Kornimate/medical-research-clean huggingface dataset:
effects of intravenous k201 on the restoration of sinus rhythm in subjects with symptomatic atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to evaluate the effects of a single intravenous infusion of k201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.


Eligibility criteria:
inclusion criteria: * symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms). * atrial fibrillation documented by ecg at the start of study drug infusion. exclusion criteria: * previous exposure to k201 * qtcf (fridericia correction) \>440 ms * qrs interval \> 140 ms * paced atrial or paced ventricular rhythm on ecg * history of receiving another intravenous class i or class iii antiarrhythmic drug within 3 days of randomization * history of amiodarone (oral or iv) in the last 3 months. * clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization * history of failed electrical cardioversion at any time in the past * history of polymorphic ventricular tachycardia (e.g. torsades des pointes) * history or family history of long qt syndrome * history of ventricular tachycardia requiring drug or device therapy * ejection fraction of 40% or less.
study of npc-07 for fluorescence-guided resection of malignant gliomas

Conditions: Malignant Glioma

Summary: the aim of the present phase iii study is to assess the positive predictive value of npc-07 (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and pharmacokinetics following a single dose of npc-07 orally, at a dose of 20mg/kg/body weight, 3 hours prior to induction of anaesthesia for surgery of patients with newly or recurrent malignant glioma (who grades iii/iv). positive predictive value will be confirmed by percentage of patients showing positive tumor cell identification in all biopsies taken from areas of strong and weak fluorescence. this study will be divided into two stages. after reviewing of the result of safety and pharmacokinetics of npc-07 in small number of subjects by independent safety monitoring committee, more subjects will receive npc-07 in step ii.


Eligibility criteria:
inclusion criteria: * aged between 18 and 70 years. * radiological suspicion of newly- or recurrent malignant glioma (who grades iii/iv). * indication for surgical tumor resection. * karnofsky performance score of 60 or higher. * provides signed informed consent prior to any study procedures. * comply with visit schedule and other rules for patients in study protocol. exclusion criteria: * porphyria, hypersensitivity to porphyrins. * renal insufficiency: creatinine 2.0 mg/dl or higher * hepatic insufficiency: alt 100 iu/l or higher, ast 100 iu/l or higher, γ-gtp 100 iu/l or higher or total bilirubin 3 mg/dl or higher * chemotherapy or other treatment for other malignant tumors * females who are pregnant or potentially childbearing or are breastfeeding * participation in other clinical trial in the previous 1 month * ineligible patient based on the judgement of the investigator.

Keywords: npc-07, 5-ala, photodynamic diagnosis, pharmacokinetics
the effect of hypermobility healthy individuals

Conditions: Respiratory Problems

Summary: benign joint hypermobility syndrome is a hereditary connective tissue problem characterized by the emergence of multiple musculoskeletal problems in hypermobile individuals without a systemic rheumatologic disease. studies have shown that hypermobility may also affect lung function. playing wind instruments requires tiring breathing activity. the effect of wind instrument on lung function and how it affects lung function is a highly controversial issue. given the distribution and importance of collagen tissue in the body, multiple effects of hypermobility are inevitable. the aim of this study was to evaluate the presence of hypermobility in young healthy individuals; the aim of the study is to investigate the effects of hypermobility on the cardiovascular system and to provide training to the participants regarding the findings.the aim of this study is to investigate the relationship of hypermobility with respiratory functions in professional hypermobile musicians and to compare this relationship with healthy hypermobile individuals who are not engaged in music.

sociodemographic data and musical backgrounds of all cases will be recorded. in accordance with the objectives, erm upper extremity hypermobility assessment questionnaire "was used for hypermobility, pulmonary function test, respiratory and oral pressure measurement and respiratory muscle strength. the george respiratory questionnaire (sgrq) will be used to assess the quality of life associated with respiration and the risk of asthma with the ile european respiratory health survey, phase 1 "questionnaire.we believe that the effects of hypermobility on pulmonary functions in healthy individuals will be clarified if this study takes place.

Eligibility criteria:
inclusion criteria for musicians be between 18-35 years playing wind instruments for at least one year for the hypermobile subgroup; obtaining ≥7 / 12 points from the upper extremity hypermobility assessment questionnaire inclusion criteria for healthy individuals not engaged in music be between 18-35 years no diagnosed health problems for the hypermobile subgroup; obtaining ≥7 / 12 points from the upper extremity hypermobility assessment questionnaire exclusion criteria for musicians having a specific respiratory problem diagnosed symptoms of nerve impingement in upper extremity smoking exclusion criteria for healthy individuals not engaged in music symptoms of nerve impingement in upper extremity smoking

Keywords: musicians respiratory hypermobility
variability and post-op aes: does preoperative cardiopulmonary variability assessment identify risk of postoperative adverse events following thoracic surgery

Conditions: Thoracic Cancer; Complication,Postoperative

Summary: major thoracic surgery is high risk as it carries a significant risk of postoperative adverse events (aes), where patients experience complications and do not recover as expected. these aes can increase the risk of mortality, hospital length of stay, as well as healthcare costs. our aim is to improve surgical safety by pioneering a marked advance in preoperative prediction of postoperative aes that will enable individualized targeted perioperative pathways to prevent postoperative aes. given that illness and stress are associated with a loss in physiologic variability (e.g. heart and respiration rate), we will use heart and lung variability assessments to improve prediction of postoperative aes. therefore, this study aims to assess the feasibility of implementing a preoperative cardiopulmonary variability assessment; determine if preoperative cardiopulmonary variability is associated with postoperative aes; and determine if this variability assessment is superior and complementary to existing measures of risk and frailty.


Eligibility criteria:
inclusion criteria: * adult patient (≥18 years of age) * patients undergoing major thoracic resection for lung, esophageal or gastric cancer or mediastinal tumour (at least lobectomy, pneumonectomy, esophagectomy, gastrectomy, or mediastinal tumour resection) exclusion criteria: * urgent/emergent cases * patients with pre-existing atrial fibrillation or arrhythmia (persistent/paroxysmal) * patients that are pacemaker dependent * patients unable to participate in preoperative testing protocol (cardiopulmonary variability assessment) * patients that are pregnant
experience sampling method for symptom assessment in irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: reliable patient reported outcome measures (prom's) for symptom assessment in irritable bowel syndrome are essential in order to investigate natural disease course and potential treatment options aimed at symptom improvement, since biological markers are currently unavailable. currently used symptom assessment methods, i.e. end-of-day or end-of-week questionnaires, have considerable limitations. the experience sampling method (esm), an electronic questioning method characterized by random and repeated, momentary assessments in the subject's current state and environment, might overcome these limitations. aim of this study is to validate an ibs-specific electronic patient-reported outcome measure, based on the experience sampling method-principle, for symptom assessment in ibs.


Eligibility criteria:
inclusion criteria: * diagnosis of irritable bowel syndrome according to rome iv criteria. * ability to understand and speak the national language of the concerning center. * ability to understand how to utilize the esm-tool. exclusion criteria: * any organic explanation for the abdominal complaints. * a history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy. * start up of regularly used medication from one month before inclusion until the end of study participation.

Keywords: irritable bowel syndrome (ibs) experience sampling method (esm) ecological momentary assessment (ema) abdominal pain
research of anatomo-functional biomarkers in schizophrenia

Conditions: Schizophrenia

Summary: to objectify ur biomarkers, we propose a longitudinal follow-up of resistant patients with schizophrenia, starting before the onset of clozapine and including a multimodal brain imaging assessment (t1 and t2 weighted sequences, dti, asl-perfusion, fmri- rest) associated with clinical and biological monitoring. in order to correct the mri signal of clozapine hemodynamic effects, we will develop a new mri methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).

the identification of biomarkers of ultra-resistance (ur) to treatment in schizophrenia would allow earlier, better adapted and more effective personalized management of these patients, which would improve their functional prognosis. an early decrease in functional connectivity (fc) between some rest networks has recently been proposed as an ur biomarker by mcnabb et al. nevertheless, clozapine has, among its side effects, a direct cardiac action that profoundly modifies patient's hemodynamics. however, functional brain imaging techniques are based on bold effect which is dependent on these hemodynamic parameters. it is therefore not possible to say whether these differences in fc are inherent to the pathology or whether they are related to clozapine instauration which causes hemodynamic changes that may disturb bold signal. to objectify ur biomarkers, investigators propose a longitudinal follow-up of resistant patients, starting before clozapine instauration and including a multimodal brain imaging assessment (t1 and t2 weighted sequences, dti, asl-perfusion, fmri- rest) associated with clinical and biological monitoring. in order to correct the mri signal of clozapine hemodynamic effects, investigators will develop a new mri methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).

Eligibility criteria:
inclusion criteria: * schizophrenia or schizoaffective disorder (dsm 5) * drug resistance * written patient approval * social security number in france * curator or tutor approval if needed exclusion criteria: * pregnancy * other research participation * neurological evolution disorder * no mri contraindication

Keywords: schizo-affective disorder utra-resistance clozapine biomarker fmri
impact of immune status on secondary infections in patients with acute respiratory failure

Conditions: ARDS

Summary: this is a retrospective observational study over the period 1/2019 - 02/2024 with the aim of identifying patients with a predisposition to secondary infections.

as a reference center, charité universitaetsmedizin berlin has been treating patients with the most severe form of acute respiratory failure, known as acute respiratory distress syndrome (ards), for more than 30 years. despite lung-protective forms of ventilation and the use of extracorporeal procedures for oxygenation and decarboxylation (ecmo), mortality is around forty percent. in addition to the primary cause of ards, further infectious complications often develop during the course of the disease, which delay recovery. the aim of this study is to investigate infectious complications (ventilator-associated pneumonia, reactivation of herpes viridae, pathogen resistance despite formally correct therapy, fungal infections) depending on the immune status.

Eligibility criteria:
inclusion criteria: * male and female acute respiratory distress syndrome patients who had an immune status within 48 h of admission * patients who received intensive care treatment for acute respiratory distress syndrome ward 8i at charité in the period from 01/2019 to 02/2024 with a maximum follow-up period of 90 days exclusion criteria: * none

Keywords: ards ecmo herpes viridae
cerebral abnormalities detected by mri, realized at the age of term and the emergence of executive functions

Conditions: Premature Baby 25 to 32 Weeks

Summary: the survival of premature babies increased during the last decades. however, the neurocognitive long term development of these children is worrying, as demonstrated by epipage 1 study. these children present high risk of deficits such as cognitive deficits, adaptive malfunction, behavior disorders and difficulties in school learning. understanding the specific neuropsychological disorders at the origin of these deficits is an important objective. studies realized at school age showed that many premature children have executive functions (ef) disorders. however the specific nature of these disorders and the neuropathology associated are unknown. the aim of this study is to realise mri at term age in preterm babies born less than 32 ga and to correlate mri findings with executives functions and neurodevelopmental outcome

an mri would be realized between 39 and 41 ga at the age of 5 years, executive functions and neurodevelopmental testing would be realized. 600 newborns were recruited.

Eligibility criteria:
inclusion criteria infants who were : * born between 25 and 32 wga * hospitalized in a neonatology service which participate to the present study * included in epipage 2 follow-up study * infants whose parents had signed the consent agreement and benefit from national health insurance exclusion criteria * infants with congenital abnormalities

Keywords: premature baby mri : conventional and advanced images executive function testing at 5 years of age
the effect of glutamatergic modulation on cocaine self-administration

Conditions: Cocaine Dependence

Summary: repeated drug consumption may progress to problematic use by triggering neuroplastic adaptations that attenuate sensitivity to natural rewards while increasing reactivity to craving and drug cues. converging evidence suggests that glutamate modulation may work to correct these adaptations and rapidly restore motivation for delayed non-drug rewards relative to immediate drug use. using an established laboratory model aimed at evaluating behavioral shifts in the salience of cocaine now vs. money later, the investigators will test the effect of ci-581a on cocaine self-administration as compared to the active control.


Eligibility criteria:
inclusion criteria: 1. active cocaine dependence with at least 8 days of use or at least 4 binges of large amounts (\>$200/occasion) over the past 30 days, and displaying at least one positive utox during screening 2. physically healthy 3. no adverse reactions to study medications 4. 21-55 years of age 5. capacity to consent and comply with study procedures, including sufficient proficiency in english 6. not seeking treatment exclusion criteria: 1. meets dsm iv criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance induced psychosis, and current substance-induced mood disorder with hamd score \> 12. 2. physiological dependence on another substance, such as alcohol, opioids, or benzodiazepines, excluding caffeine, nicotine, and cannabis 3. delirium, dementia, amnesia, cognitive disorders, or dissociative disorders 4. current suicide risk or a history of suicide attempt within the past year 5. pregnant or interested in becoming pregnant during the study period 6. any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse 7. unstable physical disorders which might make participation hazardous such as end-stage aids, hypertension (\>140/90), wbc \ 2, bun \>40), or untreated diabetes 8. previous history of ketamine or midazolam misuse or abuse, and a history of an adverse reaction/experience with prior exposure to cocaine, ketamine or midazolam 9. recent history of significant violence (past 2 years) 10. abnormal pseudocholinesterase level 11. first degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis nos) 12. bmi \> 35, or a history of documented obstructive sleep apnea 13. on psychotropic or other medications whose effect could be disrupted by participation in the study
a study to assess plasma ammonia time-normalized area under the curve and rate of ureagenesis in healthy adult subjects

Conditions: Ornithine Transcarbamylase Deficiency

Summary: the objective of the study is to characterize 24-hour plasma ammonia levels, characterize urea production rates in healthy normal subjects.

during part 1, eligible subjects will be asked to participate in 3 inpatient visits, each lasting up to 3 days (day -1 to day 2). each visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of \[1-13c\]sodium acetate. sodium acetate is used as a tracer to measure the rate of ureagenesis. during part 2, eligible subjects will be asked to participate in 1 inpatient visit, lasting up to 3 days (day -1 to day 2). the visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of \[1-13c\]sodium acetate. sodium acetate is used as a tracer to measure the rate of ureagenesis.

Eligibility criteria:
inclusion criteria: * body mass index between 18 and 30 kg/m2, inclusive. exclusion criteria: * history of liver disease as evidenced by any of the following: portal hypertension, ascites, splenomegaly, esophageal varices, hepatic encephalopathy, or a liver biopsy with evidence of stage 3 fibrosis. * significant hepatic inflammation or cirrhosis as evidenced by imaging or any of the following laboratory abnormalities: alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than the upper limit of normal (uln), total bilirubin \>1.5 × uln, alkaline phosphatase \>2.5 × uln. note: the alt and/or ast levels may be repeated. * subject has a history of gout. * plasma ammonia level that is not within normal limits at screening in the opinion of the investigator or sponsor. * received any vaccine within 14 days prior to screening. * pregnant, lactating, or intending to become pregnant at any time during the study. * blood transfusion within 8 weeks prior to screening.diuretics, cyclophosphamide and other cytotoxic agents, tolbutamide, chlorpropamide, diazoxide, dichlorphenamide, pyrazinamide, probenecid, theophylline/aminophylline, riluzole, warfarin and other antithrombotic agents, supplements containing aluminum hydroxide, or iron supplements within 30 days of part 1or part 2.
attentional focus influence during cranio-cervical flexion test

Conditions: Neck; Anomaly; Muscle Weakness; Muscle Weakness Condition

Summary: the purpose of this study is to termine if a different attentional focus would alter the motor control in cervical muscles during the cranio-cervical test.

asymptomatic subjects will be recruited to this study. superficial electromyography of the sternocleidomastoid, range of motion (rom) and cranio-cervical flexion test (ccft) will be measured before, immediately after change in focus of attention, 2 days after training under a particular focus of attention, and 7 days after training the task under the same focus of attention. subjects will be randomized into three groups: internal focus of attention, external focus of attention and control group.

Eligibility criteria:
inclusion criteria: * asymptomatic subjects exclusion criteria: * cervical pain * historic of trauma/surgery to the cervical or thoracic spine or upper limbs * temporomandibular pain * neurological or systemic disorder

Keywords: cranio-cervical motor control deep flexor muscles
molecular pathology of colorectal cancer: investigating the role of novel molecular profiles, microrna's, and their targets in colorectal cancer progression

Conditions: Colorectal Cancer

Summary: molecular pathology of colorectal cancer: investigating the role of novel molecular profiles, microrna's and their targets in colorectal cancer progression

single centre observational cohort study prospectively recruited patients biomarker evaluation and identification of novel biomarkers

Eligibility criteria:
inclusion criteria: * colorectal cancer exclusion criteria: * hereditary crc; tumours with extensive necrosis
salivary-based bone loss marker detection platform for point-of-care screening - phase ii study

Conditions: Osteoporosis

Summary: the purpose of this study is to validate a human saliva sample analyzer technique designed to screen for low bone density and osteoporosis. the analyzer technique is meant to be a simple, noninvasive, easy-to-use, cost-effective, and routine means of diagnosing bone turnover using a point-of-care device that monitors salivary markers of bone turnover in a screening patient population that is at risk for low bone density or osteoporosis.

primary objective: to validate the performance of human saliva sample analyzer lfa technique against bone density as measured by quantitative computed tomography (qct). secondary objective: to validate the performance of human saliva sample analyzer lfa technique against salivary elisa method (gold standard). number of sites: single site at the university of mississippi medical center the purpose of this prospective phase ii observational study is to further refine a proprietary device and test it in a screening population composed of women 50 years of age or older who are at risk for low bone density or osteoporosis (n=200). after screening for inclusion and exclusion criteria and obtaining informed consent, participants will provide a salivary sample and will undergo quantitative computed tomography (qct) at the same visit (visit 1, day 0). no additional visits are planned. bone mineral density (bmd) will be measured by diagnostic radiologists using qct techniques and serve as the gold standard for the study. salivary samples will be analyzed by a lab at ummc for concentrations of osteocalcin (oc) and deoxypyridinoline (dpd) using enzyme-linked immunosorbent assay (elisa) techniques, while blinded to bmd measurements. de-identified and coded salivary sample will be shipped to ios who will measure concentrations of oc and dpd using lateral flow assay (lfa), while blinded to bmd measurements.

Eligibility criteria:
inclusion criteria: * female ≥50 years of age and referred for standard of care screening mammogram. * ability to provide salivary samples. * ability to lie flat on the ct scanner. * ability and willingness to provide signed and dated informed consent. exclusion criteria: * any known bone metabolism disorder (other than osteoporosis or low bone density) including sickle cell disease, current neoplastic disease, metastatic disease or any neoplastic disease involving the bones (including leukemia), or paget's disease. * body weight exceeds the weight limit (\>400lbs) of the ct table. * vulnerable subjects including pregnant women and prisoners. * subjects who have had prior qct imaging to measure bone density.

Keywords: bone density