Kornimate/medical-research-clean huggingface dataset:
body schema alterations in musculoskeletal disorders : effect of laterality

Conditions: Musculoskeletal Disorder; Rotator Cuff Tendinitis; Chronic Low Back Pain; Carpal Tunnel Syndrome

Summary: this study assess ocular movements in a hand laterality judgment task in a population of musculoskeletal disorders. reaction time, error rate and visual strategy are compared between musculoskeletal disorders and healthy patients, and between the different locations of the disorder.

musculoskeletal disorders are a major public health issue. recent studies showed that body schema alterations are involved in the chronification of those disorders. those alterations bring the opportunity for new exploration or therapeutic solutions. our hypothesis is that musculoskeletal disorders lead to motor imagery alterations relative to body schema disorders. reaction time extension et error rate increase in a hand laterality judgment task would confirm that hypothesis. it is assumed that body schema alterations of patients suffering from musculoskeletal disorders could change with localisation, dependant on disorder's laterality and distality. it is a monocentric, prospective, case-control trial, with 4 subgroups of 30 patients : shoulder rotator cuff tendinopathy, carpal tunnel syndrome, chronic low back pain, healthy subjects. we compare reaction time and error rate on a hand laterality judgement task. in that task, participants are asked to identify hand right or left laterality, when those hand is presented on a computer screen, by answering with the keyboard. hands are shown on palmar or dorsal view and with 12 different angles of rotation. an eye-tracking device register participant eye movements during the task.

Eligibility criteria:
inclusion criteria: * normal visual acuity * social security affiliation * signing consent * rotator cuff tendinopathy, chronic low back pain, carpal tunnel syndrome or healthy subject exclusion criteria: * recent trauma or surgery * psychiatric or neurological disorder * psychotropic consumption * previous experience with motor imagery * bad french comprehension * protected persons * other painful affection than the inclusion criteria
safety and feasibility of human umbilical cord mesenchymal stem cell-derived secretome in the treatment of liver cirrhosis: a comprehensive evaluation of fibrosis reduction, immunomodulation, and hepatic regeneration: a single center, randomized, phase i clinical trial

Conditions: Liver Cirrhosis

Summary: the goal of this clinical trial is to learn if human umbilical cord mesenchymal stem cell (hucmsc) derived secretome injection is safe and effective in patient with liver cirrhosis. the main questions it ams to answer are: 1. how safe is secretome injection as an adjuvant therapy for liver cirrhosis patients? 2. how effective is secretome injection in liver fibrosis 6 months after injection? 3. does secretome injection improve liver function after 6 months after injection? 4. does secretome injection affect child turcotte pugh score? 5. how does secretome affect pro inflammatory and anti inflammatory cytokine in patient with liver cirrhosis? 6. how does secretome injection affect the quality of life in live cirrhosis patient? 7. what is the relationship between secretome injection and encephalopathy? researchers will compare secretome injection group (patients who recieve secretome injections) to best practice treatment group (patient who receive supportive treatment including hepatoprotector and ursodeoxycolic acid) researchers will compare the intervention group (patients who are injected with hucmsc derived secretome) and control group (patients who are only monitored and given their usual drugs) patients will: be injected with secretome or take hepatoprotector and ursodeoxycolic acid every 2 weeks for 4 months. do several test such us fibroscan, stroop test, psychometric hepatic encephalopathy score, short form 36 questionnaire, il-6, tnf alfa and blood test for albumin, sgot, sgpt, direct bilirubin, indirect bilirubin, inr, creatinine, ureum, hemoglobin, hematocrite, leukocyte, and thrombocyte. visit the clinic once every two weeks to receive drugs and treatment for 4 months. follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment),10th months (6 months post treatment)


Eligibility criteria:
inclusion criteria: * age above 17 years, both men and women * patient is willing to participate and sign informed consent * patient is diagnosed with liver cirrhosis confirmed by clinical examination and diagnostic imaging * liver cirrhosis patient with child-pugh class b * patient is in a stable condition without life threatening complications such as active gastrointestinal bleeding, severe infection, severe renal failure (egfr\&amp\>30) at time of registration * patient is not receiving experimental drugs for liver cirrhosis for the past 6 months * patient is able and willing to comply with research protocol including follow up visits and evaluations exclusion criteria: * patient with uncontrolled psychiatric disorders * patient who is diagnosed with hepatic or non- hepatic malignancy * lactating and pregnant patient * patient who has allergy or hypersensitivity reaction towards secretome

Keywords: liver cirrhosis secretome stem cells hucmsc
safety and dose escalation study of zinc supplementation in critically ill children

Conditions: Critical Illness

Summary: the purpose of the study is 1) to determine whether administration of intravenous zinc to critically ill children is safe, and 2) to determine an appropriate dose of zinc supplementation.

our recently published studies in children with septic shock demonstrated that pediatric septic shock is characterized by large scale repression of genes that either directly depend on normal zinc homeostasis or directly participate in zinc homeostasis. functional validation studies demonstrated that nonsurvivors of pediatric septic shock have abnormally low serum zinc concentrations. a follow-up pilot study in a general population of critically ill children demonstrated that the presence of low plasma zinc concentrations is a prevalent problem in critically ill children. in addition, low plasma zinc concentrations correlate inversely with indices of inflammation and directly with the number of organ failures. these preliminary data, coupled with the expected safety of zinc supplementation, provided the rationale for a double blinded, prospective, placebo-controlled trial of zinc supplementation in critically ill children, with the two primary study endpoints to assess efficacy being highly clinically relevant: reduction of the lymphopenia rate and improvement of glucose homeostasis. although the proposal was well-received, the primary concern precluding funding of this trial were lack of safety and dosing data for intravenous zinc. we have therefore developed a proposal for a phase i/ii study of safety and pharmacokinetics to address these concerns. it is anticipated that data generated through this proposal will provide the necessary preliminary data to re-submit our application for an interventional efficacy trial of zinc supplementation in critically ill children

Eligibility criteria:
inclusion criteria: * admission to pediatric intensive care unit * age between 1 month and 10 years * pediatric risk of mortality iii score \> 5, or presence of at least 1 new organ failure * anticipated pediatric intensive care unit length of stay \> 3 days * ability of parent or legal guardian to provide informed consent exclusion criteria: * known zinc deficiency * pre-existing bone marrow failure * new or existing diagnosis of diabetes mellitus * limitation of care orders in place * new diagnosis of brain injury, encephalopathy * clinical contraindication for zinc supplementation
electrical stimulation in patients with unipolar major depression

Conditions: Depression

Summary: double blinded randomized trial of stns as adjuvant treatment for major unipolar depressive disorder. the primary objective is to assess the safety and tolerability of an implantable stns of the v1 branch of the trigeminal nerve as an adjunctive treatment for adult patients with the diagnosis of unipolar mdd (major depressive disorder).


Eligibility criteria:
inclusion criteria: * outpatients with non-psychotic, unipolar major depressive disorder assessed via the mini structured interview and legally capacitated to sign the informed consent for participation in the study; * a score of ≥ 14 on the ham-d17 with item 1 (depressed mood) ≥ 2; * a history of treatment failure with at least 3 adequate trials antidepressants over the previous 6 weeks and less than 6 medications, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study); * patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm and lack of self-harming attempt in the past 6 months; * patients with appropriate support to be compliant with the study protocol. exclusion criteria: * patient is mentally or legally incapacitated, unable to give informed consent. * patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudo-dementia of depression) will be excluded. * patients currently receiving more than six medications for treatment of mdd; * patients with exposure to ect or rtms or any investigational treatment (for any disorder) within the past 6 months; * prior vns and/or dbs therapy (lifetime); * past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, cva, or tias; cerebral aneurysm; parkinson's or huntington's disease; or multiple sclerosis; * current pregnancy, breast feeding, plans to become pregnant during the study, or not using a medically accepted means of contraception; * other medical conditions that would increase the risk of infection or surgical related morbidity and/or would affect compliance with the study protocol.

Keywords: electrodes, implanted electric stimulation therapy
brain/neural hand exoskeleton control for restoration of bimanual tasks

Conditions: Spinal Cord Injury; Stroke

Summary: this study investigates whether spinal cord injury and stroke survivors (n=10) are able to operate a brain/neural hand exoskeleton (b/nhe) based on electroencephalography (eeg) and electrooculography (eog) for restoration of bimanual activities of daily living (adls). to assess bimanual adls, the berlin bimanual task assessment (bebita) will be applied. improvements in bebita will be evaluated with and without b/nhe use.


Eligibility criteria:
inclusion criteria (stroke): * single ischemic or hemorrhagic insult with subcortical lesion (medullary canal, internal capsula, pedunculi cerebri) * interval since stroke at least 6 months * substantial motor deficit with: * medical research council (mrc) -score of less than 2 out of 6 possible points (0=no activity; 1=visible contraction without motor effect; 2=movements with elimination of gravity; 3=movements against gravity; 4=movements against weak resistance; 5=normal force) * fugl-meyer test (upper extremity) of less than 31 points, "no to little mobility" inclusion criteria (spinal cord injury): * cervical spinal cord injury, height c5-c6 * interval after spinal cord injury at least 6 months * substantial motor deficit with american spinal cord association (asia) -classification b or c (a=no muscle function/sensitivity below the spinal cord injury; b=no muscle function, limited sensitivity present; c=low non-relevant muscle function, sensitivity present; d=functionally relevant muscle functions present; e=fully preserved or restored functions) exclusion criteria (stroke and spinal cord injury): * alcohol or drug problem (regular consumption of more than 2 alcoholic beverages per day, or taking illegal drugs) * currently undergoing neurological or psychiatric treatment based on a secondary diagnosis * severe and uncontrollable medical problems: * non-adjusted malignant high blood pressure, world health organization (who) hypertension grade ii * non-adjustable diabetes mellitus, hba1c \> 58 mmol/mol * renal failure, from kdigo glomerular filtration rate (gfr) category g3b (moderate to severe impairment) * liver failure, child-pugh stages b and c * heart failure new york heart association (nyha) grade iii-iv * malignant tumor disease * severe arrhythmia in need of treatment * severe oedemas * severe arthritis * serious cognitive impairment (minimum status below 23 points) * severe spasticity (ashworth grade ≥ 4) * pregnancy * bilateral motor deficit (in stroke patients)
cerebral palsy upper extremity orthotic device

Conditions: Cerebral Palsy

Summary: upper extremity therapies for children with cerebral palsy (cp) have been validated for improving function in higher functioning patients. those who function at the lowest end of the scale, on the manual ability classification system scale (macs) iii-v, comprise 34-54% of the population, but as yet have no evidence-based interventions specific to their needs. lower functioning children often retain some voluntary control of the elbow in spite of limited finger motion. a dynamic splint, or exoskeleton, could utilize the tenodesis effect from elbow motion to drive finger release while retaining flexor tone for grasp, potentially creating a portable, home-based therapeutic tool. the purpose of this study is to assess the effectiveness of an upper extremity orthotic device in improving the upper extremity function of children with cerebral palsy who have limited use of their hands.


Eligibility criteria:
inclusion criteria: * diagnosis of cerebral palsy, age 4-17 years, moderate-severe hand disability as graded by the manual ability classification system, active movement of the elbow, ability to follow commands and participate in goal-making and repetitive tasks exclusion criteria: * mild or extremely severe hand disability, botox or orthopaedic surgery within the past 6 months, severe contractures, lack of voluntary arm motion, unable to follow commands due to severe cognitive impairment
pegylated alfa-2b interferon therapy of patients with hepatitis c-related cirrhosis and high liver cell proliferation (p02733/mk-4031-085)

Conditions: Carcinoma, Hepatocellular

Summary: this study aims to compare the role of peginterferon α-2b (50 μg/week) vs. control (no treatment) in the prevention of hepatocellular carcinoma, in adult patients with cirrhosis and initial signs of portal hypertension who did not respond to previous combined therapy with interferon alfa + ribavirin or peginterferon alfa + ribavirin or to interferon alfa monotherapy and with a high proliferation rate before entering the study. the duration of treatment will be 3 years, and the follow-up period will be 2 years.


Eligibility criteria:
inclusion criteria: * cirrhotic participants, both sexes, child pugh a, b, hcv-rna positive, age \< 70 years * participants non-responders to ifn + ribavirin or pegifn + ribavirin or ifn monotherapy * pre-therapy liver biopsy (\ 2.0 * fibrosis score 5-6 (ishak) * initial portal hypertension, such as gastroesophageal varices or one of the following us sign: * collateral circles * spleen longitudinal diameter \> 12 cm * portal vein diameter at hilus \> 12 mm * portal flow \> 12 cm/sec * participants must have the following minimum hematologic and biochemical criteria: * hemoglobin \>= 11 g/dl * granulocyte count \> 1,000/mm\^3 * platelets \> 70,000/mm\^3 * prothrombin activity \> 50% * total bilirubin \<3 mg/dl * albumin \>= 3.5 g/dl * serum creatinine within normal limits * uric acid within normal limits * thyroid stimulating hormone (tsh), within normal limits * antinuclear antibodies (ana) \< 1:160 * written informed consent * women of childbearing potential must have a negative pregnancy test * acceptance of patients of both sexes of proper contraceptive measures for the study period exclusion criteria: * pregnant or breast-feeding women * co-infection with hiv and/or hbv * autoimmune hepatitis or history of autoimmune disease * alcoholic liver disease * metabolic disease * hcc * participants with liver and kidney transplants * evidence of decompensated liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy * chronic renal failure or creatinine clearance \< 50 ml/min * pre-existing thyroid disease unless it can be controlled with conventional treatment * history or presence of psychiatric condition, especially depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt * epilepsy and/or compromised central nervous system (cns) function * significant cardiovascular dysfunction within the previous 6 months before the study starts (eg, angina, congestive heart failure, recent myocardial infarction, moderate or severe hypertension, significant arrhythmia) * hemoglobinopathies * poorly controlled diabetes mellitus * chronic pulmonary disease (eg, chronic obstructive pulmonary disease) * clinical gout * hypersensitivity to interferons or any component of the drug
effect of intraoperative paravertebral block on postoperative pain and recovery in patients undergoing mechanical correction for scoliosis

Conditions: Scoliosis

Summary: pain management after scoliosis surgery is challenging for the anesthesiologists. this surgery causes severe postoperative pain and patients undergoing these operations are children or adolescents who are increased pain sensation compared with adults. therefore, we aim to evaluate whether intraoperative paravertebral block (pvb) decreases postoperative pain in these patients. thirty-two patients scheduled for mechanical correction due to scoliosis will be divided into pvb (n=16) and control (n=16) groups. randomly selected patients of the pvb group are performed pvb with 0.2% ropivacaine on both sides. in contrast, pvb are not performed in the control group.


Eligibility criteria:
inclusion criteria: * patients undergoing mechanical correction exclusion criteria: * the subjects who cannot communicate * the subject is a foreigner or illiterate
opioid free pterygopalatine ganglion block based multimodal anesthesia for tonsillectomy operations

Conditions: PREVENTION OF POSTTONSILLECTOMY PAIN; DECREASE POSTTONSILLECTOMY NAUSEA AND VOMITTING; DECREASE POSTOPERATIVE HOSPITAL STAY

Summary: intraoperative opioid administration versus intraoperative pterygopalatine ganglion block based opioid free anesthesia to compare outcomes such as postoperative administration of opioid rates of nausea and vomiting, post anesthesia care unit (pacu) length of stay

group a ;( opioid based multimodal anesthesia) one hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia. group b ;( opioid free pterygopalatine ganglion block based multimodal anesthesia) one hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia. for each patient, intraoperative hemodynamics, additional intraoperative analgesia required, the length of pacu stay, administration of postoperative opioids, administration of postoperative non-opioid analgesics, postoperative (visual analogue score) vas score, will be recorded.

Eligibility criteria:
inclusion criteria: * age 4 to 13 years old. * elective tonsillectomy or adenotonsillectomy surgery exclusion criteria: * allergies to xylocaine. * developmental delays. * significant cognitive impairment. * american society of anesthesiologists (asa) class 3 and 4. * patients who underwent any additional concurrent procedures such as lingual tonsillectomy.
a study to assess the safety of tpm502 in adults with celiac disease

Conditions: Celiac Disease

Summary: the goal of this clinical trial is to learn about the safety and the pharmacodynamic (pd) effects of tpm502 in adults with celiac disease. the main questions it aims to answer are: * if tpm502 is safe and well tolerated * if tpm502 can induce modifications in parameters indicating that it may induce tolerance to gluten participants will: * undergo 1-day gluten challenge during screening and after administration of tpm502 or placebo. * receive 2 infusions of tpm502 or placebo, 2 weeks apart

this is a multi center, double-blind, randomized, placebo-controlled phase 2a study to evaluate the safety, tolerability, and pd effects of two infusions of tpm502 in adult patients diagnosed with ced. the patient´s participation in the study comprises 3 phases: screening period, treatment period and follow-up period. patients fulfilling the eligibility criteria will be randomized to receive two infusions of tmp502 (or placebo) at the same dose level. patients will undergo a second gc one week after the second infusion of tpm502. the study includes 4 cohorts of patients, each cohort will receive escalating doses of tpm502 (or placebo). upon completion of the 3rd cohort, a lower dose can be investigated, if deemed relevant.

Eligibility criteria:
inclusion criteria: * availability of a documented biopsy-confirmed diagnosis of ced or documented tissue transglutaminase \>10x uln and documented positive iga anti-endomysial antibody (ema) at time of ced diagnosis (as per local guidelines) * serum anti-tissue transglutaminase 2 immunoglobin a antibodies within normal range (i.e., \<15 u/ml) at screening * serum il-2 levels (auc1-6h) above a pre-defined threshold following the gc at screening * patients must have been on gfd for ≥ 6 months * patients must have well-controlled ced, defined as mild or with no ongoing signs or symptoms felt to be related to active ced, as per investigator's assessment * hla-dq2.5 positive exclusion criteria: * known or suspected refractory ced (refractory ced type i or ii) * known intolerable symptoms following previous gcs, as per investigator's assessment * hla dq8 positive * any active gastrointestinal disease such as gastroesophageal reflux disease, esophagitis or peptic ulcer, microscopic colitis, or irritable bowel syndrome, which in the opinion of the investigator might interfere with the assessment of the symptoms related to ced * known history of or active crohn's disease, ulcerative colitis, or ulcerative jejunitis * known wheat allergy * known hypersensitivity to i.v. iron preparations or any other excipients present in the reconstituted tpm502 or placebo

Keywords: celiac disease tolerance