Kornimate/medical-research-clean huggingface dataset:
allogeneic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia

Conditions: Lymphoblastic Leukemia, Acute, Childhood;

Summary: with this protocol the all-szt bfm international study group wants to evaluate whether hematopoietic stem cell transplantation (hsct) from matched family or unrelated matched donors (md) is equivalent to the hsct from matched sibling donors (msd). to evaluate the efficacy of haematopoietic stem cell transplantation (hsct) from mismatched family or unrelated mismatched donors (mmd) as compared to hsct from matched sibling donor (msd) and matched donor (md). to determine whether therapy has been carried out according to the main haematopoietic stem cell transplantation (hsct) protocol recommendations. the standardisation of the treatment options during haematopoietic stem cell transplantation (hsct) from different donor types aims at the achievement of an optimal comparison of survival after hsct with survival after chemotherapy only. to prospectively evaluate and compare the incidence of acute and chronic graft- versus-host-disease (gvhd) after haematopoietic stem cell transplantation (hsct) from matched sibling donor (msd), from matched donor (md) and from mismatched donor (mmd).

patients with high risk or relapsed acute lymphoblastic leukaemia (all) have a worse prognosis compared to all other patients with all. for these patients additional therapy approaches are required after they have achieved remission with multimodal chemotherapy. allogeneic haematopoetic stem cell transplantation shows promising results mainly due to an immunological antileukaemic control by the graft-versus-leukaemia effect, but treatment related mortality and morbidity remains a serious problem.

Eligibility criteria:
inclusion criteria: * age at time of initial diagnosis or relapse diagnosis, respectively under or equal 18 years * indication for allogeneic hematopoietic stem cell transplantation (hsct) * complete remission before hematopoietic stem cell transplantation (hsct) * written consent of the parents (legal guardian) and, if necessary, the minor patient via informed consent form * no pregnancy * no secondary malignancy * no previous hematopoietic stem cell transplantation (hsct) * hematopoietic stem cell transplantation (hsct) is performed in a study participating centre. exclusion criteria: * age at time of initial diagnosis or relapse diagnosis, respectively above 18 years * no indication for allogeneic hsct * no complete remission before sct * no written consent of the parents (legal guardian) and, if necessary, the minor patient via informed consent form * pregnancy * secondary malignancy * previous hsct * hsct is not performed in a study participating centre.

Keywords: all hsct children adolescents
clinical and radiological outcomes of medacta shoulder system

Conditions: Primary Osteoarthritis; Secondary Osteoarthritis; Rotator Cuff Tear Arthropathy; Rheumatoid Arthritis Shoulder; Avascular Necrosis; Fracture; Revision of Shoulder Arthroplasty

Summary: this is a post-marketing surveillance on medacta shoulder system


Eligibility criteria:
inclusion criteria: * patients older than 18 years * patient with one of the following diagnosis: primary osteoarthritis secondary osteoarthritis cuff tear arthropathy; insufficient rotator cuff acute fracture (\<21d) rheumatoid or inflammatory arthritis avascular necrosis other posttraumatic condition revision of shoulder arthroplasty exclusion criteria: * patients with malignant diseases (at the time of surgery) * patients with proven or suspect infections (at the time of surgery) * patients with functional deficits other than dysfunction of the shoulder (at the time of surgery) * patients with known incompatibility or allergy to products materials (at the time of surgery)
synek score to predict poor neurological outcome post resuscitated cardiac arrest

Conditions: Prediction by the Synek Score of Poor Neurological Outcome in Postanoxic Comatose Patients Treated With Induced Hypothermia

Summary: resuscitated cardiac arrest (ca) is a frequent cause of admission in intensive care unit (icu). neurological state of postanoxic comatose patients can evolve either towards the absence of awakening or towards a more or less altered state of consciousness, ranging from the vegetative state to the full recovery of cognitive functions. most of the deaths result from active withdrawal of life-sustaining treatment, based on poor neurological outcome prediction. neurological prognostication needs therefore a multimodal approach based on reliable parameters, which should be easy to access and available at the early stage of care, in attempt to limit false poor outcome prognostication and help to not prolong futile active care in patient with severe post anoxic cerebral lesions. nowadays the prediction of neurological outcome relies on a multimodal strategy including clinical examination, biomarkers and electroencephalography (guidelines esicm 2015). early standard electroencephalography (eeg) is currently recommended and some features, notably absence of reactivity, status epilepticus or burst suppression after rewarming are strongly predictive of poor outcome. but those features require a precise analyze of the eeg usually performed by specialist. eeg patterns can be simplified and classified in five grades according to the synek classification, ranging from dominant reactive alpha activity (grade 1) to isoelectric encephalogram (grade 5). grade 1 and two are considering as good prognostic, grade 3 as intermediate and grade 4 to five as poor prognostic. nevertheless, few data are available on the performance of this classification since generalization of ttm use. we hypothesize that a multimodal strategy combining clinical examination, nse concentration and the synek score would bring a high degree of prediction. we aimed to assess the performances of the combination of clinical examination, nse analysed at 48-72h and the synek score to predict hard outcome defined by a cerebral performance category (cpc) 3-5, in postanoxic comatose patients treated with induced hypothermia


Eligibility criteria:
inclusion criteria: * patients admitted in our icu following a resuscitate cardiac arrest between november 1, 2013 to november 1, 2017 * treated with 33° induced hypothermia for 24 h * having at least one early eeg rated according to synek score * available dosage of nse performed within 48-72h post ca exclusion criteria: * moribund patients * awoke within the first 48 hours of admission * neurologic causes of ca * patients with missing data

Keywords: synek score electroencephalography cardiac arrest
biomarkers for fatigue in patients with myasthenia gravis

Conditions: Myasthenia Gravis

Summary: rationale: myasthenia gravis (mg) is a chronic autoimmune disease affecting the neuromuscular junction. although a hallmark of mg is muscle fatigability due to dysfunction of the neuromuscular junction (peripheral fatigue), a large number of mg patients also report symptoms of central or cognitive fatigue. central fatigue is defined as an experienced lack of energy, physically and/or mentally. in october 2019 we performed a cross-sectional survey study (p15.287) among 420 dutch mg patients showing a clinically relevant central fatigue rate of 62% on the checklist individual strength-fatigue subscale (cis-f). in this prior study, we identified a number of factors associated with fatigue, but these factors cannot fully explain the observed high prevalence of fatigue in mg and very little is known on its biological substrates and pathophysiology. objectives: the main objective is to investigate if there are biomarkers for fatigue in mg. the secondary objective is to investigate the muscle origin of these biomarkers. study design: this study will be an exploratory study, subdivided in part i and part ii (optional). study population: patients with myasthenia gravis recruited after previous participation in the cross-sectional fatigue survey study (p15.287). intervention: phase i: visit 1, time: 0 * blood withdrawal * muscle biopsy (not mandatory for participation) * qmg * questionnaires on medication, disease severity, fatigue, depressive symptoms and physical condition phase ii (optional): visit 2, time: 6-12 months after visit 1, after analysis of phase i results. * blood withdrawal (similar analysis as phase i) * qmg * questionnaires on medication, disease severity, fatigue, depressive symptoms and physical condition


Eligibility criteria:
inclusion criteria: * male of female patients aged ≥ 18 years * subjects must understand the requirements of the study and provide written informed consent. * diagnosis of mg: * clinical signs or symptoms characteristic for mg and * a positive serologic test for achr antibodies exclusion criteria: a medical history of other active auto-immune disorders for which the patient currently receives a medical treatment, such as thyroid disease or rheumatoid arthritis. * a medical history of neoplasms within the last year. * substance abuse. exclusion criteria for muscle biopsy * the use of anticoagulants therapy. * allergy for lidocaine
v-chordal adjustable system for chordal replacement in mitral valve insufficiency due to leaflet prolapse

Conditions: Mitral Leaflet Prolapse

Summary: the v-chordal system is a new technology for mitral repair. the valtech v-chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation. the adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.


Eligibility criteria:
inclusion criteria: * age \> 18 years * degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to esc or acc/aha guidelines. * patient able and willing to return to the implant center for follow-up visits * able and willing to give informed consent and follow protocol procedures. exclusion criteria: * inadequate echocardiographic window for transthoracic imaging * severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus. * evolving endocarditis or active endocarditis in the last 3 months. * heavily calcified annulus or leaflets. * congenital malformation with limited valvular tissue * patient requires mitral valve replacement. * previously implanted annuloplasty ring/band. * patient requires aortic or pulmonic valve replacement or repair. * patient is pregnant (urine hcg test result positive) or lactating. * patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk. * life expectancy of less than twelve months. * patient is participating in concomitant research studies of investigational products.

Keywords: heart disease device mitral valve leaflet prolapse heart valve disease cardiovascular disease neochordae
low intracranial pressure treatment strategies for chronic subdural hematoma patients

Conditions: Chronic Subdural Hematoma

Summary: the proportion of the elderly population is increasing rapidly. chronic subdural hematoma has become the most common cause of surgery in neurosurgery for elderly patients. the standard treatment for csdh is mostly surgery. clinically, we often encounter elderly patients with certain underlying diseases or organ dysfunction, especially preexisting cardiovascular disease or medication history like anticoagulant or antiplatelet drugs, resulting in poor surgical tolerance, high risk during anesthesia and hematoma recurrence. at present, the mechanism of csdh is not completely clear. our previous observational studies had shown significant correlation between csdh and intracranial hypotension. so we would like to conduct a randomized, controlled, multi-center clinical study to explore the effectiveness and safety of low intracranial pressure treatment strategies for patients with chronic subdural hematoma.


Eligibility criteria:
inclusion criteria: * patients above 14 yrs with chronic subdural hematoma confirmed by cranial imaging; * patients with mgs-gcs score ≤1 point, showing no signs of neurological deficits caused by csdh or characteristics of high intracranial pressure; * patients with mgs-gcs score ≥1 point, but with medication history of anticoagulant or antiplatelet drugs, coagulation dysfunction so that they are unsuitable or intolerant of surgery although they are in stable condition; * patients who are unwilling to operate when they have no life-threatening brain herniation or no indications for emergency surgery, which confirmed by two neurosurgeons exclusion criteria: * women pregnant or in lactation * those who are allergic to atorvastatin, hypoxamethasone; * patients with brain herniation or altered mental status; * patients with primary diseases like tumors, hemorrhagic diseases or some other critically serious conditions( eg.multiple organ failure); * patients with uncontrollable diabetes and heart failure * patients with preexisting chronic abdominal diseases (such as inflammatory bowel disease) or lung tumors or digestive system neoplasm * patients with abnormal liver function * patients had taken atorvastatin or dexamethasone, acei in the past one week * other conditions not eligible to enroll the trial confirmed by two individual doctor

Keywords: low intracranial pressure
study evaluating the effects of dvs sr and paroxetine on the pharmacokinetics of desipramine in healthy subjects

Conditions: Depression

Summary: the purpose of this study is to evaluate the effects of multiple doses of dvs sr and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy men and women between 18 to 55 years of age * healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and 12-lead electrocardiogram (ecg) * history of being a nonsmoker for at least 1 year other inclusions apply. exclusion criteria: * presence or history of any disorder or significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic condition, and any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure) or psychiatric disease * known or suspected alcohol abuse or consumption of more than 2 standard units per day within the past 6 months * use of any over-the-counter, prescription, hormonal therapy or investigational medications within 30 days of study day-1 until the end of the study other exclusions apply.

Keywords: healthy subjects major depressive disorder depression
a pilot clinical study evaluating the effect of parathyroid hormone (pth) lowering on erythropoietin consumption in calcitriol-resistant patients

Conditions: Moderate to Severe Secondary Hyperparathyroidism; Stage 5 Chronic Kidney Diseases

Summary: to evaluate the effect of pth lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.


Eligibility criteria:
inclusion criteria: a subject will only be included if all the following entry criteria are met: * patients ≥ 18 years of age * stage 5 chronic kidney disease (ckd) patients receiving hemodialysis and with moderate to severe secondary hyperparathyroidism (shpt) * patients with anemia due to renal insufficiency but who are iron replete:; transferrin saturation (tsat) \> 20% and ferritin levels \> 200 ng/ml and requiring treatment with erythropoietin (epo) * patients with vitamin b levels \> lower limit of normal (lln) and folic acid levels \> lln * patients treated only with intravenous calcitriol for at least 6 months * patients with serum intact parathyroid hormone (ipth) level \> 500 pg/ml * patients with calcium phosphate product (ca × po4) \< 65 mg²/dl² * patients willing to sign "written informed consents" before participating in any the study related activity. * patients with phosphorus levels \< 6.5 mg/dl and calcium levels \< 11.2 mg/dl exclusion criteria: a subject will be excluded from the study if he/she meets any of the following criteria: * patients who have known hypersensitivity and/or toxicity to vitamin d metabolites and/or to paricalcitol and/or to other product ingredients. * patients who have participated in a clinical study within the last month. * patients whose previous concomitant medication and laboratory data for 6 months prior to the baseline visit are not available. * patients with known contraindication to selective vitamin d receptor activators (vdras) according to the summary of product characteristics (smpc). * pregnancy, breast-feeding or planning a pregnancy within next 6 months after enrollment. sexually active female patients not accepting appropriate contraceptive methods during the course of the study will also be excluded. * hypertensive and diabetic patients who are not on an optimal and steady medication regimen for more than 30 days. * patients with microcytic (mean corpuscular volume \[mcv\] \ 100 fl) anemia at screening that may be caused by diseases such as for microcytic anemias - iron deficiency, thalassemias, anemia of chronic disease, copper deficiency, zinc poisoning, sideroblastic anemia, macrocytic anemias -ethanol abuse, myelodysplastic syndromes, acute myeloid leukemias, reticulocytosis, drug induced anemia, liver disease.

Keywords: hemodialysis chronic kidney disease secondary hyperparathyroidism,
real world testing and cost-effectiveness analysis of subcutaneous eeg

Conditions: Epilepsy

Summary: the study will investigate whether a novel method to accurately count epileptic seizures, using a ce-marked minimally-invasive ultra long-term subcutaneous electroencephalography (eeg) solution (uneeg™ subq , including 24/7 eeg subq), (i) is more accurate than a participant-reported seizure diary; (ii) is feasible and acceptable to participants and clinicians; (iii) reduces impacts of epilepsy and improves quality-of-life; and (iv) provides gains to the healthcare system when rolled-out into the national health service (nhs). 33 participants with drug-resistant epilepsy will be implanted with the uneeg™ subq device and will collect data for six months. annotated seizures from the eeg data will be sent weekly to the treating clinicians, who will communicate with the participants on a monthly basis, and will be free to make any management changes.


Eligibility criteria:
key inclusion criteria: * have given written informed consent * diagnosis of treatment-resistant epilepsy of any syndrome in which seizures are detectable in scalp eeg with two electrodes. * adults (≥18 years of age) * participant routinely keeps a seizure diary, has a smartphone and is willing to use the electronic diary for the study. * experiencing ≥10 seizures per year according to their existing seizure diary. * willing and able to comply with study procedures key exclusion criteria: * established current diagnosis of psychogenic non-epileptic attacks (dissociative seizures) * frequent vigorous involuntary movements (eg. chorea, athetosis) or frequent parasomnias with major motor components (eg. sleep walking, night terrors)

Keywords: epilepsy eeg subcutaneous eeg mobile devices wearable devices
endoscopic ultrasound-guided large diameter lumen-apposing metal stent gastro-gastrostomy for bypass reversal in patients with roux-en-y gastric bypass

Conditions: Hypoglycemia; Gastric Outlet Obstruction; Steatohepatitis; Parenteral Support; Gastric Bypass

Summary: the primary objective of this open-label pilot study is to investigate whether an endoscopically placed lumen apposing metal stent is an effective alternative to surgery in patients that have a clear indication for reversal of their gastric bypass.


Eligibility criteria:
inclusion criteria: * group 1) patients needing any kind of parenteral nutritional support (eg. hypo- albuminemia, hypovitaminoses, mineral deficiencies,...) that can not be corrected by dietary intervention/oral supplementation * group 2) patients with persistent invalidating symptomatic dumping syndrome despite optimal dietary intervention (typical complaints are headache, sweating, trembling, weakness and feeling hungry). * group 3) patients with a refractory marginal ulcers with stenosis of the gastrojejunostomy leading to feading difficulties. * group 4) patients with f3 or f4 liver fibrosis and a tendency to decompensation after bypass surgery, as demonstrated by an increase in serum bilirubin/inr and/or lowering of serum albumin. exclusion criteria: 1. uncorrectable coagulopathy 2. presence of significant portal hypertension as demonstrated by 2.1) the presence of esophageal and/or gastric varices and/or 2.2) a hepatic venous pressure gradient (if measured) equal to or more than 10mm hg and/or 2.3) the combination of 1. a platelet count \<150000/µl and 2. liver stiffness measured by elastometry equal to or more than 20 kpa (baveno guidelines). 3. pregnant women, breastfeeding women or women that can not assure adequate anticonception for the duration of the study (based on anamnesis). 4. karnofsky index less than 60 5. vulnerable patients
paroxysmal nocturnal hemoglobinuria human anti-human antibodies study

Conditions: Paroxysmal Nocturnal Hemoglobinuria; PNH

Summary: how does long term treatment with soliris affect haha in pnh patients?

to determine the long term effect of soliris (eculizumab) treatment on the presence of human anti-human antibodies (haha) in paroxysmal nocturnal hemoglobinuria (pnh) patients.

Eligibility criteria:
inclusion criteria: * pnh patients who previously participated in study e05-001; * patients who have an eculizumab naive serum sample for comparison; * patients who currently used commerical soliris; * patients who are willing and able to gie written informed consent. exclusion criteria: * there are no exclusion criteria for this study.

Keywords: paroxysmal nocturnal hemoglobinuria pnh human anti-human antibody haha soliris eculizumab