Kornimate/medical-research-clean huggingface dataset:
a study to evaluate lumasiran in children and adults with primary hyperoxaluria type 1

Conditions: Primary Hyperoxaluria Type 1 (PH1)

Summary: the purpose of this study is to evaluate the efficacy and safety of lumasiran in children and adults with primary hyperoxaluria type 1 (ph1).


Eligibility criteria:
inclusion criteria: * willing to provide written informed consent or assent and to comply with study requirements * confirmation of ph1 disease * meet the 24 hour urine oxalate excretion requirements * if taking vitamin b6 (pyridoxine), must have been on stable regimen for at least 90 days exclusion criteria: * clinically significant health concerns (with the exception of ph1) or clinical evidence of extrarenal systemic oxalosis * clinically significant abnormal laboratory results * known active or evidence of hiv or hepatitis b or c infection * an estimated gfr of \< 30 ml/min/1.73m\^2 at screening * received an investigational agent within 30 days or 5 half-lives before the first dose of study drug or are in follow-up of another clinical study * history of kidney or liver transplant * known history of multiple drug allergies or allergic reaction to an oligonucleotide or galnac * history of intolerance to subcutaneous injection * women who are pregnant, planning a pregnancy, or breast-feeding or those of child bearing potential and not willing to use contraception * history of alcohol abuse within the last 12 months, or unable or unwilling to limit alcohol consumption throughout the study

Keywords: ph1 primary hyperoxaluria rnai therapeutic sirna agt oxalate
comparison of continuous sternal ecg patch monitors (carnation and zio) trial

Conditions: Syncope; Presyncope; Palpitations; Atrial Fibrillation; Supraventricular Tachycardia

Summary: this study is intended to compare the new carnation patch monitoring system with the zio patch, which represents the current standard for continuous recording of the ecg over extended periods.

the purpose of this research is to confirm the clinical value of a new p-wave sensitive recording vector combined with an easy-to-use long-term cardiac rhythm monitoring patch system, the carnationtm ambulatory monitoring (cam) system. the p-wave is a critical aspect of the electrocardiogram and a key finding for proper arrhythmia diagnosis. the cam system is optimized for both ease of use and for maximum p-wave clarity for arrhythmia diagnosis.

Eligibility criteria:
inclusion criteria: * syncope of uncertain etiology or * pre-syncope of uncertain etiology or * palpitations of uncertain etiology or * management of known af/svt patients exclusion criteria: * any dermatitis or infected skin over the sternum (carnation patch) or left upper anterior thorax (zio patch). * a sternal or thoracic incision that extends under the patch within 3 months from the date of enrollment
continuous versus intermittent bolus infusion of paravertebral blocks for thoracic surgery

Conditions: Thoracic Diseases

Summary: the researchers are trying to determine pain medication consumption in the first 24 hours after surgery in patients given the standard continuous infusion of local anesthetic versus patients given the same total dose via programmed intermittent dosing. both groups will receive the option of patient controlled pain medication as well as the same dose of pre-programmed pain medication. the only difference is the rate of administration: continuous vs. hourly intervals.


Eligibility criteria:
inclusion criteria: * documentation of planned thoracic surgery for which a paravertebral catheter is indicated based on surgeon request as well as appropriateness of location of surgical site. * ability for subject to comply with the requirements of the study. exclusion criteria: * pregnancy. * coagulopathy at time of evaluation or surgery. * infection at the site of needle insertion. * allergy to local anesthetic. * patient refusal. * chronic opioid use
evaluation of ngs for detection and follow-up of fungal pathogens in immunocompromised pediatric patients

Conditions: Invasive Fungal Disease; Fever and Neutropenia; Invasive Fungal Infections; Immunocompromised

Summary: the sponsor hypothesize that next-generation sequencing (ngs) can identify fungal pathogens, is more accurate than other noninvasive options and can report fungal genomic load.

the sponsor aims to describe the incidence of positivity for fungal specific pathogens on ngs analysis in a high-risk immunocompromised pediatric population. secondarily, the sponsor will correlate results of the ngs analysis to other approved fungal tests if performed at the discretion of the treating provider (e.g. blood culture results, radiographic findings, biopsy results, bronchoalveolar lavage findings, galactomannan results or b-d-glucan (bg) results as evaluated via fda-approved "fungitell" assay). the sponsor will use these other fungal tests, in addition to clinical criterion, to classify subjects as having possible, probable and proven ifd according to established criteria, and compare these categories against results from ngs analysis. lastly, to quantitatively evaluate follow-up test results to determine fungal dna genomic load in subjects with positive results.

Eligibility criteria:
inclusion criteria: * prolonged fn (≥96 hours) despite broad-spectrum antibiotic therapy with anticipated delayed neutrophil recovery * any findings that trigger the primary team to consider new fungal infection in a given inpatient, such as abnormal imaging results, recrudescent fevers in the setting of neutropenia or characteristic skin rashes exclusion criteria: -those without concern for fungal infection or those currently being treated for a presumed or documented fungal infection will not be recruited for this study
short implants in edentulous mandible

Conditions: Tooth Loss; Edentulous Jaw

Summary: main aim of this study was to assess survival rates of short implants with a length of 4 mm in the edentulous mandible after 1, 3, and 5 years.

it is hypothesized that survival rates after 1, 3, and 5 years of straumann roxolid® / slactive® 4 mm short implants do not differ from values of straumann slactive implants with more than 4 mm length in the same clinical situation.

Eligibility criteria:
inclusion criteria: general criteria: * age: 18 to 70 * edentulous mandible with reduced bone level in the posterior region (\> 5 mm and \< 8 mm above nerve conduit) * physical and mental condition that allow surgery and a 5-year follow-up period to be carried out without foreseeable problems * obtained informed consent from the patient specific criteria: * limited vertical space for implant placement, where conventional implants with lengths of more than 4 mm cannot be used * tooth loss or extraction at least 8 weeks before implant surgery * healthy implantation site * favorable and stable occlusal relationship * complete denture in the mandible. if no denture available, an interims prosthesis will be fitted * natural full dentition or sufficient complete or partial dentures in the maxilla exclusion criteria: general criteria: * any conditions or circumstances which would interfere with the requirements for oral surgery * allergy to any metallic implant component * acute, untreated periodontitis * previous oro-maxillo-facial radiotherapy * any disorders in the planned implant area such as previous tumors or chronic bone disease (e.g., rheumatoid disease) * any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.) * alcohol or drug abuse * heavy smoking (\>10 cigarettes/day) * uncontrolled diabetes * severe bruxism or other destructive oral habits * pregnant or lactating women specific criteria: * need for a major bone regeneration technique * infections in adjacent tissue of the planned implantation site. * bleeding on probing (bop) and plaque index (pi) higher 25% * insufficient bone volume in the posterior region for placing a straumann roxolid® / slactive® 4mm short implant and in the interforaminal region for placing a straumann roxolid® / slactive® implant with a minimum length of 10 mm determined by radiographic analysis (opg)
rapid on-site evaluation of endobronchial ultrasound guided transbronchial needle aspiration samples by pulmonologists

Conditions: Intrathoracic Lymphadenopathy

Summary: the study is aimed at verifying if a pulmonologist in training can reliably assess the adequacy of ebus-tbna samples from intrathoracic lymphadenopathy after a period of training provided by an experienced pathologist.


Eligibility criteria:
inclusion criteria: * indication to sampling of intrathoracic lymphadenopathy based on computed tomography (ct) and/or positron emission tomography (pet)/ct findings * signed informed consent exclusion criteria: * high risk conditions for the performance of bronchoscopy and endobronchial ultrasound guided transbronchial needle aspiration (ebus-tbna) * high risk condition for deep sedation (asa 4) * pregnancy
healthy aging through movement

Conditions: Opioid Use Disorder

Summary: this study aims to examine the effectiveness of a supervised aerobic exercise program for persons with opioid use disorder (oud). participants will be enrolled in a 12-week supervised aerobic exercise intervention.

the overall project goals are to test the feasibility and acceptability of our aerobic exercise intervention with this population. study participation will include a screening and enrollment phase, a baseline assessment, and a 12-week intervention. participants will be recruited and consented by university of florida (uf) study staff.

Eligibility criteria:
inclusion criteria: * adults must be aged 21-64 years old * currently enrolled in omt (opioid maintenance treatment) or present with at least mild opioid use disorder (endorses at least 2 dsm-v criteria for oud within a 12-month period), * insufficiently physically active (defined as exercising \< 20 minutes 3 times/week * able to understand and speak english * have a body mass index 18.5-40 kg/m\^2 * willing and able to visit research center up to one time time/week for 12 weeks * participants will undergo a supervised maximal exercise test and physical exam by medical supervisor to be cleared for participation. exclusion criteria: * participants must not have heart disease, or had a stroke, uncontrolled diabetes, thyroid condition an eating disorder * an uncontrolled major psychiatric condition (e.g., schizophrenia; conditions that are well-controlled, however \[e.g., anxiety controlled through therapy\] will not be exclusionary), or other medical condition(s) that contraindicate exercise; and may not be participating in a structured exercise training or weight loss program. * participants cannot be pregnant; pregnancy is exclusionary * one individual per household may enroll.

Keywords: pain exercise
predictor of advanced subclinical atherosclerosis

Conditions: Coronary Artery Disease

Summary: evaluation of skin cholesterol for cardiovascular risk assessment in asymptomatic individuals at low, intermediate, or high risk based on framingham global risk estimates. carotid intima-media thickness (imt), a surrogate marker for atherosclerotic burden, that independently predicts the occurrence of heart attack and stroke, will be the "gold standard" comparator. hypothesis: skin cholesterol, as measured by two non-invasive tests, correlates with cad, as measured by cimt in this population.

this study will enroll 600 asymptomatic subjects at low (\ 20%) 10-year framingham global cardiovascular risk in approximately equal proportions. subjects will be enrolled from each of the three risk levels at each study site (6 total in the us). subjects will be enrolled in a consecutive manner until there are 200 subjects from each risk level. we will track the number of subjects from each risk stratum. we will also ensure adequate representation of women (at least 33%) and african americans (at least 25%)in the study. we will test the subjects with 2 non-invasive skin cholesterol tests and will take a sample of blood that will be tested for serum cholesterol values and other markers of cad. subjects will also undego a carotid imt scan. the primary objective of the study is to see if skin cholesterol correlates with cad, as measured by cimt.

Eligibility criteria:
inclusion criteria: 1. informed written consent from the subject prior to testing. 2. males or females 40-80 years of age exclusion criteria: 1. subjects taking cholesterol-lowering medications 2. known hepatitis 3. known pregnancy 4. skin disease on either hand (e.g. eczema psoriasis, rash or broken skin) 5. known cad (previous myocardial infarction, coronary revascularization procedure), cerebrovascular disease (previous stroke, transient ischemic attack, or carotid revascularization procedure), or peripheral arterial disease(claudication or previous revascularization procedure)
effects of resistance training in multiple sclerosis: a randomized trial.

Conditions: Multiple Sclerosis

Summary: this is a longitudinal study to examine the effects of a short-term training program on neurofilamet and gfap plasma levels. participants will be divided in two groups: control group (moderate aerobic training) and active group (resistance training). the change in biomarkers will be analyzed pre and post intervention in both groups. differences between groups will be also evaluated by investigators.

multiple sclerosis is a dysimmune and neurodegenerative disease of the central nervous system. despite highly effective drug, multiple sclerosis represents the main cause of non-traumatic disability in young people. interventions based on physical exercise have a positive impact on the course of the disease, although the pathophysiological mechanisms responsible for this benefit remain unknown. this project aims to investigate the impact of physical exercise on neuronal destruction in patients with multiple sclerosis. to do this, the investigators will study the evolution of the concentrations of two markers of neuronal injury, acidic gliofibrillary protein (gfap) and light chain neurofilaments (nfl) in two groups of patients: a control group and a second group subjected to a supervised resistance physical exercise program performed during 10 weeks. marker values will be compared before and after the intervention and between groups. the results will allow the investigators to delve into the pathophysiology of multiple sclerosis and the mechanism through which physical exercise impacts on the disease. in addition, the investigators will generate knowledge that will allow us to reinforce the idea of integrating physical exercise as part of the treatment in multiple sclerosis. project within the framework of the grs(gerencia regional de salud, castilla y léon) 28/10/a1/2023

Eligibility criteria:
inclusion criteria: 1. - diagnosis of multiple sclerosis according to the 2017 mc donald criteria (thompson a et al). 2. - age \> 18 years - up to no age limit 3. - disability assessed by the edss (expanded disability status scale) with a score less than or equal to 4. 4. - clinical stability. not having had an outbreak of the disease in the last 6 months. 5. - no changes in the disease-modifying treatment in the last 6 months or no treatment. 6. - radiological stability. patients with last mri (magnetic resonance imaging) performed without inflammatory activity (absence of new lesions on t2 sequences or lesions that enhance with gadolinium). 7. - they must sign the informed consent exclusion criteria: 1. - patients with a high level of physical activity according to the international physical activity questionnaire(ipaq) or latest who (world health organization) recommendations on physical activity 2. - pregnant or breastfeeding patients. 3. - concomitant pathologies that limit the performance of physical exercise

Keywords: physical exercise resistance training neurofilaments gfap
spectrometry (mrm) versus i 125 radioimmunoassay (ria) for quantification of orexin-a of patients with hypersomnolence

Conditions: Narcolepsy; Idiopathic Hypersomnia; Cataplexy

Summary: in humans, selective loss of orexin neurons is responsible for type 1 narcolepsy (nt1), or narcolepsy with cataplexy, or orexin deficiency syndrome. the international classification of sleep disorders 3rd edition (icsd-3) distinguishes between hypersomnolence of central origin: nt1, narcolepsy type 2 (nt2), or narcolepsy without cataplexy, and idiopathic hypersomnia (hi). these rare conditions are all characterised by hypersomnolence (excessive daytime sleepiness, or excessive need for sleep), which is the primary and often most disabling symptom. a level of orx-a in cerebrospinal fluid (csf) (\<110 pg/ml) is a very sensitive and specific biomarker of nt1, currently sufficient for the diagnosis of this condition. in contrast, orx neurons are thought to be intact in ih and nt2, and the pathophysiological mechanisms underlying these diseases remain unknown. thus, their diagnosis is based solely on clinical and electrophysiological criteria. the objective of this project is to determine the validity of a mass spectrometric technique for the determination of orx-a in the cerebral spinal fluid of patients suffering from hypersomnolence in comparison with the radioimmunoassay which is the reference technique.


Eligibility criteria:
inclusion criteria: * age ≥ 8 years * complaint of hypersomnolence and suspected central hypersomnolence * benefiting from a standardised assessment: clinical, biological and neurophysiological * lumbar puncture necessary for the assessment * sufficient cerebrospinal fluid taken for biological analysis (at least 1 ml) * signed informed consent exclusion criteria: * contraindication to lumbar puncture * secondary hypersomnolence * refusal to participate in the study or refusal of the lumbar puncture * adult protected by law, or subject deprived of liberty, by judicial or administrative decision or patient under guardianship or curatorship * subject not affiliated to the french social security system * pregnant or breastfeeding woman

Keywords: orexin/hypocretin sleepiness
statin for preventing hepatocellular carcinoma recurrence after curative treatment

Conditions: HepatoCellular Carcinoma

Summary: the purpose of this study is to evaluate whether statin could prevent recurrence of hepatocellular carcinoma after curative treatment

this is a multi-center double-blind randomized placebo-controlled trial. a total of 240 patients with hcc at bclc stage 0 or a will be enrolled from 8 hospitals in taiwan. after complete ablation or hepatic resection of the tumor(s), participants are randomized 1:1 to receive either atorvastatin 10mg once daily (intervention group) or matched placebo (control group) for 3 years. during the 3-year period, patients are monitored for recurrence of hcc by dynamic computed tomography (or magnetic resonance image) every 4 months. they will be followed up until death, withdrawal from participation, study termination, or 3 years after the ablative treatment. the primary endpoint is to compare the 3-year cumulative incidence of recurrent hcc between the intervention group and control counterpart. secondary endpoints are occurrence of clinical complications related to hepatic decompensation (including gastroesophageal variceal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and hepatopulmonary syndrome), liver-related mortality, and all-cause mortality.

Eligibility criteria:
inclusion criteria: * individuals with hcc bclc stage 0 or a who received curative radiofrequency ablation or hepatic resection could be eligible. * individuals who had single hcc (size \> 5.0 cm) received hepatic resection would be eligible * individuals with prior history of hcc who had ever received curative ablation or hepatic resection without any recurrence for more than 2 years could be eligible if they had a new episode of recurrent hcc which could meet either of the former two criteria. * after 12+/-1 weeks of curative treatment, eligible patients who have no evidence of local residual or recurrent tumors according to the dynamic ct or mri could be enrolled * the diagnosis of fresh hcc should be compatible with either pathological report or meet the criteria of aasld guidelines exclusion criteria: * undetermined nature of hepatic tumor * hcc with extrahepatic metastasis or major vascular invasion * with other malignant disease * child pugh score \>7 * previous history of cad event (angina, unstable angina, acute myocardial infarction) or ischemic stroke * hyperlipidemia or other indication for statin (according to taiwan nhi guideline) * advanced ckd (egfr\<30) or esrd * severe comorbidity with life expectancy \< 2 years * allergy to statin

Keywords: hepatocellular carcinoma statin curative ablation
phase ii trial of tarceva in patients with non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: a open label non- randomized phase ii trial. it is anticipated that approximately 46 patients will be treated. study objectives primary: objective response rate secondary: progression free survival, overall survival and safety of tarceva

study design: phase ii trial, open label, non-randomized and multicenter. expected total enrollment: 46 study start: january, 2006 study completation: january, 2008

Eligibility criteria:
inclusion criteria: * age 18 years. * patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage ia- iiib). * measurable disease. * written informed consent must be obtained prior to the inclusion into the trial. * karnofsky performance status of 80%. * patients must have been treated with no prior chemotherapy or radioterapy. * patients must have adequate bone marrow, liver and renal function. * bone marrow: wbc \> 3000 x 103/mm3, * platelets \> 100 x 103/mm3, * hgb \> 10.0 gm/dl, * anc \>1500 x 103/mm3, * hepatic:bilirubin \< 2 mg/dl (34 µmol/l); ast, alt, and alkaline phosphatase \< 5 x normal, * renal:creatinine \< 1.5 mg/dl (132 µmol/l). exclusion criteria: * female patients who are pregnant or lactating. * patients who have used other investigational agents within 21 days prior to study entry. * patients who have received prior treatment with erlotinib or other anti-egfr agent. * significant comorbidity.
molecular genetic mechanisms of infantile epilepsies and the impact of genetic diagnosis

Conditions: Neonatal Epilepsy; Infantile Epilepsy

Summary: the goal of this study is to discover new genetic causes of infantile epilepsies and evaluate the impact of these discoveries on infants with epilepsy and their families.

infantile epilepsies are common, affecting 1 in 1000 infants, and are associated with significant morbidity, mortality, healthcare costs, and caregiver burden. although most infantile epilepsies are believed to have genetic causes, most infants with epilepsy remain genetically "unsolved" and the full genetic landscape of infantile epilepsies is unknown, which limits our ability to develop precision therapies and ultimately improve outcomes for this vulnerable population. this study aims to discover new genetic causes of infantile epilepsies and evaluate the impact of these discoveries on infants with epilepsy and their families, contributing to knowledge that will inform our scientific understanding of normal and abnormal brain development and guide clinical care and implementation of precision medicine for infants with epilepsy.

Eligibility criteria:
infant criteria inclusion criteria: * seizure onset at less than 12 months of age * enrollment within 6 weeks of seizure-related presentation * patient at boston children's hospital exclusion criteria: * simple febrile seizures * acute provoked seizures (e.g., due to sepsis, hemorrhage, electrolyte abnormality, cerebral infarction, hypoxic ischemic encephalopathy, non-accidental injury) * genetic or acquired cause of epilepsy already identified, including brain magnetic resonance imaging findings consistent with a specific genetic etiology (e.g., tuberous sclerosis complex) * deceased prior to enrollment parent criteria inclusion criteria - parent of eligible infant (see above) exclusion criteria - not the legal guardian of the eligible infant