Kornimate/medical-research-clean huggingface dataset:
prospective evaluation of long-term outcomes after pulmonary embolism

Conditions: Pulmonary Embolism

Summary: the purpose of this study is to evaluate the long-term impact of pulmonary embolism (pe) on heart and lung function, quality of life, ability to work, symptoms of breathlessness and functional status of patients one year after their initial diagnosis and treatment for pe


Eligibility criteria:
inclusion criteria: 1. first episode of acute symptomatic pe that was objectively diagnosed\* within last 10 days 2. treated with anticoagulants 3. ≥ 18 years old * pe will be diagnosed if there is a high probability v/q scan (as per pioped study criteria 66), an intraluminal filling defect in segmental or larger vessels on ctpa or a constant intraluminal filling defect or abrupt cut-off of vessels greater than 2.5 mm diameter on pulmonary angiography 8,10. patients with non-definitive test results (e.g. low or intermediate probability v/q scan, subsegmental pe on ctpa (\~5% of pe patients 12) will not be included in order to have a strictly defined population of patients with definite pe. exclusion criteria: 1. contraindication or unable to perform cpet or 6mwt (amputated or paralyzed limb(s), severe lower extremity arthritis, preexisting cardiopulmonary condition precluding exercise including unstable angina or myocardial infarction in last 6 weeks, uncontrolled hypertension, serious cardiac dysrhythmia on resting ekg \[severe bradycardia or tachycardia, sick sinus syndrome or multifocal premature ventricular contractions\] and syncope) 2. contraindication to ctpa (allergy to iodinated contrast, crcl or egfr \< 30 ml/min) 3. severe comorbidity (congestive heart failure \[lvef \< 35%\], severe copd or restrictive lung disease \[fev1\<50%, chronic need for oxygen therapy\]) 4. previous dvt (as \~40% of patients with proximal dvt have asymptomatic pe on lung imaging 67) 5. life expectancy \< 1 year (e.g. active or terminal cancer, end-stage cardiac or respiratory disease). 6. pregnancy or lactation 7. unable to read questionnaire in english or french 8. unable to return to study centre for required follow-up visits 9. unable or unwilling to provide written informed consent

Keywords: exercise tolerance venous thrombosis pulmonary embolism quality of life (qol)
a phase iii study of insulin aspart injection to evaluate the efficacy and safety

Conditions: Diabetes

Summary: this is a multicenter, randomized, open, parallel group, active-controlled study. the study period is 25 to 26 weeks, including screening period of 1-2 weeks and treatment period of 24 weeks.

after the screening visit, all patients who met all inclusion criteria and do not meet any of the exclusion criteria were randomized into the experimental group or the controlled group. the subjects in the experimental arm will receive insulin aspart injection combined with basal insulin (lantus ®), and the subjects in the controlled arm will receive novorapid ® (active control) combined with basal insulin (lantus ®). the experimental drug or the controlled drug will be administered subcutaneously prior to three meals (or can be administered immediately after meal if necessary), and the basal insulin (lantus ®) will be administered at bedtime. the treatment period is 24 weeks, during which the subjects will be followed up at the clincic cetres at 1, 2, 4, 8, 12, 18, 24 weeks of treatment. at the end of 24-week treatment, if the adverse events continue, the subjects will be followed until recovery or stabilization of the aes.

Eligibility criteria:
inclusion criteria: * patients were diagnosed with diabetes； * bmi≤35.0 kg/m2； * insulin therapy for at least 3 months before recruitment； * hba1c7\~13% exclusion criteria: * patients to study drug allergy； * to liver and kidney impairment； * liver and kidney impairment； * used systemic steroid treatment in past 2 months .
allogeneic umbilical cord blood therapy for chronic tbi

Conditions: Traumatic Brain Injury

Summary: this open label trial is conducted to investigate the efficacy and safety of umbilical cord blood therapy for chronic traumatic brain injury patients. the study hypothesis is that the participants will show significant improvement in cognition and function after umbilical cord blood (ucb) transplantation.

traumatic brain injury patients have been increasing due to various accidents. after acute therapeutic intervention, rehabilitation is the conventional main treatment with medication. however, in chronic stage, there seems to be some limitation in obtaining functional improvement in spite of comprehensive rehabilitation. cell therapy like umbilical cord blood (ucb) transplantation has showed promising results in many animal studies. the mechanism of such neurological improvement is not fully understood. stem cells included in ucb are expected to secrete neurotrophic factors to enhance brain function. in addition, anti-inflammatory effects of ucb are suggested. autologous ucb are not available in most of the cases in fact. the aim of this clinical trial is to determine the safety and efficacy of allogeneic ucb.

Eligibility criteria:
inclusion criteria: * chronic traumatic brain injury patient (onset duration: over 6 months) * glasgow outcome scale: 2, 3, 4, 5 exclusion criteria: * high risk of pneumonia or renal function deterioration after immunosuppressant * possibility of drug hypersensitivity which is related to this study remedy * intractable seizure disorder * poor cooperation of guardian,including inactive attitude for rehabilitation

Keywords: umbilical cord blood allogeneic traumatic brain injury
using an mhealth app to transition care of type-1 diabetes from parents to teens

Conditions: Type 1 Diabetes Mellitus; Adolescent Behavior; Parent-Child Relations; Communication

Summary: type 1 diabetes (t1d) afflicts approximately 154,000 people under the age of 20. most people with t1d are diagnosed at a young age; their parents have to manage their child's condition. eventually, the child must begin to take steps to transition to self-management. during the transition from parent to adolescent self-management, difficulties arise because adolescents may not be fully aware of, or want, to take responsibility for all the necessary tasks to successfully manage their t1d. though there are other apps on the market to help with diabetes care, none do what the proposed app will do. the proposed self-management mobile app allows for monitoring the patients' t1d by linking their self-management information to their parents' cell phone, and thus also helps to bridge communication gaps. prior research suggests that these are critical gaps that must be filled in order for successful transition in care to occur, the proposed app will help fill some of these gaps.


Eligibility criteria:
inclusion criteria: the adolescents must: 1. have a t1d diagnosis according to the ada practice guidelines; 2. be 10 to 15 years old; 3. have had a diagnosis of t1d for at least six months; 4. have an a1c \> 7;97 5. have had at least two outpatient visits in the past two years; 6. be treated at sparrow for diabetes; 7. be fluent in english; 8. have a parent/guardian willing to participate; 9. be allowed to use a mobile phone for the study; 10. have permission from their care team. the parent/guardian must: 1. have an adolescent with t1d who is 10 to 15 years old; 2. be fluent in english; 3. have daily access to email and the internet (for appointment reminders and technical support). exclusion criteria: the exclusions for adolescents include: 1. significant medical conditions other than t1d; 2. being treated for thyroid disorders, celiac disease, or eating disorders; 3. being in foster care. exclusion criteria for both the adolescents and parents/guardians include: a) a diagnosis of a major psychiatric or neurocognitive disorder (e.g., traumatic brain injury, dementia, schizophrenia, bipolar disorder, borderline personality disorder, and mental retardation).
biomarker analysis in post-covid patients

Conditions: Post-COVID-19 Syndrome

Summary: headache is one of the most common neurological manifestations of covid-19. however, it is unclear whether chronic headache after the initial diagnosis, is associated with ongoing damage of the central nervous system. we investigate cpost-covid-19 patients with persistent headache lasting longer than 3 weeks, to hospitalized acute covid-19 patients with neurological symptoms and to other non-covid-19 disease-controls. readout are neurologial and glial biomarkers in csf.

measurements of neuronal and glial markers in csf were performed on a simoa analyzer (quanterix) using the neurology 4-plex a (nf-l, tau, gfap, uch-l1) kit.

Eligibility criteria:
inclusion criteria: * diagnosis of covid, parkinson's disease, primary headache, multiples sclerosis, facial paralysis * persistent post-covid-19 headache after 3 months of infection * post covid-patients without persistent headache * must be able to perform lumbar puncture exclusion criteria * unknown history of covid infection * lumbar puncture not possible

Keywords: persistent headache
the problem of incomplete myocardial revascularization in percutaneous coronary intervention in patients with nstemi

Conditions: NSTEMI

Summary: the study included all patients admitted to the intensive care unit of the district hospital and sent to the angiographic department for diagnosis and performance of pci with a diagnosis of nstemi, including myocardial infarction (mi) and unstable angina, determined by clinical data, ecg signs and laboratory indicators. data from patients living in the sergiev posad municipal district will be analyzed in order to achieve maximum registration of adverse events during one year of follow-up.

objective: to investigate the problem of incomplete myocardial revascularization in percutaneous coronary interventions in patients with acute coronary syndrome without st segment elevation who were admitted to the angiographic department of the sergiev posad city hospital in the moscow region. the study will include all patients admitted to the intensive care unit of the regional hospital and sent to the angiographic department for diagnosis and performance of pci with acute coronary syndrome nstemi, including myocardial infarction (mi) and unstable angina, determined by clinical data, ecg signs and laboratory indicators. anamnestic, clinical, biochemical indicators, cardiovascular risk factors, comorbid index that determines the course of acute coronary syndrome and prognosis (grace), a number of angiographic data, including the number of affected arteries and variants of the index "syntax score 50" and modified "syntax score 30", "syntax score 70" and" syntax score 90" to separate complete and incomplete revascularization, an integral indicator of the quality of the remaining index syntex, the absolute value of which is corrected during data analysis. the data of patients living in the city of sergiev posad will be reviewed in such a way as to minimize the subsequent year of follow-up, using a telephone survey and the emias electronic system

Eligibility criteria:
inclusion criteria: - all patients who were referred to an angiographic unit with a diagnosis of nstemi for diagnostic coronary angiography and/or pci from november 2018 to february 2019. exclusion criteria: * patients with myocardial infarction with ecg- confirmed st elevation of more than 1 mm in two leads. * residents of areas other than the area in question that may be difficult to contact.
long term follow-up of hippocampal dbs for refractory epilepsy

Conditions: Refractory Epilepsy

Summary: follow up of the patients at ghent university hospital treated with hippocampal dbs for refractory epilepsy. endpoints: * long term evaluation of the effects of hippocampal dbs on seizure frequency and cognition * evaluation of the satisfaction of patients and neurologist regarding the rechargeable dbs battery


Eligibility criteria:
inclusion criteria: * treated with hippocampal dbs for refractory epilepsy at ghent university hospital exclusion criteria: * (none)
comparison of dynamic radiographs in determining fusion level in adolescent idiopathic scoliosis correction

Conditions: Adolescent Idiopathic Scoliosis

Summary: the purpose of this study is to identify the flexibility radiograph(s) that can most accurately predict the curve behaviour after surgical correction of ais. with these findings, the investigators hope to give further guidance for the selection of fusion levels and to incorporate different dynamic radiographs into the lenke classification, leading to a more universal application that can consistently lead to good surgical and clinical outcome.

the lenke classification is the most widely-accepted classification for adolescent idiopathic scoliosis (ais) in the world. its recommendations for fusion of the minor curves depend on its structurality. it defines a minor curve as structural if there is inflexibility on side-bending more than 25 . however, a recent delphi survey from a panel of experts in ais management showed that there was no consensus as to which type of dynamic radiograph was optimal. up to two thirds of the surgeons did not use side-bending as a routine, and hence they cannot apply the lenke classification accurately in clinical practice nor follow its recommendations for fusion. furthermore, the current classification does not give specific recommendations regarding the selection of fusion levels and does not take into account the clinical appearance of the patients which impact on treatment. consequently, there are still controversies regarding the upper instrumented vertebra (uiv) and lowest instrumented vertebra (liv) selections, and following the recommendations may not allow fusion of the least number of segments nor give best clinical results eg shoulder balance.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ais who reach the threshold for surgical correction. * patients aged 10 to 18 years exclusion criteria: * neuromuscular deformity * prior fusion or spine surgery * spinal tumor diagnosis * congenital anomalies

Keywords: ais
azithromycin in the treatment of cryptosporidiosis in patients who have not had success with other drugs

Conditions: Cryptosporidiosis; HIV Infections

Summary: to provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies.


Eligibility criteria:
inclusion criteria patients must have: * cryptosporidiosis infection. * life expectancy of at least 1 week. * failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic or other therapies for cryptosporidiosis. * consent of parent or guardian for patients under the legal age of consent. patients with documented favorable response to azithromycin under pfizer protocol 066-143 may receive maintenance therapy under this protocol. patients with persistent diarrhea requiring intravenous (iv) fluid therapy to maintain hydration may receive iv azithromycin after approval by the clinical monitor. patients whose disease worsens despite a minimum of 2 weeks of oral therapy or patients whose disease shows no improvement after 4 weeks of oral therapy will also be considered for a trial period of intravenous azithromycin. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * known hypersensitivity or significant intolerance to macrolide antibiotics. * eligibility and current treatment at a medical center performing study 066-143, another study of azithromycin for treatment of cryptosporidiosis in aids patients. required: * must have failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic therapies for cryptosporidiosis.

Keywords: antidiarrheals cryptosporidiosis diarrhea acquired immunodeficiency syndrome azithromycin
brain tv (tissue velocimetry) for emergency assessment of suspected stroke

Conditions: Stroke

Summary: this study uses a doppler ultrasound technique being developed at the university of leicester called \&#34;brain tissue velocimetry\&#34; (brain tv), to investigate brain tissue motion over the cardiac cycle.

brain motion is highly sensitive to heart and brain biomechanics, but the impact of brain injury on brain tissue motion has yet to be explored. preliminary brain tissue motion measurements from a small number of patients suggest that brain biomechanics may be disturbed in the presence of brain injury. this study combines transcranial tissue doppler (tctd) ultrasound with brain magnetic resonance imaging (mri) to establish whether analysis of brain tissue motion provides clinically useful information for emergency diagnosis and monitoring of suspected stroke.

Eligibility criteria:
inclusion criteria: * participant (or consultee) is willing and able to give informed consent (or assent) for participation in the study. * adult, aged 18 years or over. * suspected stroke (any severity and any stroke type). exclusion criteria: * unable (in the investigators' opinion), or unwilling, to comply with the study requirements. * patients with pre-existing chronic brain conditions that may make affect informed consent, such as severe learning difficulties, dementia, or alzheimer's disease, will be excluded.
anterior capsule polishing effect on effective lens position

Conditions: Cataract

Summary: * the purpose of this study is to evaluate effects of anterior capsule polishing on effective lens position (elp) and actual axial movement of the intraocular lens (iol) by measuring anterior chamber depth (acd) * patients with bilateral age-related cataract undergo bilateral uneventful cataract surgeries with in-the- bag implantation of a single-piece hydrophobic acrylic foldable iol (sn60wf). the anterior capsule was extensively polished using whitman shepherd double-ended capsule polisher in one eye randomly, and the other not. the acd was measured 1day, 1 week, 1month, 3 months and 6 months with anterior segment optical coherence tomograph (as-oct) postoperatively. the actual axial movement of iol was defined as the root mean square (rms) of the change in elp at each visit.


Eligibility criteria:
inclusion criteria: * bilateral age-related cataract * good overall physical constitution * uneventful surgeries of both eyes with in-the-bag iol implantation exclusion criteria: * history of intraocular surgery or laser therapy * history of ocular trauma or ocular disease * high myopia * diabetes * severe retinal pathology * patients who could not return on time

Keywords: age related cataract phacoemulsification anterior capsule polishing optical coherence tomography anterior chamber depth
a study to characterize the clinical course of pregnant women and children at high risk for early onset severe hemolytic disease of the fetus and newborn

Conditions: Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN); Erythroblastosis, Fetal

Summary: the primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn (eos-hdfn).

the outcomes of interest will be assessed from the information collected on the standard of care treatment for eos-hdfn in pregnant women and their offspring from current pregnancy.

Eligibility criteria:
pregnant female participants must be ≥18 years of age with an estimated gestational age of ≥ 8 weeks; not currently pregnant with multiples (twins or more); and no other clinically relevant abnormalities currently or in their history that the investigator would deem them ineligible to participate.

Keywords: hemolytic disease of the fetus and newborn (hdfn) erythroblastosis, fetal early onset severe hemolytic disease of the fetus and newborn (eos-hdfn) m281 pregnant women
safety and tolerability of rpe stem cell-derived rpe(rpesc-rpe) transplantation in patients with dry age-related macular degeneration (amd)

Conditions: Dry Age-related Macular Degeneration

Summary: the main objective of the study is evaluation of the safety and tolerability of rpesc-rpe-4w as therapy for dry amd.

rpesc-rpe-4w is allogeneic rpe stem cell (rpesc)-derived rpe cells (rpesc-rpe) isolated from the rpe layer of human cadaveric eyes are transplanted under the macular. this first-in-human phase 1/2a open-label dose-escalation interventional study plans to enroll a total of 18 subjects

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of dry amd. 2. ability to understand and give informed consent. 3. adult male or female \>55 years of age. 4. medically suitable to undergo vitrectomy and subretinal injection (\>60% on karnofsky scale). 5. postmenopausal if female (expected to be common for the age limitation), or the female partner of a male subject unable to father children. 6. if male, willing to use barrier and spermicidal contraception during the study. exclusion criteria: 1. allergy or hypersensitivity to dilation drops or fluorescein. 2. active major medical conditions limiting ability to participate in the study. 3. active malignancy or treatment with chemotherapy. 4. systemic immunosuppressant therapy within past six months. 5. history of toxoplasmosis, retinal histoplasmosis or tuberculosis. 6. receipt of investigational product (ip) in a clinical trial within prior six months. 7. any other medical condition, which, in the investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results. 8. pregnant or nursing females.
improving cardiovascular risk stratification using t1 mapping in general population

Conditions: Myocarditis; Heart Failure; Myocardial Fibrosis; Vascular Inflammation

Summary: magnetic properties of myocardial tissue change in the presence of disease. this is detectable in the change of rate of magnetic relaxation, and measurable by t1 and t2 mapping using cardiovascular magnetic resonance (cmr). these markers provide novel quantifiable imaging measures for myocardial tissue characterisation. despite similar principles, the measurements differ considerably between different sequences, vendors and field strengths, yielding a necessity to establish robust sequence-specific normal ranges, diagnostic accuracy, relationships with clinical characteristics, cardiovascular risk factors, routine cardiac imaging parameters, and prognosis. a further unknown relates to separation between healthy myocardium and subclinical disease in subgroups of patients with suspected cardiac involvement. examples include patients with possible inflammation, such as in patients with a recent covid-19 infection or vaccination. anticipated recruitment of a total of 3000 subjects, with 1500 subjects per field strength (1.5 and 3.0 tesla).


Eligibility criteria:
inclusion criteria: 1. able to provide informed consent 2. 18 years of age and over 3. absence of a valid clinical indication for cmr, and/or known or clinically relevant cardiac disease exclusion criteria: * accepted contraindications for a contrast-enhanced cmr study (in line with mri safety and smpc for contrast agent)

Keywords: inflammation remodeling