Kornimate/medical-research-clean huggingface dataset:
surveillance of humira injection in korean patients

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Crohn's Disease; Psoriasis

Summary: patients who take humira as prescribed by physicians as per korean label will be enrolled and observed in normal medical practice setting for not less than 3 months following first dose of humira. information on demographics, diagnosis and medical history, results of tuberculosis skin test, results of chest x-ray, humira treatment information, concomitant medication, physician's global assessment for effectiveness, disease activity assessment for rheumatoid arthritis, disease activity assessment for crohn's disease, disease activity assessment for psoriasis and adverse events will be recorded on case report forms.


Eligibility criteria:
inclusion criteria: * adult patients (19 years and above) with one of the following indications: * moderately to severely active rheumatoid arthritis or * active and progressive psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate or * severe active ankylosing spondylitis who have had an inadequate response to conventional therapy or * severely active crohn's disease who have had no response, intolerance or contraindication to corticosteroid therapy or immunosuppressants or * moderately to severely active psoriasis patients who have had no response, have intolerance or have contraindication to systemic therapies including cyclosporine, methotrexate or photochemotherapy (puva). * patients who give verbal or written authorization to use their personal and health data. exclusion criteria: - patients with known hypersensitivity to adalimumab or any of its excipients.

Keywords: postmarketing drug surveillance
chemotherapy with or without enoxaparin in pancreatic cancer

Conditions: Pancreatic Cancer

Summary: to evaluate the safety and efficacy of chemotherapy with or without enoxaparin. this study is powered to decrease the dvt/ vte events rate from 10% to 3% with enoxaparin in the experimental arm. n=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%

approximately 20% of patients (pts) diagnosed with pancreatic adenocarcinoma (pa) develop venous thromboembolism, which may contribute to the dismal prognosis of pa. a small phase ii trial suggested an improved survival by the addition of low molecular weight heparin (lmwh) to chemotherapy. we conducted a small pilot study which indicated that the addition of enoxaparin to chemotherapy gffc chemotherapy is safe and feasible in pts with advanced pa. furthermore, results of several phase iii studies suggest that pts in good performance status may benefit from more intensive chemotherapy regimen (riess et al; heinemann et al; asco 2005). based on these considerations we started the multicenter phase iii study conko 004. 540 patients are to be recruited into this study. primary stratification takes place according to karnofsky performance status and kidney function. patients with kps \> 80% and normal kidney function receive gffc +/- lmwh (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w +/- enoxaparin 1mg/kg daily s.c.). pts with kps \ 1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) +/- lmwm +/- enoxaparin 1mg/kg daily s.c. after 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) +/- enoxaparin 40mg/d s.c.

Eligibility criteria:
inclusion criteria: * histological or cytological pancreatic carcinoma, stage iv a, b * no preceding radio or chemotherapy of the primarius or the reference lesions * karnofsky performance status ≥ 60% * measurable tumor lesion by spiral ct or mrt not older than 14 days * no deep venous thrombosis within the last 2 years * patient compliance and geographical proximity of the residence, which make an adequate follow up possible * sufficient bone marrow reserve: leukocyte ≥ 3.5 × 109 /l, thrombocyte ≥ 100 × 109 /l * signed informed consent * minimum age of 18 years * women/men must provide sufficient pregnancy prevention exclusion criteria: * preexisting indication for anti-coagulation of other reason * bleeding in the last 2 weeks or increased bleeding risk (e.g. serious coagulating disturbance, active stomach or intestine ulzera, or had operational interferences in the last 2 weeks) * body weight \ 100 kg * pregnancy or insufficient preventing methods in the study process * serious illness, which are incompatible with a study participation * hypersensitivity to study drugs * patients with serious kidney malfunction (creatininclearance \< 30 ml/min)

Keywords: heparin lmwh pancreatic cancer
efficacy study of nicorandil on neointima

Conditions: Angina, Unstable; Diabetes Mellitus

Summary: the investigators aim to investigate the effect of oral nicorandil on neointima after coronary drug-eluting stent implantation in patients with diabetic mellitus.

in the era of bare metal stent (bms), the restenosis rate was about 25%. the introduction of drug-eluting stent (des) reduces restenosis rate to 4%-10%. neointimal hyperplasia and restenosis remain to be problems after des implantation. besides, des causes an increase in uncovered struts, late stent thrombosis, neoatherosclerosis, and heterogeneous neointima. diabetes mellitus (dm) results in increased risk for atherosclerosis, in-stent restenosis, neoatherosclerosis and late-stent thrombosis. nicorandil, a hybrid of adenosine triphosphate-sensitive potassium (k-atp) channel opener and nitrates, has been shown to reduce target vessel revascularization after stent implantation, target lesion revascularization after rotational atherectomy, and restenosis in patients undergoing percutaneous coronary intervention (pci). intracoronary optical coherence tomography(oct) has emerged as a high-resolution imaging method for analysis of neointima that grows over the stent. we aim to examine the effect of nicorandil on the neointima after coronary des implantation in patients with unstable angina and dm.

Eligibility criteria:
inclusion criteria: * unstable angina with diabetes mellitus and is not given glibenclamide * have clinical indication of percutaneous coronary intervention * de novo severe stenosis in a native coronary artery * lesion suitable for stent and optical coherence tomography examination * reference vessel size between 2.5 and 4.0mm * drug-eluting stent implantation only exclusion criteria: * acute myocardial infarction within 2 weeks before percutaneous coronary intervention * contraindications to treatment with nicorandil (allergy, glaucoma, digestive ulcer, is currently taking phosphodiesterase-5 inhibitor) * bypass restenosis * pci history * hypotension * intolerance of platelet inhibitors and statins * impaired liver function * renal insufficiency requiring hemodialysis * pregnancy * connective tissue disease * life expectancy ≤ 12 months * left main coronary artery disease * bypass graft lesion and lesions unsuitable for oct * unwillingness or inability to provide informed consent

Keywords: neointima tomography, optical coherence drug-eluting stents nicorandil
treatment protocol for non-metastatic unilateral retinoblastoma

Conditions: Unilateral Retinoblastoma

Summary: this protocol provides guidelines for the management of non-metastatic unilateral retinoblastoma and introduces an innovative adjuvant therapy for higher risk patients based upon the results of the grupo de america latina de oncologia pediatrica (galop) i study. conservative therapy will be not protocolized.

patients with non-metastatic retinoblastoma undergoing enucleation will be staged using the american joint committee on cancer (ajcc), version 8, tumor, node, metastasis (tnm)- h system and the international retinoblastoma staging system (irss). irss stage i patients recognized as higher risk will be assigned for adjuvant therapy. those with standard risk will not receive adjuvant therapy after enucleation. higher risk patients are defined as those with pathological retrolaminar optic nerve invasion and-or any degree of scleral invasion (pt3b, pt3c, pt3d). based on the results of the galop i protocol, they will receive a reduced dose adjuvant chemotherapy regimen with 3 cycles of alternating cyclophosphamide, vincristine and idarubicin alternating with another 3 cycles of carboplatin and etoposide. six doses of intrathecal topotecan will be given. patients presenting with severe buphthalmia (ct3c-ct3e) will receive neo-adjuvant therapy with the same intensive regimen but including a higher dose of carboplatin as per galop i protocol plus intrathecal topotecan and secondary enucleation followed by adjuvant chemotherapy for a total of 8 cycles. stage ii patients (pt4) will receive the same adjuvant regimen plus orbital radiotherapy (45 cgy).

Eligibility criteria:
inclusion criteria: * histological diagnosis of retinoblastoma confirmed at participating institutions * ophthalmological diagnosis of unilateral retinoblastoma in patients undergoing conservative therapy. * no prior therapy for retinoblastoma * lansky performance scale greater or equal to 50 * normal organ function in those patients assigned for chemotherapy * signed informed consent exclusion criteria: * patients with unilateral retinoblastoma and germline mutations of the rb1 gene or family history for retinoblastoma
mind body syndrome (mbs) therapy for the treatment of chronic pain

Conditions: Chronic Pain

Summary: to determine if mind body syndrome (mbs) therapy will reduce or eliminate pain in patients suffering from chronic pain syndromes without organic etiology.


Eligibility criteria:
inclusion criteria: * adult patient 18 \> years old * chronic pain without clear organic etiology after full evaluation by primary care physician or subspecialist * pain persistent for a minimum of 3 days a week for the past three months prior to enrollment exclusion criteria: * patients \< 18 years of age * diagnosed organic disease as cause of pain, such as but not limited to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis) * patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia and bi-polar disorder. mild to moderate depression and anxiety will not be considered as exclusions * pregnancy * severe depression or recent suicide attempt

Keywords: mind body syndrome mbs chronic pain
cardiac assessment in obese and overweight children

Conditions: Obesity, Childhood

Summary: is to assess cardiac functions of overweight and obese children attending assiut university children hospital in one year duration .

the prevalence of overweight and obesity in children is increasing worldwide at an alarming rate in both developing and developed countries .the relation between obesity and cardiac structure and function in children is less well documented and conflicting results have been reported .in addition, obesity is associated with a heterogeneity of metabolic abnormalities , (e.g., dyslipidemia , insulin resistance hyperglycaemia and hypertension , that may provide a plausible biologic link between obesity and the increased risk of cardiovascular morbidity and mortality .the clustering of these risk factors for cardiovascular disease is referred to as the "metabolic syndrome." although the concept and definition of the metabolic syndrome are controversial at the moment, there is no doubt that a cluster of cardiovascular risk factors is present in obese children and adolescents and that their presence increases with worsening obesity .children are likely to be the ideal candidates for providing insight into the myocardial changes related to obesity because they are suggested to be free of other cardiovascular risk factors indifferent echocardiographic studies .

Eligibility criteria:
inclusion criteria: 1. - age: children at 2-18 years . 2. - overweight children whose body mass index at or above the 85th percentile and below the 95th percentile for the same age and sex 3. - obese children whose body mass index at or above the 95th percentile for the same age and sex. exclusion criteria: 1- obese children below two years 2 - cases with syndromic obesity, diabetes * thyroid and parathyroid and those with congenital heart diseases
a clinical study to evaluate safety and performance of peek-optima™ ha enhanced.

Conditions: Degenerative Disc Disease; Spondylolisthesis; Retrolisthesis

Summary: the purpose of this trial is to collect clinical outcomes including radiographic and ct outcomes in patients who undergo spinal fusion using the keos lumbar interbody fusion device.

this prospective, non-comparative, single-center, post-market trial will evaluate the safety and efficacy of the peek-optima ™ ha enhanced keos lumbar interbody fusion device in patients suffering from degenerative disc disease, spondylolisthesis and retrolisthesis in the lumbar spine. the trial will capture clinical outcomes, radiographic and ct outcomes over a 24 month period post operatively. one centre will be involved in the recruitment of 30 patients the clinic involved will focus on this type of treatment.

Eligibility criteria:
inclusion criteria: 1. aged 18 years of age or older. 2. primary diagnosis of symptomatic degenerative disc disease (ddd) or symptomatic degenerative disc disease (ddd) with spondylolisthesis (grade 1), or retrolisthesis, at one or two contiguous levels from l2 to s1. 3. have discogenic back pain. 4. suitable for transforaminal lumbar interbody fusion (tlif) surgery. 5. indicated for surgical treatment with the keos lumbar ibfd with autologous bone graft. 6. completed at least 6 months of conservative non-operative treatment. 7. female subjects of childbearing age must have a negative pregnancy test. 8. able to understand this clinical study, co-operate with procedures. 9. able to give voluntary, written informed consent to participate. exclusion criteria: 1. not undergone previous spinal surgery at the affected disc level(s). 2. evidence of tumour and/or malignant disease. 3. known osteoporosis or severe osteopenia. 4. known rheumatoid arthritis, ankylosing spondylitis or who are immunocompromised. 5. known allergy to the material used in the instrumentation. 6. evidence of an active infection. 7. any conditions outlined as contraindicated in the instructions for use. 8. receiving any drug treatment that may affect bone metabolism. 9. female subjects who are pregnant or lactating. 10. current smokers or have stopped smoking less than 6 months ago. 11. known drug or alcohol abusers. 12. currently enrolled in a clinical study.

Keywords: lumbar degenerative disc disease spondylolisthesis retrolisthesis
transcrestal maxillary sinus floor elevation with injectable bone substitute

Conditions: Edentulous Alveolar Ridge

Summary: to investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. patients needing unilateral sinus floor elevation (residual crestal height \<5 mm) for the placement of a single implant were enrolled. xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. simultaneous implant placement was performed when adequate primary stability was achievable. graft height was measured immediately after surgery (t0) and after six months of healing (t1). univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at t1.

purpose: to investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. methods: patients needing unilateral sinus floor elevation (residual crestal height \<5 mm) for the placement of a single implant were enrolled. xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. simultaneous implant placement was performed when adequate primary stability was achievable. graft height was measured immediately after surgery (t0) and after six months of healing (t1). univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at t1.

Eligibility criteria:
inclusion criteria: * residual bone crest height \<5 mm and width ≥6 mm in the planned implant site; * healed bone crest (at least 6 months elapsed from tooth loss/extraction); * age \>18 years; * written informed consent given exclusion criteria: absolute medical contraindications to implant surgery; * uncontrolled diabetes (hba1c \> 7.5%); * treated or under treatment with antiresorptives; * irradiated in the head and neck area in the last five years; * pregnant or breastfeeding; * substance abusers; * psychiatric problems or unrealistic expectations; * patient not fully able to comply with the study protocol. * large sinus cavity (distance \>12 mm between buccal and palatal walls at 10-mm level, comprising the residual alveolar crest); * maxillary sinus conditions contraindicating sinus floor elevation; * poor oral hygiene and motivation (full mouth plaque score \>20% and or full mouth bleeding score \>10%)
safety study of abatacept to treat rheumatoid arthritis (a)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to compare the incidence rates of infection among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis * claims indicating infusion, injection, or dispensing of abatacept, a dmard, or a bdm * age 18 years or older at the time of drug initiation * enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation exclusion criteria: * below 18 years of age at the time of bdm or dmard initiation * lacking six months of continuous enrollment prior to the initiation of one of the study drugs
epidural neuroplasty using racz catheter during lumbar fixation in situ for lumbosacral spondylolisthesis

Conditions: Analgesic Efficacy; Epidural; Neuroplasty; Racz Catheter; Lumbar Fixation; Lumbosacral Spondylolisthesis

Summary: this study aims to evaluate the analgesic efficacy of epidural neuroplasty using a racz catheter during lumber fixation in situ for lumbosacral spondylolisthesis.

lumbosacral spondylolisthesis, a common neurosurgical disorder, involves the anterior displacement of a vertebra in relation to the one below it. it often leads to back pain and neurologic symptoms. epidural lysis of adhesions is a procedure which treat chronic lbp in patients which didn't respond to medical treatments.the technique of radiofrequency ablation (rfa) uses high-frequency current to produce tissue coagulation and heat. it involves the use of radio waves, applied through a percutaneous probe to generate heat and create a lesion in a spinal sensory nerve

Eligibility criteria:
inclusion criteria: * age from 18 to 65 years. * both sexes. * patients suffering from spondylolisthesis grade 0, 1, 2 complaining of low back pain and/or sciatica. exclusion criteria: * uncooperative patients. * patients in need of discectomy for lumber disc prolapse. * patients with severe canal stenosis and in need of spinal laminectomy. * contraindications to perform the proper technique e.g., coagulopathy and skin infection. * body mass index (bmi) ≥35 kg/m2. * history of allergy to contrast medium. * previously operated traditional spine surgeries.
pain perception with tenaculum placement

Conditions: Pain

Summary: randomized controlled trial that compares methods of tenaculum placement during intrauterine device insertion and their effect on pain. the two methods being compared are slow tenaculum placement versus tenaculum placement at time of cough. subjects will be asked to rate their pain using visual analog scale. primary outcome measured is pain at time of tenaculum placement. secondary outcomes are overall pain with intrauterine device insertion and provider satisfaction with tenaculum placement.

the two commonly described strategies for tenaculum placement, slow versus having the patient cough while the tenaculum is placed are utilized by providers based on preference and/or their previous training. there is no published study that compares these methods to one another. the investigators aim to compare these strategies, slow tenaculum placement versus the cough method, and their effects on pain at time of placement. 96 subjects will be randomized to each method. the subject will be asked to rate their pain using a 100-mm visual analog scale after speculum placement, after tenaculum is placed, and after completion of the procedure. the provider will be asked to rate their satisfaction with tenaculum placement on a likert-type 5 point satisfaction scale. 1: not at all satisfied, 2: slightly satisfied, 3: moderately satisfied, 4: very satisfied, 5: extremely satisfied. all data to be collected using redcap database.

Eligibility criteria:
inclusion criteria: * women ages 18 years and older * undergoing intrauterine device placement * english or spanish speaking exclusion criteria: * primary language other than english or spanish
detection of β thalassemia carriers by red cell parameters obtained from the h2 automatic counter

Conditions: Thalassemia; Iron Deficiency

Summary: β thalassemia is an autosomal recessive hemoglobinopathy and considered as the most widespread genetic mutation. according to the world health organization (who) between 1.5-7% of the world population are carriers for this disease, and every year 60,000-400,000 birth of new patients are reported. in israel, the incidence of carriers for β thalassemia is around 20% among the jewish from kurdish origin and around 5-10% among the arab population. β thalassemia is a severe disease which requires many resources, both medical and financial. the disease is expressed by chronic hemolytic anemia which requires regular blood transfusions every 3 weeks. as a result of the blood transfusions and the iron absorption by the digestive tract, those patients suffer from severe hemosiderosis which is the main mortality cause in the disease, mainly in the second decade for life. daily treatment with iron chelator is required. moreover, despite the actual treatment, the quality of life of those patients is still low. therefore the implementation of a prevention program which includes finding an effective and inexpensive way for identifying the β thalassemia carriers is a humanitary and publicly important goal. in β thalassemia carriers, laboratory tests will show hypochromic microcytic anemia. those findings are similar in iron deficiency anemia, but the rbc number and the rdw are normal in thalassemia carriers. few researchers tried in the past to determine cutoff point for diagnosis of β thalassemia carriers by different formulas. we used the algorithm svm (support vector machine) to find a reliable formula that can separate patients with iron deficiency anemia/ healthy from patients with β thalassemia minor (carriers). this formula can be inserted to any automatic blood counter and search for suspected carriers without deliberately intention and without any further blood test.


Eligibility criteria:
inclusion criteria: * blood count and hgb electrophoresis analysis received from pregnant women send for screening for thalassemia. exclusion criteria: * age below 17 yrs and older than 50 yrs. * sever anemia with hgb level below 8 gr/dl.

Keywords: thalassemia iron deficiency carrier screening