Kornimate/medical-research-clean huggingface dataset:
effect of vaccination in patients with recurrent respiratory papillomatosis

Conditions: Squamous Papilloma of the Larynx

Summary: vaccines against human papillomaviruses are now commercially available. one of the commercial vaccine contains antigens of both lr hpv types which cause virtually all cases of rrp. clinical trials have documented the safety and immunogenicity of this vaccine as well as its effectiveness in prevention of incident and persistent infection of the vaccinal types as well as a development of lesions caused by these types. after vaccination the antibodies level increases dramatically and the high levels of antibodies are present in the blood still after 6 years. furthermore, the neutralization antibodies to the vaccinal antigens have been detected in the cervical mucus of vaccinated women. the preliminary data are now available showing the presence of hpv-specific antibodies in the oral cavity in women after vaccination. the level of antibodies has been dependent on time since vaccination.

in our previous studies we have documented that in patients with rrp the level of hpv-specific antibodies is low and increases only after numerous surgery procedures. therefore the application of this vaccine to patients with rrp can stimulate increased level of antibodies in the blood as well as presence of virus-specific neutralization antibodies on the surface of upper aero digestive tract and neutralize viruses shed from new papillomas and in this way protect patient from spreading of the infection as well as to facilitate the decrease of load of infectious virus shed from the lesion. this can possibly lead to the inhibition of growth of the papillomatous lesion.

Eligibility criteria:
inclusion criteria: patients with rrp which sign the informed consent form with both parts of the study will be enrolled. exclusion criteria: patients who experience severe side effects of vaccination after the first or second dose will not be vaccinated with the third dose and they will be excluded from the study. patients who will not receive all three doses within one year and 30 days will be also excluded.

Keywords: hpv recurrent respiratory papillomatosis antibodies
heart at home- a self-care study

Conditions: Heart Failure

Summary: in the study benefits of using mobile phone assisted remote patient monitoring including self-measurements of blood pressure, heart rate and weight as well as monitoring of personal health status are investigated in the care of heart failure patients.


Eligibility criteria:
inclusion criteria: * diagnosis of systolic heart failure * nyha (new york heart association) classification \> 1 * left ventricular ejection fraction ≤ 35% * need for a regular control visit * time from the last visit no longer than 6 months exclusion criteria: * patients who were known to enter a major medical operation * severe comorbidity, * participation in other clinical trial during last three months- * poor compliance in terms of familiarity with mobile phone

Keywords: self-care, heart failure, telemonitoring, health care utilization
study on postoperative adrenal function assessment in patients with primary aldosteronism

Conditions: Primary Aldosteronism

Summary: this study employs a prospective, single-center, open, observational research design to evaluate postoperative adrenal cortical function in patients with primary aldosteronism (pa) and to explore indicators predicting postoperative adrenal insufficiency and their predictive efficacy

patients suspected of having primary aldosteronism and admitted for treatment, who are diagnosed with primary aldosteronism through at least one confirmatory test, and subsequently diagnosed with unilateral primary aldosteronism via bilateral adrenal vein sampling and acth stimulation test, will undergo surgery. those who have an acth stimulation test within one week postoperatively will be included in the study. this study employs a prospective, single-center, open, observational research design to evaluate postoperative adrenal cortical function in patients with primary aldosteronism (pa) and to explore indicators predicting postoperative adrenal insufficiency and their predictive efficacy

Eligibility criteria:
inclusion criteria: * patients diagnosed with unilateral primary aldosteronism who undergo surgical treatment and have their cortical function assessed by an acth stimulation test within one week postoperatively. exclusion criteria: * patients using medications that affect adrenal cortical function. * patients with a history of adrenal surgery * pregnant or breastfeeding women * patients with severe underlying diseases (such as liver or kidney failure) that may affect adrenal cortical function
risk stratification and early alerting regarding covid-19 hospitalization

Conditions: Covid19

Summary: the purpose of this research is to remotely monitor individuals who have tested positive for covid-19 to learn more about progression and recovery from the disease. individuals who test positive for covid-19 will wear the current health wearable device continuously and answer a brief series of questions on current health tablet daily for up to 30 days. the health data will be used to develop predictive models of hospitalization risk.


Eligibility criteria:
inclusion criteria: * living in the united states (contiguous states) * aged 21 years or older * able to provide documentation of +polymerase chain reaction (pcr) or +antigen test for covid-19 within the past 48 hours * self-reports that comfortable and willing to wear the wearable device and interact with a tablet-based interface daily * able to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow up. exclusion criteria: * under the age of 21 * received a positive test result more than 48 hours prior to contacting study staff or has a pending test for covid-19 * cannot confirm a pcr or antigen positive test for covid-19 * is unable to read english * is unwilling to wear the device 24 hours/day except for showering/bathing or interact with a tablet-based interface for daily questionnaire * is unwilling or unable to provide baseline data required for entry into the study * is unable to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow-up * heavy tattooing on both upper arms * known atrial fibrillation (permanent or paroxysmal) * has taken/is taking part in a covid-19 vaccine or treatment trial

Keywords: wearable at-home
cipn decision aid for the improvement of chemotherapy decision making in patients with breast cancer

Conditions: Breast Carcinoma

Summary: this clinical trial studies how well a chemotherapy-induced peripheral neuropathy (cipn) decision aid works in improving chemotherapy decision making among patients with breast cancer. cipn involves numbness or tingling in the hands or feet and is a debilitating side effect of several commonly used classes of cancer drugs. cipn symptoms are typically minor at first but can progress with continued treatment to severe symptoms that can affect long-term function, falls risk, and quality of life. symptoms sometimes resolve after treatment but in patients who experienced cipn, symptoms are still present 1 year post-treatment in about two-thirds of patients and 3 years post-treatment in approximately half of the patients. previous studies indicate patients lack awareness of long-term cipn symptoms. a decision aid that provides information about permanent cipn, that helps patients understand their treatment priorities, and prepares them for a discussion with their medical oncologist may lead to improvements in treatment decision making, satisfaction with decision making, and ultimately increase patient's achievement of their treatment goals.


Eligibility criteria:
inclusion criteria: * patients with breast cancer * currently receiving cycle three of taxane treatment * approval of medical oncologist to enroll patient * experiencing any cipn based on enrollment screening question, "in the last 7 days, what was the severity of your numbness or tingling in your hands or feet at its worst? none, mild, moderate, severe, very severe. patient is eligible if their answer is anything except "none" * access to a smartphone or similar device that can complete cipn decisionaid via qualtrics while in the waiting room exclusion criteria: * inability to read or speak english
adipose tissue content of fatty acids present in dairy fat and risk of stroke. the danish diet, cancer and health cohort

Conditions: Stroke

Summary: background: although low-fat dairy products are an integral part of a diet recommended for stroke prevention, the role of dairy fat in relation to the risk of stroke is not yet clear. objective: therefore the association of adipose tissue content of fatty acids, for which dairy products are a major source (12:0, 14:0, 14:1 cis-9, 15:0, 17:0, 18:1 trans-11 and 18:2 cis-9, trans-11), with incident total stroke and stroke subtypes will be investigated. design: the study is a case-cohort study nested within the danish diet, cancer and health cohort, including all incident stroke cases and a random sample of the total cohort.the fatty acid composition of adipose tissue biopsies was determined by gas chromatography and the content of specific fatty acids was expressed as percentage of total fatty acids. stroke cases were identified in the danish national patient registry and the diagnoses were individually verified. cox proportional hazard regression will be used to estimate the association between fatty acids and stroke.


Eligibility criteria:
inclusion criteria: born in denmark, aged 50-64 years, residing in the urban and suburban areas of copenhagen and aarhus, denmark. - exclusion criteria: pre-existing cancer diagnosis. previous stroke. -
safety and efficacy of at-1501 in patients with iga nephropathy (igan)

Conditions: IgA Nephropathy; IgAN

Summary: this is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of at-1501 in patients with biopsy proven igan and at least 0.75 g/24 hours of protein in their urine at the time of screening.

phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of at-1501 in patients with biopsy proven igan and at least 0.75 g/24 hours of protein in their urine at the time of screening. up to 42 eligible patients will receive one of 2 doses of at-1501. all patients are scheduled to receive at-1501 by intravenous infusion every 3 weeks for approximately 2 years.

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years of age 2. biopsy proven igan 3. urine protein ≥ 0.75g/24 hours at screening despite optimization with ace inhibitors or angiotensin receptor blockers (arb) 4. egfr ≥ 45 ml/min per 1.73 m2 or egfr \< 45 ml/min per 1.73 m2 and ≥ 30 ml/min per 1.73 m2 with a kidney biopsy within 2 years of screening showing \< 50% tubulointerstitial fibrosis 5. agree to comply with contraception requirements during and for 90 days after study completion. exclusion criteria: 1. any secondary igan as defined by the investigator 2. patients who have undergone a kidney transplant 3. any history of kidney disease other than igan 4. any history of diabetes (type 1 or type 2) 5. seated blood pressure \> 140 mmhg (systolic) or \> 90 mmhg (diastolic) at the screening visit. patients must be on a stable dose and regimen of an ace inhibitor or arb for at least 90 days 6. pregnancy or breastfeeding.

Keywords: iga nephropathy igan at-1501 cd40l monoclonal antibody proteinuria egfr upcr
molecular genetic, host-derived and clinical determinants of long-term survival in glioblastoma

Conditions: Glioblastoma

Summary: this pro - and retrospective multicenter clinical epidemiological study studies the molecular genetic, host-derived and clinical determinants of glioblastoma patients with an overall survival of more than 5 years. the different research focusses are: * identification of clinical parameters and patient characteristics / host-related factors in long-term survivors (focus 1) * identification of molecular tumor characteristics in long-term survivors (focus 2) * assessment of therapy-related parameters, including neuro-toxicity (focus 3) * immunological studies (focus 4)


Eligibility criteria:
inclusion criteria: * age \> 18 years at diagnosis * histopathological diagnosis of glioblastoma (reference histology available) and * survival \>5 years from diagnosis * availability of tumor tissue from initial glioblastoma diagnosis (ffpe or fresh-frozen) to validate the diagnosis centrally. * signed consent form (living patients) or ethics approval for anonymous data collection in case of retrospective analysis of deceased patients exclusion criteria: * not applicable
the effects of risperidone and olanzapine on thinking

Conditions: Schizophrenia; Psychotic Disorders

Summary: the goal of this research is to find ways to maximize the benefits of antipsychotic medications for cognition. hypothesis: risperidone and olanzapine will show greater benefits than conventional medications on assessments of social cognition, particularly affect perception and social perception.


Eligibility criteria:
inclusion criteria: * diagnosed with schizophrenia disorder by a dsm iv. * competent to sign informed consent * no history of poor response to risperdal and zyprexa * no organic brain disease exclusion criteria: * mental retardation or any chronic medical illness which results in the patient not being appropriate for a switch to risperdal or zyprexa.

Keywords: schizophrenia cognition antipsychotic medication information processing social cognition psychotic
covid-19 safe enrollment

Conditions: Covid19

Summary: in order to safely and effectively reopen businesses and universities across the us, institutions will need to develop approaches to rapidly identify covid-19 cases and manage their spread while balancing program effectiveness, feasibility, costs, and scalability. the investigators will evaluate the implementation of a covid-19 screening program that coordinates several existing systems at the university of pennsylvania including saliva-based viral testing and test different outreach strategies (opt-in vs opt-out) to improve program enrollment.

the coronavirus disease 2019 (covid-19) pandemic has resulted in close to 10,000,000 reported cases worldwide, including more than 2,000,000 aggregated reported cases and 120,000 deaths in the united states. initial efforts to address the covid-19 pandemic were aimed at testing symptomatic individuals, implementing stay-in-place orders, and at increasing hospital capacity to meet surge demands. while the us continues to confront the current crisis, we must plan for the future by putting in place tools to enhance our ability to conduct effective screening, containment, and case management. widespread covid-19 testing is needed to safely and effectively reopen schools and businesses across the us. however, currently approved testing options require reagents that are limited in supply, severely hindering scalability. emerging evidence indicates that saliva testing with the option of at-home sample collection can accurately identify covid-19 viral infection. additional diagnostic testing options will continue to increase patient access. moreover, this approach provides an option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor's office, hospital, or testing site. collection by the patient also reduces exposure of health care workers to the virus and preserves limited personal protective equipment. with access to expanded testing, health systems and universities will need to test alternative methods to manage covid-19 spread while balancing program effectiveness, feasibility, costs, and scalability. insights from the field of behavioral economics offer promise for designing and sustaining these kinds of policies. specifically, research has demonstrated that an opt-out framed recruitment strategy compared to a conventional opt-in strategy can improve enrollment and adherence to behavioral interventions. for these reasons, the investigators propose to evaluate the implementation of a covid-19 screening program that uses saliva-based testing and to test approaches to improve program enrollment.

Eligibility criteria:
inclusion criteria: •university of pennsylvania staff, faculty, and trainees that have returned to work on campus who have been identified by leadership at the university of pennsylvania perelman school of medicine. exclusion criteria: •participants will not be eligible for the study if they identify any reason they are unable to participate in the study.

Keywords: covid-19 coronavirus opt-in opt-out behavioral science
the effect of the non-invasive brain stimulation on the speech fluency enhancement

Conditions: Stuttering/ Developmental

Summary: the aim of this study is to determine the effectiveness of concurrent transcranial direct current stimulation (tdcs) and fluency training in adults with developmental stuttering. we examine the severity of stuttering to investigate the effect of treatnment. in the control group the anodal tdcs and daf will applied on six consecutive days (1 milliampere \[ma\] for 20 mins per day), and the control group will received the sham stimulation and daf for the same time. the severity of stuttering measured by means of tasks and questionnaires before and after treatment sessions and 6 weeks after intervention.


Eligibility criteria:
inclusion criteria: * history of developmental stuttering * participants diagnosed with moderate to severe stuttering * right handed * native speaker of farsi exclusion criteria: * speech or language disorders other than stuttering * received stuttering treatment within the past year * hearing loss * history of neurological or psychiatric disorders * history of seizure * taking any medication that may affect brain function such as anti-depressants
hostile interpretation bias training to treat irritability

Conditions: Irritable Mood; Mood Disorders

Summary: hostile interpretation bias may be a feature of severe, chronic irritability in children, one of the most common psychiatric symptoms of childhood. interpretation bias training (ibt) is a computer-based training program that may reduce irritability in youths. this trial lays the groundwork for a test ibt on irritability.

this trial lays the foundation for a preliminary test of efficacy of ibt on irritability by establishing ibt's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. the design is a single-blinded, randomized controlled trial of ibt on its targets. the study will have four arms, with 25 participants in each arm for all four conditions of training (active versus sham) and scanning (in mri or out of mri scanner). during ibt, participants judge as happy or angry facial expressions which are on a continuum between happy and angry. the point at which judgments shift from predominantly happy to angry on this continuum is the indifference point. during training feedback encourages no change in the indifference point or a change in the indifference point towards more happy judgments of ambiguous faces. a shift in indifference point towards more benign judgments is interpreted as a reduction in hostile interpretation. the design will test whether active relative to sham ibt shifts the indifference point towards more benign judgments. neural response to active versus sham ibt will be measured in half the sample.

Eligibility criteria:
inclusion criteria: * adolescents in mental health treatment, with at least: 1. mild, clinically significant irritability, and 2. typical intellectual functioning (iq\>80) exclusion criteria: * any of the following mental health diagnoses: 1. current post-traumatic stress 2. lifetime bipolar i or ii disorder 3. lifetime cyclothymic disorder 4. lifetime psychotic disorder 5. lifetime autism spectrum disorder * major medical problems, including head trauma. * mri-specific safety exclusions for the mri arms. * clinical instability.
evaluation of ari with opsens savvywire

Conditions: Aortic Valve Insufficiency

Summary: the goal of this observational study is to establish the degree of agreement to aortic regurgitation (ar) severity during aortic valve intervention between the aortic regurgitation index (ari) measured by the opsens savvywire, echography and aortography in subjects with severe aortic stenosis (as) undergoing echo guided valve intervention. the main question it aims to answer is how the ari measured with the opsens savvywire compared with regurgitation evaluation derived by echography and aortography.


Eligibility criteria:
inclusion criteria: * patients undergoing tavr suitable for intraoperative acquisition of tee/tte * age \> 18 years * able and willing to give informed consent. exclusion criteria: * hemodynamic instability making use of additional hemodynamic measurement inappropriate or 24-hour survival unlikely * subject is considered part of a vulnerable population.
iscador qu as supportive treatment in pancreatic cancer (union for international cancer control, uicc stages ii-iv)

Conditions: Pancreas Cancer

Summary: efficacy and safety of a supportive treatment with european mistletoe extract iscador® qu ("quercus", i.e. from oak tree) in patients with pancreatic cancer (union for international cancer control, uicc stages ii-iv), in addition to conventional oncological therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional therapy only. primary endpoints: reduction of adverse effects of conventional therapy; reduction of therapy or disease induced symptoms (both are quality of life parameters and evaluated after 1 year); prolongation of disease free and/or overall survival (dfs, os) after 3 years. prospective observational confirmation study of previous retrospective cohort study. as this is a non-interventional cohort study, all therapies and measurements are performed on directive by the treating physician and/or request by the patient only.

see summary

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pancreatic cancer, adenocarcinoma, uicc stage ii-iv * age between 18 (austria: 19) and 85 years * no previous malign tumor * ecog 0-2 * estimated life expectancy \> 3 months * surgical resection of the tumor (r0, r1) or determination of interoperability * conventional oncological therapy and measurements, or passive after-care ("best care") * follow-up for several years feasible * patient gives written consent to use the anonymized date for evaluation exclusion criteria: * other iscador® sorts than qu in the test group * other mistletoe preparations in the test group * any mistletoe preparation in the control group * non-oncological immunomodulating, -stimulating or -suppressive drugs (e.g. echinacea, interferons, polyerga®, bcg, azathioprine). allowed are approved tumor inhibiting immuno- or targeted therapies (e.g. bevacizumab, cetuximab) and tumor specific vaccines * hiv infection, aids, organ transplantation * contraindications for iscador® qu (allergy against mistletoe, acute inflammatory disease or fever \> 38.5°c, active tuberculosis, hyperthyreosis with not-adjusted metabolism, primary brain or spinal tumor, brain metastases) * patients participating in another clinical study with non-approved substances

Keywords: pancreatic cancer mistletoe supportive treatment long-term study non-interventional cohort study controlled study with parallel groups