Kornimate/medical-research-clean huggingface dataset:
a study to evaluate a computerized stethoscope called ©voqx to diagnose heart disease

Conditions: Isolated Aortic Stenosis; Mitral Regurgitation

Summary: the purpose of this study is to determine whether recording heart sounds with an acoustic stethoscope, combined with artificial intelligence (computer information), will show similar abnormalities to an echocardiogram or cardiac catheterization.

in the current study the plan is to recruit 600 patients who have been referred to the echocardiogram laboratory for routine clinically indicated echocardiography, or to the cardiac catheterization laboratory for routine clinically indicated catheterization procedures. individuals with normal heart structure and sounds, isolated aortic stenosis (of varying severity), and isolated mitral regurgitation (of varying severity) will be included, while excluding individuals who have multiple valve involvements or combined valve pathologies. each patient will have baseline testing using the ©compusteth device, which will be used to auscultate and record each patient's heart sounds at the bedside prior to the index echocardiogram or cardiac catheterization procedure. this process will take less than 10 minutes and is outlined below. patients will then proceed with their clinically indicated echocardiograms or cardiac catheterization procedures. amongst the first 200 study participants, the results of the echocardiograms and invasive cardiac catheterization procedures will be used to train the ©voqx device to identify normal heart and to screen and grade for various cardiac structural pathologies, aortic stenosis, and mitral regurgitation, diagnosed by gold-standard testing. subsequently, after the ©voqx device has been trained how to characterize and identify sounds that correspond to various structural cardiac pathologies, the next step is to prospectively 'test' how well the ©voqx device is able to screen normal heart from cardiac pathologies, such as aortic stenosis, and mitral regurgitation, and identify the severity of the valve disorder in the subsequent 200 participants of the study. this will be done by comparing the results obtained from auscultation with the ©voqx device against the results obtained from gold-standard testing with echocardiography or invasive cardiac catheterization.

Eligibility criteria:
inclusion criteria * aged 18 years of age or older. * referred to the echocardiogram laboratory for routine clinically indicated echocardiography, or to the cardiac catheterization laboratory for routine clinically indicated catheterization procedures * individuals with normal heart sounds, isolated aortic stenosis (any degree of severity), or isolated mitral regurgitation (any degree of severity) exclusion criteria * patients with unstable cardiovascular or pulmonary disease * patients with mixed valvular heart disease, corresponding to more than one type of valve pathology (i.e.: aortic stenosis and aortic regurgitation), or more than 1 valve involved (i.e.: aortic stenosis and mitral regurgitation)
topical 0.01% atropine for the control of fast progressing myopia

Conditions: Myopia Progressing; Childhood

Summary: myopia prevalence has dramatically increased worldwide in recent years in the general population and among children. progressive myopia increases gradually with growth until the age of 20-25 years. at the same time, there is a remarkable increase in the prevalence of severe myopia (more than -6 diopters). severe myopia is associated with many complications, which can lead to blindness. there is thus an increase in the number of myopic patients in general, and severe myopic patients in particular. the management of myopia and its complications is therefore a major public health issue. all the means likely to slow the evolution of myopia (thus to limit the prevalence of strong myopia) must be developed to limit the consequences. 0.01% atropine seems to be a drug with a great interest to slow down the progression of myopia. the aim of the present study is to evaluate the efficacy at 1 year of 0.01% atropine (1 drop per day administered for 1 year) on the reduction of fast progressing myopia in children aged 4 to 12, compared to a control group (instillation of a placebo).


Eligibility criteria:
inclusion criteria: children from 4 to 12 years * myopia from -1 to -6 * fast progressing myopia (\>0.75 diopter / year) * informed consent obtained exclusion criteria: astigmatism \> 1.5 diopters * anisometropia \> 2 diopters * concomitant pathology of anterior or posterior segments * other ocular diseases (ocular inflammation, strabismus ...) * atropine hypersensitivity or allergy

Keywords: myopia (progressing) childhood atropine 0,01%
comparison of the analgesic effect between the motor cortex stimulation and the trans-spinal stimulation in the algoneurodystrophy.

Conditions: Algoneurodystrophy

Summary: the purpose of this study is to compare the analgesic effectiveness of two motor cortex neurostimulations (tdcs and rtms) and the trans-spinal neurostimulation (tsdcs ) in the algoneurodystrophy.

* entry into the study : after informed consent, patients will be randomised into three groups : tdcs, rtms, tsdcs. the physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (iwrs). * baseline : participants, will record on a book, a daily visual numeric scale(vns) of pain intensity for 1 month. * the beginning of the treatment : after the baseline, sessions of neurostimulation will begin. sessions of neurostimulation will have a decreasing rhythm. five sessions per week during the two first weeks, two sessions per week during the third week, one session during the fourth week and then two sessions per month for four months. * after the end of neurostimulation sessions, patients will be followed for 1month. throughout their participation in the study, patients will complete their vns report book (1month of baseline before the treatment, 3 months during neurostimulation, 1 month after neurostimulation). patients will have 5 evaluation examinations: * the first, one just before the beginning of the neurostimulation, * the second, 1 month after the beginning of neurostimulation * the third, 3 months after the beginning of neurostimulation * and the last one, 1 month after the end of neurostimulation.

Eligibility criteria:
inclusion criteria: * patient's written consent * patient suffering from an algoneurodystrophy for more than a year. * diagnosis of algoneurodystrophy confirmed by an osseous scintigraphy * stable treatment for at least 1 month * patient non-responsive to pharmacological treatments * vns \> 3 at the time of screening exclusion criteria: * drug addiction * history of epilepsy, head trauma, psychiatric pathology likely to hamper the progress of the study. * intracranial ferromagnetic material or an implanted stimulator * mri contraindication * algoneurodystrophy due to a nervous lesion * pregnant women, parturient women, breast-feeding mother. lack of effective contraception

Keywords: rtms, tdcs, tsdcs, pain, algoneurodystrophy , neurostimulation
safety and efficacy of implantable collamer lens versus implantable phakic lens ipcl in myopic patients; a comparative study

Conditions: Myopia

Summary: phakic intraocular lenses (piol) have proven to be a great alternative to corneal refractive surgery in certain situations. they offer several advantages over corneal techniques, such as being suitable for high myopes and causing relatively fewer higher-order aberrations. in addition, piols have been shown to provide better retinal image magnification and higher contrast sensitivity compared to laser in situ keratomileusis, regardless of whether the myopia is low or high.


Eligibility criteria:
inclusion criteria: * myopia of more than 6 diopter exclusion criteria: * unstable refraction * unstable refraction
small circulating rna as molecular markers of lung disease in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the aim of our study is to assess mirnas expression profiles in the circuling blood of patients with cystic fibrosis and highlight "signatures" that could reflect the pulmonary status of patients

the objective of this project is to study the circulating mirna profiles in 40 patients with cystic fibrosis (5 samples which are acquired through a secondary use) and 40 healthy individuals to assess whether these biomolecules could be used as markers of the pulmonary disease in cystic fifbosis. moreover by comparing mirnas expression level between cystic fibrosis (cf) patients with severe (n=20) or moderate (n=20) pulmonary impairment, we want to assess whether some of these mirnas may be used as markers for the severity of cf pulmonary disease. the identification of sensitive and early markers, from a non-invasive sampling could enable more effective and early treatment of cf patients.

Eligibility criteria:
inclusion criteria: * patients with cystic fibrosis (cf) (mim#219700) who are compound heterozygous or homozygous for cf causing mutations healthy controls non -smokers and free pulmonary disease exclusion criteria: * participation or within the exclusion period of other clinicals trials patients carrying mutations of clinical varying consequences or non cf-causing mutations * smokers

Keywords: patient with cystic fibrosis patient without cystic fibrosis
sentinel node extended in squamous cell vulvar cancer

Conditions: Vulva Cancer; Sentinel Lymph Node

Summary: the aim of this study is to investigate the feasibility of sentinel node biopsy in patients with squamous cell vulvar cancer, currently not regarded suitable for the sentinel node technique, i.e. patients with tumors ≥4cm, multifocal tumors or locally recurrent disease. a positive result of this pilot study might constitute the basis for a future full-scale multinational trial.

primary objectives: this study is primarily a pilot and feasibility trial, aiming to evaluate if sentinel node biopsy has a satisfactory detection rate and negative predictive value in certain groups of vulvar cancer patients. outline: the study is planned as a prospective, multi-center cohort study in sweden. since 2017, the treatment of vulvar cancer patients has been accredited to four tertiary referral university hospitals in sweden; the sahlgrenska university hospital in gothenburg, the linköping university hospital, the skåne university hospital in lund and the karolinska university hospital in stockholm. eligible patients will undergo a sentinel node biopsy additionally to their radical inguinofemoral lymphadenectomy and detection rate and negative predictive value for the sentinel procedure will be calculated. the study will consist of four patient groups: patients with squamous cell vulvar cancer and: 1. primary tumors ≥4cm 2. primary multifocal tumors 3. local recurrence, earlier no treatment of the groins or only sentinel node biopsy 4. local recurrence, earlier treatment of the groins with radiotherapy / inguinofemoral lymphadenectomy it is estimated to include 20-30 patients in each study group during a time frame of about 24 months. results: results are to be expected in the end of 2021.

Eligibility criteria:
inclusion criteria: * patients with squamous cell vulvar cancer and 1. primary tumors ≥ 4cm 2. multifocal primary tumors 3. local recurrence, earlier no treatment of the groins or only sentinel node biopsy 4. local recurrence, earlier treatment of the groins with radiotherapy / inguinofemoral lymphadenectomy * ≥ 18 years of age * considered clinically appropriate for surgery * informed consent exclusion criteria: * eastern cooperative oncology group performance status \> 2 * disability to read or write in swedish * dementia / severe psychiatric illness leading to disability to understand the study / study information * signs of inguinal lymph node or distant metastases * ongoing pregnancy
accu-chek mission: smbg in patients with diabetes on insulin study (compass) - multiple center, open, and non-randomized study

Conditions: Diabetes Mellitus Type 2

Summary: compass is a status and intervention study for the self-monitoring of blood glucose (smbg) in type 2 diabetic patients with insulin treatment. this multi-centre, open-label prospective study will assess the use and frequency of smbg and blood glucose control and its influencing factors with the help of accu-chek integra glucometer. patients with type 2 diabetes mellitus who have received more than 3 months of insulin therapy are eligible to participate in this study. the anticipated duration of the study is 6 months.


Eligibility criteria:
inclusion criteria: * type ii diabetes mellitus patients who have received insulin treatment for more than 3 months * patients willing to sign written informed consent form * patients who meet the criteria for the first cross-sectional investigation and have an hba1c \< 7% will receive the second cross-sectional investigation exclusion criteria: * patients unable or unwilling to comply with the requirements of the protocol
analysis of volatile organic compounds in the exhaled air in inflammatory bowel disease

Conditions: Volatile Organic Compounds; Inflammatory Bowel Disease

Summary: the availability of noninvasive biomarkers for diagnosis and stratification of inflammatory bowel disease (ibd) courses is lacking. thus, the aim of this study is to evaluated the accuracy of exhaled breath volatile metabolite analysis on diagnosis and stratification of patients with inflammatory bowel disease.

background: the diagnosis and differentiation of inflammatory bowel diseases (ibd) is challenging due to the absence of a gold standard diagnostic modality for confirmation. exhaled breath volatile metabolite analysis focusing on diagnosis and differentiation of ibd is a promising approach. thus, the aim of this study is to evaluated the accuracy of exhaled breath volatile metabolite analysis for patients with inflammatory bowel disease. method: a single center, prospective study of diagnostic testing will be conducted, recruiting crohn's disease (cd), ulcerative colitis (uc), and healthy controls (hc). the exhaled breath volatile metabolite will be analyzed using gas chromatography/mass spectrometry (gc-ms). the informations of patient's disease location, disease activity, laboratory parameters and current medications will be collected to determine the feasibility of exhaled breath volatile metabolite analysis.

Eligibility criteria:
inclusion criteria: * patients with inflammatory bowel disease (crohn's disease or ulcerative colitis) * healthy controls who do not have any gastrointestinal disease or symptom exclusion criteria: * pregnant or lactating woman * subjects who diagnosed liver cirrhosis, severe congestive heart failure, severe renal insufficiency, uncontrolled hypertension, endocrine disorder, metabolic disorder, prior malignancy, immune deficiency * subjects with mental retardation and cognitive impairment
open-label extension to evaluate the long-term safety, tolerability and analgesic efficacy

Conditions: Cancers, Pain; Lower Back Pain

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone er as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain.


Eligibility criteria:
inclusion criteria: * the subject enrolled in this study must have been previously randomized and dosed in the double-blind treatment period of study en3202-016 or en3202-019 and completed the exit visits for these studies. * males or females, age 18 and 75 years, inclusively. * the subject continues to have chronic moderate to severe back or cancer pain that requires opioid medication. women must continue to be of non-childbearing potential. exclusion criteria: * the subject experienced any serious drug related adverse events in studies en3202-016 or en3202-019. * the subject withdrew from en3202-016 or en3202-019 for a reason other than lack of efficacy. * subjects with known allergies to opiate-class narcotic agents (morphine, codeine, hydrocodone, propoxyphene, meperidine, oxycodone, etc.) or naproxen, or subjects who have any medical condition in which opiates are medically contraindicated.
hyperbaric oxygen therapy in chronic traumatic brain injury or post-traumatic stress disorder

Conditions: Traumatic Brain Injury; Post-traumatic Stress Disorder

Summary: this is an observational research study whose purposes are to see: 1. if 40 hyperbaric oxygen therapy sessions at 1.5 atmospheres (hbot 1.5) or more (60, or 80 hbot's) help, worsen, or have no effect on subjects with chronic tbi/pcs (traumatic brain injury/post-concussion syndrome) and/or ptsd (post-traumatic stress disorder). 2. if improvements or worsening of symptoms can be recorded with computerized and written tests for memory and thinking, and with questionnaires about the subject's quality of life and health. 3. determine the long-term outcome of the treatment. 4. confirm, in large numbers of study participants at multiple sites nationwide, the strong positive results obtained in pilot studies


Eligibility criteria:
inclusion criteria: 1. any 18-65 year-old patient with mild-moderate tbi or ptsd. (if a military injury, subject may be active duty or a veteran. if active duty, participants will have to voluntarily contact nbirr.) 2. have demonstrated a \>20% decrement (compared to pre-deployment baseline) in anam composite score or specific sub-score with regard to "simple reaction time" and/or "procedural reaction time". 3. have a diagnosis of tbi, chronic tbi/pcs or tbi/pcs/ptsd or ptsd made by a military (military etiology of blast injury) or civilian specialist. 4. negative pregnancy test in females. 5. less than 90% on the percent back to normal rating scale. (if patient is considered 100% normal before tbi, patient should be less than 90% normal for entry into the study). exclusion criteria: 1. pulmonary disease that precludes hbot (e.g., asthma unresponsive to medication, bullous emphysema). 2. unstable medical conditions that are contraindicated in hbot (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year). 3. severe confinement anxiety (claustrophobia; e.g., patients who require anesthesia conscious sedation for mri or who cannot go in elevators). 4. pregnancy. 5. other pre-tbi neurological diagnoses.(seizure disorders, multiple sclerosis, parkinson's, lyme, etc.) 6. participation in another experimental trial with active intervention. 7. high probability of inability to complete the experimental protocol (e.g. terminal condition). 8. past or current history of mental retardation unless diagnosed post tbi (baseline iq ≤ 70). 9. pre- or post-tbi history of systemic illness with impact on central nervous system. (principal investigator in consultation with study sponsor medical officer will make the ultimate decision). 10. any pre-existing chronic infection not related to battlefield injuries or government service.

Keywords: traumatic brain injury post-traumatic stress hyperbaric oxygen hbot tbi ptsd
eradication of gut microbiota

Conditions: Diabetes; Obesity; Osteoporosis; Inflammation

Summary: the aim of the study is to assess the effect of eradication of gut microbiota on 1) glucose metabolism including postprandial plasma responses of the incretin hormones gip and glp-1, insulin, c-peptide and glucagon, 2) metabolomic profiles and resting energy expenditure (ree) 3) appetite, satiety, food intake, gastric emptying and gall bladder emptying, 4) levels of markers of bone formation and resorption as well as serotonin, 5) markers of systemic inflammation, and 6) on the (prospective) composition of bacteria in faeces, blood and saliva. thus, the overall objective is to provide detailed knowledge on the physiological role of gut microbiota combined with bioinformatic analyses of the functional implications of changes in bacteria composition on the level of both species and phylum.


Eligibility criteria:
inclusion criteria: * danish caucasian ethnicity * informed consent * normal fasting plasma glucose * normal hba1c (\<6 %) * normal serum lipids * normal thyroid function * normal danish diet * non-smoking * normal stool habits exclusion criteria: * known bone disease * liver disease (alat or asat \>2 upper normal value) * kidney disease (serum creatinine \>130 μm) * anaemia * bmi \ 25 kg/m2 * known gastrointestinal disease (including prior bariatric surgery,lactose -intolerance, celiac disease, inflammatory bowel disease) or known familial disposition for lactose intolerance, celiac disease, inflammatory bowel disease * antibiotic treatment within 6 months prior to study including malaria prophylaxis * medication which cannot be on hold for the study period * contraindications against/allergy towards the used antibiotics (including prior allergic reactions related to beta-lactam antibiotics, aminoglycosides or vancomycin)
health effects of diesel exhaust in asthmatic patients: a real-world study in a london street

Conditions: Asthma

Summary: acute exposure to diesel exhaust under normal city conditions leads to a worsening of symptoms of asthma, with reduction in lung function in asthmatic nonsmoking adults, dependent on the exposure dose and on the background severity of asthma. the worsening asthma is accompanied by increased oxidative stress and inflammation in the lungs.

the investigators will recruit 60 nonsmoking asthmatics of mild and of moderate severity. they will be exposed to oxford st. or to hyde park for 2 hours each, at a walking pace. real time exposure to pm2.5, carbon monoxide and nitrogen dioxide will be made each time. health outcome measurements will be made before and after exposure to each street. statistical analyses will be made to examine the effect of diesel exposure on changes in health outcome measures.

Eligibility criteria:
inclusion criteria: subjects will be selected according to the current severity of their asthma; thirty from steps 1 and 2 and thirty from step 3 of the world health organization (who) global initiative for asthma (gina) asthma guidelines. these will include mild and moderate asthmatic states. depending on baseline fev1, subjects will undergo either a methacholine bronchial hyperresponsiveness assessment or airways reversibility testing. subjects with normal fev1 (\>80% predicted) or normal fev1/fvc ratio will undergo methacholine challenge. subjects with fev1 \<80% predicted will undergo airways reversibility testing. subjects must have either a pc20 of less than 8mg/ml methacholine, or improvement in fev1 of 12% or more, following inhalation of short acting β-agonist (salbutamol 200μg from metered dose inhaler \[mdi\]). skin prick testing will be conducted for common allergens (house dust mite, grass pollen, aspergillus fumigatus and cat hair). the results will only be for descriptive purposes, not as subject inclusion/exclusion criteria. subjects may be atopic or non-atopic (according to history and allergy testing).

Keywords: exposure to oxford street exposure to hyde park