Kornimate/medical-research-clean huggingface dataset:
bilateral deficit phenomenon in patients with haemophilic arthropathy

Conditions: Hemophilia

Summary: trial to assess the bilateral deficit phenomenon during dynamic plantar flexion task in patients with haemophilic arthropathy describe the differences in terms of the physical variables (muscular strength, range of motion and proprioception) in patients with hemophilia who have conducted a home treatment with a digital tool. bookmark the relationship between clinical history of joint bleeds and clinical manifestations in standing and walking.

* assess the bilateral deficit phenomenon during dynamic plantar flexion task in patients with haemophilic arthropathy. * indicate the independent variables that influence the development of strength and contractile activity, with or without previous joint bleeds in haemophilia patients with minors. * observe the descriptive variables people influence the standing, the incorporation from sitting and jumping.

Eligibility criteria:
inclusion criteria: * patients diagnosed with hemophilia a and b. * with or without joint involvement clinically diagnosed, and with or without a previous history of hemarthrosis joint load legs. * in prophylactic regimen with fviii / fix concentrates . * residents in the autonomous community of the region of murcia. exclusion criteria: * patients without walking ability. * patients diagnosed with other congenital coagulopathy (von willebrand disease, etc..). * patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests. * patients whose parents or guardians have not signed the informed consent document.

Keywords: haemophilia arthropathy bilateral deficit phenomenon proprioception
pbfs guided precision neuromodulation treatment for asd

Conditions: Autism Spectrum Disorder

Summary: this study aims to evaluate the neuromodulation (i.e., itbs) effectiveness for treating autism spectrum disorder (asd) by targeting at the pbfs-guided executive function brain network or social brain network.

autism spectrum disorder is characterized by executive function deficiency and social interaction difficulty. using the developed technique, personalized brain functional sectors (pbfs), we could precisely identify individualized brain function networks based on the resting-state functional mri scan. a tailored dorsal lateral prefrontal cortex (dlpfc) region situated within the executive function network and a tailored dorsal medial prefrontal cortex (dmpfc) region situated within the social network will be selected as intervention targets. the participants will be equally randomized to the following three groups, active itbs to the left dlpfc, active itbs to the left dmpfc, and sham itbs to either the left dlpfc or left dmpfc at a ratio of 2:2:1:1. each participant will receive 1800 pulse active or sham itbs (100% rmt) in each session, 3 sessions daily, 5 days per week for 8 weeks, as well as background behavioral training between itbs sessions.

Eligibility criteria:
inclusion criteria: * 6-30 years old * have the diagnosis of autism spectrum disorder * ados-2 score is higher than the asd cut-offs * capacity to follow the study procedures, including fmri scan under sedation, assessment, and rehabilitation training * participant's parents or other legal guardians give informed consent exclusion criteria: * current or history of psychotic disorders, such as schizophrenia, bipolar disorder * severe self-injury or suicidal behavior presented in the last 1 year * severe visual, auditory, or motor disability that interferes with any study procedure * current, history or family history of epilepsy * known severe physical diseases, such as congenital heart defects, traumatic brain injury * metal implantations, which are contradicted by mri or tms, such as artificial cardiac pacemakers, stents, cochlear implants * received tms, tcs, fus, or other neuromodulation treatment in the last 3 months * currently participating in other clinical trials

Keywords: tms, fmri, asd, personalized
bioequivalence of orfadin 20 mg compared to orfadin 10 mg capsules.

Conditions: Healthy

Summary: the purpose of this study is to evaluate the bioequivalence between orfadin 20 mg and 10 mg capsules in healthy volunteers.

this is an open, randomized 2-way crossover study in 12 healthy volunteers. subjects will receive single oral 20 mg doses of nitisinone administrated as one 20 mg capsule or as two 10 mg capsules of orfadin. there will be a 3-week washout period between the doses. there will be a screening visit within 3 weeks prior to the first dose. during each treatment period, subjects will be admitted to the clinic from the afternoon on the day before drug administration (i.e., on day -1) and remain at the clinic until the 48-hour post-dose blood sample has been collected in the morning of day 3. they will then return for ambulatory visit in the morning of day 4 (72-hour sample). a follow-up visit will take place 7-14 days after the last dose.

Eligibility criteria:
inclusion criteria: * healthy male and female volunteers between 18-55 years of age, inclusive. * bmi between 18,5-30,0 kg/m2, inclusive. exclusion criteria: * subjects with current keratopathy, or other abnormalities found by slit-lamp examination. * subjects who are heavy smokers or consume more than 5 cups of coffee per day. * subjects with history of drug and/or alcohol abuse or a positive drug screen or alcohol breath test. * subjects with positive screens for hepatitis b surface antigen, hepatitis c antibodies and human immunodeficiency virus (hiv) 1-2 antibodies. * subjects who were enrolled in another concurrent clinical study or intake of an investigational medicinal product within three months prior to inclusion in this study. * subjects who donate more than 50 ml of blood within 60 days prior to drug administration or donate more than 1,5 liters of blood in the 10 months prior to first drug administration. * female subjects that are pregnant or breastfeeding. * female subjects of childbearing potential and all male subjects must be willing to use effective forms of contraception.

Keywords: orfadin nitisinone bioequivalence
ultrasound guided anterior quadratus lumborum block

Conditions: Postoperative Pain; Ultrasound

Summary: percutaneous nephrolithotomy (pnl) is frequently used today for renal stones. percutaneous nephrolithotomy (pnl) procedure has become the treatment of choice for many patients with symptomatic renal stones . patients undergoing pnl suffer from acute postoperative pain, despite a multimodal analgesic regime. this is a randomised controlled trial efficacy of the anterior quadratus lumborum block (qlb) in terms of analgesic efficacy in patients who undergo percutaneous nephrolithotomy.

many analgesic procedures such as nsaid, opioid and regional anesthesia procedures are used as a part of multimodal analgesia for postoperative percutaneous nephrolithotomy pain. in this study we will use the ultrasound -guided anterior quadratus lumborum block . local anesthesic will be injected between quadratus lumborum muscle and psoas muscle with ultrasound.analgesic effect of this block will be detected by using morphine consumption and visual analogue scale .

Eligibility criteria:
inclusion criteria: * patients who were in the american society of anesthesiologists (asa) i-iii class and underwent elective percutaneous nephrolithotomy exclusion criteria: * previous history of opioid use preoperatively, * allergy to local anesthetics, * the presence of any systemic infection,

Keywords: quadratus lumborum block pain ultrasound percutaneous nephrolithotomy
remote optimization, adjustment and measurement for deep brain stimulation

Conditions: Parkinson Disease

Summary: the purpose of the roam-dbs study is to compare the time needed to achieve a 1 point improvement patient's global impression of change (pgic) relative to the subject's status at the end of the adroit initial programming visit in subjects who receive programming updates via in-clinic sessions and subjects who additionally have the option of receiving programming updates via virtual clinic sessions. the study intends to demonstrate shorter times to achieve benefit in the virtual clinic cohort.

the roam-dbs study is a prospective, multi-center, randomized control, open-label, post-market cohort study intended to gather clinical data on the effect of the neurosphere virtual clinic feature (remote care) on the time needed to optimize dbs stimulation parameters after implant. the study will enroll up to 100 subjects from up to 15 centers in geographies where abbott dbs systems with the virtual clinic feature are approved, which may include north america, and europe. subjects should be participants in the adroit study (nct04071847). subjects will be followed to a 3 month visit where the primary endpoint will be assessed. subjects will be further followed for 1 year for final data assessment. subjects will remain enrolled in adroit after the end of the roam study, and will complete the adroit 6 month and 1 year visits under that protocol. the study is expected to enroll subjects for up to 2 years, and complete all follow-up visits within 3 years.

Eligibility criteria:
inclusion criteria: 1. subject is a participant in the adroit study. 2. subject is over 21 years old. 3. subject is able to read and write. 4. subject is indicated for implant with an infinity ipg for parkinson's disease. 5. subject has not previously been implanted with a dbs system. 6. the treating physician believes virtual clinic is appropriate as a component in the treatment regime for this subject. 7. subject will have access to the abbott virtual clinic system through a participating site. 8. subject will have internet access on their patient controller in a location suitable for a virtual clinic session. 9. subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure. exclusion criteria: 1. subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study. 2. subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results. 3. as assessed by the treating physician, lead misplacement would prevent the dbs therapy from providing clinically meaningful benefit. 4. subject is unable to use the virtual clinic feature. 5. subject will not be able, in the investigator's opinion, to demonstrate or articulate symptoms during a virtual clinic visit.

Keywords: abt-cip-10413 virtual clinic infinity dbs system
a sample collection study to validate the astute medical nephrocheck test in critically ill subjects at risk for acute kidney injury

Conditions: Acute Kidney Injury

Summary: the objective of this sample collection study is to collect blood and urine samples. this study is observational and will have no impact on the medical management of the subject.


Eligibility criteria:
inclusion criteria: * males and females 21 years of age or older * subjects must be enrolled (first study-specific sample collection) within 24 hours of icu admission * subjects enrolled from ed or floor must be admitted to the icu within 24 hours of enrollment * subjects enrolled in the icu must have been admitted to the icu or transferred into the study icu from another icu no more than 24 hours prior to enrollment * expected to remain in the icu for at least 48 hours after enrollment * use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment * at least one of the following acute conditions documented within 24 hours prior to enrollment * respiratory sofa score of ≥ 2 (pao2/fio2 \<300) * cardiovascular sofa score of ≥ 1 (map \< 70 mm hg and/or any vasopressor required * subject (or authorized representative) able and willing to provide written informed consent for study participation. exclusion criteria: * special populations including women with known pregnancy, prisoners or institutionalized individuals * previous renal transplantation * known moderate to severe aki prior to enrollment (e.g., rifle-i or rifle-f/ akin 2 or akin 3 * already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment * known infection with human immunodeficiency virus (hiv) or active hepatitis (acute or chronic) * subjects with a history of chronic kidney disease (ckd) without a baseline serum creatinine value (baseline within 6 months of enrollment)

Keywords: kidney renal
peri-operative assessment of coagulopathy in neonates and infants undergoing cardiac surgery

Conditions: Congenital Heart Disease

Summary: this prospective study will aim to globally assess the coagulopathy induced during cardiac surgery with cardiopulmonary bypass (cpb) in a large pediatric population. the investigators primary objective will be the understanding of cpb-induced coagulopathy based on demographic and surgical characteristics, and coagulation assays. secondary objective will aim at determining the relationship between coagulation assays, postoperative blood loss, and transfusion requirements. the ultimate goal will be to design an algorithm using point-of-care monitoring that could be used to guide hemostatic therapies in neonates and children undergoing cardiac surgery.to do this, investigators will examine the coagulation in the laboratory based setting.


Eligibility criteria:
inclusion criteria: * neonates weighing greater than 2.5 kg * patients equal to or less than 12 months of age * undergoing elective cardiac surgery with cardiopulmonary bypass exclusion criteria: * emergent procedure * the patient is deemed to be in a moribund condition (american society of anesthesiology (asa 5))

Keywords: congenital heart disease point-of-care coagulation monitoring rotaional thromboelastometry
quick icd study: is extensive electrophysiological testing before, during and after icd-implantation still necessary ?

Conditions: Cardiac Arrest

Summary: the purpose of this study is to evaluate the strategy of implanting an icd with or without eps before, during and after icd-implantation in a randomised controlled trial, using a combined endpoint of major icd-related adverse events as the primary outcome measure.

usually, eps before and during icd-implantation is performed to allow risk stratification, to test serial antiarrhythmic drugs, to find suitable ablation sites in patients with hemo-dynamically stable monomorphic vts, to exclude supraventricular tachycardias as a cause of cardiac arrest and to help programming detection rate and enhancement criteria in the icd. however, routine eps preceeding icd-implantation exposes the patient to some risk and the health care system to considerable costs. so the question has been raised, whether such testing is still necessary and costseffective, if the indiaction for icd-implantation is clear on a clinical ground.the purpose of this study is to evaluate the strategy of implanting an icd with or without eps before during and after icd-implantation in a randomised controlled trial, using a combined endpoint of major icd-related adverse events as the primary outcome measure (see details under "endpoints"). the results will be viewed against the extra costs and patients´ quality of life both study arms.secondary outcomes are considered as differences in decisions between the groups and difference of events in the two groups.

Eligibility criteria:
inclusion criteria: * structural heart disease and survived cardiac arrest or hemodynamically unstable vt (bpm \> 200/min) exclusion criteria: * conditions, which make a secondary cause for cardiac arrest probable or are not compatible with a single chamber icd; co-morbidity, prior icd pm, or eps
gene modified allogeneic neuroblastoma cells for treatment of relapsed/refractory neuroblastoma

Conditions: Neuroblastoma

Summary: neuroblastoma affects approximately 500 children a year in the united states. when the tumor occurs in infants, it is frequently localized and responds well to therapy. even disseminated disease can be eradicated in about 75% of infants, and indeed may undergo spontaneous remission. in older children, the prognosis is far worse, and 80% or more of those with disseminated tumor can be expected to relapse within 3 years. this study will utilize the concept of exploiting the immune system to eradicate neuroblastoma. in tumors in which there is consistent expression of tumor specific antigens as part of the malignant process, it may be possible to generate immune t-cells ex-vivo or in-vivo by using the specific protein or peptide(s) derived therefrom and eradicate the tumor. this study will evaluate the use of four to eight injections of il-2 gene-transduced autologous neuroblastoma cells to induce a local, polyclonal t-cell infiltrate as well as an anti-tumor immune response.

secondary objectives for this protocol included the following: * to determine whether major histocompatibility complex (mhc) restricted or unrestricted antitumor immune responses are induced by injection of modified allogeneic neuroblasts and the cell doses required to produce these effects. * to obtain preliminary data on the antitumor effects of this treatment regimen.

Eligibility criteria:
* diagnosis of recurrent advanced stage neuroblastoma. * must have a life expectancy of at least 8 weeks. * must have recovered from the toxic effects of all prior chemotherapy before entering this study, and have an absolute neutrophil count of \>500/mm3. * not be currently receiving any investigational agents or have not received any tumor vaccines within the previous six months. * bilirubin \<1.5 mg/dl. * creatinine \<1.5 mg/dl. * ecog performance status of 0-2 as below: * does not have rapidly progressive disease. * not pregnant or lactating.

Keywords: neuroblastoma immunotherapy gene therapy
evaluation of a decision assisting tool for prenatal testing

Conditions: Pregnancy

Summary: this is a randomized study of an interactive, computerized descision-assisting tool for prenatal testing decision making (pt tool) versus standard educational booklets distributed to all pregnant women by the state of california (control). we hypothesize that, compared to controls, women randomized to view pt tool will have greater knowledge about prenatal testing and its potential outcomes and better risk comprehension, and that they will be more satisfied with the intervention and have lower decisional conflict.

we will evaluate the tool in a randomized controlled trial among 500 patients receiving prenatal care at one of the obstetrics clinics and practices affiliated with the university of california at san francisco (ucsf), san francisco general hospital (sfgh), kaiser san francisco, or california pacific medical center (cpmc). after completing a baseline questionnaire, participants will be randomized to view either a control or intervention group. patients assigned to the control group will view the computerized version of the age-appropriate educational pamphlet concerning prenatal testing developed by the state of california. patients assigned to the intervention group will use the computerized decision support tool/educational module which provides important background information about chromosomal abnormalities, and patient-tailored information about the advantages and limitations of diagnostic testing.

Eligibility criteria:
inclusion criteria: * pregnant at less than 24 gestational weeks exclusion criteria: * not able to speak english or spanish

Keywords: prenatal testing amniocentesis decision making down syndrome
atherosclerotic coronary vulnerable plaque: correlation with coronary artery calcium

Conditions: Coronary Artery Disease

Summary: the aim of this study is to compare the relationship between the coronary artery calcification assessed by mdct with the plaque characteristics and necrotic lipid core content of non-intervened coronary segments assessed with near infrared spectroscopy (nirs) in patients with symptomatic coronary artery disease (cad).

a total of 60 patients, from a single center, who meet all of the study inclusion criteria and none of the study exclusion criteria will be prospectively enrolled in this study. qualifying patients will be referred to the study site for clinically indicated, non-emergent cardiac catheterization with nirs evaluation, either proceeded or followed by coronary artery calcium score (cacs) evaluation. qualifying patients that are referred directly to cardiac catheterization with nirs assessment secondary to symptoms or abnormal functional test will be sent for cardiac cacs assessment following the catheterization before discharge from the hospital. in this group, patients who require ad hoc pci upon initial angiography will be excluded to avoid artifacts on cacs. in patients who are referred for a clinically indicated cardiac catheterization with ivus evaluation within 3 months after mdct with cacs, nirs of at least two (2) major epicardial vessels will be completed prior to any (if necessary) coronary revascularization.

Eligibility criteria:
inclusion criteria: * patient is ≥18 years of age * patient is clinically indicated due to angina, abnormal functional test or other ischemic symptoms to undergo non-emergent cardiac catheterization with ivus evaluation i.if the patient has not had a cardiac mdct with cacs meeting the protocol requirements within 3 months prior to the cardiac catheterization, the patient is able to undergo cacs following lipiscan ivus and nirs evaluation, prior to any coronary revascularization ii. if the patient has had a cardiac mdct evaluation with cacs meeting the protocol requirements within 3 months prior to the cardiac catheterization, lipiscan ivus and nirs imaging will be completed in at least two (2) major epicardial vessels prior to any coronary revascularization * at least two (2) major epicardial native vessels are suitable for interrogation by lipiscan ivus imaging and nirs evaluation, defined as: i.at least 30 mm of vessel that is \> 2.0mm in diameter ii.no other contraindications to imaging * no contraindications for lipiscan ivus and nirs evaluation * no contraindications for cacs evaluation by mdct * subject must be able to provide informed consent form and comply with the protocol requirements exclusion criteria: * evidence of clinical hemodynamic instability in the 6 hours before either procedure * prior history of percutaneous coronary intervention (pci) with stent placement * prior history of bypass grafts * female subject that is pregnant or lactating * any other factor that the investigator feels would put the patient at increased risk or otherwise make the patient unsuitable for participation in the protocol
ultrasound-guided thermal ablation for benign thyroid nodules

Conditions: Thyroid Nodule (Benign)

Summary: to evaluate long-term outcomes of ultrasound-guided thermal ablation for benign thyroid nodules

to evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for benign thyroid nodules by a multicenter study

Eligibility criteria:
inclusion criteria: 1. confirmation of benign nodule status on two separate fine- needle aspiration or core-needle biopsy 2. no suspicious malignant features on ultrasound examination 3. report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation 4. refusal or ineligibility for surgery 5. follow-up time ≥12 months exclusion criteria: 1. follicular neoplasm or malignancy findings on biopsy 2. nodules with benign result on biopsy had suspicious of malignancy in us 3. patients with contra-lateral vocal cord paralysis 4. previous radiation to the head and neck 5. follow- up time less than 12 months