Kornimate/medical-research-clean huggingface dataset:
acamprosate safe to use in individuals with liver disease.

Conditions: Alcohol-related Liver Disease

Summary: is acamprosate safe to use in individuals with liver disease.

adult patients aged 21 or over with a diagnosis of alcohol-related liver disease and alcohol use disorder (aud) and abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.

Eligibility criteria:
inclusion criteria: * aged 21 or over * diagnosis of alcohol-related liver disease and aud. * the diagnosis of alcohol-related liver disease will be determined by a hepatologist based on history of regular and excessive alcohol consumption in the absence of other causes of liver cirrhosis or acute hepatitis, compatible clinical, imaging and laboratory findings and typical histology on liver biopsy, if performed. underlying liver disease may include alcoholic hepatitis, advanced (f3-f4) fibrosis, and/or portal hypertension. * the diagnosis of aud will be determined by a hepatologist and/or addiction psychiatrist based on history obtained that is consistent with dsm-5 diagnostic criteria for aud (all categories of mild, moderate and severe considered eligible) (american psychiatric association, 2013; questions from nih, 2016). * abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment. * at study enrollment, initial meld-na score must be less than 20 for the five individuals enrolling in the first phase of the pilot safety assessment. the second phase of the pilot safety assessment will include individuals with a meld-na of 20 or more at enrollment. * have capacity to provide consent themselves exclusion criteria: * individuals with a glomerular filtration rate (gfr) of less than 30 ml/min * congestive heart failure (nyha class ii or higher) * hypotension, requiring the use of vasoconstrictors (i.e. midodrine) * pregnancy, lactation or refusal to use a reliable method of birth control if a sexually active female of childbearing potential. although no human trial data is available, animal studies suggest possible teratogenic effects of acamprosate (merck, 2005).
a smartphone application for screening of developmental disorders in children

Conditions: Development, Child

Summary: the detection of developmental disorders in the child is often late because the parents do not have the information necessary to consult at the first clinical signs. for example, the diagnosis of autism spectrum disorders is made at the age of 5, so earlier diagnoses are possible earlier or even in the 1st year with appropriate questionnaires. an application (malo) has been developed to allow through regular questionnaires from 1 month to 3 years old to assess the child's development by his parents in the form of a digital health record assessing several areas at regular intervals (monthly the 1st year then every 3 to 12 months): sensory, psychomotor development, sleep, height and weight, cognitive and addictions (especially to screens). the questions will be adapted to the age of the child. an alert suggesting to consult the general practitioner or the pediatrician will be generated according to an algorithm validated by a committee of experts. based on a study model on health data already carried out as part of the triage application for patients suspected of covid 19 coronavirus disease.fr with 14 million users in 6 months having improved the relevance of calls to the 15 (8 times fewer unnecessary calls) and general practitioners. this study will assess parental interest in this application.


Eligibility criteria:
inclusion criteria: * parent of a child or more under 3 years of age (1 month to 3 years) exclusion criteria: * parent of a child who has already been diagnosed with a developmental disorder, known physical or mental disability
nucleoplasty for contained herniated lumbar discs

Conditions: Herniated Disc

Summary: this is a prospective randomised double blind comparison trial. fifty patients will be included, 25 in the nucleoplasty treatment group, 25 in the control group. the nucleoplasty group will undergo the nucleoplasty treatment. control group will undergo a sham treatment. both groups will undergo a standardised post-operative care program. the study hypothesis is that nucleoplasty will lead to earlier pain reduction as compared with the sham treatment.

this study will include patients with a contained lumbar hernia of at least 6 weeks existence in whom leg pain is the predominant complaint. standard treatment for these patients is conservative, as an operation is not without risks and is not always effective. furthermore, complaints will usually resolve in due time. however, the pain limits the patients in their daily activities, often for a prolonged period. in this study, nucleoplasty will be compared with a sham treatment and not with conservative treatment, as the discography is thought to have some therapeutic effect. the primary outcome will be the proportion of patients with at least a 2.5 points decrease on a ten-point jensen vas score 3 months after treatment.

Eligibility criteria:
inclusion criteria: * mono radicular leg pain for at least 6 weeks as a result from a lumbar contained herniated disc. leg pain must be of greater impact than concomitant back-pain * failing conservative treatment; analgesics and/or physical therapy. failing means persisting pain leading to problems with daily activities. * magnetic resonance imaging (mri): must be performed \< 6 weeks before start treatment. on mri signs of contained herniated disc, maximum 33% obliteration of the spinal channel. no signs of other significant spine pathology (see exclusion criteria). * neurological investigation by neurologist. symptoms should be clinically related to the disc herniation level. * age \>18 and \< 60 years * mean leg pain on visual analogue scale (vas) \>50 mm (0 -100) exclusion criteria: * herniated disc with more than 33% obliteration of the spinal channel. * annulus rupture with sequestrated herniated disc. * pain on vas below 50 mm * pain existing longer than one year * less than 50% preserved disc height * conflict with social security/insurance. * major motor impairment as a result of the herniation, paresis grade 3 or more using a medical research council (mrc) score * other degenerative causes of nerve root compression; ligament flavum or facet joint hypertrophy, degenerative spinal channel stenosis, loss of lumbar kyphosis, discopathy with signs of schmorls' nodules and loss of nucleus pulposus signal. other causes of radicular syndrome such as cancer, radiculitis or neural degeneration. * spinal instability (spondylolisthesis, spinal fracture or tumor) * history of back surgery, chemonucleolysis or other intra discal procedures * coagulopathies or oral anti-coagulation therapy * infection * pregnancy

Keywords: hernia nucleoplasty radicular pain contained lumbar herniated disc
prematurity related ventilatory control (pre-vent) - specific aim 3

Conditions: Infant,Premature

Summary: to determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes

this study will enroll the subset of infants enrolled in the main study (prevent aim 1; 401-1000g at birth and/or 22w 0d-28w 6d; enrolled at \<1 week postnatal age; eligible for full care and surviving beyond 24 hours, with informed consent; and with no major malformations) who are receiving oxygen supplementation at 32w and 36w postmenstrual age (pma), and are not judged too unstable by the attending neonatologist. for infants on oxygen supplementation at 32w pma, the investigators will use data from the 96 hours of intensive multiparametric physiologic monitoring at 32w pma. for infants on oxygen supplementation at 36w pma, we will use the 96 hours of intensive multiparametric physiologic monitoring at 36w pma as well as data from the sleep study. the first 24 hours of data collection will be the baseline data. over the next 72 hours, the investigators will evaluate 3 interventions in a cross-over manner with the initial intervention (cannula or oxygen environment) randomly assigned: intervention 1 (24-48h of data), intervention 2 (48-72h of data) and intervention 3 (72-96h of data).

Eligibility criteria:
inclusion criteria: - inborn infants weighing 401-1,000 grams on admission and/or 22w 0/7d to 28w 6/7d (\<29 weeks) inclusive completed weeks of gestation infants eligible for full care and resuscitation as necessary, and surviving beyond 24 h of age enrollment in main study protocol (aim 1 of prevent apnea) at \<1 week post-natal age this study will enroll the subset of infants from aim 1 who are receiving oxygen supplementation at 32w and 36w pma, and are not judged too unstable by the attending neonatologist informed consent from parent/guardian exclusion criteria: - refusal or withdrawal of consent major congenital malformations (e.g., not including patent ductus arteriosus, small hernia)

Keywords: apnea of prematurity bradycardia hypoxemic episode oxygen delivery
does optical coherence tomography optimise results of stenting

Conditions: Acute Coronary Syndromes

Summary: optical coherence tomography (oct) is a recent imaging modality that yields cross-sectional images with a resolution 10 times greater than that of intravascular ultrasound (ivus). oct uses a near-infra-red light source to obtain images of the interior walls of the coronary arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess placement and response to stenting. - to date, no study has evaluated whether optical coherence tomography (oct) contributes to optimizing percutaneous coronary intervention (pci) and stenting. the doctors study is a randomized, open label study to evaluate whether oct-guided angioplasty would provide useful clinical information beyond that obtained by angiography, and whether this information would subsequently modify physician behavior and treatment choices. in particular, we will evaluate the impact of changes in procedural strategy resulting from the use of oct on the value of fractional flow reserve (ffr) obtained after angioplasty and stent implantation of a lesion responsible for non-st segment elevation acute coronary syndromes.


Eligibility criteria:
inclusion criteria: patients aged 18 to 80 years inclusive, admitted for acute coronary syndrome (acs) with the following symptoms : * clinical signs of ischemia (chest pain) at rest lasting for at least 10 minutes in the previous 72 hours; * and at least one of the following two criteria : * new st segment depression ≥1 mm or transitory st segment elevation (\<30 minutes) (≥1 mm) on at least 2 contiguous leads of the ecg; or * elevation (\>upper limit of normal, uln) of cardiac enzymes (ck-mb, troponin i or t). and presenting an indication for coronary angioplasty with stent implantation of the target lesion considered to be responsible for the acs. and written informed consent. exclusion criteria: potential subjects who meet any of the following criteria will be excluded from the study: * left main stem disease * presence of coronary artery bypass grafts * cardiogenic shock or severe hemodynamic instability * severely calcified or tortuous arteries * persistent st segment elevation * one or more other lesions considered angiographically significant and located on the target vessel * severe renal insufficiency (creatinine clearance ≤30 ml/min) * bacteraemia or septicaemia * severe coagulation disorders * patients who refuse to sign the informed consent form

Keywords: acute coronary syndromes non-st elevation myocardial infarction angioplasty fractional flow reserve optical coherence tomography
skin samples of diabetic patients and healthy volunteers collection

Conditions: Type 2 Diabetes

Summary: the main objective of this study is the obtention of skin micro-samples collected from healthy volunteers and diabetic patients (type 2 and mody), intended to be used afterwards to obtain stem cell lines, in the framework of new therapeutic strategies of type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diabetic patients diagnosed for type 2 diabetes, with a bmi between 20 and 25, without familial history and known genetic cause of diabetes. * diabetic patients diagnosed for mody diabetes (1, 2, 3, 4, 5 or 6), with a bmi between 20 and 25. * healthy volunteers, siblings of mody patients (1, 2, 3, 4, 5 or 6). * healthy volunteers without familial history of diabetes. * patients over 18 years old. * patients with social insurance coverage * patients who signed a consent form exclusion criteria: * type 1 diabetic patients. * pregnant women or women who might get pregnant
evaluating changes in spermatogram following bilateral laparoscopic inguinal hernia repair in fertile males

Conditions: Hernia

Summary: in this prospective open armed study we aim to see if bilateral hernia repair using a mesh alters the spermatogram (sperm count) or testicular volume.


Eligibility criteria:
inclusion criteria: * males ages 18-40 years, undergoing bilateral laparoscopic hernia repair, who agree to have a sperm test both prior to and following surgery. exclusion criteria: * history of prostatic surgery, testicular surgery, azospermia on first spermatogram, single testis, patients after chemotherapy, patients receiving hormonal therapy, patients receiving alpha blockers for any indication, patients who are receiving or received oral antifungal therapy six months prior to surgery
deep brain stimulation to treat symptoms of parkinson's disease

Conditions: Parkinson Disease; Movement Disorders

Summary: the purpose of this study is to evaluate the safety and efficacy of bilateral stimulation of the subthalamic nucleus (stn) of the brain when using the ans totally implantable deep brain stimulation system as an adjunctive treatment for reducing some of the symptoms of parkinson's disease that are not adequately controlled with medication.

this is a prospective, controlled, multi-centered, 12 months post-implantation study. a maximum of 15 sites will enroll a total of 136 patients. all study participants will have the study device surgically implanted. after implant surgery, study participants will return to the clinic for evaluation 30 days after surgery, three months after surgery, six months after surgery and twelve months after surgery. at the baseline, three, six and twelve month visits the patient's parkinson's symptoms and ability to perform daily activities will be evaluated using a number of accepted assessment tools including a dyskinesia diary, evaluation of pd symptoms, quality of life scoring and patient extension study to monitor the safety and efficacy of the ans libra/libra deep brain stimulation system. after the 1 year study, patients may enter another protocol (c-06-04) to continue to monitor the safety and efficacy of the libra deep brain stimulation system. patients may be followed for an additional 4 years. if necessary, patients may continue to have access to the investigational device under protocol (c-13-02) which allows for compassionate use access to it.

Eligibility criteria:
inclusion criteria: * person is 18 to 80 years of age * person has been diagnosed with parkinson's disease for at lease five (5) years * person experiences at least six (6) hours or more daily "off-time" or moderate to severe dyskinesias during waking hours * person has a history of improvement of parkinson's symptoms with l-dopa (levodopa) therapy * person must be willing to maintain a constant dose of anti-parkinson's disease medication for at least one month prior to study enrollment * person must be available for appropriate follow-up times for the length of the study exclusion criteria: * person has any major illness or medical condition that would interfere with participation in the study * person currently suffers from untreated, major depression * person has an electrical or electromagnetic implant (e.g. cochlear prosthesis or pacemaker) * person has had a prior surgery for the treatment of pd symptoms, including previous dbs surgery * person has dementia * person has a history of seizures

Keywords: parkinson disease movement disorders deep brain stimulation libra l-dopa levodopa neuromodulation neurostimulation electrical stimulation of the brain stn subthalamic nucleus
pharmacokinetics study of cj-30060 after single dose administration in health male volunteers

Conditions: Hypertension; Hyperlipidemias

Summary: to compare the pharmacokinetics and safety after a single dose administration of cj-30060 and exforge® 5/160mg, crestor 10mg in healthy male volunteers.

the purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of cj-30060 and exforge® 5/160mg, crestor 10mg in healthy male volunteers.

Eligibility criteria:
inclusion criteria: * healthy male aged 20 to 45 years at the screening * subject who is over 50kg with bmi between 18 kg/m2 to 29 kg/m2 (inclusive) * subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions. exclusion criteria: * subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease. * subject who have symptoms, result from acute disease within 28days before first administration. * subject who have chronic persisting disease with clinical significance. * subject who fall under the criteria below in laboratory test. * ast/alt \> unl (upper normal limit) x 2 * total bilirubin \> unl x 1.5 * in case of renal failure that creatine clearance is less than 50ml/min according to cockcroft-gault * cpk \> unl x 2.5 * subject who with low blood pressure with clinical significance at screening test. (systolic blood pressure is less than 90 mmhg and diastolic blood pressure is less than 60 mmhg) * subject with any positive reaction in hbs ag, anti-hcv ab, anti-hiv ab, vdrl tests.
using mhealth to modernize diabetes care

Conditions: Diabetic Foot

Summary: in this study the investigators are testing a device that may help us tell how well the participants' wound is healing. this device is called the mimosa, and it shines different "colours" of light on the participants' skin. it will not touch the participants' skin, or change how the participants' wound is healing. the mimosa is designed to be used alongside the camera that is built into the participants' cell phone, and the investigators will use a cell phone to take a picture of the participants' skin. this picture will tell us how much oxygen is getting to the participants' wound, which can tell us more about how the participants are healing. the mimosa device is an experimental diagnostic tool, and will not influence how the participants' wound is healing.

the investigators have developed a tool called the multispectral mobile tissue assessment (mimosa) device, which attaches to a smartphone and assesses tissue health parameters in a quick, non-invasive way using near-infrared light. this study will use mimosa to monitor patients at 4 sites in toronto (st. michael's hospital, women's college hospital, south riverdale community health centre and at westpark healthcare centre). these study sites were chosen to cover patients from diverse clinical backgrounds: st. michael's hospital is an acute care centre for the diabetic lower extremity, women's college hospital is an outpatient wound clinic focused on the management of dfus, south riverdale is a community health centre focused on prevention, and westpark is a rehabilitation site focused on post-operative/amputation care and preservation of the opposite limb. conducted on patients who present with a non-healing diabetic foot ulcer and are already receiving standard best practice as prescribed by the diabetic foot multi-disciplinary team.

Eligibility criteria:
inclusion criteria: 1. diabetes: type i or type ii. 2. outpatient or inpatient 3. diabetic foot ulcer 4. adhere to monitoring schedule exclusion criteria: 1. presence of invasive infection requiring intravenous antibiotics 2. cognitively able to give consent \& participate in study 3. active malignancy 4. end stage renal disease 5. patients who are participating in another clinical study for ulcer management 6. patients with a known history of poor compliance with medical treatment 7. patients who are unable to understand the aims of the study and not give informed consent

Keywords: nir diabetes diabetic foot ulcer (dfu). wound
comparison imaging system between spatially modulated quantitative spectroscopy and skin spect dermoscopy

Conditions: Melanocytic Nevus

Summary: the purpose of this study is to obtain skin spectroscopic data from two imaging systems. comparison groups: * skin spect dermoscope * spatially modulated quantitative spectrometer

the researcher can compare the spectroscopic data from the two systems as well as the relative concentrations of melanin, oxy- and deoxy- hemoglobin calculated from the measurements. skin spect can measure larger area of skin, whereas spatially modulated quantitative spectrometer is a point-based measurement.therefore, larger nevi will require multiple spatially modulated quantitative spectrometer measurements for comparison with corresponding sub-regions of the larger skin spect measurements. only sub-regions of the image data from skin spect that match the locations spatially modulated quantitative spectrometer acquired data will be used in this correlation study. this researcher ensure that the spectral data collected by the two instruments are collected from the same spatial locations, should lesion heterogeneity be present.

Eligibility criteria:
inclusion criteria: * skin lesion a mole located on flat surface of the body exclusion criteria: * mole located on complex surface * pregnant women
hyperoxia before and after cardiac arrest and myocardial damage

Conditions: Cardiac Arrest

Summary: several studies show how patients with hyperoxia after cardiac arrest has increased mortality, but the association of hyperoxia before cardiac arrest and myocardial damage has never been investigated. neither has the association between hyperoxia after cardiac arrest and myocardial injury. our research hypothesis is that hyperoxia before cardiac arrest aggravates myocardial damage, secondly we wish to analyze the association between hyperoxia after cardiac arrest and myocardial injury. the exposure variables is oxygenation within 48 hours before and 48 hours after cardiac arrest, our primary outcome is myocardial damage and will be measured as peak troponin within 30 days after cardiac arrest.


Eligibility criteria:
inclusion criteria: * 18 years or older * with a record of icd-10 diagnosis of cardiac arrest in 2014, admitted to a hospital in the capital region of denmark. * first recorded cardiac arrest in 2014 * admitted to icu * serum troponin measured within 7 days after cardiac arrest exclusion criteria: * out of hospital cardiac arrest, ohca * in of hospital cardiac arrest, ihca, but with no registered saturation before cardiac arrest.