Kornimate/medical-research-clean huggingface dataset:
virta health registry

Conditions: Multiple Chronic Conditions; Chronic Disease; Disease Progression; Long-Term Care; Telemedicine

Summary: the purpose of this registry is to establish a research data repository, comprised of data generated in the course of providing clinical services to patients treated by virta health, to conduct secondary research on clinical interventions and chronic diseases.

the purpose of this registry is to establish a research data repository, comprised of data generated in the course of providing clinical services to patients treated by virta health, to conduct secondary research on clinical interventions and chronic diseases. the scope of research under this protocol includes the following: 1. examining the effectiveness, safety, and sustainability of virta health clinical interventions for treating chronic diseases and prevention of or regression of associated adverse health outcomes. 2. examining the cost-effectiveness and economic impact of virta health clinical interventions for treating chronic diseases and preventing or regressing associated adverse health outcomes. 3. identifying demographics, clinical characteristics, comorbidities, concomitant treatments, genetic variants, and behavioral phenotypes that predict more or less favorable clinical outcomes of subjects to virta health clinical interventions for chronic diseases. 4. examining the impact of mental health and the behavioral modification components of virta health clinical interventions on disease markers, comorbidities, and adverse health outcomes associated with virta health clinical interventions. 5. characterizing typical presentation patterns, genetic determinants, biochemistry, and pathophysiology of the chronic diseases treated by virta health. 6. exploring relationships between dietary composition and physiologic characteristics of chronic diseases. 7. exploring the interrelationship and common clinical/biological features of the various chronic diseases under treatment by virta health. 8. compiling case reports and case series of interesting disease presentations and outcomes, of the chronic diseases virta health treats, that may inform about the disease state and treatment responses. 9. validating the integration of technological aids into virta health clinical interventions. where the impacts of devices are examined, devices will be fda-approved and approved, marketed devices. no safety data will be collected on devices; rather, research will focus only on the feasibility of adding the device to the treatment program, its relationship with participant behaviors and health outcomes, and patient satisfaction attributable to the device. 10. understanding the relationships of patient needs, educational methods, and use of the virta health online application, to subsequent patient satisfaction/clinical outcomes.

Eligibility criteria:
virta health patients
observational cohort of covid-19 patients in hubei province

Conditions: 2019 Novel Coronavirus Disease

Summary: this study intends to use the relevant case data of covid-19 in hubei province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of covid-19 patients, so as to provide a theoretical basis for the treatment of these diseases and reduce the mortality.

hubei province, as the forefront of the fight against epidemic, has the largest number of patients infected with sars-cov-2 and the highest quality medical data. however, so far, these data have not been fully analyzed, if these data can not be mined and used, it will be a great loss to the whole human race. by fully mining and analyzing these data, we can sum up a large number of experiences related to covid-19, summarize various laws of this kind of disease, and provide clinical evidence based on large samples for the research of this disease, eventually contribute china's experience to the global fight against the epidemic. based on the above background, this study intends to use the relevant case data of covid-19 in hubei province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of covid-19 patients, so as to provide a theoretical basis for the treatment of these diseases and reduce the mortality.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18, regardless of gender; 2. a history of epidemiology, including travel or residence in high-risk areas or other communities with case reports within 14 days before the onset of the disease, or have a history of contact with novel coronavirus infection (those who are positive for nucleic acid tests); or patients with fever or respiratory symptoms from the community with case reports; or aggregative onset; 3. corresponding clinical manifestations, including respiratory symptoms such as fever, with typical imaging features of covid-19, normal or decreased white blood cell count and decreased lymphocyte count in the early stage of the disease; 4. clear etiological evidence, including real-time fluorescent rt-pcr detection of novel coronavirus nucleic acid positive, or viral gene sequencing, is highly homologous to novel coronavirus. exclusion criteria: patients who meet any of the following criteria cannot be enrolled in this study: 1. patients refused to participate in this study; 2. according to the researchers, patients are unable to complete this study or comply with the requirements of this study (due to management or other reasons).

Keywords: covid-19 sars-cov-2 risk factors mortality
the effect of vasopressor therapy on renal perfusion in septic shock

Conditions: Septic Shock; Acute Kidney Injury

Summary: acute kidney injury (aki) is a common complication of septic shock and together these conditions carry a high mortality risk. in septic patients who develop severe aki renal cortical perfusion is deficient despite normal macrovascular organ blood flow. this intra-renal perfusion abnormality may be amenable to pharmacological manipulation, which may offer mechanistic insight into the pathophysiology of septic aki. the aim of the current study is to investigate the effects of vasopressin and angiotensin ii on renal microcirculatory perfusion in a cohort of patients with septic shock.


Eligibility criteria:
inclusion criteria: * within 48 hours of intensive care admission * evidence of suspected or confirmed infection * sequential organ failure (sofa) score increase of 2 or more (assuming a baseline of 0 if no previous measures) * requirement for norepinephrine infusion as the sole vasopressor agent in a dose of \>0.1mcg/kg/min * lactate \>2mmol/l at any stage prior to randomisation exclusion criteria: * known intolerance to sonovue™ contrast medium, vasopressin or angiotensin ii * patients receiving other vasoactive drugs in addition to norepinephrine * patients with known chronic kidney disease (ckd) stage 4 or 5 (baseline glomerular filtration rate (gfr) \<30mls/min) * patients receiving extra corporal membrane oxygenation (ecmo) * patients with acute occlusive coronary syndromes requiring intervention * patients with mesenteric ischaemia * patients with a history or presence of aortic dissection or abdominal aortic aneurysm * patients with raynaud's syndrome or acute vaso-occlusive conditions * pregnancy
a phase i-ib/ii study to determine the maximum tolerated dose (mtd) of auy922 alone and in combination with bortezomib, with or without dexamethasone, in patients with relapsed or refractory multiple myeloma.

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: this is a phase i-ib/ii, open-label, multicenter study of auy922 administered intravenously in patients with multiple myeloma to determine the maximum tolerated dose. the phase ii part will investigate the efficacy of auy922 in patients with multiple myeloma. additionally, the study includes a phase ib combination part of auy922 administered in combination with bortezomib, to determine the maximum tolerated dose of the combination drugs in patients with multiple myeloma.


Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of active multiple myeloma. * phase i and phase ii part: patients must have received at least 2 but not more than 4 prior line of therapy and their disease has progressed during or after last therapy. * phase ib part: patients must have received no more than 2 prior lines of therapy (excluding dexamethasone as single agent). * ecog performance status of ≤ 2. * patients must have acceptable neutrophil and platelet counts as well as adequate kidney and liver function. * patients must have magnesium levels above lower limit of normal or correctable with supplements. * patients must be willing and able to undergo bone marrow biopsy/aspirate. * able to sign informed consent. exclusion criteria: * prior treatment with any hsp90 or hdac inhibitor for the treatment of multiple myeloma. * patients with unresolved diarrhea ≥ ctcae grade 2. * patients with acute or chronic liver disease. * patients using medications that have a relative risk of prolonging the qt interval. * clinically significant cardiac diseases. * patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g. gilbert's syndrome). * pregnant or lactating women. * fertile women of childbearing potential (wcbp) not using adequate contraception. * male patients whose partners are wcbp, not using adequate contraception. * patients who unwilling or unable to comply with the protocol. * phase ib part: peripheral neuropathy ≥ ctcae grade 1. * phase ib part: prior treatment with bortezomib. other protocol-defined inclusion/exclusion criteria may apply

Keywords: auy922 multiple myeloma hsp90 inhibitors phase i/ii
a study using botulinum toxin type a as headache prophylaxis in adolescents with chronic migraine

Conditions: Migraine Disorders

Summary: to evaluate the efficacy and safety of botulinum toxin type a versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.


Eligibility criteria:
inclusion criteria: * medical history of chronic migraine for at least 6 months * 15 or more headache days during a 4 week period exclusion criteria: * previous use of any botulinum toxin of any serotype for any reason * diagnosis of myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis * treatment of headache using acupuncture, transcutaneous electrical stimulation (tens), cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks prior to the week -4 screening visit * use of any headache prophylaxis medication within 4 weeks prior to the week -4 screening visit
chronic effects of estrogen in microcirculation

Conditions: Postmenopausal Symptoms

Summary: this study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese women after three months of follow-up intervention.

estrogens exert pleiotropic actions on the cardiovascular system through binding to estrogen receptors. traditionally, estrogen receptors have been recognized as transcription factors regulating the expression of target genes, however, numerous studies have revealed rapid actions of estrogen in different systems, so-called 'extranuclear actions'. at this level, estrogen triggers rapid vasodilatation, exerts anti-inflammatory effects, regulates vascular cell growth and migration, and confers protection to cardiomyocytes. our aims are to investigate estrogen´s chronic effects on microcirculation. the study will assess the potential benefits of estrogens on: chronic low-grade inflammation, metabolic profile, microcirculation and blood rheology. postmenopausal obese women will be randomly submitted to estrogen (transdermal 17-β-estradiol 1mg/day) or placebo therapy during three months in a double-blind fashion. at baseline and after intervention, nailfold videocapillaroscopy, laser-doppler flowmetry and venous occlusion plethysmography, inflammatory biomarkers, hormonal status, metabolic profile, plasma viscosity and anthropometrical measures will be assessed in all subjects.

Eligibility criteria:
inclusion criteria: * history of natural menopause defined by the absence of menses for at least 12 months and a serum concentration of fsh \> 35 iu/l * bmi between 27 to 34.9 kg/m² * non-smokers * not on use of any hormones or supplements for a minimum of 6 months prior to the study * no absolute contraindications to the use of physiological replacement doses of estrogen exclusion criteria: * renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases * diabetes mellitus, glucose intolerance or altered fasting glucose

Keywords: menopause obesity capillary microcirculation estrogen microvascular function
examination of occupational justice, activity performance and quality of life in homeless people

Conditions: Homeless Persons

Summary: this concerns the participation of individuals experiencing homelessness, as a disadvantaged group, in meaningful and purposeful occupations, evaluated within the framework of occupational justice. homeless individuals face numerous social and economic barriers that impact their full participation in societal occupations. however, since survival becomes the primary goal for homeless individuals, meaningful occupations often revolve around surviving on the streets. the aim is to identify problems and constraints to participation in daily life activities so that their participation can be enhanced.

"the data collection tools will be implemented during face-to-face interviews with participants. interview durations will vary between 45 to 90 minutes. interviews with individuals who accept the invitation to participate will be conducted in public places such as cafes, parks, and other community areas in the beyoğlu district. the data collection process, initiated after ethical approval, will be concluded upon reaching a sufficient number of participants. homeless individuals contacted through the 'çorbada tuzun olsun derneği' will be informed about the research and invited to participate. individuals with neurological or psychiatric conditions that hinder communication and collaboration will not be included in the study. fourteen homeless individuals aged 18 or older, literate, able to communicate and collaborate, and currently living on the european side of istanbul will be included in the study. data collection instruments for the study include a demographic information form, semi-structured interview guide, canadian occupational performance measure, occupational justice health questionnaire, world health organization quality of life scale short form, and occupational balance questionnaire."

Eligibility criteria:
inclusion criteria: * fourteen homeless individuals aged 18 or older, literate, able to communicate and collaborate, and currently living on the european side of istanbul will be included in the study. exclusion criteria: * individuals with neurological or psychiatric conditions that hinder communication and collaboration will not be included in the study.

Keywords: homelessness activitiy performance occupational justice quality of life
hemostasis during asparaginase treatment in acute lymphoblastic leukemia(all)

Conditions: Acute Lymphoblastic Leukemia

Summary: asparaginase is an important drug in the treatment of childhood leukemia. one of the rare but severe side effects to the treatment is thrombosis in or outside the central nervous system. the aim of this study is to investigate and describe the influence on the coagulation parameters during prolonged treatment with asparaginase. hopefully this knowledge will help to foresee the risk of thrombosis and thus making it possible to prevent these.


Eligibility criteria:
inclusion criteria: * childhood all, eligible to receive standard risk or intermediate risk therapy as described in the protocol, written informed consent has been obtained exclusion criteria: * no allergic reactions to peg-asparaginase

Keywords: all peg-asparaginase prolonged treatment thrombosis central venous line echocardiography
essential hypertension

Conditions: Essential Hypertension

Summary: the purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral administration of act 280778 on dbp compared to placebo after 28 days.


Eligibility criteria:
inclusion criteria: * males and females aged 18 to 75 years (inclusive) at screening. * body mass index (bmi) between 18 and 35 kg/m2 (inclusive) and body weight at least 50 kg at screening and prior to enrollment. * 12-lead ecg without clinically relevant abnormalities measured at screening. * clinical chemistry, hematology, coagulation, virus serology, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening. * signed informed consent in the local language prior to any study-mandated procedure exclusion criteria: * mean sbp \> 180 mmhg. * severe, malignant, or secondary hypertension. * episodes of hypertensive crisis or hypertensive emergency within 6 months prior to enrollment. * previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions considered to be of clinical significance. * e6 severe coronary artery disease indicated by myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft within the last 12 months prior to enrollment. * angina pectoris within 6 months prior to enrollment
safety study of sbrt and docetaxel for locally recurrent or second primary squamous cell carcinoma of the head and neck

Conditions: Head and Neck Cancer

Summary: the purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (sbrt) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.


Eligibility criteria:
inclusion criteria: * recurrent or second primary squamous cell head and neck cancer * defined area of recurrence on imaging * previous head and neck radiation (rt) to \>/= 50 gy * performance status score 0-1 * time interval from previous rt \>/= 9 months * volume of disease appropriate for protocol treatment * minimum estimated survival of \>/= 3 months * age \>/= 18 * adequate labs exclusion criteria: * primary tumors of the salivary gland * original pathology report and radiation therapy records not available * prior spinal cord dose \> 45 gy * surgery or chemotherapy within 4 weeks * prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers are permitted
ocular sequelae of patients hospitalized for respiratory failure during the covid-19 epidemic

Conditions: COVID19; Ophthalmopathy

Summary: ophthalmologic damages secondary to covid-19 coronavirus infection are little described. the ocular involvement is probably multiple, ranging from pathologies of the anterior segment such as conjunctivitis and anterior uveitis to disorders that threaten vision such as retinitis or optic neuropathy. on the other hand, in addition to this impairment, when patients are hospitalized for acute respiratory failure, complications related to possible resuscitation, medication prescriptions, positioning and oxygenation. covid-19 itself, has several components: * an apoptotic action of the viral attack which will generate cellular destruction, whether pulmonary, cardiac or renal or maybe ocular * a secondary autoimmune action with the development of major vascular inflammation, possibly reaching the retinal, choroidal, and optic nerve vessels. a secondary "hyper" inflammatory syndrome with flashing hypercytokinemia and multi-organ decompensation is described in 3,7% to 4 ,3% of severe cases. * a thromboembolic action

upon discharge from hospital for covid-19 infection (or during a telephone call for patients already discharged at the start of the study), patients will be informed of the study. an ophthalmology appointment will be given to them between 4 and 6 months after their discharge. during the ophthalmology appointment, the patient's clinical data will be collected during an interview (medical and treatment history, blood group). the patient will benefit from a full ophthalmological examination.

Eligibility criteria:
inclusion criteria: * patients having been hospitalized for a confirmed covid-19 infection (ct-scanner or pcr- polymerase chain reaction) exclusion criteria: * pregnant or breastfeeding woman

Keywords: covid19
effisayil™ 1: a study to test spesolimab (bi 655130) in patients with a flare-up of a skin disease called generalized pustular psoriasis

Conditions: Generalized Pustular Psoriasis

Summary: to evaluate efficacy, safety, and tolerability of spesolimab (bi 655130) compared to placebo in patients with generalized pustular psoriasis (gpp) presenting with an acute flare of moderate to severe intensity.


Eligibility criteria:
inclusion criteria: * patients with gppga of 0 or 1 and a known and documented history of gpp per european rare and severe psoriasis expert network (eraspen) criteria regardless of il36rn mutation status, with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated c-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above uln) or -- patients with an acute flare of moderate to severe intensity meeting the (eraspen) criteria of gpp with a known and documented history of gpp (per eraspen criteria) regardless of il36rn mutation status, with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated c-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above uln) * male or female patients, aged 18 to 75 years at screening. * signed and dated written informed consent prior to admission to the study in accordance with ich gcp and local legislation prior to start of any screening procedures. * women of childbearing potential must be ready and able to use highly effective methods of birth control per ich m3 (r2) that result in a low failure rate of less than 1% per year when used consistently and correctly. note: a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. tubal ligation is not a method of permanent sterilization. a postmenopausal state is defined as no menses for 12 months without an alternative medical cause * further inclusion criteria apply exclusion criteria: * patients with sapho (synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome. * patients with primary erythrodermic psoriasis vulgaris. * patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques. * drug-triggered acute generalized exanthematous pustulosis (agep). * immediate life-threatening flare of gpp or requiring intensive care treatment, according to the investigator's judgement. life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress syndrome, or renal failure. * severe, progressive, or uncontrolled hepatic disease, defined as \>3- fold upper limit of normal (uln) elevation in ast or alt or alkaline phosphatase, or \>2-fold uln elevation in total bilirubin. * further exclusion criteria apply