Kornimate/medical-research-clean huggingface dataset:
pediatric vaccinations

Conditions: Pediatric ALL; Vaccination; Immunization

Summary: as the covid-19 pandemic hit new york city in the spring of 2020, many families were home-bound due to the city-wide lockdown. as a result, families in new york city were unable to attend their child's healthcare appointments and many young children did not receive their regularly-scheduled vaccinations. parts of the city-wide lockdown did eventually lift in the summer of 2020 as positive covid-19 virus rates declined in nyc. however, regularly scheduled vaccination rates (non-covid-related) remain low. yet, it is critical that young children receive their mandatory vaccines in a timely manner to decrease the chance of contracting preventable illnesses. thus, the investigators seek to increase vaccination rates among children ages 0-2 years in sunset park brooklyn.


Eligibility criteria:
inclusion criteria: * children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in nyu brooklyn family health centers network. exclusion criteria: * children above the age of 2 who do not attend nyu brooklyn family health centers network
the relationship between covid-19 and pneumothorax in patients hospitalized with covid-19 during the pandemic

Conditions: COVID-19; Pneumothorax

Summary: it is aimed to examine the retrospective features of covid-19 patients followed in our hospital with pneumothorax.

it is aimed to examine the retrospective features of covid-19 patients followed in our hospital with pneumothorax. the files of covid-19 patients with pneumothorax were reviewed retrospectively. the radiological records and treatment protocols of the patients were reviewed. the results were evaluated in terms of its relationship with pneumothorax.

Eligibility criteria:
inclusion criteria: * over 18 years * covid-19 patient * having a diagnosis of pneumothorax * pcr test positive and lung tomography pneumonic involvement exclusion criteria: * pcr test negative

Keywords: covid-19 pneumothorax
comparison of two combined therapeutic methods for treatment of lateral epicondylitis

Conditions: Lateral Epicondylitis

Summary: to compare the effectiveness of two combined therapeutic methods including corticosteroid injections with elbow cast versus ice massage and non-steroidal anti inflammatory drugs (nsaids).

design: randomized clinical trial. setting: boo-ali and baqyiatallah hospital in tehran. patients: 50 randomly selected patients, in two groups of 25 subjects. interventions: corticosteroid injections with elbow cast versus icing and nsaids. outcome measures: patients were evaluated for outcomes, complications and patients' satisfaction at 2nd, 4th, and 12th week after beginning of treatment. we measured the pain severity by visual analogue scale (vas).

Eligibility criteria:
inclusion criteria: * pain at the lateral side of the elbow * pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension, or resisted extension of middle finger at the metacarpophalangeal joint * pain to be continued for longer than 6 weeks or even with recurrent pain during similar period exclusion criteria: * previous history of receiving any treatment for lateral epicondylitis within 6 months prior to intervention * patients who were unable to return for follow up * patients with nerve entrapment * pregnancy * breast-feeding * presence of systemic neuromuscular disorders such as myasthenia gravis * upper limb fractures * other arm/forearm pathology such as radial nerve compression * known thrombocytopenia * coagulopathy or bleeding diathesis * history of diffuse pain syndrome * history of inflammatory arthropathy * intolerance/allergy to corticosteroids or nsaids or any contraindication for these * untreated depression * history of narcotic use for pain management greater than 1 month or history of narcotic abuse problem

Keywords: lateral epicondylitis treatment corticosteroid elbow cast icing nsaids
preoperative stent study

Conditions: Pancreas Cancer

Summary: randomized study comparing the effect of plastic stents to that of expandable metal stents as pre-operative drainage of the bile ducts prior to whipple operation.

patients suffering from a locally invasive tumour process in the periampullary area usually seek medical attention because of jaundice. not only do patients suffering from jaundice show significant symptoms of exhaustion and purities, but they are also at higher risk for developing post-operative complications. experimentally, the liver exhibits a reduced capacity for tolerating ischemia in the presence of jaundice. several different etiologic factors suggest cause complication such as presence of toxic substances as bilirubin and bile salts, impaired nutritional status, effects of endotoxins, bacterial translocation, modulation of the inflammatory cascade with cytokine release, reduction of cellular immunity and nutritional. these complications primarily consist of septic complications (cholangitis, abscesses, and leakage), haemorrhage, impaired wound healing and renal disorders. summarily, these issues have motivated pre-operative bile flow drainage by way of stent. traditionally, pre-operative bile flow drainage has been achieved by insertion of a ep because these are considered easy to remove and cause less tissue reaction in the bile ducts. however, multiple studies have found the disadvantage with the ep is that it provides poorer bile drainage than the sems. in palliative situations, metal stents have been associated with fewer side-effects in the form of fever relapse of jaundice, etc. these effects are likely due to better bile flow through the stent. it remains unclear if metal stents can provide similar advantages in the curative situation.

Eligibility criteria:
inclusion criteria: * the primary inclusion criteria are all patients with operable periampullary cancer and jaundice who have not previously undergone bile flow drainage. exclusion criteria: * define as failed ercp, patients who have previously undergone bile flow drainage or radical surgery is not possible.

Keywords: pancreas cancer sems plastic stent whipple jaundicie
preoperative gabapentin for chronic pain after thoracotomy (gabathomie).

Conditions: Postoperative Pain; Chronic Pain

Summary: to assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic pain after thoracotomy.

randomized, double blind study enrolling 200 adults undergoing thoracotomy. patients receive either 75 mg hydroxyzine before surgery and placebo 3 times daily for 10 days or 1200 mg gabapentin before surgery continued for 10 days. all patients receive also a thoracic epidural analgesia. assessment of chronic pain at 3 month with an evaluation by a physician (pain intensity, pain quality and analgesia requirement). assessment of acute pain in the early postoperative period (pain intensity, pain quality and analgesia requirement).

Eligibility criteria:
inclusion criteria: * age \> 18 years * elective lung resection via thoracotomy exclusion criteria: * extended pleurectomy and chest wall resection * previous ipsilateral thoracotomy * previous ipsilateral radiotherapy * thoracotomy for pyothorax * chest injury * palliative surgery * contraindicated placement of a thoracic epidural catheter * allergy to medications on protocol * pre-existing pain syndrome * current treatment with morphine, gabapentin, pregabalin, anticonvulsivants or tricyclic antidepressants * a history of past or current drug addiction * severe hepatic, renal or cardiovascular disorders * inability to understand the study protocol or to answer the questionnaires on pain and quality of life * severe psychiatric disorders * incompetent adults under some form of guardianship * refusal of the protocol * persons without social security coverage * pregnant or lactating woman

Keywords: gabapentin thoracotomy chronic post-thoracotomy pain acute post-thoracotomy pain quality of life neuropathic pain
a study of lu af82422 in participants with multiple system atrophy

Conditions: Multiple System Atrophy

Summary: to find out the effect of lu af82422 on disease progression in participants with multiple system atrophy.

this study will consist of a double-blind period (dbp) and will include an optional open-label treatment extension (ole) period. participants in the dbp will be randomized to lu af82422 or placebo (2:1). all participants entering the ole will receive lu af82422 during the ole.

Eligibility criteria:
key inclusion criteria: * the participant is diagnosed with possible or probable msa of the multiple system atrophy parkinsonian type (msa-p) or multiple system atrophy cerebellar type (msa-c) sub-type at the screening visit. * the participant had onset of motor and/or autonomic (orthostatic or urinary) msa symptoms within 5 years prior to the screening visit in the judgement of the investigator. * the participant has an umsars part i score ≤16 (omitting item 11 on sexual function) at the screening visit. * the participant has a cognitive performance evaluated by the montreal cognitive assessment (moca) with a score ≥22 at the screening visit. open-label extension entry criteria * the participant has completed the eot visit and did not withdraw in the dbp. * the participant has consented to participate in the ole. * the participant has completed the dbp within the last 5 months and will be enrolled into the ole no later than end of q1 2024. * the participant is, in the investigator's opinion, likely to comply with the protocol. * the participant has not received any other investigational product since the eootdbp visit. key exclusion criteria: * the participant has been treated with an anti-α-synuclein monoclonal antibody, mesenchymal stem cells or an inhibitor of α-synuclein aggregation within the last 12 months. * the participant has any past or current treatment with an active vaccine targeting α-synuclein. * the participant has 2 or more blood relatives with a history of msa. * the participant has evidence (clinically or on mri) and/or history of any clinically significant disease or condition other than msa (for example, serious neurological disorder, other intracranial disease, or systemic disease). * the participant has a current diagnosis of movement disorders that could mimic msa (for example, parkinson' disease, dementia with lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, pharmacological, or post-encephalitic parkinsonism), per investigator discretion. other inclusion and exclusion criteria may apply.

Keywords: multiple system atrophy neurodegenerative disorder autonomic failure
open dose escalating trial to determine the maximum tolerated dose in paediatric patients with advanced cancers for whom no therapy is known

Conditions: Leukemia; Neoplasms

Summary: the present trial will be performed according to an open design to determine the maximum tolerable dose (mtd) by evaluation of dose-limiting toxicity (dlt) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. a further objective is to collect data on safety, tolerability, toxicity, efficacy (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric cancer patients


Eligibility criteria:
inclusion criteria: * paediatric patients with leukaemia or advanced solid tumours including lymphomas (age 2 - less than 18 years) for whom no further treatment is known * lansky score \> 60 for children 2 to less than 12 years * karnofsky score \> 60 for children aged 12 or older * life expectancy of at least 6 weeks as judged by the investigator * parents or legal guardians have given written informed consent and informed assent suitable for the respective age group obtained exclusion criteria: * patient eligible for other anti-leukaemic therapy with curative intent or effective therapy known for solid tumour therapy * presence of cardiac disease (lvef by echocardiography less than 25 %) * symptomatic central nervous system involvement of the malignant disease * primary cns tumour * inadequate lab parameters * inadequate venous access * qtc prolongation * pregnancy, breastfeeding * other diseases or cts that might interfere with evaluation of safety
acceleration time assessment for prediction of critical limb ischemia

Conditions: Critical Limb Ischemia

Summary: critical limb ischaemia (cli), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it. the growing prevalence of this condition and the associated healthcare costs make it an important public health objective. diagnostic criteria for critical limb ischaemia differ between learned societies and countries. its diagnosis is most frequently based on the combination of a clinical criterion (ischaemic decubitus pain and/or necrotic wounds, with a time to onset \> 2 weeks) and a haemodynamic criterion (ankle systolic pressure (asp) \< 50mmhg or toe systolic pressure (tsp) \< 30 mmhg or transcutaneous oxygen pressure (tcpo2) \< 30 mmhg). recent studies have highlighted the importance of pulsed doppler flow analysis in quantifying arteriopathy of the lower limbs, both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries (dorsal artery of the foot and lateral plantar artery). the main aim of this study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from cli so that they can be referred to a reference centre as early as possible.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * patient referred to the vascular medicine department of one of the investigating centres for arterial doppler ultrasound of at least one lower limb and for whom a measurement of the systolic pressure index at the toe will be performed. * presence of proven arterial disease, asymptomatic or not, defined by the presence of one of the following criteria: * rest ankle systolic pressure index ≤ 0.90 * rest toe systolic pressure index ≤ 0.70 exclusion criteria: * patient with haemodynamic instability, unable to tolerate a delay in therapeutic management caused by the ultrasound examination and measurement of systolic pressure at the toe; * patients with surgical management of the lower limb (in relation to lower limb arteriopathy), already scheduled at the time of inclusion. * patients with a life expectancy of less than 24 hours; * history of transmetatarsal amputation or amputation at a more proximal level compromising the measurement of systolic pressure and occlusion at the toe and/or tcpo2; * refusal to participate

Keywords: systolic rise time critical limb ischaemia
a study to evaluate the appropriateness of the voriconazole dosing regimen

Conditions: Fungal Infection

Summary: a pilot study was performed to evaluate the appropriateness of the voriconazole dosing regimen based on the population pharmacokinetic model and the influence of sex on the pharmacokinetics of voriconazole


Eligibility criteria:
inclusion criteria: * those who have been informed of the nature of the trial and have voluntarily agreed to participate in this study and have signed an irb approved consent before all screening tests * healthy korean male and female volunteers aged 20 to 45 * those with a body weight of 50 kg or more and less than 90 kg and a body mass index (bmi) of 18 or more and less than 27 (bmi(kg/m2) = body weight (kg)/{height(m)}2 * cyp2c19 em or pm exclusion criteria: * subjects with clinical evidence of significant respiratory, circulatory, renal, hepatic, endocrine, blood, neuropsychiatric, skeletal or other chronic diseases, alcohol or drug addiction * subjects with a history of gastrointestinal disorders (crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of the test drug * those with a history of substance abuse within the last 2 months * those who have taken any prescribed medicines or herbal medicines within 2 weeks prior to the date of the first medicines, or those taking any general medicines (otc) or vitamin preparations (eligible if the other conditions are reasonable according to the judgment of the investigator) * those who donate blood within 30 days before the date of the first dose or who have participated in the clinical study of other clinical trial drugs or marketed drugs within 3 months * those who have had significant adverse reactions such as hypersensitivity reactions to azole drugs including drugs for clinical research * those who are not planning on or planning to have a pregnancy during the trial and are not able to use a recognized method of contraception (eg, sterilization surgery of the person and partner, intrauterine contraceptive device, or diaphragm contraception (such as diaphragm or condom use) * persons who are continuously drinking (21 units / week, 1 unit = 10 g of pure alcohol) or who can not abstain from 3 days before the first dose to the end of the clinical trial * those who smoked more than 10 cigarettes per day for the last 3 months or who can not quit smoking 3 days before the first dose * those who consume grapefruit / caffeine-containing food within 3 days of the first dose or who cannot be prohibited during the clinical study period * screening tests for urine pregnancy (β-hcg) positive or lactating women * those with genetic problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption. * a person who is found to be unsuitable for participation in clinical research due to safety laboratory results or other reasons
anti-inflammatory efficacy for prophylaxis of cystoid macular edema (cme) after phacoemulsification

Conditions: Cystoid Macular Edema; Cataract

Summary: to compare the anti-inflammatory efficacy of ketorolac of tromethamine 0.4% and nepafenac 0.1% eye drops for prophylaxis of cystoid macular edema (cme) after small-incision cataract extraction.

this prospective randomized clinical trial study included patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract. exclusion criteria were previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmhg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to nsaids. enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded. study protocol preoperatively, patients had an extensive ophthalmologic examination, including measurement of corrected distance visual acuity (cdva), refraction, slitlamp examination, intraocular pressure (iop), fundoscopy, corneal endothelial cell count by noncontact specular microscopy (noncon robo, konan), central corneal thickness (cct) measurement (pentacam, oculus, inc.), and biometry with the iolmaster partial coherence interferometry device (carl zeiss meditec ag). the targeted postoperative refractive error was 0.0 d. the visual acuity measurements were recorded with logmar udva and cdva. in addition, a baseline spectral-domain oct (sd-oct) scan was performed before surgery and postoperatively after 1, 4 and 12 weeks. all sd-oct imaging was performed with a spectral-domain heidelberg spectralis oct devise (heidelberg engineering, inc., heidelberg, germany). patients were assigned in a 1:1 ration to 1 of 2 treatments groups using a computer-generated randomization list. the study medications were ketorolac tromethamine 0.4% (acular ls, allergan) in group 1, and nepafenac 0.1% (nevanac, alcon) in group 2. patients were instructed to instill ketorolac tromethamine 0.4% 1 drop in the operative eye 4 times a day (breakfast, lunch, dinner, and before bedtime), and nepafenac 0.1% 1 drop 3 times a day.

Eligibility criteria:
inclusion criteria: * patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract. exclusion criteria: * previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmhg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to nsaids. enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded

Keywords: cystoid macular edema nonsteroidal anti-inflammatory drug oct phacoemulsification.
tissue composition of newborn infants of obese and lean mothers

Conditions: Obesity

Summary: 0-hypothesis: the tissue composition of newborn infants is not modified by lifestyle intervention during pregnancy

obese pregnant women (bmi \> 30) are randomized to exercise, diet or control (1:1:1) in order to reduce weight gain during pregnancy. shortly after birth, tissue composition will be measured (dexa)in 200 infants (65 from each group). the amount of fat tissue is subsequently analyzed between the groups and compared to results from another 65 infants of lean mothers

Eligibility criteria:
inclusion criteria: healthy term neonates informed and written consent from both parents - exclusion criteria: sick or preterm infants no consent -

Keywords: obesity lifestyle pregnancy newborn infant
phase ii placebo controlled study of thalidomide in patients with mycobacterial and hiv infections

Conditions: HIV Infections; Mycobacterium Infections; Tuberculosis

Summary: objectives: i. evaluate whether thalidomide modulates toxic host inflammatory responses in patients receiving antitubercular therapy. ii. evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of hiv and mycobacterial infections, and limits progression of hiv immunodeficiency. iii. evaluate whether thalidomide stimulates immunity in patients with hiv and/or mycobacterial infections.

protocol outline: this is a randomized, double blind study. patients are stratified by type of infection. patients are randomly assigned to oral thalidomide or placebo. therapy is administered daily for up to 8 weeks, beginning the night before antitubercular treatment is initiated.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- human immunodeficiency virus (hiv) or mycobacterial infection that requires at least 10 days of inpatient antitubercular treatment mycobacterial infection confirmed by positive acid-fast bacilli smear or culture for mycobacterium tuberculosis at least 1 of the following signs and symptoms required: * temperature over 38 degrees c on at least 2 occasions within 1 week prior to treatment * weight loss greater than 5 kg * pulmonary involvement in at least 1 lobe on x-ray night sweats on at least 2 occasions within 1 week prior to treatment --prior/concurrent therapy-- concurrent rifampicin, isoniazid, pyrazinamide, and ethambutol for tuberculosis allowed --patient characteristics-- * no neuropathy and not at risk for neuropathy * not pregnant * negative pregnancy test * fertile patients must use effective contraception during and for 4 weeks after study

Keywords: bacterial infection human immunodeficiency virus infection immunologic disorders and infectious disorders mycobacterium infection mycobacterium tuberculosis infection rare disease viral infection