Kornimate/medical-research-clean huggingface dataset:
arbiter-ii: aorfix™ bifurcated safety and performance trial: phase ii, angulated vessels

Conditions: Abdominal Aortic Aneurysm

Summary: to assess the safety and performance of aorfix™ stent grafts in the treatment of abdominal aortic and aorto-iliac aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac arteries.

the aorfix™ stent graft is currently a ce-marked product indicated for aaa where the angle of the aneurysm is \ 60o (between 60 to 90 degrees) as measured by 3-dimensional reconstruction in order to widen the indication. the investigation is a prospective open label, single arm, multi-centre clinical study. the study group will consist of 25 evaluable participants. in order to account for patients lost to follow up (estimated at approximately 20%) up to 30 patients will be enrolled in the study.

Eligibility criteria:
inclusion criteria: * diagnosis of abdominal aortic aneurysm 50 mm or larger in diameter, 40 mm or larger in diameter if symptomatic (i.e. pain, embolisation), or documented aaa growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery(ies), or any saccular aneurysm. * infrarenal neck with a minimum length of 15 mm and a neck angulation between 60° and 90°, as assessed in 3 dimensions. * the iliac artery diameter must be of appropriate diameter (1 mm smaller than the device diameter), with an appropriate distal landing length. the tortuosity of the common or external iliac arteries or femoral arteries must be low to medium (refer to operations manual). * patient provides written informed consent. * patients \>18 years who are suitable for endovascular repair. * patient fit for endovascular surgery, with a diameter at the access sites of 7mm or larger bilaterally. * patient has a life expectancy longer than the duration of the study. exclusion criteria: * patient has a ruptured aneurysm. * patient has insufficient length of proximal aneurysm neck (\<15mm from aneurysm to lowest renal artery and \<20 mm from the aneurysm to the sma). * aneurysm extends above renal arteries. * proximal neck of aneurysm has significant loose thrombus associated with it, or significant circumferential calcifications. * pregnant or nursing patients. * patient unfit for bail-out surgery and appropriate anaesthesia. * patient with an acute or chronic aortic dissection or mycotic aneurysm (defined by localised asymmetric aneurysm sac). * patient has current non-localised infection. * patient has known allergy to graft materials, nitinol, or contrast media. * patient's where imaging is problematic; an example is an obese patient. * patient has co-morbidities that deny vascular access, including small / tortuous access vessels.

Keywords: abdominal aortic aneurysm study
conventional exercises plan with or without laser guided feedback for patients with non-specific low back pain

Conditions: Low Back Pain

Summary: low back pain (lbp) is a significant health issue. it impacts a significant portion of the adult population, reaching up to 80%, and results in substantial healthcare and socioeconomic expenses. to find out what changes occurred after the application of two exercise modalities \[conventional exercise (ce) and laser-guided exercise (lge)} and pne on pain, pain pressure thresholds, disability, catastrophizing, kinesiophobia, and lumbar proprioception in subjects with nsclbp.


Eligibility criteria:
inclusion criteria: * both male and female ages between 18 and 45 years (11). * patients diagnosed with nonspecific low back pain (11). * patients with pain intensity of "3" or greater on numeric pain rating scale exclusion criteria: * patients with neurological symptoms. * patients diagnosed with fatigue syndrome * females having pregnancy * history of low back surgery
study to evaluate the natural history of osteoporosis in children and adolescents with systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: this is a study to determine if people with lupus have weak bones. test which is a better method for detecting bone changes: * dual energy x-ray absorptiometry (dxa) * single energy quantitative computed tomography (seqct) evaluate whether weak bones are associated with things like medications or amount of fat and muscle.

this is a longitudinal cohort study to evaluate the natural history of osteoporosis in children and adolescents with systemic lupus erythematosus. the specific aims are: * to compare the bmd of children and adolescents with systemic lupus erythematosus to healthy controls utilizing dual energy x-ray absorptiometry (dxa) and single energy quantitative computed tomography (seqct). the following questions will be addressed at baseline: what is the variation of bmd seen among subjects with systemic lupus erythematosus? is the bmd of children with systemic lupus erythematosus diminished relative to healthy controls? if bmd is diminished, what is the severity of the reduction? * to characterize the annual change in bmd for children and adolescents with systemic lupus erythematosus over a five year period in a longitudinal cohort study utilizing arial and volumetric densitometry methods of both trabecular- and cortical-rich regions of bone. * to compare the use of dxa and seqct for measuring bmd in children and adolescents with systemic lupus erythematosus. * to characterize the determinants of bmd and corresponding markers of bone metabolism in a longitudinal cohort of pediatric systemic lupus erythematosus subjects. * to bank systemic lupus erythematosus subject blood and urine specimens for future analysis. future analysis will focus on newly developed bone metabolism markers, as this is a currently evolving area. * to evaluate body composition in systemic lupus erythematosus utilizing whole body dxa and to determine the contribution of body composition abnormalities to bmd. research design and method: this study includes a baseline cross-sectional component comparing systemic lupus erythematosus subjects to normal healthy controls followed by a longitudinal follow up study of systemic lupus erythematosus subjects. systemic lupus erythematosus subjects and controls will be evaluated in a single-day visit to the university of california, san francisco pediatric clinical research center for clinical assessment and phlebotomy followed by a radiologic evaluation at the department of radiology.

Eligibility criteria:
inclusion criteria: * systemic lupus erythematosus subjects 4/11 of the american college of rheumatology criteria for sle (23), age less than 22 years. exclusion criteria: * neonatal sle or drug-induced systemic lupus erythematosus * subjects who are pregnant, and subjects weighing over 300 pounds, as the densitometry techniques are not reliable above this weight. * subjects receiving calcium or vitamin d supplementation will not be excluded but this information will be recorded and evaluated further in the dietary/nutritional assessment.
impact of neutrophil extracellular traps (net) on thrombolysis in acute phase of cerebral ischemia

Conditions: Cerebral Infarct

Summary: cerebral infarcts represent a major cause of morbidity/mortality in spite of therapeutics for a premature recanalisation (intravenous recombinant tissue plasminogen activator (rt-pa) and thrombectomy). thrombolysis failure by the administration of rt-pa is frequent, in particular in proximal occlusion. experimental studies suggest that neutrophils could play an important role in the thrombus development via the organization of a network (net) within the thrombus. targeting this network of net could, in addition to the fibrinolysis, increase the rate of recanalisation and thus improve the neurological prognostic after a cerebral infarct. the aim of the research is to study of the biochemical and histological composition of the stemming thrombi of cerebral thrombectomies with in vitro analysis of the sensibility in the thrombolysis induced by rt-pa +/- desoxyribonuclease i (dnase i).


Eligibility criteria:
inclusion criteria: * patient over 18 * having a cerebral infarct consecutive to a wide calibre arterial occlusion * taken care for mechanical thrombectomy exclusion criteria: * patient benefiting from a legal protective measure * pregnant or breast-feeding woman * opposition of the patient to participate in the study

Keywords: neutrophil extracellular traps
inhaled gm-csf for respiratory virus-associated severe pneumonia

Conditions: Acute Respiratory Distress Syndrome; Pneumonia; Respiratory Virus Infection

Summary: this study will investigate the safety and efficacy of the administration of inhaled gm-csf to patients with respiratory virus-associated pneumonia.


Eligibility criteria:
inclusion criteria individuals must meet all of the following criteria to be eligible for inclusion in this study: male or female age ≥ 18 years and ≤ 80 years able to understand and willing to sign a written informed consent document, or if incapacitated, has a designated legal representative who is able to understand and willing to sign a written informed consent document able and willing to adhere to study visit schedule and study procedures currently either oro-tracheally or naso-tracheally intubated diagnosis of respiratory viral infection determined by: polymerase chain reaction (pcr)-based respiratory virus panel (rvp) positive for at least one of the following: respiratory syncytial virus (rsv) influenza a/b parainfluenza 1/2/3 human metapneumovirus adenovirus rhinovirus exclusion criteria individuals meeting any of the following criteria will be excluded from participating in this study. active tracheostomy history of either autoimmune pap or primary genetic pap diagnosis history of the presence of histopathologically- or radiographically-documented, clinically significant pulmonary fibrosis history of clinically significant cardiovascular disease including but not limited to congestive heart failure associated with new york heart association (nyha) functional classification of \>1 (i.e., with any degree of symptoms) history of typical or atypical angina within the past 6 months regardless of possible relief by nitrates history of clinically significant coagulopathy, bleeding diathesis, or other hematological disease history of severe allergic or anaphylactic reaction to sargramostim, other yeast-derived products, or any component of the study drug history of any other serious medical condition that, in the opinion of the principal investigator, would interfere with the ability of the patient to complete the study concomitant current or recent prior use of specific medications including lithium, either active or prior use within two weeks of screening and/or enrollment active non-steroidal anti-inflammatory drug use, including but not limited to ibuprofen women who are pregnant (i.e. have a positive serum pregnancy test), intending to become pregnant, breast feeding, or women of child-bearing potential who are unwilling to use contraception or maintain abstinence during the course of the study history of active tobacco/marijuana/e-cigarette use
map the sma: a machine-learning based algorithm to predict therapeutic response in spinal muscular atrophy

Conditions: Spinal Muscular Atrophy

Summary: spinal muscular atrophy (sma) is caused by the homozygous loss of the survival motor neuron (smn) 1 gene, which leads to degeneration of spinal alpha-motor neurons and muscle atrophy. three treatments have been approved for sma but the available data show interpatient variability in therapy response and, to date, individual factors such as age or smn2 copies,cannot fully explain this variance. the aim of this project is: * collect clinical data and patient-reported outcome measures (prom) from patients treated with nusinersen, risdiplam, onasemnogene abeparvovec, * identify novel biomarkers and rna molecular signature profiling, * develop a predictive algorithm using artificial intelligence (ai) methodologies based on machine learning (ml), able to integrate clinical outcomes, patients' characteristics, and specific biomarkers. this effort will help to better stratify the sma patients and to predict their therapeutic outcome, thus to address patients towards personalized therapies.


Eligibility criteria:
inclusion criteria: * confirmed genetic diagnosis of sma (5q) * clinical phenotype of type i or ii or iii; * able to provide (patient/caregiver) written informed consent exclusion criteria: * none
efficacy and safety of afq056 when combined with increased doses of l-dopa in parkinson's disease patients with moderate-severe l-dopa induced dyskinesia

Conditions: Parkinson's Disease

Summary: this phase iib exploratory study is designed to determine whether afq056 is safe and effective and whether it can increase the therapeutic window of l-dopa in patients whose control of their parkinson's disease symptoms is limited by the development of dyskinesia induced by use of l-dopa.


Eligibility criteria:
inclusion criteria: * outpatients with parkinson's disease (pd), treated with l-dopa, experiencing off time and dyskinesias for at least three months exclusion criteria: * surgical treatment for pd * cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated) * advanced, severe or unstable disease (other than pd) that may interfere with the study outcome evaluations other protocol-defined inclusion/exclusion criteria may apply

Keywords: parkinson's disease dyskinesia drug-induced levodopa l-dopa
umbilical cord mesenchymal stem cells infusion for initial type 1 diabetes mellitus

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1; Mesenchymal Stem Cells; Umbilical Cord

Summary: the purpose of this study is to determine whether umbilical cord mesenchymal stem cells of treatment for initial type 1 diabetes is safe and effective.

type 1 diabetes mellitus (t1dm)is characterized by the autoimmune destruction of the pancreatic β cells.patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. the investigators hope umbilical cord mesenchymal stem cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of type 1 diabetes by ada criteria less than 9 weeks. * ability to provide written informed consent from patients or child guardian. exclusion criteria: * diabetic ketoacidosis. * evidence of retinopathy at baseline. * body mass index \>30. * severe or acute organ damage. * infectious diseases, e.g. hiv infection, or hepatitis b or c infection. * severe psychiatric disorder. * presence of malignancy.

Keywords: diabetes mellitus diabetes mellitus, type 1 mesenchymal stem cells umbilical cord
predictive value of procalcitonin for the detection of bacteraemia in patients presenting to the emergency department for low risk chemo-induced febrile neutropenia

Conditions: Febrile Neutropenia, Drug-Induced

Summary: calif study is a monocentric observational study which aim is to analyse the value of adding procalcitonin (pct, a pre-hormon increased in bacterial infection and septicaemia) in the management of chemo-induced febrile neutropenia occurring in patient with solid tumour. febrile neutropenia will be managed according to international guidelines. pct will be dosed at initial presentation. primary objective is to determine the optimal value of pct for the detection of septicaemia in low risk (according to mascc score). the investigators plan also to compare two risk stratification scores: the validated mascc score and a recently developed score which includes pct and other more objective items.


Eligibility criteria:
inclusion criteria: * more than 18 years old * patients with solid malignant tumor treated by chemotherapy (neoadjuvant, concomittant, adjuvant or metastatic) * febrile neutropenia chemo-induced (fever \> 38°c, neutrophils \< 500 /microliter or nadir \< 500 /microliter) * patients non hospitalized at the event (when he presented febrile neutropenia) * informed consent signed exclusion criteria: * thyroid medullar carcinoma * patient not able to understand protocol (mental retardation, psychiatric disorders, .... )
safety, tolerability and efficacy of mp-376 given for 28 days to cystic fibrosis (cf) patients

Conditions: Cystic Fibrosis (CF)

Summary: patients with cystic fibrosis (cf) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in cf patients. aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat cf patients with pulmonary infections caused by multi-drug resistant pseudomonas aeruginosa and other bacteria. high concentrations of mp-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.

this trial will be a double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of levofloxacin administered as mp-376 of three dosage regimens given for 28 days by the aerosol route to cf patients. study with completed results acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria (selected): * \> 16 years of age * confirmed diagnosis of cystic fibrosis * positive sputum culture for p. aeruginosa within the past 18 months * patients are able to elicit a forced expiratory volume in 1 second (fev1) \>/= 25% but \</= 85% of predicted value at screening * have received at least 3 courses of inhaled antimicrobials over the preceding 12 months * clinically stable with no changes in health status within the last 30 days * able to reproducibly produce sputum and perform spirometry exclusion criteria (selected): * use of any nebulized or systemic antibiotics within 30 days prior to baseline * history of hypersensitivity to fluoroquinolones or intolerance with aerosol medication * evidence of acute upper within 10 days or lower respiratory infections within 30 days prior to dosing * creatine clearance \ /= 3 x upper limit of normal (uln) at screening
chiropractic and self-care for back-related leg pain

Conditions: Sub-acute and Chronic Back-related Leg Pain

Summary: the primary aims of the project are to determine the clinical efficacy of chiropractic spinal manipulative therapy (smt) plus self-care education versus self-care education alone in 192 patients with sub-acute and chronic back related leg pain (brlp) in both the short-term (after 12 weeks) and long-term (after 52 weeks). the primary outcome variable is leg pain and secondary outcome variables include low back pain, disability, bothersomeness and frequency of symptoms, general health status, and fear avoidance behavior. secondary aims are to describe and estimate between group differences in patient satisfaction, improvement, medication use, straight leg raise, torso endurance, and three biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response to sudden load. patient perceptions of treatment will also be assessed.


Eligibility criteria:
inclusion criteria: * back-related leg pain \> 3 on 0 to 10 scale. * sub-acute or chronic back-related leg pain defined as current episode \> 4 weeks duration. * back-related leg pain classified as 2, 3, 4, or 6 using the quebec task force (qtf) classification system. this includes radiating pain into the proximal or distal part of the lower extremity, with or without neurological signs, with possible compression of a nerve root. * 21 years of age and older. * stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in the previous month). exclusion criteria: * ongoing treatment for leg or low back pain by other health care providers. * progressive neurological deficits or cauda equina syndrome. * qtf classifications 5 (spinal fracture) and 11 (other diagnoses including visceral diseases, compression fractures, metastases). these are serious conditions not amenable to the conservative treatments proposed. * qtf 7 (spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking). * uncontrolled hypertension or metabolic disease. * blood clotting disorders. * severe osteoporosis. * inflammatory or destructive tissue changes of the spine. * patients with surgical lumbar spine fusion or patients with multiple incidents of lumbar surgery. this is a subgroup of low back pain patients which generally have a poorer prognosis. * pregnant or nursing women. * current or pending litigation. patients seeking financial compensation tend to respond differently to treatment.
fascial dehiscence and mortality

Conditions: Postoperative Wound Breakdown

Summary: nationwide cohort study on short- and long-term mortality of patients with and without postoperative fascial dehiscence. the cohort will be comprised of patient undergoing open colonic resection for colonic cancer registered in the danish colorectal cancer group database. the exposure is fascial dehiscence and the outcome of interest 30-day, 3- and 5-year mortality.


Eligibility criteria:
inclusion criteria: * all patients who underwent open colonic resection identified in the dccg exclusion criteria: * none

Keywords: fascial dehiscence mortality
a study to evaluate effectiveness and safety of er oros paliperidone in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the effectiveness and safety of extended release osmotic controlled-release oral delivery system (oros) paliperidone compared to placebo in patients with schizophrenia. olanzapine will be used as a reference drug in the study.

this is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. patients will be randomized into 1 of 3 treatment groups to receive oral dosages of extended release (er) osmotic controlled-release oral delivery system (oros) paliperidone 6 mg, olanzapine 10 mg, or placebo. they will receive two capsules of paliperidone er 3 mg, placebo or olanzapine 5 mg once daily after breakfast for 6 weeks. the study will include a screening period, followed by double-blind treatment for 6 weeks.

Eligibility criteria:
inclusion criteria: * patients who have given their own consent in writing to participate in the study * patients diagnosed with schizophrenia according to the diagnostic criteria of dsm-iv (diagnostic and statistical manual of mental disorders, 295.30, 295.10, 295.20, 295.90, 295.60) * patients who have acute symptoms of schizophrenia * both inpatients and outpatients are acceptable exclusion criteria: * a dsm-iv (diagnostic and statistical manual of mental disorders) of a mental disease diagnosis other than schizophrenia * a dsm-iv diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test * total panss (positive and negative syndrome system) score at the screening test \ 120 * patients treated with three or more types of antipsychotic within 28 days before the screening test * parkinson's disease (except for those with drug-induced extra pyramidal symptoms) * patients with a complication of or a past history of cerebrovascular accident * patients with a complication of or a past history of diabetes mellitus

Keywords: schizophrenia jns007er positive and negative syndrome scale (panss) paliperidone extended release osmotic controlled-release oral delivery system (oros) paliperidone