Kornimate/medical-research-clean huggingface dataset:
explor® modular radial head data collection

Conditions: Degenerative Conditions of the Radial Head/Neck; Post-traumatic Conditions of the Radial Head/Neck

Summary: the purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the explor® modular radial head. this data collection effort will document the clinical outcomes of the radial head.

data collection intervals are: pre-operative, operative, 3 months post-op, 1 year post-op, 3 years post-op, and 5 years post-op. data collected includes: historical data, operative record, mayo clinic performance index for the elbow, quick dash outcome measure, complications, lost to follow-up, protocol deviations, and radiographic evaluation of elbow and wrist.

Eligibility criteria:
inclusion criteria: the inclusion criteria will be the same as the indications stated in the fda cleared (510(k) k040611) and (510(k) k051385) labeling for the device. 1. replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: 1. joint destruction and/or subluxation visible on x-ray 2. resistance to conservative treatment 2. primary replacement after fracture of the radial head 3. symptomatic sequelae after radial head resection 4. revision following failed radial head arthroplasty the device is intended for single use with or without bone cement. modular radial head replacement prostheses have received fda clearance for cemented and non-cemented application. patient selection factors to be considered include: 1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of weight and activity levels, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity. exclusion criteria: the exclusion criteria will be the same as the contraindications stated in the fda cleared labeling (510(k) k040611) and (510(k) k051385) for the device. these contraindications include: absolute contraindications: 1. infection 2. sepsis 3. osteomyelitis relative contraindications: 1. uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions 2. osteoporosis 3. metabolic disorders which may impair bone function 4. osteomalacia 5. distant foci of infections which may spread to the implant site 6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Keywords: elbow fracture elbow dislocation radial head fracture radial neck fracture
lung infection in icu (lung-i3)

Conditions: VAP - Ventilator Associated Pneumonia

Summary: objective of lung-i3 study is to assess the quantitative and functional differences in cells between blood and bronchoalveolar lavage (bal) fluid after an infection, with a special focus on alveolar macrophages and neutrophils


Eligibility criteria:
inclusion criteria: all the following criteria * age 18 years or greater * severe icu patients hospitalized for one of the above diseases: * septic shock (requirement of vasopressor to maintain a mean arterial pressure of 65 mm hg or greater and serum lactate level greater than 2 mmol/l (\>18 mg/dl) in the absence of hypovolemia) caused either by pneumonia (n=20) or another source n=20) * severe trauma (level i and ii), injury severity score ≥ 25 or * burn with tbsa over 20% * nad \> 0.1 µg/kg/min * at least 2 sofa criteria ≥ 2 points exclusion criteria: * aspiration pneumonia * unable to obtain a valid and written consent from a patient or their legally authorized representative in accordance with the local regulatory instances (this includes in fr: person not affiliated to a health insurance scheme, or not a beneficiary of such a scheme. persons who are the subject of a legal protection order. person with restricted freedom following a legal or administrative decision and a person admitted without their consent pursuant to articles l.3212-1 and 3213-1, which are not included in article l.1121-8 of the french public health code.) * copd * smoke inhalation in burn patients * participation in an intervention study * pregnant or breastfeeding women * immunocompromised patients, defined as * patients with solid tumors with chemotherapy in the last 3 months or a progressive metastatic disease * hematologic malignancies * solid organ transplantation * hiv infection with or without aids * treatment with corticosteroids (\> 3 months at any dosage or ≥ 1 mg/kg prednisone equivalent per day for \> 7 day) * treatment with other immunosuppressive drugs.

Keywords: vap - ventilator associated pneumonia sepsis lung infection broncho-alveolar lavage icu
translational study for brafv600 serum and plasma determination in patients with brafv600 metastatic melanoma

Conditions: Stage IV Skin Melanoma

Summary: this is a multi-centric translational study with biological samples collection. the aim of this study is to validate a method to detect brafv600 in blood samples. samples: blood from patients with brafv600 metastatic melanoma collected following standard medical practice. the treatment is not the aim of the study. patients can be treated either with specific or no-specific drug.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of melanoma and brafv600 * signed informed consent form * unresectable phase iii or phase iv melanoma * the patients should be starting a treatment for melanoma (either first line or subsequent lines)
influence of silicone hydrogel extended contact lens wear on corneal sensitivity

Conditions: Cornea

Summary: soft contact lens wear reduces the amount of oxygen reaching the eye, which may have an influence on corneal sensitivity. the aim of this study is to measure corneal sensitivity with means of liquid jet esthesiometry at baseline and after 6 days of continuous, extended contact lens wear.

contact lens wear may have an influence on corneal sensitivity, by three mechanisms: hypoxic, mechanical and inflammatory. extended silicone hydrogel contact lens wear increases the risk of infections. a change in corneal sensitivity may be considered as an indicator for change in corneal physiology. it is there the aim of this study is to measure corneal sensitivity with means of liquid jet esthesiometry at baseline and after 6 days of continuous, extended contact lens wear.

Eligibility criteria:
inclusion criteria: * no contact lens wear three days before first visit * corneal radius between 7.4 and 8.0; if corneal radius \>8.0, corneal diameter must be at least 12 mm; if corneal radius \< 7.4, corneal diameter must be \< 12.0 * osdi score no higher than 13 points exclusion criteria: * systemic disease that may have an influence ocular healtjh * active ocular disease and no history of ocular surgery

Keywords: silicone hydrogel contact lens extended contact lens wear corneal sensitivity esthesiometry
delirium in covid-19: germany-wide covid-19 intensive register

Conditions: Intensive Care Unit Delirium; Covid19; Post Intensive Care Unit Syndrome

Summary: the global pandemic caused by the sars-cov-2 virus is confronting the german health system with a novel pathogen. this means that a timely evaluation of all available results is required. in the field of intensive care in particular, there are significant gaps in knowledge, particularly with regard to delirium. in this respect, this study also serves directly to investigate the pathways of delirium outcome in covid-19 patients.


Eligibility criteria:
inclusion criteria: all patients with sars-cov-2 positive covid-19 disease * age≥18 years * proven by positive pcr tests from nasal/ throat swabs as well as samples from the deep respiratory tract. * period 01.01.2020 to 21.02.2022 exclusion criteria: * none
a novel method for enhancement of standard rest electrocardiograms (ecg) provides new parameters for early detection of coronary artery disease (cad)

Conditions: Cardiovascular Diseases

Summary: the investigators aim to determine whether a new method of enhancing and improving ecg acquisition, analysis and display is effective. the investigators will perform superimposition and summation of multiple standard ecg cycles, in the same lead, by temporal alignment to the peak r wave and voltage alignment to an improved baseline at the t-p segment.


Eligibility criteria:
inclusion criteria: * patients undergoing routine coronary angiogram exclusion criteria: * patients with significant irregular heart rhythm * patients with heart failure
azd9773 dose escalation study

Conditions: Severe Sepsis

Summary: this is a double-blind, placebo-controlled, multi-center, dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending intravenous infusions of cytofab (azd9773) in adult patients with severe sepsis.


Eligibility criteria:
inclusion criteria: * clinical evidence of infection requiring treatment with parenteral antibiotics * patients must meet multiple systemic inflammatory response syndrome (sirs) criteria * patients must meet criteria for cardiovascular and/or respiratory dysfunction * sepsis (infection plus sirs criteria) must be present prior to organ dysfunction exclusion criteria: * moribund and death is considered imminent, or patient not expected to survive 90 days because of underlying medical condition, or classified as do not resuscitate or do not treat * patient cannot attain a map \>60 mmhg when measured via an arterial line and/or a systolic blood pressure (sbp) \>80 mmhg in the presence of vasopressors and iv fluids for a period of ≥2 hours * receiving immunosuppressants, or high dose steroids within 2 months of provision of informed consent * any history of hypersensitivity reaction to sheep products, latex, papain or papaya, or chymopapain or previously administered antivenom manufactured using ovine serum, digoxin immune fab (digifab™ , digibind® ), crotalidae polyvalent immune fab (ovine) (crofab™ ), or other sheep derived product. * treatment with anti tumor-necrosis-factor (anti-tnf) antibodies within 8 weeks before provision of written informed consent.

Keywords: sepsis septic shock systemic inflammatory response syndrome
anecortave acetate safety in patients with open-angle glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma; Oular Hypertension

Summary: the purpose of this study was to evaluate the safety and intraocular-lowering efficacy of anecortave acetate depot when administered by anterior juxtascleral depot (ajd) for the treatment of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension. * other protocol-defined inclusion criteria may apply. exclusion criteria: * patients with any form of glaucoma other than open-angle. * other protocol-defined exclusion criteria may apply.

Keywords: anecortave acetate open-angle glaucoma iop oht
sexual risks in prep users

Conditions: HIV Infection; Prep Prescription; Vaccinations; Sexually Transmitted Diseases

Summary: primary purpose of the study: to describe sexual behavior of prep users, whatever mode of intake, ie continuous or on-demand; it has been shown in some studies, an increase of sexual risks in prep users, and therefore an similar increase of stis (sexually transmitted diseases); using a self-questionnaire, we'd like to evaluate sexual behavior before, and 6 months after, starting prep. secondary purposes: to describe medical characteristics of prep users (past medical condition, demographic characteristics, vaccinations, kidney function, serological results, urine and anal/pharyngeal swabs), clinical and biological prep safety, stis occurrence, and antibiotic prescriptions, continuous or on-demand intake, prep indication.


Eligibility criteria:
inclusion criteria: * non hiv-infected subjects * men aged 18 years or older * having non protected sexual relationship * taking prep (emtricitable/tenofovir disoproxil fumarate) either every day, or on-demand * affiliated to social security exclusion criteria: * hiv-infected patients * refusal of study participation * not on prep * not fluent in french language * safeguarding justice * on guardianship or trusteeship

Keywords: prep sexual behavior hiv syphilis chlamydia infection hepatitis gonococcus
self-retaining bicanalicular intubation stent versus bicanalicular silicone tube for management of canalicular obstruction

Conditions: Canalicular Obstruction

Summary: the aim of the study is to evaluate outcomes of the use of self_retaining intubation set versus bicanalicular silicone tube in management of canalicular obstruction

epiphora is a condition due to obstruction of lacrimal passages either proximal or distal. canalicular obstruction is a condition in which the lacrimal canaliculi are narrowed or occluded. canalicular obstructions can be anatomically classified as proximal type in which the obstruction found at the initial 2-3 mm from the punctal opening while in mid canalicular type obstruction at 3-8 mm from the punctum and the distal type in which a membrane of the common canaliculs to the lacrimal sac. canalicular obstruction can be acquired or congenital. acquired canalicular obstruction may result from infectious and inflammatory eyelid disorders, ocular surface disease, systemic or topical medications, irradation, iatrogenic, intrinsic cannalicular tumors and trauma. the correct chioce of the techinque for given canalicular obstruction and therefore the long-term success depends on the site and degree of the obstruction, incomplete obstruction or stenosis can be treated with canalicular stenting. proximal and mid canalicular obstructions need reconstruction by excising the focal canaliculus obstruction near the punctum and the cut ends of the canaliculus can be anastomosed over a stent. dacryocystorhinostomy with retrograde intubation of the lacrimal system has shown some success may avoid the need for a jones tube. patients with symptomatic distal canalicular obstruction should undergo timely insertion of a bicanalicular silicon stent to prevent permanent and complete closure of the canaliculi. there are several modalities of canalicular intubation for the patients with distal canalicular obstruction. in patients with nasolacrimal duct and canalicular obstruction ,preferred procedures include dacryocystorhinstomy with bicanalicular or monocanalicular intubation .however,in patients with canalicular obstruction without nasolacrimal duct obstruction use bicanalicuar silicone intubation. in 2014 p.bige' designed self-retaining bicanaliculs intubation setii(srsii) which is the latest innovation in the field as these silicone stent segments traverse both canaliculi till the lacrimal sac. in which each end of this semicircular device has 2 stout angulated wings/flanges which pose no resistance while proceeding forward into the canaliculus, but once they get into open cavity (lacrimal sac), the flanges open up and give resistance to their removal against the common canalicular opening.

Eligibility criteria:
inclusion criteria: * patients with epiphora due to distal canalicular obstruction. exclusion criteria: patients with epiphora due to * punctual stenosis * lid malposition * intra-operative nasolacrimal duct obstruction * previous eyelid or lacrimal drainage surgery * untreated conjunctivitis, blepharitis. dacrocystitis proximal and mid canalicular obstruction.
ostpre-fracture prevention study

Conditions: Fractures; Osteoporosis

Summary: the purpose of this study is to determine the effect of calcium 1000 mg/d and vitamin-d3 800 iu/d divided in two daily doses on the incidence of falls and fractures, bone mineral density and bone metabolism in postmenopausal women 65-71 years of age.

in aging population osteoporotic fractures in postmenopausal women are a growing problem and a cause of remarkable morbidity, individual suffering and costs. the effect of calcium and vitamin-d in fracture prevention have been tested in elderly patients mostly over 70-75 years of age and results with low dose intervention have been controversial. the aim of this study is to determine the effects of calcium (1000 mg/d) and vitamin-d (800 iu/d) in 65-71 year-old postmenopausal women in a clinical trial on two levels: a) a randomized postal interview trial (n=3432) and b) a randomized clinical trial (n=606). 5407 women of the ostpre-cohort received a postal enquiry with questions of health related issues and willingness to participate a calcium and vitamin-d survey. 4706 enquiries were returned. 3432 eligible women were randomised to the active treatment group (n=1718) to receive the intervention and control group (n=1714), that did not receive placebo, they were told to go on as before in terms of calcium or vitamin-d substitution. on the level of the interview trial end point variables, falls and fractures, are collected by telephone interviews annually and on the level of the clinical trial every four months. in clinically examined subset of 606 subjects axial and heel bone mineral density (bmd), heel quantitative ultrasound (qus) measurement, anthropometric measurements, a comprehensive set of clinical (muscle strength, balance, functional capacity) and laboratory tests (serum calcium, phosphate, afos, creatinine, cholesterol, triglycerides, complete blood count, 25-oh-d-vitamin, pth, osteocalcin and trap5b and reserve, serum and urine samples) will be performed and food diary will be obtained at baseline and after 3 years follow-up and baseline blood samples will be taken for dna-analyses.

Eligibility criteria:
inclusion criteria: * alive member of the original population based sample (n=14220) of kuopio osteoporosis risk factor and prevention study * age 65 years or older on 30.11.2002 * not participating any previous bmd-measurement in ostpre * living in the province of kuopio * adequately filled baseline enquiry * willing to participate calcium and vitamin-d -survey

Keywords: osteoporosis fractures risk of fracture vitamin-d calcium falls bone mineral density bone metabolism
gestational age specific thyroid function reference range

Conditions: Thyroid; Reference Values; Pregnancy

Summary: it has been well accepted that maternal thyroid dysfunction has adverse affects on both mothers and fetuses. however, the dramatical changes during pregnancy make the interpretation of thyroid function test (tft, i.e. free triiodothyronine \[ft3\], free thyroxine \[ft4\] and thyrotropin \[tsh\]) very difficult. previous studies have shown that the level of thyroid hormones differs from non-pregnant population and varies from gestational ages. moreover, studies have shown the agreement among different instrument platforms was quite low. this study is aimed to determine gestational age specific tft reference ranges of the local pregnant population for all available platforms currently used under hospital authority and department of health.


Eligibility criteria:
inclusion criteria: * pregnant women receiving pregnancy and postnatal care in the department of obstetrics \& gynaecology, prince of wales hospital, hong kong exclusion criteria: * 1. previous history of thyroid dysfunction (hypothyroidism or hyperthyroidism); * 2. autoimmune disease, particularly those receiving corticosteroid or immunosuppressant: e.g. systemic lupus erythematosus; * 3. disease associated with thyroid dysfunction: e.g. molar pregnancy

Keywords: thyroid reference values pregnancy
enhancing the effectiveness of electroconvulsive therapy in severe depression

Conditions: Depression

Summary: electroconvulsive therapy (ect) is the most powerful antidepressant treatment available and is often life-saving. there are concerns, however, that standard bitemporal ect (the most commonly used form of ect worldwide) causes persisting retrograde amnesia. however, clinical trials have indicated that high-dose unilateral ect may be as effective as bitemporal ect but have much less cognitive side-effects. the trial aims to test the primary experimental hypothesis: high-dose (6 x st) right unilateral ect is as effective as (i.e. not inferior to) standard (1.5 x st) bitemporal ect for severe depression in terms of hamilton depression rating score (hdrs) at the end of the treatment course.

the study is a two-group parallel design randomised controlled non-inferiority trial and has been registered (isrctn23577151). consented patients with major depressive disorder (dsm-iv) will be randomly allocated to a course of bitemporal (bt) ect (1.5 x st) or high-dose right unilateral (rul) ect (6.0 x st). to facilitate generalizability of results, the trial takes place under "real world" conditions and so both groups continue usual care and medications during the treatment phase and thereafter. patients are followed-up for 12 months after completing their allocated course of ect. completion of the primary outcome depression-rating measure (i.e. hdrs) and the secondary outcome of most interest (autobiographical memory, using the ami-sf) will be prioritised in the data collection. patients, their treating clinicians and raters are blind to treatment; clinicians administering ect are not involved in post randomisation assessments or formal data analysis. success of blinding for patients and raters will be assessed after the second and final treatments. the trial statistician is also blinded to allocation status. sample size: in a large series (n = 253) of depressed patients, petrides et al. (2001) found a mean (sd) reduction in 24-item hdrs of 25.6 (9.4) after treatment with bitemporalt ect (1.5 x st). we therefore estimate that 69 patients will be required per treatment group to have 80% power to demonstrate, using a one-sided equivalence t-test at 5% level, that mean reduction in 24-item hdrs achieved using high-dose rul ect is no more than 4 points (i.e. equivalent to 3 points on 17-item hdrs) less than that achieved using standard bt ect, assuming a common within-group sd of change scores of 9.4 and equal expected group mean change scores.

Eligibility criteria:
inclusion criteria: * patients ≥18 years diagnosed with major depressive episode (dsm-iv) and referred for ect exclusion criteria: * any condition rendering patients medically unfit for general anaesthesia or ect; treatment with ect in previous six months; dementia or other axis 1 diagnosis; alcohol/other substance abuse in previous six months; inability/refusal to consent.

Keywords: electroconvulsive therapy ect electrode placement effectiveness cognition autobiographical memory