Kornimate/medical-research-clean huggingface dataset:
treating patients with childhood acute myeloid leukemia with interleukin-2

Conditions: Leukemia

Summary: the purpose of this study is to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival.

we designed an open randomized study to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival. a total of 580 patients will be accrued over 7 years. treatment consists in subcutaneous application of interleukin-2 in treating patients with complete remission by a monthly regimen of 5 days during 1 year after having received a chemotherapy consisting of 1 induction and 3 consolidation treatments.

Eligibility criteria:
inclusion criteria: * age: 0 to 18 years * prior untreated acute myeloid leukemia (aml) of following cytological types : fab m0, m1, m2, m4, m4 eosinophil, m5, m6, m7, without fab classification or showing myelodysplasia (blasts \> 20 %) * isolated myeloid sarcoma * achieved complete remission * no hla identical family donor, except for the patients with t(8;21) * no contraindication for the use of interleukin-2 exclusion criteria: * trisomy 21 * promyelocytic leukemia (m3) or m3 variations * secondary aml

Keywords: controlled multicenter international randomized study direct individual benefit complete remission after chemotherapy non allogeneic transplanted
safety and tolerability of hsc835 in patients with hematological malignancies undergoing single umbilical cord blood transplant

Conditions: Single Umbilical Cord Blood Transplantation; Non-myeloablative Conditioning; Acute Lymphocytic Leukemia; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia

Summary: this study was designed to evaluate the safety and tolerability of hsc835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (ucb) transplantation (ducbt) with non-myeloablative (nma) conditioning.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis that qualifies them for ucbt * adequate organ function * availability of eligible donor material exclusion criteria: * pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used * human immunodeficiency virus (hiv) infection * active infection

Keywords: hsc835 single umbilical cord blood transplantation non-myeloablative conditioning regimen umbilical cord blood ucb transplantation
study of cs-3150 in patients with primary aldosteronism

Conditions: Primary Aldosteronism

Summary: to examine antihypertensive effect and safety of cs-3150 in patients with primary aldosteronism.


Eligibility criteria:
inclusion criteria: * male and female subjects aged 20 years or older at informed consent * patients diagnosed primary aldosteronism by screening test of plasma aldosterone concentration (pac) and aldosterone to renin ratio (arr), and confirmatory testing * patients satisfying following blood pressure; * sitting systolic blood pressure (sbp) ≥ 140 mmhg and \<180 mmhg * sitting diastolic blood pressure (dbp) ≥ 90 mmhg and \<110 mmhg exclusion criteria: * secondary hypertension except primary aldosteronism or hypertensive emergency * patients diagnosed diabetic nephropathy * patients with type 1 diabetes * estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m2 * serum potassium level \< 3.0 or ≥ 5.1 milliequivalent (meq)/l

Keywords: primary aldosteronism hypertension mineralocorticoid receptor antagonist developmental phase iii
nab-paclitaxel in combination with carboplatin as first-line therapy in patients with nsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a single-arm non-interventional study (nis) to evaluate the effectiveness, safety and quality of life (qol) in patients with advanced nsclc receiving the combination of nab-paclitaxel and carboplatin as first line palliative therapy in a real life setting.

the present nis is designed to provide additional knowledge in terms of effectiveness, safety and quality of life in routine administration of the combination of nab-paclitaxel (abraxane®) and carboplatin as first line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) who are not candidates for potentially curative surgery and / or radiation therapy. the combination of abraxane® and carboplatin has been approved in europe in march 2015 based on results from a pivotal randomized, open label phase iii study with 1,052 patients.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of locally advanced / metastatic, unresectable nsclc * according to smpc exclusion criteria: * according to smpc

Keywords: metastatic locally advanced unresectable nsclc
studying dexamethasone and prednisone sensitivity in samples from younger patients with high-risk b-cell precursor acute lymphoblastic leukemia

Conditions: Leukemia

Summary: rationale: studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research trial is studying dexamethasone and prednisone sensitivity in samples from younger patients with high-risk b-cell precursor acute lymphoblastic leukemia.

objectives: * identify differences in the effect of dexamethasone (dex) and prednisone (pred) on glucocorticoid receptor (gr) occupancy and gene expression in high-risk (hr) b-cell precursor (bcp)-acute lymphoblastic leukemia (all) samples from patients aged 1-9. * identify differences in gene expression and gr occupancy of response elements in hr bcp-all patients \> 10 years old in response to both dex and pred. outline: archived samples are analyzed for gene expression analysis and genomic location of glucocorticoid receptor by chip sequencing (chipseq) and rna sequencing. data of gene expression and chipseq data sets are compared by luciferase reporter assay.

Eligibility criteria:
disease characteristics: * patients diagnosed with high-risk b-cell precursor acute lymphoblastic leukemia * samples from patients treated and not treated with dex and pred patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: b-cell childhood acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia
a study to evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan in healthy male volunteers

Conditions: Essential Hypertension

Summary: to evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan.


Eligibility criteria:
inclusion criteria: * age: 20 - 45 years * sex: male * body weight: greater than 55 kg * written informed consent exclusion criteria: * known allergy to fimasartan, ketoconazole and rifampicin * existing cardiac or hematological diseases * existing hepatic and renal diseases * existing gastrointestinal diseases * acute or chronic diseases which could affect drug absorption or metabolism * history of any serious psychological disorder * positive drug or alcohol screening * smokers of 10 or more cigarettes per day 3 month ago * participation in a clinical trial during the last 2 months prior to the start of the study
efficacy and safety study of hs-25 in chinese adults with primary hypercholesterolemia

Conditions: Primary Hypercholesterolemia

Summary: to determine the efficacy of hs-25 (20mg) in reducing low density lipoprotein-cholesterol (ldl-c) levels after a 12-week period of treatment in adults with primary hypercholesterolemia; to determine the safety of hs-25 (20mg) in subjects with ldl-c

this is a 12-week, randomized, double-blind, placebo-controlled study designed to assess the effects of the cholesterol absorption inhibitor hs-25 on ldl-c levels in adults who have untreated ldl-c levels ranging from 3.36-4.88mmol/l(130-189 mg/dl)and fasting triglyceride levels \< 350 mg/dl. eligibility is restricted to 18-75 years old men or women who are using a highly effective birth control method or are not of childbearing potential. patients with diabetes, a history of myocardial infarction or other clinical evidence of atherosclerotic vascular disease are not eligible for participation in the study.

Eligibility criteria:
inclusion criteria: * subjects who are 18 to 75 years of age, male or female using a highly effective birth control method or not of child-bearing potential, at visit 1 (screening visit). * ldl-c 130 to 189 mg/dl (inclusive) on a cholesterol lowering diet but no lipid modifying drug treatment for at least 6 weeks. * a qualifying ldl-c value must be obtained at the beginning and end of the placebo run-in (visit 2 and visit 3) and the visit 3 value must be within 12% of the value at visit 2, higher or lower; the average of both qualifying values must be in the range of 130 to 189 mg/dl (inclusive) for inclusion in the study. * tg ≤ 350 mg/dl on a cholesterol lowering diet but no lipid modifying drug treatment for at least 6 weeks and tg levels must be ≤ 350 mg/dl at both visit 2 and visit 3 * signed written informed consent. exclusion criteria: * liver transaminases \> 1.5 x upper limit of normal. * homozygous familial hypercholesterolemia. * subject who was diagnosed as diabetes with aged greater than 40 years old. * subject who was diagnosed as diabetes with one of the following of cardiovascular risk factorss: hypertention bp ≥ 140/90mmhg,or smoking, or low hdl-c (1.04mmol/l), or bmi≥28kg/m2. * women who are pregnant or breast feeding. * atherosclerotic cardiovascular disease including arteriosclerotic heart disease, acute coronary syndrome，coronary artery bypass graft,coronary angioplastyperipheral arteriosclerosis,cerebrovascular accident * history of severe endiocrine disease (for example thyroid function abnormal) * history of a positive test for human immunodeficiency virus, hepatitis b or hepatitis c. * history of advanced cancer * arrhythmias need to be treated by medications * had severe injured or surgery in 6 months before study start. * hypersensitive to hs-25 or place. * history of intolerance to ezetimibe. * participation other studies in three months. * treatment with a fibric acid derivative (eg, fenofibrate, gemfibrozil), probucol, warfarin, systemic corticosteroid, cyclosporine or other immunosuppressant agent within the prior 12 weeks.
treatment of newly diagnosed peripheral t-cell lymphoma

Conditions: Newly Diagnosed Peripheral T-cell Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of apatinib combined with chop regimen(cyclophosphamide, vincristine, epirubicin, prednisone in the treatment of newly diagnosed peripheral t-cell lymphoma.

patients with peripheral t-cell lymphoma usually have a bad prognosis. these patients cannot be treated successfully with the conventional chop regimen. apatinib is a small-molecule multitargeted tyrosine kinase inhibitor. the investigators have been proceeding this trial to evaluate the efficacy and safety of the apatinib combined with chop regimen(cyclophosphamide, vincristine, epirubicin, prednisone in the treatment of newly diagnosed peripheral t-cell lymphoma.

Eligibility criteria:
inclusion criteria: * age range 14-70 years old; ecog performance status 0-2. * estimated survival time \> 6 months. * histological confirmed peripherial t-cell lymphoma. * have taken no treatment. * none of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/l, platelet ≥ 100×109/l, alt and ast ≤ 2×uln, serum bilirubin ≤ 1.5×uln, serum creatine ≤ 1.5×upper limitation of normal (uln), serum albumin ≥ 30g/l, serum plasminogen is normal. * at least one measurable lesion. * none of other serious diseases, cardiopulmonary function is normal. * pregnancy test of women at reproductive age must be negative. * patients could be followed up. * none of other relative treatments including the traditional chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments. * volunteers who signed informed consent. exclusion criteria: * patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, 30 days after major surgery, hypertension uncontrollable drugs, grade iii-iv cardiac insufficiency, severe liver and kidney dysfunction); * abnormal coagulation (inr \> 1.5 or prothrombin time (pt) \> uln + 4 seconds or aptt \> 1.5 uln), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy； * urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g; * disagreement on blood sample collection. * patients allergic of any of drug in this regimen or with metabolic disorder. * pregnant or lactating women. * serious medical illness likely to interfere with participation. * serious infection. * primitive or secondary tumors of central nervous system. * chemotherapy or radiotherapy contraindication. * the evidence of cns metastasis. * history of peripheral nervous disorder or dysphrenia. * patients participating in other clinical trials. * patients taking other antitumor drugs. * patients estimated to be unsuitable by investigator.

Keywords: peripheral t-cell lymphoma apatinib targeted therapy rr pfs
metal-metal articulations versus standard 28 mm cementless total hip arthroplasty

Conditions: Osteoarthritis, Hip

Summary: younger hip patients often need revision of their hip replacement due to wear and loosening. newer concepts (resurfacing and large head total hip replacement) with articulation surfaces in metal may reduce the wear, increase the longevity of the implant and give an improved function. the possible downside is that these concepts releases metal debris to the body. the investigators wish to see if the newer interventions are a clinical improvement compared to standard. the investigators also wish to investigate the extent of metal released to the body and any effect on the immune system. finally the investigators wish to investigate the stability of these new implants and their ability to preserve the bone around the implant. the investigators hypothesis is: that the metal on metal articulations will not have better clinical outcomes than standard the resurfacing implant is expected to preserve the bone of the upper femoral bone. the implants are expected to be stabile within the first year.


Eligibility criteria:
inclusion criteria: * primary hip osteoarthritis * secondary osteoarthritis due to mild dysplasia * age from 40 to 65 years exclusion criteria: * dysplasia with ce angle \< 25 degrees on the ap projection * severe femoral head deformation * reduced femoral neck length * leg length discrepancy more than 1 cm * need for restoration of offset * deformation after fractures or earlier osteotomies * a previous hip arthroplasty * inflammatory arthritis * endocrinological disease with bone metabolic manifestations * renal disease * malignant disease * neuro/muscular or vascular diseases of the affected leg * osteoporosis * use of opioid pain killers due to other diseases * high dose corticosteroids * obese with bmi \> 35 * pregnant or planning to be * ppresented problems that would prevent completing our follow-up program

Keywords: arthroplasty, replacement, hip bone density rehabilitation t-lymphocytes chromium alloys
botulinum toxins intralesional injection for scar pain

Conditions: Scar Keloid; Hypertrophic Scar

Summary: botulinum toxins has been approved by the fda to treat chronic migraine. botox had been shown to inhibiting the release of inflammatory mediators and peripheral neurotransmitters from sensory nerve to treat neuropathic pain. in the clinical practice, botox indeed effect in scar pain. however, investigators need well controlled study to prove this finding and assess the improvement of scar appearance.

after surgery or trauma, scar tissues would form during the healing process. however, hypertrophic scars and keloids might happen to some patients, both of which are often pruritic and erythematous. besides, the markedly elevated tumor-like appearance usually brings much concern to patients. moreover, significant pain or discomfort could happen to keloids. various treatment strategies were mentioned but without a solid solution to all of the scars. investigators hope to evaluate the differences of scar volume, appearance and symptoms (itching and pain) in participants receiving simultaneous intralesional injection of botulinum toxin type a and/or steroids. besides, side effects would also be recorded. investigators hope to establish a more effective intralesional injection therapy for participatns suffering from hypertrophic scars and keloids.

Eligibility criteria:
inclusion criteria: 1. patients have visible hypertrophic scars or keloids over three months after trauma or surgery. 2. patients have symptoms of pain, itching or erythema. exclusion criteria: 1. patients had either botulinum toxin type a or triamcinolone intralesional before in the same scar 2. the scar size is larger than 10 cm2 3. immunocompromised status 4. systemic infection status 5. allergic to botulinum toxin type a or steroids

Keywords: botulinum toxin type a triamcinolone scar pain scar itch
virtual walking for neuropathic pain in spinal cord injury

Conditions: Spinal Cord Injury; Neuropathic Pain

Summary: spinal cord injury neuropathic pain (sci-np) is a common problem, and when severe, is one of the most problematic of secondary conditions that is minimally to modestly responsive to currently available treatments. it is usually described as burning or stabbing, and is located at or below the level at which their sensation changes from normal to impaired; persons with no feeling at all in their legs for example can experience pain in the legs. the purpose of this project is to further investigate the use of a novel visual stimulation treatment; a technique that has shown benefit in other populations with chronic pain secondary to deafferentation. to accomplish this, a novel treatment - virtual reality (vr) walking - will be examined. should this treatment show benefit, a portable, accessible means of treatment will be available for persons with sci and for whom transportation to health care providers is often difficult.

this treatment will be investigated in two-phase project: phase 1: determine the efficacy of vr treatments as a home-based approach and determine the effect of vr treatment on reversal of maladaptive cortical reorganization associated with sci-np, as has been shown in other populations with neuropathic pain secondary to deafferentation. phase 2: determine the effectiveness and immediate analgesic effect of vr treatment among persons with both tetraplegia and paraplegia. the primary outcome variable of this research is the severity of sci-np with a secondary outcome of level of pain interference with daily activities. in the phantom pain literature for persons with amputations, treatment paradigms based on visual stimulation, called mirror therapies, have proven helpful. these approaches involve the person viewing a mirror image of their intact limb to produce the visual illusion of a return of the missing limb, often with a marked reduction in pain following. investigations have demonstrated that such approaches reduce pain in some individuals and that this change is associated with reversal of the functional reorganization in the somatosensory cortex. there has been one study of neuropathic pain in sci that demonstrated good neuropathic pain relief with a mirror image of the upper half of the individual with sci with the lower half of their body represented by a rear projection screen generated image of walking legs. we have collaborated with this author, and developed and pilot tested a virtual walking dvd that is presented via virtual reality goggles to enhance the first person sense of immersion. results were sufficiently encouraging to cause us to seek funding for current, broader project

Eligibility criteria:
inclusion criteria: traumatic onset sci, at least three months post onset, between 19 and 65; at least 6th grade reading level; neuropathic pain averaging at least 4/10. - exclusion criteria: unable to independently transfer to the fmri scanning table, current pressures sores, contraindications to scanning; non-compliance with a pre-assignment task. -

Keywords: spinal cord injury neuropathic pain
to evaluate the efficacy and safety of maxiocel versus aquacel extra for the management of chronic wounds

Conditions: Wound

Summary: the objective of this study is to evaluate the efficacy and safety of maxiocel vs aquacel extra in the management of exuding ulcers/wounds over a period of 4 weeks

the current study intends to compare the efficacy of the chitosan wound dressing (maxiocel) with another marketed dressing (aquacel extra). maxiocel is made up of chitosan and aquacel extra with carboxymethyl cellulose. both are polymeric dressings.

Eligibility criteria:
inclusion criteria: * male or female 18 years old or above (till 80 years) * patients who are willing to sign the written informed consent * clinically diagnosed with an unhealed or non-healing diabetic foot ulcer / venous ulcer / arterial ulcer / other ulcers / wounds, etc. * wound duration between 1 to 24 months * a target wound area between 1 cm2 and 50 cm2 * exuding wounds / ulcers exclusion criteria: * known allergy/hypersensitivity to the dressing * pregnant women * underlying or diagnosed with serious diseases or deemed unsuitable for this clinical study by the study's clinician * dry wounds * being treated with a high dose of steroids or immunosuppressant therapy or systemic antibiotics * presenting a progressive neoplastic lesion treated with radiotherapy or chemotherapy * patients who had deep vein thrombosis in the previous 3 months * ulcers with clinical signs of infection or erysipelas of the lower limb or biofilm * subjects included in clinical study at present or during the past 30 days * clinical suspicion of osteomyelitis