Kornimate/medical-research-clean huggingface dataset:
personalized antisense oligonucleotide therapy for a single participant with chchd10 als

Conditions: Amyotrophic Lateral Sclerosis

Summary: this research project entails delivery of a personalized antisense oligonucleotide (aso) drug designed for a single participant with amyotrophic lateral sclerosis (als) due to a pathogenic variant in chchd10

this is an interventional study to evaluate the safety and efficacy of treatment with an individualized antisense oligonucleotide (aso) treatment in a single participant with amyotrophic lateral sclerosis (als) due to a pathogenic variant in chchd10

Eligibility criteria:
inclusion criteria: * informed consent/assent provided by the participant (when appropriate), and/or participant's parent(s) or legally authorized representative(s). * ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records. * genetically confirmed neurological disorder. exclusion criteria: * participant has any condition that in the opinion of the site investigator, would ultimately prevent the completion of study procedures. * use of an investigational medication within less than 5 half-lives of the drug at enrollment
exposure, relaxation, & rescripting therapy-child

Conditions: Post Trauma Nightmares; Traumatic Stress

Summary: the study implements a trauma-related nightmare treatment for children aged 8 to 13 years. relevant outcome progress and outcome measures on symptoms, nightmare distress and duration, academic indicators, and sleep quality will be examined.

untreated trauma-related nightmares and sleep-related disorders are associated with chronic health problems, burdening both the suffering individual and the health-care system. the study implements an innovative, cost-efficient, nightmare treatment for trauma-exposed children. it is one of the first randomized clinical trials with children, adapting an efficacious adult therapy to a 5-session nightmare treatment for 8-13 year-olds. trauma nightmares are a mechanism in development and maintenance of secondary post-trauma psychopathology, medical problems, and family dysfunction. therefore, this treatment may prevent long-term secondary health and behavioral problems. it provides a viable health care option to montanans, lessening long-term financial, medical, and behavioral health expenses. scientific models currently view ptsd treatment as primary, often leaving nightmares untreated. that approach does not address the pernicious impact of trauma-nightmares in individuals with sub-threshold ptsd or whose nightmares are a primary condition. the theoretical innovation of this therapy can advance the field's understanding of the development of trauma sequelae.

Eligibility criteria:
inclusion criteria: * children age 8-13 with ptsd criterion a event as defined by the dsm-iv and nightmares occurring at least once per week over a minimum of one month * have a parent or legal guardian who is able to participate in treatment assignments at home and be able to read and speak english exclusion criteria: * adult, no traumatic experience, no nightmares, apparent psychosis, pervasive developmental disorder, or mental retardation, not able to read and speak english

Keywords: nightmare ptsd trauma children children age 8 to 13
endovascular embolization of chronic subdural hematomas after surgery

Conditions: Chronic Subdural Hematoma

Summary: chronic subdural hematomas (csh) are one of the most frequent pathologies in emergency neurosurgical practice. standard therapy for symptomatic csh is surgical drainage. however, the recurrence rate after surgery is high (10 to 20% in the most of series, although it has been reported from 2 to 37%). middle meningeal artery embolization (mmae) is a promising minimally invasive procedure that has recently been proposed as an alternative or adjunctive treatment to surgery. the investigators hypothesize that early post operative endovascular treatment can reduce the recurrence rate in high-risk patients, improving neurological outcomes by reducing the need for reinterventions, hospitalizations, and post-operative complications. the aim of the investigators is to analyze the efficacy of and safety of early post-surgical embolization of mma in reducing the risk of csh recurrence.

the study was designed as an open-label, multicenter randomized trial involving patients with symptomatic csh and surgical evacuation criteria. patients will be randomized in a 1: 1 ratio to receive surgical drainage (the standard of care) or surgical drainage plus early endovascular embolization of mma (\< 72 hours after surgery). endovascular procedures will be performed with non-adhesive embolizing fluids. the primary outcome will be the recurrence of csh at 6 months and secondary outcomes will be the risk reduction of recurrence in patients with risk factors, functional status measured by the modified rankin scale (range, 0 \[no disability\] to 6 \[death\]) at 6 months and complications related to endovascular procedure.

Eligibility criteria:
inclusion criteria: * chronic subdural hematoma equal or greater than 10 mm, midline shift equal or greater than 5 mm or neurological symptoms attributable to mass effect. * recent diagnosis or recurrence * surgical treatment performed \< 72 hours * informed consent signed by the patient or they responsible family member exclusion criteria: * advanced disease with life expectancy \< 6 months * condition that contraindicated endovascular procedure: pregnancy, renal failure defined as creatinine clearence \< 30 ml/min, allergy to iodinated contrast. * unavailability for follow up st 6 months * patient expressly refuses treatment

Keywords: middle meningeal artery embolization
pompe gene therapy- screening for eligibility

Conditions: Pompe Disease (Late-onset)

Summary: the purpose of this study is to determine eligibility for the future clinical trial of gene therapy in adults with late-onset pompe disease. this screening protocol will enroll up to 20 adults patients (\>=18 yo) with late-onset pompe disease. study assessments include review of medical history, vital signs, physical examination, muscle function testing, lung function testing, blood and urine collection, serum pregnancy test and ecg. the study results will be collected to perform descriptive statistical analysis and used to determine eligibility for the proposed clinical trial of gene therapy in the future.


Eligibility criteria:
inclusion criteria * diagnosis of pompe disease by blood or skin fibroblast gaa assay and two pathogenic variants in the gaa gene. * age: at least 18 years at enrollment. * subjects are capable of giving written consent. * receiving ert at a stable dose for at least 104 weeks. exclusion criteria * any condition that would interfere with participation in the study as determined by the principal investigator. * pregnancy or nursing mothers. * history of active hepatitis b, hepatitis c, or cirrhosis * receiving any investigational agent.
safety and immunogenicity of a commercially available influenza vaccine (formulation 2007/2008) when administered to non elderly and elderly subjects

Conditions: Influenza

Summary: to evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged \> 18 years


Eligibility criteria:
inclusion criteria: * \> 18 years of age or older exclusion criteria: * any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (copd) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days, any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days.no women in breast feeding.

Keywords: adjuvanted influenza vaccine
lus and consequences of high fio2 in children

Conditions: Perioperative/Postoperative Complications

Summary: the purpose of this study is 1. to evaluate effect of high fio2 on the development of intraoperative atelectasis in mechanically ventilated children using lus. 2. to investigate the correlation between lung consolidation score and patient clinical variables including pulmonary mechanics, sao2%, abg, and perioperative respiratory complications.

the who and united states centers for disease control and prevention (cdc) recently recommended the administration of 80% inspired oxygen fraction (fio2) during and immediately after surgery performed with general anesthesia and endotracheal intubation. the recommendation was based on some data suggesting that intra-operative high fio2 reduces incidence of surgical site infections. the dilemma of applying high or low perioperative fio2 arises in daily practice of pediatric anesthesia because children are at increased risk of developing hypoxemia due to their physiological characteristics including smaller functional residual capacity and increased metabolic requirement compared with adult. however, considering that atelectasis occurs in most pediatric patients undergoing general anesthesia, it is important to titrate perioperative level of fio2 to minimize the risk of developing atelectasis and hypoxemia. the use of fio2 80% at induction and emergence, whilst limiting fio2 to 35% during maintenance of anesthesia, may prevent the occurrence of atelectasis and ensure sufficient oxygenation. conversely, the use of fio2 100% at induction and emergence, which is reduced to fio2 80% during maintenance of anesthesia, may increase the margin of safety to avoid hypoxemia. in children, the pulmonary consequences of using high fio2 during general anesthesia have not been fully characterized over the early perioperative period. lus has shown reliable sensitivity and specificity for diagnosis of anesthesia-induced atelectasis in children \[7\]. it can identify children needing a recruitment maneuver to re expand their lung and help optimize ventilator treatment during anesthesia. our hypothesis is that clinical data are necessary to validate the lung sonographic findings of atelectasis and negative consequences of administrating high perioperative oxygen concentration.

Eligibility criteria:
inclusion criteria: * age of 1-6 years. * asa physical status (i-ii). * endotracheal intubation and mechanical ventilation. * elective non-abdominal and non-thoracic surgery * lasting for more than 2 hours. exclusion criteria: * asa classification more than ii * thoracic or abdominal surgery. * pre-existing lung disease. * pre-operative chest infection or abdominal chest us finding. any thoracic deformity patients with cardiac, liver or kidney disease.
cultural competence education given according to the peer education model

Conditions: Culture Shock; Cultural Competence

Summary: the aim of the study is to determine the effect of cultural competence education given according to the peer education model on the cultural competence levels of student nurses.

nursing students will be given cultural competence training (with peer education model) and then the effectiveness of this training will be evaluated.

Eligibility criteria:
inclusion criteria * not receiving training on cultural competence, * participated in cultural competence peer training for the experimental group, * filled out the survey 3 times on the specified dates for the experimental and control groups, * volunteer to participate in the research, * 3rd and 4th year nursing students. exclusion criteria: * receiving training on cultural competence, * not participating in cultural competency peer training for the experimental group, * failure to fill out the survey 3 times on the specified dates for the experimental and control groups, * those who do not volunteer to participate in the research, * 1st and 2nd year nursing students, * students who want to leave the study.

Keywords: cultural knowledge, cultural practice, cultural sensitivity, cultural competence
basiliximab treating interstitial pneumonia of cadm

Conditions: Lung; Disease, Interstitial, With Fibrosis; Dermatomyositis

Summary: this is a 52-week, randomized, open and routine treatment controlled study. this study will assess the safety and efficacy of basiliximab as an add-on treatment for interstitial pneumonia in clinical amyopathic dermatomyositis (cadm) patients. 100 cadm patients are planned to be enrolled in a single center.


Eligibility criteria:
inclusion criteria: * fulfill sontheimer-bohan-peter diagnosis criteria for dermatomyositis. * agreement of contraception. * serum creatine kinase ≤ 1.5 fold of upper normal level. * interstitial pneumonia: (meet at least two in four of following) 1. interstitial pneumonia images in high resolution ct; 2. dlco (diffusing capacity)≤ 60% predict in lung function test; 3. elevated serum kl-6; 4. serum anti-mda5 (+). exclusion criteria: * previous application of immunosuppressives or any target treatment for dermatomyositis. * clinically significant active infection including ongoing and chronic infections history of human immunodeficiency virus (hiv). * confirmed positive tests for hepatitis b or positive test for hepatitis c active tuberculosis. * abnormal renal function at screening (serum creatine\>300μmol/l，or egfr\<60ml/min/1.73m2, or end-stage renal disease). * abnormal liver function test at screening (alt, ast or total bilirubin over 2 fold of upper normal level. * history of any malignancy.
pharmacokinetics and metabolic activation of capecitabine

Conditions: Metastatic Colorectal Cancer

Summary: the objective of this pharmacokinetic study is to exclude a possible influence of cetux on the plasma disposition and metabolic activation of capecitabine (ccb) and when this regimen is given combined with oxaliplatin (oxpt).


Eligibility criteria:
inclusion criteria selected: * signed written informed consent * male or female \> 18 years * k-ras wild type adenocarcinoma of the colon or rectum * metastatic colorectal carcinoma * ecog \<= 2 exclusion criteria selected: * brain metastasis * previous chemotherapy * stage 3 or 4 heart failure * uncontrolled angina * pregnancy or lactation

Keywords: colorectal carcinoma k-ras wild type capecitabine cetuximab oxaliplatin pharmacokinetics exclude a possible influence of cetux plasma disposition metabolic activation ccb oxpt
bladder bank (a prospective banking study)

Conditions: Bladder Carcinoma

Summary: this study collects blood and urine samples from patients with bladder cancer to support the development of tests for early detection of bladder cancer.

primary objective: i. to establish a biobank of samples (blood and urine) to support the development of non-invasive tests for early detection of bladder cancer. outline: this is an observational study. patients undergo blood and urine sample collection and have their medical records reviewed while on study.

Eligibility criteria:
inclusion criteria: * age \&gt; 18 years * patient has undergone office-based evaluation for hematuria \[computed tomography (ct), ultrasound, cystoscopy\] exclusion criteria: * patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible) * patient has recurrent muscle invasive bladder cancer * patient has ever been previously diagnosed with utuc (upper tract urothelial carcinoma) prior to bladder resection * patient has received chemotherapy class drugs for the treatment of non-target origin cancer in the 5 years prior to current collection * patient has had any prior radiation therapy to the target lesion prior to current collection * patient has had a biopsy to the target organ and/or lesion within 3 days before collection * patient has undergone cystectomy or cystoprostatectomy * patient has transurethral instrumentation (placement of urinary catheter) within 7 days prior to urine collection * patient has had a urinary tract infection within 14 days prior to urine collection * patient has chronic indwelling urinary catheter
disrupt cad iii post-approval study (pas)

Conditions: Coronary Artery Disease; Myocardial Infarction

Summary: the study design is a prospective, multicenter, observational, single-arm post-approval study using data collected in the national cardiovascular data registry (ncdr®) cathpci registry®.

subject population: patients ≥18 years of age with severely calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (pci) and with clinical characteristics similar to the disrupt cad iii ide study. approximately 1000 patients in the cathpci registry® (including a minimum of 30 patients with permanent pacemakers \[ppm\] or implantable cardioverter defibrillators \[icds\]) will be enrolled. subjects will be followed through discharge.

Eligibility criteria:
inclusion criteria: 1. subject is ≥18 years of age 2. subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for pci 3. left ventricular ejection fraction \>25% within 6 months 4. the target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure 5. lad, rca or lcx (or of their branches) with: * stenosis of ≥70% and \<100% or * stenosis ≥50% and \<99% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve (ffr) value ≤0.80, or ifr \<0.90 or ivus or oct minimum lumen area ≤4.0 mm² 6. the lesion length must not exceed 40 mm 7. the target vessel must have timi flow 3 at baseline (visually assessed; may be assessed after pre-dilatation) 8. evidence of calcification at the lesion site by angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location exclusion criteria: 1. subject experienced an acute mi (stemi or non-stemi) within 30 days prior to index procedure 2. new york heart association (nyha) class iii or iv heart failure 3. renal failure with serum creatinine \>2.5 mg/dl or chronic dialysis 4. subjects in cardiogenic shock or with clinical evidence of acute heart failure 5. target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft 6. previous stent within target lesion (in-stent restenosis)

Keywords: intravascular lithotripsy percutaneous coronary intervention
diet and plasma cholesterol - secular trend analysis

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Hypercholesterolemia

Summary: to define the role of dietary variables on changes in plasma cholesterol levels over time in the framingham cohort and the framingham offspring cohort.

background: mortality from coronary heart disease has declined over 40 percent since the late 1960s. possible explanations for the decline include the observed trends in risk factors such as changes in rates of hypertension, dyslipidemia, and glucose intolerance; lifestyle changes such as improvements in diet and decreases in the levels of cigarette smoking; and better detection and treatment of heart disease. the specific effects of risk factor, lifestyle, or detection and treatment changes on the declining population rates of coronary heart disease morbidity and mortality were unknown in 1990. secular trend analyses were needed to elucidate the relative contribution of these factors, particularly dietary variables, on population rates of coronary heart disease. design narrative: multiple regression was used to assess the effect of dietary variables on changes in serum cholesterol between 1957-1960 and 1966-1969 in a sample of 200 men for whom repeated measurements existed in the framingham cohort. analysis of covariance was used to assess influence of dietary intake on differences in serum cholesterol levels between independent samples of men studied in 1957-1960 and 1966-1969 in the framingham cohort, and independent samples of women studied between 1957-1960 and 1984-1988 in the framingham cohort and offspring cohort, and independent samples of men studied between 1966-1969 and 1984-1988 in the framingham cohort and offspring cohorts respectively. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
assessment of hematopoietic recovery following chemotherapy for non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: a study to determine the accuracy of flt-pet in quantifying tumor cell proliferation at the initial staging of patients with non-hodgkin's lymphoma in comparison wit the "gold standard" fdg-pet.

the first primary objective reflects a necessary and preliminary requirement: to reproduce published results and validate the use of flt-pet. in this study, 35 patients will be selected to undergoing imaging with both flt and fdg pet.

Eligibility criteria:
inclusion criteria: * 18 years or older * women must not be pregnant or breast feeding * histologic diagnosis of non-hodgkin's lymphoma (any stage) * must undergo treatment with chemotherapy and/or radiotherapy exclusion criteria: * may not have received previous therapy with radiopharmaceuticals * may not have received prior therapy with cytotoxic chemotherapy and/or monoclonal antibodies
a safety and efficacy study to assess ozurdex® in patients with macular oedema secondary to retinal vein occlusion (rvo)

Conditions: Macular Edema; Retinal Vein Occlusion

Summary: this study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed ozurdex®. all care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.


Eligibility criteria:
inclusion criteria: * diagnosis of macular edema following retinal vein occlusion * prescribed ozurdex® exclusion criteria: * previous treatment with ozurdex®