Kornimate/medical-research-clean huggingface dataset:
effect of tinzaparin on inflammatory biomarkers during the acute phase of deep vein thrombosis

Conditions: Deep Vein Thrombosis; Inflammatory Response

Summary: anticoagulants influence either coagulation, inflammation and inflammatory processes in deep vein thrombosis (dvt). acute dvt cause an inflammatory response that may persist for a long period of time. there is a need to describe patterns of change in serum biomarker levels after acute dvt, and explore the association between trajectory biological patterns and clinical evolution in the era of various anticoagulants in the acute phase of treatment in order to be able to further avoid recurrence and late sequelae. it appears that direct oral anticoagulants and heparin alter inflammatory markers in different ways. it is therefore important to study the evolution of markers according to the different treatments used and secondarily to compare them with each other. tinzaparin is used in the long term in patients with dvt, it is necessary to measure the evolution of inflammatory markers and then in another study to compare with the other molecules.


Eligibility criteria:
inclusion criteria: * adult patients with a first episode of symptomatic, proximal dvt of the lower limbs, confirmed by duplex ultrasound (dus) * indication for treatment with tinzaparin * patient covered by french national health insurance, * written informed consent. exclusion criteria: * recent dvt (less than 2 months) objectively proven by venous ultrasound - severe ilio-femoral dvt requiring recanalization * duration of treatment of more than 24 h since diagnosis * patients with acute symptoms (leg pain and swelling) for more than 5 days * planned surgery in the following 3 weeks, impossible to postpone * active haemorrhage or high risk of haemorrhage * symptoms of post thrombotic syndrome * active neoplasm * apl syndrome * renal insufficiency (creatinine clearance (cockcroft-gault) \<20 ml/min) * hepatic disease / or hepatic insufficiency / or serious liver disease * hyperkaliemia more than 5 mmol/l * patients with mechanical prosthetic heart valve * weight more than 105 kgs in order to avoid difficulties with a dosage of 20000ui of tinzaparin any anti-inflammatory drugs or anti-platelet therapy * any other concomitant anticoagulant treatment such as vka, heparin, fondaparinux and direct oral anticoagulants * contraindications to tinzaparin according to their smpc * patient with asthma, if patients need to receive tinzaparin 10000ui antix-a/0.5ml for the study,(due to sodium metabisulfite in the solution) * pregnant women or breastfeeding * patient with age under 18 * patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)

Keywords: deep vein thrombosis inflammatory response
development and validation of a sputum biomarker mrna panel for the diagnostic work-up of asthma 3

Conditions: Asthmatic Patients

Summary: the main objectives of the study are: 1. to unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (leukotriene antagonists) the investigators have developed a non-invasive technique based on mrna analysis of induced sputum that enables us to study airway inflammation in detail. this technique forms the basis for our current project based on the following hypotheses: 1. different molecular asthma phenotypes exist: a th2 phenotype and a non th2 phenotype as reported by woodruff and colleagues (woodruff pg et al). sputum mrna cytokine levels can be used to diagnose th2 asthma and discriminate this from non-th2 asthma. 2. based on our previous research and preliminary data that non-th2 asthma can be further divided in th17 asthma and th1+th2 asthma; besides these, a fourth group without th2, th17 or th1 characteristics also exist. 3. these subgroups have different responses to anti-leukotrienes.


Eligibility criteria:
inclusion criteria: * uncontrolled persistent asthmatics on daily inhaled corticosteroids (gina) exclusion criteria: * viral/fungal/bacterial infection +fever (\<1 month) * asthma exacerbation (\<3 months) * other respiratory disease (cf, ciliary dyskinesia,bronchiectasis) * cardiac patients using beta-blockers
digital pathology and ai for liver outcomes in masld

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease

Summary: the aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the digital pathology (dp) fibronest phenotypic fibrosis composite score (ph-fcs), derived from standard digital pathology liver biopsy images, in predicting clinical hepatic decompensation events in patients with metabolic dysfunction-associated steatohepatitis (mash).

mash, or metabolic dysfunction-associated steatohepatitis, presents histological liver changes resembling those caused by alcohol abuse, but in the absence of alcohol intake. common among adults with conditions like obesity and type-2 diabetes, mash, especially its severe form, is anticipated to become a leading cause of end-stage liver disease. currently lacking approved treatments, mash poses a significant burden on liver health and transplantation. diagnosis and assessment rely on subjective histological review, prone to variability and limitations in detecting subtle changes. consequently, there's an urgent need for accurate, continuous histological biomarkers. the fibronest ph-fcs offers a promising solution, utilizing high resolution digital pathology and sophisticated algorithmic methods for sensitive and reproducible fibrosis severity assessment and prediction of clinical events. in a 2003 proof of concept retrospective study on 400 patients, its prognostic performance was excellent. in this proposed multi-center retrospective study, we aim to confirm the ph-fcs's prognostic value on a large cohort of 1,700 masld patients. we will also compare the prognostic performance of the ph-fcs with the prognostic performance of the nash-cr fibrosis stages, and with non-invasive biomarkers like fib-4 and elastography/fibroscan, also collected retrospectively from the point of initial diagnosis. this study seeks to: (i) confirm ph-fcs's prognostic utility on a large scale. (ii) compare biopsy-based ph-fcs with nash-crn f stages (iii) compare biopsy-based ph-fcs with non-invasive biomarkers.

Eligibility criteria:
inclusion criteria: * adult pts ( \>=18 years old) with masld defined histologically. * liver biopsy with fibrosis stains available for digitization or already digitized. * clinical follow-up \>1 year available recording liver-related outcomes either through hospitalization icd-10 codes or through clinical observation exclusion criteria: * liver diseases other than masld note: no exclusion based on bariatric surgery, significant weight loss or enrollment in nash clinical studies, but data is collected for data analysis / competing effects (see data analysis plan)

Keywords: nafld mafld digital pathology artificial intelligence fibrosis score liver disease hepatic decompensation
the safety and efficiency of sildenafil in the treatment of severe post-capillary pulmonary hypertension caused by copd

Conditions: COPD; Pulmonary Hypertension

Summary: over half of chronic obstructive pulmonary disease (copd) patients develop pulmonary hypertension. the current therapy focuses only on the basic disease and there are a lot of controversies about the use of pah target therapy in group 3 pulmonary hypertension. our study is to explore whether sildenafil, a pulmonary arterial hypertension (pah) target drug, could be efficient and safe in improving symptoms and survival of severe pulmonary hypertension caused by copd.


Eligibility criteria:
inclusion criteria: * stable for over 1 month * mean pulmonary artery pressure ≥35mmhg, pulmonary wedge pressure≤ 15mmhg * never received target therapy before exclusion criteria: * patients with other serious respiratory diseases * patients with pulmonary hypertension other than group 3 * patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases * patients with limited life expectancy * patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months * psychopath or addict * nonstable patients with type ⅰor ⅱ respiratory failure * patients with contraindication for sildenafil * patients in pregnancy or breastfeeding
an open label study of levetiracetam in japanese pediatric patients with partial seizures

Conditions: Epilepsy; Partial Seizures

Summary: objective of the first period: to evaluate the efficacy of levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

objectives of the second period: to provide the levetiracetam treatment to subjects who are judged by the investigators to benefit from the long-term treatment and who are willing to continuously receive this drug. to continuously evaluate the safety of the levetiracetam long-term administration at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the first period of this study.

Eligibility criteria:
inclusion criteria: * the patient has partial epilepsy and the diagnosis must be confirmed in the last 6 months * the patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to baseline and must have at least 8 partial seizures during the 8-week prospective baseline period * patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg exclusion criteria: * the patient has a treatable seizure etiology * the patient has epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including rasmussen and landau-kleffner diseases * the patient has a history of status epilepticus during the 3 months prior to visit 1 * the patient has a past and present history of pseudo seizures * the patient has a current diagnosis of lennox-gastaut syndrome

Keywords: keppra levetiracetam children epilepsy partial seizures
effect of low vs moderate-intensity endurance exercise on physical functioning among breast cancer survivors

Conditions: Breast Neoplasms

Summary: the purpose of this study is to evaluate the effect of two exercise programs: 1) one program will be at low intensity; 2) the other program will be at moderate intensity. one hundred forty two women who are breast cancer survivors will be recruited. participants will be educated on a home exercise program to be performed at either low or moderate intensity, according to group assignment. evaluations to participants will consist of function and quality of life.

improvements in early diagnosis and treatment for breast cancer in women have resulted in increased survivorship. an unintended consequence of increased survival, however, is that more women are living with the negative sequelae associated with cancer treatment, including decreased physical function. exercise has been beneficial in arresting these sequelae, but adherence to exercise guidelines continues to be a challenge. as most breast cancer survivors are middle-aged and older, an alternative to enhance exercise engagement and adherence might be providing a low intensity exercise program. the overall purpose of this study is to assess the impact of a low intensity versus moderate intensity endurance exercise program on physical functioning on breast cancer survivors. it is hypothesized that participants of the low intensity exercise program will demonstrate similar physical functioning as participants in the moderate intensity exercise program. the theory of planned behavior will serve as framework for the intervention. a convenience sample of 142 women, residents of puerto rico, age 50 or older, with a diagnosis of breast cancer, stage 0 thru iii, who have received surgical treatment for breast cancer, with or without adjuvant therapy, will be randomly assigned to a low intensity or moderate intensity endurance intervention. both interventions will be home-based, have a duration of 6 months, and be provided by physical therapists. an evaluator blinded to group assignment will assess participants at baseline and at completion of the intervention. primary outcome measures will consist of physical functioning, and health-related quality of life.

Eligibility criteria:
inclusion criteria: 1. fifty years of age or older 2. be a resident of the san juan metropolitan area of puerto rico (pr) 3. diagnosed with breast cancer 4. be classified in breast cancer stage grouping 0 to iii according to the american joint committee on cancer classification of malignant tumors (tnm) staging system (2013) 5. have completed adjuvant curative therapy at least two months to 5 years prior to recruitment exclusion criteria: 1. women who have contraindications to exercise, such as extreme fatigue or anemia, unstable cardiac disease; uncontrolled diabetes; uncontrolled hypertension; coagulopathies; inability to ambulate independently 2. women with metastasis or secondary cancers 3. women who already meet the national standard for exercise (≥ 150 minutes per week of moderate exercise).

Keywords: exercise physical functioning hispanic
vagal nerve stimulation as an alternative therapy for premature ventricular contractions

Conditions: Premature Ventricular Contraction

Summary: prospective randomized control pilot study

the primary aims of this investigator initiated study is : aim 1: to assess the ability of non-invasive vagal nerve stimulation to suppress premature ventricular contractions and aim 2: to compare the efficacy of lower-level tragus stimulation and heart rate variability- biofeedback in suppression of premature ventricular contractions.

Eligibility criteria:
inclusion criteria: * normal left ventricular systolic function * frequent pvcs exclusion criteria: * current use of any (i and/or iii) antiarrhythmic medication * contraindication to use beta blockers and non-dihydropyridine calcium channel blockers * complete atrioventricular block and pacemaker dependent * ongoing uncontrolled hypertension with systolic blood pressure\> 180 * family history of dilated cardiomyopathy in a first degree relative * alcohol use disorder or illicit drug use * actively being treated atrial fibrillation/ flutter with rapid ventricular response * moderate to severe valve disorders * patient with shortwave/microwave therapy equipment

Keywords: nivns non-invasive vagal nerve stimulation llts- low-level tragus stimulation hrv-bf - heart rate variability biofeedback
intraoperative pathway in diep flap breast reconstruction

Conditions: Breast Cancer

Summary: efficiency in the operating room can be difficult in long cases with multiple surgeons. we used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.

a team based approach was developed with an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.

Eligibility criteria:
inclusion criteria: * all cases prior to pathway exclusion criteria: * none

Keywords: intraoperative pathway breast reconstruction diep flap
transcranial direct current stimulation in post-stroke fatigue

Conditions: Fatigue; Stroke

Summary: this is a double-blind, sham-controlled, anodal tdcs study to understand the effect of increasing motor cortex excitability on post-stroke fatigue.


Eligibility criteria:
inclusion criteria: diagnosed with stroke at least 3 months post-stroke exclusion criteria: other neurological conditions on anti-depressants severe motor impairment (affected hand grip \ 11 in the depression sub-section of hads questionnaire contraindications for tms or tes
posterior capsular opacification and glistenings in hydrophobic and hydrophilic intraocular lenses

Conditions: Cataract; Intraocular Lens Opacification

Summary: a prospective randomized controlled clinical study to measure posterior capsular opacification, objective measurement of glistenings and intraocular lens tilt and decentration as well as visual outcomes following insertion of a monofocal, aspheric, hydrophobic acrylic intraocular lens: the rayone® hydrophobic lens 800c and a monofocal aspheric, hydrophilic acrylic intraocular lens: the rayone® hydrophilic lens 600c


Eligibility criteria:
inclusion criteria: 1. unilateral or bilateral cataracts requiring surgical intervention 2. age over 18 years 3. able to understand informed consent and the objectives of the trial 4. not pregnant, not breast feeding 5. no previous eye surgery 6. corneal astigmatism less than 1 diopter in both eyes. exclusion criteria: 1. age-related macula degeneration 2. glaucoma 3. previous retinal vascular disorders 4. previous retinal detachment or tear 5. any neuro-ophthalmological condition 6. any inherited retinal disorder or pathology 7. previous strabismus surgery or record of amblyopia 8. previous tia, cva or other vaso-occlusive disease 9. already enrolled in another study
effect of olmesartan and nebivolol on ambulatory blood pressure and arterial stiffness in acute stage of ischemic stroke

Conditions: Stroke, Ischemic

Summary: single-blind, randomized, active-treatment controlled clinical study evaluating the effect of omesartan and nebivolol versus no treatment on 24-hour brachial and central aortic blood pressure in hypertensive patients with acute ischemic stroke

a total of 60 patients with hypertension and acute ischemic stroke (clinic bp \>160/100 mmhg and \<220/120 mmhg at day 3 of stroke onset) will be randomly allocated to therapy with olmesartan (20 mg/day) or nebivolol (5 mg/day) or no treatment between the 3rd to 7th day of hospitalization.

Eligibility criteria:
inclusion criteria: 1. patients with a first diagnosis of an acute ischemic stroke (permanent or transient) 2. bp levels \>160/100mmhg at start of the third day of hospitalization 3. bp levels \>160/100mmhg and \<220/120mmhg at start of the fourth day of hospitalization exclusion criteria: 1. patients with confirmed hemorrhagic stroke with computer tomography at hospital admission. 2. patients with chronic atrial fibrillation or other cardiac arrhythmia. 3. patients with bp levels \>220/120 mmhg during the hospitalization or patients with other hypertensive emergency situation (i.e. acute myocardial ischemia, aortic dissection, acute pulmonary edema, acute renal failure, hypertensive encephalopathy) which demands fast bp reduction with the use of intravenous antihypertensive drugs, according to current guidelines {jauch, 2013 340 /id}. 4. patients with specific indication for treatment with blockers of the renin-angiotensin-aldosterone system (raas) other than hypertension (i.e., congestive heart failure, acute myocardial ischemia). 5. patients with specific indication for treatment with β-blockers other than hypertension (i.e., heart failure, tachyarrhythmia or angina pectoris). 6. patients with specific contra-indications for raas blockers (hyperkalemia, history of angioedema) and patients with a history of allergic reaction or severe hypotension after olmesartan treatment. 7. patients with specific contra-indications for β-blockers (heart rate \<60/min without a treatment with bradyarrhythmic drugs), chronic obstructive pulmonary disease or asthma and patients with history of allergic reaction after nebivolol treatment.
glycemic index in subjects with diabetes mellitus insulin requesting

Conditions: Diabetes Mellitus, Type 2

Summary: to evaluate the acute effect of a low and high glycemic index breakfast on the glycemic response and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus diagnosis. * minimum period of six months under intensive insulin therapy. * fast insulin prescription before breakfast. * 35 and 70 years of age. * bmi between 25 and 39.9 kg/m2. * hba1c less than or equal to 10 % (86mmol/mol) * menopausal women under hormone replacement therapy exclusion criteria: * pregnant women. * puerperal women. * subjects with neurological disease, endocrine disorder no treatment, kidney disease in stage iv or v, cancer, liver disease, chronic obstructive pulmonary disease, human immunodeficiency virus. * subjects with history of stroke, acute myocardial infarction or gastrointestinal resection.

Keywords: glycemia satiety insulin breakfast low glycemic index high glycemic index
robotic assisted surgery in upper aerodigestive tract surgery

Conditions: Head and Neck Cancer; Oropharyngeal Cancer; Hypopharyngeal Cancer; Upper Aerodigestive Tract Neoplasms

Summary: to evaluate the use of the davinci robotic system for better visibility and access of head and neck lesions and decreased amount of surgery time.

this trial is a single institution non-randomized study to evaluate the efficacy and safety of the da vinci® robotic surgical system. this study will evaluate the use of the davinci robotic system for better visibility and access of head and neck lesions and decreased amount of surgery time. this is a robotic system used by surgeons to perform surgery in a less invasive manner.

Eligibility criteria:
inclusion criteria: * head and neck lesions requiring surgical resection, biopsy, or invasive treatment; * lesion amendable to robotic assisted surgery treatment; * age \> 19 years; * patient must sign informed consent. exclusion criteria: * psychological condition that renders the patient unable to understand the informed consent; * poor mouth opening, with maximal opening less than 1.5 cm.

Keywords: lesions biopsy surgery
the effectiveness and safety of gabapentin for post-operative pain after cesarean section

Conditions: Pain

Summary: the purpose of this study is to determine whether a single dose of gabapentin, given before cesarean section, will reduce pain in the initial 24 hours after surgery. gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of surgeries. we believe that it may be effective for treating pain after cesarean sections, but it has never been studied for this purpose.

a cesarean section is a surgical procedure and, like all surgeries, there is pain after the operation. the purpose of this study is to find out if patients have less pain after a cesarean delivery when they receive a single dose of a gabapentin before the surgery. we are also interested in whether or not the dose of gabapentin reduces the need for other pain-killing medication during this time. patients will be randomly assigned to receive either gabapentin or a placebo. in addition, all patients will receive the usual standard of care and medication for pain (intrathecal morphine,oral paracetamol and diclofenac). at 4, 12, 24 and 48 hours after the operation, patients will be asked about their pain and satisfaction with pain management. the dose of gabapentin given is thought to be safe for the baby, and we plan to investigate whether the gabapentin has any effect on the baby's pain response when given his/her vitamin k injection. gabapentin has also been shown to reduce long-term pain that can develop, and patients will be followed up at 6 weeks to be asked about their pain at that time.

Eligibility criteria:
inclusion criteria: * women undergoing elective cesarean delivery exclusion criteria: * patients unable to communicate in english * patients with an american society of anesthesiologists (asa) classification of 3 or higher * patients with contraindications to any of the medications used in the study * patients with contraindications to spinal anesthesia * patients who have taken any pain medication in the past week * patients with fetuses having congenital abnormalities * patients with severe mental disorders * patients with hiv or hepatitis infections * intravenous drug users * patients with uncontrolled hypertension and diabetes * patients with central nervous system tumours

Keywords: cesarean section gabapentin