Kornimate/medical-research-clean huggingface dataset:
is urethral catheter necessary after ureteroscopy and dj stent placement?

Conditions: Complications; Urethral Catheter; Ureteral Catheterization; Ureteroscopy; Lower Urinary Tract Symptoms; Flank Pain

Summary: after semirigid or flexible ureteroscopy operations where a dj stent was placed, there is diversity in practice of placing a urethral catheter. the presence of vesico-ureteral reflux due to dj stents has been proven to exist and can cause flank pain and uti due to retrograde urine flow. the main purpose to place a urethral catheter is to keep a low-pressure bladder in order to prevent reflux alongside the dj stent. however, this practice doesn't have an evidence-based support on the literature and some surgeons also advice patients to void frequently in the early postoperative period to avoid these aforementioned complications. the purpose of this study is to compare the 2 different approaches after ureteroscopy and dj stent placement by evaluating the patient-reported outcomes along with laboratory tests.

ureteral stents and foley catheters are the most commonly used disposables in urological practice. ureteral double j (dj) stents are frequently used to relieve ureteral obstruction and almost as a routine part of the ureteroscopic procedures by many surgeons. dj stent placement has the potential side effects such as flank pain and urinary tract infection (uti) due to retrograde urine flow. as the bladder pressure increases during voiding, urine reflux occurs both beside and through the dj stent. in order to overcome these problems, stents with antireflux mechanisms are produced, however these new stents comes with higher costs compared to conventional stents. foley catheters are the hands and feet of all urologists and insertion of a foley catheter can easily keep the bladder pressures as low as required. the practice of insertion of a foley catheter into the urinary bladder after ureteroscopy for kidney or renal stones and dj stent placement doesn't have an evidence-based background and it routinely depends on the choice of the surgeon. the aim of this study is to evaluate whether routine insertion of a bladder catheter following ureteroscopy and dj stent placement can reduce stent-related problems due to reflux and urinary tract infections.

Eligibility criteria:
inclusion criteria: * adult patients * patients with indications for semirigid or flexible ureteroscopy and dj stent placement for unilateral ureteral and/or kidney stones according to european association of urology urolithiasis guidelines exclusion criteria: * none
bevacizumab and retinal vascular occlusions

Conditions: Edema Macular; Vascular Occlusion

Summary: to evaluate the effects of intravitreal bevacizumab in macular edema in retinal vascular occlusion.


Eligibility criteria:
inclusion criteria: * vascular occlusion and edema macular diagnosticated by fluorescein angiography and coherent optic tomography exclusion criteria: * previous surgery * uveitis * glaucoma
a long term follow-up study up to 4 years after study vaccination to assess immunogenicity and safety of the investigational vaccine in adults

Conditions: Respiratory Disorders

Summary: the purpose of this long-term follow-up of a phase i study is to evaluate the kinetics of the antibody response to nthi-mcat antigens and long-term safety, in subjects aged between 50-71 years at the time of enrolment in the nthi-mcat-001 study. these subjects were previously exposed to two adjuvanted formulations of the nthi-mcat vaccine administered according to a 0, 2 months schedule in the nthi-mcat-001 (201281) study. the subjects that had received saline placebo controls will also be included in this follow-up study to make comparisons with the investigational vaccines. no vaccinations will be administered in this trial.


Eligibility criteria:
inclusion criteria: * subjects who previously participated in step 2 of study nthi-mcat-001 (201281), and performed the last study visit (month 14) and received the 2 study vaccinations. * subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits). and subjects' legally acceptable representative(s) \[lar(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * written informed consent obtained from the subject/ lar(s) of the subject prior to performance of any study specific procedure. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) during the period starting 30 days before the first follow-up study visit (month 19 to month 20), or planned use during the study period. * chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since the end of the nthi-mcat-001 study. for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. inhaled and topical steroids are allowed. * administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab). * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). * administration of immunoglobulins and/or any blood products during the period starting 3 months before the first follow-up visit or planned administration during the study period. * current alcoholism and/or drug abuse. * has significant disease (including significant neurological or psychological disorders), in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration. * any other condition that the investigator judges may interfere with study findings.

Keywords: safety immunogenicity
effect of a life coaching intervention on the well-being and distress of physicians

Conditions: Distress, Emotional; Burnout

Summary: there is a widespread epidemic of distress and burnout (i.e., extreme distress) among canadian physicians. burnout is costly to physicians, patients, and healthcare organizations as it compromises physicians' own health and reduces their capacity to deliver high quality, safe care to patients. life coaching delivered by certified coaches is a personal development tool. life coaching has been proven to help individuals maximize their strengths and skills to handle stressors, regain control over their lives, act according to their core values, and achieve their full potential, consequently reducing their vulnerability to burnout. the investigators will evaluate life coaching for physicians' well-being in the current canadian context. physicians from centres in canada will be randomly assigned to life coaching (intervention) or no coaching (control) group. the coaching group will receive a 1-hour initial coaching session followed by five 30-minute coaching sessions occurring at a frequency of every 2 to 3 weeks within 5 months (total of 3.5 coaching hours). all coaching sessions will be delivered virtually by certified life coaches. the investigators will assess the impact of coaching on physician distress and quality of life before and after the intervention.


Eligibility criteria:
inclusion criteria: * registered staff physician, resident, or fellow * currently practicing in canada * (for the 'francophone minority patients' group only) sometimes conducts thorough consultations completely in french for french-speaking patients outside quebec exclusion criteria: * previously received life coaching in the last 5 years * currently receiving psychotherapy
a long-term safety study evaluating the safety and systemic exposure of ar-15512

Conditions: Dry Eye Disease

Summary: this will be a phase 3, 12-month, multicenter, vehicle-controlled, double-masked, randomized phase 3 study conducted at approximately 10 sites in the united states. all subjects enrolled will have dry eye disease (ded). the study will consist of a baseline visit (day 1) as well as visits on days 14, day 90, day 180, day 270, and day 365 (study exit). in addition, there will be dispensing visits on days 45, 135, 225, and 315.

at the end of the screening visit, subjects will undergo a protocol-specified washout period for prohibited prior and concomitant therapies. at the baseline visit, subjects who qualify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 2:1 ratio to receive 0.003% ar-15512 or ar-15512 vehicle administered as 1 drop in each eye twice a day for 365 days (12 months). at the end of the day 365 visit, subjects will exit the study. aerie pharmaceuticals was acquired by alcon on november 22, 2022.

Eligibility criteria:
key inclusion criteria: * previous history of dry eye disease (ded) within the previous 12 months of the baseline visit. * have used or desired to use artificial tears for ded symptoms within 3 months prior to the baseline visit. * schirmer test score with or without topical anesthesia as specified in the protocol within 1 year of the baseline visit. * total ocular surface staining score as specified in the protocol at the baseline visit. * corrected visual acuity as specified in the protocol at the baseline visit. * good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history, and vital signs (heart rate and blood pressure) at the baseline visit. key exclusion criteria: * history or presence of any ocular disorder or condition (other than ded) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety. * current evidence of other significant ophthalmic disease requiring topical medication (e.g. glaucoma, ocular hypertension) which may interfere with vision (e.g., cataract, macular degeneration) or other disease which the investigator believes may interfere with study findings or interpretation. * use of contact lenses in either eye within 7 days prior to the baseline visit or planned use during the study. * use of medications as specified in the protocol. * use of lid heating therapy (i.e., lipiflow®, ilux®) or meibomian gland probing/therapeutic expression within 6 months prior to the baseline visit or anticipated during the study.
a randomized controlled trial for hypertension control by integrating cloud bp system and cpoe

Conditions: Hypertension

Summary: importance: less than fifty percent of patients with hypertensive disease manage to maintain their blood pressure (bp) within normal levels. practical (pragmatic) and sustainable models are needed in order to improve bp management in patients with hypertension. objective: to evaluate whether cloud bp system integrated with computerized physician order entry (cpoe) is useful for improving bp management as compared with traditional care.

design, setting and patients: a randomized clinical trial study of 382 adults recruited from 786 patients who had been diagnosed with hypertension and receiving treatment for hypertension in two district hospitals in the north of taiwan. physicians had access to cloud-based bp data from cpoe. neither participants nor investigators were blinded to group assignment. the study was conducted for a period of seven months. interventions: patients from two hospitals were randomized into a control group which received traditional care (n=212) and an intervention group (n=170) which received a cloud-based home bp monitoring device. the device measured and transmitted bp data to the cloud server, which was integrated with the cpoe system in the hospitals. physicians could access the bp data during the patient encounter to adjust the antihypertensive therapy accordingly. meanwhile, patients could browse their own bp data from their computers, smart phones, tablets and so on. primary outcome(s) and measure(s): the primary outcomes were control of systolic bp to less than 140 mm hg and diastolic bp to less than 90 mm hg at two, four and six months. the secondary outcomes were changes in bp and antihypertensive drug prescription at two, four and six months.

Eligibility criteria:
inclusion criteria: * secondary hypertension * expectant mother * stroke, myocardial infarction or had surgery within 3 months * atrial fibrillation * inter-arm difference (iad) \>20 mm hg * unsuitability as recognized by physicians. exclusion criteria: * unable to participate in this trial for the whole process * lived alone and unable to read text message

Keywords: home blood pressure computerized physician order entry (cpoe) telemonitoring hypertension
self-management pessary project

Conditions: Pelvic Organ Prolapse

Summary: the goal of this multicenter observational study is to study self-management of pessary therapy in patients with pelvic organ prolapse. the primary question it aims to answer is: • how many patients succeed learning self-management if offered a standardized training? secondary outcomes are: * how many patients are willing to learn self-management? * what patient factors contribute to successfully learning self-management and willingness to self-manage? * how satisfied are patients with pessary therapy and self-management? * the occurrence of side-effects * continuation and quitting of pessary therapy and self-management * cross-over to surgery * number of visits to doctor because of pessary therapy * healthcare costs participants will be asked to fill in questionnaires three times during the study (upon inclusion, 6 weeks and 12 months after starting self-management or after starting pessary therapy with a correctly fitting pessary). researchers will compare the self-managing patient to the non-self-managing patients.


Eligibility criteria:
inclusion criteria: * fitted a ring, sieve of knob pessary * above 18 years old * able to understand patient information exclusion criteria: * fitted a new pessary to replace an old one (continuing former pessary therapy) * fitted a new pessary after they experienced adverse effects of a former pessary

Keywords: pelvic organ prolapse pessary self-management
detecting pulmonary arterial hypertension (pah) in patients with systemic sclerosis (ssc) by ultrasound

Conditions: Systemic Sclerosis; Pulmonary Hypertension

Summary: doppler signals can be recorded from the lung parenchyma by means of a pulsed doppler ultrasound system incorporating a special signal processing package; i.e. the transthoracic parametric doppler (tpd) (echosense ltd., haifa, israel). systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. the tpd system may provide important insight into pulmonary blood vessels characteristics by the lds signals that are related to pulmonary hypertension. the tpd performance in detecting pah in ssc patients will be assessed in the study.


Eligibility criteria:
inclusion criteria: 1. able and willing to give signed informed consent prior to enrollment 2. male or female, ≥ 18 years of age 3. diagnosis of ssc according to 2013 acr/eular ssc classification criteria (van den hoogen 2013): score ≥ 9. 4. patients with rhc data available from measurement within 3 weeks prior to tpd assessment 5. no change in or initiation of pah specific therapy between the last rhc and tpd exclusion criteria: 1. people unable or unwilling to give informed consent. 2. pcwp or lvedp \> 15 mmhg 3. any ph etiology outside group 1 (dana point, 2008) 4. pregnant women 5. patients having severe chest wall deformity

Keywords: systemic sclerosis, pulmonary hypertension
low carbohydrate versus mediterranean diet in adolescents with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the goal of this clinical trial is to compare the effect of low carbohydrate diet versus mediterranean diet on blood sugar values in adolescents with type 1 diabetes. the main question aims to answer whether a low carbohydrate diet is as effective as the mediterranean diet for better glycaemic control in type 1 adolescents. the investigators are also aiming to check whether low carbohydrate diet is safe and does not elevate cholesterol blood levels and whether the diet is adherable among youth with type 1 diabetes. participants with type 1 diabetes wearing a continuous glucose monitor and that will sign an informed consent will be randomly selected for 2 groups. one group will get the mediterranean diet program and the other will get the low carbohydrate diet program, both for a duration of six months. each participant will attend a cooking workshop at the beginning of the study. blood work and stool samples will be taken at the beginning and 3 times through the study periodd. each participant will attend meetings with the dietician thorough the period of the study.

background and objective: improved glycemic control of type 1 diabetes (t1dm), with low rates of adverse events was reported via an online community of children and adults who consume a of low carbohydrate diet (lcd). the investigators aim to compare the effects of a low carbohydrate diet (lcd) with those of a mediterranean diet on glycemic control, lipid profile, bone metabolites and the microbiome profile in adolescents with type 1 diabetes. design a randomized, controlled trail. families of adolescents in the diabetes clinic in edmond and lily safra children's hospital will be approached and offered to participate in a dietary intervention study. after participants will sign the informed consent, they will randomly be assigned into 2 diet treatment groups, the lcd (n=20) and the mediterranean diet (n=20). baseline nutrition teaching session and training and will be conducted for all participants and their parents. participants will attend visit with the dietician at baseline, 2, 4, 8,12 weeks and will be given a 3-day food dairy to complete twice in that period. measurements of weight, height, blood pressure, hba1c, time in range, number of hypoglycemia, lipid profile, creatinine, bone metabolites will be measured at baseline and 12 and 24 weeks and gut bacteria profile at baseline and at 24 weeks. personality, quality of life, and socioeconomic questionnaires will be given to children and their parents. contribution of the suggested research: in this research the investigators are aiming to show that lcd is as good as mediterranean diet with improved glycemic control, safe, and adherable for adolescent with t1d.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * connected to a continuous glucose monitoring (cgm) exclusion criteria: * history of eating disorder * family history of mental disorders

Keywords: adolescents glycemic targets low carbohydrate diet mediterranean diet
prevalence of menstrual cycle related pain complains in adolescents and young adults

Conditions: Dysmenorrhea; Pelvic Pain

Summary: the aim of this study is to determine the prevalence of menstrual cycle related pain complains in adolescents and young adults.

an internet questionnaire with 12 items was used: adolescents * start of menstruation * characteristics of menstrual cycle * pain related to menstrual cycle (questions based on well-known pain-complaints related to the presence of endometriosis) * analgetics * influence on school carrier * influence on social life young adults * idem as for adolescents * influence of pain on an eventual sexual relationship

Eligibility criteria:
inclusion criteria: * 3rd year high school girls * 1st year university young females exclusion criteria: * pre-menarcheal girls

Keywords: adolescents young adults dysmenorrhea pelvic pain
the interaction between mucosal microbiota colonization and the immune response to an intranasal influenza live attenuated vaccine

Conditions: Influenza

Summary: this is a single-center, randomized, open-label trial designed to explore the interaction between mucosal microbiota colonization in the nasal cavity and gut and the immune response to an intranasal live attenuated influenza vaccine (laiv). the study plans to enroll 200 children and adolescents aged 6-17 years, with approximately 50% in the 6-11 years age group and 50% in the 12-17 years age group. participants and their guardians must be able and willing to comply with the clinical trial protocol and provide informed consent. eligible participants will be randomly assigned in a 1:1 ratio, stratified by age groups, to either the immediate vaccination group or the delayed vaccination group. nasal swabs will be collected for all participants of both the immediate vaccination group or the delayed vaccination group after randomization for the detection of nasal and gut microbiota. then, the immediate vaccination group will receive one dose of 0.2 ml of laiv 28 days after randomization, while the delayed vaccination group will receive one dose of 0.2 ml of laiv 56 days after randomization. blood and mucosal samples (nasal stool) will be collected on the day before vaccination and on 28 days after vaccination for humoral and mucosal immunogenicity analysis. moreover, the occurrence of adverse events within 28 days after vaccination will be collected.


Eligibility criteria:
inclusion criteria: 1. individuals aged 6-17 years. 2. volunteers and their guardians are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form. exclusion criteria: 1. allergy to any component of the vaccine product, including eggs, excipients, or gentamicin sulfate. 2. individuals with acute illnesses, severe chronic illnesses, acute exacerbations of chronic illnesses, or fever. 3. pregnant or lactating women. 4. individuals with leigh syndrome who are receiving treatment with aspirin or aspirin-containing medications. 5. individuals with immunodeficiency, immunosuppression, or those undergoing immunosuppressive therapy. 6. individuals with uncontrolled epilepsy, other progressive neurological disorders, or a history of guillain-barré syndrome. 7. individuals with rhinitis or asthma. 8. individuals with a personal or family history of seizures, chronic diseases, epilepsy, or allergic tendencies. 9. individuals who have received immunoglobulin injections within the last 3 months prior to vaccination. 10. individuals who have used other live attenuated vaccines within 1 month prior to vaccination. 11. individuals planning to use antiviral drugs for influenza within 48 hours before or 2 weeks after vaccination. 12. individuals planning to use any other intranasal medication within 2 days after vaccination.

Keywords: intranasal influenza live attenuated vaccine nasal microbiota gut microbiota colonization mucosal immunity