Kornimate/medical-research-clean huggingface dataset:
predictive value of pre-tavi infrahissian conduction time in the occurrence of complete atrioventricular block

Conditions: Aortic Stenosis, Severe

Summary: the purpose of the study is implantation of a pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)

the main objective is to assess the predictive value of the pre-tavi infrahelic conduction time interval (infraheal conduction time measured before percutaneous aortic valve implantation) on the risk of pacemaker implantation at 30 days post-tavi, in patients with right bundle branch block prior to surgery. the aim of the study is to identify a pre-interventional marker of the risk of rhythmological complication after the tavi procedure (transcatheter aortic valve implantation), in order to better anticipate it. this is an interventional, prospective, longitudinal (follow-up: 12 months), multicenter (4 centers) study.

Eligibility criteria:
inclusion criteria: * patient suffering from severe aortic stenosis, eligible for a tavi procedure (transcatheter aortic valve implantation) ; * patient presenting with complete right bundle branch block during the pre-tavi electrocardiogram, with qrs interval ≥ 120 ms (depolarization of the ventricles); * patient able to understand the information related to the study, to read the information leaflet and agreeing to participate in the study. ; * patient having signed a consent. exclusion criteria: * contraindication to transcatheter aortic valve implantation ; * patient under guardianship or curatorship, or under a regime of deprivation of liberty; * patient participating in another clinical trial, or in a period of exclusion from another clinical trial; * patient not benefiting from a social security scheme.
open-label extension study of kuvan for autism

Conditions: Autistic Disorder

Summary: this is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism.

this is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism. during this protocol, all subjects will be receiving brand-name kuvan 20 mg/kg/day for 16 weeks; subject who complete the first 16 weeks will have the option of continuing on kuvan at the same dose for up to 90 days after the last subject has completed the first 16 weeks of this protocol. the purpose of the study primarily is to gather additional information on safety and efficacy in this population.

Eligibility criteria:
inclusion criteria: * all subjects must have completed earlier trial, chc 0901 (nct00850070) * parents must be willing and able to sign informed consent exclusion criteria: * child failed to complete chc 0901 (nct00850070)

Keywords: autism autistic disorder tetrahydrobiopterin sapropterin treatment
study of sequential perfusion of liver grafts to prevent nonanastomotic biliary strictures after liver transplantation

Conditions: Liver Transplantation; Transplant Recipient

Summary: the study was designed to investigate whether, compared with conventional sole perfusion with high-viscosity solution of university of wisconsin (uw), sequential perfusion of liver grafts with low-viscosity and high-viscosity preservation solutions could further decrease the incidence of nonanastomotic biliary strictures (nas) after liver transplantation.

the exact etiology of nonanastomotic biliary strictures (nas) with a patent hepatic artery after liver transplantation remains unclear so far. microangiopathy is strongly suspected to be involved in the etiology, so sufficient flushing of peribiliary plexus (pbp) which directly nourishes the donor biliary tree may be pivotal to prevent nas with a patent hepatic artery. solution of university of wisconsin (uw solution) is a standard for liver graft flushing, but accused of high viscosity and hyperaggregation effect on erythrocytes by ingredient hydroxyethyl starch as well as initial vasoconstriction by high potassium content, which together constitutes a hindrance to solution penetration and thorough flushing of liver microcirculation including pbp. several studies have revealed the relationship of high viscosity of uw solution with the development of nas. the investigators, therefore, have hypothesized that sequential perfusion with low-viscosity and high-viscosity preservation solutions might improve the patency of pbp in contrast with conventional sole perfusion with high-viscosity uw solution, and as a result, the incidence of nas with a patent hepatic artery after liver transplantation would be significantly decreased.

Eligibility criteria:
inclusion criteria: * age≥18 years * ability to provide written informed consent prior to study entry * receiving a whole liver graft * primary transplantation exclusion criteria: * participant in other clinical trials * fulminant liver failure as the cause of transplantation * primary biliary cirrhosis, autoimmune hepatitis or primary sclerosing cholangitis as primary liver disease * retransplantation * non-liver organ(s) failure prior to study entry * donor/recipient abo-blood-group-incompatibility

Keywords: orthotopic liver transplantation preservation solution peribiliary plexus nonanastomotic biliary strictures primary non-function
bone mineral density and cancer recurrence in patients with early stage prostate cancer

Conditions: Osteoporosis; Prostate Cancer

Summary: rationale: measuring bone mineral density may help doctors predict whether prostate cancer will come back. it may also help the study of prostate cancer in the future. purpose: this clinical trial is studying whether bone mineral density affects cancer recurrence in patients with early stage prostate cancer.

objectives: * determine bone mineral density (bmd) in patients with clinically significant early stage prostate cancer. * determine whether patients who have a higher level of bmd and have had a radical prostatectomy for cure are less likely to have an early relapse (i.e., less than 3 years) than those patients with a low level of bmd. outline: this is a case-controlled study followed by a prospective, longitudinal, cohort study. patients undergo bone mineral density (bmd) measurements by dual-energy x-ray absorptiometry with a densitometer. posteroanterior measurements of the total hip are also recorded. patients also undergo blood collection to examine markers that provide evidence of systemic disease. patients are followed every 6 months for 3 years. projected accrual: a total of 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * biopsy-confirmed early stage prostate cancer * disease localized within the capsule * no evidence of regional or distant spread (i.e., t1-2, n0, m0 disease) * a cohort of patients must have undergone a prior radical prostatectomy * prostate specific antigen \< 12 ng/ml * gleason score ≥ 6 patient characteristics: * creatinine clearance ≤ 2.0 mg/dl * no paget's disease * no hyperthyroidism or hypothyroidism * no cushing's disease * no chronic liver disease * no major health problems that would cause a significant reduction in mobility or activities of daily living prior concurrent therapy: * see disease characteristics * no prior bisphosphonates, thyroxin, or calcitonin * no prior agents that suppress psa levels (e.g., finasteride) * no prior androgen or estrogen therapy * more than 12 months since prior glucocorticoids * more than 12 months since prior herbal supplements that are known to lower psa levels

Keywords: osteoporosis stage i prostate cancer
different doses of roxadustat treatment for anemia in peritoneal dialysis patients

Conditions: Renal Anemia

Summary: a multi-center, randomized, controlled study to evaluate the effect of different doses of roxadustate on hemoglobin target-met in peritoneal dialysis patients

roxadustat is an orally hypoxia-inducible factor prolyl hydroxylase inhibitor (hif-phi) to promote erythropoiesis on patients with chronic kidney disease. two phase 3 clinical trials have verified the efficacy and safety of roxadustate as therapy for anemia in patients with ckd and undergoing dialysis. a high increasing rate of hb or hb overshooting triggered by roxadustat need dosing reduction or even drug withdrawal, possibly leading to a large hb variation and adverse subsequences. therefore, we were of interest to investigate whether a lower starting dose of roxadustat could achieve comparable hb target at week 12 while lowering the risk for hb over 130g/l through a prospective peritoneal dialysis (pd) cohort. peritoneal dialysis patients diagnosed with renal anemia will be divided into standard roxadustat dosage group and lower roxadustat dosage group. after 12 weeks, we will compare the target-met, overshooting and variation ratio of hemoglobin between these two groups.

Eligibility criteria:
inclusion criteria: 1. adult patients diagnosed with chronic kidney disease stage 5 2. maintenance on pd for more than three months. 3. weight between 45kg and 110kg 4. renal anemia, and hemoglobin between 90g/l and 120g/l 5. stop taking erythropoietin for enough time （erythropoietin treatment discontinuation for ≥3 days if using erythropoietin of 3000u single strength, or ≥7 days if using erythropoietin of 10000u single strength） or free of erythropoietin use 6. signed the informed consent. 7. willing to follow the study procedure exclusion criteria: 1. hematologic malignancy or aplastic anemia. 2. blood loss or hemolysis. 3. taking roxadustat, or allergy or intolerance to roxadustat 4. severe liver injury or active hepatitis. 5. pregnancy or breastfeeding 6. cancer, receiving radiotherapy and chemotherapy within 6 months. 7. refractory hypertension

Keywords: roxadustat renal anemia peritoneal dialysis
key technology research and application demonstration of individual protective equipment for high-level biosafety laboratories

Conditions: Biosafety Protection; Infectious Diseases

Summary: systematically evaluate the safety performance, intelligent application effect and experience of ppe developed in different scenarios.

in high-level biosafety laboratories, the national center for infectious disease medicine, medical consortiums and other national platforms, systematic assessment of the project developed individual physical protection equipment in different scenarios of the safety performance, the intelligent application of the effect and the use of experience, the assessment of the indicators covering the protection performance, safety, stability, comfort, environmental protection, intelligence, ease of operation, including but not limited to local breakage protection performance, aerosol protection performance, airtightness, liquid penetration performance, differential pressure stability, noise value, air supply flow, ease of wear and removal, ease of movement, ease of operation, degradability, degree of intelligence, etc., and ultimately determine the technical indicators and testing methods of individual physical protective equipment, and establish evaluation technical standards. based on the determined technical indexes and testing methods of individual physical protective equipment, we will carry out parallel comparative evaluation of similar foreign imported equipment, and form a technical research report on the evaluation of the performance of relevant protective equipment. optimise the quantitative performance indexes of ppe for domestic shortcomings and weaknesses. prepare standard operation norms and technical standards for individual physical protective equipment.

Eligibility criteria:
inclusion criteria: * staff at outbreak sites, infectious disease wards, bsl-3 and 4 laboratories exclusion criteria: * na
sperm phenotype and differentially methylated regions

Conditions: Infertility, Male

Summary: testicular dysgenesis syndrome (tds) is known to cause epigenetic abnormalities in spermatozoa. anogenital distance (agd) is considered to be a suitable clinical marker of tds, but the direct link between agd and epigenetic abnormalities is still missing. infertile men (n=10) presenting with shortened agd and a control group of normal semen donors (n=10) with normal agd will then be asked to provide one semen sample each. using a flow cytometer and sorter (facs) their spermatozoa will be sorted into populations of spermatozoa with/without dna fragmentation or with/without chromatin decondensation. these sorted populations of spermatozoa will then be examined for differences in epigenetic imprinting differences using whole genome expression analysis. whereas the sorting of spermatozoa will be carried out in basel, the epigenetic analysis will be carried at the university of geneva.

a subset of 10 men with shortened agd (together with a control group of 10 fertile donors with normal agd) will be asked to provide up to three semen samples, each of which then will be sorted with facs into subpopulations with/without dna fragmentation and into subpopulations with/without chromatin decondensation. spermatozoa with fragmented dna will be separated through facs-sorting of spermatozoa with intact dna using the yopro 1-dye, which has been shown to correlate significantly with the degree of dna fragmentation in the nuclei of sperm. in addition, spermatozoa with abnormal chromatin remodelling will be separated through sorting from spermatozoa with condensed chromatin using the fluorochrome chromomycin a3 (cma3), which competes for protamin for binding to the minor groove of dna thereby correlating with the persistence of histones in the sperm nuclei. pilot experiments have demonstrated the highly significant and close correlation of cma3 with anilin blue staining. anilin blue staining is not suitable for the sorting experiment, because it requires fixation of the spermatozoa. sorting based on cma3 can be carried out with living spermatozoa. the sorted and anonymized samples will then be sent frozen in dry ice to a laboratory at the university of geneva for the assessment of differences in the epigenetic imprinting of the dna using whole genome expression studies.

Eligibility criteria:
inclusion criteria: * infertile men with known anogenital distance exclusion criteria: * sperm concentration must be more than 15 million/ml to allow appropriate sorting with flow cytometry...
survey for parental perception of procedural analgosedation in pediatric age.

Conditions: Analgesia; Sensation, Hyperalgesic

Summary: the conduction of this study may provide useful information about how much parents know and understand about procedural sedation, helping to identify any gaps. in addition, expectations and concerns about procedural sedation may be highlighted so that strategies aimed at improving communication by health care personnel can be developed. the results may guide the development of training programs for health care personnel so as to improve the management of procedural sedation and interaction with parents.

the study involves the completion of a survey by parents/guardians, the remaining interventions will be performed following the normal care procedure outpatient regimen, according to normal clinical practice.

Eligibility criteria:
inclusion criteria: * parents of children between the ages of 2 months and 14 years who are afferent to the withdrawal clinic exclusion criteria: * none

Keywords: procedural analgosedation
education on bdnf on pain levels

Conditions: Chronic Pain; Musculoskeletal Pain

Summary: the promotion of neuroplasticity in conjunction with strategies for restructuring maladaptive cognitions that largely cause the activation of neural networks that contribute to the perpetuation of pain is therefore a fundamental neurophysiological principle for establishing a neurophysiological basis for pain. perpetuation of pain, is therefore a fundamental neurophysiological principle for establishing physiotherapy therapeutic to establish therapeutic strategies from physiotherapy that contribute to improve the quality of life of patients with chronic pain. patients with chronic pain. based on the theory that neurotrophic factors such as bdnf play a fundamental role in the initiation and or maintenance of hyperexcitability of central neurons in pain, we consider that the levels of this neurotrophic factor, such as bdnf, may have an important role in the perpetuation of pain. that the levels of this neurotrophic factor may be modified by the application of a therapeutic education protocol, favoring therapeutic education protocol, favoring a reduction in pain intensity.


Eligibility criteria:
inclusion criteria: * males and females aged 18 to 65 years with musculoskeletal pain for a minimum of 3 months * patients recruited by information pamphlets from the university clinic of the rey juan carlos university, and cseu la salle * not having received physiotherapy treatment for this same process in the last 3 months. * ability to perform all the clinical tests and to understand the study process, as well as to obtain informed consent. exclusion criteria: - systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type ii diabetes.

Keywords: bdnf pain neuroscience education exercise
celtra duo computer assisted design/computer assisted machining (cad/cam) dental crown study

Conditions: Fractured Tooth; Decayed Tooth; Unsatisfactory Restoration of Tooth

Summary: this investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. the ceramic has been approved by the fda for patient treatment. a computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. the purpose of the study is to measure how well the high strength crowns function over an extended period of time.

the study will be composed of two groups of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. a maximum of two crowns per patient will be completed. all the crowns will be made from the same high strength ceramic material (celtra duo/dentsply sirona). the two groups of crowns will be made using two different processes to create the surface texture and finish for the crown. one group of celtra duo crowns (group 1) will be glaze-fired in a porcelain oven and the second group (group 2) will be hand-polished. all the crowns will be cemented using two adhesive techniques. all of the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement technique (calibra universal cement/dentsply). all of the hand polished crowns will be cemented using an adhesive bonding technique using prime \& bond elect (dentsply) with a dual cured resin cement (calibra ceram/dentsply). the crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. at each appointment an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.

Eligibility criteria:
inclusion criteria: * must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar * reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration * teeth to be vital and asymptomatic prior to treatment * no more than two restorations will be placed per patient. if a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth. exclusion criteria: * devital or sensitive teeth * teeth with prior endodontic treatment of any kind * teeth with a history of direct or indirect pulp capping procedures * patients with significant untreated dental disease to include periodontitis and rampant caries * pregnant or lactating women * patients with a history of allergies to any of the materials to be used in the study * patients unable to return for the recall appointments

Keywords: cad/cam ceramic crown
safety and effectiveness assessment of pegagen® (pegfilgrastim) in the prevention of chemotherapy-induced fn

Conditions: Chemotherapy-induced Neutropenia

Summary: the present study was an observational, multicenter, non-interventional, single arm, open label, pms study conducted in iran. the primary objective of this study was safety assessment, including the rate of aes. the secondary objective was the effectiveness evaluation in the prevention of chemotherapy-induced fn.

the present study was an observational, multicenter, non-interventional, single arm, open label, pms study conducted in iran. data was gathered in two booklets, each containing information on four cycles of chemotherapy, which was filled by the designated physician. the duration of pegagen® treatment was at the physicians' discretion based on the patient's condition. the primary objective of this study was safety assessment, including the rate of aes. the secondary objective was the effectiveness evaluation in the prevention of chemotherapy-induced fn. this study was single arm and 654 subjects participated across various tumor types and regimens.

Eligibility criteria:
inclusion criteria: * patients aged ≥18 years, * with the diagnosis of various types of cancers (such as lymphoma, breast, lung, testicular, prostate, ovary and gastrointestinal cancers), receiving first-line chemotherapy regimens with a high fn risk, which pegagen® is injected due to physician decision.

Keywords: febrile neutropenia pegfilgrastim post-marketing surveillance chemotherapy-induced neutropenia myelosuppressive chemotherapy
diagnosis of central adrenal insufficiency in patients with prader-willi syndrome

Conditions: Prader Willi Syndrome; Adrenal Insufficiency

Summary: the purpose of this study is to determine presence of central adrenal insufficiency in children with prader willi syndrome using low dose (1 mcg) acth stimulation test compared to results of overnight metyrapone test.


Eligibility criteria:
inclusion criteria: * individuals with prader willi syndrome ages 2 years and older exclusion criteria: * individuals who are ill at the time of study * individuals who are pregnant at the time of study * individuals who it is deemed unsafe to stop taking medications known to affect the results of they study (hydrocortisone, phenytoin, estrogen, acetaminophen, oral anti-diabetic agents).

Keywords: metyrapone acth stimulation test