Kornimate/medical-research-clean huggingface dataset:
endovascular registry evaluating safety, efficacy and patient comfort (elite)

Conditions: Vascular Diseases

Summary: a single-center, prospective, cohort analysis of the femoral introducer sheath and hemostasis (fish) vascular closure device will study 100 consecutive patients on which the device will be used to close the femoral artery after angiogram and/or endovascular procedure. study will be conducted in order to establish the level of comfort and confidence that this device provides for both patients and physician in terms of hemodynamic and usage outcomes.

the learning experience of new medical device technologies is a well-defined event but varies widely by device and user. several factors influence rate of learning, including the device, the patient population the training technique, clear communication, and the rate of usage. previous publication have reported on the learning curve of vascular closure technologies including; angioseal, perclose \& starclose. these reports established the curve to be close to 50 experiences in order to provide predictable results. many prior studies have studied the safety and efficacy of vascular closure devices. however, it is substantial to also study device success when in the hands of one specific operator. this study will examine 100 consecutive subjects which the fish vascular closure device will be used on, and examine outcomes in the following way: primary endpoint: o safety: severe adverse events rate (sae) (device related only) (transfusion/vessel occlusion) secondary endpoints: * safety: minor adverse event rate (mae) (hematoma) * success rate (time to hemostasis (tth) \< 10min) * time to hemostasis (tth) mm:ss - measured from sheath pull to absence of arterial bleeding. * time to ambulation (tta) hh:mm - measured form sheath pull to walking 20 feet. * patient comfort - subjective measure (see scale below) measured baseline (pre-procedure/ post procedure/ 15 days and 30 days) * physician confidence and comfort (c\&c)(measured every 10 patients)

Eligibility criteria:
inclusion criteria: * all patients on which a fish device will be used for vascular closure, deemed appropriate by the principal investigator. exclusion criteria: * patients on which a fish device will not be used for vascular closure and another method will be used - deemed appropriate by the principal investigator (i.e. manual compressions, perclose, angioseal, etc.).

Keywords: comfort confidence usage outcomes
a pmcf study confirm the performance and safety of the tuftex over-the-wire (otw) embolectomy catheters

Conditions: Thrombus; Embolus; Occlusion; Vessel

Summary: a pmcf study to confirm the performance and safety of the lemaitre® tuftex over-the-wire embolectomy catheter

this clinical investigation is a prospective, single-arm, multicenter, post-market study to proactively collect clinical data on the lemaitre® tuftex over-the-wire (otw) embolectomy catheters and to confirm its performance in removing arterial emboli and/or thrombi, to identify and analyze emergent risks on the basis of factual evidence, and to ensure the continued acceptability of the benefit/risk ratio. the intended purpose of the device in this post market clinical study is identical to the indication of use of the device. the tuftex otw post-market study is initiated by the sponsor and manufacturer of the device, lemaitre vascular, inc. the investigation will take place in 4 sites, most likely in 3 different countries. a total number of 112 subjects is anticipated to be enrolled, who are intended to undergo surgical treatment for the removal of a emboli and/or thrombi. the anticipated enrollment period is 48 months, and the participation per subject is 1 month. the total study duration is expected to be 56 months (4 months start-up, 48 months of recruitment, 1 month of follow-up, 3 months of closure.

Eligibility criteria:
inclusion criteria: 1. male and female subject, ≥ 18 years of age at time of enrollment. 2. subject who is scheduled to undergo surgical treatment for the removal of an emboli or thrombi during an embolectomy and/or thrombectomy procedure, where one of the lemaitre® embolectomy catheter will be used. 3. subject signed an informed consent for participation. 4. subject diagnosed with a embolus/thrombus. 5. subjects for whom thrombolytic therapy had failed or was contraindicated. exclusion criteria: 1. co-morbidity that in the discretion of the investigator might confound the results. 2. subjects who are unable to read or write. 3. pregnant or lactating women at time of enrollment 4. subjects who are immune compromised
psychobiology in inflammatory bowel disease(ibd)

Conditions: Inflammatory Bowel Disease

Summary: patients with ulcerous colitis and crohn's disease, age 18-60, with a relapse within the last 18 months and an activity index ≥4, with a long time stress level ≥60 on the perceived stress questionnaire (psq) were randomized to a stress management intervention program or treatment as usual and followed up for 18 months.

the study includes distressed patients with ulcerous colitis and crohn's disease with relapse or enduring activity last 18 months and an simple activity index ≥4, on stable medication last 4 weeks. all patients were followed by a gastroenterologist at baseline, 3, 6, 12 and 18 months follow up and a psychiatrist or clinical psychologist at 18 months. half of the patients received additional psychosocial intervention (education, relaxation, supportive psychotherapy with stress management). assessments include gastrointestinal assessments; blood tests; psychiatric evaluations and psychometric evaluations.

Eligibility criteria:
ulcerous colitis and crohn's disease verified by histology and endoscope relapse last 18 months or enduring activity activity index≥4 psq≥60

Keywords: ibd, psychological, stress management
myo-inositol/d-chiro-inositol ratio in follicular fluid

Conditions: Women Infertility

Summary: considering the importance assumed by follicular microenvironment for a proper oocyte development, this study is a prospective observational clinical trial which aims to evaluate whether the embryo blastocyst quality may be affected by different myo-inositol (mi) and d-chiro-inositol (dci) levels in the follicular fluid (ff) of the aspired oocytes. the study includes egg donors and egg receiving couples participating in the oocyte donation program. mi/dci is calculated in ff and related with blastocyst grade.


Eligibility criteria:
inclusion criteria: * clear follicular aspirate obtained during oocyte retrieval; * each specimen of follicular fluid containing only one oocyte. exclusion criteria: * hyperglycaemic women; * pcos women also if euglycaemic; * diabetic subjects having low concentrations of detectable mi in association with an anomalous mi transport.
simplified inferior vena cava collapsiblity

Conditions: Circulatory Failure

Summary: fluid administration is a cornerstone therapy in critically ill patient. fluid restriction or overload can therefore change patient's outcome and mortality. close monitoring of pr (capacity of increase the cardiac output after fluid therapy) is recommended by experts' guidelines. few bedside simple tests are available to predict pr in spontaneously breathing patients. a team of investigators from lille (roger salengro hospital) have already showed that inferior vena cava collapsibility (cvci) accuracy of prediction of pr is excellent in standardized sponteanous breathing patient. however, the standardized inspiration maneuver remains challenging because requiring specific and non-widely available equipment.

the primary objective of this study is to confirmed the excellent accuracy of cvci to predict pr when standardized inspiratory maneuver is simplified. the secondary objective is to test cvcis in different period of cardiac cycle guided by electrocardiogram. after receiving a loyal information patients will give their non-objection. during systematic echocardiography, patients will have to breathe in different conditions in order to homogenize their inspiratory effort. this maneuver will be repeated three times.

Eligibility criteria:
inclusion criteria: * patient requiring an evaluation of pr by echocardiography for * presence of at least one clinical sign of acute circulatory failure (mean arterial pressure \ 90 bpm, capillary refill time \> 3 sec, oliguria (urine output \< 0,5 ml/kg/h over 1 hour or more)) * noradrenaline administration * age \> 18 years old * spontaneous breathing patient requiring oxygen administration without mechanical assistance exclusion criteria: * intolerance of inspiratory maneuver defined by: * clinical sign of acute respiratory failure * active abdominal expiration * hemodynamic response of passive leg raising not evaluable: * intracranial hypertension * impaired transthoracic or abdominal echogenicity * high grade aortic insufficiency * pregnancy * abdominal compartment syndrome * lower limb amputation * urgent hemodynamic therapy within half an hour * modification of hemodynamic support (fluid therapy or modification of catecholamine dose)

Keywords: fluid therapy preload responsiveness spontaneously breathing critically ill patient standardized inspiratory maneuver
fixed-free htn trial

Conditions: Hypertension

Summary: evaluation of the effect of fixed triple anti-hypertensive therapy with losartan-amlodipin-hctz vs any free triple combination therapy chosen by the treating physician for patients with uncontrolled hypertension

patients who have uncontrolled hypertension and who require triple therapy will be randomized to receive: 1. fixed combination containing 3 anti-hypertensive drugs: losartan 100 mg + amlodipin 5 mg + hydrocholorothiazide 12.5 mg one tab/day 2. or any other therapy decided by the treating physician containing three anti-hypertensive agents but supplied as "free" therapy, meaning supplied as 2 or 3 separate tablets patients will have a baseline ambulatory blood pressure recording. the same recording will be repeated at 2 months of therapy. we expect fixed triple combination to be more effective because the drugs used work synergistically together and the compliance will be higher

Eligibility criteria:
inclusion criteria: * patients already on free triple anti-htn therapy whether controlled or not or patients on double anti-htn therapy who are uncontrolled\* or patients on monotherapy and who have a bp \> 160/100 mm hg * bp is defined as uncontrolled if \> 135/85 at home or \> 140/90 in clinic on at least 2 occasions exclusion criteria: * contra-indication for the use of arb or acei, ccb or hydrochlorothiazide history of angina pectoris or myocardial infarction \ 3 drugs
glucagon resistance in patients with nafld

Conditions: Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Glucose Metabolism Disorders

Summary: the investigators propose that the sensitivity to glucagon in hepatic lipid metabolism is impaired in subjects with non-alcoholic fatty liver disease (nafld) and steatohepatitis (nash). moreover, they propose a dys-coordinated, reduced glucagon sensitivity in hepatic lipid metabolism and endogen glucose production in patients with nafld and nash compared with healthy subjects and patients with simple steatosis. this reduced sensitivity may be the basis of a more severe dyslipidemia and the production of increased concentrations of toxic lipid intermediates in plasma and muscle tissue. the study will include healthy subjects with obesity and subjects with simple steatosis and nash, tested at basal glucagonemia and moderate hyperglucagonemia to mimic insulin resistant levels during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. infusion of palmitate, vldl-triglyceride and glucose tracers in combination with indirect calorimetry as well as skeletal and adipose tissue biopsies will be employed to assess free fatty acid and vldl-triglyceride kinetics (turnover, and oxidation) and hepatic fatty acid-esterification.


Eligibility criteria:
inclusion criteria: * bmi \> 28 kg/m2 * steatosis ff% \> 5,6% on mr spectroscopy for nafld and nash groups exclusion criteria: * active smoking * pregnancy * comorbidity other than hypertension and hyperlipidemia * participation in other radioactive isotope studies within the past 3-5 months (depending on radiation dose) * blood donation (within 3 months)
inari vision registry

Conditions: Pulmonary Embolism

Summary: this registry is a global prospective, non-randomized, multicenter, observational, active post-market data collection of inari medical devices and products.


Eligibility criteria:
inclusion criteria: 1. willing and able to provide informed consent per institution and geographical requirements 2. has received treatment with an eligible inari medical device. note: if patients are consented prior to their procedure and the procedure does not take place, the patient will be considered a screen failure. 3. currently within enrollment window relative to their procedure 4. age ≥ 18 years exclusion criteria: 1. is or will be inaccessible for registry follow-up 2. meets exclusion criteria required by local requirements 3. current or planned participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this registry 4. is pregnant or breastfeeding at the time of enrollment
endobronchial ultrasound guided transbronchial needle aspiration (ebus-tbna) for mediastinal re-staging of non-small cell lung cancer(nsclc)

Conditions: Non Small Cell Lung Cancer

Summary: the aim of this study is to determine the diagnostic values of ebus-tbna in the mediastinal re-staging after induction treatment in patients with non-small cell lung cancer. primary objective: 1. to determine the sensitivity, specificity, positive predictive value, negative predictive value and the accuracy of ebus-tbna in the detection of mediastinal metastasis in mediastinal re-staging after induction treatment. secondary objectives: 1. to compare the diagnostic values of ebus-tbna and integrated pet/ct in mediastinal re-staging 2. to evaluate the changes of ultrasonographic features of mediastinal lymph nodes after induction therapy 3. to determine procedure related complications


Eligibility criteria:
inclusion criteria: * histologically proven non-small cell lung cancer * patients who have initially histologically proven n2 disease (stage iiia) * patients who underwent induction treatment (chemotherapy or chemoradiation therapy) and are considred for surgery * written informed consent exclusion criteria: * contraindications for bronchoscopy * medically inoperable patients * patients who are found to have m1 disease, inoperable t4 disease or supraclavicular metastasis after induction treatment
the impact of using a smartphone health application in the improvement of cardiovascular disease risk factors

Conditions: Hypercholesterolemia; Obesity; Diabetes Mellitus; Hypertension

Summary: this study investigates the effectiveness of mobile health application (mhealth apps) in the improvement of cardiovascular disease risk factors including metabolic and behavioral factors. the app will be tested on patients with any of the modifiable risk factors of cvd such as hypertension, obesity, hyperlipidemia, and impaired glycemic control/type 2 diabetes mellitus .

the investigators aim in this study to reduce the risk of cardiovascular disease in patients with hypercholesterolemia, diabetes, obesity and hypertension. this will be achieved by motivating healthy lifestyle among the participants such as increasing physical activity and intake of healthy diet and reducing alcohol and tobacco consumption. the tool which will be used to motivate healthy lifestyle is a smartphone application which will be specifically designed to motivate behavioral change. thus, the investigators hypothesis is that participants who have full access to the mobile application will show improved healthy lifestyle, reduced blood pressure, cholesterol and glucose and reduced bmi compared to the participants who don't have access to the mobile application.

Eligibility criteria:
inclusion criteria: * presentation with at least one of the following metabolic abnormalities: * hypertensions (systolic blood pressure ≥ 130 mmhg and/or diastolic blood pressure ≥ 85 mmhg) * obesity (waist circumference ≥ 80 cm (women) or ≥ 94 cm (men) and bmi ≥ 25 kg/m2) * dyslipidemia (triglycerides ≥ 1.7 mmol/l or/and hdl-cholesterol ≤ 1.29 mmol/l (women) or ≤ 1.02 mmol/l (men) or/and ldl-cholesterol \> 5.18 mmol/l, serum total cholesterol ≥ 5.2 mmol/l) * impaired glycemia/type 2 diabetes (fasting plasma glucose ≥ 5.6 mmol/l) * arabic or english language speaking and able to read and write in one of these languages * possession of a smart mobile phone willing to utilize a mobile application for cvd management. exclusion criteria: * a history of stroke, myocardial infarction or any related cardiovascular complications complicated diabetes mellitus e.g., proliferative diabetic retinopathy, end-stage renal disease * unavailability of a smartphone or any reason that will not allow the participant to use the app properly. (such as; difficulty or inability to use mobile applications, unavailability of network services...etc.). * medical conditions that restrain the participant to be physically active. * high chance of loss to follow up at the famco clinic (due to upcoming travel, temporary employment and thus eligibility to be treated at the clinic, irregular visits due to distance from home...etc.)

Keywords: mobile health application cardiovascular disease prevention metabolic risk factors behavioral risk factors
ribajuste clinical trial investigating the efficacy and safety of dose adaptation of ribavirin

Conditions: Chronic Hepatitis C

Summary: the aim of this study is to compare two therapeutical strategies concerning the combination therapy (peginterferon alfa-2a and ribavirin) in naïve patients with chronic hepatitis c of genotype 1. "reference" strategy corresponding to standards of care recommended by the french consensus conference versus "test" strategy corresponding to adaptation strategy of ribavirin dose during the first week according to auc (area under the curve) of ribavirin plasmatic concentration after the first intake (day 0) of 600 mg


Eligibility criteria:
inclusion criteria: * 65 years \>age \>= 18 years * chronic hepatitis c documented by pcr performed within 3 months and at liver biopsy within 18 months or with serum markers of fibrosis performed within 3 months before inclusion or fibroscan performed * naive patients for who the physician decided to initiate a combination treatment of chronic hepatitis c with pegylated interferon alfa-2a plus ribavirine * genotype vhc-1 * compensated liver disease (child-pugh \<=6) * negative hbsag test and hiv-rna test * negative pregnancy test at baseline in women in age of procreation and efficient contraception all along the treatment period, and up to 7 months after discontinuation for women and men * signed consent form * patient with a social cover exclusion criteria: * non hcv liver disease * non-1 hcv genotype * organ transplant whatever the organ * clinical or radiological evidence of liver carcinoma * severe psychiatric disorder * non compensated thyroid dysfunction * woman pregnant or breast-feeding * recent history of epilepsy (less than 6 months) * absolute contraindications to one of the drug of combination therapy * biological abnormalities at pre-treatment check-up, such as: neutropenia (\<1500/mm³); haemoglobinemia (\<13 g/dl for men et \<12 g/dl for women); thrombopenia (\<90 000/mm³); * kidney failure (creatinine clearance\>70 ml/min) * hypersensitivity to epoetin or one of its excipients * treatment by epoetin within 2 months prior inclusion * chronic cardiac failure (grade iii or iv - nyha classification) * high blood pressure unwell-controlled (sbp \> 180 mmhg during inclusion in spite of hypertension treatment) * previous history or risk of venous thrombosis * major surgery within the previous 3 months

Keywords: chronic hepatitis c,genotype1,naïf,bitherapy,ribavirin adaptation,ribavirin auc
an exploratory open label study of adjunctive l-lysine treatment in patients with schizophrenia

Conditions: Schizophrenia

Summary: the objective of the present study was to investigate the possibility of using l-lysine, an amino acid that occurs naturally in food and which interferes with nitric oxide (no) production, for the treatment of schizophrenia. l-lysine, 6 g/day, was administered to ten patients with schizophrenia as an add-on treatment to conventional antipsychotic treatment. the study was designed as a single-blinded, cross-over study where patients were randomly assigned to initial treatment with either l-lysine or placebo and screened at baseline, after four weeks when treatment was crossed over, and after eight weeks when treatment was terminated. the four-week l-lysine treatment regimen caused a significant increased in blood concentration of the amino acid and was tolerated well. the analysis of outcome measures showed a significant decrease in symptom severity as measured by the positive and negative syndrome scale (panss). furthermore, the patient's ability to solve the wisconsin card sorting task (wcst) was significantly improved indicating increased problem solving capacity and cognitive flexibility. subjective reports from three of the patients also indicated decreased symptom severity and enhanced cognitive functioning. in summary, these findings suggest potential beneficial effects of l-lysine treatment on symptom severity and cognitive deficits in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * a stable phase of illness * a stable dose of antipsychotic medication * no other major medical conditions or other psychiatric diagnosis * normal admission laboratory tests and vital signs exclusion criteria: * substance abuse, apart from smoking

Keywords: schizophrenia l-lysine panss