparoscopic surgery for the surgical management of women diagnosed with ectopic pregnancies has become the standard of care in many institutions around the world. laparotomy is still the standard of care at kalafong hospital. there is very little high quality evidence with regard to the optimal surgical management approach for women with ruptured ectopic pregnancies. the study aims to compare laparotomy with laparoscopy in this group of women with regards to outcomes such as length of hospital stay, number of days off work and pain. this randomised study will be conducted at kalafong hospital, on 140 patients diagnosed with ruptured ectopic pregnancy who are haemodynamically stable and are able and willing to provide informed consent.

Eligibility criteria:
inclusion criteria: * age \>18 years * able to give informed consent * must have two of the following three: * systolic blood pressure \>90 mmhg * pulse rate \<100 beats per minute * heamoglobin \>8 g/dl exclusion criteria: * \<18 years * haemodynamically unstable * not able to give informed consent

Keywords: laparoscopy ruptured ectopic pregnancy
external fixation versus splinting of acute calcaneus fractures

Conditions: Calcaneus Fracture

Summary: aim: * determine if external fixation decreases soft tissue complications compared to splinting. * determine if external fixation decreases time to definitive surgical stabilization and improves final fixation compared to splinting. * determine if external fixation improves functional outcomes as evaluated by validated functional scoring systems. hypothesis: * external fixation improves definitive fixation and functional outcomes of acute calcaneal fractures with decreased complication rates compared to splinting


Eligibility criteria:
inclusion criteria: * voluntary consent * age 18 to 69 * clinical and/or advanced imaging confirming an acute calcaneal fracture that has occurred within 2 days of which, eventually definitive surgery is recommended/accepted. * unable to consent exclusion criteria: * age \<18 * prior surgery of the affected extremity * prisoners * pregnant women * inflammatory arthritis * non-english-speaking patients

Keywords: staged external fixation splinting soft tissue complications
kupewa: optimizing strategies to implement provider recommendation of hpv vaccination for adolescent girls and young women with hiv in malawi

Conditions: Human Papilloma Virus (HPV)

Summary: the goal of this clinical trial is identify an effective and implementable set of implementation strategies to increase provider recommendation of human papillomavirus (hpv) vaccination, and hpv vaccine uptake, among girls and young women in malawi. the main questions it aims to answer are: 1. which implementation strategies produce the greatest increase in provider recommendation for, and uptake of, hpv vaccination among girls and young women receiving hiv care. 2. what is the acceptability, appropriateness, feasibility, and cost of these implementation strategies. 3. what is the sustained effect of these implementation strategies. the implementation strategies will be conducted with health workers (clinical officers, nurses, and medical assistants): training about hpv vaccination, coaching on how to give a hpv vaccination recommendation, and a system to remind health workers to offer the hpv vaccine to eligible clients.


Eligibility criteria:
inclusion criteria: * health workers: people who provide medical care and counseling (typically medical assistants, clinical officers, and nurses), and interact with adolescent girls and young women aged 9-24 and/or their parents/caregivers. * clients: non-pregnant females aged 9-24 (for those aged 9-17, their male or female parent/guardian will also be eligible for participation) who have not completed the hpv vaccine series and present for hiv care at a participating health facility during the study period. exclusion criteria: * health workers: less than 18 years of age, or not an active and regular provider of medical care or counseling at the facility, or unable or unwilling to provide informed consent * clients: \ 24 years old, or pregnancy, or completed hpv vaccine series prior to study, or unable or unwilling to provide informed consent
serologic response to shingrix vaccine in patients with cll and wm treated with btk inhibitors

Conditions: Chronic Lymphocytic Leukemia (CLL); Waldenstrom Macroglobulinemia (WM)

Summary: the primary objective of the study is to assess the capability of a patient with chronic lymphocytic leukemia (cll) or waldenström macroglobulinemia (wm) to generate an immune response to the shingrix vaccine under first-line btk inhibitors.

chronic lymphocytic leukemia (cll) and waldenstrom's macroglobulinemia (wm) are known risk factors for zoster reactivation, commonly called shingles. although a recently fda-approved recombinant, adjuvanted herpes zoster vaccine (shingrix) is currently being offered to these populations, no study has specifically evaluated them. the purpose of the study is to complete a single-arm trial evaluating if patients with cll or wm, while on treatment with first-line btk inhibitors, can achieve immunologic response to shingrix. if effective, this will result in a new, well-tolerated shingles prevention strategy for these patients. the primary objective is to assess the capability to mount a humoral immune response to shingrix in patients with cll or wm under first-line btk inhibitors.

Eligibility criteria:
inclusion criteria: * they are at least 50 years of age; * have been diagnosed with chronic lymphocytic leukemia (cll) or waldenström's macroglobulinemia (wm) * have been on first-line btk inhibitor (ie ibrutinib or acalabrutinib) for at least 3 months, * prior treatment with single agent rituximab is permitted if last dose was administered over one year ago; * have at least a one-year life expectancy; * have a history of varicella (chicken-pox) or lived in the us or any endemic country for \> 30 years. * prior radiation therapy is allowed exclusion criteria: * they have a known hypersensitivity to a vaccine component; * had herpes zoster reactivation within the past year; * had received or were scheduled to receive a live virus vaccine in the period from 4 weeks prior to dose 1 through 28 days post-second dose; * had received or were scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to dose 1 through 7 days post- second dose; * are unable to give informed consent; * have absolute lymphocyte counts greater than 20,000 x 109/l; * are receiving treatment for cll or wm with an additional agent other than a btk inhibitor; * had rituximab treatment within a year prior to study start; * had prior chemotherapy.

Keywords: shingles vaccine (shingrix) chronic lymphocytic leukemia (cll) waldenstrom macroglobulinemia (wm) pilot study
post urs chemotherapy instillation

Conditions: UTUC

Summary: the goal of this study is to evaluate the safety and oncological outcomes of single chemotherapy bladder instillation following endoscopic treatment for utuc in utuc suspected patients .the main aim is to determine the efficacy of a single, post urs, chemotherapy bladder instillation to reduce ivr. participants will be given single chemotherapy bladder instillation within 24h following ureteroscopy and will follow routine follow-up for ivr which will include white light cystoscopy ;patients with suspected ivr (based on either imaging or cystoscopy) will undergo turbt.

urs is routinely used for both diagnosis and treatment of utuc - it is used either as an initial diagnostic procedure or as a curative procedure in cases amenable for endoscopic tumor ablation; either with low-risk disease or an imperative indication due to impaired renal function. following extirpative surgery patients are prone to ivr. those patients undergo routine follow-up with cystoscopy and in cases of ivr require turbt and further management based on bladder cancer protocols. in this setting, a single post-operative bladder instillation with various chemotherapeutic agents has shown a significant reduction in ivr rates following rnu. retrospective evidence suggests there is an increase ivr rates following urs for utuc. in this study the investigators seek to evaluate the efficacy of a single, post urs, bladder instillation with chemotherapy to reduce ivr.

Eligibility criteria:
inclusion criteria: * radiographic and/or cytological suspicion for utuc * planned endoscopic procedure for treatment / diagnosis of utuc * patients with bladder cancer history are eligible if meeting both following criteria: no recurrence within the last two years are not on active bladder irrigation protocol * patients with history of utuc are eligible if last endoscopic treatment or rnu was \>1 year prior to enrollment * age ≥ 18 years * performance status ecog 0-2 exclusion criteria: * subjects who have had bladder / prostate radiotherapy * subjects with bladder cancer history on active bladder irrigation protocols or with active disease within two years prior to enrollment * subjects with previously treated utuc within one year prior to enrollment * subjects with metastatic disease

Keywords: diagnostic urs single-dose chemotherapy bladder instillation ivr
automated breast ultrasound as an adjunct to screening digital breast tomosynthesis

Conditions: Breast Cancer

Summary: the purpose of this study is to assess whether the invenia™ automated breast ultrasound (abus) device, as an adjunct to digital breast tomosynthesis (dbt), improves breast cancer detection in women with dense breasts. the study aims to collect information about cancer detection, treatment, and outcomes based on individual and combined technologies in patients who receive abus exams in addition to dbt. the results of this study are intended to be used to extend understanding of abus as an adjunct in dbt screening in patients with dense breasts.

following consenting procedures, subjects will undergo standard of care dbt of both breasts or of one breast if they have had prior uni-lateral mastectomy. subjects will also undergo abus of both breasts or of one breast if they have had prior uni-lateral mastectomy. these imaging exams will be done per the sites routine practice, and can be done in any order. images will be read and assessed by one (1) mammography quality standards act (mqsa)-qualified reader. the evaluating radiologist will use the image reconstruction views appropriate for the evaluation, per his or her medical judgment, and handle diagnostic evaluations in accordance with the standard of care at the investigational site. the dbt images will be read and assessed first and independent of abus images. dbt plus abus will then be read per routine practice and assessed. images will not be read until both imaging exams have been completed. if screening shows a suspicious finding, subjects will receive standard of care follow-up and appropriate workup, which may include biopsy (as needed), to determine cancer status. subjects will be followed at approximately one year (11- to 16-months) unless negative histopathology with image concordance or positive cancer status is histologically determined prior to one-year follow-up. follow up procedures will be conducted as per the sites standard of care.

Eligibility criteria:
inclusion criteria: 1. are asymptomatic adult women (aged 40 years or older); 2. are presenting for a dbt breast cancer screening exam; 3. have heterogeneously dense or extremely dense breasts (bi-rads c or d) 4. are able and willing to participate. exclusion criteria: 1. have been previously included in this study; 2. have undergone diagnostic or surgical intervention in the last 12 months, including, but not limited to, core or open biopsy, clip placement, fine-needle aspiration, cytopunction, breast reduction or reconstruction, implant removals; or 3. have had a breast cancer diagnosis or treatment in the past 12 months and have re-entered the screening population.

Keywords: screening diagnostic