Kornimate/medical-research-clean huggingface dataset:
optimization of a tool for predicting postoperative clinical evolution after lumbar surgery

Conditions: Spine Disease; Spinal Fusion; Surgery; Spine Degeneration

Summary: the objective of the study is the establishment, optimization and prospective evaluation of a digital predictive platform capable of providing for each lumbar spine operated patient a clinical predictive status: patient green (success) orange (treatment failure ), red patient (complication) in order to optimize his medical care up to 6 months.


Eligibility criteria:
inclusion criteria: * major patient * eligible for lumbar decompression surgery, instrumented or not * social insured * having given consent * eligible for the acts described in protocole exclusion criteria: * minor * pregnant or breastfeeding woman * safeguard measure or guardianship * arthrodesis on more than 2 levels * interventions linked to a traumatic or infectious context are excluded
qr-bromocriptine as an adjunct to insulin and metformin in the treatment of type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: qr-bromocriptine as an add-on treatment to insulin and metformin in the management of type 2 diabetes will result in improved glycemic control, reduced exogenous insulin requirement, increased lean fat mass and improved pancreatic beta-cell function.

to assess improvement in glycemic control, reliance on exogenous insulin, improvements in lean body mass composition, and improvements in pancreatic beta-cell function.

Eligibility criteria:
inclusion criteria: 1. male and female patients, age 30 to 65 years of age, 2. clinical diagnosis of type 2 diabetes at least 6 months prior to enrollment, 3. stable on current treatment consisting of either human or recombinant multi-dose insulin therapy (mdi) with metformin, 4. hba1c of 7.5-12%, inclusive, 5. demonstrated willingness to check and record blood glucose readings at seven time points as instructed in the study protocol. 6. medically controlled hypertension, at least on one anti-hypertensive 7. medically controlled hyperlipidemia, on or off cholesterol-lowering therapy 8. bmi \>30 exclusion criteria: 1. pregnancy or lactating, 2. type 1 diabetes, 3. concomitant use of forbidden medications: prescription sympathomimetics (within seven days of screening), ergot alkaloid derivatives, and anti-migraine medications, 4. patients with history of drug or alcohol abuse within 3 years of enrollment, 5. patients at risk for hypotension, including those who have: * recent blood donation within 30 days of enrollment, * a history of syncopal migraines, or * significant gastroparesis or orthostatic hypotension which could signify advanced autonomic neuropathy. 6. uncontrolled mental illness especially with history of psychosis, 7. any severe, uncontrolled or terminal medical condition which the investigator feels would interfere with the patient's ability to participate and comply with the study protocol, 8. serum creatinine \>1.4mg/dl in females or \>1.5mg/dl in males that would preclude the patient from taking metformin, 9. lfts elevated \>3x upper limit of normal, 10. patients working rotating, varying or night shifts, or 11. patient with circumstances or abnormalities (e.g. blindness or history of non-compliance) that would interfere with the interpretation of safety or efficacy data or completion of the study.
enoxaparin versus unfractionated heparin in subjects who present to the emergency department with acute coronary syndrome (rescue)

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to determine the efficacy and safety of enoxaparin compared to unfractionated heparin (ufh) for patients diagnosed with acute coronary syndrome (acs) in the emergency department (ed). efficacy is assessed by using a composite score consisting of 30-day all-cause mortality, non-fatal myocardial infarction (mi) and recurrent angina requiring revascularization.


Eligibility criteria:
inclusion criteria * rest angina lasting at least 10 minutes that is highly suggestive of myocardial ischemia and is not explained by trauma or obvious abnormalities on chest x-ray, occurring within 24 hours of randomization; * timi risk score greater than or equal to 4 (a qualitative test for ck-mb or troponin may be utilized for screening purposes; however, a quantitative test must still be performed.) exclusion criteria * increased bleeding risk as defined by any of the following: * ischemic stroke within the last year * any previous hemorrhagic stroke, intracranial tumor, or intracranial aneurysm * recent (\<1 month) trauma or major surgery (including bypass surgery) * active bleeding (other than minor skin abrasions) * impaired hemostasis including any one of the following: * known international normalized ratio (inr) \>1.5 * past or present bleeding disorder (including congenital bleeding disorders such as von willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders) * known or history of thrombocytopenia (platelet count \<100,000/ml) * history of thrombocytopenia with glycoprotein iib/iiia inhibitor therapy, heparin, or enoxaparin * angina from a secondary cause such as: * severe, uncontrolled hypertension (systolic blood pressure \>180 mm hg despite treatment) * anemia * valvular disease * congenital heart disease * hypertrophic cardiomyopathy * restrictive or constrictive cardiomyopathy * thyrotoxicosis. * bundle branch block not known to be old in the context of angina. * undergone a percutaneous coronary intervention (pci) within the past 24 hours. * a known allergy to heparin, low molecular weight heparin, pork or pork products. * any contraindications to treatment with ufh or lmwh. * a recent (\<48 hours) or planned spinal/epidural anesthesia or puncture. * thrombolytic therapy within the preceding 24 hours. * any other clinically relevant serious diseases, including severe liver disease or renal failure \[creatinine clearance \<30 ml/min\], rendering implementation of the protocol or interpretation of the study results difficult. * treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or has previously enrolled in this trial. * inability to comply with the protocol (e.g., has uncooperative attitude, inability to return for follow-up visits). * inability to understand the nature, scope, and possible consequences of the study or is otherwise unable to provide informed consent. * a prosthetic heart valve
internet-based support for informal caregivers of patients with head and neck cancer - carer esupport

Conditions: Head and Neck Cancer

Summary: the aim of this randomized controlled trial is to investigate the effects of internet-based support (carer esupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer. the main question\[s\] it aims to answer are: * what are the effects of internet-based support on informal caregivers preparedness for caregiving? * what are the effects of internet-based support on informal caregivers burden and wellbeing? informal caregivers who are randomized to carer esupport will have access to carer esupport for 18 weeks and they will be asked to complete questionnaires (outcome measures) at: * baseline (before randomization) * 18 weeks (post-intervention) and at * 3 months after the intervention is completed (long term follow-up). informal caregivers in the intervention group will be compared to informal caregivers who receive standard care support regarding preparedness for caregiving, caregiver burden and wellbeing.


Eligibility criteria:
inclusion criteria: * informal caregivers who have been identified as an informal caregiver by a patient who have consented to that the informal caregivers is approached. * informal caregivers of patients with head and neck cancer who are about to start radiotherapy or have undergone at most five radiotherapy treatment session. radiotherapy may be combined with surgery and/or medical oncological treatment. exclusion criteria: * informal caregivers who do not understand and read swedish or suffer from cognitive impairment, and informal caregivers with who need support or treatment that cannot be provided by carer esupport.

Keywords: informal caregivers internet-based support preparedness for caregiving caregiver burden quality of life
management following lumbar puncture in children

Conditions: Spinal Puncture Complications

Summary: the study is carried out in a prospectively randomly controlled way. in the context of acknowledgement and understanding from parents, by comparing with traditional process (lying without the pillow and fasting water and food for four hours following lumbar puncture), an optimized postoperative management (lying without the pillow for half an hour following lumbar puncture) is randomly selected. all children will be evaluated by the flacc (the face, legs, activity, cry, consolability behavioral tool) scale to assess the degree of pain after lumbar puncture. any postoperative condition will be recorded and analyzed. a questionaire about bad memory during lumbar puncture for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.

the purpose of this study is to establish an optimized lumbar puncture management process on the basis of fully understanding of parents and children. an improved process consisting of comfortable lp will be established upon completion of this study.

Eligibility criteria:
inclusion criteria: * children with indications of lumbar puncture; * voluntarily signed the informed consent exclusion criteria: * topical anesthetic skin allergies; * skin infection in lumbar puncture site; * severe intracranial hypertension; * unstable vital signs; * coagulopathy; * intracranial hemorrhage and occupying; * low back pain; * headache and low back pain before lumbar puncture; * past headache after lumbar puncture; * mental retardation, neuropsychiatric symptoms; * children could not immediately act after the lumbar puncture(such as disturbance of consciousness or suffering from underlying diseases or drainage); * the case with repeated puncture in one operation
proteomics study of mild cognitive impairment and alzheimer's disease

Conditions: Alzheimer Disease, Early Onset; Protein; Disease

Summary: this study intends to adopt standardized and rigorous cross-sectional research, collect biological specimens (including blood, feces, urine, saliva and tongue coating) from eligible subjects, and use liquid chromatography/mass spectrometry (lc-ms/ms) technology to explore early warning indicators of protein in patients with mild cognitive impairment and alzheimer's disease

the problem of population aging is getting worse, the prevalence of senile dementia is increasing, and alzheimer's disease (ad) is the most common type of dementia. there is no effective treatment for ad. most interventions can only alleviate the condition and delay the development. therefore, early diagnosis and prevention of ad are extremely important. however, the current diagnostic measures are not suitable for clinical promotion due to their traumatic nature, so there is an urgent need for a more suitable clinical early identification and diagnosis method. proteomics research technology is the leading research technology in china. it can be applied to research on disease markers, pathogenesis, and drug target discovery. therefore, this study intends to adopt standardized and rigorous cross-sectional research, collect biological specimens (including blood, feces, urine, saliva and tongue coating) from eligible subjects, and use liquid chromatography/mass spectrometry (lc-ms/ms) technology to explore early warning indicators of protein in patients with mild cognitive impairment and alzheimer's disease

Eligibility criteria:
inclusion criteria: 1. older than 55-year-old，male or female. 2. patients meet the diagnosis of mild cognitive impairment (mci) or alzheimer's disease(ad) or whose family members were diagnoed with ad 3. complete self-rating scale for memory impairment (ad-8 scale) 4. those who agree to participate in clinical research and sign informed consent. exclusion criteria: 1. patients with acute cardiovascular and cerebrovascular diseases, acute infections (pneumonia, urinary tract infection, oral infection, digestive tract infection), severe renal dysfunction, and uremia; 2. pregnant or lactating women;

Keywords: alzheimer disease biomarker protein
study to assess the efficacy and safety of clbs12 in patients with critical limb ischemia (cli)

Conditions: Critical Limb Ischemia; Buerger Disease; Thromboangiitis Obliterans; Atherosclerosis Obliterans

Summary: a prospective, open label, controlled, randomized, double arm, multi-center study to assess the efficacy and safety of clbs12 in patients with critical limb ischemia (cli) due to arteriosclerosis obliterans (aso) with a single arm sub-study to assess the safety and potential efficacy of clbs12 in patients with cli due to buerger's disease (bd).

main aso study: this study will compare safety and efficacy of intramuscular transplantation of autologous cd34+ cells (clbs12) plus standard of care (soc) pharmacotherapy (cell treatment arm) versus soc pharmacotherapy alone (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids) (control arm) in subjects with cli categorized as rutherford score 4 or 5 due to aso aged 20 to 85 years and with no endovascular or surgical revascularization options. subjects assigned to the cell treatment arm will continue soc pharmacotherapy and will also receive subcutaneous injections of gran® 5 ug/kg/day for 5 days and undergo apheresis on the last day of gran® administration. then each subject in the cell treatment arm will receive intramuscular injections of autologous cd34+ cells. subjects assigned to the control arm will continue to receive soc pharmacotherapy alone with the possibility of receiving cell treatment via the rescue option. bd substudy: a single arm substudy is included to assess the safety and efficacy of intramuscular transplantation of clbs12 in patients (n=\~5) with cli categorized as 4 or 5 rutherford score due to bd aged 20 to 85 years. subjects who give informed consent will be screened for eligibility within 28 days before registration. subjects will continue soc pharmacotherapy and will also receive subcutaneous injections of gran® 5 µg/kg/day for 5 days (pretreatment days 1 5) to mobilize cd34+ cells into the peripheral blood and undergo apheresis on pretreatment day 5 to collect cd34+ cells. the choice of pharmacotherapy will be made by the investigators. each subject in a cell treatment arm will receive intramuscular injections of up to 1 × 10\^6 autologous cd34+ cells/kg/limb. all subjects will be evaluated for efficacy and safety assessments during approximately 12 months. efficacy assessments include cli free status, afs, pfs, abi, tbi, spp, tcpo2, icd, vas, and aqa.

Eligibility criteria:
inclusion criteria: * subject has cli caused by aso or bd exclusion criteria: * \< 20 years old

Keywords: cli, aso, tao
efficacy of ciclesonide during the cold season in patients older than 12 years with persistent asthma

Conditions: Asthma

Summary: the aim of the study is to evaluate the efficacy of ciclesonide in patients with persistent asthma over 3 months, especially in the cold season. ciclesonide will be inhaled by a metered-dose inhaler. the study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria:
main inclusion criteria: * history of persistent bronchial asthma main exclusion criteria: * hypersensitive to compounds of alvesco * other criteria as defined in the summary of product characteristics (fachinformation chapter 4.3)

Keywords: asthma ciclesonide inhaled steroids alvesco
randomized clinical trial of tune in 3.0: a social/emotional program for adults with autism spectrum disorder

Conditions: Autism Spectrum Disorder; Autism; Autistic Disorder; Asperger Syndrome

Summary: the purpose of this study is to test a novel, cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. the treatment, named tune in (training to understand and navigate emotions and interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings. the investigators will test the efficacy of tune in to improve social functioning in adults with autism spectrum disorder (asd), using a randomized controlled trial using the srs-2 as the primary outcome measure.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * meet asd diagnostic criteria supported by an outside diagnostic evaluation and/or by the clinical and developmental information gathered from a phone screen * be willing to complete screening surveys (outcome measures) * social responsiveness score, second edition, self-report srs survey score of greater than or equal to 60 exclusion criteria: * severe self-injurious or aggressive behaviors; or with suicidal or homicidal ideation or behaviors (e.g. suicide attempt) within the last 6 months * major mood episode (major depressive episode, manic episode), psychotic symptoms, or a psychiatric hospitalization within the last 6 months * a history of intellectual disability or low shipley-2 score

Keywords: social skills emotion regulation autistic adults
relative bioavailability of an extemporaneous oral suspension of aprepitant in healthy adult volunteers

Conditions: Chemotherapy-induced Nausea and Vomiting

Summary: antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (cinv) are still common and are among the most distressing side effects of chemotherapy. aprepitant is commercially available in canada as capsules. an oral liquid aprepitant formulation would be ideal for oral administration to patients unable to swallow capsules.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects as determined by responsible physician (see 4.3) (i.e. have no clinically significant diseases captured in the medical history, on physical examination and/or laboratory tests) * 18 to 55 years of age * bmi within 18.5 to 30 kg/m2 * non-smoker * systolic blood pressure between 90-140 mmhg, diastolic blood pressure between 60-90 mmhg, and heart rate between 60-100 bpm, inclusive. * female subjects of childbearing potential should be either sexually inactive (abstinent) or be using one of acceptable methods of birth control for 15 days prior to the first dose of the study, throughout the study and for at least 30 days after the last aprepitant dose. * able to swallow whole aprepitant capsules * willingness to adhere to the protocol requirements as evidenced by the informed consent form (icf) duly read, signed and dated by the volunteer. exclusion criteria: * clinically significant illness or surgery within 8 weeks prior to dosing. * positive for hepatitis b, hepatitis c, or hiv at screening as per medical history. * history of allergic reactions to the study drug and/or its excipients. * subjects concurrently treated with drugs that are metabolized through cyp3a4, including but not limited to pimozide, terfenadine, astemizole, or cisapride, ketoconazole, itraconazole, clarithromycin, diltiazem, warfarin, rifampin, carbamazepine, and phenytoin etc. * history of drug or alcohol abuse within the last 6 months. * severe mental disorders. * blood donation of 50 ml to 499 ml of whole blood within 30 days, or more than 499 ml of whole blood within 56 days prior to drug administration. * pregnant or breastfeeding. * use of recreational drugs, prescription medications (other than hormonal contraceptive agents),non-prescription medications (over-the-counter) or natural health products within 7 days or 5 half-lives (whichever is longer) prior to the administration of the first dose of study medication. * consumed grapefruit or grapefruit products within 7 days of each study period * any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
study of external neuromodulation to improve signs and symptoms of dry eye in visual display terminal users

Conditions: Visual Display Users With Previously Undiagnosed Dry Eye

Summary: two study arms - sham and treatment; there will be a cross over of the sham group to the treatment group at day 15.

this is a post market study. the active device will be the fda cleared device used within its labeling. the sham group will receive an itear device which looks identical to and makes noise similar to a fully functional itear device but has a tip that does not vibrate. all subjects in the sham group will crossover to the treatment group after 2 two weeks and all patients will continue to 30 days. the study will be conducted at up to 5 sites in the united states. it will enroll 30 subjects for 30 days. this is a double-masked study with 10 subjects receiving sham and 20 subjects receiving treatment. the subjects and the examining investigators are masked to treatment until the crossover.

Eligibility criteria:
inclusion criteria: * \> 6hrs visual display terminal * osdi \> 13 * one of: schirmer \ 2, or meibomian gland expression \<12 exclusion criteria: * opinion of investigator that subject not be in the study
acute medically ill vte prevention with extended duration betrixaban study (the apex study)

Conditions: Venous Thromboembolism (VTE)

Summary: the purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. the safety of betrixaban will also be studied.


Eligibility criteria:
inclusion criteria: * men and non-pregnant, non-breastfeeding women * anticipated to be severely immobilized for at least 24 hours after randomization * hospitalized with one of the following * congestive heart failure * acute respiratory failure, * acute infection without septic shock, * acute rheumatic disorders * acute ischemic stroke with lower extremity hemiparesis or hemi paralysis exclusion criteria: * a condition requiring prolonged anticoagulation or anti-platelets * active bleeding or at high risk of bleeding * contraindication to anticoagulant therapy * general conditions in which subjects are not suitable to participate in the study

Keywords: phase iii