Kornimate/medical-research-clean huggingface dataset:
corneal epitheliotropic factors in autologous serum eye drops in nonautoimmune and stevens-johnson syndrome with dry eye

Conditions: Stevens-Johnson Syndrome

Summary: autologous serum eye drops (ase) have been becoming popular in treatment of severe dry eye for the past decade. one of the most beneficial properties of the ase over artificial eye drops is the epitheliotropic capacity owing to the presence of growth factors and other proteins. there have been reports on alteration of serum growth factors in autoimmune diseases such as rheumatoid arthritis. alteration in serum growth factors may lead to different therapeutic effect of ase. we therefore would like to know if there are any alteration growth factors, epidermal growth factor (egf), transforming growth factor-beta1 (tgf-β1), transforming growth factor-beta2 (tgf-β2), and fibronectin, in ase from stevens-johnson syndrome (sjs) patients with dry eye, which constitutes a major group of ase usage in siriraj hospital, as compared with non-autoimmune dry eye. we also study stability of these factors following different storage conditions.

ten sjs patients with dry eye and 10 non-autoimmune dry eye patients are recruited in this study. twenty to forty ml of peripheral venous blood is drawn and the serum is separated. the serum is diluted with balanced salt solution (bss) to provide 20% ase. the levels of efg, tgf-β1, tgf-β2, and fibronectin in 20% ase are quantitated by enzyme-linked immunosorbent assay (elisa) method and are compared between the two groups of samples. to study the stability of these serum factors under storage conditions used in clinical settings, 20% ase are stored at different temperature and time i.e., at 4 ํc for 1 week and 1 month, and at -20 ํc for 1, 3 and 6 month. their levels are then measured following each storage condition.

Eligibility criteria:
inclusion criteria: sjs group * patients diagnosed with sjs with dry eye syndrome * age more than 18 years old control group * patients diagnosed with dry eye syndrome * age more than 18 years old dry eye syndrome is defined as the having at least one symptom and one sign as the following: symptoms 1. dryness sensation in the eye 2. sandiness sensation in the eye 3. burning sensation in the eye 4. redness of the eye 5. eye irritation 6. eye stuck shut in the morning signs 1. meibomian gland dysfunction 2. tear film break-up time (tfbut) \< 10 sec 3. fluorescein staining at cornea 4. schirmer test without anesthesia score ≤ 5 mm / 5 min 5. ocular surface problems exclusion criteria: * taking immunosuppressive drugs * acquired immunodeficiency syndrome (aids) patients or other immunodeficiency conditions * having autoimmune disorders (except for sjs in case group) * having systemic underlying diseases such as uncontrolled diabetes mellitus (dm), chronic kidney disease, liver cirrhosis, or systemic infection * pregnant women

Keywords: autologous serum eye drops egf tgf-β1 tgf-β2 fibronectin stevens-johnson syndrome dry eye
a study to evaluate tolerability and efficacy of evolocumab (amg 145) in japanese subjects

Conditions: Hypercholesterolemia and High Risk for Cardiovascular Events

Summary: the primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (ldl-c) when used in addition to statin therapy in japanese adults with hypercholesterolemia and high cardiovascular risk.


Eligibility criteria:
inclusion criteria: japanese adult, on statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks, fasting ldl-c greater than or equal to 115 mg/dl (3.0 mmol/l), fasting triglycerides less than or equal to 400 mg/dl (4.5 mmol/l); exclusion criteria: new york heart association (nyha) class iii or iv, poorly controlled hypertension, recently diagnosed or poorly controlled type 2 diabetes, last known left ventricular ejection fraction \< 30%, myocardial infarction, unstable angina, percutaneous coronary intervention (pci), coronary artery bypass graft (cabg), stroke, planned cardiac surgery or revascularization within 6 months of randomization, uncontrolled cardiac arrhythmia.

Keywords: japanese, hypercholesterolemia, high risk for cardiovascular events
a trial of evonail® solution for prevention or treatment of onycholysis

Conditions: Breast Cancer; Docetaxel Chemotherapy

Summary: this study is a prospective randomized controlled study of evonail® solution for prevention or treatment of onycholysis in patients with breast cancer receiving docetaxel chemotherapy.


Eligibility criteria:
inclusion criteria: * patients with breast cancer receiving adjuvant/neoadjuvant docetaxel chemotherapy exclusion criteria: * patients with breast cancer receiving palliative docetaxel chemotherapy * patients having onycholysis before docetaxel treatment
a longitudinal study of function and participation in life activities of patients with developmental disabilities

Conditions: Child Development Disorders

Summary: a longitudinal study of function and participation in life activities of patients with developmental disabilities

developmental disabilities (dd) is defined as a group of neurodevelopmental issues, leading to significant lag in one or more areas (e.g. cognition, speech, motor, self-care and psychosocial function) for various reasons. on the basis of international classification of functioning, disability and health -children and youth version (icf-cy) framework, problems related to developmental disabilities further limit activities of daily living (adl) and participation of patients.

Eligibility criteria:
inclusion criteria: 1. patients with developmental disabilities 2. age 0-25 y/o 3. agree to sign informed consent exclusion criteria: 1. active medical condition (e.g. infection) 2. concurrent progressive or degenerative disease (e.g. neurogenerative disease) 3. concurrent illness or disease not typically associated with dd (e.g. pneumonia)

Keywords: developmental disabilities body function and body structure participation life activities quality of life
chronic thromboembolic pulmonary hypertension (cteph) incidence in patients with central versus peripheral embolism

Conditions: CTEPH

Summary: chronic thromboembolic pulmonary hypertension (cteph) has been associated with increased morbidity and mortality. patients with pulmonary embolism (pe) have elevated risk for development of cteph. it is not known, whether the location of pulmonary embolism (central vs. peripheral) nor fibrinolysis have an impact of cteph incidence. this study has been performed to assess the cteph incidence in different populations: in patients with central vs. peripheral pe and in patients with or without fibrinolysis therapy for pe.

the embolus localization during index pulmonary embolism might be of potential relevance for cteph development. in the present study patients with confirmed pulmonary embolism for at least 12 months will be screened for cteph. the incidence of cteph will be correlated to thrombus location (central vs. peripheral) and the index use of fibrinolysis.

Eligibility criteria:
inclusion criteria: * acute pulmonary embolism for at least 12 months exclusion criteria: * known pulmonary hypertension other than cteph
study of ixekizumab in healthy participants

Conditions: Healthy

Summary: the purpose of this study is to compare the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. information about any side effects (including injection site reactions \[isrs\]) will be collected.


Eligibility criteria:
inclusion criteria: * healthy male participants or female participants who agree not to get pregnant * are male participants or female participants with chronic, stable medical problems that, in the investigator's opinion, will not place the participant at increased risk by participating in the study exclusion criteria: * have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study * are allergic or hypersensitive to the study medicine * have dullness or loss of sensitivity on either side of your abdomen * have any condition that could affect pain perception from an injection * had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study * have any type of hepatitis, human immunodeficiency virus (hiv) infection, or other serious infection * show evidence of active or latent tuberculosis (tb) * presence of significant neuropsychiatric disorder or a recent history of depression * have excessive tattoos or scars over the abdomen or other factors such as rash or excessive folds of skin that would interfere with injection site assessments * have had any active or recent infection within 4 weeks of day 1 that, in the opinion of the investigator would pose an unacceptable risk to the participant if participating in the study
study of single ascending and multiple doses of pf-04447943 in japanese subjects.

Conditions: Healthy

Summary: this study is designed to investigate the safety, tolerability, and pharmacokinetics of pf-04447943 after single and multiple-dose administration to healthy young adult and elderly japanese subjects, respectively.


Eligibility criteria:
inclusion criteria: * for young cohort, healthy male and/or female japanese of non-child bearing potential between the age of 18 and 55 years, inclusive. * for elderly cohort, healthy male and/or female japanese of non-child bearing potential between the age of 65 and 85 years, inclusive. * body mass index (bmi) between 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs). exclusion criteria: * pregnant or nursing women; women of childbearing potential. * males who are unwilling to abstain from sexual intercourse or use a condom with all child-bearing potential women for the duration of the study.

Keywords: phase 1 pharmacokinetics healthy young adult japanese healthy elderly alzheimer disease
psychatric effect of ectopic pregnancy

Conditions: Ectopic Pregnancy

Summary: assessment of anxiety,depressive symptoms and post traumatic stress after ectopic pregnancy determine factors associated with development of anxiety,depressive symptoms and post-traumatic stress after ectopic pregnancy

ectopic pregnancy is any pregnancy in which the fertilized ovum implants outside the intrauterine cavity. more than 95 percent of ectopic pregnancies occur in the fallopian tubes. another 2.5 percent occur in the cornua of the uterus, and the remainder are found in the ovary, cervix or abdominal cavity. ectopic pregnancy causes major maternal morbidity and mortality, with pregnancy loss, and its incidence is increasing worldwide. previous ectopic pregnancy becomes a more significant risk factor with each successive occurrence. with one previous ectopic pregnancy treated by linear salpingostomy, the recurrence rate ranges from 15 to 20 percent, depending on the integrity of the contralateral tube. the unanticipated and sudden loss of a pregnancy can be a devastating and traumatic experience resulting in high levels of psychological morbidity for some women. epls can significantly contribute to the overall burden of psychopathology within a population. recognition of this impact is important, so that severely affected individuals may be screened and treated appropriately. further research to establish risk factors to promptly identify and treat these patients, and to optimize their management, is crucial"

Eligibility criteria:
inclusion criteria: * all pregnant woman 18:45 years old presented with ectopic pregnancy. exclusion criteria: * intrauterine pregnancy * previous diagnosis of psychiatric disorders * unwell to give consent
early antiviral responses to rhinovirus infection in asthma

Conditions: Asthma

Summary: the bulk of the morbidity and mortality related to asthma is during periods of acutely increased symptomatology called 'exacerbations'. roughly half of asthma sufferers experience such an exacerbation each year. most of these events are triggered by viral infections, usually the common cold virus (rhinovirus). a key part of the body's defence against viral infections is to produce antiviral proteins called 'interferons', which have a myriad of effects to stop viruses. previous work on cells taken from volunteers with asthma and healthy controls and infected with rhinovirus in the lab suggests interferon production is impaired in asthma. however when human volunteers with asthma are infected with rhinovirus, high levels of interferon are found a few days later - along with high numbers of virus. whether the high virus numbers are the result of an initially weak interferon response, with subsequently unchecked viral replication leading to exaggerated interferon levels, is unknown as no one has measured interferons early in infection. by infecting volunteers with asthma and healthy controls with rhinovirus at a known time, only done in a handful of centres worldwide, we will be able to measure interferons within hours of infection and well before symptoms develop.


Eligibility criteria:
for asthma group: inclusion criteria: * age 18-55 years * doctor diagnosis of asthma * previous asthma exacerbation exclusion criteria: * smoking history over past 12 months * sinonasal disease, including current symptoms of allergic rhinitis * asthma exacerbation or an upper respiratory viral infection within the previous six weeks * current or concomitant use of oral steroids, monoclonal antibodies or nasal sprays * neutralising antibodies to rhinovirus (rv)-16 * clinically significant diseases other than asthma which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, influence the results of the study, an/or the patient's ability to take part in it * inability to understand written or verbal information in english for healthy control group: inclusion criteria: • age 18-55 years exclusion criteria: as for asthma group and in addition: • history of asthma
efficacy of platelet rich plasma injection in diabetic neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: to evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (prp) injection in the treatment of diabetic peripheral neuropathy compared to traditional medical treatment.

background: neuropathy is a common complication of diabetes mellitus (dm) with a wide clinical spectrum that encompasses generalized to focal and multifocal forms not only leads to an impaired quality of life, but also to an increased morbidity and mortality . till now there is no available effective therapy for the treatment of diabetic peripheral neuropathy (dpn). autologous platelet-rich plasma is easy and cost-effective method as it provides necessary growth factors that promote wound healing/growth, angiogenesis, and axon regeneration . objective: to evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (prp) injection in the treatment of diabetic peripheral neuropathy compared to traditional medical treatment. method : prospective double blinded randomized controlled trial was conducted . all included patients had type 2 dm selected from endocrinology unit department of internal medicine, assuit university hospital, egypt . dpn of at least 5 years duration of symptoms . patients with other causes of neuropathy like hereditary neuropathies , entrapment neuropathies ,connective tissue diseases , vertebral diseases ,thyroid disorders and end organ failure were excluded . neuropathy was assessed by the modified toronto clinical neuropathy score (mtcns) 2001 (3) , baseline pain and nerve conduction studies were done. then they were double blindly divided into two groups, group i underwent prp preineural injection under ultrasound guidance plus medical treatment . group װreceived medical treatment only( control group) . blood glucose was strictly controlled in both groups . patients were followed every month for 3 months by mtcns and by nerve conduction studies. results were expressed as means ± standard deviation or frequencies. independent student's t test was done for comparison between groups

Eligibility criteria:
inclusion criteria: * diabetic peripheral neuropathy of at least 5 years duration of symptoms exclusion criteria: * hereditary neuropathies , entrapment neuropathies , connective tissue diseases , vertebral diseases , thyroid disorders and end organ failure
follow-up study for patients who completed study alx0681-c301 (post-hercules)

Conditions: Acquired Thrombotic Thrombocytopenic Purpura

Summary: the objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (attp).


Eligibility criteria:
inclusion criteria: 1. completed the final (28 day) follow-up visit in study alx0681-c301. 2. \>= 18 years of age at the time of signing the informed consent form. 3. provided informed consent prior to initiation of any study specific activity/procedure. exclusion criteria: 1. not being able/willing to comply with the study protocol procedures. 2. currently enrolled in a clinical study with another investigational drug or device.
patient experience and technical success of community sleep studies

Conditions: Obstructive Sleep Apnea

Summary: this study looks at the quality of the common mechanisms used to diagnose obstructive sleep apnoea (osa) by patients in their own homes. these are pulse oximetry as a stand alone measurement and multi-channel respiratory studies that measure oximetry but also record some combination of signals including airflow at the mouth and or nose, chest and abdominal expansion, body position and snoring. this study will examine the patient acceptability of these methods and the proportion of studies that achieve various levels of technical quality ranging from a full night with all data available to a completely failed study and categories in between.

there is a study underway to develop a non-contact detector of breathing (safescan) as a new method of diagnosing obstructive sleep apnoea (osa). there are a number of different methods already available to achieve this end but one proposed advantage of the new safescan device is that it will not affect sleep quality and because there are no measuring devices attached to the patient it is less likely that the signal will be lost in the night due to the normal movements of sleep. however there are no data available that quantify these factors as an issue for the current techniques and devices. the proving study for safescan is a comparison of the ability of the device to measure sleep apnoea compared to full in-hospital polysomnography (psg) and one outcome will be the proportion of studies that have lost data. however the future use of the safescan device will be in the community. the common diagnostics used by patients in their own homes are pulse oximetry as a stand alone measurement and multi-channel respiratory studies that measure oximetry but also record some combination of signals including airflow at the mouth and or nose, chest and abdominal expansion, body position and snoring. we propose a study to examine the patient acceptability of these methods and the proportion of studies that achieve various levels of technical quality ranging from a full night with all data available to a completely failed study and categories in between. in addition there will be an analysis of the results to explore whether there are features of the patients such as age and obesity that make technical success or failure of the studies more likely.

Eligibility criteria:
inclusion criteria: patient able to provide assent by completion of the research questionnaire adult patients (≥ 18 years of age) patients undergoing a home sleep study exclusion criteria: patients unable to complete questionnaires due to language or other barriers
preparation prior to colonoscopy in children

Conditions: Inflammatory Bowel Diseases

Summary: colonoscopy is a routinely performed examination of children and adolescents in the diagnostic process of inflammatory bowel disease (ibd). it is necessary that the bowel is clean so the colonoscopy can be optimally performed. the cleansing of the bowel by means of laxatives prior to the examination is, however, considered difficult by many children. getting smaller children to cooperate and to drink a substantial volume of laxative fluid prior to the examination can be particularly difficult. there are several possible cleansing procedures and combinations of procedures for the cleansing of the colon, for example by means of polyethylene glycol and sodium picosulphate, which are the two most commonly used methods. cleansing by means of polyethylene glycol can, due to the necessary intake of a substantial quantity of fluid, be particularly frustrating for patients. often the only way to carry out the preparation is with the insertion of a nasogastric tube, which can cause discomfort for some children. cleansing the colon by means of sodium picosulphate, which involves an intake of a small quantity of fluid, has been suggested to be a good sufficient method resulting with a satisfactory result in terms of bowel cleanliness. however, studies have so far encompassed only a smaller number of children and further studies are needed to confirm that there is no difference between the two methods in terms of resultant bowel cleanliness. the purpose of this randomized controlled study is to compare preparation by means of polyethylene glycol and preparation with sodium picosulphate prior to colonoscopy in children. one hundred children scheduled for colonoscopy in southern sweden will be randomized into either patient group 1 (for preparation with polyethylene glycol) or patient group 2 (for preparation with sodium picosulphate). for the random sampling, data-driven selection will be implemented. a consort flowchart (2012) will be encompassed by the study. to assess the cleanliness of the intestinal tract (and volume of fluid in the intestine), the ottawa scale will be used (rostom \& jolicoeur, 2009). all colonoscopy examinations will be performed by the same paediatric gastroenterologist, to whom no information about which preparation method was used by each child will be disclosed. furthermore, the gastroenterologist will, meet with the children first after the investigation has been completed. all information regarding the investigation will be given to the patient by the admitting physician. during the colonoscopy the gastroenterologist will evaluate the intestinal cleanliness and submit the reports in sealed coded envelopes to the nurse in charge of the patient.


Eligibility criteria:
inclusion criteria: * elective colonoscopy exclusion criteria: * not swedish speaking

Keywords: colon preparation child