Kornimate/medical-research-clean huggingface dataset:
vascular fingerprint validation study

Conditions: Testicular Cancer

Summary: the vascular fingerprint is a simple selection tool to identify testicular cancer patients with a high risk of arterial cardiovascular events during and in the first year after cisplatin chemotherapy. eventually, this selection method allows a relative small randomized intervention study with i.e. lmwh during chemotherapy to prove the effectiveness and safety in lowering the chance of an arterial cardiovascular event.

since the introduction of cisplatin in the late seventies (1), the prognosis of metastatic testicular cancer patients has dramatically improved, with long-term survival rates of 80-90% (2). however, cure rates are compromised by the increased risk of cardiovascular events (3-5). approximately 1-5% of the patients with metastatic testicular cancer develop arterial cardiovascular events during or shortly after cisplatin- and bleomycin containing chemotherapy (3-7). arterial cardiovascular events include ischemic stroke and myocardial infarction. these arterial events are a source of serious treatment-induced morbidity and mortality as recently clearly confirmed by fung (8). no established standard prophylaxis is available. there is an unmet need to have the possibility to identify high risk patients before start of chemotherapy in whom prophylactic anti-coagulant treatment may prevent events (9). an identification tool could maximize the benefit of an intervention without introducing too much unnecessary harm: preventive interventions also carry risk. recent data from the investigators' cancer center showed that before chemotherapy 22% of the metastatic cancer patients had ≥3 of the following 5 traditional cardiovascular risk factors present (high risk vascular fingerprint, figure 1): overweight, smoking, hypertension, dyslipidemia and impaired blood glucose. these patients had an increased risk to develop arterial events during or early after chemotherapy: 19% of the patients with a high risk vascular fingerprint developed an arterial cardiovascular event whereas only 2% of the patients with ≤2 risk factors developed an event . the vascular fingerprint seems an easy method to identify which metastatic testicular cancer patients are at a high risk for early arterial events and who may benefit from prophylaxis with for example low molecular weight heparins (lmwhs). to be used in the clinic these data need to be confirmed in an independent cohort.

Eligibility criteria:
inclusion criteria: 1. diagnosis of metastatic tc and an indication to start with first-line cisplatin-based chemotherapy for metastatic tc 2. classified into igcccg good or intermediate prognosis group 3. younger than 50 years of age at start of chemotherapy 4. signed informed consent exclusion criteria: 1. history of previous cardiovascular disease 2. retroperitoneal mass \> 5 cm 3. indication for anticoagulant therapy at start of chemotherapy
survivorship care plans in a community oncology practice

Conditions: Breast Cancer; Prostate Cancer; Colorectal Cancer

Summary: this is a two part observational study evaluating the feasibility of implementing an ehr-based model within a community oncology practice.

part 1: the research team will use a sociotechnical work systems model, developed by researchers at the university of wisconsin (uw) systems engineering initiative for patience safety (seips), to guide analysis of the work system barriers and facilitators to implementing an ehr-based care planning model in community oncology practice, collected from direct observations. part 2: the research team will measure reach/maintenance (percentage of survivors with ehr-based survivorship care plans (scps) over a 9-month time period) and impact (pre/post survey of patient satisfaction and perceived care coordination).

Eligibility criteria:
inclusion criteria: * clinicians: provide cancer care to brca, crca or prca * clinicians: are a physician, advanced practice practitioner, nurse, or equivalent * patients: have a diagnosis of breast, colorectal, or prostate cancer for which and ehr-based scp will be provided * patients: have been treated with curative intent (e.g. surgery, chemotherapy and/or radiation therapy) for a stage 1-3 cancer diagnosis * patients: have received some part of active cancer treatment * patients: have complete active treatment (defined as surgery, chemotherapy, and/or radiation therapy). her2-based and endocrine therapies may be ongoing and do not need to have been completed exclusion criteria: * unable to complete or unwilling to answer questions in english * patients: received all active cancer treatment elsewhere (e.g. "observation - only" patients) * patients: have metastatic cancer

Keywords: brca prca crca
project attention deficit hyperactivity disorder (adhd) and electroencephalography (eeg)-neurofeedback therapy

Conditions: ADHD

Summary: background: electroencephalography (eeg)-neurofeedback has been shown to offer therapeutic benefits to patients with adhd in several mostly uncontrolled studies with relatively small sample sizes. it is unknown how eeg-neurofeedback affects brain functioning and exerts therapeutic effects in adhd. this study is designed to examine the efficacy and safety of eeg-neurofeedback in a scientific rigorously way and to study the underlying neurobiological mechanisms of eeg-neurofeedback. objectives: 1. to investigate the efficacy of eeg-neurofeedback in reducing behavioral symptoms of adhd. 2. to investigate whether eeg-neurofeedback is able to improve neurocognitive functioning. 3. to investigate whether eeg-neurofeedback is able to improve neural functioning. study design: double-blind randomized placebo-controlled treatment study.study population: 120 subjects with adhd (age 8-15, iq of 80 or more). intervention: 60 subjects with adhd receive 30 sessions eeg-neurofeedback, and 60 subjects with adhd receive placebo eeg-neurofeedback. main study parameter: adhd-dsm-iv rating scale, rated by the investigator. hypothesis: the hypothesis is eeg-neurofeedback can reduce symptoms of adhd.


Eligibility criteria:
inclusion criteria: * diagnosis adhd, classified by the (diagnostic and statistical manual of mental disorders, 2000) * age between 8 and 15 * a full scale iq of more than 80 * psychopharmaca- naïve or -free, or using a stable dosage of psychostimulants or atomoxetine but still with room for improvement (defined by an average score of more than 1 on adhd-dsm-iv rating scale). * deviant eeg of more than 1.5 standard deviation compared to the database exclusion criteria: * currently intensive (i.e. weekly) individual or group psychotherapy * regular use of medication other than psychostimulants or atomoxetine * diagnosis of one or more of the following comorbid psychiatric disorders: * major depression * bipolar disorder * psychotic disorder * chronically motor tic disorder or gilles de la tourette * conduct disorder * autism spectrum disorders * eating disorders * neurological disorders (e.g. epilepsy) currently or in the past * cardiovascular disease currently or in the past * participation in another clinical trial simultaneously * eeg-neurofeedback training in the past * use of alcohol or drugs

Keywords: adhd children eeg-neurofeedback
informative of surface electromyography and prognostic factors in assessing the recovery of balance and gait after stroke

Conditions: Brain Ischemia

Summary: the aim of the biomedical research is to determine the informativeness and prognostic factors of surface electromyography by assessing the probability of recovery of balance and gait parameters in the second stage of rehabilitation of persons with cerebral infarction.


Eligibility criteria:
inclusion criteria: * cerebral infarction for the first time; * age from 18 to 89 years old; * muscle strength according to the oxford scale is 3-5 points; * able to walk without the help of others; * is able to communicate and understand instructions properly; * agrees to participate in the study (voluntary, explicit, informed written consent to participate). exclusion criteria: * muscle strength according to the oxford scale is 0-2 points; * unable to walk without the help of others; * sensorimotor aphasia or other perceptual disorders; * do not sign the informed consent.

Keywords: surface electromyography gait balance ischemic stroke
efficacy of azithromycin in msaf cases to improve maternal and neonatal outcomes

Conditions: Meconium Stained; Azithromycin; Postpartum Endometritis

Summary: meconium stained amniotic fluid increases the risk of maternal complications (e.g., dystocia, operative delivery, and postpartum endometritis) and neonatal complications (e.g., sepsis, admission to the neonatal intensive care unit \[nicu\], and meconium aspiration syndrome). the goal of the study is to compare between azithromycin vs placebo in cases of meconium stained amniotic fluid during the first stage of labor in multigravida women and their effect on maternal and neonatal outcomes.

meconium stained amniotic fluid, a troublesome situation both for obstetrician and pediatrician, it is associated with high rates of caesarean section, perinatal morbidity and mortality. the rate of meconium-stained amniotic fluid varies from 12 to 20%.it is higher in underdeveloped countries.our study design would be a prospective randomized trial. consented, eligible pregnant women presenting during the first stage of labor at or more than 37 weeks of gestation with meconium stained amniotic fluid will be randomized to receive azithromycin capsule (zithromax, pfizer) (250 mg / 12hrs on empty stomach for 3 days)(group 1).group 2 will be offered placebo capsules (manufactured in pharmacy department with the same shape, color and consistency as azithromycin capsule for 3 days).

Eligibility criteria:
inclusion criteria: 1. multigravida pregnant women with meconium stained amniotic fluid encountered either by spontaneous/artificial amniotomy during the first stage of labor in the ward provided that the gestational age at delivery is 37 weeks of gestation or more. 2. singleton living gestation 3. cephalic presentation 4. adequate pelvis 5. an informed written consent for the proposed study. exclusion criteria: 1. primigravids 2. women with previous cesarean section 3. multifetal gestation 4. intrauterine fetal death 5. malpresentations 6. prematurity (\<37 weeks ) 7. abnormally invasive placenta during the current pregnancy 8. medical disorders with pregnancy 9. contracted pelvis 10. evidence of maternal infection 11. allergy to azithromycin or other macrolides that is self-reported or documented in the medical record.

Keywords: azithromycin placebo postpartum endometritis
assess the seroconversion status of health care workers suspected or confirmed cases of covid-19 patients

Conditions: Covid-19

Summary: a large number of health care workers (hcws) would be potentially getting exposed to covid19. some of them would be asymptomatic or may get subclinical symptoms. our hcw would have higher exposure and possibly higher seroconversion either symptomatic or with clinical symptoms than the general population. this study is aimed to understand the rate of seroconversion states at different stages of exposure. it is crucial to collect baseline immune status and the early immunological changes that might occur in asymptomatic or symptomatic health care workers and to compare that with the suspected or confirmed cases by following them for six weeks.

this prospective observational, longitudinal study is being conducted at max super specialty hospital, saket, new delhi. below mentioned are the study objectives- primary objectives * to determine the extent of infection in the healthcare workers (hcw) of a tertiary care hospital in india, by determining the seropositivity * to compare immune changes that might occur in healthcare workers who are asymptomatic or symptomatic with the proven positive cases in opd or ipd at max hospital. secondary objectives * to determine the fraction of asymptomatic or subclinical infections * to understand the seroconversion status at different stages of exposure to front line hcw the study population would include all employees of max hospitals, delhi-ncr, who have been tested for covid-19. samples and data of the covid positive patients admitted in the hospital will also be collected and opd patients coming to the hospital for covid-19 testing will be one of the study subsets.

Eligibility criteria:
inclusion criteria: * healthcare workers of max hospital, irrespective of age and gender or * covid-19 positive patients admitted in the hospital or * out-patients getting tested for covid-19 exclusion criteria: * refusal to give informed consent, or contraindication to venipuncture.

Keywords: seroconversion healthcare workers covid-19
impact of a smartphone intervention on tanzanian women's childbirth location

Conditions: Maternal Death Affecting Fetus or Newborn; Delivery Complication; Obstetric Complication; Birth Injuries; Delivery; Injury, Maternal; Delivery Problem for Fetus

Summary: this study investigates whether training community health workers (chw) to use a smartphone-based prenatal counseling application as a "job aid" instead of the existing paper based standard is associated with increased women's use of maternal health services in singida region, tanzania.

in low-income countries, frontline community health workers (chws) have potential to improve women's access to maternal health services through prenatal counseling and referral. however, chw performance can often be enhanced with sufficient training, incentives, supportive supervision and job aids. smartphone-based applications designed to assist chws with referrals, health education and client counseling may improve the quality of care delivered during household visits. there is a need for rigorous scientific studies on the impact of such interventions. this study investigates whether chws' use of a smartphone-based application increases women's use of maternal health services in singida region, tanzania. it is hypothesized that smartphone-assisted counselling by chws can increase use of health facility-based delivery services compared to a control group of chws using standard paper-based protocols. this study is conducted within the context of larger project - sustain-mnch project (supporting systems to improve nutrition, maternal, newborn and child health), implemented by world vision through multiple partners.

Eligibility criteria:
inclusion criteria: * client of one of the chws enrolled in the mhealth study * visited at least once by a chw following intervention (baseline training for chws) and during their most recent pregnancy * most recent delivery was a live birth and the child is still living exclusion criteria: * none

Keywords: maternal health community health health services tanzania evaluation cluster randomized trial
the comparison of 50% as versus pfat+ 0.05 % coe in severe dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: the present study aimed to evaluate and compare the efficacy of a 1 month clinical trial of 50% as for the treatment of severe dry eye syndrom (des) based on schirmer's test, tear break-up time (tbut), fluorescein staining, and ocular surface disease index (osdi) scores, as compared to conventional preservative-free artificial tears (pfat) plus 0.05% coe treatment in patients with severe des

this is an retrospective comparative study. the designation of the patient whether to use as 8\*1 or conventional pfat 8\*1 plus coe 2\*1 was determined randomly. student's paired samples t-test, independent samples student's t-test, wilcoxon signed-rank test and mann-whitney u test were used to compare data. all patients responded well to both treatments after the first 1-month treatment period, based on comparison of before and after treatment osdi scores, schirmer's test results, tbut values, and oxford scale scores.

Eligibility criteria:
inclusion criteria: * refractory to conventional treatment (those that did not respond well to entire dry eye medications containing hydroxypropyl methylellulose, carboxyl methylcellulose, polyvinyl alcohol, polyethylene glycol-propylene glycol, sodium hyaluronate, mineral oil, dextran, and carbomer artificial tears with or without preservatives) * had low tbut (\< 5 s) (5μl of fluorescein sodium 2% eye drops was used) * low schirmer's test i score without topical anesthesia ( basic+reflex secretion), positive corneal and conjunctival fluorescein staining (≥grade 1 according to the oxford scale) (3) and an osdi score \> 40 osdi was a reliable and valid test for quantifying the severity of dry eye symptoms exclusion criteria: * active ocular infection or any other inflammation not associated with dry eye * a severe associated ocular allergy, eyelid or eyelash abnormality * current contact lens use, history of refractive surgery * associated glaucoma * current use of any type of topical eye drops other than dry eye medications * any known graft-versus host disease * known severe anemia (hemoglobin\<11 g/dl-1) * medically uncontrolled significant cerebrovascular and cardiovascular disease * pregnant and lactating patients

Keywords: dry eye autologous serum cyclosporine ophthalmic emulsion
implementation study of dementia guidelines in primary care

Conditions: Dementia

Summary: the purpose of this study is to determine whether a specially developed dementia training program for duos of general practitioners and primary care nurses is able to increase the number dementia diagnoses in elderly people living in the community and increase the adherence to clinical dementia guidelines

background early diagnosis of dementia benefits both patient and caregiver. nevertheless, dementia in primary care is currently under-diagnosed in developed countries. in several countries educational interventions were developed to improve dementia diagnosis and management in primary care. some of these interventions were successful in increasing the number of dementia diagnoses and in changing attitudes and knowledge of health care staff. however, none of these interventions focussed on collaboration between gps and nurses in dementia care. we developed a dementia training program (dtp) aimed at stimulating collaboration in dementia primary care. we expect it to increase the number of cognitive assessments and dementia diagnoses, as well as to improve attitudes and knowledge of gps and nurses. methods/design the dtp is a complex educational intervention and consists of 2 workshops, a coaching program, and case-based consultations either face-to-face or by phone or e-mail, access to an internet forum, and a computerized clinical decision support system on dementia diagnostics and management. 100 duos of gps and nurses will be recruited, from which 2/3 will be allocated to the intervention group and 1/3 to the control group. the effects of implementation of the dtp will be studied in an assessor blinded cluster-randomised controlled trial. primary outcomes are the number of cognitive assessments and dementia diagnosis in a period of 9 months, starting after workshop participation of the duos. secondary outcomes are measured on gp and nurse level: rate of adherence to national guidelines for dementia diagnosis, attitude, confidence and knowledge regarding dementia diagnosis and management; on patient level: number of emergency calls, visits and consultations and patient satisfaction; and on caregiver level: informal caregiver burden and satisfaction. data will be collected from gps' electronic medical dossiers, self registration forms and questionnaires. statistical analysis will be performed by using manova-method. also, exploratory analyses will be performed, in order to gain insight into barriers and facilitators for implementation and the causal relations between the rate of success of the intervention components and the outcomes.

Eligibility criteria:
inclusion criteria: * gp and practice or district nurse must participate as a duo exclusion criteria: * none

Keywords: improvement dementia early diagnosis dementia management primary care
ziconotide for non-cancer pain by intrathecal administration

Conditions: Pain, Chronic

Summary: although ziconotide's marketing authorization does not restrict its use to a given type of pain, the drug has been used mainly in cancer patients. most data on ziconotide-based intrathecal (it) treatment has therefore been obtained in this population, for whom the drug's place is clearly documented (national and international recommendations). in contrast the management of non-cancer pain is less straightforward, partly because of the very large range of possible clinical conditions, and the utilization of ziconotide is poorly documented, mainly described in single-centre small series. due to the lack of data, physicians are often reluctant to undertake this type of treatment, which may represent a loss of opportunity for patients. this registry aims at providing information on patients suffering from non-cancer pain refractory to standard therapy, treated by ziconotide-based intrathecal analgesia. patients suffering from all types of non-malignant pain will be eligible for the study, including but not limited to spinal cord injury, radiculopathy, failed back surgery, diabetic neuropathy, central pain syndrome, complex regional pain syndrome, chemotherapy-induced neuropathy, fibromyalgia. the collected data will cover the first 2 years of treatment.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years, 2. chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy, 3. having received information on and not opposed to data collection, inclusion criteria specific for the retrospective cohort: currently treated by ziconotide-based ita according to smpc whatever the duration of treatment inclusion criteria specific for the prospective cohort: naïve of ita and candidate to ziconotide-based ita or already treated by it route without ziconotide, scheduled for addition of ziconotide in the pump exclusion criteria: 1. contraindication to intrathecal therapy or to ziconotide 2. any condition that may jeopardize appropriate follow-up of the treatment 3. patient under guardianship or deprived of liberty by a judicial or administrative decision or unable to express opposition to data collection.

Keywords: ziconotide intrathecal analgesia non-cancer pain severe chronic pain