Kornimate/medical-research-clean huggingface dataset:
bevacizumab eliminates the angiogenic threat for retinopathy of prematurity

Conditions: Retinopathy of Prematurity

Summary: the purpose of this study was to determine the efficacy and additional advantages of intravitreal bevacizumab in the treatment of rop for both zone i and zone ii posterior.

this phase 2 study assessed the anti-neovascularization activity of intravitreal bevacizumab, as determined by regression of neovascular vessels of retinopathy of prematurity (rop), in neonates with acute stage 3 rop in zone i or posterior zone ii with plus disease. this study enrolled 150 confirmed cases of vision threatening rop which have definite plus disease \[ranging from early treatment for retinopathy of prematurity, to cryotherapy for retinopathy of prematurity . this was done because of the controversy regarding determining plus disease and the increasing concern that many infants are being treated whose rop would spontaneously regress. bevacizumab will be administered intravitreally using 0.625 mg (0.025 ml) injections into each eye. there was no intent to give additional doses unless there was a recurrence of vision threatening stage 3 rop with plus disease since the disease is self limited by completion of vascularization. clinical response and any evidence of ocular toxicities were documented by retinal imaging system (manufactured by clarity medical systems, inc.) taken pre-injection, one week and one month post injection, and at 6 months of age (54 weeks postmenstrual age)(window of 50 to 70 weeks pma)(primary outcome) and at 12 months of age (80 weeks postmenstrual age)(window of 75 to 100 weeks pma)(structural documentation). using the same retinal imaging system, fluorescein angiograms have been taken when possible to document structural outcomes in greater detail. no evidence of systemic toxicities were documented by appropriate clinical and laboratory tests.

Eligibility criteria:
inclusion criteria: 1. infants who have been screened by the american academy of ophthalmology, the american academy of pediatrics, and the american association for pediatric ophthalmology and strabismus guidelines (≤1500 grams at birth and ≤30 weeks gestation) who develop stage 3 rop in zone i or posterior zone ii. 2. informed consent from a parent or guardian. exclusion criteria: 1. infants who have a congenital systemic anomaly or have a congenital ocular abnormality. 2. infants who cannot be treated by conventional laser therapy because of problems with media clarity. generally, blind external cryotherapy would be utilized as an initial therapy and the infant would be excluded from the study even if the media clear subsequently. 3. informed consent from a parent or guardian refused. this will mean that an infant automatically will receive laser therapy. bevacizumab (avastin®) treatment cannot be given outside of the protocol. no data will be used from an infant without informed consent.

Keywords: vascular endothelial growth factor angiogenesis inhibitor premature infants bevacizumab zone i or posterior zone ii rop aggressive posterior rop stage 3 rop neonatal intensive care unit
covid-19 vaccine text outreach

Conditions: Covid19

Summary: this project aims to evaluate different approaches to increase covid-19 vaccine uptake among at-risk patients at penn medicine in an equitable and systematic manner through a centralized outreach program. the investigators will evaluate different text-based scheduling and messaging approaches informed by behavioral science to increase uptake among eligible patients, including the use of clinician endorsement, opt-out framing, and scarcity.

this project will evaluate a centralized approach to increasing covid through direct outreach to eligible patients via text messaging. this pragmatic randomized controlled trial has the following aims: aim 1: to conduct systematic large scale text message outreach for vaccine delivery among a defined group of penn medicine in a way that advances equity. aim 2: to offer different scheduling workflows through text messaging that might increase uptake and reduce disparities. aim 3: to compare the equity and efficiency of different messages informed by behavioral science, including pcp endorsement, opt-out framing, and scarcity.

Eligibility criteria:
inclusion criteria: * patients of penn medicine aged 18+ who reside in philadelphia and who have had at least 1 visit in the past 5 years with a penn medicine primary care provider (pcp) exclusion criteria: * patients who have completed any dose of the vaccine at penn medicine, are currently scheduled to receive the vaccine, have externally documented vaccination records, or have previously received text-message based vaccine outreach.

Keywords: vaccination uptake text messaging outreach
digital health interventions for obsessive compulsive disorder (ocd)

Conditions: Obsessive-Compulsive Disorder

Summary: the investigators are testing two digital health interventions for obsessive compulsive disorder (ocd). the investigators hope that these digital health programs will increase access to treatment for ocd.

the primary aims of this study are to test the feasibility, acceptability, and efficacy of two digital health interventions for adults with ocd recruited nationally. eligible subjects (n=120) will be randomly assigned (50/50 chance) to 12 weeks of app-based cbt on their personal smartphone or 12 weeks of web-based health and well-being education in addition to completing clinical assessments and questionnaires from home. all participants will have access to a coach to help guide them through their assigned program. total participation time for the study is approximately 6 months, and all study appointments (5 total) occur over secure phone or video conference call.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * current diagnosis of primary obsessive compulsive disorder (ocd), based on the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5), mini international neuropsychiatric interview (mini) * currently living in the united states exclusion criteria: * psychotropic medication changes within 2 months prior to enrollment (participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period) * past participation in ≥4 sessions of cognitive behavioral therapy (cbt) for ocd * past use of a cbt for ocd app * current severe substance use disorder * lifetime bipolar disorder or psychosis * acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥2 on the suicidal ideation subscale of the columbia suicide severity rating scale (c-ssrs). * current severe comorbid major depression, as indicated by clinical judgment and/or a quick inventory of depressive symptomatology, self-report version (qids-sr), total score ≥ 21 * current post-traumatic stress disorder (ptsd) * concurrent psychological treatment * does not own a supported mobile smartphone with a data plan * lack of technology literacy that would interfere with ability to engage with smartphone treatment

Keywords: obsessive-compulsive disorder ocd randomized controlled trial digital health
pharmaceutical care in type 2 diabetes

Conditions: DIABETES MELLITUS, TYPE 2

Summary: the purpose of this study is to examine the effect of a pharmaceutical care program on the level of glycated hemoglobin for hyperglycemic users of brazilian public health care system in drug treatment for type 2 diabetes.

the chronic diseases, including diabetes mellitus (dm) are a major public health problems of today. there is evidence that glycated hemoglobin (a1c) levels above 7% are associated with a progressively greater risk of chronic complications related to dm. however, approximately 60% of diabetics do not achieve glycemic control. in brazil, pharmacists are not involved in direct care of patients with dm. the investigators conducted a randomized controlled trial, for six months, in ouro preto, minas terais to determine the effect of pharmaceutical intervention on glycemic control in patients with diabetes and hyperglycemic (a1c \> 7%). one hundred and twenty-nine subjects were randomized to receive usual care only or usual care and pharmaceutical intervention. the population of those who had access in the brazilian public health care system, as consultations with doctors, nurses and nutritionists, laboratory tests and access to essential medicines were considered as conventional health care.

Eligibility criteria:
inclusion criteria: * minimal age 18 years old * use of diabetes oral medication * minimal glycohemoglobin 7% exclusion criteria: * pregnant and nursing women * people unable to attend the study site * participants of other programs of pharmaceutical care

Keywords: pharmaceutical services diabetes mellitus
3d ct guidance for transjugular intrahepatic portosystemic shunt creation

Conditions: Portal Hypertension

Summary: to prospectively evaluate the efficacy of real-time 3d ct-image guidance and co2 portography during transjugular intrahepatic portosystemic shunt (tips) creation.


Eligibility criteria:
inclusion criteria: 1. cirrhosis 2. scheduled for indicated tips procedure exclusion criteria: 1. presence of portal vein thrombosis 2. presence of ascites 3. presence of hepatic vein occlusion or stenosis 4. proven malignancy including hepatocellular carcinoma 5. end-stage renal disease under renal replacement therapy; 6. cardiorespiratory failure 7. pregnancy or patients not giving informed consent for tips procedures
evaluation of satisfaction in patients undergoing non surgical lifting by means of coned wires.

Conditions: Pain; Complications

Summary: an email questionnaire about subjective satisfaction and discomfort has been sent to 243 patients undergoing non-surgical facial and cervical lift 1 week, 1 month, 6 months and 1 year after treatment.

243 patients underwent non-surgical coned wires (silhouette soft) facial and cervical lift between october 2013 and november 2014. the procedures has been executed in our aesthetic clinics in milan, bologna, turin, genoa, rome, asti, san remo and palermo. among the 243 patients, 217 were females and 26 males, with age ranging from 19 to 76 years. 103 patients underwent only facial lift, of which 12 only in the frontal area, 61 only on cheek and malar area, and 30 on both the areas. 39 patients underwent only cervical lift, of those 14 by means of appliance of 1 or 2 wires, 25 by means of appliance of more than 2 wires. 101 patients underwent both facial and cervical non surgical lift. we sent to every patient a email questionnaire1 week, 1 month, 6 months and 1 year after treatment. in the questionnaire, patients has been asked to enter a value between 1 and 5 about subjective satisfaction regarding the aesthetic improvement (ranging from 1, poor, to 5, excellent), and discomfort related to treatment (ranging from 1, no perceived discomfort, to 5, impossibility to execute working and social activities). the data has been analyzed and related to other factors such as: * number of wires applied on each patient * other aesthetic or regenerative medicine treatments executed on the same patient on the same year * total expenditure related to aesthetic treatments in the same year

Eligibility criteria:
inclusion criteria: * patients undergoing facial and cervical non surgical lift by means of resorbable coned wires exclusion criteria: * patients with asymmetry

Keywords: coned wires, wire lift, patient discomfort
the potential of sperm retrieved by micro-tese to fertilize vitrified/warmed oocytes

Conditions: Azoospermia, Nonobstructive

Summary: couples referred for microdissection-tese (m-tese) due to klinefelter's syndrome, maturation stop in the spermatogenesis, or failed retrieval of testicular spermatozoa by conventional techniques with needle or trucut are included. the women are stimulated with fsh in ivf protocols and the aspirated oocytes vitrified with usual applied techniques. fresh sperm retrieved by micro-tese are used for fertilization of the warmed oocytes. when it is not possible to obtain testicular sperm, the couples are offered fertilization with warmed oocytes. fertilization, cleavage, implantation and pregnancy rates using sperm from the patients versus from sperm donors will be compared.


Eligibility criteria:
inclusion criteria: couples referred for micro-tese exclusion criteria: none

Keywords: azoospermia micro-tese klinefelter's syndrome cryptorchidism vitrified oocytes
music therapy and humanization in ed healthcare professionals

Conditions: Stress; Burnout; Quality of Life (QOL); Music Therapy; Humanization of Care

Summary: background: healthcare professionals in emergency departments frequently experience stressful situations that could jeopardize their mental health, sense of purpose, and ability to empathize with patients, families, and colleagues. research question: what is the impact of a short music therapy program on the intra- and interpersonal factors of humanized care among emergency nursing staff at the university hospital fundación santa fe de bogotá (fsfb)? methodology: this research is a mixed-methods pilot and feasibility study. for the quantitative component, we will apply the humas (healthcare professional humanization scale) and proqol (professional quality of life) measure at the start and at the end of the music therapy program. for the qualitative component, focus group interviews will be conducted and analyzed via thematic analysis. discussion: this study seeks to support the nursing staff of the fsfb emergency department through an interactive, creative, and participatory music therapy self-care program focused on one of the most important pillars of the institution: the humanization of care.


Eligibility criteria:
inclusion criteria: * be a member of the emergency department nursing staff at the fsfb for a minimum of 6 months. * be able to commit to participating in eight music therapy sessions over a four-week period. * have the minimum reading skills to understand the questionnaires exclusion criteria: - staff with untreated mental health disorders.
substance-focused sbi as a complement to internet-based psychiatric treatment: rct

Conditions: Substance Use Disorders (SUD)

Summary: objectives: this study evaluates the efficacy of escreen for internet psychiatry patients treated for major depressive disorder, panic anxiety and social phobia. the escreen brief internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. progress over time is shown in diagrams detailing consumption levels. method: this is a two-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. participants with problematic alcohol use (audit \>7 for men and \>5 for women) and/or problematic drug use (dudit \> 1 for both men and women) are randomized into one of two groups: t1, escreen referral or control group. outcomes on alcohol and drug use as well as health-related symptoms are assessed after 3, 6 and 12 months. the hypothesis is that the group receiving the escreen intervention will reduce their alcohol/drug use to a larger extent than the control group at follow-up compared to the baseline level.

this study evaluated the efficacy of escreen for internet psychiatry patients treated for major depressive disorder, panic anxiety and social phobia. the escreen brief internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. progress over time is shown in diagrams detailing consumption levels. the design was a two-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. participants with problematic alcohol use (audit \>7 for men and \>5 for women) and/or problematic drug use (dudit \> 1 for both men and women) were randomized into one of two groups: t1, escreen referral or control group. outcomes on alcohol and drug use as well as health-related symptoms are assessed after 3, 6 and 12 months. the hypothesis was that the group receiving the escreen intervention would reduce their alcohol/drug use to a larger extent than the control group at follow-up compared to the baseline level. the results have not yet been analyzed due to technical issues. however, qualitative interviews have been conducted with participants and our intention is to publish the qualitative results in tandem with the quantitative results available.

Eligibility criteria:
inclusion criteria: audit \>7 for men and audit \>5 for women, and/or dudit \>0 exclusion criteria: dudit = 0 and audit \<8 (men) or \<6 (women)

Keywords: randomized controlled trial alcohol drugs internet screening brief intervention
a prospective, two-arm, non-interventional study of jakavi® (ruxolitinib) in patients with myelofibrosis

Conditions: Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis

Summary: this was a prospective, two-arm, non-interventional study of jakavi® (ruxolitinib) in patients with myelofibrosis

the purpose of this nis was to gather data from the daily clinical practice of the jakavi®-treatment in a broad patient population. in order to evaluate the direct effect of jakavi®, only jak inhibitor naive patients were documented in the first study arm; patients pretreated with jak inhibitors were documented in the second study arm to evaluate the long-term efficacy of jakavi® in this subpopulation. the documentation of all patients was carried out prospectively and began after the baseline visit. the medical decision on which therapeutic and diagnostic measures to take was made solely by the responsible physician. the observational period per patient was 36 months. the visit schedule after the baseline visit was set by the responsible physician according to standard clinical care, the clinical condition of the respective patients and the smpc.

Eligibility criteria:
inclusion criteria: * male and female patients with primary myelofibrosis (pmf), post-polycythemia vera-myelofibrosis (ppv-mf), or post-essential thrombocythemia-myelofibrosis (post-et-mf), for whom jakavi® therapy is indicated. * patients that were informed about all aspects of this nis and provided written informed consent. exclusion criteria: -

Keywords: primary myelofibrosis pmf post-polycythemia vera myelofibrosis ppv mf post-essential thrombocythemia myelofibrosis post et mf ruxolitinib jakavi
s-cei of nexium in paediatric patients

Conditions: Peptic Ulcer, Gastroesophageal Reflux

Summary: to capture safety and efficacy when nexium are administered to pediatric patients in clinical practice after launch

the objective of this investigation is to capture the followings when nexium capsules or nexium granules for suspension (single-dose package) are administered to pediatric patients in clinical practice after launch. 1. development of adverse reactions which are unexpected from precaution for use 2. development of adverse reactions 3. efficacy

Eligibility criteria:
inclusion criteria: * patients aged 1(inclusive) to 15 (exclusive) years * patients who have been prescribed nexium for the first time for "gastric ulcer", "duodenal ulcer", "anastomotic ulcer", "reflux oesophagitis", "non-erosive reflux disease", or "zollinger-ellison syndrome", . exclusion criteria: * patients with a history of hypersensitivity to components contained in this product. * patients during treatment with atazanavir sulfate and rilpivirine hydrochloride.
pre-formed alloreactivity in renal transplant recipients

Conditions: Kidney Transplantation; Acute Graft Rejection

Summary: this investigator-initiated study will analyse the role of pre-formed alloreactive t cells on acute rejection episodes and graft outcome in kidney transplant recipients after living donation.

in recipients of solid organ transplants, preformed alloreactive t cells may mediate acute rejections and compromise long-term graft survival. previous studies on the role of alloreactive t cells in transplantation were hampered by the fact that experimental assays to quantify alloreactivity were technically demanding and not suitable for use in a clinical setting. based on a recent development of a whole-blood assay, alloreactive t cells may be quantified and characterised within one day. this assay therefore provides the experimental basis to study the development and the role of alloreactive t cells in a clinical setting in patients after renal transplantation. this will be performed in a multicenter study in living donor renal transplant recipients where preformed alloreactivity of the recipient towards the living donor will be determined and associated with standard clinical parameters of graft function and long-term graft outcome on follow-up. in addition, the development of donor-specific antibodies will be analysed after transplantation. if this project was able to provide evidence for a role of alloreactive t cells in acute rejection episodes or long-term graft function, this assay may in future be used to guide individualized immunosuppressive drug treatment early after transplantation. it will thereby aid in distinguishing patients where standard immunosuppressive drug regimens are sufficient from the minor population of patients at high risk for rejection who will benefit from intensified drug regimens.

Eligibility criteria:
inclusion criteria: * written informed consent * first or second renal transplantation * living donor renal transplantation * recipient older than 18 years * negative cross match * planed quadruple, tacrolimus-based (low-dose) immunosuppressive drug regimen (tacrolimus, 2g mmf starting dose, (methyl)prednisolone according to center practice, basiliximab at day 0 and day 4) * planned start of tacrolimus (advagraf®) 3 to 10 days prior to transplantation (trough levels 5-10 ng/ml during the first 3 months, 5-7 ng/ml thereafter) exclusion criteria: * planed t-cell depleting induction therapy * pregnancy * pre-existing, moderate to high dose immunosuppressive medication * pre-existing, severe lymphopenia (\&lt; 400/µl)

Keywords: alloreactive t cell donor-specific antibody
escitalopram in patients with social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: the purpose of this study is to evaluate the effect of escitalopram after 12 weeks of treatment in patients with social anxiety disorder (sad), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.

the study will be performed in russia, as an open-label, uncontrolled, one arm trial. the patients will receive escitalopram for 12 weeks. start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national summary of products characteristics (spc).

Eligibility criteria:
inclusion criteria: * the patient suffers from sad, diagnosed according to icd-10 (international classification of diseases) * the patient meets criteria set in the national spc for escitalopram * the patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history and vital signs exclusion criteria: * the patient has/has had an alcohol or drug abuse-related disorder, as defined in icd-10 * the patient has contraindications to escitalopram * the patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram * the patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance * the patient is pregnant or breast-feeding * the patient, if a woman of childbearing potential, is not using adequate contraception

Keywords: social anxiety disorder sad antidepressant anxiolytic