Kornimate/medical-research-clean huggingface dataset:
effect of early extracorporeal diaphragm pacing combined with tilt table in ventilated patients.

Conditions: Early Mobilization; Critically Ill; Mechanical Ventilation; Diaphragm Dysfunction

Summary: the aim of this study is to test the effect of 1week of extracorporeal diaphragm pacing (edp) combined either with or without tilt table verticalization (ttv) on diaphragm function in patients with mechanical ventilation compared to conventional physiotherapy (cpt).

in order to explore whether extracorporeal diaphragm pacing (edp) combined with tilt table verticalization (ttv) improves diaphragm function in mechanically ventilated patients, the investigators conducted a three-arms randomized controlled trial of 90 ventilated patients in the icu of a general hospital in the southern china state of guangzhou. after assessment of inclusion and exclusion criteria, patients were randomly assigned to one of the following three groups: (1) edp with ttv and with conventional physiotherapy (cpt) (n = 30), (2) edp without ttv and with cpt (n = 30), and (3) conventional physiotherapy (cpt; n = 30).

Eligibility criteria:
inclusion criteria: * duration of mechanical ventilation prior to enrollment≤ 72 hours. * expected duration of mechanical ventilation≥72 hours. * participants (or their legal representatives) have signed informed consent. exclusion criteria: * pregnancy or breast-feeding. * prone ventilation or current extracorporeal membrane oxygenation. * hemodynamic instability: mean arterial pressure is less than 65 millimeters of mercury (mmhg) or higher than 85 millimeters of mercury (mmhg), heart rate \> 150 beats / minute, intravenous use of larger doses of vasopressors (such as dopamine \> 10 mg/ (kg· min) or norepinephrine/epinephrine \>0.1 mg/ (kg· min)) or aortic balloon counter pulsation; respiratory rate\< 5 breaths per minute; oxygen saturation\< 88%. * new-onset myocardial ischemia. * unstable cervical spine fracture and spinal cord injury. * deterioration of neurological function, requiring intracranial pressure monitoring and ventricular drainage, or active control of intracranial hypertension. * current neuromuscular block treatment or pre-existing neuromuscular disease or neuromuscular junction disease affecting respiratory muscle (such as myasthenia gravis, guillain-barré syndrome, etc.). * there are contraindications to diaphragmatic pacing (local skin, tissue incompleteness or infection, chest x-ray examination shows pneumothorax or pleural effusion accounting for 1/3 of bilateral chest cavity). * body mass index (bmi) ⩾40 kg/m2. * known / suspected phrenic nerve palsy. * patients who refuse active treatment or are in the terminal stage of malignant tumors, have an expected life expectancy of \< 6 months, etc. * participated in other clinical studies related to mechanical ventilation within 2 months prior to the start of the study.
pulmonary perfusion by iodine subtraction mapping ct angiography in acute pulmonary embolism

Conditions: Pulmonary Embolism

Summary: * pulmonary embolism (pe) is a diagnostic and therapeutic challenge. the risk of death of untreated pe is approximately 25%. on the other hand, anticoagulant treatment is associated with a haemorrhagic risk (2% of major haemorrhagic accidents per year, of which 10% are fatal). a diagnostic accuracy is therefore necessary. * two approaches are available to diagnose pe: 1. a functional approach, represented by pulmonary ventilation / perfusion scintigraphy (v / p), which looks for the functional consequences of pe. the main disadvantage of this approach is that there is a high rate of non-diagnostic examinations. on the other hand, it allows a mapping of pulmonary perfusion at the microcapillary scale, and thus allows the quantification of the vascular obstruction index, which would be an independent risk factor of pe recurrence. 2. a morphological approach, represented by ct pulmonary angiography (ctpa), which allows the visualisation of the clot itself. this approach is currently the most used but has some limitations, including a risk of over-diagnosis of pulmonary embolism and the inability to reliably quantify the index of vascular obstruction. lung subtraction iodine mapping ct is a new technique allowing, during the realization of a ctpa, without additional irradiation, to provide a mapping of the iodine. this mapping of iodine could potentially be used to evaluate pulmonary perfusion. it would then be possible to obtain, during a single examination, in addition to the anatomical information of the thoracic angioscan, information on the pulmonary perfusion and thus to assess the functional consequences of pe. no study to date has evaluated the performance of the pulmonary subtraction ct for the evaluation of pulmonary perfusion in the context of acute pulmonary embolism suspicion.


Eligibility criteria:
inclusion criteria: * all patients who have been diagnosed with acute pulmonary embolism on the aquilion one genesis scan (toshiba, medical system, tokyo, japan) at the brest university hospital, and who have had a mapping of the iodine derived from the subtraction images. exclusion criteria: * tomoscintigraphy not feasible within 24 hours. * massive pulmonary embolism or with signs of gravity * pregnant or lactating women * minor patient * protected adults * incapacity / refusal to give consent * hypersensitivity to pertechnetate (99m tc) * hypersensitivity to human albumin
the role of the gut microbiota in the systemic immune response during human endotoxemia

Conditions: Endotoxemia

Summary: the purpose of this study is to determine whether treatment with antibiotics, which harm the gut flora, causes the immune system to be less effective.

rationale: sepsis ranks among the top ten leading causes of death worldwide. most nonsurvivors die in a state of immunosuppression. the gut microbiota exerts numerous beneficial functions in the host response against infections. gut flora components express microorganism-associated molecular patterns (mamps) such as lipopolysaccharide (lps), which are recognized by pattern recognition receptors (prrs) expressed by neutrophils and macrophages. mamps from the intestinal microbiota constitutively translocate to the circulation and prime bone marrow derived neutrophils via prrs. antibiotic treatment, which is standard of care for all patients with sepsis, depletes the gut microbiota and leads to a diminished release of mamps and other bacteria derived products. this causes diminished priming of systemic immunity, which may attribute to sepsis associated immunosuppression and an increased susceptibility to invading bacteria. objective: to investigate the role of the gut microbiota in the systemic priming of immune effector cells during human endotoxemia study design: randomized, between- and within-subject-controlled intervention study in human volunteers intervention: all subjects will receive lipopolysaccharide (endotoxin; 2 ng/kg bodyweight) intravenously to induce experimental endotoxemia. eight subjects will be pretreated with broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for seven days (washout period of 36 hours before endotoxemia), in order to deplete the gut microbiota. blood and faeces will be sampled before, during and after endotoxemia.

Eligibility criteria:
inclusion criteria: * healthy * male between 18 and 35 years of age * capable of giving written informed consent * chemistry panel without any clinically relevant abnormality * normal defecation pattern exclusion criteria: * major illness in the past 3 months or any chronic medical illness * history of any type of malignancy * past or current gastrointestinal disease * known positive test for hepatitis c antibody, hepatitis b surface antigen or hiv antibody 1 or 2 * current or chronic history of liver disease * subject uses tobacco products * history, within 3 years, of drug abuse * history of alcoholism * any clinically relevant abnormality on the 12-lead ecg * the subject has received an investigational product within three months * use of prescription or non-prescription drugs * use of antibiotics within 12 months * known allergy to antibiotics * subject has difficultly in donating blood or accessibility of a vein in left or right arm. * subject has donated more than 350 ml of blood in last 3 months * difficulty swallowing pills * body mass index more than 28

Keywords: antibiotics gut microbiota endotoxemia innate immunity
phase ii study of oxaliplatin and navelbine for second-line treatment of advanced nsclc.

Conditions: Previously Treated Metastatic Non-Small Cell Lung Cancer

Summary: the purpose of this study is to determine the response rate to treatment with oxaliplatin and navelbine in patients with previously treated nsclc. oxaliplatin and navelbine have not been clinically evaluated yet. however, navelbine has been safely administered with other platinum compounds.

this is a non-randomized trial for patients with previously treated non-small cell lung cancer. each patient will receive 6 cycles of chemotherapy consisting of oxaliplatin and navelbine. oxaliplatin is given intravenously every 21 days and navelbine is administered intravenously on day 1 and day 8 every 21 days.

Eligibility criteria:
inclusion criteria: * locally advanced or metastatic non-small cell lung cancer that has recurred, progressed, or failed to respond to previous systemic chemo. * measurable disease * good performance status (ecog 0,1 or 2) exclusion criteria: * previously treated with oxaliplatin or navelbine * symptomatic cns metastases

Keywords: non-small cell lung cancer
real world data collection on the synergy disc

Conditions: Cervical Degenerative Disc Disease

Summary: this is a real world data collection observational study at a single site. there are both prospective and retrospective cohorts. the study will examine the safety and effectiveness of the synergy cervical disc system in patients with degenerative cervical disc disease.


Eligibility criteria:
inclusion criteria: age 21 or above at the time of the surgery. have had (retrospective cohort) or the decision has been made to have (prospective cohort) the synergy disc implanted skeletally mature patients for reconstruction of the disc from c3-c7 following a single or multiple level discectomy for intractable radiculopathy intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: herniated disc and/or osteophyte formation symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (ct, mri, x-rays, etc.) failed a minimum of 6 weeks conservative treatment written informed consent given by subject. exclusion criteria: moderate to advanced spondylosis diagnosis of osteoporosis active systemic infection or infection at the operative site pregnancy marked cervical instability on lateral, coronal, or flexion/extension radiographs cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level severe pathology of the facet joints of the involved vertebral bodies previous diagnosis of osteopenia or osteomalacia more than one immobile vertebral level between c1 and t1 from any cause morbid obesity vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)-

Keywords: radiculopathy myelopathy disc replacement motion preservation
neuroregen scaffold™ combined with stem cells for chronic spinal cord injury repair

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or neural stem cells combined with neuroregen scaffold transplantation in patients with spinal cord injury.


Eligibility criteria:
inclusion criteria: 1. male or female, 18-65 years old. 2. completely spinal cord injury at the cervical and thoracic level (c5-t12). 3. classification asia a with no significant further improvement. 4. patients signed informed consent. 5. ability and willingness to regular visit to hospital and follow up during the protocol procedures. exclusion criteria: 1. a current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, huntington's disease, parkinson's disease). 2. serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans). 3. history of life threatening allergic or immune-mediated reaction. 4. clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis). 5. history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders. 6. severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree ii or above conduction abnormalities displayed via 12-lead ecg. 7. lactating and pregnant woman. 8. alcohol drug abuse /dependence. 9. participated in any other clinical trials within 3 months before the enrollment. 10. a drug or treatment known to cause effect on the central nervous system during the past four weeks. 11. a drug or treatment known to cause major organ system toxicity during the past four weeks. 12. poor compliance, difficult to complete the study. 13. any other conditions that might increase the risk of subjects or interfere with the clinical trial.
heliox for neonate with acute respiratory distress syndrome (ards)

Conditions: ARDS

Summary: acute respiratory distress syndrome (ards) in neonates has been defined, the role of heliox is not clear.this study aimed to determine whether ards neonate would benefit from heliox when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

acute respiratory distress syndrome (ards) can result in severe hypoxemia refractory to mechanical ventilation, mechanical ventilation including high frequency oscillation ventilation is the main method. but it is partial unuseful.

Eligibility criteria:
inclusion criteria: 1. infant less than 28 days 2. diagnosis of ards 3. informed parental consent has been obtained exclusion criteria: 1. major congenital malformations or complex congenital heart disease 2. transferred out of the neonatal intensive care unit without treatment
acute effect of empagliflozin vs dapagliflozin over pulse wave velocity in type two diabetes

Conditions: Diabetes Mellitus Type 2 Without Complication

Summary: to date one of the main independent biomarkers of cardiovascular disease is the arterial stiffness parameters measured by carotid-femoral pulse wave velocity. it is known that sglt2 inhibitors develop cardiac protection over long term administration, but there's not enough studies about acute effects in early administration.

measure basal carotid-femoral pulse wave velocity through a pulse pen tonometer by diatecne among basic physical examination, blood test, anthropometric and hemodynamic measurements; then administrate randomly dapagliflozin 10 mg, empagliflozin 25 mg or placebo for 7 days and then perform all of the measurements and blood test again.

Eligibility criteria:
inclusion criteria: * diagnosis of t2dm * hba1c \> 7 y \< 10 * bmi 25 - 34.9 kg/m2 * signature of consent under information exclusion criteria: * hypertension * treated with insulin and / or loop diuretics and thiazides * t1dm * hypotension * any autoimmune disease * liver disease * women whitout birth control method * women taking oral birth control or under hormone replacement therapy * woman pregnant or breastfeeding * untreated thyroid disease * patients with a cardiovascular disease that contraindicates the use of this pharmacological class * glomerular filtration rate \<60ml/min (cockcroft-gault)
passive vs active vr on hpt using the thermal sensory analyzer with a peltier-based contact thermode

Conditions: Pain; Anxiety

Summary: this is a prospective, crossover study of healthy participants evaluating the impact of passive vs. active virtual reality (vr) games on heat pain threshold (hpt).

virtual reality (vr) is an emerging, non-pharmaceutical intervention used to reduce perceived pain and anxiety in patients. vr's effect on pain and anxiety on patients is well-studied as is how vr games improve recalled pain and anxiety in pediatric burn and bone-fracture patients undergoing painful medical procedures. however, how differences in vr application construction (such as passive play vs. active play) impact patient perception of pain and anxiety is not well understood. in this study, we will measure the impact of passive vs. active vr applications on heat pain threshold (hpt) and immediate vs. recalled pain and anxiety levels.

Eligibility criteria:
inclusion criteria: * greater than 18 years of age * english speaking * hearing intact exclusion criteria: * a history of severe motion sickness * currently have nausea * history of seizures * have hearing loss; are pregnant * are currently taking beta blockers, chronotropic heart medications, or opioids or other prescription pain medications * history of chronic pain or acute pain syndromes.

Keywords: thermal sensory analyzer (tsa-ii) peltier-based contact thermode virtual reality
a study to characterize multidimensional model to predict the course of crohn's disease (cd)

Conditions: Inflammatory Bowel Diseases; Crohn Disease

Summary: the descriptive purpose of this study is to characterize clinical and nonclinical factors of participants with cd, participant flow and visits to other specialists in the hospitals of the healthcare network of the autonomous community of madrid with implementation of electronic medical records. the clinical and nonclinical factors include: demographic and baseline clinical characteristics, lifestyle, relapses, complications, day hospital visits, surgery, presence of complications such as perianal fistulas and complex perianal fistulas. the predictive purpose of this study is to develop a statistical predictive model with the information obtained from the descriptive purpose, in the hospitals of the healthcare network of the autonomous community of madrid, capable of assigning any participant diagnosed with cd a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications.

this is a retrospective and non-interventional study of participants with cd. the study will collect data from electronic medical records (emrs) of the participants in the hospitals of the healthcare network of the autonomous community of madrid with implementation of emrs and will describe the determining factors and develop a statistical model for predicting likely outcomes in participants with cd. this study will conduct an additional substudy to evaluate the performance of the system through a human assessment to be performed by the clinical experts at each participating site. the study will have a retrospective data collection from emrs of the participants referring to last 5 years. the study will enroll approximately 3000 participants. all participants will be enrolled in one observational cohort. this multi-center trial will be conducted in spain. the overall time for data collection in the study will be approximately 5 years.

Eligibility criteria:
inclusion criteria: 1. diagnosed with cd from the medical centers participating in the study.

Keywords: drug therapy
evaluating urmc's massive transfusion protocol

Conditions: Blood Coagulation Disorders; Trauma; Acute Coagulopathy

Summary: the purpose of the study is to evaluate the efficacy of the university of rochester medical center's current massive transfusion protocol. upon arrival of trauma level one designated patients the treating team evaluates the patient's injuries. if the patient is initiated under the facilities massive transfusion protocol and meets other inclusion and exclusion criteria the patient will be enrolled in the study. study procedures include collection of a blood sample following the transfusion of each shipment, through shipment 5, of blood products outlined in the current massive transfusion protocol. each blood sample will be run on a thromboelastograph to evaluate the patient's hematostatic state through resuscitation. one final blood sample will be collected 24 hours following the discontinuation of the massive transfusion protocol and also ran on the thromboelastograph. due to the critical need for medical intervention, consent procedure will be waived at time of enrollment. an authorized representative for the patient will be identified and approached to obtain consent for use of data collected.


Eligibility criteria:
inclusion criteria: * trauma level 1 patient initiated under massive transfusion protocol * age greater than or equal to 18 years old exclusion criteria: * females who are pregnant

Keywords: massive transfusion protocol
safety and preliminary efficacy study of sa4503 in subjects recovering from ischemic stroke

Conditions: Ischemic Stroke

Summary: the purpose of this study is to evaluate the safety and tolerability of sa4503 in patients recovering from a recent stroke. secondary, to evaluate the efficacy of sa4503 compared to placebo.

further study details as provided by m's science corporation:

Eligibility criteria:
key inclusion criteria: * males or females 18 years of age or older * experienced a stroke from 48 to 72 hours before randomization * a total score of \>/=4 on the nihss, or \>/=2 on the upper or lower extremity motor scores of the nihss * medically and neurologically stable within 24 hours prior to randomization key exclusion criteria: * patients with transient ischemic attack * patients with stroke in progression * unstable cardiac, hepatic, or renal disease, or other major medical disorder
a study of the abuse liability potential of ro4917838 in recreational drug users

Conditions: Healthy Volunteer

Summary: this randomized, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of ro4917838 in recreational drug users. in a pre-study (part 1), subjects will receive a single dose of either diazepam or placebo in an inpatient crossover design, with a wash-out period of at least 10 days between treatments. subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the main study (part 2) and will be randomized to single oral doses of ro4917838 (3 dose levels), diazepam and placebo in a double-blind, double-dummy inpatient crossover design. washout-periods between the 5 treatment periods in part 2 will be at least 10 days.


Eligibility criteria:
inclusion criteria: * healthy male or female volunteers, 18 to 55 years of age inclusive * recreational drug abuse experience (\>/= 10 times lifetime abuse of a cns depressant, \>/= 1 abuse of cns depressant in the previous 3 months * body mass index (bmi) 18 to 30 kg/m2 inclusive * main study (part 2): able to differentiate between diazepam and placebo exclusion criteria: * history of any significant disease or disorder * history or current diagnosis of substance dependence (excluding caffeine and nicotine) * currently seeking or history of participating in treatment for substance-related disorders, including successful completion of such treatment * any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator * positive for hepatitis b, hepatitis c or hiv infection * pregnant or lactating women * participation in an investigational drug or device study within the last 30 days prior to day 1 of the study * confirmed positive drug screening at screening / any day -1 (allowed positive thc at screening and any day -1 and positive benzodiazepine at screening only) * positive alcohol breath test at screening / any day -1 * heavy smoker (\> 20 cigarettes, \> 8 pipefuls or \> 8 cigars per day)