Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of diclofenac sodium (0.1%) gel in patients with uv induced painful sunburn

Conditions: Sunburn

Summary: diclofenac sodium 0.1% will be applied to sunburned skin when the intensity of pain reaches a certain level in order to evaluate the efficacy and safety of the treatment on this induced pain.


Eligibility criteria:
inclusion criteria: * have no skin problem which could interfere with the study results or increase the risk of adverse events have no exposure to excessive or chronic uv radiation (i.e., sunbathing, tanning salon use, phototherapy) within four weeks prior to inclusion, or planned during the study period have non tanned skin on the areas to be exposed (back) have a normal tolerance to uv and sun. exclusion criteria: * women who are pregnant, planning pregnancy or lactating a known hypersensitivity to diclofenac, aspirin, ibuprofen or other nsaids; use of oral or topical treatments during the month preceding the trial, which may interfere with the results of the trial other protocol-defined inclusion/exclusion criteria may appl

Keywords: sunburn, diclofenac, topical nsaid
niclosamide for familial adenomatous polyposis

Conditions: Familial Adenomatous Polyposis

Summary: familial adenomatous polyposis (fap) leads to adenomas and eventual adenocarcinomas in colon and less frequently, duodenum. chemopreventive strategies have been studied in fap patients to delay the development of adenomas and cancers. the non-steroidal anti-inflammatory drugs (nsaids) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and duodenal adenomas in fap patients. however, these drugs showed gastrointestinal damage and cardiovascular risks, and new preventive strategies are needed. niclosamide, an anti-helminthic drug, has recently been suggested to have a suppressive effect on tumorigenesis via inhibition of wnt pathway, and have no significant safety issues. the investigators devised a double-blind randomized controlled trial to evaluate the effect of niclosamide on polyps of colorectum and duodenum in fap patients.

this clinical trial is a double-blind randomized controlled trial to evaluate the effect of niclosamide on polyps of colorectum and duodenum in fap patients. fap patients, satisfied an enrollment criteria, will be randomly assigned in a 2:1 ratio to receive niclosamide (650 mg) or placebo tablets orally once a day for 6 months. the base-line and six-month endoscopic examination (colonoscopy/sigmoidoscopy and upper gastrointestinal endoscopy) will be recorded, and photographs will be taken at the tattoo-marked area. the number and size of polyps, and a qualitative assessment of the total extent of polyposis will be measured. if there is no significant improvement in any of the 12 initial cases (niclosamide 8: placebo 4), this trial will be discontinued.

Eligibility criteria:
inclusion criteria: * patients with familial adenomatous polyposis(fap) who are 20 to 65 years of age. * fap patients who have colonic or duodenal polyp. * fap patients who have five or more polyps 2mm or more in diameter in endoscopic examination. exclusion criteria: * fap patients who had a history of colectomy within the previous 12 months or need to undergo colectomy within 8 months after randomization. * fap patients with malignant disease, including colorectal cancer. * fap patients who used nsaids (non-steroidal anti-inflammatory drugs) or aspirin three or more times a week within 6 months of randomization. * pregnant or breast-feeding patients. 6. patients with abnormal results of serum laboratory tests (renal function and liver function test).

Keywords: chemoprevention niclosamide familial adenomatous polyposis
stimulating private sector malaria control

Conditions: Malaria

Summary: preliminary evidence from ongoing research provides strong indications that protecting farmers from malaria would be profitable for outgrowing agribusinesses in sub-saharan africa. the study team invests in experimental research to investigate this conjecture in more detail.

the study evaluates whether the sourcing of insecticide-treated nets and their distribution to smallholder farmers for free would be a profitable investment for a cotton outgrowing agribusiness in zambia. the study therefore carries out a major net distribution through the existing distribution channels of a cotton outgrowing agribusiness, evaluates the impact of this distribution on smallholder cotton yields, and values the profitability implications for the outgrowing agribusiness.

Eligibility criteria:
inclusion criteria: * farmers who contracted with the participating cotton outgrowing company in the 2010-2011 season
mode evaluation in sick sinus syndrome trial (modest)

Conditions: Sick Sinus Syndrome

Summary: the purpose of this study is to determine the incidence of atrial fibrillation and heart failure in patients with pacemaker therapy with different pacing modes (aai, ddd, and a novel algorithm to minimize ventricular pacing).

background: dual-chamber pacemaker therapy has become the mainstay for treating symptomatic sick sinus syndrome (sss). this approach aims to results in a physiologic conduction pattern, while protecting against atrioventricular conduction anomalies. smaller studies and subgroup analyses of larger trials suggest that ventricular stimulation associated with this treatment has adverse effects, especially an increased incidence of atrial fibrillation and heart failure. methods: in modest, a study on patients with sick sinus syndrome who have an indication for pacing therapy, atrial pacing (aai) is compared with dual-chamber pacing (ddd) combined with a novel algorithm developed to lower the number of ventricularly paced beats. the study aims to assess the impact of ventricular pacing on the development of atrial arrhythmias and to test the hypothesis that ddd pacing using the algorithm is associated with a higher rate of atrial arrhythmias as atrial pacing. included will be patients with sss and no high degree av node disease except for patients with first-degree av block ≤300ms. patients will be followed stratified by their wenckebach point (≥ 120 bpm versus \< 120 bpm). conclusion: modest is a large, prospective, randomized, multicenter trial aiming to compare a novel type of dual-chamber pacing approach (that includes an algorithm designed to lower the number of ventricularly paced beats) with pure atrial pacing, assessing the impact on the incidence of atrial arrhythmias in patients with sick sinus syndrome.

Eligibility criteria:
inclusion criteria: * symptomatic sinus bradycardia, sinusarrest * symptomatic sa block * bradycardia-tachycardia-syndrome * binodal diseases exclusion criteria: * 1st degree av block * 2nd degree av block * 3rd degree av block * total right bundle branch block * indication for biventricular stimulation * inter atrial conduction delays (p-wave \> 150ms) * permanent or therapy refractory atrial fibrillation * heart failure acc. nyha iii or iv * myocardial infarction less than 6 months before pacemaker implant * hypertrophic obstructive cardiomyopathy * symptomatic hypo- or hyperthyreosis * cardiogenic shock * pregnancy * lactation period * unstable angina pectoris * poorly controlled diabetes mellitus * neuromuscular diseases * patients under 18 years of age * patients involved in other studies * reduced expectancy of life due to other diseases * patients who cannot attend follow-up visits regularly

Keywords: cardiac pacing, artificial atrial fibrillation heart failure pacemaker leads pacing mode
iop pattern in primary angle closure and primary angle closure glaucoma patients, before and after lpi

Conditions: Glaucoma

Summary: the purpose of the study is to determine the relationship of the intraocular pressure patterns recorded during 2 sessions using triggerfish, before and after elective laser peripheral iridotomy in angle closure glaucoma patients


Eligibility criteria:
inclusion criteria: * diagnosis of primary angle closure (pac) or primary angle closure glaucoma (pacg) with indication for laser peripheral iridotomy (lpi). pac is defined by the presence of a partial or complete iridotrabecular contact(itc) in more than 2 quadrants with either raised intraocular pressure (iop) (ie. more than 21 mmhg) and/or pas; however, with normal optic disc and visual field. pacg is defined by the presence of itc with either raised iop and/or pas, and evidence of glaucomatous optic disc and visual field * no iop-lowering drug treatment or a 4-week wash-out period prior to study day 0 * aged ≥18 years, of either sex * not more than 6 diopters spherical equivalent on the study eye * have given written informed consent, prior to any investigational procedures exclusion criteria: * history of acute angle closure glaucoma on the study eye * secondary angle closure glaucoma on the study eye * history of ocular surgery within the last 3 months on the study eye * history of ocular laser treatment, including previous lpi on the study eye * corneal or conjunctival abnormality precluding contact lens adaptation on the study eye * severe dry eye syndrome on the study eye * patients with allergy to corneal anesthetic * patients with contraindications for silicone contact lens wear * patients not able to understand the character and individual consequences of the investigation
blown nasal secretion measurements in rhinosinusitis: repeatability and validity compared to nasal lavage

Conditions: Rhinosinusitis

Summary: to process blown nasal secretions from subjects with rhinosinusitis and to obtain a specimen by nasal lavage. to investigate the reliability and validity of the measurements we will determine their repeatability and compare them with those of nasal lavage in the same subjects.


Eligibility criteria:
inclusion criteria: * patients suffering from rhinitis with our without sinusitis exclusion criteria: * unable to provide blown nasal sample
use of a 3d printer to make custom sleep masks for positive airway pressure treatment

Conditions: Sleep Apnea; Pediatric Sleep Apnea

Summary: this is a small pilot study to look at the feasibility of creating a customized sleep mask for use with continuous positive airway pressure (cpap) or other similar treatments for sleep apnea. the participant will have three dimensional (3d) pictures of the face taken by special cameras. the pictures will be sent to a 3d printer and a mask will be created based on the participant's face contours. the participant will use the mask for about 6 months. the study will measure the amount it is used during sleep and if there is an increase in reported comfort.

the aim of this study is to improve adherence and effectiveness of noninvasive ventilation by decreasing the side effects commonly seen with noninvasive ventilation. studies have shown that even though noninvasive ventilation (niv) with positive airway pressure (pap) is successful at treating obstructive sleep apnea and hypoventilation, individuals have poor compliance with therapy. the reasons for poor compliance are numerous, but one significant and continually reported reason is poor mask fit. a poor mask fit is not only uncomfortable, but frequently causes side effects such as dry eyes, congestion, skin irritation and breakdown, and ineffective ventilation from inadequate pressures due to air leaking around the mask. pediatric patients tend to be especially difficult to fit with conventional masks because of their smaller facial features and the lack of masks developed for pediatric use. in this study, patients will be fitted with a custom made niv mask following facial imaging with a 3d camera (artec 3d scanner). the facial image will be used to construct an niv mask model using computer design software that will then be created by using a 3d printer.

Eligibility criteria:
inclusion criteria: * on stable niv settings for a minimum of 2 months. exclusion criteria: * new diagnosis

Keywords: cpap noninvasive ventilation mask
study of use of ctc in nsclc

Conditions: Non Small Cell Lung Cancer; Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to assess whether the detection of circulating tumor cells (ctc) could be used as a tool to earlier diagnose, more accurately predict treatment response / failure and predict overall survival in non-small cell lung cancer (nsclc) patients

lung cancer remains the most common cause of cancer mortality in the world for both men and women. more than half of patients diagnosed will die within the first year. given these concerning facts, we are in need of novel methodologies to diagnose patients at earlier stages of the disease, more accurately predict treatment response / failure and predict overall survival. the use of ctc has been investigated and shown to predict progression free survival and overall survival in metastatic breast cancer, and recommended as a breast cancer tumor marker by the american society of clinical oncology. there have also been relationships between ctc's and survival, shown in metastatic colorectal and prostate cancer. however, ctc's have not been thoroughly investigated in non-small cell lung cancer. this trial will assess if the detection of circulating tumor cells could be used as a tool to help further advance treatment for nsclc patients.

Eligibility criteria:
inclusion criteria: for subjects with lung malignancies: * 18 years of age and older * diagnosis of new or recurrent non-small cell lung cancer * awaiting treatment and follow up * have radiographic measurable metastatic disease that can be followed * be able to sign an irb approved informed consent form * life expectancy greater than 12 weeks for subjects with copd and without lung malignancies: * 18 years of age and older * diagnosis of copd * no current or prior malignancies (except squamous or basal cell carcinoma of the skin) * be able to sign an irb approved informed consent form for healthy control subjects (dry runs): * 18 years of age and older * has no current or prior malignancies (except squamous or basal cell carcinoma of the skin) * patients must sign an irb approved informed consent form exclusion criteria: for subjects with lung malignancies: * have other concurrent lung cancer malignancies, or any other form of malignancy (except squamous or basal cell carcinoma of the skin) * ecog performance status of 4 * pregnant female (self-reporting) * cognitively impaired * prisoner for subjects with copd and without lung malignancies and healthy controls: * any other form of malignancy (except squamous or basal cell carcinoma of the skin) * pregnant female (self reporting) * cognitively impaired * prisoner
spyglass in post liver transplant biliary complications.

Conditions: Liver Transplant Disorder; Biliary Anastomosis Complication

Summary: the purpose of this study is to describe spyglass choledochoscopy in patients with post orthotopic liver transplant (olt) biliary strictures prior to endoscopic therapy and ductal changes after treatment stents.

a prospective observational clinical study to be conducted in hospital israelita albert einstein, a large open-access, private tertiary referral center. consecutive eligible patients with suspected post olt biliary complications referred to endoscopic retrograde cholangiopancreatography (ercp) will be considered to spyglass as follows. in those patients with confirmed biliary stricture, spyglass direct choledochoscopy will be performed prior to endoscopic treatment with stents. after final stent removal, choledochoscopy will be repeated to evaluate biliary ductal mucosa.

Eligibility criteria:
inclusion criteria: * patients referred to endoscopic management for biliary post liver transplant complication without previous treatment exclusion criteria: * patients referred to endoscopic management for biliary post liver transplant complication with any previous treatment. * below 18 years of age * pregnancy

Keywords: biliary stricture cholangioscopy spyglass liver transplant
alternative risk markers in coronary artery disease (armcad)

Conditions: Coronary Artery Disease

Summary: estimating the risk of future cardiovascular events such as death, stroke and myocardial infarction using traditional risk factors (such as age, gender, smoking, diabetes, hyperlipidaemia and hypertension) is well accepted in patients with and without existing cardiovascular disease. these estimates are based on a number of robust observational studies, including the original framingham study. while these methods apply reasonably well on a population level their application to the individual patients is not always straightforward. in addition, risk charts, such as those published by the joint british societies and american heart association, may underestimate risk in certain groups, notably diabetics and patients of indo-asian background, whilst overestimating risk in others (by as much as 50% in some studies).

a number of variables including clinical, biochemical, and enzymatic have been evaluated to see if they add to conventional "risk-reduction" models such as framingham and if so, to understand if they may be used in routine clinical practice. the aim of this study is to assess several known and a few novel risk-factors (heart rate variability, pulse wave analysis, high-sensitivity crp and bnp) prior to planned elective coronary angiography (cross-sectional analysis) and in a prospective cohort of high and low-risk patients.

Eligibility criteria:
inclusion criteria: * adults (18 years or older) * male or female exclusion criteria: * acute coronary syndrome * urgent angiography * assessment would constitute harm to patient * informed consent not obtained

Keywords: risk coronary artery disease heart rate variability pulse wave analysis bnp crp
comparison of lens care regimens with a silicone hydrogel lens (emerald)

Conditions: Myopia

Summary: the purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.

the purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings

Eligibility criteria:
inclusion criteria: a person is eligible for inclusion in the study if he/she: 1. is at least 17 years of age and has full legal capacity to volunteer. 2. has read, understood and signed an information consent letter. 3. is willing and able to follow instructions and maintain the appointment schedule. 4. is presently using either bi-weekly or monthly replacement lenses. 5. has symptoms of ocular dryness as determined by specific pre-screening criteria. 6. is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction. 7. has clear corneas and no active ocular disease. 8. has had an ocular examination in the last two years. exclusion criteria: a person will be excluded from the study if he/she: 1. is an asymptomatic lens wearer. 2. is a daily disposable contact lens wearer. 3. is a current extended wear contact lens wearer. 4. currently uses one of the study lens care regimens. 5. has any clinically significant blepharitis. 6. has undergone corneal refractive surgery. 7. is aphakic. 8. has any active ocular disease. 9. has any systemic disease affecting ocular health. 10. is using any systemic or topical medications that may affect ocular health. 11. has known sensitivity to the diagnostic pharmaceuticals to be used in the study. 12. is participating in any other type of clinical or research study.
prevention of postpartum depression in low-income women

Conditions: Depression, Postpartum

Summary: this study will determine whether a prevention program reduces the incidence of postpartum depression in pregnant women who receive public assistance and are at risk for postpartum depression.

the impact of major depression in the postpartum period is profound, with considerable emotional pain for the new mother as well as disturbances in infant development. unfortunately, few preventive interventions have been developed or systematically tested to reduce the risk of postpartum depression. an area of even greater neglect is the development of such an intervention for financially disadvantaged women who are at high risk for postpartum depression and for the disturbances associated with postpartum depression. this study will develop a psychosocial intervention for financially disadvantaged pregnant women at risk for postpartum depression. participants are randomly assigned to receive either the "life at home with a new baby" intervention or care as usual. women who receive the intervention join a counseling group in which information about mother-baby relationships is shared. this information is reinforced with a follow-up "booster" session after the infant is born. participants are assessed at baseline, after the booster session (for the intervention condition) or after 2 weeks postdelivery (for the care as usual condition), and at 3 months postpartum. depression levels and social adjustment are measured at baseline and 2 weeks after delivery. functional status is also measured. a self-report questionnaire is completed by the mothers to measure parental distress, parent/child dysfunctional behavior, and difficult child interactions. at 3 months postpartum, a brief standardized interview is used to assess the presence of a depressive disorder.

Eligibility criteria:
inclusion criteria: * receive public assistance * at risk for postpartum depression * pregnant women between 23-32 weeks gestation
non-pharmacologial, non-invassive intervention before cardiac surgery: a randomized controlled trial

Conditions: Cardiac Surgery

Summary: perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. the goal of this clinical trial is to learn if ischemic preconditioning and transcranial electrical stimulation to reduce perioperative neurological complications. it will also learn about the safety of remote ischemic preconditioning and transcranial electrical stimulation before cardiac surgery. the main questions it aims to answer are "do remote ischemic preconditioning and transcranial electrical stimulation make good effect on perioperative neurological complications?" "are remote ischemic preconditioning and transcranial electrical stimulation safe?" researchers will compare remote ischemic preconditioning and transcranial electrical stimulation to traditional treatment to see if remote ischemic preconditioning and transcranial electrical stimulation work to reduce perioperative neurological complications. participants will:undergo remote ischemic preconditioning and transcranial electrical stimulation or sham treatment twice every day for 3 days before surgery. undertake psychological assessment and clinical symptom follow-up after cardiac surgery.


Eligibility criteria:
inclusion criteria: 1. age range: 18-80 years old; 2. surgical patients with heart disease; 3. elective surgery; 4. patients identified as high-risk for postoperative neurological complications; previous stroke history; moderate to severe stenosis of the head and neck arteries was evaluated; 5. be able to understand and comply with the requirements of clinical trial protocols, and voluntarily sign informed consent forms. exclusion criteria: -

Keywords: cardiac surgery cognitive function stroke delirium non-invasive neuromodulation remote ischemic preconditioning