Kornimate/medical-research-clean huggingface dataset:
impact of infectious diseases specialists on the appropriateness of antimicrobial therapy in surgical and medical wards

Conditions: Patients Receiving Antimicrobial Therapy

Summary: context: antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. the intervention of infectious disease specialists (ids) could improve the appropriateness of prescriptions and reduce their use. the impact of ids has not been yet fully estimated using a randomized trial to compare the quality of care of patients who will benefit of the intervention. objectives: to show using a randomized trial that patients with ids advice will receive more appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients who will not receive ids advice. methods: prospective randomized trial comparing antibiotic exposure and appropriateness of prescriptions in two groups of patients: * control group: antibiotic prescriptions will be initiated and managed by the attending physicians * intervention group: antibiotic prescriptions will be systematically evaluated by the ids and changed if judged necessary by the attending physicians, following ids' advice. study process: the study will took place in 4 university hospitals. two medical or surgical wards will participate by hospital. for each ward, the period of the study will be 2 x 4 weeks.total duration of the study: 12 months.


Eligibility criteria:
inclusion criteria: * adults * hospitalized in surgical or medical wards * receiving antimicrobial therapy for active infection or prolonged surgical prophylaxis * therapy prescribed by the attending ward physician exclusion criteria: * patients receiving antimicrobial therapy not prescribed by the attending ward physician

Keywords: surgical and medical wards adults antimicrobial therapy
a comparison of the effect of warm and cold water exercise training on vascular function in type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: warm water based cycling exercise training would more favorable than cold water based cycling exercise training and land based cycling exercise in vascular function in type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * the inclusion criteria included type 2 diabetes (as defined by the american diabetes association), a baseline glycosylated hemoglobin (hba1c) value of 7-9%, and no previous exercise training in the past 6 months. all participants were free from diabetic nephropathy, diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases. exclusion criteria: * participants were excluded if they dropped out or completed less than 80% of the training schedule.

Keywords: type 2 diabetes vascular function water exercise warm water cold water
a study to evaluate the pharmacokinetics, pharmacodynamics and safety of canagliflozin in older children and adolescents with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate the pharmacokinetics (blood levels) and pharmacodynamics (the action or effects a drug has on the body) of canagliflozin in children and adolescents with type 2 diabetes mellitus aged 10 to 17 years (inclusive). other purposes are to investigate safety and assess the ease of swallowing the tablets.

the participants who meet the eligibility criteria, will receive a single dose of placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) and this will be followed by baseline 24 hour pharmacodynamic assessments. on the next morning participants will receive the first canagliflozin dose and will be discharged home to continue canagliflozin treatment for 13 additional days. there will be 2 treatment groups (8 participants in each): the first group will receive canagliflozin 100 mg daily, the second group will receive either canagliflozin 300 mg or canagliflozin 50 mg daily. the canagliflozin dose for the second treatment group will be determined after the sponsor has evaluated the results from the first 5 participants. on day 14 of treatment the participants will be admitted again for 24 hour pharmacokinetic and pharmacodynamics assessments. the participants will continue to take their normal dose and schedule of metformin during the entire study. the total duration of the study is approximately 50 days.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes mellitus * be on a stable regimen of metformin immediate release (ir) monotherapy of at least 1,000 mg/day for at least 8 weeks before screening * able to swallow whole tablets * absence of pancreatic autoimmunity * participants and their caregivers must agree to perform the fasting fingerstick glucose self-monitoring during the study exclusion criteria: * history of type 1 diabetes mellitus * history of maturity onset diabetes of the young (mody) and any secondary form of diabetes * current clinically significant medical illness e.g., significant pulmonary disease, renal or hepatic insufficiency, uncontrolled thyroid disease * systolic or diastolic blood pressure outside the range considered normal for the participant sex, age and height * for females, participants will be excluded if pregnant

Keywords: diabetes mellitus, type 2 canagliflozin jnj-28431754 pharmacokinetics pharmacodynamics children adolescents
safety and efficacy study of mix vaccine in prostate carcinoma patient

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (mv). enrolled patients will receive standard treatment according to national comprehensive cancer network (nccn) guide line with or without combining mv injection. the efficacy and side effect will be compared between the two groups.

in the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. in the control arm patients will be receiving standard therapy according to national comprehensive cancer network (nccn) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (mv). mv will be injected weekly till disease progression. blood sample will be obtained at baseline and every week before mv injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). patients will be evaluated for toxicity throughout the study. side effect, progression free survival, immunology index and general status will be recorded.

Eligibility criteria:
inclusion criteria: * patients diagnosed with prostate carcinoma based on histology * evaluable lesions on imaging study * without known immunodeficiency * age \>18 and \<80 years ago exclusion criteria: * patients is unable or unwilling to sign informed consent * any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication * positive hiv and/or rpr (rapid plasma reagin) * female patient who is pregnant or breast feeding * patients, based on the opinion pf the investigator, should not be enrolled into this study * prior anti-cancer vaccine or biological immunotherapy * allergic to any known ingredient of the mv compound

Keywords: mix vaccine, prostate carcinoma, immunotherapy
peg-rhg-csf in secondary prevention of nab-paclitaxel combined with s-1 in advanced pancreatic cancer

Conditions: PEG-rhG-CSF; Pancreatic Cancer

Summary: a prospective, open, single-arm clinical study to evaluate the efficacy and safety of jinyouli（peg-rhg-csf） in the first-line treatment of advanced pancreatic cancer with nab-paclitaxel combined with s-1.chemotherapy regimen: (1) chemotherapy: nab-paclitaxel, 260mg/m2, intravenous infusion for 30 minutes, d1, q3w. s-1, 80-120mg, po bid, d1-14, q3w. (2) patients who met the eligibility criteria were given jinyouli injections 24 hours after the end of intravenous infusion of nab-paclitaxel during the treatment period.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years, ≤70 years; * patients with advanced pancreatic cancer diagnosed by histopathology，the expected survival time is more than 3 months; * neutropenia of ≥2 degree occurred with the nab-paclitaxel + s-1 regimen in the previous cycle. * kps score≥70; * the peripheral blood routine of the patients was normal: anc ≥ 2.0x10\^9/l, platelet count ≥ 90x10\^9/l, hb ≥ 80g/l before enrollment, and there was no bleeding tendency; * patients volunteered to participate in the trial, signed a written informed consent, willing to be followed up. exclusion criteria: * there are uncontrollable infections at the moment or systemic antibiotic treatment within 72 h of chemotherapy； * any abnormal bone marrow hyperplasia and other abnormal hematopoietic function； * patients who had received bone marrow or hematopoietic stem cell transplantation within 3 months； * patients with other malignancies that have not been cured or with brain metastases； * total bilirubin(tbil), alanine aminotransferase (alt) and aspartate aminotransferase (ast) \>2.5 uln, or \>5 uln if there is liver metastasis; * serum creatinine (cr) exceeded the upper limit of normal value； * allergic to this product or other biological products derived from genetically engineered escherichia coli； * suffering from a mental or nervous system disorder, without self-awareness or coordination； * patients expected to have a short survival or have difficulty tolerating chemotherapy； * pregnant or lactating female patients； * patients using other drugs of the same category or in clinical trials of other drugs； * not suitable for participation at investigators' discretion.

Keywords: peg-rhg-csf secondary prevention pancreatic cancer
new markers of cystic fibrosis transmembrane conductance regulator (cftr) function in sweat

Conditions: Cystic Fibrosis; Biomarkers

Summary: the aim of the study is to identify new biomarkers of cftr function in sweat and in sweat gland.

sweat is a watery solution containing trace amounts of proteins and peptides that may contribute to the antimicrobial defense system of the skin barrier, playing a role in innate immune responses against potential pathogens. the peptide and metabolite composition of sweat has not been fully explored. evidence suggests that the composition of the skin barrier could vary with diseases. the causes and consequences of the changes of sweat proteins and peptides in humans are unknown. this clinical trial will focus on multiomics analysis of sweat, mainly of the antimicrobial peptides that play a key role in the host-pathogen interaction. antioxidants, anti-bacterial and anti-inflammatory compounds may contribute to the regulation of systemic inflammation and pathophysiological disorders. in cystic fibrosis, inflammatory responses are altered, exaggerated and persistent, even in the absence of infection. it is therefore relevant to study the influence of cftr mutations on the profile of antimicrobial peptides expressed in sweat. the clinical study will potentially lead to the discovery of novel non-invasive biomarkers of the disease in sweat.

Eligibility criteria:
inclusion criteria: * subject aged of 18 years or more. * the patients with cystic fibrosis must have a confirmed diagnosis, be clinically stable, have a forced expiratory volume in one second (fev1) ≥ 30 and an o2 saturation ≥ 92%. f508del homozygous will been tested. * heterozygosity (parents of patients) will be confirmed by the presence of a single f508del mutation. exclusion criteria: * presence of an acute infection * pregnancy and lactation * subjects currently included in another clinical trial * subjects with forearm skin alterations * subjects with signs of dehydration * smokers

Keywords: cystic fibrosis sweat sweat glands omics analysis
transcutaneous spinal cord stimulation for chronic low back pain

Conditions: Chronic Low-back Pain

Summary: as a leading cause of disability worldwide, chronic low back pain (clbp) represents a significant medical and socioeconomic problem with estimated health care spending of $87 billion/annually. the efficacy of dorsal column electrical stimulation to inhibit pain was first described over 50 years ago. since then, several large clinical trials have investigated the therapeutic potential of electrical spinal cord stimulation (scs) and found that over 70% of patients with intractable pain had over 50% pain relief after 1 year of treatment. thus, scs is a promising therapeutic intervention that has superior patient outcomes when compared to traditional modalities for the treatment of clbp. to date, scs for treatment of clbp has been delivered via epidural electrodes, requiring neurosurgical implantation. although, the implantable stimulators have a low rate of adverse events, secondary complications associated with surgical intervention still occur.transcutaneous spinal cord stimulation (tscs) is a rapidly developing non invasive neuromodulation technique in the field of spinal cord injury. its application potentiates lumbosacral spinal cord excitability enabling motor functions, (e.g. independent standing, postural control) in patients with chronic complete motor paralysis. given that epidural and transcutaneous scs activate similar neuronal networks, tscs for clbp treatment may be advantageous due to its non-invasive nature which may also allow for a mass market production and rapid patient availability if tscs is proven efficacious. in this pilot study we will establish the feasibility of tscs to acutely improve patient reported outcomes (pain scores) and several objective measures, including sit-to-stand biomechanics, neurophysiological and neuroimaging outcomes.


Eligibility criteria:
inclusion criteria: * low back pain * able to get in and out of chair unassisted * no changes in medication within 2 weeks of study enrollment * stable dose of their medications within 2 weeks of study enrollment exclusion criteria: * body mass index (bmi) \> 28 * hardware in the spine from prior surgeries * presence of epidural stimulation leads * presence of any additional neuromuscular pain unrelated to spinal condition * intolerance to any form of electrical stimulation, such as neuromuscular stimulation in the past * lack of perceived endurance to go through multiple experimental assessments in one day/complete the study which may take up to 3 hours * changes in medications within 2 weeks of study enrollment * moderate/severe depression (beck depression inventory score \> 20)

Keywords: non-invasive, spinal cord stimulation, neuromodulation
effect of passive gait training on the cortical activity in patients with severe brain injury.

Conditions: Craniocerebral Trauma; Traumatic Brain Injury; Subarachnoid Hemorrhage; Anoxic Brain Injury

Summary: the aim of this study is to determine effect of proprioceptive stimulation with passive gait training on the cortical activity in patients with severe brain injury, demonstrated as changes in eeg (electroencephalogram)and erp (event related potentials). hypotheses: 1) proprioceptive stimulation increases eeg-frequency in patients with impaired consciousness due to severe brain injury. 2) proprioceptive stimulation increases conductivity speed of the cognitive p300-component of erp in patients with impaired consciousness due to severe brain injury.

design: prospective controlled non-randomized study. materials and methods: 45 patients with severe brain injury and 15 healthy volunteers will be included in this study. the study design is illustrated below: 1. baseline measurement of electroencephalography (eeg) and event related potentials (erp) 2. gait training in the tilt table with integrated stepping system(20 min). 3. control measurement of eeg and erp effect parameters: se outcome measures. statistical evaluation: all collected data will be tested with reference to normal distribution. if the data is not distributed normally, then we will use either a logarithmic transformation before we use parametric statistics, or we will use non-parametric statistics for further calculations. further analysis of the data will be done with the help of variance analysis with an inter-individually factor as a group (patients vs control persons) and intra-individually factors as: 1) experimental condition (before vs after training), 2) topographic distribution (anterior vs central vs posterior). significance level is set to 0.05 for all effect parameters.

Eligibility criteria:
inclusion criteria: patient goup: 1. severe brain injury 2. ongoing impaired state of consciousness (rlas\<4) 3. stable vital functions 4. written consent from relatives/legal guardian control group: 1. no history of neurological diseases in the past 2. age over 18 years 3. written consent - exclusion criteria: patient and control goup: 1. age older than 80 years 2. other neurological diseases 3. lack of baep 4. severe co-morbidity 5. pregnancy 6. tilt table contraindications: orthostatic circulatory problems, unstable fractures, severe osteoporosis, sken problems, joint problems, severe asymmetry (major difference in leg length over 2 cm), co-operation problems (psychotic illnesses or neurotic disturbances), adjustment problems (i.e. integrated stepping system cannot be safely adjusted to the patient)

Keywords: severe traumatic brain injury subarachnoid hemorrhage anoxic brain injury passive gait training tilt table with integrated stepping system electroencephalogram event related potentials
oral state of patients affected by an oral cancer before and after radiotherapy - 3-years prospective study

Conditions: Oral Cancer

Summary: context: the oral cancer is the 5th cancer in order of frequency for human in france. it is the country where the mortality by oral cancer is the most raised in europe. the most frequent location concerns the oral cavity prevalency of which is one of higher in the world. the main risk factors are the tobacco and the alcohol. the oral cancer is treated in the great majority of the cases by radiotherapy which is going to pull xerostomy, responsible for the degradation of the oral state. furthermore, it will increase the risk of appearance of osteoradionecrosis (orn) when the patient is carrier of buccal lesions and\\or when he will have to undergo surgical acts. consequently, the initial oral state of the patients is to be estimated so as to eliminate any source of the infection. an unfavourable initial state will increase the risk of degradation of this one and appearance of orn. however, at present few epidemiological data are available concerning the oral state of the patients presenting an oral cancer. objective: the main objective of this study is to describe, before radiotherapy, the oral state of the patients presenting an oral cancer and to follow the evolution of this oral state for three years and to register the patients quality of life. the secondary objectives are to describe the distribution of risk factors of the degradation of the oral state (oral hygiene, food habits, xerostomy, consumption of tobacco and alcohol) in this population and to register the impact of the dental restorations on the radiological assessment. methods: this prospective epidemiological study of observation will be realized in the service of odontology of the timone hospital (marseille, france) in association with the services of orl and maxillofacial surgery of timone as well as the services of radiotherapy and medical oncology of timone and paoli calmettes institute (ipc). all the toothed patients affected by an oral cancer untreated will be included, or treated surgically only, of more than 18 years old and for whom an initial dental assessment will be realized. the main assessment criteria will be the cad index and the parodontal state. expected results and perspectives: this study will allow to have epidemiological data concerning patients' oral state affected by an oral cancer before and after radiotherapy. it will allow to set up a consensus of good practice.


Eligibility criteria:
inclusion criteria: * patient with a first oral cancer * patient with teeth * patient not yet treated for the oral cancer exclusion criteria: * patient with a cancer already treated or with an oral cancer ongoing treatment. * patient without teeth * patient with trouble for comprehention and without capabilities for brushing teeth
vadastuximab talirine (sgn-cd33a; 33a) combined with azacitidine or decitabine in older patients with newly diagnosed acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study in aml patients is to test whether vadastuximab talirine (sgn-cd33a; 33a) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.

hypomethylating agents (hmas), such as decitabine or azacitidine, are considered a standard treatment for older patients with aml. the primary goals of this study are to test whether patients treated with an hma (either decitabine or azacitidine) in combination with 33a will have better anti-tumor activity and/or survive longer than patients treated with an hma in combination with placebo. patients who meet eligibility criteria will be randomly assigned to one of two treatment groups: 1) 33a plus hma (experimental arm); or 2) placebo plus hma (comparator arm). in addition to evaluating survival and remission rates, the minimal residual disease (mrd)-negative remission rate, duration of remission, event free- and leukemia-free survival, and safety and tolerability will be compared between arms.

Eligibility criteria:
inclusion criteria: * newly diagnosed, previously untreated, cytologically/histologically confirmed de novo or secondary aml according to world health organization (who) classification (except for acute promyelocytic leukemia (apl)) * intermediate or adverse cytogenetic risk * eligible for therapy with either decitabine or azacitidine * acceptable hematologic and organ function exclusion criteria: * aml associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or t(15;17) * patients who are candidates for allogeneic stem cell transplant at the time of enrollment * patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis * received prior treatment with hma or chemotherapy for antecedent myelodysplastic syndrome (mds)

Keywords: antibodies, monoclonal antibody drug conjugate antigens, cluster of differentiation 33 (cd33) drug therapy immunotherapy