Kornimate/medical-research-clean huggingface dataset:
detection of vascular injury in diabetes through eye and nailfold data (dividend) - a pilot study

Conditions: Type 1 Diabetes Mellitus

Summary: this project aimed to explore novel methods of detecting small blood vessel disease in a paediatric population with type 1 diabetes mellitus. to do this the techniques of nailfold capillaroscopy, laser doppler flowmetry, retinal (eye) vessel analysis and 24-hr ambulatory blood pressure monitoring were used. each of these techniques investigated different areas of small blood vessels around the body. it was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel investigations would be associated with small blood vessel disease and that widespread changes to these blood vessels would be detected through associations between the different novel investigations.


Eligibility criteria:
inclusion criteria: * 8-18 years old * have a diagnosis of type 1 diabetes mellitus exclusion criteria: * \ 18 years old * significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)

Keywords: paediatric and adolescent population nailfold capillaroscopy laser doppler flowmetry retinal vessel calibre retinal vessel fractal analysis 24 hour ambulatory blood pressure monitoring
dopamine in orthostatic tolerance

Conditions: Postural Tachycardia Syndrome

Summary: one goal of this study is to determine whether people with different amounts of dopamine-beta-hydroxylase (dbh) have different responses to events that affect blood pressure and heart rate. we will also study whether increasing dietary salt improves symptoms during upright posture. finally, we will examine whether the dietary sodium level influences serum dbh activity and whether dbh level influences the response to sodium. dbh levels and the function of the sympathetic or involuntary nervous system will be assessed in normal volunteers and in patients with postural tachycardia syndrome (pots).


Eligibility criteria:
inclusion criteria: * upright plasma norepinephrine \> 600 pg/ml, or * an increase in heart rate of \> 30 beats per minute upon standing, and * withdrawal of all medications for at least 3 days, and * no associated medical illness, and * age 18 - 60 years old. exclusion criteria: * older than 60 years of age * routinely taking medications affecting the autonomic nervous system * any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic) other than pots * anemia (hct \< 30) * women of childbearing age who are pregnant or nursing * unable to give informed consent
safety and tolerability of ferric carboxymaltose (fcm) versus iron dextran in treating iron deficiency anemia

Conditions: Anemia

Summary: the objective of this study is to evaluate the safety of fcm in patients with anemia who are not dialysis dependent.


Eligibility criteria:
inclusion criteria: * subjects ≥18 years of age and able to give informed consent * iron deficiency is the primary etiology of anemia * history of intolerance or an unsatisfactory response to oral iron * screening visit central laboratory hgb ≤11 g/dl * screening visit ferritin ≤100 ng/ml or ≤300 when tsat was ≤30% exclusion criteria: * previous participation in a fcm trial * known hypersensitivity reaction to fcm or iron dextran * requires dialysis for treatment of chronic kidney disease * current anemia not attributed to iron deficiency * received iv iron, rbc transfusion(s), or antibiotics 10 days prior and during the screening phase * anticipated need for surgery during the 30 day period prior to screening or during the study period * ast or alt greater than 1.5 times the upper limit of normal * received an investigational drug within 30 days of screening * women who are breastfeeding * pregnant or sexually-active females who are not willing to use an effective form of birth control
myopic macular haemorrhages

Conditions: Myopic Macular Haemorrhages

Summary: 1. to identify the underlying causes of macular haemorrhages in patients with high myopia 2. in the eyes found to have macular haemorrhages secondary to choroidal neovascularisation, we hope to identify the risk factors for the development of choroidal neovascularisation in high myopia 3. to study the functional outcome of these eyes as assessed by visual acuity 4. to study the morphological outcome of these eyes by clinical assessment (and fundal photography) and fluorescein angiography

primary aims * to identify the underlying aetiologies of macular haemorrhages in myopic eyes * to study the functional and morphological outcome of these eyes with macular haemorrhages 6 months later secondary aims * to study the subgroup of eyes with myopic choroidal neovascularisation (cnv), in particular the risk factors for cnv in myopes * to study the subgroup of eyes with macular haemorrhages in the absence of cnv plan of investigation: 1. patient with myopia (\>-6.00ds) presents with loss of central vision 2. examination reveals a macular haemorrhage 3. investigations * refraction * axial length\* * fundus fluorescein angiography * indocyanine green angiography\* 4. determine if a myopic cnv is present or absent 5. management of patient: treatment vs no treatment * treatment being 1. conventional laser 2. pdt 6. review at 6 months * bcva * clinical appearance (fundal photo) * ffa 7. review at 12 months * bcva * clinical appearance

Eligibility criteria:
inclusion criteria: * high myopia (greater than -6.00ds) * macular haemorrhage exclusion criteria: * macular haemorrhages from other causes eg. diabetic retinopathy, hypertensive retinopathy * allergy to fluorescein or indocyanine green dyes

Keywords: high myopia choroidal neovascularisation lacquer crack fundus fluorescein angiography indocyanine green angiography axial length
driving pressure as a predictor of mortality in acute respiratory distress syndrome patients

Conditions: ARDS

Summary: the aim of this study is to make analysis of potentially modifiable factors contributing to outcome of mechanically ventilated ards adult patient receiving lung protective strategy. primary objective: is to evaluate whether dp was superior to the variables that define it in predicting hospital outcome including mortality. secondary objective: is to identify manageable factors associated with outcome such as ventilator-related parameters and to investigate the role of non-modifiable factors such as demographic characteristics, severity of illness.

the acute respiratory distress syndrome (ards) is an acute and intense inflammatory disease process of the lungs, characterized clinically by severe hypoxemia and bilateral pulmonary infiltrates. the hospital mortality ranges between 35% and 45% (1). traditionally, critically ill patients requiring mechanical ventilation (mv) were ventilated using high tidal volumes (vt) and high airway pressures, until the pivotal ards net randomized controlled trial (rct) demonstrated that a "lung-protective" mv strategy using a vt of 4-8 ml/kg predicted body weight (pbw) and moderate levels of positive end-expiratory pressure (peep) improved survival (2). the driving pressure (dp) (calculated as the pplat minus applied peep) has been suggested as a major determinant for the beneficial effects of the three main components of lung-protective mv, namely, vt, pplat, and peep. and also a given dp would have different effects on outcome depending on the vt, pplat, and peep (3). a retrospective analysis of several trials in patients with ards comparing different peep levels at the same vt or different vt levels at the same peep, or a combination of both, found that δprs is the stronger predictor of mortality as compared with pplats (3).

Eligibility criteria:
inclusion criteria: * ards patients: who are treated with lung-protective mv and assessed on standardized ventilatory settings(4) at 24 hours after ards onset . all patients will meet the american-european consensus conference criteria for ards (5) on peep greater than or equal to 5 cm h2o and berlin criteria for moderate or severe ards (6). exclusion criteria: * patients with left atrial hypertension, as diagnosed by the attending physician, as the primary cause of respiratory failure. * anticipated duration of mechanical ventilation of less than 48 hours. * severe chronic respiratory disease; neuromuscular disease that would prolong mechanical ventilation. * intracranial hypertension; morbid obesity; pregnancy.

Keywords: driving pressure
an open-label, single-arm, multicenter pharmacokinetic study of intramuscular erwinaze® (asparaginase erwinia chrysanthemi)/erwinase® (crisantaspase)

Conditions: Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

Summary: the purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to \<40 years with all or lbl who have developed a hypersensitivity to native e. coli asparaginase or pegaspargase.


Eligibility criteria:
inclusion criteria: 1. have a diagnosis of all or lbl 2. be 18 to \<40 years of age at the time of enrollment 3. have a documented ≥ grade 2 clinical hypersensitivity reaction to native e. coli asparaginase (e.g., elspar or kidrolase) or pegaspargase (oncaspar) 4. have the following asparaginase doses remaining in their treatment plan: * at least two (2) consecutive weeks of native e. coli asparaginase treatment or * at least one (1) dose of pegaspargase (oncaspar) 5. have a direct bilirubin ≤ grade 2 (\<3.0 mg/dl \[52 µmol/l\]) 6. have amylase and lipase within normal limits (per institutional standards) 7. have a serum asparaginase activity below the detectable limit during screening prior to the first dose of study drug (erwinaze) 8. consent to use a medically acceptable method of contraception throughout the entire study period and for 4 weeks after the study is completed. medically acceptable methods of contraception that may be used by the subject and/or the partner include abstinence, birth control pills or patches, diaphragm and spermicide, condom and vaginal spermicide, surgical sterilization, postmenopausal, vasectomy (\>6 months prior to baseline), and progestin implant or injection. 9. have signed informed consent exclusion criteria: 1. prior history of ≥ grade 3 pancreatitis 2. prior history of a major thrombotic event as assessed by the investigator, or any subject with a history of asparaginase-associated serious hemorrhagic or thrombotic event requiring prolonged anticoagulation therapy with agents such as heparin 3. prior treatment with erwinaze 4. pregnant or lactating female subjects or female subjects of childbearing potential not willing to use an adequate method of birth control (listed above) for the duration of the study 5. subjects with a history of human immunodeficiency virus (hiv) or hepatitis. 6. any other condition that would cause a risk (in the investigator's judgment) to subjects if they participate in the trial
dysphagia in thoracic surgical patients

Conditions: Thoracic Diseases

Summary: the proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (vfmi) in individuals undergoing throacic surgical procedures. it also seeks to determine the impact of postoperative swallowing impairment on health-related outcomes.

swallowing impairment and vfmi are common, yet often overlooked, complications of thoracic surgical procedures. the true incidence of both dysphagia and vfmi in this patient population is unclear due to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patents undergoing thoracic surgery. the study is therefore aimed to determine the incidence of dysphagia and vfmi in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. in addition, the study is also aimed to assess the relative impact of vfmi and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status

Eligibility criteria:
inclusion criteria: * adults aged 18 - 90 years old * undergoing planned or emergent thoracic surgery via clamshell and/or extended thoracotomy * confirmed negative covid-19 test * willing to participate in postoperative swallowing evaluation testing. exclusion criteria: * individuals under the age of 18. * pregnant * or those testing positive for covid-19 * additionally, the inability to demonstrate appropriate alertness and cognitive status following the procedure will exclude a participant from participating in this study to ensure protection of vulnerable individuals.

Keywords: dysphagia extubation vocal fold mobility impairment peak cough flow (pcf)
central china congenital heart disease associated pulmonary arterial hypertension cohort study

Conditions: Pulmonary Arterial Hypertension

Summary: the study will recruit and follow up patients for five years patients newly diagnosed with congenital heart disease associated pulmonary arterial hypertension(chd-pah) from the investigator's hospital. the main aim of the study is to describe the aetiology, natural history and management practices of chd-pah in central china.

baseline include: an echocardiogram to assess the size, shape, pumping action and the extent of any damage to the heart. lung function tests which include blowing measurements to assess gas volumes within the lungs as well as assessment of how the lungs exchange gases. right heart catheterisation (rhc) to diagnose pah optional cardiac magnetic resonance tests. 6 minute walk distance (6mwd). to measure exercise capacity electrocardiogram (ecg), a test that measures the electrical activity of the heart blood tests main outcome measure include: death heart/lung transplantation atrial septostomy hospitalization due to worsening of pah start of new specific pah treatment persistent decrease of \>15% from baseline in 6mwd (or \>30% compared with last study-related measurement) persistent worsening of world health organization (who) functional class (fc）

Eligibility criteria:
inclusion criteria: -clinical diagnosis of chd-pah (by rhc) exclusion criteria: * pah due to other criteria; * unable to participate
efficiency of the imaging strategy for the management of suspected covid-19

Conditions: COVID-19

Summary: emergency departments have been placed at the heart of the patient triage strategy during the covid-19 epidemic. in the absence of scientific knowledge on the most efficient strategy to put in place in emergency structures, the centers have proposed very heterogeneous protocols resulting from collaboration with local radiology and virology teams. while the pandemic in france appears to be currently under control, it is important to assess the sorting strategies put in place to deal with a new epidemic.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject treated in the emergency rooms of participating centers for suspicion of covid-19 presenting with fever\> 38 ° and / or respiratory signs (dyspnea, cough, sputum) and / or other symptoms suggestive of covid-19 (diarrhea , confusion ...) and / or people over 85 or living in an institution during the study period from march 9 to may 8, 2020 * subject affiliated to a social health insurance protection scheme * subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research exclusion criteria: * subject having expressed opposition to participating in the study * subject under guardianship or guardianship * subject under safeguard of justice

Keywords: covid-19 sars-cov-2 dyspnea cough sputum diarrhea confusion
platelet rich plasma and hydrodissection for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome (cts) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. rather than other progressive disease, cts is characterized by remission and recurrence. although many conservative managements of cts, the effectiveness of these methods is insignificant or only persist for a short duration. the platelet rich plasma (prp) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. since 2014, three small clinical trials showed the positive effect of prp in peripheral neuropathy included ctsin a pilot research. however, these studies have not entirely proved the effects of prp on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. the investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided prp injection in patients with cts.

after obtaining written informed consent, patients with bilateral cts will been randomized into intervention and control side. participants in intervention group received one-dose ultrasound-guided prp injection and control side received one-dose ultrasound-guided normal saline injection. no additional treatment after injection through the study period. the primary outcome is boston carpal tunnel syndrome questionnaire (bctq) and secondary outcomes include visual analog scale (vas), cross-sectional area (csa) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. the evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the treatment.

Eligibility criteria:
inclusion criteria: * age between 20-80 year-old. * diagnosis was confirmed using an electrophysiological study exclusion criteria: * cancer * coagulopathy * pregnancy * inflammation status * cervical radiculopathy * polyneuropathy, brachial plexopathy * thoracic outlet syndrome * previously undergone wrist surgery or steroid injection for cts

Keywords: platelet rich plasma hydrodissection
comparison of the ultrasound supra-inguinal fascia iliaca block vs femoral nerve block

Conditions: Hip Fracture

Summary: patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (fibsi) and femoral nerve block (fnb) for fibsi, the probe is placed transversely between anterior superior iliac spine (asis) and the pubic spine. the transducer is translated laterally to identify the sartorius muscle. cephalic inclination of the probe. the medial end of the transducer faces towards the umbilicus, which is the final position. the 100mm neurostimulation needle is advanced in the in plan approach to pass through the iliac fascia. once the correct position is confirmed, 30 ml of 1% ropivacaine is gradually injected between the iliac fascia and the iliac muscle. for fnb, the probe was placed under the inguinal ligament. the femoral vessels and the nerve section are visualized; the 100mm neurostimulation needle is advanced in the in plan approach and 30ml of 1% ropivacaine has been injected along the nerve sheath

patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (fibsi) and femoral nerve block (fnb) for fibsi,the probe is placed transversely between the eias and the pubic spine,the transducer is translated laterally to identify the sartorius muscle. cephalic inclination of the probe: the iliac muscle is located at the medial border in the shadow of the superior anterior iliac spine.the medial end of the transducer faces towards the umbilicus, which is the final position. the anatomy identified, from superficial to deep, consisting of subcutaneous fat, internal oblique muscle, transverse abdominal muscle, iliaca fascia covering the iliac muscle. the 100mm neurostimulation needle is advanced in in plan approach to cross the iliaca fascia. with the tip of the needle just below the iliaca fascia, 2 ml of local anesthetic was injected to confirm the location of the tip. once the correct position is confirmed, 30 ml of 1% ropivacaine is gradually injected between the iliac fascia and the iliac muscle. for fnb,the probe was placed under the inguinal ligament. femoral vessels and sectional nerve are visualized. the nerve was located, an 100mm neurostimulation needle is advanced in in plan approach, and 30 ml of 1% ropivacaine was injected along the nerve sheath.

Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiologists) class i, ii, and iii patients scheduled for emergency surgery with the diagnosis of proximal femur fracture exclusion criteria: * hemorrhagic diathesis, * peripheral neuropathies, * allergy to amide local anaesthetics, * mental disorders, * those on analgesics within 8 hour prior to performing nerve block

Keywords: analgesia hip fracture nerve block
evaluation of the performance of two contact lenses compared to a marketed lens

Conditions: Refractive Ametropia

Summary: this study will serve to evaluate and compare the performance of two new lenses to a marketed lens.


Eligibility criteria:
inclusion criteria: * healthy, female adult, at least 18 years of age, and no more than 34 years of age * the subjects must be female, light eye caucasian, non-hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes * must have rated the concept statement positively (i.e., a rating of 4 or 5). * optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (d) * any cylinder power must be: \<=0.75d * visual acuity must be best correctable to 20/25 or better for each eye * must have normal eyes (no ocular medications or ocular infection of any type) * must read and sign the statement of informed consent * must appear able and willing to adhere to the instructions set forth in this clinical protocol. exclusion criteria: * ocular or systemic allergies or disease which might interfere with contact lens wear * systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear * clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear * clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear * any ocular infection * any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear * any color deficiencies (colorblindness) - to the best of the subject's knowledge * pregnancy or lactation * diabetes * infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. hiv) * habitual contact lens type is toric, multifocal, or is worn as extended wear. * subject presents with one dark iris color and one light iris color. * subject has heterochromia iridis (a difference in color between parts of one iris). * the subject must not be an employee or family member of the clinical study site.