Kornimate/medical-research-clean huggingface dataset:
a study comparing the outcome of anterior lumbar fusion and total lumbar disc replacement

Conditions: Disc Disease Degenerative; Disk Degeneration; Disc Disease Lumbar

Summary: total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement. the study aims to compare total disc replacement to anterior fusion, sparing the muscles of the back and thus comparing the two different methods using the same surgical approach.

a total of 170 patients are planned to be enrolled in the study. if the patients meet the inclusion criteria and accept to participate they will be randomized to either anterior lumbar fusion or total disc replacement. the method of choice will be blinded for the patients until the two year follow up is completed. follow-up: after one and two years. questionnairs: odi, vas, euroqol, and ga flexion- extension x-ray after one and two years complications will be retrieved from the patient journals.

Eligibility criteria:
inclusion criteria: * patients with disabling pain from degenerative disc disease(ddd) both clinical and radiological, in one or two segments of the lumbar spine from l4-s1, were prolonged conservative treatment has failed. * the patient should be able to understand swedish written and spoken. * the patient should be between the ages 18-65. the patient has to accept to participate in the study exclusion criteria: * more than two degenerated segments. * degeneration above the l4 segment. * did not agree to participate in the study * previous history of tumor, vertebral fracture, infection, lumbar fusion and dominating leg pain. * need for posterior decompression * pregnancy * psychiatric illness or drug abuse
phase ii trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (gleevec)

Conditions: Chronic Myelogenous Leukemia

Summary: to determine the safety and efficacy of decitabine in patients with philadelphia chromosome-positive chronic myelogenous leukemia accelerated phase that were previously treated with imatinib mesylate (sti 571) and became resistant/refractory or were found to be intolerant to the drug.


Eligibility criteria:
inclusion: * histologically confirmed diagnosis of cml accelerated phase * ph chromosome-positive * previous treatment with imatinib mesylate resulting in: i) hematologic resistance / hematologic refractory: based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) imatinib mesylate intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment. * patients must have recovered from the side effects of previous cml therapy for accelerated phase with the exception of hydroxyurea * age \>/= 2 years * bilirubin \</= 3 x the upper limit of normal (uln), sgot and sgpt \</= 3 x uln, except \</= 5 x uln in leukemic involvement of the liver, serum creatinine \</= 2 x uln * who performance status 0-3 * a negative serum hcg pregnancy test in patients of childbearing potential * able to give signed informed consent directly or through a parent or guardian for minors exclusion: * leukemic involvement of the central nervous system * active malignancy other than cml or non-melanoma cancer of the skin * previous treatment for cml with another investigational agent within 28 days of study entry * at study entry, patients who were treated with: imatinib mesylate within the past 48 hours; interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks * patients who had received hematopoietic stem cell transplantation within 6 weeks of day 1 decitabine therapy * patients with grade 3/4 cardiac disease or any other serious concurrent medical condition. * patients who are pregnant or nursing. all patients of childbearing potential must practice effective methods of contraception while on study. * patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements * patients with systemic, uncontrolled infections

Keywords: chronic myelogenous leukemia cml cml-ap accelerated phase decitabine 5-aza-2'deoxycytidine methylation sti 571 imatinib mesylate gleevec bcr/abl
neuromodulation on motor function in parkinson's disease

Conditions: Idiopathic Parkinsons Disease

Summary: the aims of the present study was to analyze the effect of consecutive sessions of transcranial direct current stimulation associated to kinesiotherapy about gait performance of parkinson' s disease. for this, the primary outcome was evaluation of gait performance by means of space and temporal parameters as speed (meter/second ), stride frequency (steps/min) and stride length (m). the secondary outcome is motor cortex excitability which is analyzed by means of single pulse transcranial magnetic stimulation (tms) intends to determine: motor evoked potential amplitude (mep) and rest motor threshold (rmt).

this study consist by interventions involving screening followed by evaluation, where volunteers were subjected to the many tests: history, session iii of the unified scale modified parkinson's disease - unified parkinson 's disease rating scale, ten meters walk test - walk test 10 meters and shoot gait, (using studio version 8 software). on the same day, the subjects underwent assessment of brain excitability to determine motor threshold and amplitude of the motor evoked potential (mep). the randomization of the volunteers was conducted by an external search through opaque envelopes ordered according to a random distribution. the subjects were divided into two groups : control group , this group submitted to transcranial stimulation sessions a sham continuous current (sham tdcs) and gait training , and experimental group, subjected to the stimulation by transcranial direct current sessions (active tdcs ) and gait training.

Eligibility criteria:
inclusion criteria: * main eligibility criteria were idiopathic parkinson's disease * both sex * hoehn and yahr stage i to iii * showing mild to severe gait disturbances * stable medication usage * age 40 to 80 years * and absence of cognitive impairment and disorders interfering with participation in cueing therapy. exclusion criteria: * presence of chronic disabling pathologies of lower limb * presence of pacemaker or severe cardiovascular conditions * a history of tumor, prior neurosurgical brain * intervention, or severe cardiovascular conditions, including the presence of a pacemaker * a diagnosis of epilepsy or major psychiatric disorders. * participants with other neurological, muscular, or psychiatric disorders (e.g. peripheral neuropathies, uncorrected visual problems, hearing problems, vestibular dysfunction, stroke, seizure, migraine, or frequent severe headaches) were excluded. * participants with surgical implants, significant postural tremor, dyskinesia, severe freezing or dementia were also excluded.

Keywords: idiopathic pd hoehn and yahr stage i to iii stable medication usage age 40 to 80 years absence of cognitive impairment
multi donor mismatched stem cell transplantation (mdt)

Conditions: Graft-Versus-Host Disease

Summary: the proposed research focuses on the development of innovative protocol of mismatched stem cell transplantation with combined 2 different haplo stem cell transplantation (sct) donors which are mismatched to the recipient (and preferably to each other), in a patient in need for sct, lacking an hla match related or an unrelated donor. this innovative protocol named multi donor stem cell transplantation (mdt) is designed to facilitate engraftment even when reduced intensity conditioning or a low cell dose are used, improve the graft vs. leukemia (gvl) effect and enhance immune reconstitution (using quantitative and qualitative parameters).


Eligibility criteria:
inclusion criteria: 1. patient age 0-70 years old with leukemia in 1st remission at high risk of relapse because of unfavorable prognostic features, at 2nd cr or mds without an readily available matched donor (related or unrelated). 2. patients must have a mismatched donor willing and capable of donating peripheral blood stem cells and/or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (mismatched defined as 3/6-4/6 hla matching). 3. each patient / patient's guardian must sign written informed consent. 4. patients must have an ecog ps ≤ 2; creatinine \ 40%; dlco \>50% of predicted; serum bilirubin \<3 gm/dl; elevated gpt or got \<3 x normal values. exclusion criteria: 1. not fulfilling any of the inclusion criteria. 2. not in cr (if the indication for transplant is leukemia). 3. active life-threatening infection. 4. overt untreated infection. 5. hiv seropositivity, hepatitis b or c antigen positivity with evidence of active hepatitis. 6. pregnant or lactating women. 7. donor contraindication (hiv seropositive confirmed by western blot, hepatitis b antigenemia, hcv, evidence of bone marrow disease, unable to donate bone marrow or peripheral blood due to concurrent medical condition). 8. previous autologous or allogeneic stem cell transplantation. 9. inability to comply with study requirements.

Keywords: stem cell transplantation gvhd
circulating fetal cells and breast cancer

Conditions: Breast Cancer

Summary: after pregnancy, fetal cells remain in a woman's body for years. these cells may be involved in different physiological situations (e.g. wound healing) and diseases (e.g. cancer).the study will evaluate the level of circulating fetal immune cells in patients with breast cancer vs controls with benign breast tumors, and further characterize these fetal cells. patients participation will be limited to accepting that an additional blood sample is collected on the day of their preop consultation and blood test.

breast cancer is the most common cancer in the female population. the protective mechanism associated with pregnancy is not fully understood. during pregnancy fetal cells cross the placental barrier and may remain in the maternal circulation even for up to 30 years after childbirth. this phenomenon is called fetal microchimerism. the presence of circulating fetal cells would have a protective role against breast cancer. however, their phenotype and role in the anti-tumor response is not explored. the objective of the study is to identify the sub-population (s) of circulating fetal immune cells that may have an impact on the processes of carcinogenesis in breast cancer, in the context of fetal microchimerism.

Eligibility criteria:
inclusion criteria: * women aged 18-50 * having had a male child * informed and not having objected to participating in the research. patients: - having a diagnosis of breast cancer controls: * operated on for benign breast tumors * cancer free exclusion criteria: * autoimmune disease * immunomodulatory treatment * history of cancer other than breast cancer * ongoing hormonal treatment * women not affiliated to the social security * under ame (state medical aid) * under tutorship / curatorship

Keywords: breast cancer microchimerism hematopietic fetal cells
association between fractional exhaled nitric oxide and asthma control

Conditions: Bronchial Asthma

Summary: the purpose of this study is to determine mean or median of fractional exhaled nitric oxide (feno) in thai atopic asthmatic patients that divided into subgroups due to level of asthma control according to the global initiative for asthma guideline.

from many previous studies, fractional exhaled nitric oxide (feno) has many benefits such as non-invasive, easily to perform, less time consume, has direct association with severity of inflammation of bronchial trees and sputum eosinophils, has benefit for diagnosis and monitoring the treatment in asthmatic patients. in thailand, this field of study is less extend, especially in children population. we hypothesized that in uncontrolled or partly controlled group may have high level of fractional exhaled nitric oxide (feno) than controlled group. it is therefore desirable to examine the association between fractional exhaled nitric oxide (feno) and level of asthma control among atopic asthmatic thai children and will be the main objective of this research.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of atopic bronchial asthma * follow up in clinic of allergy and clinical immunology, siriraj hospital exclusion criteria: * smoker or past history of smoking * has chronic disease eg. hiv infection, pulmonary hypertension, systemic lupus erythematosus, liver cirrhosis, gastroesophageal reflux, copd, bronchiectasis * drink ethanol within 48 hours before enrollment * history of upper or lower respiratory tract infection within 6 weeks before enrollment * drink caffeine within day before enrollment * during pregnancy * history of systemic steroid use within 8 weeks before enrollment

Keywords: bronchial asthma level of control of asthma fractional exhaled nitric oxide (feno) asthma control test (act)
hyperbaric oxygen therapy compared with standard therapy in treating chronic arm lymphedema in patients who have undergone radiation therapy for cancer

Conditions: Breast Cancer; Lymphedema; Perioperative/Postoperative Complications; Radiation Fibrosis

Summary: rationale: hyperbaric oxygen therapy may be effective in repairing damaged tissue and reducing lymphedema caused by radiation therapy for cancer. purpose: this randomized phase ii trial is studying hyperbaric oxygen to see how well it works compared to standard therapy in treating chronic arm lymphedema in patients who have undergone radiation therapy for cancer.

objectives: primary * compare the efficacy of hyperbaric oxygen (hbo) therapy vs standard management, in terms of reduction of lymphedema, in patients with chronic arm lymphedema after radiotherapy for cancer. secondary * determine the mechanisms of tissue reperfusion and healing in patients treated with hbo therapy. outline: this is a randomized study. patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo hyperbaric oxygen therapy over 90 minutes 5 days a week for 6 weeks. * arm ii: patients receive standard management. patients are followed at 3, 6, 9, 12, and 15 months. peer reviewed and funded or endorsed by cancer research uk projected accrual: a total of 63 patients (42 for arm i and 21 for arm ii) will be accrued for this study.

Eligibility criteria:
disease characteristics: * history of early breast cancer (t1-3, n0-1, m0) * prior breast surgery with or without axillary dissection * prior breast/chest wall radiotherapy with or without radiotherapy to the supraclavicular fossa and/or axilla, completed at least 2 years ago * arm lymphedema * at least 15% increase in arm volume * no evidence of cancer recurrence * hormone receptor status: * not specified patient characteristics: age * over 18 sex * female or male menopausal status * not specified performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified pulmonary * no chronic obstructive airway disease * no bullous lung disease * no acute or chronic pulmonary infection * no uncontrolled asthma * no untreated pneumothorax other * physically and psychologically fit for hbo therapy * no claustrophobia * no epilepsy * no eustachian tube dysfunction * no recurrent attacks of vertigo * no contraindication to mri (e.g., intracranial ferrous material) prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * see disease characteristics surgery * see disease characteristics * no prior ear operations other * no prior hyperbaric oxygen (hbo) therapy, except as treatment for decompression illness

Keywords: lymphedema radiation fibrosis perioperative/postoperative complications stage i breast cancer stage ii breast cancer stage iiia breast cancer
disrupting the bone marrow microenvironment with g-csf in acute lymphoblastic leukemia

Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma

Summary: the purpose of this study is to determine the ability of g-csf to disrupt the bone marrow microenvironment as a means to increase the efficacy of chemotherapy in patients with relapsed or refractory acute lymphoblastic leukemia (all).

in this study, we will combine g-csf as priming prior to and during the administration of salvage chemotherapy regimen in all. abundant data suggests that leukemic cells receive key growth and survival signals from the bone marrow microenvironment. our preclinical data show that 4-5 days of g-csf treatment is associated with a loss of osteoblasts and decreases expression of key chemokine/ cytokines which support lymphocyte development. the investigators hypothesize that g-csf will disrupt the protective effects of the bone marrow microenvironment and augment the effect of chemotherapy in adults with all. this is a pilot study of g-csf priming in adult patients with relapsed or refractory all to determine the feasibility and to characterize the effect of g-csf treatment on the marrow microenvironment.

Eligibility criteria:
inclusion criteria: * acute lymphoblastic leukemia diagnosed according to who criteria (\>25% lymphoblasts in bm) which is relapsed or refractory to therapy. patients with t(9;22) must be refractory to bcr-abl tyrosine kinase inhibitors. * age ≥ 18 years * ecog performance status ≤ 3. * adequate organ function defined as: * calculated creatinine clearance ≥ 50 ml/min * ast, alt, total bilirubin ≤ 2 x institutional uln except when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (eg. hepatic infiltration or biliary obstruction due to leukemia) * women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study. * able to provide signed informed consent prior to registration on study. exclusion criteria: * previous salvage chemotherapy with ifosfamide and etoposide * pregnant or nursing * received any other investigational agent or cytotoxic chemotherapy within the preceding 2 weeks * received colony stimulating factors filgrastim or sargramostim within 1 week or pegfilgrastim within 2 weeks of study * severe concurrent illness that would limit compliance with study requirements
correlation between melatonin levels in different biological fluids

Conditions: Neurodegenerative Diseases

Summary: the goal of this observational study is to evaluate and to correlate melatonin levels in plasma, saliva and cerebrospinal fluid (csf) samples of patients undergoing lumbar puncture diagnostic for specific neurological diseases.


Eligibility criteria:
inclusion criteria: * neurodegenerative disease exclusion criteria: * age \< 18 years * pregnancy * coagulations disorders * anticoagulant therapy
uemr for medium-sized pedunculated colon polyps

Conditions: Colon Polyp

Summary: underwater emr (uemr) is an emerging technique for endoscopic resection. the purpose of this research is to observ wether the uemr for medium-sized pedunculated polyps is safe and effective.


Eligibility criteria:
inclusion criteria: patients age between 18-75 years old with pedunculated colonic polyps (measuring between 10 and 20mm), who willing to participate in this study. exclusion criteria: 1. pregnancy, 2. inflammatory bowel disease, 3. familial polyposis 4. the use of anticoagulant therapy or antiplatelet therapy 5. the absence of informed patient consent. 6. polyps showing signs of deep submucosal invasion
fiber tolerability in children aged 3-7 year

Conditions: Signs and Symptoms, Digestive

Summary: determination of the digestive tolerability of the promitor® in children from 3 to 7 years old.

the aim of the trial is to determine, using a dose escalation design, the digestive tolerability of the promitor®given at the doses of 6, then 9 and finally 12 g (corresponding to 4, 6, and 8 g of fibers respectively) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fiber) over one week of intake in children from 3 to 7 years old. as it is an exploratory study there is no categorization between primary and secondary objectives.

Eligibility criteria:
inclusion criteria: 1. healthy children 2. aged between 3 and 7 years old 3. acceptance of the taste of the product 4. having breakfast on daily basis 5. consent and/or assent received according to regulation 6. informed consent of both parents/guardians (in respect with the french regulation) 7. parents/guardians affiliated to a health insurance (in respect with the french regulation) exclusion criteria: 1. specific food regimen 2. intolerability or food allergy 3. antibiotic or any medication impacting the gut transit during the 2 weeks before the study 4. chronic gastrointestinal disease 5. gastroenteritis in the 2 weeks preceding the study 6. constipation or diarrhea based on romeiii criteria (in average: more than 3 stools per day or less than 3 stools per week) 7. children and parents expected not to understand and perform the trial correctly (i.e.: troubles in learning and/or speaking) 8. child in a situation which, in the opinion of the principal investigator, could interfere with the optimal participation to the study or constitute a particular risk of non-compliance 9. having participated in another clinical trial for 1 month, or currently participating in a clinical trial 10. under legal protection or deprived from his rights following administrative or judicial decision (in respect with the french regulation)

Keywords: fiber tolerability children