Kornimate/medical-research-clean huggingface dataset:
topical vitamin d in acute graft versus host disease of the skin

Conditions: Graft Vs Host Disease

Summary: the purpose of this study is to evaluate the efficacy of calcipotriene cream. this is a synthetic vitamin d3 derivative for topical use. it is used to treat grade 1-3 acute skin graft versus host disease (gvhd) in hematopoietic stem cell transplant (hsct) recipients. calcipotriene will be used as the exclusive topical therapy in addition to standard of care gvhd treatment prescribed for the study subject by the primary physician.

acute skin gvhd affects about one third of pediatric and adult transplant recipients. chronic gvhd (cgvhd) affects 40-60% of adult patients who have undergone allogeneic hsct. it is a major cause of non-relapse mortality and morbidity. systemic prednisone is the first-line treatment for cgvhd; however, about one-half of all patients do not respond to this initial therapy, and there is no standard second-line therapy. immunosuppressive therapy used for treatment of gvhd brings significant risk of infection, poorly affecting clinical outcomes. vitamin d affects immunoregulation, fibroblast proliferation, collagen synthesis and endothelial cell function, and the investigators hypothesize that topical vitamin d application will have a positive effect on acute and chronic skin gvhd. the investigators hypothesize that topical vitamin d cream may restore normal cell function and decrease the use of steroid creams in acute gvhd of the skin.

Eligibility criteria:
inclusion criteria: * hsct recipients with acute grade i through iii gvhd based on glucksberg criteria. recipients of multiple transplants are still eligible to participate in this research study. * each study subject is to have calcium and vitamin d level prior to starting study, if not obtained within 30 days of beginning treatment. exclusion criteria: * patient with active cellulitis at the start of the treatment. * patients with hypercalcemia or vitamin d levels above 100 μg/l. * patients with known allergy to any of the topical therapy components. * patients who have received previous treatment with topical vitamin d cream.

Keywords: hematopoietic stem cell transplant graft versus host disease
the french cohort and biobank of devic's neuromyelitis optica and related neurological disorders (nmosd) (nomadmus)

Conditions: Neuromyelitis Optica Spectrum Disorders; Neuromyelitis Optica Spectrum Related Disorders

Summary: devic's neuromyelitis optica (nmo) is rare. epidemiological and demographic data are poor, based mainly on monocentric cohorts. moreover, nmo might be difficult to distinguish from multiple sclerosis and begin with atypical or incomplete clinical presentations. therefore, nmo is still underdiagnosed. the constitution of a nationwide and prospective cohort, including not only nmo but also clinical syndromes suggestive of a first episode (dnmo-spectrum disorders (sds)), should allow to gather a critical mass of cases and answer questions that could not have been addressed at the level of a single centre. objectives: the main objective is to describe the clinical, radiological and biological features of nmo spectrum disorder (nmo, isolated longitudinally extensive transverse myelitis (letm), relapsing or not; isolated atypical optic neuritis (on)) and their evolution. the second aim is to create a biobank dedicated to nmo (serum, whole blood for rna and dna extraction, cerebrospinal fluid), to promote translational research in the field. methods: nomadmus is a prospective, multicentre, observational study of patients nmosd and related disorder in france. prevalent cases are included retrospectively and then followed prospectively. incident cases are included from disease onset and followed prospectively. a minimal set of data has been defined and synthesized on specific paper forms derived from the european database for multiple sclerosis (edmus) forms. patients are systematically tested regarding their aqp4-igg and mog-igg status. all the data are centralised in a edmus-derived database in lyon, the eden software. all cases are validated and classified by an expert committee.


Eligibility criteria:
inclusion criteria: definite devic's neuromyelitis optica nmo according to established criteria (wingerchuk 1999, wingerchuk 2006, international panel 2015) * high risk syndromes for nmosd, defined as: recurrent or simultaneous optic neuritis, idiopathic single or recurrent longitudinally extensive transverse myelitis (spinal cord lesion seen on mri \>3 vertebral segments) * patients tested positive for aqp4-igg autoantibody or mog-igg autoantibody * living in france since 5 years minimum exclusion criteria: * none

Keywords: neuromyelitis optica myelitis optic neuritis autoantibody demyelination
allogenic mesenchymal stem cells and physical therapy for ms treatment

Conditions: Multiple Sclerosis

Summary: this study aims at expanding umbilical cord derived mesenchymal stem cells (mscs) to a clinical scale according to good laboratory practice and study its efficacy when compared to a supervised physical therapy program alone.

umbilical cord derived mscs bank will be generated and all patients given the same cells from the same biological sample. thorough clinical, cognitive and motor analysis will be performed at baseline and compared to outcomes at 3 different time points of all enrolled patients. the study will consist of three arms: 1- stem cells treatment 2- stem cells and supervised physical therapy 3- supervised physical therapy

Eligibility criteria:
inclusion criteria: * a clinical diagnosis of definite ms according to the revised mcdonald criteria. * expanded disability status scale (edss) ≤ 7 * failure of standard medical therapy * disease duration of at least three years prior to enrollment. exclusion criteria: * pregnant and lactating women * previous treatment with immunosuppressive agents in the last 12 months prior to enrollment * recent ms relapse in the month prior to enrollment * treatment with oral or parenteral steroids for any cause in the month prior to enrollment * significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders * previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment * any contra-indication for magnetic resonance imaging (mri) or gadolinium contrast. * positive serology for hiv, hepatitis b or hepatitis c * any history of malignancy or exposure to radiation at any time prior to enrollment * any contra-indication to lumbar puncture * severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.

Keywords: umbilical cord mesenchymal stem cells multiple sclerosis neuroimmunology autoimmune disease physical therapy
exploring the clinical impact of myc aberrations and their relationship with microenvironment in diffuse large b cell lymphoma and high-grade b cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma; High-grade B-cell Lymphoma; High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements

Summary: this is a observational, retrospective and prospective study designed to assess the potential correlations between myc alterations, lymphoma mutational landscape and functional immune contextures in diffuse large b-cell lymphoma or high-grade b-cell lymphoma

diffuse large b-cell lymphomas (dlbcl) and high-grade b-cell lymphomas (hgbcl) are a group of heterogeneous diseases representing more than a third of lymphomas in adults. 5-years overall survival of patients affected by dlbcl and hgbcl is around 70-60% and efficient prognostic markers are warranted to improve patients' survival by better tailored therapeutical approaches. genetic rearrangements of the myc gene occur in 5-10% of dlbcl at diagnosis, and the presence of double translocations involving both myc and bcl2 ("double-hit", dh), associated or not with bcl6 ("triple-hit", th) translocation, is associated with unfavorable prognostic impact. intensification of treatment compared to standard chemotherapy (r-chop) appears to reduce the risk of recurrence in patients with dh or th lymphomas, but a survival advantage has not been demonstrated. numerical changes in myc (gain of copy number, gcn) may also affect the outcome of patients with dlbcl, but their prognostic relevance and the benefit of treatment intensification is still controversial. additionally, novel scientific evidence indicates a contribution of lymphoma micro-environment (lme) in disease genomic subtype and patient prognosis. we aimed this study at investigating potential biological links between myc aberrations, lymphoma mutational landscape and functional immune contextures in dlbcl and hgbcl.

Eligibility criteria:
inclusion criteria: * diagnosis of nodal and extranodal diffuse large b cell lymphoma, high grade b cell lymphomas (including low-grade transformed lymphomas; double and triple hit; 11q aberration; not otherwise specified) after 1st january 2019 * presence of one myc translocation or gain of copies (gcn: \> 3 copies in more than 30% of the nuclei) or amplification evaluated by fish * availability of immunohistochemical analysis of cd10, bcl6, mum1, bcl2, myc, ki67 * have received curative treatment (e.g. r-chop, r da epoch, intensified "burkitt like" chemotherapies) as first-line therapy * histological material of adequate size and quality to perform histological review with any additional investigations (immunohistochemistry, fish and other molecular analysis). a ffpe block must be provided for patient enrollment. * age between 18 and 79 years exclusion criteria: * primary lymphomas of the central nervous system, plasmablastic lymphoma, burkitt's lymphoma, primary mediastinal b lymphoma * have received palliative treatment

Keywords: diffuse large b cell lymphoma high-grade b-cell lymphoma myc bcl2 bcl6 double hit triple hit lymphoma micro-environment
the length of uteroovarian ligament and the risk of ovarian torsion

Conditions: Ovarian Torsion

Summary: ovarian torsion is one of the gynecological emergency. this complication requires high clinical suspicion and early detection, to prevent permanent loss of ovarian function. the long uterine ovarian ligament could be a risk factor for ovarian torsion. we want to measure the uterine ovarian ligament length during routine laparoscopy/laparotomy and to compare the length between the torsion group and other non torsion patients

female patient who are going to undergo laparoscopy/laparotomy for any gynecological reason will ask to participate. during the operation the uteroovarian ligament length will be measure by sterile ruler (calibrated plastic device 1 mm in diameter). the length of uteroovarian ligament will compared between the patient who will diagnose with ovarian torsion (study group) and the other women (control group)

Eligibility criteria:
inclusion criteria: * indication for gynecological operation * hemodynamically stable exclusion criteria: * ovarian torsion in the past * history of pelvic inflammatory disease (pid)

Keywords: the length of uterine ovarian ligament
smoking abstinence and lapse effects in smokers with schizophrenia and controls

Conditions: Tobacco Use Disorder; Schizophrenia

Summary: this project tests two hypotheses concerning the low smoking cessation rates in smokers with schizophrenia. the first hypothesis is that smokers with schizophrenia experience stronger and more sustained effects of smoking abstinence on negative mood and smoking urge than control smokers without psychiatric illness. the second hypothesis is that smokers with schizophrenia experience stronger reinforcing effects of a smoking lapse (i.e., more rewarding effects of smoking after a period of abstinence) than control smokers without psychiatric illness.

in this study, smokers with schizophrenia and smokers without psychiatric illness participate in a nicotine preference task before and after a 3-day period of continuous smoking abstinence. the investigators will experimentally control abstinence by providing participants with high-value cash incentives contingent upon smoking abstinence verified with breath carbon monoxide levels. the investigators will measure nicotine withdrawal and smoking urge during the abstinence period. in the nicotine preference task, participants will make choices between nicotine-containing and denicotinized cigarette puffs to provide a measure of nicotine reinforcement, and the investigators will also measure the effects of smoking on mood. after the second nicotine preference task, participants will receive a small-value reinforcer if they continue to abstain for another day, and the investigators will measure time to the second lapse.

Eligibility criteria:
inclusion criteria: * cigarette smokers, 20-50 cigarettes per day * schizophrenia or no psychiatric illness * age 18 or older * male or female exclusion criteria: * unstable symptoms or medication * not interested in quitting smoking within 6 months

Keywords: nicotine reinforcement craving relapse
quilt-2.018: safety & efficacy of folfiri with amg 479 or amg 655 vs folfiri alone in kras-mutant metastatic colorectal carcinoma

Conditions: Metastatic Colorectal Cancer

Summary: this is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the united states, europe, and asia. approximately 150 eligible kras-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-vegf therapy will be randomized in a 1:1:1 ratio to receive amg 479 placebo plus amg 655 with folfiri, or amg 479 plus amg 655 placebo with folfiri, or amg 479 placebo plus amg 655 placebo with folfiri


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease * mutant-type kras tumor at screening * eastern cooperative oncology group (ecog) performance status of 0 - 1 * adequate hematology, renal, hepatic, and coagulation function exclusion criteria: * history or known presence of central nervous system metastases * history of other malignancy * prior irinotecan-based chemotherapy for advanced/metastatic disease * prior death receptor agonists, or other systemic igf-1r agonists in any setting * uncontrolled cardiovascular disease

Keywords: amg 655 amg 479 colon cancer rectal cancer monoclonal antibody clinical trial colorectal cancer metastatic colorectal cancer metastatic cancer antibody-2nd line kras adenocarcinoma
study to evaluate the efficacy and safety of hyoscine butylbromide tablets for the treatment of occasional or recurrent episodes of gastric or intestinal spasm-like pain or discomfort

Conditions: Abdominal Pain

Summary: in contrast with hyoscine butylbromide capsule 10mg, study is to evaluate the efficacy and safety of hyoscine butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of 3 days for the treatment of occasional or recurrent episodes of self-reported gastric or intestinal spasm-like pain or discomfort


Eligibility criteria:
inclusion criteria: 1. written informed consent given by the patient 2. male and female patients aging from 18 to 70 3. subjects with occasional or recurrent episodes of gastric or intestinal spasm-like pain, or discomfort, such as occur e.g. in irritable bowel syndrome, which has been present for at least 3 months 4. the pain intensity score upon screening is at least 4 cm in vas score exclusion criteria: 1. patients with the following concomitant disease were not eligible for enrolment * painful gastric or intestinal spasm of organic origin such as crohn's disease, ulcerative colitis, lactose intolerance, gastritis, ulcer. exception: diverticulitis and mild gastritis if dominant symptom was cramp pain, but ineligible if heartburn or reflux were dominant symptoms * pain related with malignancy * patients with other severe pain states of organic origin * mechanical stenosis of the gastrointestinal tract, megacolon * urinary retention associated with mechanical stenosis of urinary tract * narrow-angled glaucoma * tachyarrhythmia * myasthenia gravis * meulengracht-gilbert syndrome * known depression or known mental illness, anxiety disturbance 2. frequent vomiting that might have prevented adequate absorption of the active ingredient after the film-coated tablet was taken 3. patients taking the following concomitant medication are not eligible for enrolment * analgesics * spasmolytics * anticholinergics * affecting gastrointestinal motility, such as propantheline metoclopramide, cisapride, loperamide, diphenoxylate, opioid analgesics, antacids and other ulcer treatment * regular administration of laxatives * narcotics * antidepressant treatment or treatment with psychoactive drugs 4. pregnancy and/or lactation or planned pregnancy 5. known hypersensitivity to n-butylscopolammonium bromide 6. alcohol or drug abuse 7. simultaneous participating in another clinical trial, or discontinuing from another clinical trial before randomization (administration of study medication); moreover, in the case of screening failure or premature discontinuing from the trial, repeated enrolment is forbidden 8. unwilling to or unable to complete the entire trial procedure according to the protocol 9. in investigator's opinion, the patient was not proper for the trial
physiological response to protein and energy-enhanced food products during winter military training

Conditions: Military Operational Stress Reaction; Malnutrition (Calorie); Weight Loss; Muscle Wasting

Summary: soldiers commonly lose muscle mass during training and combat operations that produce large energy deficits (i.e., calories burned \> calories consumed). developing new combat ration products that increase energy intake (i.e., energy dense foods) or the amount and quality of protein consumed (i.e., essential amino acid \[eaa\] content) may prevent muscle breakdown and stimulate muscle repair and muscle maintenance during unavoidable energy deficit. the primary objective of this study is to determine the effects of prototype recovery food products that are energy dense or that provide increased amounts of eaas (anabolic component of dietary protein) on energy balance, whole-body net protein balance, and indices of physiological status during strenuous winter military training.

up to 96 norwegian soldiers participating in a winter training exercise at the garrison in sør-varanger (gsv) will be enrolled in an approximately 11-day, randomized controlled study. participants will be randomly assigned at the beginning of the training exercise to groups provided 3 norwegian army arctic combat rations and approximately 1500 supplemental calories from food products with increased energy density (en-dense), increased essential amino acids (eaa), or low energy density (control) each day. participants will be instructed to consume all of the supplemental food products provided to them and consume the arctic combat rations ad libitum. the effect of consuming en-dense, eaa, or control food products during strenuous military training on physiological status and recovery will be assessed using dietary analysis, stable isotope methodologies, physical performance measures, gut health analyses, blood sampling, and questionnaires. this design will test the hypothesis that 1) en-dense ration products will attenuate the energy deficit during the training, thereby limiting whole-body protein losses and decrements in physiological status; and 2) the protein-sparing benefit of eaa will limit whole-body protein loss regardless of the energy deficit.

Eligibility criteria:
inclusion criteria: male and female norwegian soldiers aged 18 years or older participating in the winter training exercise at the garrison in sør-varanger. exclusion criteria: * any injury or health condition limiting full participation in the training program. * allergies or intolerance to foods used in the study (including but not limited to lactose intolerance/milk allergy) or vegetarian practices.
efficacy of ultrasound guided erector spinae plane block

Conditions: Hemodynamic Instability; Patient Satisfaction; Postoperative Pain; Regional Block

Summary: thoracic epidural and paravertebral blocks are the most widely regional technique used for postoperative analgesia after surgery, but they are difficult to perform and carry a risk of serious complication. in this study, investigator asses the efficacy of ultrasound espb on intraoperative and postoperative hemodynamics and patient satisfaction

this prospective, double-blinded, randomized, controlled study was conducted at the period from october 2018 to december 2019. sixty adults' patients asa i-iii, their ages ranged from 25-60 years undergoing abdominal surgery under general anesthesia. each patient assigned written informed consent before the block performance. patients refused, known allergy to the used drugs, with history of coagulopathy, major organ failure and obesity (bmi\>40 kg/m2) were excluded from the study. patients were randomly allocated into two equal groups by a computerized randomization table: espb group, and control group. the patient and the staff providing the postoperative care were blinded to the group assignment. espb group: will undergo esp block with 40 ml bupivacaine 0.25% (20 ml on each side) control group: anesthetized with the protocol followed by minia university hospital. anesthetic technique was standardized for all patients.

Eligibility criteria:
inclusion criteria: 1. age18-70 . 2. both gender. 4. asa i-iii . exclusion criteria: 1. patient refuse 2. drug allergy. 3. morbid obesity (bmi \>40 kg/m2). 4. psychiatric disorder. 5. opioid dependence .

Keywords: espb postoperative pain regional block
the effect of creatine supplementation on muscle function in childhood myositis

Conditions: Juvenile Dermatomyositis

Summary: this project will bring together a multidisciplinary team of pediatric rheumatologists, neurologists, metabolic geneticists and exercise physiologists to determine the effect of creatine (cr) supplementation on muscle function and muscle metabolism in children with dermatomyositis (dm). the investigators propose using well-established exercise testing techniques as well as new, powerful exercise imaging protocols in order to better delineate the effects of cr on muscle pathophysiology in a non-invasive way. evidence from this study will provide information regarding the effect of creatine supplementation on muscle function in dm. improvements in muscle function and fatigue through cr use may also contribute to an improvement in quality of life and have significant clinical implications for the treatment of children with dm.


Eligibility criteria:
inclusion criteria: * ages 7 to 18 years * diagnosis of probable jdm (onset \<16 years) according to bohan and peter criteria * subjects on a stable course of medication (unlikely to change over study treatment period as determined by the treating physician) * minimum height of 132.5cm exclusion criteria: * subjects newly diagnosed with jdm within the previous 6 months * subjects unable to cooperate with study procedures, or too weak to participate in the exercise testing * subjects with impaired kidney function as determined from baseline visit screening lab values * subjects who are currently pregnant or planning to become pregnant within the study period * subjects who are shorter than 132.5cm