Kornimate/medical-research-clean huggingface dataset:
imaging of trabeculectomy blebs using the spectral domain optical coherence tomography

Conditions: Glaucoma; Filtering Blebs

Summary: the aim of this study is imaging of trabeculectomy blebs regarding structure and function with the spectral domain optical coherence tomography.

after a trabeculectomy with mitomycin c 0,02% for 3 minutes, the blebs are controlled by a glaucoma specialist on day 1, week 1,2,3,4, month 3 and 6 after surgery. the glaucoma specialist will evaluate the bleb appearance according to a standardized protocol. at the same time points the bleb will be imaged with the spectral domain optical coherence tomography, to monitor bleb changes objectively. the investigators hope to see signs of bleb incapsulation and scarring earlier and then treat the patient accordingly.

Eligibility criteria:
inclusion criteria: glaucoma patients who need a trabeculectomy with mitomycin c 0,02% for further reduction of intraocular pressure, informed consent exclusion criteria: patient without glaucoma, under 18 years of age, not willing to take part in the study

Keywords: glaucoma trabeculectomy filtering bleb spectral domain optical coherence tomography
decide-hf: heart rate variability in heart failure patients

Conditions: Systolic Heart Failure

Summary: the purpose of this study is to determine whether heart rate variability-like parameters are related to changes in the disease status of a subject that suffers from a disease that decreases the pumping function of the heart.


Eligibility criteria:
inclusion criteria: * subject has signed and dated the study-specific informed consent form * subject is 18 years of age or older * subject is expected to remain available for follow-ups * subject is able and willing to comply with the protocol requirements * subject has predominant normal sinus rhythm * subject has systolic heart failure and is at the moment of enrollment in nyha class ii or iii and has an ejection fraction of less then 40% * subject has had a hf-related hospitalization in the past 12 months exclusion criteria: * subject needs permanent atrial pacing (\> 10%) * subject has intermittent 2nd or intermittent 3rd degree block * subject has persistent or permanent af * subject has long qt syndrome, brugada syndrome, jervell and lange- nielsen syndrome, romano-ward syndrome, andersen-tawil syndrome or timothy's syndrome * subject has had recent (\<2 months) acute coronary syndrome * subject has had recent (\<2 months) revascularization * subject has a pending cardiac transplant or revascularization * subject has severe stenotic valvular heart disease * subject has severe pulmonary (forced expiratory volume in 1 s \ 0.2 mmol/l) disease * subject is participating in another study that may affect the results of this study
the outcome of combined partial fistulectomy or fistulotomy and cutting seton procedure in high perianal fistula

Conditions: High Anal Fistula

Summary: the aim of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study.

anal fistula is an abnormal tract with two openings: external one opens in perianal skin and the internal one opens in anal canal. and according to relation between fistula and anal sphincters there are intersphincteric, transphincteric, suprasphincteric and extrasphincteric. varieties of surgical procedures are encountered for management of this disease but complications such as recurrence and incontinence still facing surgeons strongly. in previous study of total 31 patients post-operative complications were; incontinence of gas (16.13%), incontinence of stool (3.23%), recurrence (3.23%) with conclusion of that: outcomes of fistulotomy with cutting seton were satisfactory in most patients (1). in this study and aiming to reduce the complications rate data will be collected about the outcomes of combined partial fistulectomy or fistulotomy and cutting seton procedure in a prospective study. the goals of treatment are draining infection, eradicating the fistulous tract and avoiding persistent or recurrent disease while preserving anal sphincter function.

Eligibility criteria:
inclusion criteria: * adult with age of or above 18 years. * patients with high perianal fistula; trans-sphincteric, intra-sphincteric or supra-sphincteric. * patients sable to comply to with the study protocol. exclusion criteria: * patients with low perianal fistula * patients with preoperative incontinence. * patients with comorbidities such as tb , malignancy or inflammatory bowel disease. * patients diagnosed with acute anal sepsis * recurrent cases

Keywords: cutting seton fistulectomy
50 human subject repeat insult patch test

Conditions: Erythema; Sensitisation

Summary: consumer products or raw materials designed for consistent reapplication to areas of the skin may, under proper conditions, prove to be contact sensitizers or irritants in certain individuals. it is the intention of a repeat insult patch test (ript) to provide a basis for evaluation of this irritation/sensitization potential if such exists.


Eligibility criteria:
inclusion criteria: * individuals who are not currently under a doctor's care * individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the investigator. * individuals free of any acute or chronic disease that might interfere with or increase the risk of study participation. * individuals who will complete a preliminary medical history form mandated by ama laboratories, inc. and are in general good health. * individuals, who will read, understand and sign an informed consent document relating to the specific type of study they are subscribing. consent forms are kept on file and are available for examination on the premises of ama laboratories, inc. only. * individuals able to cooperate with the investigator and research staff, willing to have test materials applied according to the protocol, and complete the full course of the study. exclusion criteria: * individuals under 18 years of age. * individuals who are currently under a doctor's care. * individuals who are currently taking any medication (topical or systemic) that may mask or interfere with the test results. * subjects with a history of any acute or chronic disease that might interfere with or increase the risk associated with study participation. * individuals diagnosed with chronic skin allergies. * female volunteers who indicate that they are pregnant or lactating.

Keywords: hript irritant
agents intervening against delirium in intensive care unit

Conditions: Delirium

Summary: delirium is a frequent condition in the intensive care unit (icu) with no existing evidence-based treatment. the aim of the aid-icu study is to assess the benefits and harms of haloperidol treatment for the management of icu acquired delirium.

delirium among critically ill patients in the intensive care unit (icu) is a common condition associated with increased morbidity and mortality. no evidence-based treatment exist of this condition. haloperidol is the most frequently used agent to treat icu-related delirium, but according to the available literature there is no firm evidence of efficacy and safety of this intervention. aid-icu aims to assess the benefits and harms of haloperidol in adult, critically ill patients with delirium in the icu.

Eligibility criteria:
inclusion criteria: * acute admission to the icu and * age ≥ 18 years and * diagnosed delirium with validated screening tool as either cam-icu or icdsc exclusion criteria: * contraindications to haloperidol * habitual treatment with any antipsychotic medication or treatment with antipsychotics in the icu prior to inclusion * permanently incompetent (e.g. dementia, mental retardation) * delirium assessment non-applicable (coma or language barriers) * withdrawal from active therapy * fertile women (women \< 50) with positive urine human chorionic gonadotropin (hcg) or plasma hcg. * consent according to national regulations not obtainable * patients under coercive measures by regulatory authorities * patients with alcohol-induced delirium (delirium tremens)

Keywords: icu delirium haloperidol
optimizing the previs device for prediction of postoperative ileus

Conditions: Ileus

Summary: the research proposed in this study will develop a noninvasive prototype device that will capture intestinal sounds, process signals, and display predictive information in real-time at the point-of-care using algorithms already developed at this institution.

following major abdominal surgery, up to 30% of patients develop a poorly understood condition known as ileus. when ileus occurs, the bowels shut down and patients often develop abdominal dissension, nausea, vomiting, and even more serious complications. because this condition does not develop until many days after surgery has been completed, clinicians do not know if they should begin allowing patients to eat or withhold nutrition until they show signs of bowel function such as passing gas or having bowel movements. clinicians have different approaches but none are ideal: 1) feed all patients early and the ones that develop an ileus will have their diets reverse, suction tube placed in their stomach, and hopefully don't get develop more serious complications, or 2) don't feed patients until they pass gas or have a bowel movement, which delays nutrition and prolongs hospital stays for the 70% of patients who will not develop an ileus participants in this study will be asked to wear a 3-ounce device that adheres to the skin of the abdominal wall for 10 days. they will also be asked to answer questions each day of their hospital stay regarding how they have tolerated eating.

Eligibility criteria:
inclusion criteria: patients undergoing elective intestinal resection surgery by the colorectal surgery service at uihc. age 18 to 100. exclusion criteria: allergies to any of the device components. inability to have prototype device applied to their abdominal wall due to a condition (ie:fistulas, stomas, drains, etc).

Keywords: ileus abdominal surgery bowel obstruction postoperative ileus
the effects of hemodialysis session on vascular stiffness

Conditions: Arteriopathic Disease; Arterial Calcification; Complication of Hemodialysis; Aortic Stiffness

Summary: central blood pressure and pulse wave velocity were measured using a complior analyse device before and immediately after the end of the dialysis session.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * patients on maintenance hemodialysis at least 3 months * stable dry weight * single-pool kt/v \>1.4 * no clinical cardiovascular disease during the 6 months preceding entry * medical staff (medical doctors, nurses) exclusion criteria: * not meet the above criteria * episode of illness (for example: infection) * pregnancy
use of corticosteroids in children with cellulitis

Conditions: Cellulitis

Summary: the aim of this study is to evaluate the efficacy of addition of corticosteroid therapy to antibiotic treatment during the first 48 hours of admission to the hospital in patients with cellulitis and its impact in the duration of the stay.

cellulitis is a common skin and soft tissue infection in the pediatric population. although most of the time treatment could be administered on an ambulatory setting , sometimes it may require hospitalization and parenteral antibiotic administration. using corticosteroids during antibiotic treatment may reduce inflammation and length of stay. objective: to evaluate the efficacy of using corticosteroids as adjuvant treatment during the first 48 hours of treatment after hospitalization in patients with cellulitis. patients and methods: this is a double blind, randomized, controlled trial that will take place at pediatric hospital, during one year. it will include children aged 1 month to 18 years, admitted due to cellulitis. once included in the clinical trial, the patients will be randomized to receive dexamethasone 0,6 mg/kg/day or placebo (saline solution) during the first 48 hours. considering an average stay of 4 ± 2 days, we calculated a sample size of 124 children (62 children per group) to detect a 25% difference (1 day reduction) in the length of stay, with a power of 80% and a confidence of 95%.

Eligibility criteria:
inclusion criteria: * children aged 1 month to 18 years * hospitalized due to cellulitis * patients who have given their written informed consent to participate exclusion criteria: * skin chronic diseases * immunodeficiency (primary or acquired) * chronic use of systemic corticosteroids * sepsis * varicella * history of adrenal insufficiency * pregnancy or breast feeding * uncontrolled diabetes mellitus * known hypersensitivity to systemic or topical corticosteroids * patient undergoing immunosuppressive therapy for another disease * participation in another drug biomedical research * any other contraindication for treatment with corticosteroids

Keywords: cellulitis soft tissue infections skin diseases, infectious corticosteroids glucocorticoids dexamethasone
a two-period open-label trial evaluating efficacy and safety of dasiglucagon in children with congenital hyperinsulinism

Conditions: Congenital Hyperinsulinism

Summary: the objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (sc) infusion in reducing hypoglycemia in children with chi.


Eligibility criteria:
inclusion criteria: * established and documented diagnosis of chi based on standard of care * experiencing ≥3 events of hypoglycemia per week (plasma glucose \[pg\] \<70 mg/dl \[\<3.9 mmol/l\]) according to the investigator's evaluation * previously undergone near-total pancreatectomy or being treated with a non-surgical approach, having been evaluated as not eligible for pancreatic surgery * if somatostatin analogues or sirolimus are used, the therapy should be well established as judged by the investigator, especially when considering their biological half-life exclusion criteria: * previous administration of dasiglucagon * known or suspected allergy to the trial drug or related products * previous participation (randomization) in this trial * circulatory instability requiring supportive medication or presence of pheochromocytoma * requires exogenous insulin * body weight of \<4 kg (8.8 lbs.) * documented hba1c ≥7% subsequent to near-total pancreatectomy and within 6 months prior to screening * known or suspected presence of significant central nervous system disease/injury such that in the investigator's opinion will affect trial participation * use of systemic corticosteroids, e.g., hydrocortisone \>20 mg/m2 body surface area or equivalent in the 5 days before screening * use of anti-inflammatory biological agents, or other immune modulating agents in the 3 months prior to screening * any clinically significant abnormality identified on echocardiogram that in the opinion of the investigator would affect the patient's ability to participate in the trial * any recognized clotting or bleeding disorders * has participated in an interventional clinical trial (investigational or marketed product) within 3 months of screening or 5 half-lives of the drug under investigation (whichever comes first), or plans to participate in another clinical trial.
optimal improvement of vein graft patency long term by the implementation of novel endoscopic harvesting techniques

Conditions: Coronary Artery Disease

Summary: this is an observational study of lone coronary artery bypass grafting procedures with endoscopic vein graft harvesting using best harvesting practices.

this is a prospective, multi-center, non-randomized, observational study of 100 patients who will undergo routine coronary artery bypass grafting. eligible candidates will undergo lone coronary artery bypass graft (cabg) procedures with endoscopic vein harvesting using best harvesting practices, defined as: systemic heparinization prior to vein manipulation, standardization of vein graft harvesting techniques, pressure limiting syringe and 3 month use of dual anti-platelet therapy. patients will undergo a ct angiography at 30 days and 12 months to assess vein graft patency.

Eligibility criteria:
inclusion criteria: * age greater than 18 and able to provide consent * eligible for endoscopic vein harvesting * minimum of two non sequential vein grafts * willing to comply with requirements of protocol exclusion criteria: * previous cabg * previous or concomitant valve surgery * any other concomitant cardiac procedure other than surgical ablation or incidental pfo repair * intolerance to iodine or iv contrast that cannot be controlled with pre-medication * renal insufficiency with gfr measurement ≤ 40, unless dialysis dependent * abnormal platelet level defined as plt count \>400,000 * abnormal platelet function (hypercoagulable state) as evidenced by teg testing * allergy to or presence of a condition that the investigator feels may prevent safe administration of asa or plavix post-operatively. * patient has a co-morbid condition that in the opinion of the investigator poses undue risk for successful endovascular harvesting of the vein
diagnostic reliability of oct biomarkers for ierm

Conditions: Idiopathic Epiretinal Membranes

Summary: several optical coherence tomography (oct) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (ierm) have been described in single predictor analyses in the past. aim of the study is to assess the reliability of diagnosis of oct biomarkers and to calculate their impact on postsurgical visual acuity in a multiple regression analysis.

several optical coherence tomography (oct) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (ierm) have been described in single predictor analyses in the past. a recent multifactorial analysis outlined macular thickness and dril to be significant predictors for postsurgical visual acuity (karasavviodou et al.). nevertheless, reliability of diagnosing oct biomarkes among patients with ierm was not yet assessed, to our knowledge. aim of the study is to assess the reliability of diagnosis of oct biomarkers and to calculate their impact on postsurgical visual acuity in a multiple regression analysis.

Eligibility criteria:
inclusion criteria: * a) presence of an ierm, * b) indication for membrane peeling, defined as significant loss of visual acuity and/or metamorphopsia due to the erm, * c) pseudophakia at the final visit at 3 months after surgery, and * d) written informed consent for study participation. exclusion criteria: * macular edema caused by conditions other than erm were excluded from the study.
a brief cognitive task intervention for nhs staff affected by covid-19 trauma (gains-2 study)

Conditions: Intrusive Memories of Traumatic Event(s)

Summary: frontline healthcare staff are frequently exposed to traumatic events at work (e.g., witnessing patients die), amplified by the covid-19 pandemic. a significant proportion experience intrusive memories of these events that pop suddenly into mind: they can disrupt functioning and can contribute to post-traumatic stress disorder. previous research has shown that a brief behavioural intervention can reduce the number of intrusive memories after a traumatic event. in this study we will test the effect of a digital imagery-competing task, a digital music-listening task and treatment as usual (tau) for national health service (nhs) staff with intrusive memories of work-related traumatic events from the pandemic. we test the effect on the number of intrusive memories (primary outcome), and other clinical symptoms (ptsd, anxiety, depression, and insomnia), in addition to work functioning, general functioning and quality of life (secondary outcomes). intervention feasibility, acceptability and implementation will also be explored (additional outcomes). we will recruit approximately 150 nhs staff (via the intensive care society, social media and direct advertising by nhs trusts) with intrusive memories of traumatic events experienced during the covid-19 pandemic. the study is funded by the wellcome trust (223016/z/21/z).

a statistical analysis plan will be prepared prior to the first interim analysis using bayesian analyses for statistical inference. regular monitoring will be performed by p1vital products to verify that the study is conducted, and data are generated, documented and reported in compliance with the protocol, gcp and the applicable regulatory requirements. quality assurance representatives from the sponsor may carry out an audit of the study in compliance with regulatory guidelines and relevant standard operating procedures.

Eligibility criteria:
inclusion criteria: * aged 18 or above. * able to read, write and speak in english. * worked in a clinical role with covid-19 patients in the nhs during the covid-19 pandemic. * experienced at least one traumatic event related to their clinical work during the covid- 9 pandemic meeting criterion a of the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) criteria for post-traumatic stress disorder (ptsd): "exposure to actual or threatened death, serious injury, or sexual violence" by "directly experiencing the traumatic event(s)" or "witnessing, in person, the event(s) as it occurred to others". * experience intrusive memories of the traumatic event(s). * experienced at least three intrusive memories in the week prior to screening. * have internet access. * willing and able to provide informed consent and complete study procedures * willing and able to be contacted by the research team during the study period. * have not taken part in a previous study of this intervention from this research team exclusion criteria: • have fewer than three intrusive memories during the run-in week.