Kornimate/medical-research-clean huggingface dataset:
mrs to determine neuroinflammation and oxidative stress in mps i

Conditions: Mucopolysaccharidosis Type I

Summary: neuroinflammation and oxidative stress have been shown to be present in persons with mucopolysaccharidosis type i (mps i), but their effect on disease severity and disease progression is unknown. the investigator intends to employ brain magnetic resonance spectroscopy (mrs), a non-invasive technique, along with analysis of neuroinflammation and oxidative stress biomarkers in the blood, to measure and determine the level of oxidative stress and neuroinflammation, and their impact on clinical variability in mps i patients.

persons with mps i have a wide range of clinical manifestations including central nervous system (cns) impairment. the role of neuroinflammation and oxidative stress is one avenue of investigation which may clarify the broad neurological impairment in mps i. finding biomarkers that accurately describe the underlying and ongoing brain pathology is a key not only to understanding the disease, but also to understanding the possibility of new therapeutic approaches for mps i patients. the investigator will compare patients with hurler syndrome, and hurler-scheie or scheie syndrome, with healthy controls. there will be 10 participants in each group, resulting in a total of 30 participants. within the hurler-scheie or scheie syndrome group, the investigator will examine the association of clinical severity with the proposed measures. these findings might help determine whether hematopoietic cell transplantation (hct), which is the treatment for hurler syndrome patients, results in decreased oxidative stress and neuroinflammation as compared to hurler-scheie or scheie syndrome patients, who are treated by enzyme replacement therapy (ert). additionally, these findings might help determine whether therapies directed at reducing neuroinflammation and oxidative stress in mps i could enhance neurological outcomes. study hypothesis: neuroinflammation and oxidative stress are present in mps i subjects and are reflective of disease severity.

Eligibility criteria:
inclusion criteria: mps i participants must meet the following: 1. diagnosis of hurler syndrome, or hurler-scheie syndrome, or scheie syndrome 2. 6 years of age or older at time of screening healthy control participants must meet all of the following: 1. absence of neurological disorder 2. 6 years of age or older at time of screening exclusion criteria: persons who have any of the following will not be enrolled in this study: 1. any surgically implanted pacemaker 2. any indwelling electronic device, including programmable shunts 3. orthodontic braces, unless non-metallic 4. other implanted metal in the body other than titanium 5. an inability or unwillingness to complete an mri/mrs because of low cognitive function or behavioral dysregulation 6. pregnancy

Keywords: mucopolysaccharidosis type i mps i mps ih mps ihs mps is mucopolysaccharidosis i
stellate ganglion block for major depressive disorder.

Conditions: Treatment Resistant Depression; Major Depressive Disorder

Summary: this is a feasibility study, to investigate a new treatment option for major depressive disorders by performing a stellate ganglion block (sgb). a sgb is an injection of local anesthetic into the sympathetic nervous system (peripheral nervous system) located in the lower part of the neck, to relieve pain in the head, neck, upper arm, and upper chest.


Eligibility criteria:
inclusion criteria: 1. 18 - 65 years of age 2. major depressive disorder without psychotic symptoms according to dsm-5 criteria 3. hamilton depression rating scale (hamd)\>17 4. current major depressive episode as confirmed by the mini international neuropsychiatric interview (mini) 5. failure of at least two trials of antidepressant therapy during the current episode 6. capacity to provide informed consent exclusion criteria: 1. depression secondary to stroke, cancer or other severe medical illness 2. major depressive episode in people with bipolar disorder. 3. dementia 4. post-traumatic stress disorder (ptsd) 5. acute suicidality defined as score ≥3 on hamd item 3 6. previous electroconvulsive therapy 7. known history of intolerance of hypersensitivity to local anesthetic 8. current substance abuse or dependence (except for caffeine or nicotine dependence) and/or recent history (last 12 months) of current alcohol abuse or dependence, as defined in dsm-5 criteria 9. unwilling to maintain current antidepressant regimen. 10. a clinical finding/condition that is unstable or that, in the opinion of the investigator(s) would negatively be affected by an sgb (e.g. movement disorder where patient is unable to lie still for injection or anatomical variants making an sgb impractical).

Keywords: feasibility trial stellate ganglion block bupivacaine
effects of wb-ems in ulcerative colitis patients

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine the effect of 12 weeks of wb-ems either applicated passive in a supine resting position or active during slight movements compared with a non-training control group on body composition, muscle strength and qol in patients with ulcerative colitis. our main hypothesis is that active wb-ems application is significantly more favorable to address our primary endpoints compared with passive application. our secondary hypothesis is that passive wb-ems application is significantly more favorable to address our primary endpoints compared with non-training control.


Eligibility criteria:
inclusion criteria: * ulcerative colitis * ambulatory subjects exclusion criteria: * variables that conflicts with wb-ems application (e.g. cardiac pacemakers) * absence of more than two weeks during the interventional period.

Keywords: whole body electromyostimulation inflammatory bowel disease lean body mass muscle strength
patients with severe acute exacerbation of copd ans admitted in icu register.

Conditions: COPD Exacerbation

Summary: the objective of this prospective observational study is to describe the epidemiological, clinical and biological characteristics of admitted patients in icu for severe acute exacerbation of copd, to assess the different therapeutics used, to evaluate the prognosis of patients with short, medium and long term ( 1 year) and the various factors associated with survival in icu

this is a prospective study for which data will be collected from pseudonymised. general information on the research activity clinic of the intensive care service of the ch of versailles is provided by poster, patient booklet or debrief hospitalization, indicating to relatives and/ or patients their possible participation in retrospective or prospective studies. this research is conducted in accordance with the reference methodology mr 004 approved by the national commission of informatics and libertés (cnil) and to which the centre hospitalier de versailles is committed to comply. for this purpose, an information note will be given to each patient participating in this project in order to seek its non-opposition of participation in this study. this prospective study is based solely on the examination of files medical. the data collected are only non-sensitive medical data. this study complies with legal and regulatory requirements. in addition, this research project was submitted to the ethics committee (ec) of the société de réanimation de langue française (srlf) who gave an opinion favorable on 06/10/2022 (registration number referenced: ce srlf 22- 056).

Eligibility criteria:
inclusion criteria: 1. age ≥ 40 years old 2. copd documented or strongly suspected * chronic respiratory symptoms (dyspnoea, cough and/or sputum) * exposure to a known risk factor for copd (such as tobacco smoke) * if available, respiratory function tests showing non- or partially reversible obstructive syndrom (post-bronchodilator ratio fev1/cv \< 0.7) 3. severe acute exacerbation, defined as a worsening of the patient's usual respiratory symptoms with signs of acute respiratory distress (polypnoea ≥ 30 cycles.min-1 or use of accessory respiratory muscles) and/or hypercapnic acidosis (with paco2 ≥ 45 mmhg and ph ≤ 7.35) 4. admission to an icu, a step-up unit or a respiratory care unit exclusion criteria: 1. known asthma (according to the criteria of the international "global initiative for asthma" guidelines) 2. patient refusal to participate (information note, application for non-opposition)
clinical case series evaluating skin wellness system

Conditions: Moisture-associated Dermatitis; Fungal Infection in Perineal Area

Summary: the purpose of this evaluation is to observe the performance of two (2) different skin care treatment protocols on the skin: #1 kendall™ body wash \& shampoo in combination with the moisture barrier cream; or #2 kendall™ 2-in-1 cleanser in combination with the anti-fungal cream. the scientific evidence supports using these types of skin care products to keep the skin healthy in the presence of moisture, urine, stool, or fungal infection. the cleansers are preferred over soap and water and can be applied on all areas of the skin. the moisture barrier cream is formulated especially for skin exposed to moisture, urine, or stool. the antifungal cream is utilized for fungal infections associated with athlete's foot, jock itch, and ring worm to relieve itching, soreness, and irritation.

the kendall™ body wash \& shampoo is a no-rinse cleanser that gently removed dirt, urine, and stool while maintaining the natural ph of the skin (although it contains a shampoo component); it can be applied on all areas of the skin. kendall™ moisture barrier cream performs as a barrier to moisture and irritants when the natural barrier ability of the skin has been compromised. kendall™ 2-in-1 cleanser is a no-rinse cleanser that gently removes dirt, urine, and stool and protects the skin from damage. kendall™ antifungal cream is used on fungal infections to relieve itching and discomfort.

Eligibility criteria:
inclusion criteria: adult subjects with any of the following indications: * erythema, maceration, or broken (denuded) skin from moisture, urinary or fecal incontinence * irritated, unbroken skin (perineal area) * fungal infection present in the perineal area exclusion criteria: * an existing pressure ulcer of any stage where the product will be applied * subjects not expected to survive the two week trial * subjects under age 18 * subjects unable to provide informed consent (or whose designated power of attorney is unable to provide) * subjects with known sensitivity to any product preservative or other ingredient.

Keywords: incontinence-associated dermatitis skin care regimen for moisture-associated conditions perineal skin care fungal infection in perineal area
alprostadil in maculopathy study (aims)

Conditions: Macular Degeneration

Summary: evaluation of efficacy of alprostadil (prostaglandin e1) for treatment of patients suffering from dry age-related macula degeneration

results of the planned interim analysis indicated that the number of originally planned patients were not sufficient to reach statistical significance in the primary end point. instead of increasing the sample size accordingly, it was decided to terminate the study and plan future proceedings based on a careful analysis of the unblinded results.

Eligibility criteria:
inclusion criteria: * male and female subjects older than 50 years of age. * dry age-related macula degeneration (amd) with hard drusen and possibly beginning geographic atrophy in one eye * visual acuity between 0.2 and 0.7 (logmar) assessed with etdrs charts exclusion criteria: * dry amd areds category 3 or 4 in both eyes * wet amd in at least one eye * detachment of the pigmentary epithelium * glaucoma * diabetic retinopathy * medical history of retinal vein occlusion * uveitis * cataract surgery during the study * high myopia (\< -6 dpt) with pathological findings of the retina * medical history of any opthalmic surgery with complications * medical history of cataract surgery without complications within the last 12 weeks * medical history of vitrectomy * areds medication within the last 2 days * opthalmologic dietary supplements within the last 2 days * medical history of retinal hemorrhage * cardiac failure (nyha grade ii or higher) * inadequately controlled coronary heart disease or cardiac arrhythmia * subject has a medical history and/or suspicion of pulmonary edema or pulmonary infiltration * subject has a peripheral edema * myocardial infarction within 6 months prior to enrollment * subject has renal insufficiency, compensated retention (creatinine \> 1,5 mg/dl) * subject has known existing malignant disease * severe chronic obstructive pulmonary disease * subject has a venoocclusive lung disease * known hepatic disease * inadequately controlled or untreated hypertension (systolic blood pressure ≥ 180 mmhg, diastolic blood pressure ≥ 110 mmhg) * subject has upper grade cardiac valvular disorders * pregnancy or lactation period * known hypersensitivity to pge1 or to any component of the trial medication * subject has a history of chronic alcohol or drug abuse within the past 2 years * subject has known lactose intolerance * poor general state of health or other criteria * subject has other serious illness * laboratory values outside the normal range unless considered not clinically relevant by the investigator

Keywords: alprostadil prostaglandin e1 prostavasin® macular degeneration
effect of perioperative i.v. low-dose s(+) ketamine

Conditions: Hemorrhoids; Pain

Summary: the purpose of this study is to determine whether the use of perioperative intravenous s (+) ketamine reduces the amount and degree of postoperative pain. furthermore the purpose of this study is to determine whether the use of perioperative intravenous s (+) ketamine effects cognitive function in the early postoperative period.

the mechanism of development of postoperative pain is complex. central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. several studies have shown, that s (+) ketamine can be effective to reduce sensitization and postoperative pain. ketamine (2-o-chlorophenyl-2-methylamino cyclohexanone) is a n-methyl-d-aspartat (nmda) receptor antagonist. s (+) ketamine has a four times stronger affinity to the nmda receptor compared to r (-) ketamine. the duration of action for s (+) ketamine is shorter than r (-) ketamine and it has fewer side-effects. the purpose of this study is to compare the analgetic effect of pregabalin and placebo used in the perioperative period. the hypothesis is that perioperative intravenous s (+) ketamine gives significant better analgesia than placebo without effecting cognitive function. the study is including patients undergoing hemorrhoidectomy.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of disc prolapse * age 18+ * asa (american society in anesthesiology) i-ii * written consent exclusion criteria: * age \< 18 * asa \> ii * liver failure * renal failure * heart failure * glaucoma * pregnancy

Keywords: hemorrhoids hemorrhoidectomy s (+) ketamine pain
pain evaluation in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is an inflammatory chronic rheumatism where the pain remains the priority domain of improvement for the patients instead a good control of the inflammatory disease by treatments, even biotherapeutics . some studies show that less than 50 % of the patients is satisfied by the care of the pain, whereas the criteria of evaluation of the ra improve under treatment. the chronic pain, is a complex and multifactorial subjective phenomenon requiring a multidimensional evaluation, while the current criteria of follow-up of the ra (das28, acr criteria) investigate the pain in a single dimension that is the pain intensity. so, the investigators do not arrange explanation for this observed dichotomy between the improvement of the clinical and biological inflammatory criteria of the ra and on the other hand the persistence of pain. on the other hand, the interleukin (il)-6, il-17 and il-33 are cytokines occurring in the physiopathology of ra and probably in the pain processing according to recent data of the literature. the aim of this study is: * to assess the multidimensional origin of the pain in ra patients by means of questionnaires * to look for a possible correlation between the serum level of cytokines and pain.


Eligibility criteria:
inclusion criteria: * adults with ra treated with dmards and/or biotherapy, * capable of providing written consent exclusion criteria: * patients affected by a painful disease other one than ra, * fibromyalgia, * a malignancy disease, * an hemopathy, * psychiatric disorders or dementia and * acute infectious diseases and * receive or had received anti-il6 therapy
etiological diagnosis of cardiac diseases based on echocardiographic images and clinical data.

Conditions: Hypertension Arterial; Hypokinetic; Cardiomyopathies; Left Ventricular Hypertrophy

Summary: research hypothesis - recent studies have shown that high-dimensional descriptors of the cardiac function can be efficiently exploited to characterize targeted pathologies. in this project, the investigators hypothesize that echocardiograms possess a wealth of information that is currently under-exploited and that, combined with relevant patient data, will allow the development of robust and accurate digital tools for etiological diagnosis. objectives - based on key advances recently obtained in image analysis, notably by members of the consortium, the objective of this project is to develop rigorous and explainable cardiac disease prediction models from echocardiography based on the transformer paradigm (ai). the strength of this study lies in the development of a strong ai framework to model the complex interactions between high-quality image-based measurements extracted from echocardiograms and relevant patient data to automatically predict etiological diagnosis of cardiac diseases


Eligibility criteria:
inclusion criteria: * patients with transthoracic echocardiography with satisfactory image quality (sufficient echogenicity) exclusion criteria: * minor patients * patients under curatorship or guardianship

Keywords: hypertension htn arterial hypertension artificial intelligence ai cardiac remodelling left ventricular hypertrophy
3f8/gm-csf immunotherapy plus 13-cis-retinoic acid for consolidation of first remission after non-myeloablative therapy in patients with high-risk neuroblastoma

Conditions: Neuroblastoma

Summary: the purpose of this study is to find out what effects, good and/or bad, the combination of 3f8 and gm-csf has on the patient and the cancer. antibodies are made by the body to attack tumors and to fight infections. 3f8 is the name of one kind of antibody. it is made by mice, and it can attack neuroblastoma in people. 3f8 has been used safely in many patients, and it has killed cancer cells in some patients. one way it can kill cancer cells is by causing the patient's own white blood cells to attack the cancer. granulocytes are one kind of white blood cell. gm-csf increases the number of granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.


Eligibility criteria:
inclusion criteria: * diagnosis of nb as defined by a) histopathology (confirmed by the mskcc department of pathology), or b) bm metastases or mibg-avid lesion(s) plus high urine catecholamine levels. * high-risk nb as defined by risk-related treatment guidelines1 and the international nb staging system,89 i.e., stage 4 with (any age) or without (≥18 months of age) mycn amplification, mycn-amplified stage 2 or stage 3 (any age), or mycn-amplified stage 4s. * the patients are in first cr/vgpr after conventional therapy. they have no measurable mibg-avid soft tissue tumor assessable for response. * signed informed consent indicating awareness of the investigational nature of this program. exclusion criteria: * creatinine \> 3.0 mg/dl * alt, ast and alkaline phosphatase \> 5.0 times the upper limit of normal * bilirubin \> 3.0 mg/dl * patients with grade 3 or higher toxicities (using the ctcae v3.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam. patients must have normal blood pressure for age. * progressive disease * history of allergy to mouse proteins. * active life-threatening infection. * human anti-mouse antibody (hama) titer \>1000 elisa units/ml. * inability to comply with protocol requirements

Keywords: mab 3f8 retinoic acid (cis-9 & 13) bone marrow 09-159
a multi-centre study to assess the long-term performance of the pinnacle™ cup with a polyethylene-on-metal bearing in primary total hip replacement

Conditions: Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

Summary: the purpose of this study is to monitor the performance of the pinnacle™ cup with a polyethylene-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility criteria:
inclusion criteria: i) male or female subjects, aged between 18 and 70 years inclusive. ii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. iii) subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. iv) subjects undergoing primary total hip replacement who are suitable for a cementless acetabular component and a metal on polyethylene bearing. exclusion criteria: i) subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study. ii) subjects undergoing revision hip replacement. iii) subjects undergoing simultaneous bilateral hip operation. iv) subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily. v) women who are pregnant. vi) subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. vii) subjects who have participated in a clinical study with an investigational product in the last 12 months. viii) subjects who are currently involved in any injury litigation claims.

Keywords: hip cementless
postpartum deworming: improving breastfeeding and optimizing infant growth

Conditions: Intestinal Diseases, Parasitic

Summary: women of reproductive age are considered a high-risk group for worm infections by the world health organization. maternal infection and anemia contribute to infant malnutrition by affecting milk quality and quantity, and duration of exclusive breastfeeding. to date, no study has investigated the health benefits of postpartum deworming to infants or mothers. a randomized controlled trial will be conducted in peru to investigate the effectiveness of integrating deworming into routine postpartum care. the primary measure of effect will be infant weight gain between birth and six months of age. other infant and maternal health indicators will also be ascertained.


Eligibility criteria:
inclusion criteria: * deliver at hospital iquitos * plan to reside in iquitos or neighbouring area for the next 24 months * able to communicate in spanish exclusion criteria: * deliver multiples * delivery a stillborn or an infant with a serious congenital medical condition * transfered to another hospital prior to discharge

Keywords: global health deworming postpartum soil-transmitted helminths pregnant women