Kornimate/medical-research-clean huggingface dataset:
characterization of cortical injury in early ms patients: a 7t mri study

Conditions: Multiple Sclerosis (MS)

Summary: the main aim of the present study is to assess the prevalence, the topography and the clinical counterpart of cortical lesions in patient included early after the first clinical episode of multiple sclerosis. a second aim is to assess the direct contribution of cortical lesions - independent of wm injury - on the diffuse grey matter damage. thirty ms patients will be included in the six months after the first clinical episode of multiple sclerosis for a monocentric transversal mri study at 7t to assess cortical ms injury. clinical (edss) and neuropsychological assessments will be performed in the population the same day of a multi-parametric mri. mri protocol is designed to increase the detection rate of cl using multiple contrasts at high isotropic resolution (600µm3) on a whole brain exploration. thus, mri acquisition will include mp2rage, t2\*, flair and dir as previously published but also recent mri technique like flaws, focusing on the grey matter by attenuating the white matter and csf signal. finally, qsm sequences will be performed. qsm measures tissue magnetic susceptibility mostly influenced by iron, myelin and calcium content in the brain. due to physical properties of the technique (bipolarity), we suppose that high resolution qsm will be more sensitive that previous used sequences to depict cortical lesions. using this multi-contrast approach with relevant mri sequence and with a high resolution whole brain exploration might improve the detection of cl in early ms. furthermore, mri protocol allow us to estimate neuronal loss (t1 relaxation time), myelin and iron content (qsm and t2\* relaxation time) within and outside cortical lesions in gm. the present study is an opportunity to assess cortical pathology in ms from the onset of the disease, allowing to a better understanding of its origins and its impact and disease severity. this study is a preliminary requirement to longitudinal studies to precisely depict the kinetic of cortical lesion accumulation and the links with disease aggravation.


Eligibility criteria:
inclusion criteria: * patients with relapsing-remitting ms (mcdonald's criteria 2010) early (duration evolution \<2 years), * age between 18 and 45 years, * no history of neurological symptoms suggestive of demyelinating pathology, * no corticosteroids in the month preceding the completion of the mri, * realization of the mri in the first 6 months following the inaugural clinical episod exclusion criteria: * argument for a differential diagnosis (systemic lupus erythematosus, antiphospholipid syndrome, behçet's disease, sarcoidosis, lyme disease, cerebral arteritis, lymphoma cns, etc.), * history of neurological or psychiatric illness, * history of taking immunosuppressive drugs, * claustrophobia * pregnancy, * patient unable or unwilling to give consent, patient under guardianship, * patient not affiliated to a social security regime
globus pallidus stimulation to treat insomnia

Conditions: Parkinson Disease

Summary: researchers are to determine if turning on an additional unilateral dbs (deep brain stimulation) electrode with stimulation to the globus pallidus externa (gpe) region of the brain will improve insomnia (sleep).


Eligibility criteria:
inclusion criteria: * 40-80 years of age * symptomatic with parkinsonism for 7-20 years * severe insomnia based on isi score exclusion criteria: * clinically significant dementia (mmse \<23) * hoehn \& yahr \[hoehn, 1967 #1839\] stage i or v disease * other significant neurological or psychiatric disease * previous pallidotomy or thalamotomy * previous placement of other implantable devices * secondary parkinsonism (non-idiopathic parkinsonism) * inability to travel to jacksonville for post-operative study visits * severe sleep apnea * insomnia due to pain or untreated mood disorder * contraindications to 3t mri * circadian rhythm sleep disorders. * current use of hypnotics
pregnancy and medically assisted conception in rare diseases

Conditions: Rheumatoid Arthritis; Spondyloarthritis; Psoriatic Arthritis; Systemic Lupus Erythematosus; Antiphospholipid Syndrome; Sjogren Syndrome; Scleroderma; Myositis; Vasculitis; Mastocytosis; Various Autoimmune and/or Systemic and/or Rare Diseases

Summary: rare diseases frequently affect women of childbearing age. pregnancy in these women has become less rare, but remains associated with high levels of complications. one obstacle to their optimal management during pregnancy is that there are no prospective studies of pregnancy during rare diseases and several connective tissue diseases. as a consequence, the management of these pregnancies is non-standardised in terms of treatment, monitoring (frequency of consultations, laboratory tests and ultrasound), and organisation of care. moreover, although these women (all diseases combined) are frequently exposed to medications potentially incompatible with pregnancy, little is known about the frequency of these exposures and especially their consequences to mother and child. for these reasons, researchers and clinicians from different specialties created an interdisciplinary research group on pregnancy and rare diseases (gr2), intended to improve the management of these patients' pregnancies. using a single computer server, the investigators plan to set up a large prospective study of pregnancies in patients with rare diseases: various forms of myositis, lupus, antiphospholipid syndrome, sjogren syndrome, scleroderma, and inflammatory rheumatic diseases. the investigators objective is to analyse the complications of pregnancies in women with rare diseases and then to improve their management and their quality of life.


Eligibility criteria:
inclusion criteria: * woman with a rare and/or systemic disease * pregnancy confirmed by a positive beta-hcg assay or an obstetric ultrasound or medically assisted conception procedure * patient agreed to participate exclusion criteria: * adults under guardianship * people hospitalised without their consent and not protected by the law * persons deprived of their liberty

Keywords: rare diseases pregnancy pregnancy,
safety study of tecemotide (l-blp25) in non-small cell lung cancer (nsclc) subjects with unresectable stage iii disease

Conditions: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Summary: the primary objective is to document the safety of tecemotide (l-blp25) phase iii formulation in non-small cell lung cancer (nsclc) subjects with unresectable stage iii disease. this population includes stage iiia nsclc subjects, a population not studied in former clinical studies with this vaccine. the secondary objective is to document the survival of subjects treated.


Eligibility criteria:
inclusion criteria: * histologically documented unresectable stage iii nsclc. mediastinal (n2) involvement must be confirmed by biopsy * stable disease or clinical response after primary therapy of chemo-radiation treatment for unresectable stage iii disease * primary therapy should be a minimum of 2 cycles of platinum-based first-line chemotherapy, given concurrent with thoracic radiation. the combined modality should consist of either: * induction (2 cycles) chemotherapy followed by concurrent chemo-radiation therapy; or * concurrent chemo-radiation therapy followed by 2 cycles of consolidation chemotherapy; or * concurrent chemoradiation therapy alone * a minimum radiation dose of greater than or equal to (\>=) 6,000 centigray (cgy) should be administered. subjects must have completed the primary therapy at least 4 weeks and no later than 6 months prior to study entry * eastern cooperative oncology group (ecog) performance status of less than or equal to (\<=) 1 * ability to understand and willingness to sign a written informed consent * other protocol defined inclusion criteria could apply exclusion criteria: * undergone lung cancer specific therapy (including surgery) prior to primary chemo-radiation therapy * received immunotherapy/systemic immunosuppressive drugs/investigational systemic drugs within 4 weeks prior to study entry * subjects with brain metastases, pleural effusion, unless cytologically confirmed to be non-malignant * past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years * autoimmune disease or immunodeficiency * clinically significant hepatic, renal dysfunction or cardiac diseases * clinically significant active infection * pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator * other protocol defined inclusion criteria could apply

Keywords: carcinoma, non-small-cell lung, l-blp25, tecemotide
the utility of circulating tumor cells as confirmation of pathologic diagnosis in patients with suspected early stage non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the primary objective of this study is to determine whether circulating tumor cells (ctcs) can be used as a non-invasive means of confirming pathologic diagnosis in early-stage (stage i) non-small cell lung cancer (nsclc). patients scheduled to undergo surgical intervention will have blood samples obtained to test for ctcs. presence of ctcs will be compared to final pathologic diagnosis based on surgical specimens to assess the sensitivity of using ctcs alone to make a definitive diagnosis.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of stage i nsclc a. only patients with a pathologically confirmed nsclc will be retained for data analysis b. should pathologic diagnosis reveal a more advanced stage, these subjects will remain in the study 2. 18 years of age 3. ability to read and sign informed consent 4. both men and women and members of all races and ethnic groups are eligible for this trial. exclusion criteria: 1. prior cancer diagnosis, excluding previously treated non-melanoma skin cancer 2. prior or ongoing treatment of the clinically diagnosed cancer
a study of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who don't have a response to anti-tnf-α therapy (script)

Conditions: Rheumatoid Arthritis

Summary: this study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-tnf-alpha therapy. patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. a repeat course of i.v. treatment will be administered at weeks 24 and 26. all patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional dmards. the treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. target sample size is 1000.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 years of age * rheumatoid arthritis for at least 3 months * inadequate response to previous or current treatment with at least one anti-tnf-alpha agent * receiving either leflunomide or methotrexate for ≥ 12 weeks, with a stable dose for the last 4 weeks * swollen joint count (sjc) ≥ 4 (66 joint count) and tender joint count (tjc) ≥ 4 (68 joint count) at screening and baseline. * crp ≥ 0.6 mg/dl using a high-sensitivity assay. * positive rheumatoid factor or positive anti-ccp antibody or both. exclusion criteria: * rheumatic autoimmune disease or inflammatory joint disease, other than ra * any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline

Keywords: ra script anti-cd20 cd20
study of human ocular hemodynamics by holography dopple

Conditions: Glaucoma; Retinal Vascular Disorder

Summary: prospective, interventional, non-randomized, open-label study, multi-center, gehan-designed study with sequential inclusions in each subgroup, ranging from 4 subjects to a maximum 37 subjects per subgroup included

retinal perfusion can be affected by a number of local or general pathologies; however, there is currently no commercially available device to provide accurate measurements of retinal blood flow. the company quantel medical is developing a medical imaging device holodoppler (hereinafter referred to as the "holodoppler system"). system. in order to better define its medical utility, we aim to evaluate its reproducibility and accuracy in healthy subjects and those with conditions that may affect ocular blood flow.

Eligibility criteria:
inclusion criteria: criteria common to both populations ( patients and healthy volunteers) : * age ≥ 18 years and \< 75 years; * having received informed information about the study and having signed a consent to participate in the study; * affiliated or covered by social security criteria for healthy volunteers : no ocular or systemic disease deemed to affect ocular circulation by an investigator specific criteria for patients: * subjects usually followed at one of the recruiting centers; * patients with chronic glaucoma, for whom a therapeutic modification is planned in the short term; * patients with carotid stenosis; * patients with choroidal pathology: pachychoroidism having led to pigment epithelium anomalies. exclusion criteria: * for all participants: * persons covered by articles l1121-5 to l1121-8 of the csp (all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial decision or administrative decision, minors, and persons under legal protection: guardianship or curatorship); * women of childbearing age not using an effective method of contraception, or positive pregnancy test (blood or urine); * participants allergic to tropicamide when using pupillary dilatation; * inability of the subject to maintain a stable sitting position for research procedures; * temporary contraindication to holodoppler: * patient suffering from viral conjunctivitis or any other infectious disease; * patient with skin lesions on the neck or forehead, for which contact with a chin strap is not recommended. * impossibility of making acquisitions of interest (e.g. due to a pupil diameter that is too small, advanced cataracts, nystagmus, etc.). * wearing glasses or contact lenses to correct a refractive disorder is not considered a criterion for non-inclusion.

Keywords: glaucoma pachychoroid, carotid stenosis
economic analysis of robotic rectal resection in german health care system

Conditions: Rectal Cancer

Summary: analysis of cost effectiveness of robotic rectal resection, either sphincter preserving or abdominoperineal extirpation, in the german diagnosis related groups (drg) system.

robotic surgery has many well-known benefits for patients and surgeons, while it comes with higher acquisition and maintenance costs. on the other hand, a higher proportion of minimally invasive procedures can save costs by reducing complications, decreasing hospital stays due to lower morbidity, and saving personnel. to what extent can robotic surgery be cost-covering or even profitable, depending on the postoperative course? this question is investigated under the conditions of the german drg system.

Eligibility criteria:
inclusion criteria: * 18y * histologically proven rectal cancer with curative therapeutic approach * suitable for minimally-invasive surgery exclusion criteria: * no rectal cancer * primary open surgery

Keywords: robotic surgery rectal cancer low anterior resection abdominoperineal rectal extirpation economic analysis
posterior capsular injection with femoral nerve block for total knee arthroplasty

Conditions: Posterior Knee Infiltration

Summary: to assess pain control after total knee replacement surgery using two different nerve block techniques. the 2 methods are: 1. continuous femoral nerve block with ultrasound guided posterior capsular injection 2. continuous femoral nerve block with ultrasound selective tibial nerve block.

patients undergoing total knee replacement surgery experience severe post-operative pain. continuous femoral nerve block combined with selective tibial nerve block provides optimal pain control in the anterior and posterior aspect of the knee respectively. however, in patients with pre-existing neuropathy of the sciatic nerve, the blockade of tibial nerve is contraindicated because of increased risk of nerve damage that may lead to exacerbation of neurologic symptoms. in such patients where selective tibial nerve block cannot be offered, ultrasound guided posterior knee capsular injection may be an alternative technique for controlling posterior knee pain after surgery. posterior capsular injection by surgeons intraoperatively, when combined with femoral nerve block has been shown to provide pain control after total knee replacement. with posterior capsular injection, the main trunk of the tibial nerve is spared and only the terminal nerve endings innervating the posterior knee joint is blocked providing effective pain control. in this study, the efficacy of ultrasound guided posterior capsular injections performed pre-operatively will be compared to tibial nerve block in controlling knee pain after surgery. the results of this study may help establish the efficacy of ultrasound guided posterior capsular injection as an alternative to tibial nerve block in patients undergoing total knee arthroplasty.

Eligibility criteria:
inclusion criteria: * patients having primary, unilateral total knee arthroplasty * age 18-80 exclusion criteria: * history of neurologic disease, neuropathy, diabetes, or major systemic illness * allergy to local anesthetic solution or nsaids * pregnancy * chronic use of narcotics * inability to give consent/cooperate with study

Keywords: infiltration between popliteal artery and capsule of knee (ipack)
design and evaluation of mobile x-ray for rapid and accurate diagnosis of thoracic disease

Conditions: Thoracic Diseases

Summary: computed tomography (ct) is the most accurate test for evaluating patients with thoracic disease. however, access to ct is limited due to long wait times and for the sickest patients in hospital who cannot be transported from the ward to the ct scanner. the investigators propose to modify a standard x-ray unit to provide more detailed information of the chest such that a ct scan is not required for all patients.

dual-energy (de) imaging consists of acquiring paired "low" and "high"-energy x-ray images. the use of de to improve radiological contrast was first described by jacobson et al in 1958; followed by mistretta et al and alvarez and macovski in the mid-1970s. with the advent of new digital x-ray detectors that provide high dose efficiency and rapid readout of digital x-ray projections, there has been renewed interest in using de x-ray imaging for lung nodule detection. more recently, portable x-ray detectors have made bedside de imaging possible. jabri et. al. presented a portable de system with novel respiratory and cardiac gating, and hoggarth et. al. investigated the potential for de subtraction in improving the visualization of lung tumors while performing image-guided radiotherapy. the investigators group is experienced in investigating de for lung nodule detection, this theoretical framework was instrumental in optimizing a clinical prototype for high-performance de chest x-ray. it identified optimal de image acquisition and decomposition techniques, and validated the approach in comparison to human observer performance. the analysis further demonstrated that - given a high-performance flat plate detector, optimal acquisition and decomposition - de chest x-ray is possible at the same dose as conventional computer radiography (cr) and digital radiography (dr) chest x-ray, while significantly improving conspicuity of subtle lung nodules by the reduction of overlying background noise. the de work undertaken by our group is unique in terms of providing a clear theoretical framework for optimizing a clinical prototype for best performance in terms of image quality and patient exposure to ionizing radiation.

Eligibility criteria:
inclusion criteria: * the presence of lung disease (nodules, masses, consolidation and collapse), pleural disease (effusion, thickening), mediastinal and hilar lymph node enlargement, on thoracic ct exclusion criteria: * unable to consent
stretching versus walking from reducing blood pressure

Conditions: Hypertension

Summary: high blood pressure is a leading risk factor for cardiovascular disease. traditionally, one of the ways to treat or prevent high blood pressure is to prescribe aerobic exercise training (i.e.brisk walking). previous studies have shown that stretching is also very effective for reducing blood pressure. this is an exciting possibility because if stretching is more effective, it would change the way exercise is prescribed to people with elevated blood pressure. this study will now assess 20 individuals in a supervised stretching or walking program five days per week for 8 weeks to determine for certain whether stretching is superior for reducing blood pressure. this research will contribute to recommendations about the most effective exercise programs for reducing blood pressure and risk of cardiovascular disease.

the study hypothesis is that stretching (flexibility training) will be superior to brisk walking for reducing blood pressure. this is a parallel-group randomised trial. twenty participants (aged 18 and older) with borderline or stage-1 hypertension (systolic blood pressure between 130 and 159 mmhg or diastolic blood pressure between 85 and 99 mmhg) will be randomised to walking or stretching groups. each group will do 30 minutes of exercise, five days per week. exercise sessions will be supervised three days per week with participants doing exercise sessions on their own two days per week. exercise sessions involve either brisk walking or stretching. the stretching exercises will involve stretching all major muscle groups. the main outcome is 24-hour blood pressure which will be assessed at baseline, after four weeks, and after eight weeks. other outcomes will be assessed at baseline and eight weeks and include: body weight, height, waist circumference, resting heart rate, physical activity levels (questionnaire), diet (questionnaire), maximal distance walked in six minutes. all participants will be counselled on how to follow the dash eating plan, which involves reducing dietary salt intake. statistical analyses: all outcomes will be assessed with a group x time anova with alpha level of 0.05. lsd post-hoc tests will be done when necessary to identify differences between pairs of means.

Eligibility criteria:
inclusion criteria: * systolic blood pressure between 130 and 159 mmhg or diastolic blood pressure between 85 and 99 mmhg exclusion criteria: * individuals will be excluded if they have taken blood pressure medications within the past six months unless they are on a stable dose of medication and have not reach target blood pressure levels (i.e. systolic blood pressure below 130 mmhg and diastolic blood pressure below 85 mmhg)