Kornimate/medical-research-clean huggingface dataset:
follow up on freestyle valves in children

Conditions: Right Ventricle; Pulmonary Valve Stenosis; Pulmonary Valve Atresia

Summary: the purpose of this study is to determine if the medtronic freestyle porcine valve is effective over a long period of time when it is used to replace the valve that normally allows blood to flow from the right lower pumping chamber of the heart to the lungs.

during the time between june 1998 and june 2006, the medtronic freestyle® porcine aortic root (medtronic, minneapolis, mn) was used for reconstruction of the right ventricular outflow tract in children that underwent surgery at children's healthcare of atlanta. these children were born with heart problems that made it difficult for blood to flow from the lower right chamber of the heart to the lungs where it would normally pick up oxygen to be used by the body. consequently, these children required surgery to repair the valve and eliminate this restriction of blood flow to the lungs in order to preserve life. in this case, the freestyle valve was used. it is a relatively new valve and it is not known how it functions and how it impacts overall heart function over a long period of time. we are requesting permission to recruit volunteers that have received the freestyle valve for this purpose in order to determine its long term performance. specifically, we are seeking volunteers that are willing to have an echocardiogram performed. it is through the evaluation of a recent echocardiogram, as it compares to previous echocardiograms performed on the same patient, that the usefulness of the freestyle valve will be evaluated for its durability and its long term impact on heart function.

Eligibility criteria:
inclusion criteria * patients that have received the medtronic freestyle® porcine aortic root for right ventricular outflow tract reconstruction that have not had a standard of care echocardiogram performed in the last 12 months. * patients that have received the medtronic freestyle® porcine aortic root for right ventricular outflow tract reconstruction whose most recent echocardiogram is not useful for evaluating the study points despite the fact that it may have been performed within the last 12 months. * informed consent obtained from the legal guardian or patient if \> 18 years of age. exclusion criteria * patients that have not received the medtronic freestyle® porcine aortic root for right ventricular outflow tract reconstruction. * patients that are eligible to participate based on the previous criteria for whom informed consent is not obtained from the patient or legal guardian.

Keywords: cardiology echocardiograms surgery valve disease heart valve disease
mesenchymal stem cells for the treatment of pneumonia post haematopoietic stem cell transplantation

Conditions: Pneumonia; Hematopoietic Stem Cell Transplantation

Summary: the aim of this study is to determine whether mesenchymal stromal cell (msc) treatment contribute to the good prognosis in patients with transplant-related complication, pneumonia post hematopoietic stem cell transplantation (hsct).

hematopoietic stem cell transplantation (hsct) is a standard therapy strategy for most hematologic disorders and malignancies. despite the improved survival attributed to advances in hsct including transplantation techniques and supportive care, transplant-related pneumonia (severe pneumonia in particular) remains the leading cause of death for most hsct patients and a major challenge for clinicians. mesenchymal stromal cells (mscs), a form of multipotent cells, have been applied in therapy for various intractable disorders. msc exerts its therapeutic effect through various biological functions including immunoregulation, tissue repairing, self-renew and differentiating into various cell lines. the american thoracic society has also suggested mscs as a cell therapy agent for lung diseases. however, msc therapy for pneumonia following hsct has not been well investigated. by investigating the efficacy of msc treatment for hsct-related pneumonia via comparing the outcomes in patients with and without msc treatment, this study will provide a promising therapy for hsct-related pneumonia.

Eligibility criteria:
inclusion criteria: * patients with pneumonia after hsct; * patients under the age of 18 years; * patients with normal pulmonary function before hsct. exclusion criteria: * patients with other severe complications in progress when pneumonia occurred.

Keywords: mesenchymal stromal cell pneumonia hematopoietic stem cell transplantation
a study to evaluate gbt021601 in single and multiple doses in healthy participants

Conditions: Sickle Cell Disease

Summary: this first in human study is designed to evaluate the safety, tolerability, pharmacokinetics (pk), and food effect of gbt021601, a hemoglobin s (hbs) polymerization inhibitor, in healthy participants.

this is a randomized, double-blind, placebo controlled, single and multiple ascending dose study in healthy participants.

Eligibility criteria:
inclusion criteria: * healthy males and females ≥ 18 to ≤ 55 years of age * body mass index ≥ 18.0 to ≤ 30.0 kg/m2 * body weight ≥ 50 kg at screening and day -1 exclusion criteria: - positive pregnancy test or currently breastfeeding.
evaluation of patient characteristics and treatment approaches to patients with bipolar disorder in turkey

Conditions: Bipolar Disorder

Summary: a registry study to identify the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in turkey.


Eligibility criteria:
inclusion criteria: * patients previously or currently diagnosed with bipolar disorder * patients (or any of their relatives) who give a written informed consent. exclusion criteria: * patients who were previously included in this study.

Keywords: bipolar disorder patient characteristics treatment characteristics
efficacy of sr-89 for differentiated thyroid cancer with bone metastases

Conditions: Thyroid Neoplasm Follicular; Bone Metastases

Summary: using sensitive markers (such as thyroglobulin, etc) to evaluate the efficacy of strontium-89 chloride (sr-89) in differentiated thyroid cancer with bone metastases with an aim to breaking out of its palliation effect for bone pain.

using biochemical markers (such as thyroglobulin), functional markers (such as change of tumor-background ratio on bone scan), etc to evaluate the efficacy of strontium-89 chloride (sr-89) in differentiated thyroid cancer with bone metastases with an aim to breaking out of its palliation effect for bone pain.

Eligibility criteria:
inclusion criteria: * patients of differentiated thyroid cancer * positive uptake by bone metastases on bone scan * planing to have sr-89 treatment exclusion criteria: * having received treatment for bone metastases within one month of the study (such as radiotherapy, surgery, targeted therapy, chemotherapy, etc., among which denosumab and bisphosphate were allowed as basic treatment) * having received radioactive iodine therapy within half a year before the study * there are bone related events, such as fracture, spinal cord compression, etc.
recurrent neovascular age-related macular degeneration after therapy suspension

Conditions: Age-related Macular Degeneration

Summary: the purpose of this study is to investigate prospectively the recurrence rate of active macular neovascularization (mnv) and the visual outcome in patients with namd previously on a treat and extend regimen where treatment has been discontinued due to disease stability.

all study subjects had namd and were treated at diagnosis with three monthly aflibercept injections and then subsequently followed in a treat and extend regimen with extensions by two weeks if no signs of disease activity were seen. hemorrhage, intraretinal macular edema or subretinal fluid were considered signs of disease activity. patients reaching 12-week intervals without any evidence of disease activity on three consecutive visits, a bcva between 35-88 letters (snellen 20/200- 20/20) and a near vision of at least 24 points were eligible for study inclusion. if there were signs of recurrent disease activity during the follow-up, study participation was concluded at that point and intravitreal therapy was resumed. between scheduled visits patients were encouraged to monitor their vision at home using monocular visual assessments and were advised to return earlier than planned if symptoms of visual deterioration or metamorphopsia occurred. at baseline and at every follow-up visit all patients had a full dilated ophthalmic examination. optical coherence tomography (oct) images were obtained by using the zeiss cirrus oct instrument (carl zeiss meditec, inc.,dublin, ca). a pigment epithelial detachment (ped) was identified as an elevation of the rpe band and included both serous and fibrovascular ped. near vision was tested at 40cm with the addition of +3 dioptres to the bcva refraction. for near vision assessment we used the lix adult a chart (ortho-km, lund, sweden) graded in typographical points, the largest text being 24 points and the smallest 4 points.

Eligibility criteria:
inclusion criteria: * patients with inactive neovascular amd reaching 12-week intervals in a treat and extend regimen without any evidence of disease activity on three consecutive visits. * bcva between 35-88 letters (snellen 20/200- 20/20) * near vision of at least 24 points exclusion criteria: • active neovascular amd
impact of significant carotid stenosis on retinal perfusion measured via automated retinal oximetry

Conditions: Stroke, Ischemic; Stenosis, Carotid

Summary: background: large vessel carotid stenosis represent significant cause of ischaemic stroke. indication for surgical revascularisation treatment relies on severity stenosis and clinical symptoms. mild clinical symptoms such as transient ischemic attack, amaurosis fugax or minor stroke preceded large strokes in only 15% of cases. aim: the aim of this prospective study is to evaluate whether retinal perfusion is impacted in significant carotid stenosis. automated retinal oximetry could be used to better evaluate perfusion in post-stenotic basin. the investigators presume the more stenotic blood vessel, the more reduced retinal perfusion is resulting in adaptive changes such as higher arteriovenous saturation difference due to greater oxygen extraction. this could help broaden the indication spectrum for revascularisation treatment for carotid stenosis. methods: the investigators plan to enroll 50 patients a year with significant carotid stenosis and cross-examine them with retinal oximetry. study group will provide both stenotic vessels and non-stenotic vessels forming the control group. patients with significant carotid stenosis will undergo an mri examination to determine the presence of asymptomatic recent ischaemic lesions in the stenotic basin, and the correlation to oximetry parameters. statistics: correlation between the severity of stenosis and retinal oximetry parameters will be compared to the control group of non-stenotic sides with threshold of 70%, respectively 80% and 90% stenosis. data will be statistically evaluated at the 5% level of statistical significance. results will be then reevaluated with emphasis on mri findings in the carotid basin. conclusion: this prospective case control study protocol wil be used to launch a trial assessing the relationship between significant carotid stenosis and retinal perfusion measured via automated retinal oximetry.


Eligibility criteria:
inclusion criteria: study population will include patients examined in ultrasound laboratory in neurology department of university hospital olomouc, regardless of incidental finding of stenosis, examination due to acute symptoms or regular checkup of known stenosis. exclusion criteria: * patients unable undergo ophthalmological examination properly, especially on automated retinal oximetry.

Keywords: automated retinal oximetry
characterizing a 5p-linked bhr susceptibility locus

Conditions: Asthma; Lung Diseases

Summary: to identify the predisposing genes responsible for asthma and bronchial hyperresponsiveness (bhr) at region 5p13.3 in an inbred hutterite community.

background: asthma is the most common chronic disease in industrialized nations, affecting more than10 million people in the u.s. alone. familial aggregation and concordance rates in monozygotic twins have suggested a genetic component to asthma. dr. ober and colleagues have been conducting studies on the genetics of asthma and atopy in the hutterites, an inbred population of european origins that practices a communal lifestyle. a genome-wide screen with 564 markers (average spacing 6 cm) was completed in an extended pedigree of 717 hutterites who were well characterized with respect to asthma, atopy, and related phenotypes. these individuals are descendants of only 64 ancestors who lived in the early 1700's to the early 1800's. evidence for linkage with bronchial hyperresponsiveness (bhr) by the likelihood ratio test extended over 30 centimorgans (cm) on chromosome 5p, with p-values as small as 0.001. additional evidence for linkage at this same location was evident by the transmission disequilibrium test (p=0.0061). typing additional markers in this region identified a critical region of 2.4 cm, corresponding to 1.5 mb of dna, and a high risk haplotype that is over transmitted to affected individuals. the study was conducted in response to a request for applications, "positional candidate approaches in asthma gene discovery" released in ocatober, 1999. design narrative: dr. ober and colleagues characterized the 5p-linked bhr susceptibility locus in the inbred hutterites by positional cloning and replicating these findings in outbred, ethnically diverse populations. they examined single nucleotide polymorphisms (snps) spaced about 10 kb apart in each gene, and assessed the evidence for over transmission to affected offspring with each snp and snp haplotypes. associations in the hutterites were replicated in two outbred samples (a caucasian sample from germany, and an african american sample from chicago). the functional effects of associated variants were assessed by in vitro assays as well as by genotype-phenotype studies in outbred samples that had been evaluated for asthma and atopy phenotypes. identifying asthma or bhr susceptibility loci may identify novel pathways in asthma pathogenesis, thereby allowing for the development of new therapies and intervention strategies for these common diseases.

Eligibility criteria:
no eligibility criteria
implementation and delivery of cabotegravir long acting injection for prep in a community pharmacy setting.

Conditions: HIV Infections

Summary: the goal of this demonstration project or observational study is to evaluate the feasibility and acceptability of a pharmacist-managed cabotegravir long acting injectable for prep program in a community pharmacy setting. the main question it aims to answer are: * is the program feasible and acceptable at the end of 1 year of operations? * what are the facilitators and barriers of the program? participants who want to start the fda approved cabotegravir long acting injectable medication for prep will have the option participating in surveys and a review of their electronic health records. medication will be administered based on fda approved labeling guidelines and their prep care will be part of standard of care per cdc. pharmacists who want to provide the service to their patients will have the option of participating in surveys pre and post implementation.


Eligibility criteria:
inclusion criteria: * 18 years of age or older at the time of screening * weight ≥ 35 kg * hiv-negative status * willing to provide informed consent and undergo all required study procedures. exclusion criteria: * unknown or positive hiv status * coadministration of drugs that significantly decrease cabotegravir concentrations according to the fda package insert. * any participants that do not meet criteria for management under cdta

Keywords: cabotegravir pharmacy hiv prep pre-exposure prophylaxis long acting injection apretude
effects of crossover point exercise on vascular function of women in different menopausal years

Conditions: Vascular Health

Summary: recruit postmenopausal women and randomly assign them to one of four groups: early postmenopausal exercise group (ee), late postmenopausal exercise group (le), early postmenopausal control group (ec), and late postmenopausal control group (lc). all participates will undergo a graded exercise test to determine their maximum oxygen uptake, and vascular function response will be measured immediately after the exercise test. the cop exercise intensity for postmenopausal women will be obtained through the exercise test, and subjects in the ee and le groups will undergo exercise training at this intensity for a period of three months. tests and analyses of relevant indicators will be conducted on subjects in all four groups before and after the intervention. the exercise load experiments will be performed on a cycle ergometer.


Eligibility criteria:
inclusion criteria: * postmenopausal women without cardiovascular disease exclusion criteria: * women with undetermined menopause * bmi \ 28 kg/m2 * fasting plasma triglyceride levels ≥500 mgdl * diabetes mellitus or fasting glucose \>140 mgd * blood creatinine \>2.0 mgdl * uncontrolled hypertension (systolic blood pressure \>160 mmhg and/or diastolic blood pressure \>110 mmhg) * untreated thyroid disease * life-threatening illness with a prognosis of \<5 years; * history of deep vein thrombosis, * pulmonary embolism, or breast cancer; * currently receiving estrogen therapy.

Keywords: vascular health crossover point
study to determine if gardasil vaccine is safe and effective in lupus patients

Conditions: Systemic Lupus Erythematosus

Summary: cervical neoplasia is increased in women with sle most likely due to cervical infection with human papilloma virus (hpv). 70% of cervical cancer is caused by hpv types 16 and 18. gardasil vaccine prevents cervical infection with hpv types 16 and 18. thus lupus patients (who are susceptible to cervical cancer) may benefit from getting gardasil vaccine which can prevent cervical cancer. vaccines are generally safe and efficacious in sle but no studies have been done on the use of this vaccine in sle. the investigators hypothesize that gardasil vaccine is safe and effective in sle. this study will look at vaccine safety in patients with mild to moderate and minimally active or inactive sle and measure how well they make protective antibodies after receiving the vaccine. in other words this will check how well the vaccine works in sle.

to gather safety information and adverse events on the use of gardasil® in mild to moderate and minimally active or inactive sle. to gather information on sle disease activity flares after vaccination with gardasil®. to gather information on the immunogenicity or development of protective anti hpv antibodies sle after vaccination with gardasil®.

Eligibility criteria:
inclusion criteria: diagnosis of systemic lupus erythematosis (sle) by the american college of rheumatology (acr) criteria. history of a positive antinuclear antibody (ana) test result at any time in the past. 40 participants with history of mild to moderate sle disease minimally active or inactive sle disease, i.e., (safety of estrogens in lupus erythematosis national assessment (selena) systemic lupus erythematosus disease activity index (sledai), selena-sledai ≤2 at the start of the study. age ≥ 18 years and ≤ 50 years. gender: females ability to provide informed consent. maintenance prednisone dose ≤ 15 mg/day. plaquenil ≤ 400 mg/day. exclusion criteria: hypersensitivity to any vaccine component active infections including but not limited to human immunodeficiency virus (hiv positive), hepatitis b or c, tuberculosis. positive purified protein derivative (ppd) test results without evidence of prior treatment or administration of bacilli calmette-guerin (bcg) vaccine. a positive ppd is defined as ≥ 5 mm induration 24-38 hours after receiving 5tu (tu=tuberculin units) of ppd. pregnancy or desire to become pregnant during the study period. breast feeding. inability to complete the immunization series. received any blood product or component in the previous 6 months before enrollment. received any inactivated vaccine product within 14 days before enrollment. received any live vaccine product within 21 days before enrollment. fever (temperature \> 100°f) at the time of enrollment. inability to provided informed consent.

Keywords: lupus
neuropathic pain symptoms in arthritis

Conditions: Neuropathic Pain

Summary: it was aimed to compare neuropathic pain symptoms in hand osteoarthritis and rheumatoid arthritis.

the patients with hand osteoarthritis or neuropathic complaints accompanying rheumatoid arthritis who applied to the physical medicine and rehabilitation clinic of our hospital will be included. in both patient groups, the duration, character and treatments of their complaints will be compared. neuropathic pain will be evaluated with the visual analog score (vas), dolor neuropathic 4 questions (dn-4) and pain detect pain questionnaire.

Eligibility criteria:
inclusion criteria: * presence of hand osteoarthritis and rheumatoid arthritis * presence of neuropathic complaints exclusion criteria: * history of hand injury, peripheral nerve injury, fracture, and hand operation in the last 3 months * do not want to participate in the study

Keywords: hand osteoarthritis neuropathic pain neuropathic symptom rheumatoid arthritis
non-invasive melanoma assessment using a topical fluorescence reagent and optical imaging

Conditions: Skin Lesion

Summary: the use of mds to access the presence of melanoma in the skin.

a topical agent is applied to suspicious skin lesions and imaged. the images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.

Eligibility criteria:
inclusion criteria: * individuals with skin lesion with one or more of the abcde features and recommended for a skin biopsy. * the lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the mds. * male and female ≥ 21 years old. * subject is capable of giving written informed consent. * primary excision. exclusion criteria: * the lesion is less than 1 cm from the eyes. * the lesion is on the palms of hands or soles of the feet. * mucosal lesion. * pregnant females. * low study procedure compliance. * patients who are mentally or physically unable to comply with all aspects of the study. * undergoing chemotherapy. * minor or legally incompetent and not able to sign the consent form. * patient previously tested by mds and was diagnosed with melanoma during the study. * sensitivity to fluorescein
ards prediction score in critically ill patients in china

Conditions: ARDS; Septic Shock

Summary: ards is a severe disease, it's important to predict the incidence of ards.

from january 1 to january 31, 2012 and from january 1 to january 10, 2013 , all patients admit to the icus will be enrolled. the demographic characteristics, diagnosis, formerly medical history, ventilator indications, ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded.

Eligibility criteria:
inclusion criteria: critically ill patients who admitted into participating icu exclusion criteria: patients with chronic pulmonary disease such as chronic obstructive pulmonary disease (copd), asthma, lung cancer, pulmonary fibrosis and tuberculosis age less than 18 years old pregnancy died within 24 hours from icu admission ards patients who diagnosed 24hours before icu admission referral from other hospital to participating icu lack of data of ards risk factors

Keywords: mechanical ventilation, ards, ventilator strategy, outcome