Kornimate/medical-research-clean huggingface dataset:
non-interventional study with azacitidin (vidaza®)

Conditions: MDS; AML; CMMOL

Summary: the purpose of this non-interventional study is to collect data on the efficiency and safety of azacitidin in the routine application.


Eligibility criteria:
inclusion criteria: * patients who are not eligible for haematopoietic stem cell transplantation, who are at least 18 years old (no age limit to top) and who have one of the following diseases: * myelodysplastic syndrome (mds) with intermediate risk 2 or high risk according to the international prognostic scoring system (ipss) * chronic myelomonocytic leukemia (cmml) with 10-29% marrow blasts without myeloproliferative disorder * acute myeloid leukemia (aml) with 20-30% blasts and multilineage dysplasia according to classification of the world health organisation (who). exclusion criteria: * contraindication according to the summary of product characteristics of vidaza® * signed patient informed consent form is not available * patients with advanced malignant hepatic tumors * pregnant or nursing women, men and women (of childbearing age) who are unwilling to apply a reliable method of contraception during and up to three months after treatment with azacitidine * necessary or planned treatment with other systemic cytostatics * known medical history of severe decompensatoric cardiac insufficiency * medical history of clinically unstable cardiac or pulmonary disease * known or suspected hypersensitivity to azacitidine or mannitol

Keywords: azacitidin vidaza piaza myelodysplastic syndrome mds chronic myelomonocytic leukemia cmml acute myeloid leukemia aml daily routine concomitant antiemetic therapy germany non-interventional study
use of e-health based exercise intervention after covid-19

Conditions: COVID-19

Summary: reduced subjective and objective functional capacity performance are reported after covid-19 in a large proportion of subjects. the aim of this study is to examine the feasibility and effect of using an e-health tool for guidance and tracking of exercise training in a general population of adults previously infected by covid-19.

both hospitalized and non-hospitalized persons who have undergone extensive multi-disciplinary rehabilitation programs report significantly improved physical function after rehabilitation. exercise training may be the key intervention to improve fitness and subjective complaints such as fatigue, low physical fitness and dyspnea after covid-19 infection. however, traditional group-based exercise training or self-training programs at fitness centers have been shut down during the pandemic, and home-based interventions are warranted. to overcome the limitations and costs of a fitness center/personal trainer-based intervention study, more knowledge on the effectiveness and efficacy of using an e-health system to recruit, train and monitor participants after illness are needed.

Eligibility criteria:
inclusion criteria: * persons who have undergone covid-19 disease * people who struggle to be physically active enough as a result of corona disease * people who experience reduced physical fitness as a result of corona disease exclusion criteria: -- more than 100 pai per week (calculated from self-reported activity level) * uncontrolled hypertension (high blood pressure) (over 200/110). * symptomatic valve failure, hypertrophic cardiomyopathy, unstable angina, pulmonary * hypertension, heart failure and/or severe rhythm disturbances * cancer that makes participation impossible or exercise contraindicated. considered individually in consultation with the attending physician. * chronic contagious infectious diseases. * participates in other studies that are not compatible with participation in this project * post-exertional symptom exacerbation (pese)/post-exertional malaise (pem)/post-exertional neuroimmune exhaustion (pene).
analysis of the personality characteristics and lifestyle of young people who access psychiatric outpatient clinics

Conditions: Personality; Life Style

Summary: considering the growing importance of services psychiatric and psychological for adolescence and adulthood incidence of discomfort expressed in this age group, comes assessed the need to provide adequate and targeted services. reasons: the study aims to evaluate the characteristics and trends of adolescents who access the service, in order to frame the type of discomfort expressed and the expectations with respect to access to the service and the resource base on which it can the therapeutic intervention must be thought out and organised. furthermore, the study aims to identify the factors that influence the request for help and evaluate the quality of the assistance received, with the aim of improving it effectiveness.


Eligibility criteria:
inclusion criteria: - participants will be selected based on their age between 13 and 21, their availability to sign the informed consent. exclusion criteria: * patients who do not give their consent are excluded from the study. * patients who do not speak fluent italian or those who due to cognitive and/or thinking characteristics would not be able to understand or complete the questionnaire are also excluded.
new therapy of laryngeal papilloma in children

Conditions: Papilloma

Summary: this study will determine efficacy of a new and combined treatment of laryngeal recurrent respiratory papillomatosis (rrp), by using a 585 nm pulsed dye laser (pdl) and a dietary supplement, diindolylmethane (dim). we will compare this new treatment with pdl-only, in a total of 30 children (15 of each treatment), to determine whether this combined treatment would be effective and safe in preventing the rrp recurrence. this is the first study to combine pdl technique with dim, to develop a new, voice-preserving and long-term effective method of managing laryngeal rrp in children.

previous studies have demonstrated that pdl can be used to remove lesions on the vocal cords and elsewhere in the throat causing less damage to surface tissues than other commonly used lasers. in our proposed clinical study, we seek to compare treatment efficacy for rrp by combining pdl with dim, versus pdl-only treatment, in a total of 30 children with laryngeal papilloma. we will determine whether this combined treatment would be effective and safe in preventing or delaying the rrp recurrence while preserving voice quality. 30 children will be divided randomly into two treatment groups, 15 in each. the experimental group will receive one-time pdl treatment, followed by 3-month oral administration of dim and an additional 12 months with no treatment. the other group will be treated with pdl-only, as a control, and take a placebo pill for 3 months. all of the patients will be followed for a total of 15 months. we will compare lesion recurrence and laboratory tests between the two groups, to determine efficacy and safety of the new treatment. this is the first study to combine new pdl laser technique with dim, to develop a new, voice-preserving and long-term effective method of managing laryngeal rrp in children.

Eligibility criteria:
inclusion criteria: 1. 10 to 21 years of age 2. laryngeal papillomas requiring surgical treatment 3. willingness to participate in the study 4. a signed informed consent form by guardian or parent exclusion criteria: 1. age less than 10 year old, or older than 21 year 2. guardian or parent does not understand or can not sign the consent form 3. malignant diseases such as laryngeal cancer 4. history of being hypersensitive to cabbage or other cruciferous vegetables 5. pregnancy

Keywords: papilloma pdl diindolylmethane recurrence
smart heart study: cognitive benefits of cardiac rehabilitation

Conditions: Cardiovascular Disease

Summary: the proposed study will be the first to examine whether changes in blood flow patterns within the brain account for the possible cognitive benefits of cr. a clearer understanding of this possibility may provide key insight into the way cvd affects the brain, help identify effective treatments, help a greater number of patients return to work, and improve quality of life.

based on recent patient referrals, we expect that 30 participants will subsequently enroll in cr and 30 will not. cr patients will complete standardized neuropsychological tests (45-60 minutes) and transcranial doppler (30-40 minutes) during their first and last week in the cr program. patients who do not enroll in cr will undergo testing at similar intervals to serve as a matched control group. standard medical records will be collected for participants in both groups to obtain demographic and medical information. cr-specific medical records will also be collected to obtain information about possible mechanisms for cognitive benefits (e.g. improved stress test performance, reduced blood pressure, etc.). all participants will be compensated for their time.

Eligibility criteria:
inclusion criteria: - 50 to 85 years of age, able to communicate in english, history of heart disease exclusion criteria: - history of significant neurological disorders, such as stroke, alzheimer's disease, or severe head injury significant psychological problems such as schizophrenia or bipolar disorder

Keywords: cardiac rehabilitation cognitive functioning cardiovascular disease
the effects of method of anaesthesia on the safety and effectiveness of radical retropubic prostatectomy

Conditions: Prostatic Neoplasm

Summary: prostate cancer is one of the most commonly diagnosed neoplasm in men worldwide. the gold standard of therapy is radical prostatectomy, a wide surgical excision of the neoplasm and can be performed either open, laparoscopic or robotic. the open retropubic approach, still performed today, can be completed under either general anaesthesia or combined (spinal/epidural) anaesthesia without any clear guideline on which one should be preferred. in this study the investigators aim to evaluate general anaesthesia and combined (spinal/ epidural) anaesthesia in patients undergoing open retropubic radical prostatectomy and define whether these may have an impact on the oncological outcome and safety of the procedure.


Eligibility criteria:
inclusion criteria: * diagnosed with localised prostate cancer * eligible for open retropubic radical prostatectomy exclusion criteria: * metastatic prostate cancer * history of severe heart disease * history of haemostasis disorders * history of previous pelvic surgery * history of lung disease
assessment of the effect of tumor thickness and site on level iv cervical lymph nodes in squamous cell carcinoma of the tongue and floor of the mouth: a case series study

Conditions: Tongue Neoplasms

Summary: regarding oral cavity cancer, the high incidence of neck metastasis along with its impact on survival and prognosis are in favor of elective neck dissection. moreover, occult metastases could develop at lower levels in the neck (levels iv-v) regarding the tongue, the rate of skip (occult) metastasis involving unremoved level iv cervical lymph nodes in squamous cell carcinoma of the tongue ranges from 0 % - 11.4 %. however, no data is available or a correlation between the risk of level iv involvement and the affection of specific tongue subsites or a certain cutoff value of tumor thickness.


Eligibility criteria:
inclusion criteria: * patients with squamous cell carcinoma of the tongue and floor of the mouth. * age group: from 15 to 60 years old * no sex predilection exclusion criteria: * patients with recurrent squamous cell carcinoma of the tongue and floor of the mouth. * irradiated patients or those taking chemotherapy.
early diagnosis of clinical evolution from sars-cov-2

Conditions: SARS-CoV-1 Infection

Summary: the aim of the corona.bot project is to exploit the artificial intelligence methods of generator real world data facility to automatically extract structured and unstructured data from hospital databases and to implement an early risk assessment (warning system) regarding the negative outcome for patients infected with sars-cov-2. the objective of coronabed.bot is to analyze the care pathways of patients from the same cohort as corona.bot, in order to identify the total length of stay, intensive care occupations and flows between departments, based on variables demographics and first entry clinics early identification of patients with symptoms compatible with sars-cov-2 infection will enable more rapid activation of isolation procedures, contact monitoring/contact history and decisions on the most appropriate clinical pathway in terms of type of treatment and unit. similarly, the identification of factors correlated with worse outcomes will allow more effective planning for the use of critical resources (such as intensive care and others).


Eligibility criteria:
inclusion criteria: * adult patients (18 years of age or older) * admitted to the gemelli and columbus polyclinic * diagnosis of sars-cov-2 infection (suspected cases will also be included). exclusion criteria: * aaaa
a study of tocilizumab in participants with active rheumatoid arthritis (ra) and an inadequate response to non-biological disease-modifying anti-rheumatic drugs (dmards)

Conditions: Rheumatoid Arthritis

Summary: this observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe ra and an inadequate response to non-biologic dmards. data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.


Eligibility criteria:
inclusion criteria: * moderate to severe active ra (european league against rheumatism \[eular\] criteria) * inadequate response to dmards or tumor necrosis factor (tnf) antagonists * initiating treatment with tocilizumab according to spc exclusion criteria: * rheumatic autoimmune disease other than ra * prior history or current inflammatory joint disease other than ra * previous treatment with any biological drug used in the treatment of ra * previous treatment with tocilizumab * any contraindication to treatment with tocilizumab * major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment * pregnant women or nursing (breastfeeding) mothers
exploratory evaluation of flortaucipir injection in healthy volunteers and cognitively impaired subjects

Conditions: Alzheimer Disease

Summary: this early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.


Eligibility criteria:
inclusion criteria: * healthy volunteers had an mini-mental state examination (mmse) score of ≥ 29; * mci due to alzheimer's disease (ad) consistent with national institute on aging (nia)-alzheimer's association working group's on diagnostic guidelines for ad (alzheimer's dementia 7:270-9, 2011) * possible or probable ad: met clinical criteria for possible or probable ad based on the nia-alzheimer's association working group's on diagnostic guidelines for ad (alzheimer's dementia 7:263-9, 2011) exclusion criteria: * current clinically significant psychiatric disease. * evidence of structural abnormalities such as major stroke or mass on mri that would have made a diagnosis of impairment due to ad unlikely or was likely to interfere with interpretation of a pet scan on mri. * claustrophobic or otherwise unable to tolerate the imaging procedure. * current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (including, but not limited to, corrected qt interval \>450 msec). * current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer * history of alcohol abuse or substance abuse or dependence * female subjects of childbearing potential who were not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. * required medications with a narrow therapeutic window * received a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to imaging session * receiving any investigational medications or had participated in a trial with investigational medications within the last 30 days
advanced mri sequences in multiple sclerosis and its mimics

Conditions: Multiple Sclerosis

Summary: we aim to evaluate the role of conventional and advanced mri sequences in: 1. establishing the diagnosis of multiple sclerosis and differentiate it from its mimics. 2. predict the prognosis and evaluate the treatment response in the first year of patients with multiple sclerosis.

all patients in the study will be referred among those attend to assuit university hospital with clinical symptoms suspicious of ms according to mcdonald criteria 2017 with age range from (18-50 years old). mri study will be done for each patient. mri study will be repeated for those already diagnosed as ms after starting the suitable treatment as decided by attending physician after one year to assess the efficacy of treatment and the patient prognosis. mr imaging will be performed on a 1.5-t mr imaging unit (siemens, sembra medical system,german). prospectively completed data forms will be analyzed and compared. statistical tests appropriate to the nature of the data will be used. all patients will not be subjected to risk of any kind during this study. all patients' data will be confidentially kept. approval of the ethical committee of faculty of medicine, assiut university. an informed consent will be taken from all patients included in this study. * the research will be conducted only by scientifically qualified and trained personnel. * the procedures included in this study have been already used in hospital and centers in and outside egypt.

Eligibility criteria:
inclusion criteria: * all patients in the study will be referred among those attend to assuit university hospital with clinical symptoms suspicious of ms according to mcdonald criteria 2017 with age range from (18-50 years old). exclusion criteria: * o any general contraindication of mri in some cases as presence of paramagnetic substance as pacemakers or in patients with claustrophobia. * patient above 50 years old.
the totom trial: tai chi to optimize transplant outcomes for multiple myeloma

Conditions: Multiple Myeloma; Stem Cell Transplant Complications

Summary: the current proposal aims to test the feasibility of immune function analysis for tai chi easy (tce) intervention in multiple myeloma (mm) patients undergoing autologous stem cell transplantation (asct) with concurrent exploration of health related quality of life (hrqol).

the current proposal aims to test the feasibility of immune function analysis for tce intervention in mm patients undergoing asct with concurrent exploration of hrqol. the data obtained from this trial will provide supporting data for a future randomized clinical trial evaluating the impact of tce on immune function (incidence of asct related infectious complications, natural killer cell phenotype and activity, and myeloma remission rate (clonal plasma cell % at day 100, minimal residual disease (mrd)), with the evaluation of efficacy on improving hrqol during asct. successful completion of this croc project will provide necessary data to support future grant applications, in particular the feasibility of immunoassay evaluation of mm patients undergoing asct.

Eligibility criteria:
inclusion criteria: 1. diagnosis of multiple myeloma planned to undergo bone marrow transplant 2. 18 years or older 3. english speaking 4. general proficiency to read/write in english 5. able to attend tce training session per study protocol 6. ecog performance status 0-1 7. able to return to study center for routine post-transplant follow up (approximately day 30 and day 100) exclusion criteria: 1. currently performs tai chi, qiqong, or yoga at least once weekly or more 2. syncopal event in prior 60 days 3. concurrent major depressive disorder or anxiety disorder (dsmiv) as determined by treating provider 4. chronic dizziness or vestibular disorders 5. history of recurrent falls (\>2 in the prior year) 6. grade 3 or greater neuropathy 7. grade 3 or greater spinal fracture

Keywords: multiple myeloma stem cell transplant autologous stem cell transplantation asct tai chi
central neuromodulation of pain through music in healthy subjects

Conditions: Pain

Summary: the present research aims to study the neuromodulatory effect of music on the sensory component of pain. the activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.

pain is a multidimensional, complex and universal phenomenon that would be faced by almost one in two european adults. to meet the needs in terms of public health, contemporary medicine is gradually reintegrating the use of complementary therapeutic methods. music therapy is a non-medical intervention that is particularly suited to pain problems. the therapeutic use of music is an economical, practical and safe method. many clinical studies show that this activity promotes a significant decrease in pain. the ability of passive listening to music to reduce the perception of pain has been called "music-induced analgesia". the neuro-psycho-physiological mechanisms that underlie this phenomenon remain poorly understood. one hypothesis, still discussed, proposes that listening to music would stimulate, directly or indirectly, endogenous mechanisms of modulation of pain, stemming from the brainstem. in individuals undergoing nociceptive tonic stimulation, the specific neuronal activation induced by listening to music demonstrates the involvement of inhibitory descending pathways. a measurement of pain control mechanisms would account for the impact of music on central awareness. the purpose of this research is therefore to study the neuromodulatory effect of music on the sensory component of pain. the activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.

Eligibility criteria:
inclusion criteria: * healthy subjects aged 18 to 65 * subjects informed of the constraints of the study and having given their written consent. * subjects benefiting from a social security scheme. exclusion criteria: * subjects under 18 and over 65 * subjects who have previously participated in a pain study involving the induced pain test. * subjects with serious psychiatric disorders. * subjects with a diagnosis of acute or chronic pain. * subjects who have been taking antalgic substances for less than a week. * subjects with progressive disease not stabilized by medical treatment. * women in menstruation. * pregnant women. * subjects with a score greater than 10 for the depressive dimension on hospital anxiety and depression scale (hads) * subjects with an anxiety score "state" higher than anxiety "traits" on the spielberger condition state / traits anxiety inventory (stai) * subjects with a score of 32 or higher on the catastrophe rating scale (pcs-cf) * non-cooperating person. * person under legal protection * subjects not benefiting from a social security scheme * refusal of participation