Kornimate/medical-research-clean huggingface dataset:
molecular characterization of acute erythroid leukemia (m6-aml) using targeted next-generation sequencing

Conditions: Acute Myeloid Leukemia

Summary: acute erythroid leukemia (ael) is a morphologically distinct, infrequent (o5%) acute myeloid leukemia (aml) designed as m6 in the french- american-british (fab) classification. the world health organization classification recognizes two subclasses, m6a, a leukemia with myeloid blast cells, and m6b, a very rare, purely erythroid aml. it may be difficult to distinguish between a myelodysplastic syndrome and ael because of the erythroblastic proliferation, which is increased when dysplasia is present. no recurrent cytogenetic abnormality is specific of ael and the prognosis is poor with a median survival of 17 months. a study of 14 genes in a series of 92 cases has shown that mutations are frequent in ael and somewhat differ from the other amls by the lower and higher proportion of flt3-itd and tp53 mutations, respectively. only three cases of ael are reported in the tcga database. to further characterize ael, determine whether it constitutes a distinct class of aml and document the reasons for its poor prognosis, the investigators will search for molecular alterations in 40 m6a-amls using array comparative genomic hybridization (acgh) and next-generation sequencing (ngs) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation.


Eligibility criteria:
inclusion criteria: * age\>18 year * diagnosis of aml6 * written consent obtained exclusion criteria: * no written consent * no frozen samples
clbr per initial cycle with different starting dose in aged patients with poor ovarian reservation: 300iu versus 150iu

Conditions: Infertility

Summary: among aged patients with poor ovarian reservation(defined as age 35 to 42 years; antral follicle count（afc）≤ 5 or anti-mullerian hormone（amh）≤ 1.2 ng/ml), cumulative live birth rate(clbr) and time to live birth(ttlb) of the first stimulation cycle were compared between a starting dose of 300iu or 150iu rfsh in controlled ovarian stimulation with gonadotropin-releasing hormone（gnrh）antagonist protocol. this study is a prospective randomized controlled trial.


Eligibility criteria:
inclusion criteria: 1. age limits≥35 and≤42； 2. afc≤5 or amh≤1.2ng/ml； 3. bmi≤30kg/m2； 4. the first ivf/intracytoplasmic sperm injection （icsi） cycle； exclusion criteria: 1. any other underlying disease or condition considered ivf is contraindicated. 2. ovarian hyperstimulation syndrome（pcos）, moderate or severe intrauterine adhesion，untreated hydrosalpinx, adenomyosis， any myoma in cases that endometrium was affected, intramural larger than 4cm. 3. autoimmune antibody positive, untreated. 4. history of recurrent miscarriages. 5. patients seeking for preimplantation genetic testing(pgt) treatment. 6. simultaneous participation in another clinical study. 7. according to the judgment of the investigator, any reason or condition that precludes subject for participating in the study.
the prevalence of serum thyroid hormone autoantibodies in autoimmune thyroid diseases

Conditions: Autoimmune Thyroid Disease

Summary: thyroid hormone autoantibodies(thaa) in serum can interfere radioimmunoassay for the determination of free thyroid hormones. thyroid function test plays a key role in the diagnosis and treatment of autoimmune thyroid disease (aitd), and abnormal examination results in misdiagnosis and mistreatment. at present, the epidemiological results of thaa in aitd are inconsistent, and the pathogenesis has not been clarified. however, there is no relevant research on thaa in china. this project intends to collect aitd patients and healthy people, detecting thaa, at the same time testing thyroid function and thyroid autoantibodies, definiting positive rate of thaa in aitd patients, observing the effect of common therapeutic drugs for aitd on thaa, investigating the rule of thaa influencing thyroid function test results .this project will provide the basis and method for how to effectively avoid thaa interfering with thyroid function test.


Eligibility criteria:
inclusion criteria: * male or female with hashimoto thyroiditis or grave's disease aged for 18 to 65 years old exclusion criteria: * had a thyroidectomy had a thyroid fine needle puncture biopsy autoimmune diseases take drugs that affect the immune system

Keywords: autoimmune thyroid disease thyroid hormone autoantibodies hashimoto's thyroiditis grave's disease
spinal cord stimulation in the treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: parkinson's disease affects between 100'000 and 150'000 people in france. drug therapy (l-dopa and other drugs) is effective to improve motor symptoms but after an initial 'honeymoon period' lasting a few years, motor symptoms reoccur in most patients, impairing gait and walking. spinal cord stimulation is currently an important therapeutic option in the treatment of neuropathic pain. experimental and limited clinical data suggest that this technique might also be used to alleviate motor symptoms and improve walking in parkinsons patients. this exploratory study aims at measuring the benefits of spinal cord stimulation on the walking capacity of a small number of parkinsons patients who are not adequately improved by drug therapy alone.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease since more than 5 years * walking disorder with freezing episodes, insufficiently alleviated by oral dopaminergic therapy and/or physiotherapy exclusion criteria: * atypical parkinson-like syndrome (e.g. progressive supranuclear palsy) * cognitive impairment (mmse\<24) * psychiatric disease * contraindication of surgery * neuropathic pain in the lower limb or lumbar region
acute immunological effects of exercise in cancer patients

Conditions: Cancer

Summary: the aim of the study is to evaluate and compare immune response to a single exercise intervention in cancer patients and healthy age-maged individuals.


Eligibility criteria:
inclusion criteria: * adolescents and young adults \>14 years of age * undergoing acute cancer treatment (chemotherapy) * signed informed consent exclusion criteria: * inability to follow and implement test instructions * medical contraindication to hiit on cycle ergometer * chemotherapeutic treatment 48 h prior * hb \<8g/dl; platelets \< 20,000/ul.
good prognosis factors after decompressive craniectomy : a ten-year retrospective study

Conditions: Decompressive Craniectomy; Brain Injuries; Treatment Outcome

Summary: decompressive craniectomy is a treatment of refractory intracranial hypertension after various etiologies : malignant ischemic stroke, traumatic brain injury, intraparenchymal hemorrhage, aneurysmal subarachnoid hemorrhage, cerebral venous thrombosis. initially considered as a lifesaving therapy, benefits in terms of survival were shown compared to medical treatment alone. however, despite a better survival, morbidity and poor neurological outcome are frequent among survivors. the objective of the study is to identify initial good neurological outcome factors after decompressive craniectomy in a large series of patients, in order to argue surgical and intensive care decisions, considering expected benefit and quality of life.


Eligibility criteria:
inclusion criteria: * patients undergoing a decompressive craniectomy from 06/11/2008 to 06/15/2018 in chru nancy, france. exclusion criteria: * infectious ou malignant disease leading to decompressive craniectomy.

Keywords: decompressive craniectomy outcome brain injuries aneurysmal subarachnoid hemorrhage cerebral venous thrombosis intracerebral hemorrhage ischemic stroke traumatic brain injury
infection prevention after tka with or without vancomycin

Conditions: Infection

Summary: prospective, randomized, double blinded trial comparing clinical, radiological and laboratory outcomes in prevention of infection after total knee arthroplasty with or without vancomycin.

infection after surgery is one of the most common complication after total knee replacement. our prospective randomized study is intended to show if addition of vancomycin to the joint before the wound closure will decrease infection after operation.

Eligibility criteria:
inclusion criteria: * gosnartrosis exclusion criteria: * no informed consent to participate in the study age under 40 multilligament injury or single plane knee instability another musculoskeletal disorders in lower limb asa score \> ii

Keywords: tka, vancomycin
effect of vitamin d supplementation on blood pressure and hba1c levels in patients with t2d

Conditions: Diabetes Mellitus Type 2

Summary: the effect of administration of vitamin d is tested on the long-term control of blood sugar (as measured by hba1-c levels in blood) and mean blood pressure (as measured by 24 hour blood pressure profiles)in patients with stable type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria * men and women, ages ≥18 years * official diagnostic criteria for type 2 diabetes fulfilled in patients on any type of oral or parenteral glucose-lowering treatment * independent living at home * on stable regimen of bp meds (if any) with bp well controlled and/or k supplement (if any) for 2 months and which is deemed unlikely to change during the study * stable glucose control for 2 months by any approved method including insulin exclusion criteria * patients with type 1 diabetes (or insulin-requiring diabetes of unclear type) * patients on hemodialysis, with hyperparathyroidism or active cancer disease * patients with known metabolic bone disease * laboratory evidence of kidney (egfr \< 60 ml/min) or liver disease * dietary calcium intake exceeding 1500mg/d (as estimated by dietary history) * 25(oh) vitamin d levels at baseline \> 70 nmol/l * calciuria (\> 8 mmol/24 hours as measured by 24 hour urine collections) * hypo- and hypercalcemias and hypo- and hyperphosphatemias of any cause * medications that affect vitamin d metabolism (e.g. antiepileptic drugs, calcimimetics, 1-34 pth (forsteo) vitamin d therapy over and above 400u daily 6 months prior to enrollment and during the study) * foreseeable need for adaptation of either glucose- or blood pressure lowering during the next 6 months as decided by the family physician or the treating diabetologist - see above * history of binge eating or wt gain or loss exceeding 6 kg in past 18 months * patients on any type of inhibitors of plasma coagulation (i.e. coumarine, heparins)

Keywords: vitamin d blood pressure typ 2 diabetes mellitus blood glucose hba1c
study of khk2375 in subjects with advanced or recurrent breast cancer

Conditions: Breast Cancer

Summary: the primary objective of the open-label, dose-escalation study is to investigate the safety of single-dose monotherapy and repeated-dose of khk2375 combined with exemestane in female subjects with advanced or recurrent breast cancer. the secondary objective is to investigate the pharmacokinetics and efficacy.


Eligibility criteria:
inclusion criteria: * postmenopausal women aged ≥ 20 and \< 75 years at the time of consent; * estrogen receptor positive and/or progesterone receptors positive; * her2-negative * nonresectable advanced or recurrent breast cancer previously treated with nonsteroidal aromatase inhibitor (ai), and planning to be treated with exemestane exclusion criteria: * radiation therapy or immuno therapy within 14 days before the first dose of investigational product; * chemotherapy, biological medicines, other pharmacotherapy or major surgery within 21 days before the first dose of the investigational product; * prior chemotherapies of ≥ 3 regimens for advanced or recurrent breast cancer; * ongoing treatment with other investigational product
trial of artemether-lumefantrine alone and in combination with ivermectin to reduce post-treatment malaria transmission

Conditions: Malaria

Summary: the purpose of this study is to determine the safety and impact of ivermectin, administered as single or repeated dose, in combination with artemether-lumefantrine in reducing the proportion of mosquitoes that survive and become infected after feeding on a blood meal from a malaria-infected individual.


Eligibility criteria:
inclusion criteria: * asymptomatically infected individuals with any p. falciparum parasite density exclusion criteria: * age \ 25 years * malaria parasite density ≥ 10,000 parasites/µl * clinical symptoms indicating severe malaria * axillary temperature ≥ 37.5°c * body mass index (bmi) below 18 or above 32 kg/m2 * haemoglobin concentration below 11 g/dl * taken ivermectin in the last three months * loa loa as assessed by questionnaire, clinical examination and parasitological assessments * for women: pregnancy or lactation * known hypersensitivity to al or ivm * history and/or symptoms indicating chronic illness * current use of tuberculosis or anti-retroviral medication * unable to give written informed consent * unwillingness to participate in two membrane feeding assays * travel history to angola, cameroon, chad, central african republic, congo, dr congo, equatorial guinea, ethiopia, gabon, nigeria and sudan. if a potential participant has ever visited one or more of these countries, he or she will not be eligible for enrolment. * history of cardiovascular disease. * taking drugs that are known to influence cardiac function and to prolong qtc interval, such as class ia and iii: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes - macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride. * known disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia. * taking drugs which may be metabolized by cytochrome enzyme cyp2d6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine).

Keywords: transmission anopheles
miles-4: study comparing gemcitabine and pemetrexed, with or without cisplatin, in patients with nonsquamous lung cancer

Conditions: Non-small Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Stage IIIB

Summary: the purposes of this study are to test whether the addition of cisplatin to single agent chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with non squamous non small cell lung cancer (nsclc), and to test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous nsclc.


Eligibility criteria:
inclusion criteria: * diagnosis of cytologically or histologically confirmed non-small cell lung cancer. * non squamous tumor type (including those with a non-specified tumor type). * metastatic (stage iv, both m1a or m1b) or locally advanced (stage iiib, with metastasis to supraclavicular nodes) according to tnm vii edition. * both patients at first diagnosis or those with disease recurrence after former surgery are eligible. * at least one target or non-target lesion according to recist revised version 1.1. * male or female \> or = 70 years of age. * ecog ps 0 or 1. * life expectancy \> 3 months. * neutrophils \> or = 1500 mm3, platelets \> or = 100000 mm3, and haemoglobin \> or = 9 g/dl. * bilirubin level either normal or \< 1.5 x uln. * ast (sgot) and alt (sgpt) \< or = 2.5 x uln (\< or = 5 x uln if liver metastasis are present). * serum creatinine \< 1.5 x uln. * signed written informed consent. exclusion criteria: * prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease. prior surgery and/or localised irradiation is permitted. prior adjuvant chemotherapy is permitted if it did not contain gemcitabine and pemetrexed and if at least 6 months elapsed from the end of adjuvant chemotherapy. * any unstable systemic disease (including active infections, significant cardiovascular disease or myocardial infarction within the previous year, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medications or render the patient at high risk from treatment complications. * any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal psa). * patients with symptomatic brain metastasis or spinal cord compression that has not yet been treated with surgery and/or radiation; patients with cns metastases or spinal cord compression previously treated with surgery and/or radiation are eligible if they are asymptomatic and do not require steroids (anti-seizure medications are allowed). * known or suspected hypersensitivity to any of the study drugs

Keywords: elderly chemotherapy
a multicenter phenotype-genotype analysis of lgmd patients in china

Conditions: LGMD; LGMDR2; LGMDR1

Summary: limb-girdle muscular dystrophies (lgmd) are a series of rare progressive genetic disorders that are characterized by wasting and weakness of the voluntary proximal muscles. the onset of the disease is usually at young age, and most patients will be wheelchair-bound due to the progressive deterioration. since currently genetic therapies for this disease are still immature, better natural history and genotype-phenotype studies are needed for preparing future therapies.

this is multicentered-based, prospective, and observational study, which mainly focuses on the diagnosis and progression of limb-girdle muscular dystrophies (lgmd) in china. the investigators collect patient data including basic information, strength evaluations, genetic data, electromyography results, pathology imaging from muscle biopsies, and mris. previously collected patient data may also be enrolled in this study.

Eligibility criteria:
inclusion criteria: * identified with variants regarding lgmd related genes revealed by genetic sequencing * progressive weakness involving shoulder girdle and/or pelvic girdle * myopathic changes in electromyography or in pathological studies exclusion criteria: * identified with variants in other genes (non-lgmd related) that may cause muscular dystrophies

Keywords: observational
is there a comorbidity between migraine and allergic rhinitis?

Conditions: Migraine; Allergic Rhinitis

Summary: the researchers investigated the relationship between migraine and allergy. for this purpose, the researchers designed a controlled study to evaluate nasal symptoms and signs; and to perform specific immunoglobulin e (ige) measurements in migraine patients and healthy subjects. according to these results the prevalence of allergic rhinitis in migraine group was planned to be compared to that of the healthy controls, statistically.


Eligibility criteria:
inclusion criteria: * patients with migraine exclusion criteria: * other neurologic disorders that may contribute to headaches, such as stroke, cerebral palsy, trigeminal neuralgia, and seizure disorder * also acute and chronic sinusitis.

Keywords: migraine allergic rhinitis specific immunoglobulin e (ige) nasal symptoms signs of allergy.
magzen® effect on recent anxiety reaction

Conditions: Anxiety Disorders

Summary: multicentres, observational study, prospective, to evaluate the effect of magzen® in the treatment of recent anxiety reaction.

107 patients suffering from recent anxiety reaction will be included in the study. they will be treated by magzen® during 4 weeks and we will study the effect of this treatment on the evolution of their anxiety after the cure.

Eligibility criteria:
inclusion criteria: * patient suffering from recent anxiety reaction * hamilton-anxiety score ≥ 20 at inclusion * recent anxiety disorders (less than 3 months) not treated by pharmacological or psychological treatment exclusion criteria: * major depressive syndrome * anxiety disorders more than 3 months * anxiety due to death
neoadjuvant therapy with proxalutamide combined with androgen deprivation therapy（adt）for high risk prostate cancer

Conditions: Neoadjuvant Therapy \High Risk Prostate Cancer

Summary: this trial aims to evaluate the efficacy and safety of neoadjuvant therapy with proxalutamide combined with androgen deprivation therapy（adt）for high risk prostate cancer ，this trial is a randomized, controlled, double-blind, single center.treatment cycle is 6 months,


Eligibility criteria:
inclusion criteria: 1. patients must participate voluntarily and sign an informed consent form (icf), indicating that they understand the purpose and required procedures of the study 2. patients must be ≥ 18，male 3. histopathological by prostate biopsy confirmed prostatic cancer（no neuroendocrine prostate cancer or small cell carcinoma） 4. high-risk prostate cancer (t2c≤ clinical stage ≤t4 or gleason score ≥8 or psa≥20ng/ml) 5. patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection 6. ecog ps：0-1 exclusion criteria: 1. imaging or biopsy confirmed distant metastatic lesion 2. the number of regional lymph nodes metastasis \>3 3. patients had undergone the treatment of systemic chemotherapy and endocrine therapy for prostate cancer 4. patients had undergone prostate surgery、radical radiotherapy or bilateral orchidectomy
the colonic transit time: a modifiable determinant of intestinal production and uptake of microbial metabolites?

Conditions: Constipation

Summary: chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. colonic transit time is an important determinant of intestinal generation and uptake of bacterial metabolites. however, it is unknown if accelerating the colonic transit time reduces the intestinal generation and uptake of indoxyl sulfate and p-cresyl sulfate. prucalopride is a selective, high-affinity 5-ht4 receptor agonist with a stimulating effect on colonic motility and transit. it is currently used in treating chronic slow-transit constipation. an observational study will be initiated in non-chronic kidney disease patients with chronic slow-transit constipation necessitating treatment with prucalopride to observe its effect on serum concentrations and intestinal generation of indoxyl sulfate and p-cresyl sulfate.


Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 85 years * chronic slow-transit constipation as defined be 4 criteria: 1. having two or fewer spontaneous complete bowel movements week for a minimum of 6 months 2. having one or more of the following symptoms for at least one-quarter of the time: lumpy/hard stools, a sensation of incomplete evacuation, or straining during defecation. 3. slow transit time as determined by rx colon transit study ("pellet") 4. without evidence of secondary constipation or primary defecation disorder * need of therapy with prucalopride (i.e., inefficacy of dietary changes and laxatives) * follow-up visit possible after 4 weeks of treatment * written informed consent exclusion criteria: * history or new diagnosis of organic intestinal disease (e.g., inflammatory bowel disease, malignancy) * secondary constipation (drug-induced, endocrine, metabolic or neurological disorders, surgery, known or suspected organic disorders of the large intestine, or megacolon) or primary defecation disorder * use of laxatives two days before start of treatment and during treatment period. if there is no spontaneous bowel movement during 3 consecutive days, rescue treatment with bisacodyl and/or enema is allowed if necessary * presence of significant co-morbidity (uncontrolled heart, liver and lung disease) * pregnancy * chronic kidney disease, i.e., estimated glomerular filtration rate (mdrd) \< 60 ml/min/m² or need of dialysis therapy