Kornimate/medical-research-clean huggingface dataset:
comparative study between lumbar foraminal stenosis treatment modalities

Conditions: Lumbar Foraminal Stenosis

Summary: the goal of this clinical trial is to compare the clinical and radiological outcome of two different interventional techniques in lumbar foraminal stenosis decompression. the main questions it aims to answer are: does minimally invasive techniques give better results than conventional techniques? participants will: undergo minimally invasive intervention using unilateral biportal endoscopy for lumbar foraminal stenosis decompression undergo lumbar fusion for lumbar foraminal stenosis decompression keep a diary of their symptoms and improvement of these symptoms

lumbar foraminal stenosis decompression will be done using two different techniques: 1. conventional open lumbar fusion by laminectomy and facetectomy and fixation with screws and rods ± interbody cage 2. minimally invasive (unilateral biportal endoscopy) basic spine surgery instruments, 0° and 30° angled 4-mm diameter endoscopes commonly used in joint arthroscopic surgery, a radiofrequency catheter, arthroscopic burr, and a shaver. surgical approach to the foraminal area two portals are created to perform this surgery. water is infused through the endoscope through the viewing portal, and the working portal had an additional purpose as a portal for water outflow. the proximal and distal portals are created 2 cm lateral from the pedicle level on the c-arm anteroposterior image. each incision for the portals is 0.8 cm in length, which is adequate for instrument and endoscope insertion. for the left side foramen, the proximal and distal portals are used as the viewing and working portals, respectively, and vice versa for the right foramen. after the endoscope insertion through the viewing portal, we secure a space for the lower transverse process around the lateral surface of the facet joint. a radiofrequency catheter or a shaver is used to secure the space, and a radiofrequency catheter is used to control active bleeding. decompression of foraminal stenosis after a sufficient working space is obtained, the cranial 50% of the superior articular process of the thickened facet joint is removed using an arthroscopic burr or an osteotome. after removing the superior articular process, the ligamentum flavum around the foramen is removed using a curette and a kerrison punch. after completion of flavectomy, nerve root and epidural fat are identified. if herniated disc material is found preoperatively, additional discectomy is performed usually from the axilla of the root. surgery is confirmed to be completed after achieving an amount of free space concordant with the diameter of the nerve root in the foraminal zone, and then a drain tube is inserted.

Eligibility criteria:
inclusion criteria: * all patients with degenerative lumbar foraminal stenosis, diagnosed in outpatient clinic. * patients (age \>18 ) exclusion criteria: * deformity. * infection of vertebrae. * tumor of vertebrae. * instability.
safety and immunogenicity of three influenza vaccines in children aged 4 years old to less than 18 years old

Conditions: Influenza

Summary: evaluate safety and immunogenicity of three influenza vaccines in children ages greater than 4 years old to less than 18 years old.


Eligibility criteria:
inclusion criteria: 1. male or female aged 4 years to less than 18 years of age. 2. individual who had a parent or guardian who could give written informed consent after understanding the nature of the study and comply with study procedures and were available for follow-up. 3. if the individual was of an age where, according to local regulations, informed assent is required, that individual had provided assent to participate in the study. exclusion criteria: 1. individuals recently vaccinated against influenza 2. subjects with contraindications to receive influenza vaccine

Keywords: influenza influenza vaccine novartis children
camrelizumab combined with irinotecan or albumin paclitaxel for second-line treatment of advanced gastric cancer

Conditions: Second Line Treatment of Gastric Cancer

Summary: this study is a multicenter, open, and randomized clinical phase ii exploratory study. the "pick the winner" study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase iii study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). the study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (orr), total survival time (os), progression free survival time (pfs), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, then determine the second line scheme which is more advantageous.


Eligibility criteria:
inclusion criteria: * age: 18-75 * ecog score: 0 or 1 * unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancer * histologically proven adenocarcinoma * received chemotherapy based on platinum and fluorouracil within 12 months * patients not previously treated with paclitaxel or irinotecan * liver function: total bilirubin, alt and ast\<1.5 × uln (normal value upper limit) * renal function: cr\<1.5 × uln and creatinine clearance ≥ 40 ml/min * echocardiography or radionuclide cardiac function test, lvef ≥ 50% * expected survival ≥ 3 months * sign the informed consent form exclusion criteria: * patients who have received irinotecan or paclitaxel chemotherapy in the past * ecog ps score:\>2 * advanced gastric cancer patients with extensive and severe peritoneal metastasis * patients with severe liver and kidney insufficiency or cardiac insufficiency * hiv positive, active hepatitis b or c, active pulmonary tuberculosis * patients with active autoimmune diseases, including lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, etc * patients known to be allergic to any of the study drugs * pregnant or lactating female patients
bioequivalency study of 50 mg cilostazol tablets under fasting conditions

Conditions: Intermittent Claudication

Summary: the objective of this study was the bioequivalence of a roxane laboratories' cilostazol tablets, 50 mg, to pletal® tablets, 50 mg (otsuka pharmaceuticals) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to cilostazol or any comparable or similar product.
comparison of intravascular uptake and pain perception during epidural injection using 22 gauge vs 25 gauge needle

Conditions: Pain; Needle Injury

Summary: the aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral epidural steroid injection in regards to intravascular uptake and pain perception. there is the notion that a smaller gauge needle may lead to less intravascular uptake and less pain.

inadvertent intravascular injection has been suggested as the most probable mechanism behind serious neurological complications during transforaminal epidural steroid injections. there is the notion that a smaller gauge needle may lead to less intravascular uptake and less pain. the aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injection in regards to intravascular uptake and pain perception.

Eligibility criteria:
inclusion criteria: 1. patients with low back pain and/or radicular pain, 2. patients scheduled for lumbosacral tfesi. exclusion criteria: 1. patients with contrast/local anesthetic allergy, 2. patients with pregnancy, coagulopathy, systemic infection, and inability to provide informed consent, 3. vulnerable patient population including prisoners, 4. patients with severe anxiety, 5. patients with prior lumbar surgery, 6. age \<18 years old, and 7. body mass index (bmi) \> 40.
validation of the spanish version of the clinically useful depression outcome scale (cudos) scale

Conditions: Unipolar Depression

Summary: the clinically useful depression outcome scale (cudos) is a brief, self-administered instrument that not only evaluates depressive symptoms but also both functioning and quality of life. the assessment of patients´ perspective may provide valuable information that could be lost if relaying only on clinician evaluation. the purpose of this study is to achieve a psychometric validation into spanish of the cudos scale in patients with major depression disorder in a primary care setting.


Eligibility criteria:
inclusion criteria: * major depression disorder diagnosis according to diagnostic and statistical manual of mental disorders (dsm-iv-tr) criteria in the last 3 months * major depression disorder diagnosis according to prime-md criteria in the last 3 months exclusion criteria: * be unable to understand and comply with the study requirements as judged by the investigator * participation in another trial prior to enrolment into this study

Keywords: psychometric validation major depressive disorder patient-reported outcome
validation and inverse analysis of the athletic shoulder test (ash).

Conditions: Shoulder Pain; Sports Physical Therapy

Summary: to validate both the athletic shoulder (ash) test, conducted on rugby players, and its inverse, the inverse athletic shoulder (iash) test, for swimmers. this involves assessing the strength relationship between shoulder flexion and extension at three different adduction angles (180º, 135º, 90º) to identify potential injuries associated with these imbalances.


Eligibility criteria:
inclusion criteria: * high-performance swimmers. * aged between 14 and 18 years. * no acute injuries in the cervical or scapular region. * ability to perform the ash and iash tests without compensatory movements. exclusion criteria: * acute injuries in the cervical or scapular region. * inability to maintain proper positioning during the tests due to lack of adequate mobility or strength. * refusal to sign informed consent (or legal guardian's consent for minors).

Keywords: shoulder pain; isometric strength; muscle strength imbalance; sports medicine; rehabilitation
rct on adjuvant tace after hepatectomy for hcc

Conditions: Hepatocellular Carcinoma

Summary: we hypothesise that the use of transarterial chemoembolisation (tace) after liver resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver and thus improve survival. the aim of this study is to compare the survival of patients undergoing liver resection plus post-operative tace versus liver resection alone.

liver resection is the mainstay of curative treatment for hepatocellular carcinoma (hcc). however, recurrence is common after surgery and most occurs in the liver. transarterial chemoembolisation (tace) is an effective palliative treatment for hcc. it involves the infusion of chemotherapeutic agent admixed with iodised oil followed by embolisation of the hepatic arterial flow using small particles. this procedures allows application of smaller dose of chemotherapy concentrated to the liver and thus is well tolerated with minimal side effects. we conduct a randomised controlled trial evaluating the efficacy of using tace after hepatectomy in hcc patients.

Eligibility criteria:
inclusion criteria: * hcc patients received curative hepatectomy with negative resection margin * age from 18 to 70 * child-pugh class a * asa class i to iii * ecog performance status grade 0 or 1 exclusion criteria: * patients receiving concomitant local ablation or previous tace * main portal vein tumour thrombus extraction during hepatectomy * tumour arising from caudate lobe * presence of extra-hepatic disease * very early hcc with solitary tumour and size \< 2cm * impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin \ 50micromol/l * renal impairment with creatinine \> 200micromol/l * severe concurrent medical illness persisting \> 6 weeks after hepatectomy * history of other cancer * hepatic artery anomaly making tace not possible * allergy to cisplatin or lipiodol * pregnant woman * informed consent not available

Keywords: hepatocellular carcinoma randomised controlled trial transarterial chemoembolisation
bilateral cochlear implant benefit in young children

Conditions: Hearing Loss

Summary: the primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months.


Eligibility criteria:
inclusion criteria: * profound bilateral hearing loss * have independently elected to undergo bilateral implantation of advanced bionics hiresolution bionic ear system * age at implant: 12-36 months * no previous cochlear implant use * english as the primary language spoken in the home * parental willingness to follow study protocol exclusion criteria: * deafness secondary to meningitis * presence of other conditions that could affect study participation
multistem® administration for stroke treatment and enhanced recovery study

Conditions: Ischemic Stroke

Summary: a phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, multistem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.


Eligibility criteria:
primary inclusion criteria: * male or female subjects ≥18 years of age * clinical diagnosis of ischemic stroke involving cerebral cortex * occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a nihss score of 8 to 20 (inclusive) that does not change by ≥4 points during the initial screening period * a mrs score of 0 or 1 prior to the onset of symptoms of the current stroke primary exclusion criteria: * presence of a lacunar or a brainstem infarct * comatose state * brain hemorrhage * major neurological event such as stroke or clinically significant head trauma within 6 months of enrollment into the study

Keywords: ischemic stroke adult stem cells
examination of a treatment program for overweight children, adolescents, and their families

Conditions: Obesity

Summary: the current study examined the effectiveness of a behaviorally-based group intervention for overweight children and their families. the target intervention was compared to an enhanced standard of care treatment. the impact of both treatment programs on numerous outcomes was explored.

the primary objective of the present investigation was to determine the effectiveness of an empirically supported intervention for pediatric overweight in two outpatient clinical settings. a number of previous randomized clinical trials have demonstrated the efficacy of behaviorally-based group interventions for overweight children and their families. as called for by kazdin and weisz (1998) and chambless and hollon (1998) the proposed investigation was designed to demonstrate the effectiveness of such a treatment in a clinical setting, and to examine the effects of the intervention on children's quality of life (qol). because the clinical impact of empirically supported interventions is mitigated by economic and consumer variables, a secondary aim of the proposed investigation was to examine (1) the cost-effectiveness of an outpatient group intervention for pediatric obesity, and (2) the consumer satisfaction with the proposed intervention. finally, an additional exploratory aim was to examine predictors of adherence to treatment for the intervention.

Eligibility criteria:
inclusion criteria: * child between ages 7 and 17 (inclusive) * child bmi at or above the 85th percentile based on norms provided for age and gender * child's parent/guardian provides informed consent for treatment of the child as well as consent for study participation * child's parent/caregiver is willing to participate with the child in the program exclusion criteria: * presence of serious mental illnesses or significant developmental delay that would reasonably predict altered ability to adhere to the treatment protocol * current physical illness or hospitalization of the child that would interfere with group attendance or protocol adherence

Keywords: obesity overweight behavioral treatment family involvement
preoperative dexmedetomidine & ec50 of propofol

Conditions: Urologic Surgery

Summary: dexmedetomidine is a useful anaesthetic adjuvant for general anaesthesia. in this prospective randomised study, we determined whether preoperative dexmedetomidine administration could reduce the half maximal effective concentration (ec50) of propofol for successful i-geltm insertion without muscle relaxants.

propofol is a useful induction agent for lma insertion without muscle relaxants because it profoundly inhibits pharyngeal and laryngeal reactivity. a previous report showed that the effect-site concentration of propofol for successful classic lma insertion in 50% of adults (ec50) without muscle relaxants in healthy male patients was 8.72 (0.55) µg ml-1. the ec50 of propofol may be dependent on the type of lma used. a previous study comparing the ec50 of the propofol concentration between classic and proseal lma insertions demonstrated that the ec50 of propofol needed for proseal lma insertion was 35% greater than that needed for classic lma insertion. unfortunately, no investigation has been performed to determine the ec50 of the propofol concentration required for i-gel insertion without muscle relaxants. dexmedetomidine (dex), a selective alpha-2 agonist, has sympatholytic, sedative, and analgesic properties. such beneficial characteristics make dex a useful anaesthetic adjuvant for general anaesthesia. many reports have revealed the beneficial effects of dex in terms of reducing intraoperative anaesthetic requirements, postoperative analgesic demand, and increased haemodynamic responses to noxious stimuli such as endotracheal intubation. a previous investigation showed that preoperative clonidine, an alpha-2 agonist, decreased the ec50 required for lma insertion. we hypothesised that preoperative dex administration can reduce the propofol concentration required for i-gel insertion. in this study, we compared the ec50 of propofol needed for successful i-gel insertion without muscle relaxants between dex and placebo groups

Eligibility criteria:
inclusion criteria: * asa physical status i-ii patients who were 20-65 years old and scheduled for general anaesthesia for urologic surgery exclusion criteria: * patients with an allergy to alpha-2 adrenergic agonists or propofol * patients who anticipated difficult airway (cervical spinal disease, mallampati score of iii or iv, a mouth opening of \ 30 kg m-2), unstable teeth * patients with bradycardia of \<50 beats/min, heart block greater than first degree, severe cardiorespiratory dysfunction * patients with symptoms of upper respiratory infection
a study of istradefylline (kw-6002) for the treatment of parkinson's disease in patients taking levodopa

Conditions: Parkinson's Disease

Summary: to establish the efficacy of a 20 mg/day dose of istradefylline for reducing the percentage of off time in patients with advanced parkinson's disease (pd) treated with levodopa.

to establish the efficacy of a 20 mg/d dose of istradefylline for reducing the percentage of off time in patients with advanced parkinson's disease (pd) treated with levodopa. patients who meet entry criteria will be randomized in a 1 to 1 ratio to either istradefylline or matching placebo. patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline as compared to placebo.

Eligibility criteria:
inclusion criteria: 1. uk parkinson's disease society (ukpds) brain bank criteria (step 1 and 2) for pd. 2. pd stages 2-4 in the off state for modified hoehn and yahr scale. 3. on levodopa/carbidopa for at least one year, stable dose in past 4 weeks. 4. currently take at least three doses of levodopa/carbidopa per day. 5. predictable end of dose wearing off. 6. able to satisfactorily complete hauser version of a parkinson's diary. 7. have an average of 180 minutes of off time on two 24 hour diaries. 8. be at least 30 years of age. exclusion criteria: 1. neurosurgical treatment for pd. 2. history of psychosis. 3. diagnosis of atypical parkinsonism, secondary parkinsonism variant or parkinson's plus syndromes. 4. diagnosis of cancer within 5 years. 5. mini-mental status examination score of 25 or less. 6. history of seizures or neurologic malignant_syndrome. 7. clinical depression.

Keywords: parkinson's disease levodopa end of dose wearing off off time
comparison of zotarolimus-eluting stent vs sirolimus-eluting stent for diabetic patients

Conditions: Coronary Artery Disease; Diabetes

Summary: the purpose of this study is to establish the safety and effectiveness of coronary stenting with the zotarolimus-eluting stent compared to the sirolimus-eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.

prospective, two arms, single blind, randomized multi-center trial of 380 patients enrolled at 24 centers in korea. following angiography, diabetic patients with significant diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) endeavor resolute stent vs. b) cypher select. all patients will be followed for at least 1 year. angiographic follow-up at 9-months is routinely recommended.

Eligibility criteria:
inclusion criteria: * diabetic patients with angina and documented ischemia * patients who are eligible for intracoronary stenting * de novo lesion * percent diameter stenosis ≥50% * reference vessel size ≥ 2.5 mm by visual estimation exclusion criteria: * history of bleeding diathesis or coagulopathy * pregnant state * known hypersensitivity or contra-indication to contrast agent and heparin * limited life-expectancy (less than 1 year) * acute st elevation myocardial infarction on admission * characteristics of lesion left main disease in-stent restenosis graft vessels * hematological disease (neutropenia \<3000/mm3, thrombocytopenia \<100,000/mm3) * hepatic dysfunction, liver enzyme (alt and ast) elevation ≥ 3 times normal * renal dysfunction, creatinine ≥ 2.0mg/dl * contraindication to aspirin, clopidogrel or cilostazol * left ventricular ejection fraction \<30% * patients who are actively participating in another drug or device - investigational study, which have not completed the primary endpoint follow- up period. * non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).

Keywords: coronary disease stent