Kornimate/medical-research-clean huggingface dataset:
outcome analysis for minimally invasive spine surgery and navigation

Conditions: Degenerative Disc Disease

Summary: prospective/retrospective data analysis, chart reviews and clinical outcomes of minimally invasive spine surgery

study rationale and primary objective/hypothesis to assess the clinical and radiographic outcome of spinal fusion procedures using silicate-substituted calcium phosphate (si-cap), a newer-generation of synthetic ceramics designed to maximize osteoinduction and osteoconduction. study design retrospective study purpose of the study providing compelling evidence for the efficacy of si-cap in terms of resulting in satisfactory fusion. summary of methods a prospectively collected database will be reviewed retrospectively, to retrieve data of 200 patients who have undergone different spinal fusion procedures using silicate-substituted calcium phosphate (si-cap). an average follow up duration of at least 12 months will be considered. clinical outcomes will be assessed using the visual analog scale (vas), oswestry disability index (odi), and neck disability index (ndi). pre-operative scores will be compared to the latest follow-up scores. a board certified neuro-radiologist will assess the fusion rate. fusion will be determined by the presence of bony bridging on 2 consecutive sections in at least 2 planes on computed tomographic imaging. secondary endpoints and expected results the purpose of this study is to evaluate the level of clinical and radiographic improvement in patients implanted with silicate-substituted calcium phosphate (si-cap) as a bone graft substitute material for spinal fusions. more comprehensive long term studies will be able to provide compelling evidence for the efficacy of si-cap in terms of resulting in satisfactory fusion. they can more strongly support the previously published data implying that si-cap can be utilized as an alternative to autogenous bone graft in spinal arthrodesis procedures.

Eligibility criteria:
inclusion criteria: - patients with different spinal fusion procedures (including axial lumbar interbody fusion, transforaminal lumbar interbody fusion, extreme lateral interbody fusion, posterior cervical fusion, and anterior discectomy and fusion using silicate-substituted calcium phosphate as a bone graft substitute. exclusion criteria: - utilization of any other bone extenders in addition to si-cap as a bone graft substitute.
tpo-ra in primary immune thrombocytopenia (itp) in patients older than 14 years

Conditions: Primary Immune Thrombocytopenic Purpura

Summary: this multi-center study aims to study the efficacy of tpo-ras' transformation in chinese itp patients older than 14 years. this study will be conducted in itp patients who had not responded to first-line in the previous treatment .

the primary objective of this study was to evaluate the efficacy of tpo-ras' transformation in chinese itp patients older than 14 years who had not responded to first-line in the previous treatment. 100 eligible subjects will be enroll ed in this study.the dose will be adjusted according to the subject platelet count during the period from week 1 to week 6.

Eligibility criteria:
inclusion criteria: * men and women greater than or equal to 14 years of age. * participants diagnosed with primary immune thrombocytopenia with two platelet counts of \< 30x10\^9/l or with bleeding at least 7 days apart，do not have evidence of other causes of thrombocytopenia (e.g.,pseudothrombocytopenia, myeloid fibrosis). * previous treatment with poor response to first-line therapy and any of the maximum 4-week doses of eltrombopag, herombopag, avatrombopag, or 300u/kg/ day × 14-day rhtpo with no response to treatment (platelet count \< 30×109/l after treatment, or platelet count increase less than twice the baseline value, or with bleeding) * participants willing and able to comply with the requirements of the study protocol, and sign the informed consent. exclusion criteria: * patients diagnosed with secondary immune thrombocytopenia. * a history of arteriovenous thrombosis, disseminated intravascular coagulation, myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmune diseases, malignant tumors, liver cirrhosis and other diseases that were not eligible for inclusion. * liver disease with one of the following indicators: a. total bilirubin ≥ 2 times of the upper limit of normal; b. alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≥ 2 times the upper limit of normal value; patients with renal disease (serum creatinine ≥ 1.5 times the upper limit of normal); * subjects with known allergies to eltrombopag, herombopag, rh-tpo, avatrombopag, or any of excipients; * have used rituximab in the past 3 months; * splenectomy in recent 3 months; * those who are not considered suitable for this study by the researcher; * women who are pregnant or who intend to become pregnant in the near future are excluded.
effect of an add-on treatment with ivy leaves dry extract on lung function in bronchial asthma

Conditions: Asthma

Summary: the trial aims to record possible effects of a supplementary treatment with ivy leaves dry extract on different lung function parameter, on bronchial hyperreactivity, on individual markers of asthmatic inflammation and on the clinical symptom profile. the hypothesis is, that the additional therapy might improve these parameters and might help to optimize asthma therapy.


Eligibility criteria:
inclusion criteria: 1. medical diagnosis of uncontrolled, mild, persistent, allergic bronchial asthma in terms of the bronchial asthma nvl version 1.3 (2011) 2. children aged from 6 to 12 years (girls and boys) 3. signed informed consent of the patient and his legal guardians to participate in the trial after written and verbal briefing by the investigator 4. improvement of the fev1≥12% after 2 puffs of terbutaline 100 µg dur-ing steroid monotherapy with 400 µg budesonide equivalent/day or an act score ≤ 19 as an indication of insufficient asthma control 5. asthma diagnosis for at least 1 year exclusion criteria: 1. anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure 2. participation of the patient in another clinical trial within the last four weeks before enrollment in this trial 3. evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance) 4. inability to measure lung function, to test bronchospasmolysis, to determine feno or to collect exhaled breath condensate, inability to document the symptoms in a symptom log book or questionnaire; in-ability to take the trial medication properly 5. chronic illnesses of different aetiology 6. vocal cord dysfunction 7. premature birth or diagnosis of bronchopulmonary dysplasia 8. gastroesophageal reflux 9. acute respiratory infection within the previous 4 weeks 10. hereditary fructose intolerance 11. pregnant or breastfeeding girls -

Keywords: asthma children
diabetes treatment with glucobay in combination with metformin

Conditions: Type 2 Diabetes Mellitus

Summary: in this prospective, non interventional, observational post marketing survelliance study data are obtained on the efficacy, safety and tolerability of glucobay treatment on top of metformin under daily life treatment conditions.specifically investigated is the influence of glucobay on post prandial blood glucose and hba1c as well as on pateint's weight when added to an already existing metformin therapy.the study is planned to carried out in 25000 - 30000 patients from 200 trial sites in india.the pms study will be performed with commercially available medication prescribed within regular practice of the physician. no other examination will be performed than would be done without post marketing survelliance study.


Eligibility criteria:
inclusion criteria: * all patient with type 2 diabetes with one of the following treatment ongoing : 1) metformin 2) metformin + oha. * in such patients, if investigator feels that addition of acarbose would be benficial for the patients exclusion criteria: * according to local product information

Keywords: diabetes mellitus, type-2 acarbose drug therapy combination
betamethasone dosing interval - 12 or 24 hours?

Conditions: Preterm Delivery

Summary: the purpose of this study is to determine if there may be a benefit to the newborn if betamethasone is given 12 hours apart instead of 24 hours apart.

betamethasone is a medicine given to women expected to deliver after 24 but before 34 weeks of pregnancy. it is very advantageous in preventing or decreasing the many problems these small babies may face if born early. betamethasone makes breathing easier for them, also decreases the chance of them bleeding in the head and makes their chances of survival better. this medicine is used routinely in pregnancy but the best timing between doses in not well established. the 'standard' dosing schedule involves giving 2 injections of 12mg of the medicine 24 hours apart. however, many women deliver before reaching the 24-hour mark, despite the doctors best efforts to try and delay delivery, and therefore miss the opportunity for the 2nd dose.

Eligibility criteria:
inclusion criteria: * pregnant women expected to deliver preterm (either induced or spontaneously) for any obstetrical or medical indication. * gestational age between 23 and 34 weeks gestational age. * dating must either be by lmp which is consistent with ultrasound performed at any gestational age, or calculated by a sonogram less than or equal to 23 weeks. exclusion criteria: * patients at \ 34 weeks gestational age. * known drug allergy to betamethasone. * given steroid other than betamethasone for lung maturation. * any contraindication to steroid therapy.

Keywords: betamethasone for preterm labor preterm delivery infant respiratory distress syndrome
hyperglycemia and oxidative stress in the human brain with diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to use an mri exam to measure the concentrations of glutathione (gsh) and vitamin c (asc) in the brains of normal healthy persons and type 2 diabetic persons. the study will look at the relationship between chronic hyperglycemia and the levels of these naturally occurring chemicals in the brain.

cerebral gsh and asc concentrations are modulated by increased oxidative stress induced by hyperglycemia in diabetes and reflect changes in the cerebral antioxidant defense system. inhibition of cellular uptake of asc by hyperglycemia further hampers maintaining adequate antioxidant capacities. reduced concentrations of these antioxidants might serve as good indicators of increased susceptibility to oxidative damage, impaired cellular uptake or the antioxidant, and further, as sensitive in vivo biomarkers to assess early manifestations or progression of diabetic complications and the efficacy of the antioxidant therapy in the human brain. specific aims (1) to determine cerebral concentrations of gsh and asc in the living brain of healthy controls and type 2 diabetic patients; (2) to quantify the effect of chronic hyperglycemia on cellular uptake of asc across the blood-brain barrier.

Eligibility criteria:
inclusion criteria: * good health except for having type 2 diabetes * being treated with diet, insulin, or oral hyperglycemic agents * male or non pregnant female * non-smoker * hba1c 8 or above * able to provide informed consent exclusion criteria: * presence of mental illness * co-existing chronic inflammatory condition or neurological disease or diseases associated with abnormal glutathione metabolism * bmi over 35 * smoker

Keywords: diabetes type 2 diabetes
sacral neuromodulation for male overactive bladder (moab)

Conditions: Overactive Bladder; Urinary Urgency Incontinence; Benign Prostatic Hyperplasia; Prostate Cancer; Prostatectomy

Summary: to assess the post-market clinical outcomes of the axonics snm system for treatment of overactive bladder in male patients.

to assess the post-market clinical outcomes of the axonics snm system for treatment of overactive bladder in male patients who have a prior history of radical prostatectomy or radiation for prostate cancer or who have a history of cytoreductive surgical intervention for benign prostatic hyperplasia (bph).

Eligibility criteria:
key inclusion criteria: 1. participants aged ≥ 18 years at the time of enrollment 2. able to complete bladder diaries and patient questionnaires 3. primary diagnosis of urinary urgency incontinence (uui) 4. willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year 5. underwent prostatectomy for prostate cancer at least 6 months prior to enrollment 6. underwent radiation therapy for prostate cancer at least 6 months prior to enrollment 7. underwent cytoreductive surgical intervention for bph at least 6 months prior to enrollment key exclusion criteria: 1. any patient that is not a suitable candidate per investigator discretion 2. recent prostate therapy or procedure within the last 6 months at the time of enrollment 3. any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia) 4. previously implanted with a sacral neuromodulation device, including inactive snm devices 5. any prior treatment with an implantable tibial nerve stimulation (itns) 6. percutaneous tibial nerve stimulation (ptns) within the last 3 months at the time of enrollment 7. underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician 8. any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives (e.g. crohn's disease, moderate to severe fibromyalgia, chronic pain) 9. uncontrolled diabetes 10. known allergic reactions to components of the axonics snm system, including titanium, zirconia, polyurethane, epoxy, or silicone
nimotuzumab combined with chemoradiotherapy for unresectable locally advanced squamous cell lung cancer

Conditions: Non-small-cell Lung Cancer

Summary: this phase ii randomized study is to determine the efficacy and toxicity of nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.

this phase ii randomized study is to determine the efficacy and toxicity of nimotuzumab combined with chemoradiotherapy for unresectable,locally advanced squamous cell lung cancer. all patients were planned to receive radical dose of chest radiation and concurrent chemotherapy of weekly docetaxel and cisplatin, each of 1 day's duration. nimotuzumab group was treated with weekly nimotuzumab (200mg, iv) combined with chemoradiotherapy, while control group was treated with chemoradiotherapy.

Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell lung cancer * patients have measurable or evaluable lesions based on the response evaluation criteria in solid tumors (recist) criteria * unresectable phase iiia(n2) and iiib lung cancer confirmed by ct or mri * ecog performance status 0-1 * previously treated with chemotherapy or treatment-naive * no previous chest radiotherapy, immunotherapy or biotherapy. * hemoglobin≥10 mg/dl, platelet≥100000/μl,absolute neutrophil count ≥1500/μl * serum creatinine ≤1.25 times the upper normal limit(unl), or creatinine clearance≥60 ml/min * bilirubin ≤1.5 times unl, ast（sgot）≤2.5 times unl ,alt（sgpt）≤2.5 times unl,alkaline phosphatase ≤5 times unl * fev1 \>0.8 l * cb6 within normal limits * patients and their family signed the informed consents exclusion criteria: * adenosquamous carcinoma * previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ * contraindication for chemotherapy * women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose * women who has the probability of pregnancy without contraception * tendency of hemorrhage * in other clinical trials within 30 days * addicted in drugs or alcohol, aids patients * uncontrollable seizure or psychotic patients without self-control ability * severe allergy or idiosyncrasy * not suitable for this study judged by researchers

Keywords: nimotuzumab, chemoradiotherapy,squamous cell lung cancer
meoi and hrqol in cll patients treated with btkis

Conditions: Chronic Lymphocytic Leukemia

Summary: this is a multi-site observational study of medical events of interest (meoi) and health-related quality of life (hrqol) in chronic lymphocytic leukemia (cll) patients initiating treatment with the bruton's tyrosine kinase inhibitors (btki) acalabrutinib or ibrutinib in the united states (us)


Eligibility criteria:
inclusion criteria: * ≥18 years old * physician-confirmed diagnosis of cll or small lymphocytic lymphoma (sll) * btki naïve patients who initiate acalabrutinib or ibrutinib treatment alone or in combination with an anti-cd20 mab within 7 days (before or after) study enrollment\*. both treatment naïve and relapsed/refractory cll patients will be included. * provides informed consent * adequate english reading skills * able to access and use a computer, tablet, or smartphone to complete pros exclusion criteria: * use of btki any time prior to study enrollment. * currently receiving systemic treatment for another malignancy * currently enrolled in a clinical trial
vit-armin virtual, intensified and patient-tailored robotic arm therapy with the exoskeleton robot armin

Conditions: Stroke; Spinal Cord Injury; Healthy

Summary: consideration-of-concept trial (stage 1) on robotic therapy of the upper extremity with the armin therapy robot in healthy subjects and patients with neurological disease (e.g. stroke, spinal cord injury)

neurological patients (e.g., after stroke) need long-term neurorehabilitative therapy of the arm with often limited, unsatisfactory outcome. robots became a promising supplement or even alternative for neurorehabilitative training. investigators aim at developing a unique intensified and patient-tailored robot-aided training strategy of the arm. the exoskeleton robot armin will be further developed to adapt software components accordingly. the goal is to enhance treatment efficacy to an extent that the improvement in motor function is meaningful for the individual patient. it can be intensified by different strategies that will be evaluated alone and in combination. these strategies include: strength training an error-amplification strategy increased number of repetitions multisensory feedback multiplayer approach

Eligibility criteria:
inclusion criteria: healthy or cva or spinal cord injury * aged ≥18 years * no excessive spasticity of the affected arm (modified ashworth scale ≤3) * no serious medical or psychiatric disorder as assessed by their physician * no orthopaedic, rheumatological, or other disease restricting movements of the paretic arm * no shoulder subluxation (palpation \<2 fingers) * no skin ulcerations at the paretic arm * ability to communicate effectively with the examiner such that the validity of the patient's data could not be compromised * no cybersickness (e.g., nausea when looking at a screen or playing computer games) * no pacemaker or other implanted electric devices * bodyweight \<120 kg * no serious cognitive defects or aphasia preventing effective use of armin exclusion criteria - allergy against alcohol or no agreement for skin shaving
baden prevention and reduction of incidence of postoperative delirium trial

Conditions: Postoperative Delirium

Summary: the purpose of this study is to find out whether postoperative delirium can be more properly prevented by the combination of determined preventive agents in past studies. further on the investigators measure pre- and postoperative cortisol, neuron specific enolase (nse) and s-100beta levels.

the postoperative delirium remains a challenge for medical stuff concerning detection, therapy and avoidance of consequences. over the years numerous risk factors were detected which emphasizes the importance of its prevention. within these studies some possibilities, but no strictly defined rules of action for pharmacological or neuropsychological prevention are described. this is why in this randomized, double-blinded, placebo-controlled study, the investigators want to compare two agents that were found to prevent postoperative delirium to a certain level, even in combination: the investigators arrange the patients within four study groups, one receiving haloperidol, one ketamine, one both and one placebo. the patients receive the study drug only once right before induction of anesthesia. after the day of recruitment there is the day of operation and a follow-up of three days (5 days of observation in total, where the investigators will test cognitive function with mini mental status examination (mmse), delirium observation scale (dos), nursing delirium screening scale (nu-desc) or intensive care delirium screening checklist (icdsc). additionally the investigators will measure and compare pre- and postoperative cortisol, nse and s-100beta levels.

Eligibility criteria:
inclusion criteria: * age 65 years and older * signed agreement exclusion criteria: * delirium at admittance or mmse score \<24 points * high risk for postoperative icu treatment * haloperidol or ketamine intolerance * risk of lack of cooperation * drug an alcohol abuse * dementia * qt interval (qtc) prolongation (at least 460ms in men, at least 470ms women) or drugs influencing qt interval, such as class ia and iii antiarrhythmics, gatifloxacin, moxifloxacin, pentamidin, cotrimoxazol, tacrolimus, dolasetron * parkinson's disease * intake of dopaminergic drugs (levodopa, dopamine agonists) * parkinsonism * epilepsy * unable to be interviewed (severe dementia, speaking disorders, intubation, respiratory isolation, aphasia, coma, terminal illness) * delay of operation of more than 72 hours past hospital admittance * body weight \>100kg

Keywords: postoperative delirium cortisol nse s-100beta mmse nu-desc icdsc dos haloperidol ketamine combination of haloperidol and ketamine placebo prevention of