Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficacy of xaliproden (sr57746a) in preventing the neurotoxicity of oxaliplatin / 5fu/lv chemotherapy.

Conditions: Metastases; Colorectal Neoplasms; Colorectal Carcinoma

Summary: primary objective : compare the risk of occurrence of grade3-4 cumulative peripheral sensory neuropathy (psn) relative to cumulative dose of oxaliplatin between treatment group and placebo group. main secondary objective : compare the response rate (rr) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen. other secondary objectives : study of the neurotoxicity parameters (duration of oxaliplatin-induced psn (g2,3,4); overall incidence of psn during treatment; dose of onset of psn ; incidence of dose-reduction and dose delay due to psn; incidence of oxaliplatin treatment discontinuation due to psn; change in nerve conduction studies (ncs)) ; study of the safety profile (other than psn) ; study of the chemotherapy efficacy (progression free survival, overall survival).


Eligibility criteria:
inclusion criteria: main inclusion criteria : * histologically or cytologically-proven metastatic cancer of the colon or rectum. * metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease). * male or female aged \>18 years. * who performance status (ps) : 0 or 1. * measurable disease. * no prior chemotherapeutic regimen for metastatic disease. * disease-free interval from end of adjuvant therapy of at least 6 months (1 year if oxaliplatin was part of the adjuvant therapy). * prior radiotherapy is permitted if it was not administered to target lesions identified for this study - unless progression within the radiation portal is documented - and provided it has been completed at least 3 weeks before randomization. * signed written informed consent prior to study entry. exclusion criteria: main exclusion criteria : * any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-fu, as reported in approved labeling information. * received chemotherapeutic agents other than 5-fu, lv, levamisole, irinotecan, capecitabine, oxaliplatin as part of adjuvant therapy. * peripheral neuropathy \>grade 1. * concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy. * concurrent active cancer originating from a primary site other than colon or rectum. * presence of any symptom suggesting brain metastasis.

Keywords: neurotoxicity syndromes paresthesia oxaliplatin xaliproden
clinical evaluation of the application of the filmarray gi panel in post-hsct diarrhea patients

Conditions: GVHD - Graft-Versus-Host Disease

Summary: this is a prospective single arm study with the study period from june 1st, 2019 to may 31st, 2020. an historical control group will be used in the study, which includes all patients received hsct but not gi panel detection between june 1st, 2018 to may 31st, 2019. all patients receiving hsct within the year at scmc will be enrolled in the study. the stool samples will be collected from each patient at 2-3 time points, including the day before pre-conditioning (t1), 28+-3 days after hsct (t2), and the day severe diarrhea present (t3). all the stool samples will be detected by the filmarray gi panel, and the results as well as other clinical information including the laboratory examinations will be recorded and analyzed.


Eligibility criteria:
inclusion criteria: * age ≤ 18 years old; * receiving hsct; * legal guardians fully understand and sign informed consent. exclusion criteria: * receiving secondary transplantation; * cannot give informed consent or not willing to enroll the study.
a study to learn about the long-term health of adult participants from a previous study of a new melanoma treatment

Conditions: Melanoma

Summary: this study is researching the long-term effects of a combination of experimental drugs called fianlimab and cemiplimab. the study is being conducted in patients with advanced skin cancer (melanoma) who had previously been treated with fianlimab and cemiplimab in the study called r3767-onc-1613 (nct03005782). the aim of the current study is to see how safe and effective the study drugs are in a long-term follow-up. no study drug will be given during this study. cancer status will be monitored, in addition to routine care. the study is also collecting information about general health status, and other treatments that may have been received since participation in study r3767-onc-1613 (nct03005782).


Eligibility criteria:
key inclusion criteria: 1. participants with melanoma who enrolled in cohorts 6, 15, or 16 of study r3767-onc- 1613 (nct03005782) key exclusion criteria: none note: other protocol-defined inclusion/ exclusion criteria may apply

Keywords: advanced skin cancer
a2r and ectonucleotidases expression in lung cancer circulating tumor cells

Conditions: Non Small Cell Lung Cancer

Summary: early non-small cell lung cancer (nsclc), treated by surgery or radiotherapy in the case of inoperability, relapses in almost 50% of cases. circulating tumour cells (ctcs), which can be detected before surgery, represent a promising prognostic tool, but the markers characterising their aggressiveness remain to be determined. the nsclc microenvironment, in which purinergic signalling is a key pathway, controls tumour development. adenosine derived from the action of cd39 and cd73 ectonucleotidases hydrolysing extracellular atp, induces immunosuppression of nsclc by activating a2r receptors. the expression and prognostic relevance of a2r, cd39 and cd73 on ctcs is unknown. the objectives are to (i) compare the expression of a2r and cd39 and cd73 on primary tumour cells and ctcs of patients operated on for early nsclc, (ii) correlate these data with molecular characteristics and clinical response, (iii) determine on lung cancer lines whether irradiation impacts on the expression of a2r, cd39 and cd73. this work could contribute to the identification of new theranostic biomarkers.


Eligibility criteria:
i) inclusion criteria: * patient of legal age (\>18 years), any gender, * operated on for stage (ia to iib) non-small cell lung cancer (nsclc) ii) exclusion criteria: * patient with any other active cancer. * lack of evaluable material.
physical and functional effects of online exercise program on musicians playing stringed instruments

Conditions: Musculoskeletal Diseases or Conditions; Musculoskeletal Pain

Summary: musculoskeletal problems related to instrument playing or performance are frequently seen in musicians. different interventions such as strength training, endurance training and yoga have been used in the management of these problems. the first specific exercise program for professional orchestra musicians was developed by chan et al. however, it has been stated that it is difficult to encourage musicians' participation in exercise due to their constantly changing work schedules, and at this point, the use of digital media such as dvds, usbs, and educational exercise videos may have a potential role. on the other hand, it has been stated that smart wearable devices with mobile applications (such as smart watches, smart band) as digital health interventions are an interesting, interactive and efficient psychological strategy to promote physical activity and can be used as an intervention to promote a healthy lifestyle. based on the literature, in our study, the exercise program developed by chan et al., will be done online via "google meet" and symptoms can be evaluated with objective evaluation methods. unlike other studies using digital media, exercises will be performed synchronously and feedback will be given to the musicians simultaneously, as in face-to-face exercises. in addition, all participants will be given a smart band, they will be encouraged to use it until the end of the study, and the change in their physical activity levels will be evaluated.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * agreeing to exercise once a week for 8 weeks * being between the ages of 18-65 * playing a string instrument in bursa regional state symphony orchestra / bursa uludağ university state conservatory / bursa uludağ university faculty of education fine arts education department, department of music education / ege university state conservatory of turkish music * main instrument being a stringed instrument (violin, viola, cello, double bass) * playing an instrument for more than 5 years * having a musculoskeletal problem related to playing an instrument or performance exclusion criteria: * having a musculoskeletal problem that is not related to playing an instrument or performance * playing the instrument less than 15 hours per week * having had a corticosteroid injection within 6 weeks * having used anti-inflammatory or gabapentin within 3 weeks * having had any surgical operation that would prevent exercise in the last 6 months * having any diagnosed neurological and/or orthopedic problem that would prevent exercise in the last 6 months * having a diagnosed psychiatric problem * maximum subcutaneous fat thickness more than 12 mm

Keywords: musicians playing stringed instruments
effect of customized lateral nasal wall osteotomy on the pterygomaxillary separation during le fort i down-fracture

Conditions: Malocclusion; Open Bite; Le Fort; I; Orthognathic Surgery

Summary: the goal of this clinical trial is to show the effect of patient specific lateral nasal wall osteotomy to the pterygomaxillary separation during le fort i down-fracture. participants will be divided into two treatment groups. in study group, surgery planned according to the patients' indivudial anatomy and in the conventional group, surgery planned according to mean anatomical datas. researchers will compare patient specific lateral nasal wall osteotomy to see if it affects the pterygomaxillary junction seperation during le fort i downfracture.

the same surgical team performed the osteotomies under general anesthesia with nasotracheal intubation. hypotensive anesthesia was applied as a standard protocol in all patients. orthognathic surgery, including le fort i and sagittal split ramus osteotomy, was used to correct skeletal deformities. bone osteotomy was initiated on the bilateral wall of the maxilla with piezosurgery after a mucosal incision and flap elevation.lateral nasal osteotomy (lno) with nievert anderson single guarded osteotome, median septum separation with double guarded u-shaped osteotome, and pterygomaxillary junction separation with curved osteotome were performed before the down-fracture. the only difference between the conventional and study groups was the depth of the lno. in the study group, lno was performed at a depth of 2 mm less than the measured distance in the axial section. in the conventional osteotomy group, lno was performed at 30 mm for females and 35 mm for males, as suggested in the literature. a curved osteotome and a mallet were used in each case to separate the pterygomaxillary junction. the down-fracture of the maxilla was performed using a hook and a bone spreader in all patients. when the maxilla was down-fractured, lnw and the pterygomaxillary separation types were assessed intraoperatively. the maxilla was stabilized in its new position by four l-shaped osteosynthesis mini-plates at the zygomaticomaxillary buttress and the aperture piriformis regions.

Eligibility criteria:
inclusion criteria: the inclusion criteria * orthognathic surgery to treat malocclusion * sleep apnea * jaw asymmetry exclusion criteria: * cleft lip and palate * previous orthognathic surgery * rhinoplasty

Keywords: orthognatic surgery le fort i arterial bleeding down fracture lateral nasal wall pterygomaxillary junction
brain blood flow studies of language and memory

Conditions: Cerebrovascular Disorder; Epilepsy

Summary: positron emission tomography (pet) is a technique used to investigate the functional activity of the brain. the pet technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain. when a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). as the brain uses more fuel it produces more waste products, carbon dioxide and water. blood carries fuel to the brain and waste products away from the brain. as brain activity increases blood flow to and from the area of activity increases also. knowing these facts, researchers can use radioactive water (h215o) and pet scans to observe what areas of the brain are receiving more blood flow. this study is designed to use positron emission tomography (pet) with radioactive water (h215o) to determine the areas of the brain associated with memory and language. patients participating in the study will be made up of normal volunteers, patients with epilepsy, and patients with other abnormalities related to the surface of the brain (non-epileptic focal cortical dysfunctions).

this protocol will use positron emission tomography (pet) with h2015 and functional mri to examine localization of memory and language in normal control subjects, and patients with localization-related epilepsy.

Eligibility criteria:
inclusion criteria: normal volunteers: the desired age range is 18 to 55 years. subjects will have no history of head injury or other neurological disease and must not be taking any medication. female subjects of childbearing potential will be administered a pregnancy test; these subjects will not be eligible for the study requiring 2 scans. all volunteers will read and sign the consent form. patients: patients will be selected from among those referred to the clinical epilepsy section, ninds for evaluation. exclusion criteria: patients with evidence of a progressive intracranial process, who are taking any drugs (except aeds) that might affect the results, or active systemic disease will be excluded.

Keywords: positron emission tomography epilepsy stroke
the clinical importance of angle alpha by multifocal intraocular lenses.

Conditions: IOL, Cataract

Summary: purpose: to evaluate the effect of visual axis positioning on the optical performance of the tecnis miol and the diff-aa miol.

in this prospective, randomized comparative study 70 eyes of 35 subjects with senile cataract were implanted with the spherical aberration correcting diffractive, bifocal tecnis zlb00 iol, and 60 eyes of 30 age matched subjects with the spherical aberration neutral, diffractive, bifocal diffractiva iol. observation procedure was performed 1, 3, 6 months postoperatively. main outcome measures included uncorrected and corrected distance and near visual acuity, manifest refraction, ocular aberrations and visual quality metrics with 2mm and 4mm pupil, and the position of visual axis.

Eligibility criteria:
inclusion criteria: * corneal astigmatism less than 1 diopter exclusion criteria: * ocular pathology others than cataract

Keywords: multifocal iol, optical quality, angle alpha
stem cell therapy for patients with vascular occlusive diseases such as diabetic foot

Conditions: Diabetic Foot; Lower Limb Ischemia

Summary: mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.


Eligibility criteria:
inclusion criteria: * the age of 30-78 years old, men and women there is no limit. * in accordance with the ministry of health in higher medical colleges and universities teaching material the sixth edition of the annals of diabetic foot diagnostic criteria. * with severe lower limb ischemia (defined as the resting state of ankle brachial index (abi) 0.4-0.85, accompanied by resting or intermittent toe line. * treatment on a voluntary basis, and sign the informed consent. exclusion criteria: * with severe heart, liver, kidney, lung function failure or general condition is very poor can't tolerate the stem cell transplant. * clear over the past five years tumor markers in patients with malignant disease and blood levels increased significantly. * the prodrome of acute infectious diseases. * participated in clinical subjects within three months before test. * adherence is poor, can not complete the course.
timing of initiation of continuous glucose monitoring in established pediatric diabetes (the cgm time trial)

Conditions: Type 1 Diabetes

Summary: the investigators hypothesize that real-time continuous glucose monitoring (rt-cgm) will be more effective if introduced in children and adolescents with established diabetes at the same time as they are starting pump therapy. this randomized controlled trial will compare the effectiveness of simultaneous vs delayed introduction of rt-cgm in children and adolescents with type 1 diabetes who are starting insulin pump therapy.

real-time continuous glucose monitoring (rt-cgm) improves diabetes control in adults with type 1 diabetes. however, studies of rt-cgm in children and adolescents have been mostly negative. the lack of effectiveness in the pediatric population appears directly related to adherence to rt-cgm, i.e., the willingness of children and teens to wear and use this technology. most previous rt-cgm studies have focused on experienced pump users or children with new-onset diabetes. at the time of pump initiation, children and adolescents who have been living with diabetes (and their parents) are highly motivated to make changes in their diabetes management and to take on additional responsibilities to improve their diabetes control and lifestyle, the two primary reasons for initiating pump therapy in the pediatric population. the investigators hypothesize that readiness for making changes in diabetes management will be greater at the time of pump initiation than at six months after the pump start. further, the investigators hypothesize that readiness for change at the time of rt-cgm initiation will predict future adherence to rt-cgm and its effectiveness.

Eligibility criteria:
inclusion criteria: * males and females age 5-18 years old. * established t1d diagnosis for a minimum of one year. * naïve to csii therapy and ready to start csii with the veo pump (medtronic) . * willing to use rt-cgm and to be randomly assigned to either simultaneous or delayed rt-cgm initiation. * regular diabetes follow up at one of the 5 participating sites. * internet access at home (to upload rt-cgm data). * parent(s) or legally acceptable representative able to speak and read english or french. * ability of the subject and parent(s) or legally acceptable representative to participate in all aspects of this clinical trial. * written informed consent must be obtained and documented, with assent of the child if \<14 years of age. exclusion criteria * conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study. * has received oral and/or intravenous steroid therapy (for any indication, at any dose and/or for any duration) on more than 2 separate occasions in the past 12 months. use of inhaled and/or topical steroid therapy in the last 12 months does not exclude the subject. * prior use of rt-cgm for more than 50% of the time over the past 6 months. * prior enrollment in the current study. * current enrollment in another intervention trial.
effects of fludrocortisone on norepinephrine-mean arterial pressure dose-response in septic shock

Conditions: Septic Shock

Summary: septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. the association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. if hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone remains to be elucidated. the purpose of our study is to investigate the effect of a physiological dose of fludrocortisone alone on norepinephrine-mean arterial pressure dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients with septic shock.


Eligibility criteria:
inclusion criteria: * patients over than 18 years old * septic shock * haemodynamic stability (mean arterial pressure between 70 and 80 mmhg) for at least 1 hour, with a norepinephrine dose less than 0,5 µg/kg/min * written informed consent exclusion criteria: * corticotherapy * known allergy to fludrocortisone * esophageal or gastric disease * pregnant woman * inclusion in another clinical trial

Keywords: fludrocortisone pharmacology septic shock
study of daclizumab in patients with chronic, persistent asthma

Conditions: Asthma

Summary: the purpose of the study is to evaluate an investigational medication to treat chronic persistent asthma. the research is being conducted at up to 22 clinical research sites in the us and is open to both men and women ages 18 to 70 years old. participants in the study will have a number of visits to a research site over a 10-month period. all study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.


Eligibility criteria:
inclusion criteria: * history of asthma for 6 or more months * history of chronic persistent asthma requiring daily high dose inhaled corticosteroid for 3 or more months prior to enrollment exclusion criteria: * patients with 10 or more pack years of smoking history or smoking within 12 months of study enrollment * no significant disease other than asthma

Keywords: asthma daclizumab anti-tac monoclonal antibody anti-il-2 zenapax
a study of dzd9008 versus platinum-based doublet chemotherapy in local advanced or metastatic non-small cell lung cancer (wu-kong28)

Conditions: Non-small Cell Lung Cancer

Summary: this is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of dzd9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic nsclc with egfr exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage. primary objective of this study is to assess the efficacy of dzd9008 versus platinum-based doublet chemotherapy using by bicr-assessed pfs per recist 1.1 as primary endpoint. approximately 320 participants are estimated to be randomized into the study. participants enrolled will be randomized to dzd9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).


Eligibility criteria:
inclusion criteria: 1. aged at least 18 years old (or per local regulatory/irb requirement). 2. histologically or cytologically confirmed diagnosis of non-squamous nsclc, locally advanced (stage iiib and iiic according to the 8th edition of the ajcc tnm staging criteria) or metastatic (stage iv), not suitable for curative therapy. 3. adequate tumor tissue available, for central laboratory confirmation of egfr exon 20 insertion mutation 4. at least 1 measurable lesion per recist version 1.1 5. life expectancy ≥ 12 weeks 6. eastern cooperative oncology group (ecog) performance status of 0 to 1 7. adequate organ and hematologic function exclusion criteria: 1. prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic nsclc. 2. spinal cord compression or leptomeningeal metastasis. 3. concurrent egfr mutations: exon 19 deletion, l858r, t790m, g719x, s768i, or l861q. 4. history of stroke or intracranial hemorrhage within 6 months before randomization. 5. as judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and von willebrand disease).