Kornimate/medical-research-clean huggingface dataset:
equivalence of the response to vaccination of tacrolimus ointment to a steroid ointment regimen in children with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: seven-month study in pediatric patients (2-11 years) with moderate to severe ad who were considered to benefit from vaccination to prevent invasive disease caused by neisseria meningitides serogroup c.

at the week 1 visit, the patients were vaccinated with a protein-conjugated vaccine against meningitis. all patients received a challenge at the month 6 visit with a low dose of meningo polysaccharide vaccine. a control group of healthy subjects (not suffering from atopic dermatitis) received only the vaccination and the challenge dose.

Eligibility criteria:
inclusion criteria: * patients with moderate to severe atopic dermatitis and in need for treatment * patients require vaccination to prevent invasive disease caused by neisseria meningitidis serogroup c exclusion criteria: * patients have known hypersensitivity to macrolides, tacrolimus and any component of the vaccine * patients have an acute severe febrile illness, genetic epidermal barrier defect such as netherton's syndrome or generalized erythroderma, a skin infection on the affected and to be treated area * patients have already received a meningo polysaccharide or conjugated vaccine against meningitis

Keywords: atopic dermatitis meningitis vaccination tacrolimus steroids equivalence response meningococcal vaccine
extension study of the long-term safety and tolerability of octreotide acetate in patients with moderately severe or severe non-proliferative diabetic retinopathy or low risk proliferative diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: this multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study csms995 0802. during this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe npdr and low risk pdr.


Eligibility criteria:
inclusion criteria: * written informed consent provided prior to participation in the extension study * successful completion of study csms995 0804 * willingness to comply with all study requirements exclusion criteria: * more than 8 weeks interval since the completion of study csms995 0804 * premature discontinuation from study csms995 0804 other protocol-defined inclusion/exclusion criteria may apply.

Keywords: diabetic retinopathy octreotide acetate in microspheres
pressure sore prevention strategy for the prone position

Conditions: Pressure Ulcers Prevention in Prone Positioning in Intensive Care

Summary: the aim of this clinical trial is to determine whether 5-layer hydrocellular dressings are effective in preventing the development of pressure sores during prone positioning in the intensive care unit. the main questions it aims to answer are: - are hydrocellular dressings the best strategy for preventing pressure sores? is this strategy simpler and less costly? the researchers will compare hydrocellular dressings with hydrocolloid dressings to find out whether they are more effective in preventing the development of pressure sores in the prone position. participants will be given either hydrocellular or hydrocolloid dressings, and caregivers will assess whether or not pressure sores develop after prone positioning.

hydrocellular dressings will be compared with hydrocolloid dressings to determine their effectiveness in preventing pressure ulcers during ventral decubitus in intensive care. the dressings will cover the skin in at-risk areas, and caregivers will assess whether or not pressure sores develop in these areas after prone positioning. the stage of these pressure sores will also be assessed. the time spent on each strategy and the cost per strategy will also be evaluated. dressings will be applied for the entire period during which participants are placed in the prone position. if they develop pressure sores during this period, they will be followed up until their discharge from intensive care to study the evolution of these pressure sores.

Eligibility criteria:
inclusion criteria: * major patient * moderate to severe acute respiratory distress syndrom (arterial oxygen pressure /inspired fraction of oxygen ratio \< 200) requiring at least one vd session. * affiliated to the french social security system * sedated patient on mechanical ventilation exclusion criteria: * pregnant or breast-feeding women * patient under guardianship or trusteeship * minor patients
evaluation of overall compliance and duration of zomacton® treatment with the zomajet® needle-free device

Conditions: Turner's Syndrome; Human Growth Hormone Deficiency

Summary: the purpose of this strictly observational, prospective, longitudinal study is to evaluate with sufficient precision the rate of overall treatment compliance from one year to 3 years of follow-up of the patients. somatotropin is indicated in the long-term treatment of children with growth retardation related to a deficiency in secretion of growth hormone and in the long-term treatment of growth retardation related to turner's syndrome confirmed by chromosomal analysis. these are the two indications of zomacton® 4 mg and 10 mg injection solution. the use of the zomajet® needle-free device (zomajet® 2 vision, reserved for the administration of zomacton® 4 mg or of the zomajet® vision x needle-free device, reserved for the administration of zomacton® 10 mg), allows the product to be administered by percutaneous transjection (needle-free) and can be used by the child directly or by the family after an initial training. in april 2004, the cepp (commission for the evaluation of products and services) requested a follow-up of the cohort of patients using the zomajet® 2 vision system measuring the compliance and duration of use of the device. the number of patients initiated on zomacton treatment using the zomajet® needle-free device is estimated to 30. over a period of inclusion of 3 years, we therefore estimate that 90 patients will be treated. in the cohort studied the patients will be followed-up for 1 year at least and for 3 years at the maximum. the rate of treatment compliance will be evaluated according to the ratio of the actual duration of administration over the total duration recommended by the physician during the observation period.


Eligibility criteria:
inclusion criteria: * growth hormone deficiency * turner's syndrome exclusion criteria: * patients who do not meet the criteria in the treatment information sheet

Keywords: turner's syndrome somatropin human growth hormone deficiency
walking inclined plane

Conditions: Cerebral Palsy; Spastic Diplegia

Summary: the adaptations in kinematics and muscle activity, investigated by 3d gait analysis and dynamic electromyography recordings, will be studied in children with bilateral spastic cerebral palsy during level walking, and before and after a training on a treadmill with a sloped surface (7°). data will be compared with those obtained in a sample of typically developing (td) children (controls)

15 cp children and 15 td children aged 6 to 14 years will take part in this study. dynamic emg recordings will be performed as well as kinematic data assessments through a gait analysis system. three different slopes will be assessed, using a treadmill. the primary outcome measure will be the minimal knee extension value in the stance phase. the changes in kinematics will be overall assessed through the gait profile score (baker et al.). the details in changes will be assessed through statistical parametric mapping (spm). the changes in muscle activity induced by the slope will be investigated by statistical parametric mapping of the emg or kinematic data.

Eligibility criteria:
inclusion criteria for children with cp: * age = 6-14 years old * children with cerebral palsy: spastic type, bilateral involvement, forefoot initial contact and/or excessive knee flexion at mid-stance and/or decreased hip extension in late stance. * gmfcs i or ii, * score on gillette scale between 8 and 10 * able to walk at least 10 min without help inclusion criteria for td children: * age = 6-14 years old exclusion criteria: * botulinum toxin injection or lower limb surgery within the last year. * uncontrolled seizures

Keywords: cerebral palsy gait slope electromyography
serial changes in strem-1 during ventilator-associated pneumonia (vap)

Conditions: Pneumonia

Summary: triggering receptor expressed on myeloid cells (trem)-1 is a recently described molecule that plays an important role in myeloid cell-activated inflammatory responses. the aim of this study was to investigate the evolutional change of soluble trem-1 (strem-1) in bronchoalveolar lavage (bal) fluid of clinically diagnosed ventilator-associated pneumonia (vap) and its correlation with response to treatment and outcome.

a prospective, interventional study conducted between august 2006 and august 2007 in micu in mackay memorial hospital, 35 patients with clinically diagnosed vap were investigated. strem-1 was measured in bal samples using elisa at the onset, 4th - 5th and 7th - 9th day of clinical diagnosis of vap.of these 35 patients, 27 had positive bal culture. the strem-1 levels in bal fluid were measured and compared between patients with positive bal culture and negative bal culture. serial changes in strem-1 levels were evaluated in relation to patient outcome.

Eligibility criteria:
inclusion criteria: * adult patients (older than 18 years)with clinically suspected vap exclusion criteria: * mechanically ventilated patients post cardiopulmonary resuscitation * patients with end stage diseases with life expectancy less than 3 months * patients with solid or hematology transplantation * patients on immunosuppressive agents

Keywords: strem-1 bal vap
pediatric video assisted thoracoscopic surgery (vats) in management of empyema

Conditions: Thoracic Empyema

Summary: thoracic surgeons have developed a thoracoscopic procedure which is less intrusive method allows complete evacuation and washing of the debris from the pleural cavity. this approach may also have the benefit of less invasive maneuver, a shorter hospital stay and a decreased rate of postoperative complications. the aim of this study is to evaluate the advantages and disadvantages of the video-assisted thoracoscopic surgery (vats) approach in comparison with thoracotomy in management of empyema in pediatric patients.

comparison between vats decortication and open thoracotomy in cases of pediatric empyema

Eligibility criteria:
inclusion criteria: * pediatric patients 1 yrs. : ≤ 18 yrs. * patients with empyema due to pneumonia. * patients with empyema had lasted for fewer than 3 weeks. exclusion criteria: * patients \< 1 yrs. old. * patients with whom pleural empyema had lasted for more than 3 weeks. * patients with empyema had been caused by trauma. * patients whose parents refuse to be included in the study. * patients with empyema due to ruptured lung abscess. * patients with empyema due to chest wall abscess. * patients with empyema due to rib osteomyelitis. * patients with bronchopleural fistula. * patients with post-surgical empyema.

Keywords: pediatric empyema vats decortication
effects of intensive antiplatelet therapy for patients with clopidogrel resistance after coronary stent implantation

Conditions: Acute Coronary Syndromes; Percutaneous Coronary Intervention; Clopidogrel Low Responsiveness

Summary: clopidogrel resistance (cr) or low-responsiveness is associated with increased risk of ischemic events and can be detected by laboratory tests. this multicenter, randomized study is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double clopidogrel maintenance dose and/or additional cilostazol)for patients with cr after coronary stenting.


Eligibility criteria:
inclusion criterial: * aged 35 to 75 years * acute coronary syndromes * underwent successful coronary stent implantation * informed consent exclusion criteria: * contraindications to antiplatelet therapy * history of intracranial bleeding * known bleeding disorders * severe liver or kidney disease * pregnancy * left main coronary artery disease * planned non cardiac surgery within 1 year * end stage of other serious disease with life expectancy less than 1 year * heart failure with nyha grade 3 to 4

Keywords: antiplatelet therapy clopidogrel low responsiveness acute coronary syndromes percutaneous coronary intervention cilostazol
reproducibility of tearfilm osmolarity measurements using tearlab® in patients with dry eye syndrome and healthy subjects

Conditions: Dry Eye Syndrome

Summary: dry eye syndrome (des) is a common condition that affects approximately 20% of adults aged 45 and older. although several clinical tests for the diagnosis and monitoring of des are available, currently no gold standard for the assessment of des exists. it has, however, been hypothesized that the assessment of tear film osmolarity may be a new and promising approach of an objective and non-invasive method for diagnosis and monitoring of treatment success. recently, a new commercially available instrument (tearlab®, ocusens inc, san diego, usa) for the assessment of tear film osmolarity has been introduced. this instrument allows for the easy and non-invasive determination of tear film osmolarity. unfortunately, no data about reproducibility are yet available. consequently, the current study sets out to investigate the short time reproducibility of tear film osmolarity measurements using the tearlab® instrument.


Eligibility criteria:
inclusion criteria: patients with dry eye syndrome (des): * men and women aged between 45 and 80 years, with des defined as a pathological schirmer i test and / or a pathological break-up time test. schirmer i test and break up time will be tested and analyzed according to the guidelines published in the report of the international dry eyeworkshop (dews) 2007 * normal findings in the ophthalmic examination other than des healthy control group: * men and women aged between 45 and 80 years, * normal findings in the medical history and ophthalmic examination exclusion criteria: * abuse of drugs or alcoholic beverages * participation in a clinical trial * symptoms of a clinically relevant illness

Keywords: tear film osmolarity objective scattering index tear break up time schirmer i test
chronic pain after thoracotomy (video assisted thoracic surgery - vats)

Conditions: Neuropathic Pain; Thoracic Surgery, Video Assisted; Chronic Pain

Summary: this is an explorative study investigating potential nerve injury after vats.


Eligibility criteria:
inclusion criteria: * able to understand and give consent * can read * residing in denmark exclusion criteria: * unable to understand the written information in danish * abuse (medicine, drugs, alcohol) * severe psychiatric illness * conflicting neurological disease

Keywords: persistent pain neuropathic pain thoracic surgery, video assisted chronic pain
tracheal occlusion to accelerate lung growth (total) trial for severe pulmonary hypoplasia

Conditions: Congenital Diseases; Diaphragmatic Hernia; Pulmonary Hypoplasia

Summary: this trial investigates whether prenatal intervention improves survival rate of fetuses with isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to expectant management during pregnancy, both followed by standardized postnatal care.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or more, who are able to consent * singleton pregnancy * anatomically and chromosomally normal fetus * left sided diaphragmatic hernia * gestation at randomization prior to 29 wks plus 5 d (so that occlusion is done at the latest on 29 wks plus 6 d) * estimated to have severe pulmonary hypoplasia, defined prenatally as: o/e lhr \<25 %, irrespective of the liver position * acceptance of randomization and the consequences for the further management during pregnancy and thereafter. * the patients must undertake the responsibility for either remaining close to, or at the feto center, or being able to travel swiftly and within acceptable time interval to the feto center until the balloon is removed. * intended postnatal treatment center must subscribe to suggested guidelines for "standardized postnatal treatment". * provide written consent to participate in this rct exclusion criteria: * maternal contraindication to fetoscopic surgery or severe medical condition in pregnancy that make fetal intervention risk full * technical limitations precluding fetoscopic surgery, such as severe maternal obesity, uterine fibroids or potentially others, not anticipated at the time of writing this protocol. * preterm labour, cervix shortened (\<15 mm at randomization) or uterine anomaly strongly predisposing to preterm labour, placenta previa * patient age less than 18 years * psychosocial ineligibility, precluding consent * diaphragmatic hernia: right-sided or bilateral, major anomalies, isolated left-sided outside the o/e lhr limits for the inclusion criteria * patient refusing randomization or to comply with return to feto center during the time period the airways are occluded or for elective removal of the balloon

Keywords: isolated congenital diaphragmatic hernia fetal surgery pulmonary hypoplasia
safety and effectiveness study of endovascular abdominal aortic aneurysm repair using the nellix® system

Conditions: Abdominal Aortic Aneurysm (AAA)

Summary: the objective of this study is to assess the safety and effectiveness of the endologix nellix® system for the endovascular repair of infrarenal abdominal aortic aneurysms (aaa).

this study will evaluate the safety and effectiveness of the nellix system among a wide range of physicians and in consecutively enrolled subjects to assess outcomes generalizability. following appropriate government and ethics committee/irb approval the nellix® endovascular sealing system will be implanted into eligible patients who are adequately informed and have consented to join the study. enrolled patients will undergo a high resolution, contrast-enhanced computed tomography angiography (ct) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

Eligibility criteria:
inclusion criteria: * male or female at least 18 years old; * informed consent understood and signed; * patient agrees to all follow-up visits; * have aaa with sac diameter ≥5.0cm, or ≥4.5 cm which has increased by \>1.0cm in the past year. * anatomic eligibility for the nellix system per the instructions for use: * adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm); * aneurysm blood lumen diameter ≤60mm; * most caudal renal artery to aortoiliac bifurcation length ≥100mm; * proximal non-aneurysmal aortic neck: length ≥10mm; lumen diameter 18 to 32mm; angle ≤60° to the aneurysm sac; * common iliac artery lumen diameter between 9 and 35mm with blood lumen diameter ≤35mm; * ability to preserve at least one hypogastric artery. exclusion criteria: * life expectancy \<2 years; * psychiatric or other condition that may interfere with the study; * participating in enrollment of another clinical study * known allergy to device any device component; * coagulopathy or uncontrolled bleeding disorder; * ruptured, leaking or mycotic aneurysm; * serum creatinine level \>2.0mg/dl; * cva or mi within three months of enrollment/treatment; * aneurysmal disease of the descending thoracic aorta; * clinically significant infrarenal mural thrombus (\>5mm thickness over \>50% circumference); * connective tissue diseases (e.g., marfan syndrome) * unsuitable vascular anatomy; * pregnant (females of childbearing potential only).

Keywords: infrarenal abdominal aortic aneurysm aaa endologix evas endovascular sealing system
bimatoprost ophthalmic solution in increasing eyebrow and eyelash growth in patients who have undergone chemotherapy for breast cancer and in healthy participants

Conditions: Alopecia; Breast Cancer

Summary: rationale: bimatoprost ophthalmic solution may help increase eyebrow and eyelash growth in patients who have undergone chemotherapy. purpose: this randomized clinical trial is studying how wells bimatoprost ophthalmic solution works in increasing eyebrow and eyelash growth in patients who have undergone chemotherapy for breast cancer and in healthy participants.

objectives: primary * to assess the effectiveness of bimatoprost ophthalmic solution in expediting regrowth of eyebrows and eyelashes in patients who have undergone chemotherapy for breast cancer and in increasing eyebrow growth in healthy participants with no known underlying disease as assessed by two physicians and an aesthetics expert on a scale of 0-4. secondary * to assess the effectiveness of this treatment as assessed by patient self-report on a scale of 0-4. * to assess the psychological impact of this treatment as assessed by patient-completed questionnaires. outline: patients are randomized to 1 of 2 intervention arms. * arm i: patients apply topical bimatoprost ophthalmic solution to base of upper eyelid margins or to eyebrow region once daily for 4 months in the absence of unacceptable toxicity. * arm ii: patients apply topical placebo solution to base of upper eyelid margins or to eyebrow region once daily for 4 months in the absence of unacceptable toxicity. patients complete questionnaires at baseline and monthly for 5 months about changes in eyebrows/eyelashes, side effects of treatment, and the psychological impact of treatment. photographs of eyebrows or eyelashes and surrounding skin are taken at baseline and monthly for 5 months and reviewed by a physician and aesthetics expert. after completion of study treatment, patients are followed up at 1 month.

Eligibility criteria:
inclusion criteria: * meets 1 of the following criteria: * diagnosis of breast cancer (group 1) * completed chemotherapy within the past month that has resulted in eyebrow alopecia or eyelash hypotrichosis * eyebrow score of 0-2 or eyelash score of 0-2 on the study's qualitative eyebrow or eyelash growth chart * has no known underlying disease (group 2) * desires thicker, fuller, or more numerous eyebrows exclusion criteria * pregnant * does not speak a language adequately covered by study translator services * cognitive impairment * history of trauma or burn to the eyebrow region, alopecia areata, or trichotillomania * known diagnoses possibly underlying or contributing to the state of the eyebrows including, but not limited to, telogen effluvium or anagen effluvium (group 2) * active ocular disease (group 1) * thyroid hormone level abnormalities (group 2) * more than 2 years since prior ocular surgery (group 1) * prior topical medication for increasing eyebrow growth within 30 days od starting study treatment * concomitant chemotherapy for the treatment of cancer (group 1) * concomitant therapy for eyelash or eyebrow growth

Keywords: breast cancer male breast cancer alopecia
the use of image-based computer gradings in the analysis of acne, rosacea, melasma, and seborrheic dermatitis

Conditions: Acne; Melasma; Rosacea; Seborrheic Dermatitis

Summary: the study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to expert based clinical severity grading.

the study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to dermatologist based clinical severity grading.

Eligibility criteria:
inclusion criteria: * adults with acne, rosacea, melasma or seborrheic dermatitis exclusion criteria: * prisoners * adults unable to consent * artificial facial markings on day of facial photography (such as piercings and tattoos) that may interfere with imaging in the opinion of the investigator

Keywords: artificial intelligent skin