Kornimate/medical-research-clean huggingface dataset:
the efficacy, onset of effect, and safety of alfuzosin once daily in the treatment of lower urinary tract symptoms of benign prostatic hyperplasia: a randomized, placebo-controlled trial using an acute international prostate score

Conditions: Benign Prostatic Hyperplasia

Summary: primary: evaluate the safety and onset of symptom relief using an acute i-pss form (7 day form). determine onset of urinary peak flow improvement after 7 days secondary: determine improvement in bother score after 7 \& 28 days; improvement in sexual function after 28 days; assess one-month efficacy and safety


Eligibility criteria:
inclusion criteria: - men aged greater than or equal to 50 years with a history of lower urinary tract symptoms (luts) related to bph for greater than or equal to 6 months, an international prostate symptom score (i-pss) (0 to 35 points scale) of at least 13 points, a maximum urinary flow rate (qmax) between 5 and 12 ml/sec (with a voided volume of greater than or equal to 150 ml), a residual urine volume of less than or equal to 350 ml, and a bothersomeness score (0 to 6 points scale) of at least 3 points. all patients will undergo prostate size assessment by transrectal ultrasonography (trus) if not done within past 12 months. exclusion criteria: - include, but are not limited to: concomitant lower urinary tract disease; previous prostatic surgery; history of postural hypotension or syncope; concomitant use of medications that may alter the voiding pattern; and clinically relevant biochemical abnormalities. patients with a serum prostate-specific antigen (psa) \>10 ng/ml will be excluded, and those with an elevated serum psa between 4 and 10 ng/ml must have prostate cancer excluded to the satisfaction of the investigator. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
lavender oil inhalation help to overcome dental anxiety among children

Conditions: Dental Anxiety; Anxiety Disorder; Aromatherapy

Summary: the purpose of this study is to investigate the impact of lavender oil (lavandula angustifolia) on anxiety, pain and vital signs (blood pressure, heart rate and saturation) among children planned to undergone surgical intervention.

lavender oil has sedative properties. dental anxiety is one of the most common obstacles to dental care, especially for children ranges from 3% to 43% in different populations. to the best of our knowledge, this is the first study to investigate the use of lavender oil inhalation and to assess the correlation of anxiety and vital signs among children during a stressful surgical dental intervention. this study design was constructed according to the vital sign evaluations, anxiety and pain scores. primary hypothesis was that of lavender oil inhalation prior to surgical dental interventions would affect vital signs and consequently reduce anxiety and perception of pain in children.

Eligibility criteria:
inclusion criteria: * being between 6 and 12 years of age * children who are determined as frankl 2, 3 or 4 * intellectually sufficient to complete the anxiety scale * volunteer to take part in the study * whose parents were willing to participate into the study exclusion criteria: * aged under 6 * has cognitive, cooperation (i.ex. frankl 1) or systemic problems * common allergies or dental pain

Keywords: lavandula phytotherapy aromatherapy dental anxiety anaesthesia
safety and effect of l. reuteri on biomarkers of inflammation in healthy infants with colic

Conditions: Gastrointestinal; Colic

Summary: this protocol is a study of the effects of lactobacillus reuteri in 45 healthy infants with colic. the study is being conducted in order to prove treatment dose with probiotic (lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.

this study will evaluate the safety and tolerability of lactobacillus reuteri in healthy infants with colic. patients will be randomized to receive either l. reuteri at one dose orally for a total of 42 doses. the doses will be 5x108 (5 drops) during a satisfactory assessment of safety and tolerability. the time on study treatment is 6 months, and the target sample size is 45 healthy infants. secondly, the investigators aim to gather evidence supporting hypothesis of safety and tolerability of lactobacillus reuteri by administering a physical examination and testing of complete blood count, liver tests, and serum electrolytes over a forty-two day period.

Eligibility criteria:
inclusion criteria: * full-term babies with colic (21-90 days old, who cry/fuss \> 3h daily x \> 3d wk) * baby must have more than 3h crying for enrollment exclusion criteria: * severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \> 8 times daily, projectile, bilious or bloody emesis) * failure to thrive * intrauterine growth retardation * hematochezia (blood in the stools) * diarrhea (watery stools that takes the shape of a container \> 5x daily) * fever (38.2 degrees) * premature infants (\<37 wk gestation)

Keywords: crying fussiness gas hydrogen breath fecal calprotectin
retinal nerve fiber layer thickness measurements in patients with sleep apnea syndrome

Conditions: Obstructive Sleep Apnea; Hypopnea Syndrome; Glaucoma

Summary: the purpose of this study was to measure the retinal nerve fiber layer (rnfl) thickness in eyes of obstructive sleep apnea/hypopnea syndrome (osahs) using optical coherence tomography (oct), and assess whether it is decreased. the investigators then compared the results with healthy subjects database of rnfl thickness from another retrospective study.

an association between glaucoma and osahs has been reported in several studies. glaucoma is a progressive optic neuropathy involving loss of retinal ganglion cells and their axons at the level of the optic nerve head.computerized technologies have now been successfully used in evaluating retinal nerve fiber layer (rnfl) thickness in glaucoma.given the evidence of a possible link between osahs and glaucoma, it is reasonable that structural losses in retinal nerve fiber layer (rnfl) thickness would be present in osahs.indeed,decreased retinal nerve fiber layers was found in patients with osahs, the severity of which correlated with the severity of the patients' osahs using scanning laser polarimetry (slp).optical coherence tomography (oct) provides quantitative rnfl thickness data by measuring the difference in the temporal delay of back-scattered light from the rnfl and a reference mirror.during the past decade, oct has been used widely in clinical practice to discriminate glaucomatous eyes and eyes with early perimetric glaucoma from normal eyes. several studies confirmed the accuracy and reproducibility of the rnfl thickness measurements by oct. the thickness of the peripapillary rnfl was measured with the stratus oct(carl zeiss meditec, inc, dublin,ca)using the fast scan protocol(3.4).only good quality images, as judged by the well-focused and centered scans,no artifacts showing distorted anatomy, no missing parts and a signal strength ≥6, were used for further analysis. the considered oct parameters were overall average rnfl thickness and the average rnfl thickness in 4 quadrants (superior, nasal,inferior,and temporal)extracted from the standard rnfl thickness analysis report(rnfl thickness average analysis protocol).

Eligibility criteria:
inclusion criteria: * formal diagnosis of moderate or severe osahs * eligibility to sign informed consent form * older than 18 years exclusion criteria: * known glaucoma * not eligible to sign informed consent form * younger than 18 years * incompetent persons who lack decision making capability

Keywords: optical coherence tomography retinal nerve fiber layer thickness obstructive sleep apnea hypopnea syndrome glaucoma
latent tuberculosis in healthcare workers - the reality of a portuguese tertiary hospital

Conditions: Tuberculosis

Summary: prospective, descriptive study to assess latent tuberculosis infection (ltbi) among healthcare worker (hcw) in a tertiary hospital in a low-risk area.

identiﬁcation and treatment of ltbi can substantially reduce the risk of development of disease and are important tb control strategies, especially in settings with a low tuberculosis (tb) incidence, where reactivation of ltbi often accounts for the majority of non-imported tb disease treatment of ltbi can substantially reduce the risk of development of disease. in portugal the real prevalence of ltbi in low-risk hcws has not been evaluated since they are not included in the periodic screening programs. it is important to diagnose tb infections in hcws to prevent nosocomial transmission, particularly among immunocompromised patients. the risk for transmission varies by setting, occupational group, local prevalence of tb, patient population, and effectiveness of tb infection control measures. prevention of active tb disease by treatment of ltbi is a critical component for public health. tuberculin skin test (tst) is used worldwide to diagnose ltbi, whereas interferon-γ release assay (igra) are used in some countries according to their national tb programs. igra offers a potential method of serial testing to diagnose ltbi in hcws, and it has better specificity than that of tst in one-time screening. study participants should be identified and contacted by occupational health service. in association, study information should be disseminated through posters and institutional email.

Eligibility criteria:
inclusion criteria: * all hcw from our hospital with risk of exposure, working in our hospital for at least 3 consecutive months * acceptance to participate and signed informed consent form exclusion criteria: * history of previous tuberculosis * active tuberculosis * refusal to sign the informed consent form

Keywords: latent tuberculosis healthcare workers igra
cerebrovascular registry

Conditions: Cerebrovascular Disorders

Summary: patients with stroke were registered based on the who/ monica protocol and were followed-up for 28 days, starting in 2015 in prove registry

prove program started in 2015, the registration of stroke continued but followed the who stepwise method instead of who/monica .patients are followed up for two years. the corresponding questionnaire covered the patients' demographic data, medical history upon hospital admission, history of comorbidities, medications used prior to the treatment, history of drug abuse, heart and brain imaging, history of blood tests and blood diseases, hospital treatments received, hospitalization complications, medications prescribed at the time of discharge, discharge status and the definite diagnosis of type of stroke according to ct or mri. the patients were followed-up over the phone or in person from the 1st, 3rd and 12th months to two years. the patients' disabilities were measured using the barthel index and the modified rankin scale (mrs). the reliability and validity of these two questionnaires have already been investigated in persian. in addition, secondary prevention measures, rehabilitation status and the incidence of new cardiovascular events were also examined in the follow-up. the stroke registration personnel received an initial training of three two-hour sessions and monthly one-hour retraining sessions. they visited the archives of various hospitals on a daily basis and registered the data contained in the records

Eligibility criteria:
inclusion criteria: \* patients with acute stroke (hemorrhagic and non hemorrhagic) exclusion criteria: * patients who do not agree to continue cooperation * patients with incomplete documents
acute neurocardiogenic injury after subarachnoid hemorrhage.

Conditions: Subarachnoid Hemorrhage

Summary: the aim of this study is to describe acute neurocardiogenic injury after subarachnoid hemorrhage assessed with cardiac 123i-mibg scintigraphy and 18f-fdg pet/ct during the first week and the first six months after sah. the study hypothesis is that the evolution of the cardiac disturbances follows the clinical evolution.

the cardiac metabolic disturbance are assessed by a 18f-fdg pet/ct in the first week after sah and monthly until normal result. the myocardial sympathetic innervation is assessed by a cardiac 123i-mibg scintigraphy in the first week after sah and six months later. clinical outcome is assessed by glasgow outcome scale, modified rankin scale and mos-sf36 at 1, 3 and 6 months after sah.

Eligibility criteria:
inclusion criteria: * age * sah * hospitalization in the military teaching hospital sainte anne exclusion criteria: * refusal of consent

Keywords: subarachnoid hemorrhage scintigraphy neurocardiogenic injury
a clinical trial of acyclovir for viral uveitis

Conditions: Uveitis

Summary: this project is designed to test the hypothesis that acyclovir is clinically useful for patients with refractory viral uveitis.

approval of the study was obtained from the hospital's ethical committee. the study design and methodology followed the tenets of declaration of helsinki. all patients were provided with written informed consent and received a thorough explanation of the study design, aims, benefits and potential risks. this is a prospective non-comparative interventional study. aqueous humor samples were collected from participants to virus detection. participants will take oral acyclovir 100 mg three times a day and data will be collected prospectively with regard to ophthalmologic outcomes. study participants will be followed for up to 12 months to determine efficacy, and an additional 30 days for safety reports. descriptive statistics will be gathered on participant demographics, uveitis characteristics, change in immunosuppressive medications, number of responders, ophthalmologic measures and change in corticosteroid dose during the study period.

Eligibility criteria:
inclusion criteria: * age between 18 and above. * chronic, vision threatening viral uveitis. * patients can't tolerate hormone therapy bacause of drug side effects. * consent to undergo anterior chamber tap and give aqueous for the study. * able to undergo relevant tests. * able to come for subsequent follow-up visits. * ability to provide informed consent. exclusion criteria: * patients who are allergic to ayclovir. * immunocompromised patients * positive for hiv, hep b and hep c * not keen on participating in the study * patients who are incapable, either by law or mental state, of giving consents in their own right. * patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol. * patients who are pregnant or breastfeeding. * any other specified reason as determined by the clinical investigator.
early onset preeclampsia and nectin-4

Conditions: Pre-Eclampsia; Early Onset Preeclampsia; Oxidative Stress; Immunologic Diseases in Pregnancy

Summary: early-onset preeclampsia (pe) is a pregnancy disorder which may present with adverse pregnancy outcomes. nectin-4 is an adhesion molecule mainly expressed in placenta. this study aimed to evaluate the relationship between early onset preeclampsia and serum nectin 4 levels.

preeclampsia is assumed as a two-stage disorder arising from defective trophoblast invasion and failure of spiral artery remodeling as the main step responsible for the pathogenesis. pe is classified according to the disease onset time as early-onset pe before 34 weeks and late-onset pe after 34 weeks. late-onset pe is more commonly seen and accepted as a mild maternal reaction to pregnancy. in early-onset pe, unlike the late-onset, due to the improper placental invasion, the diffuse placental ischemia and the resulting oxidative stress begin at early gestation. thus, the early-onset pe may result in severe disease leading to perinatal and maternal morbidity and mortality. the nectins are calcium-independent immunoglobulin-like celladhesion molecules and have a pivotal role at cellular junctions, as well as physiological regulations(8). placenta expressesfor types of nectins; nectin-1, nectin-2, nectin-3, and nectin-4. they are localized at tight junctions and gap junctions of syncitiotrophoblasts(9). nectin-4 is a relatively novel member of nectin family which has been detected only in placenta and airway epithelium in healthy subjects. despite, there has been no study published yet to reveal the soluble nectin-4 levels in preeclampsia as well as in early onset disease. in this study, we aimed to investigate the serum nectin-4 levels in early-onset preeclampsia in comparison of the healthy pregnancies.

Eligibility criteria:
inclusion criteria: * spontaneous, * singleton pregnancies * above the 24 weeks of gestations * positive fetal cardiac activity exclusion criteria: * multiple gestations, * chronic hypertension * hypothyroidism * known malignancy,- diabetes mellitus, * presence of fetal or maternal infection, * clinical signs of chorioamnionitis (maternal fever, vaginal discharge, fetal tachycardia), * hepatic or renal failure * placenta previa or pregnancies accompanied congenital fetal abnormalities or aneuploidies

Keywords: early onset preeclampsia nectin-4 advers pregnancy outcome hypertansion
ultrasonography in norwegian emergency department patients with suspected covid-19 infection

Conditions: COVID-19; Pneumonia, Viral; Pulmonary Infection

Summary: in light of the ongoing covid-19 epidemic in norway, it is paramount to develop and utilize clinical tools for assessing and risk stratifying patients with suspected coronary infection in the emergency departments. diagnostic use of ultrasound in viral pneumonias, including covid-19 has proved to be very useful. the use of ultrasound will assist in quick detection of lung pathology compatible with increasing severity of the covid-19 disease. at the same time, the use of ultrasound diagnostics in the emergency department could improve logistics and reduce potential exposure of the corona virus to other health personnel. the purpose of the study is to assess whether ultrasound findings correlates with physical examination, labs, and other imaging diagnostics in patients with suspected or diagnosed covid-19 disease, as well as assessing whether ultrasound diagnostics can assist in risk stratification. the project is conducted as a prospective multicenter study where ultrasound diagnostics will be performed on patients with suspected coronary infection in the emergency departments. data collection takes place as part of the daily clinical evaluation of acute patients in the emergency departments. the project is planned to be completed towards the end of 2025.


Eligibility criteria:
inclusion criteria: - all emergency department patients with suspected or diagnosed covid-19. exclusion criteria: * negative screening for covid-19 * recent negative covid-19 test * no indication for isolation in the emergency department

Keywords: ultrasonography norway emergency department emergency physicians
comparative efficacy of a two daily mixed insulin injection versus a basal-bolus scheme with human insulin

Conditions: Type 1 Diabetes

Summary: the goal of this clinical trial is to compare glycemic control and variability between children and adolescents with type 1 diabetes treated by a two daily injection of premixed human insulin (humulin 30/70) and those who have a basal bolus scheme (humulin n + humulin r) in a resources limited setting. the main question it aims to answer is: what is the effectiveness of premixed human insulin on glycemic control? ten participants will be randomized initially to premix insulin human isophane suspension and insulin human injection (humulin 30/70) twice daily, and 10 persons to insulin human isophane suspension (humulin n) twice daily plus regular human insulin (humulin r) before meals. at the end of the initial 16-wk treatment (period 1), all patients will be crossed over to the alternate treatment arm for an additional 16 wk (period 2). insulin doses will be adjusted weekly by the clinical site according to a prespecified insulin intensification algorithm to achieve target fasting \[\<110 mg/dl (6.1 mmol/liter)\], bedtime \[\<130 mg/dl (7.2 mmol/liter)\], and premeal \[\<110 mg/dl (6.1 mmol/liter)\] glucose levels until hba1c was below 7.0%. subjects will receive training on the freestyle libre cgms system, electronic hand-held personal digital assistant (e-diary), and self-monitoring of blood glucose (smbg), including recording glucose, insulin doses, and symptoms of hypo- or hyperglycemia.


Eligibility criteria:
inclusion criteria: * male or female 5 - 18 years of age * be diagnosed for at least 1 year at the date of inclusion. * have been regular at consultations during the last 12 years preceding inclusion (at least 3 visits) * willing and able to inject insulin human isophane and multi-day dosing of rapid acting human insulin. * willing and able to perform self-monitoring of blood glucose (smbg) four times a day and continuous glucose monitoring (cgms) for 48 hours at three time periods during the study * have (patient or guardian) a minimum 4 years primary school level * have (patient or guardian) a connected cellphone that can install the free freestyle link application and use connected messaging app exclusion criteria: * pregnant or lactating females * opposition to participating in the study * residing outside the towns where the care centers are located * any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that in the opinion of the investigator or sponsor may interfere with the study compliance and completion of the study.
effect of detemir and sitagliptin on blood glucose control in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, europe and north america. this trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (oad) versus oral anti-diabetic drug alone.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes for at least 6 months before trial start * treatment with at least 1000 mg metformin per day for at least 3 months * insulin-naive (short-term insulin treatment of up to 14 days is allowed) * dpp-4 (dipeptidyl peptidase-4) inhibitor naive * hba1c (glycosylated haemoglobin a1c) between 7.5-10.0% by central laboratory analysis * bmi (body mass index) lesser than or equal to 45.0 kg/m2 * able and willing to take one subcutaneous injection every day * able and willing to perform mandatory smpg (self measured plasma glucose) measurements exclusion criteria: * known or suspected allergy or intolerance to any of the trial products or related products * severe hypertension * treatment with thiazolidinedione (tzd) or glp-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start * cardiac disease, within the last 12 months * impaired hepatic function * impaired renal function * proliferative retinopathy or macular oedema requiring acute treatment * female of childbearing potential * known or suspected abuse of alcohol, narcotics or illicit substances
collagen membrane combined with huc-mscs transplantation in patients with nasal septum perforation

Conditions: Chronic Nasal Septum Perforation

Summary: the purpose of this study is to assess the safety and efficacy of collagen membrane combined with human clinical grade umbilical cord mesenchymal stem cells(huc-mscs) transplantation in patients with chronic nasal septum perforation.


Eligibility criteria:
inclusion criteria: 1. patients with nasal septum perforation area less than 1cm², and requires minimally-invasive treatment. 2. male or female, 18-45 years old. 3. ability and willingness to regular visit to hospital and follow up during the protocol procedures. exclusion criteria: 1. cystic fibrosis, immotile cilia syndrome and other genetic diseases. 2. syphilis, leprosy, tuberculosis and other specific infections. 3. severe sinusitis. 4. autoimmune diseases or long term treatment with corticosteroids. 5. alzheimer's disease. 6. systemic diseases (e.g.,hypertension, diabetes and so on). 7. previous history of nasal cancer or after receiving radiotherapy. 8. drug abuse. 9. history of mental illness.