Kornimate/medical-research-clean huggingface dataset:
tiotropium (spiriva) rehabilitation study

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the study was designed to determine whether tiotropium inhalation capsules, compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (copd) who participate in pulmonary rehabilitation. in addition, assessments of the effect of tiotropium on dyspnea and quality of life following pulmonary rehabilitation were taken.


Eligibility criteria:
inclusion criteria: history of copd, fev1 of less than or equal than 60% of predicted normal and less than or equal to 70% at visit 1, male or female 40 years or greater, smoking history of more than 10 pack years (current or ex-smokers), patient can perform all study related tests, patients can inhale medication from handihaler and from meter dose inhaler, patients who would benefit from participation in a pulmonary rehab program and patients who had a medical clearance to participate in a pulmonary rehab program. exclusion criteria: patients with significant diseases other than copd, patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis, all patients with sgot greater than 80iu/l, bilirubin greater than 2.0 mg/dl or creatinine greater than 2.0 mg/dl, recent history of mi (6 months or less). any cardiac arrhythmia requiring drug therapy or has abeen hospitalized for heart failure with the past 3 years, active tb, history of ca or had treatment within the last 24 months, history of cf, bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
psychiatric co-morbidities and socio-demographic characteristics in patients with idiopathic hypersomnia

Conditions: Idiopathic Hypersomnia; Mood Disorder; Bipolar Disorder

Summary: this is a study of only patients with idiopathic hypersomnia. it is a rare and still poorly understood pathology. in clinical practice, we have found that the treatment and care offered were not always effective. the idea of this study to improve knowledge of this pathology by studying the demographic characteristics of patients and other co-morbidities, in particular psychiatric patients, to see if we can identify common factor to our patients and useful in their medical care. the main objective of this research is to allow a quantitative study of the demographic and psychiatric characteristics of patients with idiopathic hypersomnia.


Eligibility criteria:
inclusion criteria: * adult patients with a diagnosis of idiopathic hypersomnia according to the icsd 3 criteria and the performance of a 48-hour polysomnography at the sleep laboratory, between 2004 and today. exclusion criteria: * minors persons and under legal protection persons.

Keywords: demographic characteristic psychiatric morbidity
maintenance of effect of duloxetine in patients with diabetic peripheral neuropathic pain (dpnp)

Conditions: Diabetic Neuropathies

Summary: to determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * have pain due to bilateral peripheral neuropathy caused by type i or type ii diabetes with the pain beginning in the feet and present for at least 6 months. * may not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study. * score of 4 or greater on the brief pain inventory on the 24-hour average pain item. exclusion criteria: * history of substance abuse or dependence within the past year, excluding nicotine and caffeine. * serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be likely to lead to hospitalization during the course of the study. * taking monoamine oxidase inhibitor (maoi) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study. * treatment with fluoxetine within 30 days of starting the study. * unstable blood sugar control and uncontrolled or poorly controlled hypertension.
validation in a non-targeted population of single ultrasound doppler signs of liver fibrosis

Conditions: Cirrhosis

Summary: the diagnosis of liver fibrosis lesions remains an important issue in patients with chronic liver diseases. the early detection of fibrosis is important for determining disease progression and postponing the evolution of chronic hepatitis into cirrhosis via the implementation of prompt and specific treatment. however, as chronic liver disease can remain asymptomatic for a long time, numerous cirrhotic patients are diagnosed belatedly, when life-threatening complications start appearing. noninvasive methods for liver fibrosis diagnosis have been developed over the last decade. in this setting, blood fibrosis tests and transient elastography have been shown to be accurate, and are now commonly used as first-intention tests for liver fibrosis diagnosis in chronic liver diseases. however, these tests are usually performed by a hepatologist to whom the patient has been referred following the appearance of symptoms suggestive of chronic liver disease. thus the number of patient diagnosed early by these new tools, that is in the period before symptoms start appearing and during which preventative measures may be particularly beneficial, remains quite low in relation to the prevalence of the disease. this prevalence has been estimated to 0.5 to 2.8 % in general population. many studies have identified the value of hemodynamic and morphological ultrasound parameter in providing information on liver fibrosis degree. moreover, abdominal ultrasound is widely used for various symptoms, and thus could be an excellent way to detect patients with signs evoking liver fibrosis or cirrhosis, who could then be referred to a liver specialist for confirmation of the diagnosis by blood fibrosis tests and/or transient elastography. to be feasible during a nonspecific us examination, and by any radiologist, these signs should be easy and quick to collect. addition of a quick measure of hepatic stiffness could increase the screening interest of ultrasound examination. the main aim of the present study was thus to validate 3 simple us signs in patients referred for ultrasound abdominal examination for reasons other than suspicion of liver disease.


Eligibility criteria:
inclusion criteria: * patients referred to an ultrasound unit for abdominal us examination, whatever the indication. * patient with social security exclusion criteria: * age \<18 years * previously identified chronic liver disease * hematological disease * patient under guardianship
lacticaseibacillus rhamnosus ca15 (dsm 33960) strain as a new driver in restoring the normal vaginal microbiota

Conditions: Bacterial Vaginosis; Candidosis Vaginal; Urinary Tract Infections

Summary: the aim of the present randomized double-blind placebo-controlled trial is to evaluate the efficacy of a probiotic formulation, containing the probiotic strain lacticaseibacillus rhamnosus ca15 (dsm 33960), in the treatment of vaginal dysbiosis in terms of: (i) modulation of the microbiota (increase of lactobacilli and decrease of pathogens), (ii) reduction of clinical signs of inflammation, (iii) improvement of quality of life.

the aim of the present randomized double-blind placebo-controlled study is to evaluate the ability of the potential probiotic lacticaseibacillus rhamnosus ca15 (dsm 33960) strain, orally administrated, to balance the vaginal microbiota of women with vaginal dysbiosis. two hundred women, with signs and symptoms of vaginal dysbiosis, are recruited and randomly allocated to receive oral capsules containing the l. rhamnosus ca15 (dsm 33960) strain or placebo once daily for 10 days. clinical and microbiological parameters are evaluated in three scheduled appointments: at baseline (t0), 10 days after the start of the treatment (t1), and 30 days after the end of the treatment (t2). in addition, at baseline (t0) and 30 days after the end of the treatment (t2), the quality of life will be evaluated through a quality of life assessment questionnaire.

Eligibility criteria:
inclusion criteria: * presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, subjective vaginal discomfort); * presence of at least 3 amsel criteria; * nugent score greater than 7; * lactobacillary grade greater than 2 (lbg) (according to donders classification); * vaginal dysbiosis based on microbial cell count. exclusion criteria: * presence of sexually transmitted diseases due to chlamydia, neisseria gonorrhoeae or trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis; * clinically evident herpes simplex infection; * human papillomavirus or human immunodeficiency virus infections; * use of antibiotics, antifungals, probiotics, or immunosuppressants within the past four weeks; * use of vaginal contraceptives and any other physiological or pathological condition that could potentially interfere with the results of the study (e.g. pregnancy or breastfeeding, chronic diseases, neoplastic diseases, diabetes, genital tract hemorrhages); * enrollment in other programs that involve the administration of products that may affect the composition of the vaginal microbiota.
anterior mediastinum teratoma: a case report

Conditions: Teratoma

Summary: the investigators report a case of a 39-year-old man who presented an anterior mediastinal cystic mature teratoma. those kind of tumor contain elements derived from more than one of the three primary germ layers (ectoderm, mesoderm, endoderm), frequently arranged in a haphazard manner. they arise from totipotent cells and, therefore, are primarily found in gonads, and more rarely in primitive cells kidnapped in other parts of the body. the tissues are immature to well differentiated and foreign to the anatomic site. mature teratomas are either cystic or solid, although the cystic presentation predominates in gonadal sites. benign teratomas are the most common mediastinal germ cell tumor, accounting 70% of the mediastinal germ cell tumors in children and 60% of those in adults. immature teratomas are potentially malignant tumors; their prognosis is influenced by the anatomic site of the tumor, patient age, and the fraction of the tumor that is immature. treatment of benign mediastinal teratoma includes complete surgical resection, with results in a excellent long-term cure rates. complete resection of teratomas should be the goal of treatment.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of mediastinum teratoma exclusion criteria: * tumor absent

Keywords: teratoma mediastinum
caloric restriction, exercise, and glucoregulation in humans

Conditions: Diabetes

Summary: weight loss induced by caloric restriction alone (cr) and by exercise alone (ex) result in similar effects on blood glucose and insulin. the purpose of this study is to assess the hypothesis that weight loss through caloric restriction plus exercise will result in greater improvements on glucose tolerance and insulin action than similar weight losses through cr or ex alone.

participants are randomized into caloric restriction, exercise, and caloric restriction plus exercise weight loss groups. measurements of blood glucose and insulin, oral glucose tolerance, and matched glucose infusion will be done at baseline and after weight loss of 6% of body weight. other tests include maximal oxygen uptake (vo2max), strength tests, blood pressure, blood lipids, serum inflammatory markers, dual x-ray absorptiometry (dexa) for bone density and body composition, physical activity levels, dietary intakes, and measures of arterial stiffness.

Eligibility criteria:
inclusion criteria: * females postmenopausal * no diabetes, cardiovascular disease, cancer * no orthopedic problems * not currently exercising * bmi between 25 and 29.9 * nonsmokers exclusion criteria: * current regular exercisers * premenopausal women * cardiovascular disease, lung disease, cancer, diabetes
perception of advanced rehabilitation technologies among post-stroke patients and rehabilitation staff

Conditions: Post Stroke

Summary: this observational study aims to assess the perception of advanced rehabilitation technologies among three key groups involved in stroke recovery: post-stroke patients, physicians specialized in physical and rehabilitation medicine, and allied health professionals. the study is conducted at hcl - renée sabran hospital , specifically within the kermes 2 department. participants are selected using a non-probability sampling method, based on predefined inclusion and exclusion criteria. data will be collected using a structured, author-developed questionnaire designed to evaluate attitudes, perceived usefulness, ease of use, and intention to adopt technologies such as exoskeletons, social robots, wearable interactive devices, and biofeedback systems. the questionnaire is applied at a single time point after obtaining informed consent. this research responds to the growing integration of technology in neurorehabilitation and seeks to identify potential barriers or facilitators to its adoption in clinical practice. the hypothesis is that there is a significant difference in perception and acceptance of advanced rehabilitation technologies between the three groups, influenced by their respective roles, experience, and level of exposure to such technologies.


Eligibility criteria:
inclusion criteria: * patients: patients diagnosed with stroke, whether or not they have benefited from advanced rehabilitation technologies. * physicians: physicians specialized in physical and rehabilitation medicine who manage patients with stroke. * allied health professionals: physiotherapists, psychologists, occupational therapists, speech therapists, neuropsychologists, and psychomotor therapists involved in the rehabilitation of post-stroke patients. exclusion criteria: * refusal to participate in the study. * patients who do not wish to benefit from advanced rehabilitation technology. * healthcare professionals with no experience using advanced rehabilitation technologies.

Keywords: rehabilitation stroke advanced technology perception questionnaire
tavns in mild to moderate parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this study is to find out whether a non-invasive form of nerve stimulation called transcutaneous vagus nerve stimulation (tavns) is safe and effective in people with parkinson's disease.


Eligibility criteria:
inclusion criteria: * age: 40-79 y * idiopathic parkinson's disease diagnosis * disease stage: hoehn and yahr stage 2-3 * patient requires a minimum of 3 doses of levodopa daily * willingness to be videotaped exclusion criteria: * dementia or montreal cognitive assessment score \<24 * parkinson's disease psychosis * ear trauma * facial pain * traumatic brain injury or clinical history of stroke * metal implants above the shoulders * history of myocardial infarction or arrhythmia, bradycardia * active respiratory disorder * alcohol or substance use disorders * history of deep brain stimulation (dbs) or other brain surgery * epilepsy * pregnancy * b-blockers, dopamine blocking agent, antiarrhythmic medication, acetylcholine esterase inhibitor, midodrine, florinef, droxidopa, or anticholinergic drugs
investigation of asprosin a novel adipokine in periodontitis

Conditions: Periodontitis; Obesity; Diabetes Mellitus

Summary: asprosin, a recently discovered glucogenic adipokine, is mainly synthesized by white adipose tissue and released during fasting. appetite, glucose metabolism, insulin resistance, cell apoptosis, etc. asprosin is associated with diseases such as diabetes, obesity, polycystic ovary syndrome, and cardiovascular diseases. periodontal tissue may act as a source of endocrine-like inflammatory mediators (such as tnf-α, il-6 and il-1) that are important in periodontal inflammation and can affect glucose and lipid metabolism. production of tnf-α and il-6 in adipose tissues strengthens the relationship between obesity, t2dm and periodontitis.we postulated that asprosin may be candidate for explaining the triangular relationship among obesity, t2dm, and periodontal disease.

periodontal disease is a chronic, multifactorial, and infectious disease caused by bacteria. it is characterized by the formation of an inflammatory response in the supporting bone and connective tissue against microbial dental plaque, and the nature of the resulting inflammatory response determines the course of periodontal disease. type 2 diabetes mellitus (t2dm), obesity, and periodontal disease are closely related, presenting a triad association. obesity is the crucial cause of t2dm and periodontitis is the sixth complication of diabetes. asprosin circulates in the blood at nanomolar levels and is taken to the liver, where it activates the g protein-camp-pka pathway, causing rapid glucose release into the circulation. insulin-resistant humans and mice have been reported to have pathologically elevated plasma asprosin levels. it will be investigated whether asprosin, which we know to be effective on glucose metabolism, is affected by the periodontal condition.

Eligibility criteria:
inclusion criteria: - * all individuals were generally healthy, * non-smoking exclusion criteria: * pregnant or breastfeeding women * none had undergone periodontal therapy and/or antibiotic therapy in the past 6 months. * none has a contagious disease such as hiv or aids
routine mini-invasive electrophysiology study for patients feeling tachycardia, with a negative holter ecg

Conditions: Pre-excitation Syndromes; Paroxysmal Tachycardia; Atrial Fibrillation; Atrial Flutter; Wolff-Parkinson-White Syndrome

Summary: patients complaining of tachycardia but with a negative holter ecg, are for a limited time period offered a simplified electrophysiological(ep) examination. by a full electrophysiological study(ep study)electrodes are introduced for pacing and sensing i all four heart chambers. where as by the mini invasive ep study only one electrode is introduced to the right atrium. the simplified procedure represent a smaller risk of complications, requires less resources but should yield the same diagnoses in more than 90% of the cases. the study is a feasibility study to see if the procedure can discover arrythmias in a fairly unselected patient population.

sykehuset telemark performs every year approximately 800 holter ecg examinations. approximately 200 of these are on the indications tachycardia, and in about 170 patients the examination does not discover any tachycardia patients who were examined in the period from august 1. 2004 to november 1. 2005 with a negative holter are mailed a letter with information of the min invasive electrophysiological examination, and an offer of volunteer participation. patients given their informed consent are then according to waiting list called for the mini-invasive ep-study. the protocol of the ep stimulation consists of: determination of pacing threshold, pacing with 8 asynchronous beats 600ms and an extrasystole with decremental intervals from 550 ms to 200 ms. the seri is repeated with pacing on 400ms and with two extrasystoles as well as with isoprenaline stimulation.

Eligibility criteria:
inclusion criteria: * history of complains of tachycardia * no arrythmias detected by a 24 hours holter ecg * age 19 to 74 years exclusion criteria: * patients younger than 18 years * patients older than 75

Keywords: electrophysiological study paroxysmal tachycardia
exalenz lab mode system compared to biopsy for h.pylori detection

Conditions: Helicobacter Pylori Infection

Summary: the exalenz dual mode breathid® hp system comprised of idkit: hp™ two and the dual mode breathid® hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of h.pylori infection in adult patients and its results will be compared to biopsy results.

patients undergoing esophagogastroduodenoscopy (egd) for initial diagnosis of h.pylori infection or post therapy confirmation of eradication will be eligible to participate in the trial. two sets of biopsies will be taken: one set for histological analysis and one set for rapid urease test (rut) analysis. the two results will be used as a gold standard composite score in determining the presence of h.pylori bacteria in the stomach. the urea breath test (ubt) using the exalenz dual mode breathid hp system will also be performed within a week of the biopsy. the outcome of the ubt will be compared to composite score of the biopsy and the accuracy of the ubt will be evaluated. the ubt will be performed using breath collection bags, where the subject will be asked to breathe into the bags before and after ingestion of the 13c-labelled urea.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age. * have the ability and willingness to sign the informed consent form. * present with clinical indication of h. pylori and a candidate for upper endoscopy for initial diagnosis arm: • symptomatic patients naïve to h.pylori treatment in the past 18 months for post-therapy arm: * documented biopsy with positive outcome prior to eradication therapy (including method of determination) * documented eradication therapy within the past 6 months and completed at least 6 weeks prior to ubt exclusion criteria: * participation in other interventional trials. * antibiotics and/or bismuth preparations within four (4) weeks prior to breath test. * ppi or h2 blockers within two (2) weeks prior to breath test. * pregnant or breastfeeding women. * allergy to test substrates. * patient did not fast for the hour prior to the ubt
study of rvt-1401 for the treatment of patients with moderate to severe active graves' ophthalmopathy (go)

Conditions: Graves' Ophthalmopathy

Summary: the purpose of this study was to evaluate safety, tolerability, and pharmacodynamic parameters of rvt-1401 in graves' ophthalmopathy (go) patients.


Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years of age. 2. clinical diagnosis of graves' disease with hyperthyroidism associated with active, moderate to severe go with a clinical activity score (cas) ≥ 4 for the most severely affected eye at screening (on the 7-item scale) and baseline (on the 10-item scale). 3. onset of active go within 9 months of screening. 4. moderate-to-severe active go (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia. 5. other, more specific inclusion criteria are defined in the protocol exclusion criteria: 1. use of any steroid (intravenous \[iv\] or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of go within 3 weeks prior to screening. 2. use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within the past 9 months prior to baseline. 3. total igg level \< 6g/l at screening. 4. absolute neutrophil count \<1500 cells/mm3 at screening. 5. participants with decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months at screening. 6. previous orbital irradiation or surgery for go. 7. other, more specific exclusion criteria are defined in the protocol

Keywords: imvt-1401 graves' orbitopathy thyroid eye disease