Kornimate/medical-research-clean huggingface dataset:
stem cells therapy in degenerative diseases of the retina

Conditions: Retinal Degeneration; Retinitis Pigmentosa; Age Related Macular Degeneration; Stargardt Disease 1

Summary: the purpose of this study is to test the safety and effectiveness of an autologous bone marrow-derived stem/progenitor cells administered intravitreously in the subjects with degenerative diseases of the retina.

degenerative diseases of the retina are challenging for ophthalmologists. this is a common term that covers heterogenous group of diseases, f.e. retinitis pigmentosa, stargardt disease, best's disease or age related macular degeneration. undetermined etiology, wide range of factors that may trigger the onset of the disease and modulate it's course impede the implementation of an effective treatment. currently, a stem cells therapy seems to be promising option in patients with degenerative diseases of the retina. the purpose of this prospective, nonrandomized, open label, pilot study is to conduct the investigation of the safety and efficacy of intravitreal injection of autologous bone marrow-isolated stem/progenitor cells with different selected phenotypes into the subjects with degenerative diseases of the retina. especially, this clinical trial is designated to test the therapeutic (pro-regenerative and neuro-protective) functions of different stem/progenitor cell populations able to secrete bioactive neurotrophic factors. all patients enrolled will have a documented history of degenerative disease of the retina prior to study enrollment. next, autologous bone marrow-isolated stem/progenitor cells intravitreous injection will be performed. finally, treatment safety, adverse events and exploratory parameters, including best corrected visual acuity, visual field and electroretinography parameters, to establish disease progression rate will be recorded throughout the duration of the post-treatment follow up period.

Eligibility criteria:
inclusion criteria: * diagnosed degenerative disease of the retina, * age 18-65 years, * best corrected visual acuity max. 0,2 (snellen letter chart), * good understanding of the protocol and willingness to consent, * signed informed consent. exclusion criteria: * concomitant eye disease (glaucoma, etc.) * concomitant of other systemic disease or diseases, * inflammation (high protein or lymphocytosis in the csf), active infections. * diabetes, * cardio-vascular disorders, * cancer, * autoimmune diseases, * renal failure, * impaired hepatic function, * subject unwilling or unable to comply with the requirements of the protocol, * patient has been treated previously with any cellular therapy,

Keywords: stem cells retinitis pigmentosa age related macular degeneration stargardt disease electroretinography
effect of steroids on cerebral inflammation and neuronal damage after surgical aortic valve replacement

Conditions: Aortic Stenosis

Summary: the purpose of this study is to investigate if methylprednisolone is effective in reducing the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.

in a previous study we found that patients undergoing aortic valve surgery had elevated cerebrospinal inflammatory markers. in this study we aim to investigate if this inflammatory response can be reduced after treatment with steroids. 30 patients will be randomized to intraoperative treatment with either placebo or methylprednisolone 15mg/kg. csf and blood will be collected the day before and the day after surgery, analyzed for markers of inflammation (il-6, il-8), neuronal damage (s-100) and blood brain barrier function (alb).

Eligibility criteria:
inclusion criteria: * elective aortic surgery +/- coronary artery bypass grafting (cabg) exclusion criteria: * coagulopathy * preoperative neurologic deficit * uncontrolled hypertension

Keywords: cerebrospinal fluid inflammatory markers heart surgery neuronal damage blood brain barrier
stride: stress reduction in dementia caregivers

Conditions: Caregiver Stress

Summary: the investigators aim to conduct a feasibility, proof of concept randomized controlled trial (rct) of a smartphone app intervention (healthy minds program; hmp) versus wellness app (wa) among heterogeneous stressed caregivers of individuals with alzheimer's disease and related dementias (adrd). the investigators will test its feasibility (primary outcomes) and its preliminary effect in improvement in caregiver stress, emotional distress (depression and anxiety), sleep, and mindfulness. participants will be randomized to one of the two conditions described above

using the nia 2 year r21 grant mechanisms, we will examine the feasibility (markers of acceptability and demand), and proof of concept of healthy minds program (hmp) versus wellness app (wa) in decreasing stress, emotional distress and sleep dysfunction in heterogeneous, geographically diverse, stressed caregivers of individuals with alzheimer's disease and related dementias (adrd). participants in each arm will be asked to practice for 10 min/day. to achieve our aims, we will conduct a single blind, pilot, feasibility, proof of concept randomized controlled trial (rct) of hmp (12 weeks, \> 10 minutes daily) versus wa; 12 weeks, \>10 minutes daily). assessments will be conducted at baseline, post program (12 weeks later) and at 20 weeks follow-up (\~2 months after post-test). caregivers will also complete weekly assessments.

Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. english fluency and literacy 3. meeting criteria for being a caregiver (e.g., family or friend of a care recipient who provides unpaid care) 4. perceived stress scale (4 items) version \>= 6 5. willing to be randomized 6. care recipient must score \>1 on the functional assessment scale (fast) exclusion criteria: 1. any planned change in psychotropic pharmacologic treatment for the duration of the study 2. use of any consumer-based mindfulness meditation app for more than 60 min/month in the past 6 months. 3. current participation in a meditation program (e.g., mindfulness-based stress reduction, mindfulness-base cognitive therapy, etc.) 4. major illness known to worsen dramatically or require surgery in the next 20 weeks (study duration) 5. active treatment for cancer (chemotherapy, radiation) 6. imminent placement of care recipient in a nursing home or with another caregiver (within 4 months). 7. involvement in another clinical trial for caregivers. 8. for participants age 65 and older: four or more errors on the short portable mental status questionnaire (spmsq)
evolution of pulsed oxygen saturation during interval training compared to continuous training in copd patients

Conditions: COPD; Exercise; Pulmonary Rehabilitation; Desaturation of Blood

Summary: a problem often observed during exercise training is oxygen desaturation exclusively during exercise in some patients. in the case of exercise-induced desaturation, it may be suggested to train these patients in interval training to limit exercise-induced desaturation. interval training consists of alternating active phases of short duration (often 30 seconds to 1 minute) followed by a short active or passive recovery phase of equivalent duration to the previous phase. investigators therefore hypothesise that interval training on a cycloergometer or treadmill can limit exercise-induced desaturation in copd patients. the aim of the study is to observe the evolution of pulsed oxygen saturation between a continuous training session and a interval training session.


Eligibility criteria:
inclusion criteria: * a diagnosis of copd * participating in a pulmonary rehabilitation programme * with an exercise-induced desaturation less than 90% * no oxygen supplementation exclusion criteria: * under 18 years of age * pregnant woman * person not affiliated to a health insurance regime or not benefiting from a social security regime * patient under curatorship, guardianship or safeguard of justice * patient speaking a language other than french * patient with severe hypoxaemia (spo2 ≤ 80%) during exercise * patient having had a moderate or severe exacerbation (hospitalisation for respiratory reasons) in the previous 4 weeks * patients with orthopaedic, rheumatic, vascular or neurological pathology limiting their ability to make an effort * breastfeeding women

Keywords: copd pulmonary rehabilitation interval training
major liver resection: early clotting disorders and functional impairment.

Conditions: Hepatic Insufficiency; Blood Coagulation Disorders

Summary: the aim of this study is to evaluate early clotting disorders through thromboelastogram and anticoagulant proteins levels (maybe also endothelial markers) and liver function by indocyanine green clearance after major liver resection and search for a potential relationship between them.

we are prospectively recording data from patients undergoing major liver resection. we obtain a full procoagulant and anticoagulant profile preoperatively and, at first, second and sixth day after surgery. we also measure indocyanine green (icg) clearance preoperatively and in the first two postoperative days. we are also recording clinical data, focusing on medical and surgical complications. we aim to establish the potential value of icg clearance and or coagulation profile to predict clinical complications

Eligibility criteria:
inclusion criteria: * patients undergoing major liver surgery defined as resection of 3 or more hepatic segments exclusion criteria: * indocyanin green allergy * thyrotoxicosis * thrombophilia * lupus anticoagulant * coagulation factor deficiency * venous thromboembolism in the last 3 years * pulmonary thromboembolism in the last 3 years

Keywords: thrombelastography antithrombin proteins liver surgery liver function tests
early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.

intravenous thrombolysis with alteplase is recommended in treatment guidelines for patients with acute ischemic stroke. previous studies showed that intravenous tenecteplase (0.25 mg/kg) is a reasonable alternative to alteplase for all patients presenting with acute ischemic stroke who meet standard criteria for thrombolysis. after thrombolysis-induced recanalisation, reocclusion occurs in 14-34% of patients, probably because of platelet activation. early administration of antiplatelet therapy after intravenous thrombolysis could reduce the risk of reocclusion and improve outcome. the purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.

Eligibility criteria:
inclusion criteria: age 18-80 years ischemic stroke with measurable deficit on nih stroke scale treatment within 4.5 hours of stroke onset be able to engage in daily life independently before the onset of this ischemic stroke (mrs score: 0-1) patients awakening with symptoms are defined by the time last observed normal written informed consent by patient or proxy exclusion criteria: patients with premorbid modified rankin scale (mrs) score ≥3 patients for whom a complete nih stroke score cannot be obtained hemiplegic migraine with no arterial occlusion on cta seizure at stroke onset and no visible occlusion on baseline cta intracranial haemorrhage on baseline ct clinical presentation suggesting subarachnoid haemorrhage even if baseline ct is normal large areas of hypodense ischaemic changes on baseline ct patients with systolic blood pressure \>185 mm hg or diastolic blood pressure \>110 mm hg female, pregnant or breast feeding known bleeding diathesis known allergic to tirofiban or other glycoprotein iib/iiia antagonist use of oral anticoagulants and international normalized ratio (inr) ≥1,4 use of new oral anticoagulants (noac) within the last 12 hours heparin \<48 hours and increased activated partial thromboplastin tike (aptt) low molecular weight heparin(oid) \<24 hours any other investigational drug \<14 days sepsis patients with arterial puncture at a noncompressible site or lumbar puncture \<7 days major surgery or serious trauma \<14 days gastrointestinal or urinary tract hemorrhage \<14 days clinical stroke \<2 months history of intracranial haemorrhage brain neurosurgery \<2 months serious head trauma \<2 months pericarditis any serious medical illness likely to interact with treatment confounding pre-existent neurological or psychiatric disease unlikely to complete follow-up pregnancy
does botulinum toxin type-a injection an effective way of relieving pain in myofascial pain syndrome patients or not

Conditions: Myofacial Pain Syndromes

Summary: in this research prilocaine and botulinum toxin (bont-a) interventions prospectively compared to find out the effect of bont-a injection on myofascial pain syndrome (mps). the main question it aims to answer is: does botulinum toxin type-a an effective way of relieving pain in myofascial pain syndrome or not? for this purpose thirty-eight patients randomly assigned into two study groups. while bont-a injection group (big group n=19) treated with 20 units of toxin to each trigger point (tp), remaining treated with 2 ml prilocaine (pig group n=19) with same procedure. pre-treatment, 2nd and 6th weeks findings were clinically recorded.

visual analog scale (vas), 4-point verbal rating scale (vrs), pain pressure threshold (ppt), short form-36 (sf-36) and beck depression inventory (bdi) tools were used to evaluate findings of the research.

Eligibility criteria:
inclusion criteria: thirty eight patients (27 female, 11 male) admitted to the pm\&r (physical medicine and rehabilitation) department with at least one tp identified at neck, upper back and lower back muscles were included to the study. exclusion criterias: recent any injection to tp within the last 2 months, diagnosed with fibromyalgia syndrome, having respiratory or cardiovascular diseases, allergies, having psychiatric disorders, history of shoulder or cervical intervention within the last year, cervical myelopathy, radiculopathy, failure of cooperation.

Keywords: myofascial pain botulinum toxin prilocaine i̇njection
exercise training in postmenopausal patients with breast cancer

Conditions: Physical Activity

Summary: this randomized trial aims to assess if a well defined subgroup of breast cancer patients benefit from a controlled physical activity program. all patients will be screened for their physical ability to complete the interventional exercise program. only patients capable and willing to take part in this study and meeting all inclusion and exclusion criteria will be randomized. all patients are to receive identical counseling for ideal nutritional, life-style and physical activity. patients randomized to arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home.


Eligibility criteria:
inclusion criteria: * signed informed consent * postmenopausal women with hormone receptor positive breast cancer (as defined by hr \>= ++ and/or pr \>= ++) who are treated with aromatase inhibitors * ecog performance status \<= 2 * all age groups exclusion criteria: * pathologic ergometry * uncontrolled diabetes mellitus * uncontrolled hypertension * copd \> ii * active opportunistic infection * nyha heart failure iii or iv

Keywords: breast cancer physical activity sports exercise
clinical evaluation of 3m™ espe™ adper™ scotchbond™ se self-etch adhesive in class i and class ii restorations in adults

Conditions: Dental Caries

Summary: the purpose of this study is to evaluate the performance of a new dental adhesive system in the restoration of class i and class ii cavities in adult teeth.


Eligibility criteria:
inclusion criteria: * must be at least 18 years of age * must have 2 or 4 qualifying class i or class ii cavities * must be willing to sign consent form * must be willing to return to university dental clinic for 4 study appointments * must be in good medical health and able to tolerate dental procedures exclusion criteria: * current participation in other restorative product studies * known allergies to dental products * unacceptable level of oral hygiene * chronic periodontitis (gum disease) * rampant caries (cavities) * severe salivary gland problems * inability or unwillingness to attend study appointments
effects of pitavastatin treatments on the plasma lgi3 level in the patients with dyslipidemia

Conditions: Dyslipidemias

Summary: leucine-rich glioma inactivated 3(lgi3) has been postulated to have a pro-inflammatory adipokine that inter-plays with other adipokines in adipogenesis and metabolic inflammation according to recent investigations. thus, in this study, we sought to demonstrate that the treatment of statin can decrease lgi3 level along with the decrease of the atherosclerosis to further evaluate the role of lgi3 in atherosclerosis.

patients who assigned to the pitavastatin treatment first group will be given the pitavastatin 4 mg qd treatment for 12 weeks after randomization, followed by wash-out period of 3 weeks and life-style modification treatment for 12 weeks. similarly, patients who assigned to the life-style modification treatment first group, will be treated with life-style modification treatment for 12 weeks after randomization, followed by wash-out period of 3 weeks and pitavastatin treatment for 12 weeks.

Eligibility criteria:
inclusion criteria: * age 20-80 years * patients with intermediate or low cardiovascular risks needing the statin treatment * patients with intermediate or low cardiovascular risks treating the statin treatment exclusion criteria: * patients without signed informed consent * patients with myopathy * pregnant women or women with potential childbearing * patients with diabetes * patients with established coronary artery disease * patients with heart failure * life expectancy less than 1 year

Keywords: dyslipidemia
prognostic value of delta lus score of patients hospitalized for acute heart failure

Conditions: Emergencies; Acute Heart Failure

Summary: prognostic value of delta lus score of patients hospitalized for acute heart failure within 30 days of discharge.

the aim of our study is to evaluate the contribution of the variation of the lus score performed at the time of admission (lus1) and at discharge (lus2) in predicting the clinical course of patients admitted for acute cardiac decompensation 30 days after discharge. delta lus score=((lus2-lus1) \*100)/lus1

Eligibility criteria:
inclusion criteria: * patients aged over 18 years, * patients hospitalized in the emergency department for dyspnea having as etiology an acute heart failure and in whom will be performed two pulmonary ultrasound examinations (at entry and exit). exclusion criteria: * age less than 18 years * dyspnea of non-cardiac etiology (cause: pulmonary, traumatic, toxic...) * altered state of consciousness (glasgow score\<14) * hemodynamic instability: presence of peripheral signs of shock, use of vasoactive drugs * mechanical ventilation from the outset * cardiorespiratory arrest * inability to give consent to the study * missing one of two ultrasound examinations * unable to make telephone contact after one month.

Keywords: delta-lus score heart failure
multiple-dose safety study of rn316 for thetreatment of hypercholesterolemia

Conditions: Hypercholesterolemia; Dyslipidemia

Summary: the primary objective of this study is to evaluate the safety and tolerability of repeated doses of rn316 in eligible healthy volunteers. rn316 is an investigational drug that is currently being studied as a cholesterol lowering therapy.


Eligibility criteria:
inclusion criteria: * ldl-c must be greater or equal to 130 mg/dl * bmi must be between 18.5 and 40 kg/m2 exclusion criteria: * history of cardiovascular or cerebrovascular event during the past year. * poorly controlled type 1 or type 2 diabetes mellitus * subjects who have taken lipid lowering therapies within the last 3 months of screening.

Keywords: hypercholesterolemia dyslipidemia ldl cholesterol high cholesterol
effects of different doses of dexmedetomidine on postoperative cognitive dysfunction in elderly hypertensive patients

Conditions: Postoperative Cognitive Dysfunction

Summary: the purpose of this study is to identify the effects of different doses of dexmedetomidine on postoperative cognitive dysfunction in elderly hypertensive patients


Eligibility criteria:
inclusion criteria: * written informed consent * elective gastrointestinal surgery * american society of anesthesiologists class ii to iii * aged between 65 and 80 years old * weight between 45 and 75 kilogram,body mass index between 19 and 24 kg.m-2 * with primary hypertension reaching or more than 1 year * normal cognitive function,mini-mental state examination more than 27 exclusion criteria: * severe arrhythmia,atrioventricular block and secondary hypertension * liver and kidney dysfunction,pulmonary disease,endocrine disease * suspected or confirmed difficult airway * any disease or pathologic change will interfere study result * inability to exchange with serious visual and hearing impairment * long term use of sedative-hypnotic drugs and antidepressant drug * addicted to alcohol, tobacco or drug * neuromuscular disease * suspected of malignant hyperthermia * allergic to investigational products or with other contraindication * participated in other study within 30 days

Keywords: dexmedetomidine,postoperative cognitive dysfunction
duration of long acting muscarinic antagonist (lama) bronchoprotection against methacholine challenge

Conditions: Asthma

Summary: the study will assess the duration of protection of single doses of 2 different long acting muscarinic antagonists against methacholine induced bronchoconstriction.


Eligibility criteria:
inclusion criteria: * male or female asthmatics \> 19 years of age * baseline methacholine pc20 less than or equal to 4mg/ml * baseline lung function \>65% predicted * non-smoker and less than 10 pack year smoking history exclusion criteria: * use of anticholinergic within 30 days of visit 1 * poorly controlled asthma * pregnant or nursing * respiratory illness within 4 weeks of visit 1 * exposure to an agent that triggered asthma worsening (e.g. allergen) within 4 weeks of visit 1