Kornimate/medical-research-clean huggingface dataset:
a study of safety and the local anesthetic effect of ag-920 ophthalmic solution in a pediatric population

Conditions: Anesthesia, Local

Summary: a phase 3, randomized, active-controlled, study in pediatric subjects. it is designed to evaluate the safety and anesthetic efficacy of one dose of ag-920 ophthalmic solution compared to proparacaine hydrochloride ophthalmic solution.

a phase 3, randomized, active-controlled, single-masked, parallel-group design study in pediatric subjects performed in the us. it is designed to evaluate the safety and anesthetic efficacy of one dose of ag-920 compared to proparacaine. in this study, parent/legal guardians will provide informed consent (and where applicable, subjects will provide assent). subjects who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of ag 920 or proparacaine into one (study) eye. each dose of ag-920 or proparacaine hcl will consist of two drops in the study eye. after the completion of dosing, subjects will undergo an eye exam, and the ability to conduct that eye exam will be documented. investigational medicinal product (imp) dosing will be performed by the study staff.

Eligibility criteria:
inclusion criteria: 1. pre-pubescent with no childbearing potential 2. capable of undergoing an eye exam 3. subject's legally appointed and authorized representative willing to sign and date an informed consent form (icf) and, where appropriate, the subject willing to sign an assent form prior to any study-related procedures being performed. 4. parent/legal guardian and subject are willing and able to follow instructions and can be present for the required study visits and follow-up phone call for the duration of the study. 5. have a healthy, normal cornea. exclusion criteria: 1. have participated in an investigational study (drug or device) within the past 30 days. 2. have a known contraindication to local anesthetics. 3. children with known autism spectrum disorders or known to have heightened sensitivity. 4. corneal pathology that would make the corneal sensitivity lower/higher or make the test hard to perform or interpret. 5. have low visual acuity 6. manifest nystagmus 7. have had ocular surgery or general surgery within the past 45 days. 8. have had an intravitreal injection in either eye within 14 days of randomization. 9. have ocular surface disease.

Keywords: ag-920 articaine septocaine intravitreal injection proparacaine
efficacy and safety of rivastigmine in patients with mild cognitive impairment

Conditions: Cognitive Symptoms

Summary: this study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (mci).


Eligibility criteria:
inclusion criteria: * males or females who are one year post-menopausal or without childbearing potential * between the ages of 50 and 85 years old * mild cognitive impairment confirmed by mini mental state examination (mmse) score between 23 and 27 * cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver, according to the investigator's judgement exclusion criteria: * a current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances or secondary dementia * a current diagnosis of epilepsy or depression, or any other diagnosis that may interfere with the patient's response to study medication * an advanced, severe or unstable disease of any type that may interfere with efficacy evaluations other protocol-defined exclusion criteria may apply.

Keywords: mild cognitive impairment alzheimer's disease dementia mild cognitive impairment (mci)
stress management and resiliency training for physicians

Conditions: Burnout, Professional; Stress

Summary: this study is to evaluate the effects of the smart-3rp (stress management and resiliency training relaxation response resiliency program) on physician and academic faculty well-being, perceived stress, burnout, compassion, and job satisfaction.

burnout is a serious problem in healthcare, resulting in absenteeism, decreased job satisfaction, decreased empathy, anxiety, depression, increased medical errors and decreased patient satisfaction. a growing number of studies have demonstrated that programs incorporating mind-body practices increase resilience in healthcare providers and can reduce burnout and perceived stress while increasing empathy. the benson-henry institute for mind body medicine (bhi) has developed a clinical program for patients known as the stress management and resiliency training relaxation response resiliency program (smart-3rp or smart program for short). this study is to evaluate the effect of the smart-3rp on physician and academic faculty well-being, perceived stress, burnout, compassion, and job satisfaction.

Eligibility criteria:
inclusion criteria: * physicians and academic faculty of brigham and women's hospital and newton-wellesley hospital exclusion criteria: * none

Keywords: resiliency
impact of antibiotic treatment on prostate-specific antigen (psa) variability

Conditions: Prostate Infections

Summary: ciprofloxacin hydrochloride has been approved by the food and drug administration (fda) for the treatment of mild to moderate infections, including prostate infections. it has been suggested that antibiotic treatment influences psa levels due to the fact that an increase in psa levels may be caused by inflammation or swelling of the prostate. antibiotics are used to treat such inflammatory conditions. however, it has not been proven that antibiotics can be used to lower psa. this research is being done to see if treatment with the antibiotic ciprofloxacin hydrochloride affects the prostate-specific antigen (psa) blood test. this study may also help doctors in deciding which patients need a prostate biopsy.

this study is directed towards men who have been referred to the urology clinic at the johns hopkins outpatient center in baltimore, md. if a patient fits the eligibility criteria and signs a consent form, the patient will have his blood drawn for the first psa measurement. the patient must return to the johns hopkins outpatient center one week later for a second psa measurement. the patient will be randomized to receive treatment with placebo or ciprofloxacin hydrochloride for 14 days. the patient must return to the johns hopkins outpatient center at the end of the treatment cycle for the third psa measurement. the patient will return one week later for his biopsy and fourth psa measurement.

Eligibility criteria:
inclusion criteria: * must be a patient of johns hopkins urology outpatient clinic * must have an elevated psa (\> 2.5 ng/ml) and be selected on the basis of a serum psa evaluation for transrectal ultrasound (trus)/biopsy * must be able to understand and willing to adhere to the study protocol * must be willing to take the antibiotic or placebo for two weeks prior to the biopsy and agree to have the biopsy regardless of the change in psa exclusion criteria: * abnormal digital rectal examination * anyone currently being treated or who have been treated for any prostatic diseases (prostatitis, prostate benign prostatic hyperplasia (bph) surgery, prostate cancer) or urinary tract infection in the past * anyone taking medications that are likely to alter serum psa concentration (specifically, androgen steroid hormones, antiandrogens, finasteride, leutinizing hormone releasing hormone (lhrh) analogues) * anyone unwilling to sign the informed consent or who are unlikely to adhere to the study protocol * anyone with a known allergy to fluoroquinolone antibiotics * anyone on blood thinning medication (coumadin) * anyone taking tizanidine * anyone with a history of seizures or cerebral arteriosclerosis * anyone who has taken an antibiotic medication within the past two weeks

Keywords: prostate specific antigen (psa) elevated prostate specific antigen (psa)
the effects of acute total sleep deprivation versus normal sleep on metabolism

Conditions: Sleep Deprivation; Sleep

Summary: the study proposes to investigate whether acute total deprivation affects metabolism as measured through blood and peripheral tissues. its aim is also to investigate how acute total sleep deprivation affects neurodegenerative markers, as well as hormones, memory performance and aspects of appetite regulation.

it is predicted that acute total sleep deprivation will affect gene expression and dna methylation. it is also predicted that sleep deprivation will up-regulate ghrelin, and affect other neuroendocrine markers and hormones in a negative manner. it is further predicted that sleep deprivation will decrease participants' memory performance.

Eligibility criteria:
inclusion criteria: * male * age 18-28y * healthy (self-reported) and not on medication * non-smoking * normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported via diaries) exclusion criteria: * major illness * taking any serious medications * any sleep conditions (e.g. irregular bedtimes, sleep complaints) * any dietary issues with the food items provided * current or history of endocrine, neurological or psychiatric disorders * shift work in the preceding three months or for a long duration * time travel over a significant number of time zones in the preceding two months * too much weight gain or weight loss in the preceding three months
morphological changes of the brain by mri in chronic kidney disease

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Summary: the purpose of this study is to describe brain´s morphological changes induced by chronic kidney disease (ckd) in advanced stages (stages 4 and 5 defined by kdoqi guidelines) and also by haemodialysis using mri. based on the hypothesis that hypotension may cause damage in some organs including brain the investigators study if intradialytic hypotension (idh) causes any type of changes in gray and white matter of the brain.

there will be two groups: one in haemodialysis treatment and the other with chronic kidney disease patients in advanced stages (stages 4 and 5 defined by kdoqi guidelines). both groups will be evaluated with a mri without contrast. a second mri to identify brain´s morphological changes will be performed in patients of the first group a year later and in patients of the second group that will have been begun haemodialysis six months after. in a first transverse evaluation, eighteen haemodialysis sessions from the first group will be studied with a retrospective analysis. the first three sessions of each month for six months before the mri will be considered. in each session the investigators will collect haemodynamic variables (systolic arterial blood pressure pre and post dialysis), intradialytic hypotension based on different definitions (nadir90, nadir100, fall20, fall30) and proper haemodialysis variables (ktv, convective transport). in the first group and patients with ckd that will start haemodialysis, the investigators analyse the variables considered in the transverse evaluation until complete one year follow up. statistical analysis will be done with spss version 20.

Eligibility criteria:
inclusion criteria: * prevalent patients of haemodialysis (6 months minimum) * patients with ckd (stages 4 and 5) * informed consent signed exclusion criteria: * refusion to participate in the study * presence of contraindications for mri * presence of clinic neurologic disorders

Keywords: brain haemodialysis intradialytic hypotension
compliance of patients with essential hypertension treated with candesartan or candesartan/hydrochlorothiazide

Conditions: Essential Hypertension

Summary: the coca study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the subject compliance as well as the efficacy and tolerability of candesartan or candesartan/hct in subjects suffering from essential hypertension.


Eligibility criteria:
inclusion criteria: * essential hypertension * under candesartan treatment exclusion criteria: -

Keywords: essential hypertension arb compliance candesartan
treatment of anal incontinence with intersphincteric implants

Conditions: Anal Incontinence; Fecal Incontinence

Summary: the purpose of this study is to determine whether treatment with intersphincteric implants is an effective and safe treatment option for patients with anal incontinence

treatment of anal incontinence (ai) remains a challenge - although conservative treatment can reduce the severity of many patients' ai, many continue to experience symptoms that severly affect their quality of life and ability to function properly both socially and professionally. the level of ai is measured with the st marks score (ranging from 0-24 where zero is complete continence). some patients with ai are shown to have defects in the anal sphincters (i.e. traumatic lesions post partum) and can be helped with reconstructive surgery. these procedures are effective but carry substantial risk for postoperative infection, and the healing process is painful. one of the main treatment options for anal incontinence today is sacral nerve stimulation (sns), which is an effective but invasive and expensive treatment with a rather high level of infection. it is normally performed in two separate sessions and require life-long follow up and new surgical procedures every 6-7 years. historically artificial anal sphincters have been studied and shown to be effective but with high rates of infections leading to removal of the device. in more recent years studies have instead focused on "bulking agents" (injection of i.e. silicone in the submucosal space with the aim to increase the resting pressure of the anal canal), but the effect seems to be limited and the agents injected are rapidly resorbed by the body. treatment with intersphincteric implants is a novel treatment option for these patients. available studies have shown good results regarding effect and a low frequence of postoperative infections. the implants rarely dislocate and are not resorbed by the body, which contributes to their long-term effectiveness. the operation is performed under a short general anaesthesia and in available studies the postoperative symptoms are few. the first technique described was called gatekeeper (six implants), and this has since been completed by the sphinkeeper (ten implants), which is the focus of the present study.

Eligibility criteria:
inclusion criteria: 1. subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. 2. subject must be at least 18 years of age 3. subject must have a st marks score of at least 11 4. subject must be able to comply with study and study follow-up requirements. exclusion criteria: 1. subjects with crohn's disease or ulcerative colitis 2. subject has (a history of) malignancy in the rectum or anal canal 3. subject has an ongoing treatment with chemotherapy (all indications) 4. subject has verified active anal fistula(e) 5. subject is unable or unwilling to provide informed consent.

Keywords: sphinkeeper intersphincteric implants gatekeeper
immunmodulation in patients with hht

Conditions: Hereditary Haemorrhagic Telangiectasia (HHT)

Summary: hereditary haemorrhagic telangiectasia (hht), also known as rendu-osler-weber syndrome, is an inherited multisystemic disorder. literature suggests that hht is often associated with higher frequency of infectious diseases. the purpose of this study is to evaluate a variety of immunologic parameters in the blood serum of hht patients in comparison to probands.

hereditary haemorrhagic telangiectasia (hht), also known as rendu-osler-weber syndrome, is an inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and visceral arteriovenous malformations. literature and the investigators' observation suggest that hht is often associated with higher frequency of infectious diseases. this might be a hint for a immunocompromised situation. the purpose of this study is to evaluate a variety of immunologic parameters in the blood serum of hht patients in comparison to probands.

Eligibility criteria:
inclusion criteria: * aged 18 or over, hht exclusion criteria: * unable to provide informed consent
medullary colonic carcinoma

Conditions: Medullary Carcinoma of Colon; Prognostic Factors; Survival Analysis

Summary: retrospective cohort of 10 cases of colonic adenocarcinoma of medullary type, operated between 2000 and 2020 at the university hospital of limoges. collection of relevant data for this rare entity. subgroup analysis in search of prognostic factors. comparison of the data from our cohort with those from the literature.

colorectal cancer (crc) is the third most common cancer in the world after breast and prostate cancer (1). it is also the second most common cause of cancer death in france (2). most crcs are adenocarcinomas. however, there is a distinct subtype of adenocarcinoma of relatively recent recognition, called medullary carcinomas (mc). its recent recognition as a distinct entity (3) has made it difficult to study the epidemiologic characteristics of this cancer, with little population-based data. the largest cohort studied in the literature is from a us sample of 74 patients seen between 1973 and 2006 (4). the main objective of this french retrospective study is to highlight some common features in this group of patients with medullary colorectal cancers, thus improving our knowledge of this cancer subtype and in particular its prognosis. medullary colorectal cancer is a type of cancer with a prognosis of its own, probably different from the most common histological entity, colorectal adenocarcinoma. this is a retrospective study a cohort of 10 cases of colonic adenocarcinoma of medullary type, operated between 2000 and 2020 at the university hospital of limoges. a collection of relevant data was realised for the subgroup analysis in search of prognostic factors for this rare entity as well as a comparison of the data from this cohort with those from the literature.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of colorectal adenocarcinoma of medullary type between 2000 and 2020 exclusion criteria: * absence of anatomopathological confirmation on the surgical specimen

Keywords: medullary carcinoma of colon prognostic factors survival analysis
troponin poct in the diagnosis of an acute myocardial infarction

Conditions: Acute Myocardial Infarction; Troponin

Summary: thoracic pain can be caused by a life threatening disease as for instance a heart attack. fast diagnosis and treatment is necessary for an advantageous clinical outcome. when a patient enters the emergency unit, an electrocardiogram (ecg) can diagnose a heart attack by recording the electrical activity of the patients' heart. however, an increasing number of patients with an acute myocardial infarction (ami) are presenting without significant abnormalities on ecg in the latter group, diagnosis is dependent of elevated biochemical markers of myocardiocyte necrosis in the blood such as troponin. generally, troponins are determined in blood and are analyzed by radiometry or at the hospital's laboratory. time loss in the acquisition of troponin levels can occur during the workflow due to blood sampling difficulties, transport of the blood samples, processing in the laboratory, and processes inherent to the measuring assays. roche developed a portable point-of-care (poc) device that determines troponin-t in a few minutes by using small volumes of the patient's blood with the added value that this device can be used in a pre-hospital setting which might save a significant amount of time in determining troponin levels.in this way, a faster diagnosis of ami can be made improving patients' outcome.

in this prospective pilot study, 70 patients will be recruited over a time period of one year, with non-traumatic thoracic pain in a pre-hospital setting. while the ambulance or mug is transporting such a patient, he/she is asked (informed consent) if an extra blood sample can be taken for measuring troponin levels by the portable device of roche (cobas h232®). this can be done during the same venipuncture needed for standard-of-care analysis of the two other blood samples used for troponin-t by the radiometer and the laboratory. an ecg is performed in the ambulance and when it is positive, a patient is diagnosed immediately with acute myocardial infarction (ami) and will be to transported as fast as possible to the coronary care unit. the blood samples retrieved in the ambulance are transported to the lab and to the table top radiometer in the emergency unit. as stated before, an increasing number of patients with ami are presenting without significant abnormalities on ecg. therefore, the troponin-t levels in the blood sample will provide extra information to make an appropriate diagnosis. it is our hypothesis, that the cobas h232 device will provide faster results and thus a faster diagnosis of ami which benefit patients' outcome.

Eligibility criteria:
inclusion criteria: * non-traumatic thoracic pain * transportation via ambulance or mug * written informed consent form (icf) has to be obtained from the patient exclusion criteria: * age \<18 years
pros and cons of telemedicine in diagnosis and management

Conditions: the Study Focus on the Uses of Telephone and Other New Technology in Medicine, Diagnosis and Treatment

Summary: telemedicine "healing at a distance" telemedicine has many advantages especially in time of pandemics for both doctors and patients, low cost and easily accessibility. pandemics especially covid 19 has radically change the medical team thoughts about the telemedicine. it can decrease the exposure of the medical team to infection and expected by some of the medical team to be very beneficial if done in good and legal manner. although, telemedicine has many advantages, also has many disadvantages and medicolegal problems, breakdown in the relationship between medical teams and patients, mis diagnosis or wrong treatment. there are many legal and ethical aspects of telemedicine.

telemedicine "healing at a distance" telemedicine has many advantages especially in time of pandemics for both doctors and patients, low cost and easily accessibility. pandemics especially covid 19 has radically change the medical team thoughts about the telemedicine. it can decrease the exposure of the medical team to infection and expected by some of the medical team to be very beneficial if done in good and legal manner. although, telemedicine has many advantages, also has many disadvantages and medicolegal problems, breakdown in the relationship between medical teams and patients, mis diagnosis or wrong treatment. there are many legal and ethical aspects of telemedicine. these include the medical responsibilities, the confidentiality and privacy of the patients can not be maintained, the jurisdictional problems. shortage of medical practitioners and specialists, shortage of internet facilities, low education levels in some patients all are problems facing the telemedicine in developing countries. the evolution of telemedicine poses a series of legal problems ranging from the profiles on the subject of authorization and accreditation to those concerning the protection of patient confidentiality, the definition and solution of which, in the absence of specific regulatory provisions, is mainly left to the assessment of compatibility of the practices adopted so far, with the general regulatory framework. this research will be done to clarify the role of telemedicine, and if it has a share hand or the upper hand if compared with traditional medicine.

Eligibility criteria:
inclusion criteria: * doctors of all specialty * patients * police man and who work in law exclusion criteria: * no exclusion criteria

Keywords: telemedicine - malpractice - telehealth