Kornimate/medical-research-clean huggingface dataset:
trial of multidisciplinary team stress and performance in immersive simulation for management of infant in shock

Conditions: Stress

Summary: the objective of this randomized trial is to study the effect of stress on performance and the effect of repetition of simulation sessions on performance and stress. this study is a randomized controlled trial including 48 participants who composed 12 multidisciplinary teams (mdts). each mdt was made up of 4 persons: an emergency physician, a resident, a nurse, and an ambulance driver who usually compose an emergency team of the french emergency medical service (ems). 6 mdts underwent 9 simulation sessions over 1 year (repetitive sim group). 6 mdts underwent 3 simulation sessions over 1 year (control group). evidence of the existence of stress was assessed in 3 ways: salivary cortisol, holter parameters, and psychological stress questionnaires. the impact of stress on overall team performance, on technical procedure, and on teamwork, is evaluated by specific validated scales. detection of post-traumatic stress (ptsd) is performed by self-evaluation on the 7th day and after one month. the perspective is to concomitantly evaluate technical and non-technical performance, and the impact of stress on both. this is the first randomized trial studying repetition of simulation sessions and its impact on both clinical performance and stress as explored by objective and subjective assessments. the investigators expect that stress decreases team performance and that repeated simulation increases team performance. the investigators expect no variation of stress parameters regardless of level of performance.


Eligibility criteria:
inclusion criteria: * multidisciplinary team made up of 4 persons: 1. an emergency physician with less than seven years of experience , 2. a resident, 3. a nurse, 4. and an ambulance driver. exclusion criteria: * past history and/or psychiatric disease that modifies stress response, * pacemaker or implantable defibrillator, * treatment with a medication having a potential effect on stress parameters.
safety, tolerability and efficacy of acz885 on leg artery structure in patients with peripheral artery disease

Conditions: Peripheral Artery Disease

Summary: this study was designed to assess the safety, tolerability and efficacy of acz885 on the leg artery structure and physical activity in patients with atherosclerotic peripheral artery disease and leg pain from walking.


Eligibility criteria:
key inclusion criteria: * must have a signed informed consent form. * must be between the ages of 18 and 85 * must experience leg pain associated with walking and have an ankle brachial index between 0.40 and 0.9 * must be on stable aspirin and statin doses for at least 6 weeks * blood pressure within ranges specified in the protocol * able to communicate well with the investigator and understand and comply with the study procedures key exclusion criteria: * recent use of any other experimental drugs * pregnant or nursing women * women of child bearing potential unless willing to use contraception as detailed in the protocol * cannot walk 15 meters (50 feet) * people on restricted medications as listed in the protocol * any open or non-healing wounds with 3 months of study start or infection within 2 weeks or study start * significant heart disease * uncontrolled diabetes * significant kidney or liver disease * live vaccinations within 3 months of study start * history of untreated tuberculosis or active tuberculosis (tb) * patients with metal in their body (excluded due to mri scan) as detailed in the protocol.

Keywords: peripheral artery disease intermittent claudication magnetic resonance imaging
patient-ventilator interactions in long term non-invasive ventilation: influence of back-up frequency

Conditions: Obesity; Non Invasive Ventilation

Summary: in patients under bi-level pressure support ventilation for obesity hypoventilation syndrome, this study aims to determine if it is better, in terms of efficacy and patient-ventilator synchronisation to use * spontaneous mode (s) * spontaneous/timed mode (st) with an intermediate back-up rate, slightly below the respiratory rate of the patient * timed mode (t), with a ventilator respiratory rate above that of the patient. this issue has to our knowledge only been marginally studied without any consensus.

eligibility: patients under home bi-level pressure support ventilation for obesity hypoventilation in a stable clinical condition, aged over 18 methods: three consecutive sleep studies in a randomised sequence with usual parameters inspiratory positive airway pressure(ipap), expiratory positive airway pressure (epap) and change of only back up respiratory rate (rr): one night in a spontaneous mode, one with an intermediate rr, and one with a rr above that of the patient endpoints: quality of sleep and sleep structure (polysomnography), patient-ventilator synchronisation and respiratory events under niv, efficacy of ventilation: oxygen saturation measured by pulse oxymetry (sao2); transcutaneous capnography (ptcco2), and comfort.

Eligibility criteria:
inclusion criteria: * obesity-hypoventilation (ohs) patients, in stable clinical condition, treated with domiciliary nocturnal non invasive ventilation for at least two months exclusion criteria: * ohs patients: unstable cardio-respiratory status and/or acute cardio-respiratory failure three months before inclusion.
cadonilimab in locally advanced msi-h/dmmr colorectal cancer

Conditions: dMMR Colorectal Cancer

Summary: this is a two-arm phase ii clinical study to evaluate the efficacy and safety of cadonilimab (a pd-1/ctla-4 bispecific antibody) in msi-h/dmmr locally advanced colorectal cancer as the regimen of neoadjuvant treatment. eligible patients will receive cadonilimab monotherapy for eight cycles before surgery and part of patients may exempt from surgery.


Eligibility criteria:
inclusion criteria: * arm 1: histologically or pathologically confirmed colon adenocarcinoma with a stage of t3-4 or n+ according to the ct or endoscope; arm 2: histologically or pathologically confirmed rectal adenocarcinoma located within 12cm from the anus with a stage of t2-4 or n+ according to the ct or endoscope * sign the informed consent form * 18 years and older * mismatch repair deficient determined by immunohistochemistry or microsatellite instable by pcr * no prior treatment * performance status: ecog 0-1 * good organ function: blood routine: hemoglobin ≥90g/l, neutrophil ≥1.5×10\^9/l, platelet ≥80×10\^9/l; renal function: creatinine≤1.5×upper limit of normal (unl) or creatinine clearance ≥50ml/min; liver function: total bilirubin (tbil)≤1.5×upper limit of normal (unl); alt≤2.5×unl, ast≤2.5×unl; ejection fraction at least 50% (or lower limit of normal) by echocardiogram exclusion criteria: * other pathological category, such as squamous cancer * distant metastasis or peritoneum implantation * have received chemotherapy or radiotherapy in the past * known to have allergic reactions to any ingredients or excipients of experimental drugs * other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment * have received colorectal cancer surgery * diabetes was not controlled, defined as hba1c \> 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure \> 140 / 90 mmhg after antihypertensive drug * myocardial infarction, severe/unstable angina, new york heart association (nyha) class iii or iv congestive heart failure in the past 12 months * known to be infected with human immunodeficiency virus (hiv), have acquired immunodeficiency syndrome (aids) related diseases, have active hepatitis b or hepatitis c * pregnant or nursing * may increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results * there are other serious diseases that the researchers believe patients cannot be included in the study
efficacy and safety of oral famciclovir in patients with active recurrent genital herpes

Conditions: Recurrent Genital Herpes

Summary: this is a phase iii, multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of a two-day treatment with famciclovir (500 mg loading dose followed by 250 mg 12-hourly) to standard five-day treatment with famciclovir (125 mg 12-hourly) in patients with active recurrent genital herpes. this study is not recruiting patients in the united states.


Eligibility criteria:
inclusion criteria: * diagnosis of genital herpes * had at least 2 recurrences in past 12 months or 1 recurrence in past 6 months exclusion criteria: * - currently taking suppressive herpes antiviral therapy * females who are pregnant, breast feeding or planning to become pregnant during study * history of allergy to famciclovir or similar products (e.g. aciclovir, valaciclovir) other protocol-defined exclusion criteria may apply.

Keywords: genital herpes herpes famciclovir
phase ii study of kw-0761 in subjects with ccr4-positive adult t-cell leukemia-lymphoma

Conditions: Adult T-cell Leukemia-lymphoma

Summary: to evaluate the efficacy, safety and pharmacokinetic profiles of kw-0761, the anti-cc chemokine receptor 4 (ccr4) antibody, when administered weekly for 8 weeks as an intravenous infusion at a dose of 1.0 mg/kg in relapsed subjects with ccr4-positive adult t-cell leukemia-lymphoma.


Eligibility criteria:
inclusion criteria: 1. positive for serum anti-htlv-i antibody 2. acute-, lymphoma-, or chronic-type with poor prognostic factors specified in the past 3. positive for ccr4 4. relapsed subject after the response (cr, cru or pr) in the last previous chemotherapy 5. received at least one prior chemotherapy 6. subjects with an interval of four weeks or more between the last day of the previous treatment and the scheduled day of the first kw-0761 treatment 7. ps of 0 to 2 8. negative for hbs antigen and for hbv-dna by a real-time pcr exclusion criteria: 1. a history of transplantation such as hematopoietic stem cells 2. positive for hcv antibody or hiv antibody 3. active multiple cancers at the time of starting this clinical study 4. previous history of allergic reactions after receiving antibody products 5. requiring continuous systemic treatment with a steroid 6. requiring such radiotherapy after starting this clinical study 7. treated with any investigational drug other than kw-0761 within three months
study evaluating safety of patients switching to refacto af in usual care settings

Conditions: Hemophilia A

Summary: the study will be investigating safety in patients who switch to refacto af from refacto and other factor viii products.

the trial was terminated prematurely on 28 march 2013, due to the inability to recruit the planned number of subjects. the decision to terminate the trial was not based on any safety or efficacy concerns and agreement to close the study in march 2013 was agreed with ema prior to closure activity.

Eligibility criteria:
inclusion criteria: * male patients greater than or equal to 12 years of age with severe hemophilia a (fviii:c less than 1%). * treatment history of greater than 150 eds to prior recombinant or plasma-derived fviii replacement products. * transitioning to refacto af from refacto or other recombinant or plasma-derived fviii replacement products. * serum albumin greater than or equal to the lower limit of normal (lln). * platelet count greater than or equal to 100,000/µl. * prothrombin time (pt) less than or equal to1.25 × uln, or international normalized ratio (inr) less than or equal to 1.5. * hiv positive subjects must have a cd4 count greater than 200/µl and hiv viral load less than 200 particles/µl. exclusion criteria: * presence of any bleeding disorder in addition to hemophilia a. * a positive fviii inhibitor, according to the local laboratory, at screening; or any bethesda inhibitor titer greater than 0.6, regardless of the normal range for the testing laboratory. * treated with immunomodulatory therapy (including immune tolerance induction \[iti\]) during the screening period. * prior exposure to moroctocog alfa (af-cc). * known hypersensitivity to hamster protein.

Keywords: hemophilia a
the effects of cool dialysate on the sleep/wake cycle in patients on chronic hemodialysis - "the sleep cool study"

Conditions: End-stage Renal Disease

Summary: a major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is already in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. we will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes.

preliminary results demonstrate that, after one treatment, using cool dialysate instead of warm dialysate markedly normalized the rhythm of body temperature and improved indices on nocturnal sleep quantity and quality. therefore, a major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is alreay in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. we will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes. to test the efficacy of this intervention, a randomized, single-blinded, pretest-posttest, control group design is being used. the major independent variable is dialysate temperature. the major dependent variables are measures of sleep, body temperature, rest/activity patterns, and general health outcomes.

Eligibility criteria:
inclusion criteria: * all races, cause of renal failure is diabetes, hypertension, glomerulonephritis, or polycystic kidney disease; ability to read and write in english; clinically stable. exclusion criteria: * current use of sleeping medication; history of alcoholism or drug abuse; brain disease; severe hypertension; severe heart disease; low functional level

Keywords: sleep renal failure dialysis
safety, tolerability, pharmacodynamics and pharmacokinetics of jy09

Conditions: Diabetes Mellitus, Type 2

Summary: jy09 is a glucagon-like peptide-1 (glp-1) mimetic generated by genetic fusion of a exendin-4 dimer to human immunoglobulin fc. in this double-blind, randomized, placebo-controlled trial, 41 healthy subjects received placebo or escalating doses of jy09 on day 1 in the first cohort, and on days 1 and 22 in the following sequential cohort 2-4, and on days 1, 15, and 30 in the cohort 5: cohort 1: 0.3 mg; cohort 2: 0.3 + 0.7 mg; cohort 3: 0.7+1.5 mg; cohort 4: 0.7+3.0 mg; and cohort 5: 0.7 + 1.5 + 6.0 mg. the primary endpoints were the incidence of adverse events and serious adverse events related to jy09. secondary endpoints included pharmacodynamics and pharmacokinetics parameters, as well as anti-jy09 antibody incidence and titers.


Eligibility criteria:
inclusion criteria: * healthy subjects * male's mass is ≥50 kg, female's mass is ≥45 kg, have a body mass index between 18 and 26 kg/m\^2 * subjects or their legal representative signed informed consent * agree to use instruments of contraception from the time of the first dose until 6 months after the last dose of investigational drug, avoid pregnancy make yourself or your mate * able to keep good communication with investigator and comply with the requirements of the clinical trials exclusion criteria: * smokers,quitting time less than 3 months , or can't quit smoking during the trial * use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing,or being treated for a direct lower gastrointestinal or using steroids * participation in any clinical investigation within 3 months prior to dosing * donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing * significant illness within 2 weeks prior to dosing,and investigator judge doesn't fit to participate in this trial * a history of clinical significance of abnormal ecg * a history of diabetes, hyperuricemia and hyperlipidemia * a history of acute or chronic bronchial spasms * have clinical significant gastrointestinal diseases * have serious, progressive, or uncontrolled organ or system diseases * abuse of drug or alcohol within 12 months before first dosing * people who are pregnant, nursing mothers, or in the near future plan to be pregnant,or show pregnancy test positive before into group * subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study
analysis of balance and mobility for parkinson disease after whole body vibration

Conditions: Parkinson Disease

Summary: parkinson's disease has innumerous motor symptoms that impacting on the functional level of the patient, such as impairment in functional mobility and balance . previous studies have already aimed to evaluate the effectiveness of whole body vibration, but without methodological criteria. the use of whole body vibration may be an alternative for the treatment of parkinson's disease. therefore, the objective of the study is to verify which frequency of vibration is able to improve the balance and mobility of patients with parkinson's disease.

after confirming the eligibility criteria, patients will be asked to sign the informed consent form. subsequently, they will be randomly allocated to three groups: (i) group 6 hz: full body vibration (frequency 6 hz, amplitude 4 mm, five cycles lasting 1 minutes and interval between cycles of 1 minute) , (ii) 25 hz group: full body vibration (25 hz frequency, 4 mm amplitude, five cycles lasting 1 minute and interval between 1 minute cycles) and (iii) sham group: the sham vibration will be performed with the platform disconnected. additionally, a sound device will be connected producing a noise similar to that of the connected platform for a time equivalent to that of the treatment protocol. the patient will be instructed to position himself standing on the platform, with a semi knee flexion in order that the vibration wave does not propagate to the head. the allocation will be made randomly among individuals, using a random sequence table generated by the website www.randomization.com. there will be a washout time of at least one week between one intervention and another. all evaluations took place inside the laboratory, which has all the equipment for the evaluation. the evaluations will take place immediately before the intervention and immediately after.

Eligibility criteria:
inclusion criteria: * · minimum score of the montreal cognitive assessment (moca) (27 points); * regular antiparkinsonian pharmacological treatment; * staged from i to iii on the modified hoehn \& yahr scale. exclusion criteria: * · individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests; * other associated neurological disease * changes in medication in use for parkinson's disease for at least sixty days before the start of the study

Keywords: parkinson disease balance function mobility whole body vibration
metastatic or refractory soft tissue sarcomas and metronomic cyclophosphamide: further assessment of efficacy and safety

Conditions: Sarcoma; Soft Tissue Sarcoma

Summary: metronomic cyclophosphamide's use in monotherapy as a palliative treatment against non-resectable and metastatic soft tissue sarcomas relies on small retrospective cohorts' data. current litterature needs external validation of its efficacy and safety profile in these settings of usually frail patients. the investigators assessed further data and aimed to identify predictive factors of metronomic cyclophosphamide impact in metastatic soft tissue sarcomas.


Eligibility criteria:
inclusion criteria: * patients over 18 * with inoperable or metastatic soft tissue sarcoma * treated with metronomic cyclophosphamide * in 3 cancer care institutions located in 2 french regions (bourgogne and franche-comté) * between january 2005 and december 2021 exclusion criteria: * patients with bone, chondral sarcomas, desmoid, or gastrointestinal stromal tumors

Keywords: cyclophosphamide administration, metronomic
safety and efficacy study of rhangiostatin administered in combination with paclitaxel and carboplatin to patients with non-small-cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to determine the safety and efficacy of rhangiostatin protein administered in combination with paclitaxel and carboplatin to patients with non-small-cell lung cancer.


Eligibility criteria:
inclusion: * histological or cytological confirmed stage iiib nsclc with malignant pleural effusions, or stage iv nsclc or recurrent nsclc * no previous chemotherapy for nsclc * have one lesion that is bidimensionally measurable by physical exam, mri, or ct greater than 1 cm in diameter * specified lab parameters * life expectancy of at least 12 weeks * ecog performance status of 0 or 1 * understand requirements of study * agree to use effective contraceptive methods exclusion: * have cns metastases * have any active cancer in addition ot nsclc * participated in clinical trial involving conventional or investigational drugs within previous 4 weeks * have any contraindication to paclitaxel or carboplatin * have had grade 3 or greater peripheral neuropathies * be pregnant or lactating * have a history of myocardial infarction or angina pectoris/angina in the last 6 months * have had significant (30 ml or more) hemoptysis with the past 3 months * have an active infection * have a history of bleeding diathesis, hypercoagulable condition, or an active bleeding disorder * be receiving concurrent treatment with therapeutic doses of heparin or coumadin * have had major surgery within 4 weeks of stating therapy * have additional uncontrolled serious medical conditions or psychiatric illness * received rhangiostatin in other clinical protocols

Keywords: advanced non-small cell lung cancer