Kornimate/medical-research-clean huggingface dataset:
the itp-ritux cohort: rituximab in immune thrombocytopenia.

Conditions: Purpura, Thrombocytopenic, Idiopathic; Autoimmune Thrombocytopenia

Summary: the primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for immune thrombocytopenia.

rituximab (rtx) is used in the treatment of malignant non-hodgkin's indication for which it has been authorized since 1997 and why it is considered effective and well tolerated. rituximab is also effective and well tolerated in combination with methotrexate in severe rheumatoid arthritis (ra) refractory to anti-tnf. to date, the ra is the only autoimmune disease in which rituximab has proven efficacy in randomized trials and has obtained authorization in this indication. there are also data from the literature, for the benefit of rituximab in other autoimmune diseases like lupus, cryoglobulinemia associated to hepatitis c or sjogren's disease. immune thrombocytopenia (itp) is an autoimmune disease in which there is thrombocytopenia due in part to destruction of platelets by autoantibodies. in adults, the disease is most often chronic and in the most severe forms, the treatment of choice is splenectomy. rituximab was suggested during chronic itp when used with 4 weekly infusions of 375 mg/m2, 60% of patients achieve an immediate response and 30 to 40% a prolonged response. these encouraging results and the apparent good tolerance advocate for using rituximab as first-line treatment for patients refractory to splenectomy. in france, afssaps - french health products safety agency has recently issued a temporary protocol processing to authorize rituximab in this indication. nevertheless, many questions remain unresolved, including the tolerance of long-term treatment and the risk of late relapse in responders. this justifies the creation of this register, whose establishment is recommended by afssaps - french health products safety agency.

Eligibility criteria:
inclusion criteria: * itp diagnosis according to the american society of hematology society * secondary itp if the underlying disease is an autoimmune disease(lupus,sjogren..) exclusion criteria: * previous treatment by rituximab * secondary itp associated to a hematologic disease (chronic lymphocytic leukemia, hodgkin disease...) * secondary itp associated to a chronic infectious disease (hepatitis b, c, hiv)

Keywords: immune thrombocytopenia rituximab side effects tolerance safety splenectomy serum sickness
safety and effectiveness of topotecan hcl to treat hiv-infected patients with aids-related progressive multifocal leukoencephalopathy (pml)

Conditions: HIV Infections; Leukoencephalopathy, Progressive Multifocal

Summary: the purpose of this study is to see if it is safe and effective to give topotecan through a vein to treat hiv-infected patients with pml, an opportunistic (aids-related) infection caused by a virus that infects brain tissue and causes damage to the brain and the spinal cord. topotecan fights hiv and the jc virus (the virus that causes pml) in laboratory experiments.

topotecan, a cytotoxic dna topoisomerase-i inhibitor that crosses the blood-brain barrier, inhibits the replication of jc virus (the virus that causes pml) in vitro, at concentrations that are not toxic to human cells. topotecan also inhibits the replication of hiv-1 and the function of tat (which upregulates the replication of jc virus). patients are randomized to be treated immediately with topotecan or to have treatment delayed for 8 weeks. the dosing schedule for patients receiving immediate or delayed treatment is topotecan as a continuous 21-day intravenous infusion every 28 days. all patients must have received optimal, stable antiretroviral therapy for 3 weeks prior to entry and preferably will continue that therapy during the study.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * have pml, including symptoms of pml. * are able to complete the study. * agree to have a catheter inserted in a vein. * have taken at least 3 weeks of a stable anti-hiv drug combination (unless they are unable to take anti-hiv drugs). * are at least 18 years old. * agree to use effective methods of birth control. exclusion criteria patients will not be eligible for this study if they: * have a history of certain central nervous system (cns) diseases. * have a history of certain psychiatric disorders, such as bipolar disorder or schizophrenia. * have syphilis that has not been treated. * have certain severe medical problems, including aids-related opportunistic infections (such as pcp) that require treatment. * have received chemotherapy in the past 30 days. * have ever received chemotherapy for pml. * are pregnant or breast-feeding. * are taking certain medications, including any other investigational drugs.

Keywords: aids-related opportunistic infections leukoencephalopathy, progressive multifocal infusions, intravenous drug administration schedule topotecan
rituximab, gemcitabine and oxaliplatin (r-gemox) for refractory/relapsed b-cell lymphoma

Conditions: Diffuse Large Cell Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and the safety of r-gemox in refractory/relapsed patients with cd20-positive large b-cell lymphoma who are not eligible for autologous transplantation.

this is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of r-gemox in refractory/relapsed patients aged from 18 to 75 years with cd20-positive large b-cell lymphoma non eligible for autologous transplantation. it is anticipated that 50 subjects will be enrolled over 4 years (from april 2003/january 2007), but inclusion could stop earlier according to the analysis performed every 5 patients (based on triangular test). the duration of the treatment period is approximately 16 weeks and patients are followed until death. the total duration of the study is expected to be 3 years.

Eligibility criteria:
inclusion criteria: * patients diagnosed with histologically or cytologically proven, cd 20+, diffuse large b-cell lymphoma, * relapse after first or second cr, pr or less than pr to first-line treatment for the rituximab-naïve patients, or relapse after first or second cr with a minimum delay of 12 months between the last rituximab infusion and the inclusion for the rituximab-experienced patients * aged 18 - 75 years * not eligible for autologous transplantation * previously treated with chemotherapy containing anthracycline, with or without rituximab * ecog performance status 0 to 2 * with a minimum life expectancy of 3 months * having signed informed consent form prior to enrollment exclusion criteria: * burkitt's, mantle cell, t-cell lymphomas * cd 20-negative lymphoma * hiv or hbv related disease * central nervous system or meningeal involvement by the lymphoma * not previously treated with anthracycline-containing regimens * contraindication to any drug contained in the r-gemox chemotherapy regimen * any serious active disease or co-morbid medical condition (according to the investigator's decision), * poor renal function (creatinine level \> 150micromol/l), poor hepatic function (total bilirubin level \> 30mmol/l, transaminases \> 2.5 maximum normal level) unless these abnormalities are related to the lymphoma * poor bone marrow reserve as defined by neutrophils \< 1.5 g/l or platelets \< 100 g/l, unless related to bone marrow infiltration * any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma * treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study * any radiotherapy during the four weeks before inclusion * pregnant or lactating woman * adult patient unable to give informed consent because of intellectual impairment.

Keywords: b-cell lymphoma salvage therapy rituximab oxaliplatine gemcitabine
testicular sperm retrieval rate after varicocele ligation in men with non obstructive azoospermia

Conditions: Non-obstructive Azoospermia

Summary: a varicocele is an abnormal dilatation and tortuosity of the veins of the spermatic cord. although varicoceles are common in the general population and are frequently found on routine physical examinations, they represent the most common correctable cause of male factor infertility. male factor infertility affects up to half of all couples struggling to conceive, and 10-20% of men evaluated for infertility are found to be azoospermic.

generally, azoospermia is classified as obstructive azoospermia (oa) or non-obstructive azoospermia (noa). while oa is obviously caused by obstruction, noa has many possible causes and is more difficult to manage. non-obstructive azoospermia (noa) is most often a result of primary testicular dysfunction, varicoceles are found in 20% of the general male population, in up to 40% of men with infertility, and specifically 4.3-13.3% of men with noa. the role of varicoceles in noa has not been fully elucidated. the current best practice statement on the evaluation of azoospermic males from the aua acknowledges that impaired spermatogenesis associated with varicoceles may be reversible but does not give a clear recommendation for management. the primary advantage of varicocelectomy in cases of noa is the possibility of getting motile sperms in the ejaculate. other benefit of varicocele repairs in azoospermic men is that there are increased success rates of assisted reproductive techniques (art) such as intracytoplasmic sperm injection (icsi) or testicular sperm extraction (tese).

Eligibility criteria:
inclusion criteria: * men with non obstructive azoospermia. * clinically palpable varicocele ( unilateral or bilateral ). exclusion criteria: * known cases of obstructive azoospermia. * non palpable varicocele. * uncorrectable female causes of infertility. * genetic abnormalities like klinefelter syndrome.
function and modulation of fibulin-1 assembly in nucleus of corneal fibroblasts

Conditions: Function of Mitomycin C in Cornea

Summary: the purpose of this study is to investigate the role of nuclear fibulin-1 (fbln1) in human corneal fibroblasts under treatment of mitomycin c (mmc).


Eligibility criteria:
inclusion criteria: * the frozen storage cells in liquid nitrogen were amplified from the residual corneal rim of the donors with more than 20 years old following penetrating keratoplasty. exclusion criteria: * the donors were younger than 20 years old.

Keywords: human corneal fibroblasts fibulin-1 nuclear accumulation
the effect of comorbid psychiatric conditions on results of transforaminal epidural steroid injection

Conditions: Low Back Pain; Radiculopathy

Summary: low back pain (lbp) and radiculopathic pain are a major socio-economic problem affecting all age groups. 70% of people consult a doctor at least once in their life due to lbp. radicular pain is thought to be caused by inflammation of the spinal nerve roots near the intervertebral disc injury. in this context, fluoroscopic guided transforaminal epidural steroid injection (tfesi) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation in recent years. the assessment of comorbid psychiatric conditions such as depression, anxiety, and somatization disorder and given the detailed and visual information to patients who will be undergone tfesi could affect the result of the treatment in a good way. the pain questionnaire used for objectively evaluating injection outcomes is personality dependent and there are many factors that can affect it.

although information leaflets given to patients prior to surgical or non-surgical interventions have not yet been used as a standard in each clinic, the effects on patients have been frequently researched in recently. a detailed description of the treatment, the devices to be used and the disclosure of the steps of the procedure may have an effect on the result of the treatment. the aim of the study; (1) the presence of comorbid psychiatric conditions in patients with lumbar disc hernia and radiculopathy, (2) to evaluate the effect of the written and visual informative form given before the injection of the lumbosacral tfesi.

Eligibility criteria:
inclusion criteria: * lumbar radiculopathy due to lumbar disc herniation, * unresponsive to conservative treatments, * duration of pain is less than 3 months, * patients scheduled for the first time with tfesi. exclusion criteria: * the cases when fluoroscopy or epidural injection is contraindicated (coagulation disorders, pregnancy etc...), * underwent epidural injection in the last 6 months, * to have a history of lumbar spinal surgery, * inflammatory diseases (rheumatoid arthritis, spondyloarthropathy), * spinal infection or malignancy, * to benefit from six-week medical treatment, * be reluctant to participate in the work and follow up, * who are illiterate, * the patients with psychiatric disease

Keywords: transforaminal epidural steroid injection radicular pain
study of the effect of individualizing daytrana wear-times on sleep in children with adhd

Conditions: Attention Deficit Hyperactivity Disorder; INSOMNIA

Summary: methylphenidate may improve sleep in children with adhd. by leaving daytrana (methylphenidate) patch for a longer time then 9 hours, many children report short sleep latencies and better quality of sleep.

once the optimal dose of daytrana that controlled the adhd symptoms is established. the patch will be removed 1, 2, and 3 hours before bed time in a random fashion, at weekly intervals, and parents will keep a sleep diary. 25 patients will be enrolled in order to obtain statistical significance.

Eligibility criteria:
inclusion criteria: * adhd without significant comorbidity exclusion criteria: * cardiac disorder * hypertension * thyroid disease * glaucoma * history of sudden death, motor tics and/or tourette's syndrome * hypersensitivity to methylphenidate

Keywords: daytrana sleep latency adhd rating scales adhd
a study of pemetrexed in small cell lung cancer, which has returned

Conditions: Carcinoma, Small Cell

Summary: the purposes of this study are to determine 1) the safety of pemetrexed and any side effects that might be associated with it 2) whether pemetrexed can help patients with small cell lung cancer live longer 3) whether pemetrexed can make tumors smaller or disappear and for how long and 4) to see if patients feel better while taking pemetrexed


Eligibility criteria:
inclusion criteria: * diagnosis of small cell lung cancer * one prior treatment with chemotherapy or immunotherapy with greater than 3 weeks since the prior treatment * at least 18 years of age * estimated life expectancy of at least 12 weeks * ambulatory and capable of self-care(eg, up and about greater than 50% of waking hours) exclusion criteria: * have received treatment within the last 30 days with a drug that has not received fda approval for any indication * less than 2 weeks from radiation therapy * other serious illness that would compromise the safety of the patient * most second primary malignancies treated less than 5 years previously
a multiple-centered, prospective cohort study: the second prevention trial for ischemic stroke with deng zhan sheng mai capsule（spirit-dzsm-2）

Conditions: Ischemic Stroke

Summary: in order to observe the influence of the dengzhan shengmai capsule on the endpoint of patients with ischemic stroke, we hold the multi-centered prospective cohort study. from november 2007 to december 2009, 12000 subjects are included in 200 clinical research centers all over china. the subjects naturally formed two cohorts based on taking dengzhan shengmai capsule or not. the basic therapy included antiplatelet aggregation , stroke health education, management of blood pressure, blood lipid and blood glucose, etc. then all of the subjects are visited on the 360th day after inclusion. the recurrence of stroke, cardiovascular events, and peripheral arterial events are observed.


Eligibility criteria:
inclusion criteria: * 40-75 years old * ischemic stroke diagnosed by ct/mri scan * patient presenting from 14 days to 6 months of first onset of ischemic stroke. * presence of at least one risk factor of stroke (such as hypertension, diabetes mellitus, coronary heart disease, hyperlipidemia, and smoking, etc.)that can be interfered in. * informed consent. exclusion criteria: * silent cerebral infarction; * patients after vasculoplasty with intracranial artery stenosis. * watian drinking test≥grade 4. * mrs=grade 5. * cerebral infarction due to other causes except arterial sclerosis(i.e. cardiogenic embolism, arteritis, polycythemia vera, primary thrombocythemia, sickle-cell anemia,, thrombotic thrombocytopenia purpura, dic, cerebral amyloid angiopathy, moyamoya disease, intracranial vascular malformations etc); * presence of serious heart disease, heart, liver, lung, and kidney functional failure; malignancy; alimentary tract hemorrhage; * patients with mental disorder. * patients that cannot take medicine due to other causes * females during pregnancy or lactation. * already attend other clinical trial. * that unsuitable for clinical trial.
clinical study on autologous stromal vascular fraction(svf) treatment for refractory benign airway stenosis and respiratory tract fistula

Conditions: Benign Airway Stenosis; Respiratory Tract Fistula

Summary: benign airway stenosis and respiratory tract fistula are common types of airway injury. the diseases occurred after endogenous and exogenous stimuli (tuberculosis, tumor, surgery, tracheal intubation) causing damage to the airway mucosa, resulting in scar repair and irreversible loss of airway epithelium. autologous adipose vascular fraction (stromal vascular fraction, svf) is a mixture of cells obtained from adipose tissue through digestion and centrifugation, containing a variety of cell types, such as mesenchymal cells, endothelial progenitor cells, endothelial cells, pericytes, and macrophages. previous studies have shown that svf can achieve regeneration and wound healing through modulating the immune microenvironment, promoting angiogenesis, thereby promoting endogenous regeneration of the in situ adult stem cells. this project utilizes the tissue repair function of autologous svf to treat benign airway stenosis and respiratory tract fistula. to clarify the efficacy and safety of autologous svf in the treatment of airway injury.


Eligibility criteria:
inclusion criteria: * subjects aged between 18 to 75 * subjects diagnosed with benign airway stenosis, tracheoesophageal fistula(the sizes of the fistulas less than 2cm), and bronchopleural fistula * subjects willing to accept svf treatment * subjects tolerant to the bronchoscope * subjects signed informed consent exclusion criteria: * subjects with the following pulmonary diseases: asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, etc; * subjects with incomplete remission of malignant tumors or with incurable malignant tumors; * subjects with uncontrolled systemic infection; * subjects requiring anti-clotting drugs; * subjects with myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, etc; * subjects with syphilis, hiv, hbv, hcv antibody positive; * subjects with coagulation disorders such as hemophilia, giant platelet syndrome, thromboasthenia, etc; * subjects with severe renal damage, serum creatinine is more than 1.5 times the upper limit of the normal value; * subjects with liver disease or liver damage: alt, ast, total bilirubin \> 2 times the upper limit of the normal value; * subjects with a history of psychosis or suicide or epilepsy or other central nervous system diseases; * subjects with severe arrhythmias(e.g. ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or degree ii above abnormal conduction; * subjects allergic to thrombin; * subjects accepted by any other clinical study within the first three months of the study; * subjects with poor compliance; * any other conditions might increase the risk of the patient or interfere with the clinical study.

Keywords: stromal vascular fraction
validation of a kinetic model of erlotinib

Conditions: Lung Cancer

Summary: several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a pharmacokinetic (pk) has been prepared using data from the literature. this model must be validated at concentrations achieved in practice. this is a preliminary study before the implementation of a randomized trial confirming the therapeutic monitoring of erlotinib through this model.


Eligibility criteria:
inclusion criteria: * all patients receiving treatment with erlotinib monotherapy for locally advanced or metastatic nsclc either first line in patients with an activating mutation of the receptor egf-r or patients with stable disease after 4 cycles of standard first-line chemotherapy with platinum or after failure of at least one prior chemotherapy regimen * age\> 18 years * subject has signed an informed consent * treatment initiated for at least 7 days or dosage changed for at least 7 days exclusion criteria: * contraindication to the use of drug * subject to exclusion period (as determined by a previous study or in progress) * inability to give informed information (subject in emergency situations, difficulties in understanding the subject, ...) * subject under judicial protection * subject under tutorship or curatorship * pregnancy (and woman of childbearing age without contraception) * breastfeeding

Keywords: non-small cell lung cancer locally advanced or metastatic erlotinib monotherapy
today2 phase 1 immediate post-intervention observational follow-up study

Conditions: Diabetes Mellitus Type 2 in Obese

Summary: the purpose of this study is to continue to follow participants in the today clinical trial as they transition to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months (phase 1), during which time the today data are analyzed and findings interpreted to develop a long-term observational protocol (phase 2). data are collected during phase 1 for descriptive purposes; there is no primary hypothesis.

today (treatment options for type 2 diabetes in adolescents and youth) was a multi-center study of the optimal approach to treatment of type 2 diabetes (t2d) in children and adolescents. the today clinical trial of experimental interventions ended in february 2011. it is followed by today2, a longitudinal study to continue the care and observation of the today cohort beyond the end of the today intervention trial. today2 consists of two phases. 1. first is the immediate transition of today participants to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months. during this period, the findings of today are analyzed and interpreted by the study group. 2. the second phase is a protocol for long-term longitudinal follow-up of the today cohort, based on findings from today. the primary objective of the first phase of today2 is to continue to follow the today subjects for up to 24 months in order to begin to: * understand the persistence of the effects of the different treatment regimens used in today, * describe the continued evolution of beta cell function, and * describe the development of vascular complications and risk factors for complications.

Eligibility criteria:
inclusion criteria: * participated in the today clinical trial. * provided informed consent to participate in t2p1.

Keywords: type 2 diabetes mellitus pediatrics post-intervention study metformin complications