Kornimate/medical-research-clean huggingface dataset:
study of treatment for opioid dependence and anxiety disorders

Conditions: Anxiety Disorders; Opiate Addiction

Summary: anxiety is highly prevalent among individuals with opioid dependence and confers greater risk for continued opioid use and poor treatment outcomes. however, there are currently no efficacious treatments available for co-occurring opioid dependence and anxiety. the ultimate aims of this trial are the development and testing of a novel integrated cognitive behavioral treatment (i-cbt) for co-occurring opioid dependence and anxiety disorders. this clinical trial consists of two phases: (1) open-trial pilot (2) randomized control trial. we hypothesize that i-cbt will be a feasible and acceptable treatment that will result in significant reductions in anxiety and opioid use.

this stage 1 behavioral treatment development trial involves two stages: manual development and pilot testing in an open trial, and a small randomized controlled trial. in both phases, opioid use and anxiety symptoms will be measured as the primary clinical outcome, along with measures of feasibility and patient satisfaction. these results will be used to further refine the treatment manual and to evaluate whether this treatment may enhance outcomes for adults with co-occurring opioid dependence and anxiety disorders.

Eligibility criteria:
inclusion criteria: * age 18 or older * meet current diagnostic and statistical manual of mental disorders 5th edition diagnostic criteria for opioid use disorder * currently prescribed pharmacotherapy for opioid dependence * have used opioids illicitly within the previous 90 days * clinically-significant anxiety * meet current diagnostic criteria for a diagnostic and statistical manual of mental disorders 5th edition anxiety disorder * able to read and provide informed consent * intend to remain in the geographical area for the duration of the study period exclusion criteria: * meet criteria for a current substance use or psychiatric disorder requiring a level of care higher than outpatient * currently receiving cognitive behavioral therapy * recent initiation of a psychiatric medication, defined as less than 4 weeks on a stable dose; not including prn medications for sleep * are receiving and taking an as-needed (prn) prescription for benzodiazepines * presence of a psychiatric or medical condition that would interfere with participation or that requires additional care (e.g. psychosis, acute suicidality) * were admitted to mclean hospital for their current treatment episode on an involuntary status
vr-assisted cbt for adolescents with psychosis

Conditions: Psychotic Disorders

Summary: psychotic disorders typically emerge during late adolescence or early adulthood. patients, who are diagnosed with a psychotic disorder before turning 18 years, are defined as early onset psychosis patients (eop). relative to adult patients, these patients show a worse long-term prognoses. social impairment present a major barrier towards recovery, and thus and important issue to address in treatment. cognitive behavioral therapy (cbt) is the recommended psychological treatment for psychotic disorders. as part of the therapy, the patient does an exposure-based training in a social environment. this type of training has several limitations for patients with psychosis. the last decade there has been a growing interest in using virtual reality (vr) to understand and treat various psychological disorders. there is a lack of research on vr-interventions for eop patients. this study will assess the acceptability, tolerability, feasibility and clinical efficacy of a novel vr-assisted cbt interventions for adolescents with psychosis.

this study adhere to the model for research made by the international virtual reality clinical outcomes research experts groups (vr-core). the study consist of three sub-studies. first a qualitative study assessing the acceptability for vr among adolescence with psychosis. secondly, a randomized study of the feasibility of virtual reality environment for adolescents with psychosis. third, assessing the clinical efficacy of a novel vr-assisted cbt interventions for adolescents with psychosis, through a non-randomized single-case study.

Eligibility criteria:
inclusion criteria: * suffering from a psychotic disorder (icd-10 who) * in stable clinical condition (i.e. not hospitalized) * being able to speak norwegian or a scandinavian language, or english * able to provide informed consent. exclusion criteria: * primary neurological or endocrinological disorder * started a "transfer-process" to department of adult psychiatry.

Keywords: psychosis adolescents virtual reality treatment cognitive behavioural therapy early onset psychosis vr-assisted therapy
a study on pigmentation disorders in children

Conditions: Hyperpigmentation; Pediatric Dermatology

Summary: the descriptive cross-sectional study was undertaken at kanti children's hospital during the period from january 2020 to june 2021. ethical approval for the study was obtained from the institutional review board of kanti children's hospital (irb-kch). the refence number is 59/2020-021. the study focused on children with hyperpigmentation disorders presenting at the dermatology outpatient department of kanti children's hospital.


Eligibility criteria:
inclusion criteria: * children ranging from newborns to 15 years old with hyperpigmentation due to any cause exclusion criteria: * children admitted to wards

Keywords: hyperpigmentation disorders nepal pediatric observational study
fluocinolone acetonide implant compared to sham injection in patients with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.


Eligibility criteria:
inclusion criteria: * age \>= 18 years with diabetic macular edema * diagnosis of diabetes mellitus types 1 or 2 * best corrected visual acuity of 19-68 letters * retinal thickness \> 250 micron by oct * investigator is comfortable deferring macular laser treatment for 6 weeks exclusion criteria: * glaucoma, ocular hypertension, iop \>21 mmhg or concurrent therapy at screening with iop lowering agents * retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy * prior intravitreal, subtenon, or periocular steroid therapy within 6 months * any ocular surgery within the last 3 months * retinal laser treatment within the last 3 months * history of uncontrolled iop elevation with steroid use that did not respond to topical therapy * any lens opacity which impairs visualization of the posterior pole
ischemic postconditioning in cardiac surgery

Conditions: Cardiac Surgery

Summary: ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven both in animal models and in humans. this study aims to investigate the effect of ischemic postconditioning on postoperative hemodynamic function in a standard heart surgery patient population.

ischemic postconditioning is studied using cardiopulmonary bypass (cpb) and moderate hypothermia (32-34°c) in a patient population undergoing surgery of the aortic valve (repair/replacement ) or the ascending aorta. postconditioning is applied by introducing reperfusion/ischemia via the cardioplegia line while the aorta is still cross-clamped thereby preventing the risk of additional neurological complications. all patients \> 20 years eligible for aortic or aortic valve surgery and not affected by exclusion criteria, will be included. the study is carried out as a randomised controlled multicenter study including 5-6 heart surgery centers.

Eligibility criteria:
inclusion criteria: patients undergoing elective surgery of the ascending aorta or the aortic valve - exclusion criteria: * coronary artery disease requiring bypass surgery * tricuspid valve surgery * mitral valve surgery * atrial fibrillation (permanent or paroxysmal with or without concomitant ablation procedure) * patients on per oral or parenteral steroid therapy (inhalational steroids are allowed) * patients with autoimmune diseases * "redo" operations * active endocarditis (ongoing antibiotic therapy) * on the discretion of the operating surgeon or anaesthesiologist

Keywords: ischemic postconditioning adult cardiac surgery aortic valve surgery swan-ganz cardiac index
effect of dexmedetomidine on perfusion index and microcirculation in severe sepsis and septic shock patients

Conditions: Septic Shock

Summary: septic shock is one of the major causes of death worldwide with in-hospital mortality rates varying between (11.9% to 47.2 %). alterations in microcirculatory blood flow were associated with high risk of organ dysfunction and death. experimental studies on septic rats revealed that dexmedetomidine treatment can effectively reduce the generation of inflammatory mediators and yields beneficial effects on endotoxemic animals' microcirculation.

prospective randomized double blinded study. investigators planned to enroll (40 cases diagnosed with severe sepsis and/or septic shock ) admitted in 50-bed trauma and surgical icu cairo university hospital. demographic data, cause of icu admission, source of sepsis, apache ii score, sofa score 24 hours after admission. microcirculatory variables (mfi), peripheral perfusion (pi) and metabolic variables will be measured before drugs administrations and at 2, 4, 6, 24 hours thereafter. the total dose of the infused drugs, the requirement of vasopressor will be evaluated as yes/no and total dose of vasopressor will be calculated.

Eligibility criteria:
inclusion criteria: * age more than 18 years old * all mechanically ventilated patients who will be clinically suspected of having severe sepsis/septic shock defined by the criteria of the american college of chest physicians/ society of critical care medicine consensus conference exclusion criteria: * age \< 18 years old * pregnant patient * acute hepatitis or severe liver disease (child-pugh class c) * left ventricular ejection fraction less than 30% * heart rate less than 50 beats/min * second or third degree heart block * systolic pressure \< 90 mmhg despite of infusion of 2 vasopressors
efficacy and safety of garamycin® sponge in diabetic patients with a moderate or severe foot ulcer infection

Conditions: Diabetic Foot Ulcer

Summary: the purpose of this study is to determine whether garamycin sponge (gentamicin-collagen sponge) in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections.

infected skin ulcers with diabetes can be very debilitating because they are difficult to heal. diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. early aggressive treatment is necessary to treat infection and ultimately prevent the need for amputation. gentamicin is an antibiotic that is effective in treating certain kinds of infection. collagen is a protein that is found in all mammals. the gentamicin sponge being used in this study is commercially available in switzerland as garamycin® sponge. the garamycin sponge is a thin flat sponge made out of collagen that comes from bovine tendons and containing gentamicin. when applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. the high levels of gentamicin in the open infected ulcer may help treat the infection. all subjects will be given the necessary supplies and taught how to take care their foot ulcer. all subjects will also receive oral an antibiotic. additionally, subjects who are randomly assigned to receive the gentamicin-collagen sponge will place a gentamicin-collagen sponge on their ulcer during daily wound care.

Eligibility criteria:
inclusion criteria: * is aged ≥ 18. * has diabetes mellitus, according to the american diabetes association (ada) criteria. * has an open foot wound with visible inflammation, namely at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the infectious disease society of america (idsa). * has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis * meets certain minimal laboratory criteria. exclusion criteria: * has an ulcer infection which, based upon the patient's known history of hypersensitivity cannot be appropriately treated with at least one of the empiric systemic antibiotic regimens per protocol. * has received \> 48 hours of potentially effective antibiotic therapy and the wounds are clinically improving. if a patient has received an antibiotic within 72 hours, but is not improving or deep-tissue culture results indicate that the infecting pathogen is not susceptible to that antibiotic, the patient may be enrolled. * requires or is likely to require treatment with any concomitant topical product or wound therapy during the study period.
occluder size determination in transcatheter asd ii closure based on 3d tee assessment

Conditions: Ostium Secundum Atrial Septal Defect

Summary: the aim of this study is to determine whether three-dimensional tranesophageal echocardiography (3d tee) assessment of ostium secundum atrial septal defect (asd ii) may be as efficient as two-dimensional (2d) tee assessment complemented by the balloon-sizing during transcatheter closure of the defect.

a total of 50 consecutive patients eligible to percutaneous asd ii closure will be enrolled in the study. 3d-tee will be performed in the diagnostic process; the images will be recorded for further investigation, however, measurments of the defect will not be taken until after the procedure. traditional 2d-tee together with balloon-sizing assessment of the defect will be performed in enrolled patients in order to chose a device. control transthoracic echocardiography (tte) will be provided twice to evaluate the outcome of transcatheter treatment: 1 day after the procedure and 6-12 months later. the previously obtained 3d images will be retrospectively assessed by 2 independent investigators excluded from the interventionalists' team. maximum and minimum diameter, perimeter and area of the defect will be measured to propose the assumed optimal occluder size. correlation between proposed occluder size and the device used during the procedure will be statistically analyzed.

Eligibility criteria:
inclusion criteria: * asd ii suitable for percutaneous treatment * free and informed consent to analyze the medical data of the person concerned * age: patients over 16 exclusion criteria: * asd ii not suitable for percutaneous treatment * any valvular heart disease requiring cardiac surgery * no free and informed consent to analyze the medical data of the person concerned * age: under 16

Keywords: asd ii transcatheter closure percutaneous closure 3d tee balloon-sizing
anticoagulant after implantation of biological aortic valve comparing with aspirin

Conditions: Thromboembolism; Bleeding

Summary: the optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (bavr) remains controversial. the aim of this trial was to compare warfarin therapy (target inr of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after bavr with or without concomitant coronary artery bypass grafting (cabg). the aim was to evaluate thromboembolic complications, bleeding complications and death.


Eligibility criteria:
inclusion criteria: * patients with aortic valve disease where there is indication for implantation of a biological stented aortic valve with or without coronary bypass surgery. * age 60 years sinus rhythm exclusion criteria: * patients planned for double valve surgery * patients with active endocarditis * patients with atrial fibrillation/flutter * patients in anticoagulation treatment of other reason. * patients with previous cerebrovascular accidents or insults. * patients with tci * patients with hypercoagulable conditions, disseminated intervascular coagulation, haemophilia or any other blood coagulapathy or related condition, whereby the blood coagulation process is not readily controllable * patients with pacemaker * any other disease than valve disease that will considerably increase the operative risk and increase the probability that the patient dies within one year after the operation, for example because of terminal cancer * patients that is hiv-positive or have active aids * patients that are known drug abuser * patients in chronic haemodialysis or other types of dialysis

Keywords: thromboembolic complications bleeding complications haemorrhagic complications anticoagulant therapy aspirin biological aorta valve
polish transcatheter aortic valve-in-valve implantation (viv-tavi) registry

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency; Ventricular Outflow Obstruction, Left

Summary: in the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.this indicates that population with failed surgical bioprostheses requiring viv-tavi will grow significantly and therefore, meticulous prospective data collection is necessary for future analyses in order to better understand potential limitations of this procedure.

the study is a prospective multicenter evaluation of transcatheter aortic valve-in-valve implantations in polish health centers. duration of this study is expected to be 6 years to ensure that all of the enrolled patients will complete at least 2 years of follow-up.

Eligibility criteria:
inclusion criteria: * failing surgically implanted aortic bioprosthetic valve (stented/stentless/homograft) demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency * qualification for tavi by decision of the local heart team * patient provided written informed consent

Keywords: tavi valve-in-valve aortic stenosis
a study of ro5217790 in participants with high grade cervical intraepithelial neoplasia (cin) associated with high risk human papillomavirus (hr-hpv) infection

Conditions: Cervical Intraepithelial Neoplasia

Summary: this randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of ro5217790 on histologic resolution in participants with high grade cin associated with hr-hpv infection. participants will be randomized to receive 3 subcutaneous injections of either placebo or ro5217790 on days 1, 8, and 15. study assessments will be made at baseline, at month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.


Eligibility criteria:
inclusion criteria: * have a diagnosis within 2 months prior to the first dose of ro5217790 of cin 2/3 confirmed by colposcopy-directed punch biopsy; patients must have at least 1 quadrant of residual cin2/3 disease remaining after biopsy. entry to the trial will be allowed based on the local assessment of this criterion; however, cin 2/3 diagnosis will have to be confirmed by the central pathologist for the purposes of analyzing the study * have satisfactory colposcopy, i.e. the entire acetowhite or disease area as well as the entire squamocolumnar junction visualized by colposcopy * have detection at screening of a single or multiple hr-hpv infection by analysis of liquid based cytology (lbc) material on the roche linear array assay consistent with any of the trial strata as specified in study protocol exclusion criteria: * have colposcopically visible cin2/3 disease extending over more than 2 quadrants * have any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the transformation zone and surveillance of cin. if an endocervical curettage (ecc) is performed, and the endocervical curettings reveal cin, patients are eligible as long as the endocervical lesion is directly extending from the primary lesion and is colposcopically visible in its entirety * have vulvar (vin) or vaginal (vain) intraepithelial neoplasia * have atypical endometrial or glandular cells or evidence of carcinoma on biopsy * have a serious, concomitant disorder, including active systemic infection requiring treatment * have a prior history of or current malignancy other than adequately treated skin cancer (squamous cell cancer or basal cell carcinoma), unless the history of skin cancer is at the site of study treatment administration * have a proven or suspected immunosuppressive disorder or autoimmune disease * have any significant cardiac, hepatic or renal disease * have active viral infections including human immunodeficiency virus (hiv), hepatitis c virus (hcv), hepatitis b virus (hbv), cytomegalovirus (cmv), and epstein barr virus (ebv) within 30 days of receiving study treatment. mild viral infections such as herpes simplex virus 1 (hsv-1) or common cold are not excluded

Keywords: cervical intraepithelial neoplasia ro5217790
screening for inherited heart disease

Conditions: Heart Disease; Hypertrophic Cardiomyopathy

Summary: genetically inherited heart diseases like hypertrophic cardiomyopathy (hcm) are conditions affecting the heart passed on to family members by abnormalities in genetic information. these conditions are responsible for many heart related deaths and illnesses. presently, there are several research studies being conducted in order to improve the understanding of disease processes and symptoms associated with genetically inherited heart diseases. this study is designed to determine the eligibility of patients diagnosed with or suspected to have inherited heart disease to participate in these research studies.

patients with hypertrophic cardiomyopathy (hcm) and other inherited cardiac diseases are being studied under several research protocols to determine their pathogenesis and clinical manifestations. the purpose of this protocol is to determine the eligibility of patients with known or suspected inherited heart conditions for our research protocols.

Eligibility criteria:
inclusion criteria subjects and family members known or suspected to have inherited a cardiac disease such as hcm. exclusion criteria patients with cardiac conditions that are not known to be inherited.

Keywords: hypertrophic cardiomyopathy hcm evaluation for research medical advice