Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of edoxaban in thoracoscopic ablation

Conditions: Atrial Fibrillation; Anticoagulants and Bleeding Disorders

Summary: the aim of this study is to compare the safety and efficacy of edoxaban and warfarin for prevention of stroke during a 6-month follow up after total thoracoscopic ablation.

in korea, 5% of patients older than 65 years and 10% of patients older than 80 have a history of atrial fibrillation (af), which is often associated with sudden death and stroke. medication and percutaneous radiofrequency catheter ablation are commonly used treatment modalities. pharmacotherapy is primarily symptomatic treatment; moreover, the effect of conversion to a normal rhythm is minimal, and mainly aimed at stabilizing heart rate. catheter ablation is associated with a high incidence of recurrence in chronic af, and it is difficult to treat left atrial appendage, thereby preventing discontinuation of anticoagulation therapy post procedure. thoracoscopic ablation is known to be a less invasive and more effective modality to treat patients with chronic atrial fibrillation. however, anticoagulation therapy is mandatory in the early postoperative period due to intracardiac thromboembolism associated with atrial stunning despite conversion to a sinus rhythm and resection of the left atrial appendage. further investigation would be required to assess the efficacy and safety of novel oral anticoagulants such as edoxaban compared to that of warfarin for stroke prevention during the early postoperative period (6 months) after a thoracoscopic procedure. the need to maintain a constant level of blood coagulation and the potential development of complications such as hemorrhages are drawbacks associated with the use of warfarin. while novel oral anticoagulants such as edoxaban do have a role in atrial fibrillation, data regarding their effectiveness and incidence of complications after arrhythmia surgery do not exist. in this study, we will compare warfarin and edoxaban with respect to safety and efficacy, after they are used for 6 months following thoracoscopic ablation in patients with chronic atrial fibrillation

Eligibility criteria:
inclusion criteria: 1. patients aged 18 years or older (not exceed 80 years old). 2. elective thoracoscopic ablation. 3. presence of atrial fibrillation (paroxysmal, persistent, long-standing persistent). exclusion criteria: 1. chronic obstructive pulmonary disease (copd). 2. history of pulmonary tuberculosis. 3. other cardiac comorbidities including valvular disease, coronary artery disease. 4. congenital heart anomalies except for atrial septal defect. 5. known, clinically important anemia or thrombocytopenia. 6. pregnancy or lactation. 7. malignancy. 8. intracardiac mass or thrombus 9. life expectancy less than 1 year.

Keywords: atrial fibrillation thoracoscopic ablation anticoagulation
turbinate cauterization in pediatric patients with nasal obstruction

Conditions: Sleep Apnea; Nasal Obstruction

Summary: patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and tonsillectomy. it will compare the amount of nasal congestion for each group with the idea that it will be less if treated with turbinate cauterization. assessments from baseline to 6 months post procedure will be compared between the two groups.

to assess if inferior turbinate cautery improves nasal obstruction in children undergoing adenotonsillectomy.

Eligibility criteria:
inclusion criteria: * ages 3-16 * obstructive sleep apnea warranting adenotonsillectomy * history of daytime nasal obstruction and or mouth breathing * failed medical treatment with either oral anti-histamine or nasal steroid spray. * turbinate hypertrophy on physical exam defined by \>50% obstruction exclusion criteria: * \ 16 * unwillingness to comply with study procedures * congenital head and neck malformations, genetic syndromes, craniofacial anomalies * no evidence of turbinate hypertrophy or symptoms of nasal obstruction * pregnancy or breastfeeding * bleeding disorders * current therapy with coumadin or pradaxa

Keywords: nasal obstruction
improving mental health among the lgbtq+ community

Conditions: Anxiety; Depression

Summary: the overall aim of this program of research is to improve the mental health of people who identify as lgbtq+ by increasing their social support through a brief intervention. the purpose of the proposed project is to establish the effectiveness of our empirically-supported, brief acceptance-based behavioral therapy (abbt). to achieve the specific aims, the investigators will conduct a fully-powered, randomized clinical trial (n=240) with two treatment arms: treatment-as-usual (tau) vs. abbt.

during the covid-19 pandemic, up to 81% of adults in the united states experienced worsening mental health. a major cause was the social isolation triggered by the pandemic due to quarantining, loss of family or friends, and loss of work. for individuals who lost social connections or were unable to adapt to maintain their connections, social support decreased and loneliness worsened, putting them at much higher risk for anxiety and depressive symptoms. importantly, people who identify as lgbtq+ have been particularly affected by the social isolation caused by the pandemic and were already at much higher risk of social isolation, loneliness, and mental illness, including suicidality, before the pandemic. the objective of this r01 fully-powered trial is to examine the effectiveness of a brief acceptance-based behavioral telehealth intervention (abbt) to improve mental health during the covid-19 pandemic by strengthening social support among lgbtq+ individuals. the aims of this proposal are: (1) to examine the effectiveness of abbt in reducing mental health morbidity by conducting a fully-powered, rct (n=240) of abbt vs. treatment-as-usual; and, (2) to examine potential mediators and moderators of abbt treatment effects. primary outcomes will be anxiety and depressive symptoms.

Eligibility criteria:
inclusion criteria: * present to recruitment clinic for any type of clinical care * identify as lgbtq+ * self-reported ≥ mild anxiety and/or depressive symptoms, based on the gad-7 and phq-9 * 18 years or older * ability to speak and read english exclusion criteria: * none

Keywords: anxiety depression lgbtq+ covid-19 brief intervention social support acceptance-based behavior therapy
phase 3 papulopustular rosacea study

Conditions: Papulopustular Rosacea

Summary: the purpose of this study is to demonstrate that cd5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with papulopustular rosacea (ppr) and continues to be safe up to 12 months.


Eligibility criteria:
inclusion criteria: 1. the subject has papulopustular rosacea with an investigator global assessment (iga) score rated 3 (moderate) or 4 (severe), 2. the subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face. exclusion criteria: 1. the subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne, 2. the subject has rosacea with more than two nodules on the face.

Keywords: ppr
an efficacy and safety study of rivaroxaban with warfarin for the prevention of stroke and non-central nervous system systemic embolism in patients with non-valvular atrial fibrillation

Conditions: Atrial Fibrillation; Stroke; Embolism

Summary: the purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).

patients with non-valvular atrial fibrillation who are at risk for stroke and non-central nervous system (non-cns) systemic embolism, will be randomized (assigned by chance) to receive treatment with rivaroxaban or warfarin, two different anticoagulants (substances that prevent blood clots). treatment will be double-blinded (neither the patient nor study staff will know which study drug is assigned to patients during the study). patients assigned to rivaroxaban will receive rivaroxaban 20 mg orally (p.o.) once daily (od) plus warfarin placebo p.o. od titrated to a target sham international normalized ratio (inr) of 2.5. patients with moderate renal impairment at screening will receive rivaroxaban 15 mg p.o. od. patients assigned to warfarin will receive warfarin p.o. od titrated to a target inr of 2.5 plus rivaroxaban placebo p.o. od. the maximum expected length of treatment is up to 32 months but may be extended up to 4 years.

Eligibility criteria:
inclusion criteria: * patients must have documented atrial fibrillation on 2 separate occasions within 6 months before screening * history of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus exclusion criteria: * significant mitral stenosis * transient atrial fibrillation caused by a reversible disorder * active internal bleeding * severe disabling stroke * history of intracranial bleeding * hemorrhagic disorders

Keywords: atrial fibrillation stroke embolism non-central nervous system systemic embolism non-valvular atrial fibrillation blood clot rivaroxaban warfarin anticoagulants arrhythmias, cardiac
short-term existential behavioural therapy for informal caregivers of palliative patients: a randomised controlled trial

Conditions: Depression

Summary: the purpose of the study is to test the effectiveness of a short-term manualised individual psychotherapy, called existential behavioural therapy (ebt), to prevent depression in informal caregivers of palliative patients.

the investigators have developed and pilot-tested a short-term manualised individual psychotherapy, called existential behavioural therapy (ebt), to reduce psychological distress in informal caregivers of palliative patients. the investigators propose to conduct a two-arm randomised controlled trial (rct) to test the effectiveness of ebt against usual care for the reduction of distress and the promotion of quality of life. two one-to-one manualised psychotherapeutic sessions will be compared to a treatment-as-usual control group.treatment-as-usual includes two supportive sessions. the design will be an unblinded rct consisting of two conditions (ebt and treatment-as-usual), with assessment at pre- and post-treatment and follow-ups at four weeks and six months. the trial will take place in the clinic of palliative care, university of munich (klinik und poliklinik für palliativmedizin der lmu münchen).

Eligibility criteria:
inclusion criteria: * ≥ 21 years of age * informal caregivers of palliative patients at last stage of life and during bereavement; * fluent german language skills exclusion criteria: * psychiatric conditions such as schizophrenic disorder, psychotic disorder etc.; * pronounced cognitive impairment e.g. delirium, dementia

Keywords: informal caregivers mental stress quality of life psychotherapeutic intervention
healing effects of rebamipide and omeprazole in helicobacter pylori-positive gastric ulcer after eradication therapy

Conditions: Stomach Ulcer

Summary: the purpose of this study is to evaluate the ulcer healing efficacy of rebamipide in comparison with omeprazole in helicobacter pylori-positive gastric ulcer after eradication therapy.

this study is designed to evaluate the ulcer healing efficacy of rebamipide administered following the eradication therapy in comparison with the well known ppi, omeprazole. this is a double-blind, comparative study which is expected to prove the role of rebamipide in gastric ulcer healing after the eradication therapy. this study may contribute to further clinical research on a new type of ulcer treatment by looking at the treatment modality based on the enhancement of defensive factors.

Eligibility criteria:
inclusion criteria: * patients aged 20 or older at the time of writing the informed consent * h. pylori-positive patient. * patients who are diagnosed with gastric ulcer by endoscopy and have the following ulcer characteristics; non-scarring ulcer (stage a1, a2, h1, h2 according to the sakita-miwa classification), single ulcer, ulcer size of 5 to 20mm in diameter exclusion criteria: * patients who previously underwent h. pylori eradication therapy * malignant gastric ulcer * linear ulcer * patients with history of upper gi tract resection or vagotomy * patients with continuous nsaids use within 4 weeks prior to study initiation * patients with ulcer complications including perforation or pyloric stenosis * gastric ulcer prone to bleeding (e.g. exposed blood vessels at ulcer base) * patients with infectious mononucleosis * patients with known hypersensitivity to penicillin, clarithromycin, omeprazole, amoxicillin or rebamipide * patients on medications such as terfenadine or pimozide which are contraindicated with clarithromycin usage * pregnant or possibly pregnant women, lactating women, or those with a plan to conceive during this study * blood test results of hb ≤ 8.0 g/dl, platelet ≤50,000 /㎕, total wbc ≤ 4000/㎕ or ≥ 10,000/㎕, and with serum test results showing the levels of ast, alt, alp, ldh, bun, and creatinine exceeding twice the normal range of respective institution. * other patients deemed not eligible for this study by investigators

Keywords: helicobacter pylori stomach ulcer rebamipide omeprazole
implantoplasty as adjunct to combined surgical therapy of peri-implantitis

Conditions: Peri-Implantitis

Summary: implantoplasty entails polishing of the implant surface during the surgical therapy of peri-implantitis. given the controversy behind implantoplasty as surface decontamination method in the treatment of peri-implantitis, the goal of this clinical trial is to assess the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (inteross® + autogenous bone, sigmagraft, ca, usa) + implantoplasty in combined defects when compared to the extent of implantoplasty along the exposed implant surface upon the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (inteross® + autogenous bone, sigmagraft, ca, usa).


Eligibility criteria:
inclusion criteria * all patients in age of 18 to 80, non-smokers * with no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease. * peri-implantitis defined according to the efp/aap consensus meeting * combined defect configuration exclusion criteria: * pregnancy or lactation * history of or current smokers * uncontrolled medical conditions, * cement-retained restoration * lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.
rewards- in-stent restenosis

Conditions: In-Stent Coronary Artery Restenosis

Summary: to define the long-term incidence and frequency of isr follow des implantation. compare the clinical presentation, treatment and intervention success among de novo coronary artery stenosis and des isr. compare short- and long-term outcomes of de novo coronary artery stenosis and des isr, assessed by incidence of mortality, mace, mi, and tlr/tvr at index hospitalization, 30 days, 6 months, 1 year, 3 years, and 5 years, if available.

drug-eluting coronary stents (des) significantly reduced the rate of neointimal hyperplasia and in-stent restenosis (isr) compared to bare metal stents (bms) for the treatment of coronary artery disease. in addition, the continued evolution in scaffold and polymer design with concomitant improvements in antiplatelet therapy has improved the rates of late and very late stent thrombosis. however, despite novel metal scaffold technology, increasing operator experience, and improvement in adjunctive implantation techniques, the incidence of isr in durable-polymer des remains a problem, with 1-year rates as high as 12 to 15%. the outcomes associated with isr highlight the fact that this is by no means a benign process and studies report mi rates as high as 19.4% with one study demonstrating a total rate of death or nonfatal mi of 3.5%. in addition, isr presenting as acute coronary syndrome (acs) has an independent effect on major adverse cardiac events. the emergence of fully bioresorbable vascular scaffolds (bvs) has provided an exciting alternative to combat the long-term structural and functional effects on the coronary vessel seen with implantation of a permanent metal scaffold, regardless of the drug coating. initial studies have demonstrated the non-inferiority of bvs compared to contemporary des in regards to death, mi, and mace. in addition, intravascular imaging has confirmed complete resorbtion of the bvs by 3 years time. the long-term benefits of such technology have yet to be fully assessed. however, based on literature outlining the complicated course of isr in short-term and that seen in the bare metal stent era, it is projected that complete resorbtion of the vascular scaffold should improve long-term outcomes of patients with ischemic heart disease. currently, the clinical presentation, incidence, and outcomes of isr in contemporary des are not completely understood. the goal of this particular study is to retrospectively evaluate the long-term impact of isr over a 10-year period in current contemporary des. the data can be compared to de novo coronary artery lesions with similar characteristics and complexity to highlight the significant differences in the clinical course of each disease. ultimately, the investigators will hopefully demonstrate the need for improvement in this arena, which the bvs will potentially provide.

Eligibility criteria:
inclusion criteria: * patients, male or female, \> 18 years of age, * patients who received at least one (1) commercially available drug eluting stent exclusion criteria: none
evaluation of the omnyx™ integrated digital pathology system in the primary diagnosis of surgical pathology specimens

Conditions: Primary Diagnosis of Surgical Pathology Specimens

Summary: a multi-site, randomized-read order, retrospective, paired-design evaluation of the omnyx™ integrated digital pathology (idp) system with de-identified and previously signed-out cases from all major organ systems. pathologist will read and diagnose cases on a conventional light microscope and on the omnyx™ idp system for whole slide images (wsi) with a randomized read order. college of american pathologists (cap) cancer protocol checklists will be used to capture diagnostic reporting. diagnoses rendered by site reading pathologists will be captured on cap checklists and compared directly to the ground truth (gt) diagnosis for both modalities.

following the fda issued guidance document, "informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable"- 2006, the specimens are surgical pathology samples from leftover human specimens from clinical cases, archived and previously signed-out across the majority of surgical pathology subspecialties

Eligibility criteria:
inclusion criteria: • all surgical pathology samples from pre-identified list provided by fda exclusion criteria: * gross evaluation only specimens (including hardware and specimens that do not require microscopic review for diagnosis) * immunofluorescence specimens * fluid-based specimens * intraoperative consultation specimens only (frozen preparation) * specimens from which a slide(s) fails quality control according to user manuals and training and issue(s) cannot be remediated at the time of procurement and over-labeling; this includes having too many labels such that slide damage or scanner failure is likely (as outlined in omnyx user manuals). * specimens for which any slide (other than a blank) that should be in the case part cannot be located
multi-institutional registry for prostate cancer radiosurgery

Conditions: Prostate Cancer Early Risk Treated by Radiosurgery; Prostate Cancer Intermediate Risk Treated by Radiosurgery

Summary: to address pertinent questions regarding the utilization of stereotactic body radiotherapy (sbrt) to treat prostate cancer. the florida robotic radiosurgery association (frra) launched the first registry for prostate cancer patients treated with sbrt. the registry is designed to track surrogate treatment endpoints including prostate specific antigen (psa), international prostate symptom score (ipss),sexual health in men (shim), and visual analogue scale (vas) scores, in addition to physical and survival data. utilizing an independent vendor (advertek, inc.) experienced with the design and implementation of similar electronic registries, frra developed a data collection tool that staff members with a basic medical background can use to register and upload pertinent patient data, requiring no more than 20 to 30 minutes per patient. participating patients will be monitored in follow-up for three years, with analysis and publication of the results semi-annually.

to address pertinent questions regarding the utilization of radiosurgery (sbrt) to treat prostate cancer. the florida robotic radiosurgery association (frra) launched the first registry for prostate cancer patients treated with sbrt. the registry is designed to track surrogate treatment endpoints including psa, ipss, shim, qol, karnofsky performance status, vas scores, urine and bowel health, in addition to physical and survival data. utilizing an independent vendor (advertek, inc.) experienced with the design and implementation of similar electronic registries. frra developed a data collection tool that staff members with a basic medical background can use to register and upload pertinent patient data requiring no more than 20 to 30 minutes per patient. participating patients will be monitored in follow-up for three years, with analysis and publication of the results semi-annually.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of prostate cancer * early or intermediate risk exclusion criteria: * high risk prostate cancer

Keywords: radiosurgery prostate cancer early intermediate cyberknife
sulfonylurea add-on study in patients with type 2 diabetes mellitus (0431-035)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus with inadequate glycemic control exclusion criteria: * patients with type 1 diabetes mellitus