Kornimate/medical-research-clean huggingface dataset:
soluble corn fiber effect on bone resorption in post menopausal women

Conditions: Osteoporosis, Postmenopausal

Summary: this study is designed to study the dose response effect of continuous soluble corn fiber (scf) intake over a 50 day period on bone resorption in healthy post menopausal women using the 41calcium methodology. to further understand the dose response effect of scf bone biomarkers will be studied. our hypothesis is that soluble corn fiber will reduce bone resorption in a dose dependent manner in comparison to placebo when estimated by urinary 41calcium excretion as well as bone biomarkers of resorption.

subjects will be dosed with 41calcium , a long-lived radio isotope, which will become deposited in the skeleton after about 100 days. during this time subjects will collect 24 h urine monthly to monitor the decrease in 41calcium urinary excretion. subsequently, the baseline level of 41calcium urinary excretion will be evaluated over a 50 day baseline period with 24 h urine collections every 10 days. participants will then be randomized to one of three doses of soluble corn fiber (0,10,20 g/d) to be consumed in two equivalent doses per day for 50 days. women will collect 24 h urine every 10 days. each 50 day period will be followed by a 50 day washout period during which the subjects will continue to collect urine every 10 days.

Eligibility criteria:
inclusion criteria: * women at least 4 years postmenopausal exclusion criteria: * medications affecting bone resorption

Keywords: soluble corn fiber osteoporosis bone loss
intermittent theta-burst stimulation to improve negative symptoms and cognition in schizophrenia

Conditions: Schizophrenia Patients

Summary: the planned randomized, sham-controlled, double-blind, monocentric study aims to evaluate the effectiveness of intermittent theta-burst stimulation (itbs) on negative symptoms and cognitive deficits in schizophrenia. both the cerebellar vermis and the left dorsolateral prefrontal cortex will be stimulated successively within the same session. the goal of this trial is to learn if intermittent theta-burst stimulation (itbs) of the cerebellum and the left dorsolateral prefrontal cortext (dlpfc) can treat negative symptoms and improve cognition in patients with schizophrenia. the main question it aims to answer is: does itbs of the cerebellum and the left dlpfc improve negative symptoms in patients with schizophrenia? researchers will compare itbs to sham stimulation to see if itbs improves negative symptoms. participants will: * receive 10 sessions of itbs over the course of 2 weeks * undergo extensive examination before itbs treatment, immediately after itbs treatment and 4 weeks after itbs treatment. the examination includes assessment of negative symptoms; psychometric assessment of cognition, social cognition, depressive symptoms; functional magnetic resonance imaging; assessment of eye movements; blood and saliva sampling; assessment of adverse events and stimulation associated sensations. the study thus seeks to determine whether itbs of the fronto-cerebellar network might improve negative symptoms and cognition by altering the network's functional activity. additionally, it will investigate whether a pro-inflammatory cytokine profile could affect itbs outcomes and whether inflammatory markers could be affected by itbs.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia (icd-10: f20.-) * age: 18-65 years * ability to give informed consent * signed informed consent form exclusion criteria: * any electronic implants * non-mri-compatible metal implants (e.g., pacemaker, cochlear implant, insulin pump, metal fragment injuries, work in the metal-processing industry) * non-tms-compatible metal implants (compatible items include: earrings, piercings, dental fillings, crowns, implants) * claustrophobia * epilepsy * history of traumatic brain injury within the last 3 months * history of stroke * active central nervous system (cns) infection * history of cns infection within the last 3 months * pregnancy * current drug, medication, or alcohol abuse * simultaneous participation in another clinical trial * planned changes in psychopharmacological medication within the next 2 weeks * severe physical illnesses that could endanger the patient, affect the examinations or make the mri scanning cause additional burden

Keywords: itbs intermittent theta-burst stimulation negative symptoms cognition schizophrenia
autologous bone marrow mononuclear cells in liver cirrhosis

Conditions: Liver Cirrhosis Due to Virus C Chronic Hepatitis

Summary: this is a phase i clinical study to evaluate feasibility, safety and kinetics of cellular therapy with autologous bone marrow-derived mononuclear cells (bmmc) in patients with liver cirrhosis due to virus c hepatitis. another aim is to study liver tissue changes induced by the bmmc presence. all the patients have moderate liver disfunction and will be submitted to a liver biopsy before bmmc injection. the cells will be labeled with 99mtc and infused through a peripheral vein. scintigraphy will be performed 24 hours after infusion. patients will be submitted to frequent clinical, laboratorial and image evaluation during a one-year follow-up. a second liver biopsy will be done in the 3rd month after infusion to check histological, cellular and molecular evolutive changes.


Eligibility criteria:
inclusion criteria: * chronic virus c hepatitis * liver cirrhosis * moderate liver disfunction exclusion criteria: * malignant disease * pregnancy * significant comorbidity * portal vein thrombosis

Keywords: hepatitis c cirrhosis stem cell
effect of apical enlargement to different preparation sizes and tapers on pain and bacterial reduction in necrotic pulp

Conditions: Necrotic Pulp

Summary: the aim of this prospective randomized clinical trial is to evaluate the effect of different apical size and taper preparation (35. 04; 35. 06; 45. 04 and 45. 06) on postoperative pain at 6, 12, 24, 48 and 72 hours, and intra-canal bacterial count in patients having mandibular premolars with necrotic pulps.

* patients will be clinically and radiographically examined and their eligibility will be assessed. eligible patients will be treated in one visit. * patients will be randomly assigned to one of 4 groups: experimental groups of root canal instrumentation with edgefile x7 to size #35/0.06 or #45/0.04 or #45/0.06 or the comparator group to size #35/0.04. intra-canal bacterial count will be measured using a culture technique. bacterial samples will be taken before and after root canal instrumentation. after endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 400 mg as rescue medication. * postendodontic pain intensity and incidence at the different pain categories (no, mild, moderate, severe) will be assessed at 6, 12, 24, 48 and 72 hours postoperatively using numerical rating scale (nrs).

Eligibility criteria:
inclusion criteria: * systemically healthy patients, american society of anesthesiologists (asa) i and ii. * patient's age ranges between 18 to 35 years with no sex predilection. * patients with single-rooted mandibular premolars with asymptomatic necrotic pulp. * patients who can understand the numerical rating scale (nrs). * patients able to sign informed consent. exclusion criteria: * pregnant females. * mandibular premolars with periodontal pockets greater than 5 mm or greater than grade i mobility. * patients have a positive history of antibiotic use or analgesic use within the past week or required antibiotic premedication for dental treatment (such as prosthetic joint prophylaxis). * patients have teeth that have been previously accessed. * teeth with extensive crown destruction by caries that will not permit rubber dam placement. * teeth associated with acute periapical abscess, swelling or a fistulous tract. * radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Keywords: apical enlargement postoperative pain intra-canal bacterial reduction preparation taper edgefile x7
hair cortisol and testosterone levels in patients with sarcoidosis

Conditions: Sarcoidosis

Summary: the investigators studied whether scalp hair cortisol and testosterone levels differed between sarcoidosis patients both with and without fatigue and healthy controls.

rationale: fatigue is a common symptom in patients with sarcoidosis and has great impact on quality of life. several aspects in the pathogenesis of sarcoidosis and co-morbidities accompanying sarcoidosis could contribute to fatigue. however, until now the etiology of fatigue in sarcoidosis is unknown. measurements of steroid hormones in scalp hair could possibly be directional in elucidating the underlying mechanism and could also be used as a screening and follow up tool in interventional studies. objective: a pilot to investigate whether cortisol and testosterone levels measured in hair differ between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue and healthy subjects. study design: a prospective observational study, using hair samples of sarcoidosis patients with and without fatigue, compared to an already existing age matched healthy control group. study population: adult sarcoidosis patients at the outpatient clinic of the pulmonary department of the erasmus mc, rotterdam main study parameters/endpoints: cortisol and testosterone levels in scalp hair, correlation with fatigue assessment scale.

Eligibility criteria:
inclusion criteria: * age of at least 18 years * diagnosis of sarcoidosis based on consistent clinical features/bal fluid analysis/ pa according to the latest ats/ers/wasog statement on sarcoidosis * able to speak, read and write in dutch * presence of sarcoidosis related fatigue, defined as a ≥ 22 score on the fatigue assessment scale * other causes of fatigue are excluded or contributing comorbidities are optimally treated (e.g. osas, hypothyroidism or anemia) exclusion criteria: * unable to understand questionnaires (intellectual impaired or language barrier) * hair length \< 1 cm * use of systemic and/ or inhalation steroids in the last year * use of methylphenidate (ritalin) \< 1 month before the study

Keywords: sarcoidosis scalp hair cortisol and testosterone fatigue biomarker psychological distress
birth defect registry in south west region of france

Conditions: Congenital Abnormalities

Summary: regional population-based registry for the epidemiological surveillance of congenital anomalies

by systematically collecting data on congenital anomalies, the registry aims to : * provide essential epidemiological information on congenital anomalies in south west of france * promote etiological research concerning congenital anomalies, particularly with regard to environmental risk factors (systematic questionnaire) and other teratogenic agents (drugs) * act as an information and resource center for the population, health professionals and managers regarding clusters or exposures or risk factors of concern. * evaluate the effectiveness of primary prevention * assess the impact of developments in prenatal screening * study the fate of children with congenital anomalies, particularly in terms of neurodevelopment, through the creation of cohorts.

Eligibility criteria:
inclusion criteria: children or fetuses: * born alive or stillborn or fetal death in utero or medical termination of pregnancy * of mothers domiciled in new aquitaine at the time of delivery * and presenting a congenital or chromosomal anomaly defined according to the eurocat network, diagnosed antenatally or postnatally up to one year of life. * of which the non-opposition of both holders or of the only holder of parental authority has been given * whose mother and/or father is affiliated or beneficiary of a social security system. exclusion criteria: * refusal of at least one of the holders of parental authority
efficacy of hand exoskeleton controlled by bci in post stroke patients

Conditions: Poststroke/CVA Paresis

Summary: the purpose of this study is to assess the efficacy of non-invasive bci-exoskeleton technology based on eeg patterns recognition matching to motor imagery in post-stroke patients with hand paresis.

the bci training is based on eeg activity patterns recording during hand motor imagery. a subject sit comfortably 1m from a computer screen which presents visual instructions during the session. the robotic exoskeleton is fixed to the paretic hand. subject visually fixate on a circle presented in the center of the screen and receive instructions from three surrounding rhomboidal arrows. subject is given three commands instructing them to relax or imagine slow hand opening movement with the right or left hand. the "relax" command means that the subject have to sit still and look at the center of the screen. commands are presented randomly, each of 10 sec duration. a visual cue provides the subject with feedback regarding the mental task recognition: the central circle turned green if the classifier recognizes the task in agreement with the given command, or remains white if the signal is not recognized. in addition to visual feedback the subject is provided with kinesthetic feedback: the exoskeleton is opening the hand when the classifier recognizes the imagery of paretic hand movement. the eeg is registered with 30 electrodes distributed over the head in accordance with the standard international 10-20 system. eeg signals are filtered from 5-30hz. a bayesian approach for eeg pattern classifying is used in the system. the activity sources most relevant for bci functioning will be identified using an independent component analysis (ica). classification accuracy will by measured with cohen's kappa (kohavi and provost, 1998). the procedure may consist from up to three sessions, the duration of 1 session is 10 min, there are 5 min time brake between session and total duration of procedure is up to 45 min. the number of procedures - at least 10. the maximal interval between procedures is 3 days.

Eligibility criteria:
inclusion criteria: * signed informed consent * medical history of primary acute cerebrovascular event (ischemic or hemorrhagic stroke) at least 4 weeks before screening * focal stroke located in a hemisphere * post stroke hand paresis (mild to plegia according to medical research council (mrc) scale for muscle strength) exclusion criteria: * montreal cognitive assessment (moca) scale \< 22 * left handedness * sensory aphasia * severe impairment of vision * modified ashworth scale (mas) ≥ 4

Keywords: post stroke hand paresis brain injury
smartphone-based ophthalmoscopy

Conditions: Diabetic Retinopathy Grading

Summary: a subset of 120 diabetic patients underwent dilated examination and smartphone ophthalmoscopy. the smartphone was equipped with a compact add-on that filtered and delivered the smartphone's led light coaxially to the camera, allowing a clear and convenient view of the retina.


Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetes * ability to provide written informed consent exclusion criteria: * significant optic media opacities
impact of early enteral vs. parenteral nutrition on risk of gastric-content aspiration in patients requiring mechanical ventilation and catecholamines

Conditions: Acute Respiratory Failure; Shock

Summary: to evaluate the impact of enteral nutrition on microaspiration of gastric content and pharyngeal secretions

a common obstacle to enteral nutrition is gastrointestinal intolerance, with regurgitations potentially responsible for gastric-content aspiration. several studies involving technetium 99m (99mtc) labeling of gastric contents have established that gastric-fluid microaspiration is common in critically ill patients receiving both endotracheal ventilation and enteral nutrition. however, to our knowledge, no studies have specifically addressed the role for enteral nutrition in the occurrence of microaspiration. the objective of this ancillary study is to compare the frequency of gastric-content microaspiration in patients given enteral versus parenteral nutrition during the nutrirea2 trial. the new knowledge of risk factors for microaspiration provided by this study may help to improve strategies for preventing microaspiration and ventilator-associated pneumonia (vap).

Eligibility criteria:
inclusion criteria: * invasive mechanical ventilation expected to be required more than 48 hours * nutrition started within 24 hours after initiation of endotracheal mechanical ventilation * treatment with vasoactive drug administered via a central venous catheter * age over 18 years * signed information exclusion criteria: * abdominal surgery within 1 month before inclusion * history of esophageal, gastric, duodenal or pancreatic surgery * bleeding from the esophagus, stomach or bowel

Keywords: vasoactive drug mechanical ventilation early enteral nutrition intensive care unit early parenteral nutrition critical care medicine nosocomial infection mortality shock
exercise and arterial modulation in youth

Conditions: Cardiovascular Disease; Childhood Obesity; Hypertension; Endothelial Dysfunction

Summary: the project is designed as a large scale, cross-sectional study. the aim of the study is to investigate the association of micro- and macrovascular function with physical fitness and body composition in primary school children.

the investigators will examine whether physical fitness, body composition and blood pressure differently affect large and small arteries in young children. furthermore, the investigators will examine whether pulmonary dysfunction is associated with vascular disorders and if subcutaneous advanced glycation endproducts (age's) mediate some of the vascular alterations observed.

Eligibility criteria:
inclusion criteria: * primary school children aged 6-8 years who can participate in physical education lessons with written consent from their parents. exclusion criteria: * children with a medical certificate that prohibits physical exercise with no consent from their parents.

Keywords: arterial stiffness retinal vessels physical activity children
investigation of maintaining visual performance achieved with cyclosporine therapy

Conditions: Dry Eye Syndromes

Summary: this study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (restasis®) in patients with dry eye disease.


Eligibility criteria:
inclusion criteria: * history of dry eye in both eyes * willing to use eye drops for dry eye symptoms exclusion criteria: * anticipate wearing contact lenses during the study * laser-assisted in situ keratomileusis (lasik) surgery within the past 12 months * any ocular and/or lid surgeries within the past 6 months * cataract surgery in either eye * current or anticipated use of temporary punctal plugs during the study
atrial fibrillation and neuropathic pain after thoracotomy and continuous application of magnesium sulphate.

Conditions: Atrial Fibrillation; Neuropathic Pain

Summary: atrial fibrillation and chronic neuropathic pain are adverse events occurring after posterolateral thoracotomy for lung resection. the continuous application of magnesium sulphate may have a prophylactic effect. the investigators record the incidence of atrial fibrillation during a seven day period after thoracotomy as well as the incidence of chronic neuropathic pain during a three months period, comparing one group with a continuous application of magnesium sulphate against one group without magnesium sulphate.


Eligibility criteria:
inclusion criteria: * 18 years or older * posterolateral thoracotomy for lung parenchyma resection * informed consent exclusion criteria: * hypersensitivity for magnesium sulphate * pre-existing atrial fibrillation * participation in another trial * pregnancy or breastfeeding

Keywords: atrial fibrillation neuropathic pain posterolateral thoracotomy lung resection
hpv prevalence in the mouth and oropharynx of the tonsillectomy population

Conditions: Chronic Tonsillitis

Summary: the principal aim of this study is to provide vital current data on the prevalence, distribution and natural history of human papilloma virus (hpv) infection in the mouth. this data is an essential requirement for the assessment, development and evaluation of cost effectiveness of prophylactic vaccination and screening programmes.

patients undergoing a tonsillectomy operation for non-cancerous reasons will be recruited for this study. they will be asked to complete two questionnaires (study and sexual practices), provide saliva, urine and a blood sample. following anaesthesia, oropharyngeal brushings and a tonsillectomy will be performed and all the samples will be processed for evidence of hpv infection.

Eligibility criteria:
inclusion criteria: 1. subjects undergoing tonsillectomy for non cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea 2. age - 0 to 65 years 3. subject or legal guardian has given informed written consent exclusion criteria: 1. subjects undergoing adenoidectomy alone with no tonsillectomy 2. subjects with previous oropharyngeal cancer or oral cancer, or any other head and neck cancer such as nasopharyngeal or laryngeal cancer that is currently undergoing or has previously been diagnosed or treated 3. learning disability preventing an adult over 16 years old from giving their own consent

Keywords: hpv oral cancer oropharyngeal cancer tonsillectomy