Kornimate/medical-research-clean huggingface dataset:
constitution of a biological cohort following bone marrow sampling from mds or aml patients and age-matched healthy donors

Conditions: Myelodysplastic Syndromes; Acute Myeloid Leukemia; Cardio-vascular Surgery

Summary: it is of clinical significance to better characterize the intrinsic defects harbored by mesenchymal stromal cells (msc) in myelodysplastic syndromes (mds) and acute myeloid leukemia (aml) context, as compared to physiological conditions. such research initiative aims to dissect the cross-talk between malignant hematopoietic stem cells (hsc) and their bone marrow (bm) partners in crime, further prospecting for innovative stromal-directed strategies for the treatment of myelodysplastic syndromes (mds) and acute myeloid leukemia (aml).

myelodysplastic syndromes (mds) are a heterogeneous group of clonal malignancies that are characterized by ineffective hematopoiesis, progressive bone marrow failure, cytogenetic and molecular abnormalities, and increased risk for progression to acute myeloid leukemia (aml). it is a well-accepted theory that mds and aml originate from primary alterations of hematopoietic stem cells (hsc) compartment, which confer a survival advantage to them at the expense of physiological hematopoiesis. more recently, there is growing evidences regarding the contribution of the bone marrow (bm) microenvironment to the pathogenesis of mds and aml. of particular interest, several studies have pointed towards a pivotal role of mesenchymal stromal cells (msc), one of the main components of the bm niche, in the initiation and propagation of myeloid disorders. in this context, it is of clinical significance to better characterize the intrinsic defects harbored by msc in mds and aml context, as compared to physiological conditions. such research initiative aims to dissect the cross-talk between malignant hsc and their bm partners in crime, further prospecting for innovative stromal-directed strategies for the treatment of mds and aml.

Eligibility criteria:
inclusion criteria: * patients with diagnosed myelodysplasia or acute myeloid leukemia (study place: icln) - specific to the cases cohort * age-matched healthy donors undergoing a cardiovascular surgery - specific to the control cohort * signed written informed consent form * patient affiliated to a social security regimen or beneficiary of the same exclusion criteria: * medical history of hematological disorders * thrombocytopenia, anemia... * patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. l.1121-6, l.112-7, l.1211-8, l.1211-9) * pregnant or breastfeeding women * refusing participation

Keywords: myelodysplastic syndromes acute myeloid leukemia bone marrow mesenchymal stromal cell healthy donor
post marketing study to evaluate the efficacy and safety of micafungin treatment on invasive aspergillosis

Conditions: Invasive Aspergillosis

Summary: the objective of this study is to evaluate the efficacy and safety of intravenous micafungin for the treatment of proven or probable fungal infections caused by aspergillus sp. (fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in china.


Eligibility criteria:
inclusion criteria: * patients who are diagnosed as proven or probable infections caused by aspergillus (including fungemia, respiratory mycosis and gastrointestinal mycosis) with reference to the definition of eortc/msg * females of childbearing potential are not pregnant in the study and reliable methods of contraception should be maintained during the whole study. * patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained. exclusion criteria: * patient received any echinocandins drug within 1 month prior to enrollment. * patient was enrolled in any other clinical study within the last month. * ast/alt \> 5 times the upper limit of normal (uln) * total bilirubin\> 2.5 times uln * bun/ccr \> 3 times uln * hiv positive patient * patient has a history of hypersensitivity, or any serious reaction to any component of this product or other echinocandins. * patient has a life expectancy of \<1 month * subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance. * pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use reliable contraception for the duration of the study and for 6 weeks following completion of the study. * patient has been previously enrolled in this study.

Keywords: aspergillosis antifungal micafungin
surgical management of post-traumatic kyphosis

Conditions: Post-Traumatic Kyphosis

Summary: the goal of this observational study is to examine the safety and efficacy of posterior sugary only in addressing post traumatic kyphosis. the main question\[s\]it aims to answer are: is it a safe procedure? is it a sufficient approach to address deformity? participants will be managed by posterior only surgery to address their deformity and will be assessed for the radiological and functional outcomes.


Eligibility criteria:
inclusion criteria: - all patients with age range from 18-65 years old with ptk underwent corrective surgery and have been followed for at least 2 years with complete documentation. exclusion criteria: * traumatic cervical spine deformities * pathologic fracture spine * congenital or developmental cases * degenerative cases

Keywords: post-traumatic kyphosis posterior only surgery
clinical validation of navoy® acute kidney injury in swedish icu patients

Conditions: Acute Kidney Injury

Summary: the study aims to evaluate the performance of the prediction algorithm navoy® aki in a swedish adult icu patient population versus fulfilment of kdigo diagnostic criteria.


Eligibility criteria:
inclusion criteria: * the study will only include the subjects from the sep-se-02 study population. (nct04570618) exclusion criteria: * none
study of apremilast to treat subjects with active ankylosing spondylitis

Conditions: Ankylosing Spondyloarthritis

Summary: apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (pde4), an enzyme that modulates inflammatory cytokines. this clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.

patients were randomized in a 1:1:1 ratio to placebo, apremilast 20 mg bid and apremilast 30 mg bid. the duration of the study was approximately 5 years. the double blind period (when patients nor the physician knew whether placebo or apremilast was taken) was 24 weeks. at week 16, participants who did not have either a ≥ 20% improvement or a ≥ 1 unit improvement from baseline in at least two of the four spondyloarthritis international society (asas) domains were entered in "early escape" from their current treatment in a double-blinded manner. however, such participants were permitted to continue in the study. at week 24, participants may have entered a long-term extension phase for up to an additional 4.5 years (236 weeks). at "second escape" (at week 24), apremilast 20 mg bid treated participants transitioned to receive double-blinded apremilast 30 mg bid and remained on double-blinded apremilast 30 mg bid because they continued to improve with a longer duration of treatment. after week 24 and during the early portion of the long-term extension through week 52, all participants continued on either double-blinded apremilast 20 mg bid or 30 mg bid treatment. after all participants had completed week 52 or had terminated early from the study and the 52-week data base was locked, apremilast 20 mg bid or 30 mg bid treatment was provided.

Eligibility criteria:
inclusion criteria: * must have a documented diagnosis of ankylosing spondylitis as defined by low back pain and stiffness, which improves with exercise, but is not relieved by rest for more than 3 months prior to screening. at the completion of screening procedures, a documented diagnosis of definite active as, as defined by the modified new york criteria (1984) whereby both criteria, at least 1 radiographic criterion and at least 1 clinical criterion, must be met * bath ankylosing spondylitis disease activity index (basdai) is ≥ 4 * total back pain is ≥ 4 * on stable dose of as medication (or lack of medication) prior to randomization and through week 24 exclusion criteria: - prior treatment with a tumor necrosis factor (tnf) blocker and any biologic treatment for as

Keywords: spondylitis spondyloarthritis spondyloarthropathy oral preparation
global study of mk-2060 (anti-factor xi monoclonal antibody) in participants with end stage renal disease receiving hemodialysis (fxi hemodialysis study) (mk-2060-007)

Conditions: End-Stage Renal Disease; End-Stage Kidney Disease; Kidney Failure, Chronic

Summary: the purpose of this study is to evaluate the efficacy and safety of two different doses of mk-2060 (a monoclonal antibody against factor xi) in end stage renal disease (esrd) participants receiving hemodialysis via an arteriovenous graft (avg). data from this study will be used to aid dose selection of mk-2060 in future studies. the primary hypothesis is that at least one of the mk-2060 doses is superior to placebo in increasing the time to first occurrence of avg event.


Eligibility criteria:
inclusion criteria: * current diagnosis of esrd. * receiving hemodialysis (including hemodiafiltration) ≥3 times per week for a minimum of 3 hours per session via a mature normally functioning, uninfected avg with at least 75% of the sessions meeting these criteria over the 4 weeks prior to randomization. * a female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (wocbp) or is a wocbp and agrees to follow contraceptive guidance during the intervention period and for at least 90 days after the last dose of study intervention. exclusion criteria: * recent history of cancer (\<1 year). non-melanoma skin cancers are allowed. * mechanical/prosthetic heart valve. * recent hemorrhagic stroke or lacunar stroke (\<1 month). * recent evidence (\<1 month) of bleeding requiring hospitalization or unplanned medical attention, a history (≤2 years) of recurrent bleeding episodes including epistaxis, gastrointestinal (gi) bleeds or genitourinary (gu) bleeds requiring medical treatment or events requiring treatment with blood products. * recent history (\<1 year) of drug or alcohol abuse or dependence. * currently receiving or planning to receive anticoagulants or antiplatelet medications (intradialytic heparin and aspirin are permitted). * planning on receiving a living donor renal transplant within 12 months (participants are permitted to be candidates for deceased donor renal transplants). * planning on receiving an arteriovenous fistula (avf) placement within 12 months.
pain relief for osteoarthritis through combined treatment (proact)

Conditions: Osteoarthritis of Knee

Summary: this mechanistic clinical trial proposes to test whether a five-day course of mindfulness meditation training (mmt) and tdcs, and their combination, can enhance pain modulatory balance and pain-related brain function, reduce clinical pain, among african americans and non-hispanic whites with knee osteoarthritis (oa). this approach will provide evidence that targeting stress and pain-related brain function will reduce oa-related pain and ethnic group differences therein.


Eligibility criteria:
inclusion criteria: * unilateral or bilateral symptomatic knee oa based on american college of rheumatology clinical criteria * participant reports primary ethnic/race group as either african american or non-hispanic white exclusion criteria: * actively symptomatic systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus), or fibromyalgia that results in pain outside the knee that is equal to or worse than the participant's knee pain. * a history of clinically significant surgery to the index knee. * daily use of opioids. we will exclude patients using opioids daily as both continued use and temporary withdrawal from these medications this could affect pain perception and response to interventions. other medications being used will be recorded and controlled in statistical analyses as needed. * use of some centrally acting sodium channel blockers, calcium channel blockers and nmda receptor antagonists, because some of these medications can block tdcs effects. other medications can potentially influence response to tdcs (e.g. ssris, beta-blockers); therefore, consistent with recent recommendations (2), we will assess use of these medications and include them as covariates in our statistical models. * uncontrolled hypertension (i.e. sbp/dbp of \> 150/95) or unstable or activity limiting cardiovascular or peripheral arterial disease. these exclusions are in place primarily for safety reasons, because the cold pressor task represents a cardiovascular challenge. however, uncontrolled hypertension can also affect pain perception, which is another reason for excluding these individuals. * neurological disease (e.g. parkinson's, multiple sclerosis, epilepsy) or evidence of previous brain injury, including stroke and traumatic brain injury. * serious psychiatric disorder requiring hospitalization within the past 12 months or characterized by active suicidal ideation. * current substance use disorder or history of hospitalization for treatment of substance use disorder. * diminished cognitive function that would interfere with understanding of study procedures.
study to evaluate the efficacy, safety and tolerability of pxt002331 (foliglurax) in reducing motor complications of levodopa therapy in parkinson disease's patients

Conditions: Parkinson Disease

Summary: this will be a double-blind, randomised, placebo-controlled parallel-arm phase ii proof of concept in subjects with pd treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and levodopa-induced dyskinesia (lid)


Eligibility criteria:
inclusion criteria: * males or females diagnosed after the age of 30 years with idiopathic pd for at least 3 years * disease severity of 2 to 4 on the modified hoehn and yahr scale when in the off state * been treated with a stable regimen of levodopa-containing therapy * subjects who are on a long-acting formulation of levodopa-containing therapy, including apodespan pr (or equivalent), must be on a stable dose for at least 6 weeks prior to the first screening visit * experienced motor fluctuations with wearing off over a period of at least 3 months prior to randomisation * experienced lid over a period of at least 3 months prior to randomisation * female subjects will be women of non-childbearing potential * subjects must pass a hauser diary concordance test * subjects are able, with or without the help of a caregiver, to understand the purpose and risks of the study and provide signed and dated informed consent and authorisation to use confidential health information in accordance with national and local subject privacy regulations exclusion criteria: * subjects with atypical, secondary or drug-induced parkinsonism * subjects with a mini-mental state examination (mmse) score \<25 * any known contraindication to the use of levodopa, including a history of malignant melanoma or a history of narrow-angle glaucoma. * subjects who have had a clinically significant illness within 4 weeks of first dose, as determined by the investigator. * any advanced, severe or unstable disease (other than pd) that may interfere with the primary and secondary study outcome evaluations * subjects who have undergone prior neurosurgical operation for pd or transcranial magnetic stimulation. * subjects who are participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to the baseline visit. * female subjects of childbearing potential * subjects who are pregnant (as determined by positive serum pregnancy test at screening and/or baseline), breastfeeding or lactating. * subjects who, in the opinion of the investigator, should not participate in this study.

Keywords: levodopa-induced dyskinesia (lid) wearing-off foliglurax parkinson's disease mglur4 pam
seroquel in acute mania: study to investigate if valproate add-on therapy is superior to quetiapine monotherapy in acutely manic patients

Conditions: Bipolar Disorder

Summary: the primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day initial treatment period with quetiapine. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * patients suffering from a manic or mixed episode. exclusion criteria: * patients who have not provided personal informed consent, * known intolerance, hypersensitivity or lack of antimanic response to sodium valproate or quetiapine fumarate, * involuntary admittance/detainment.

Keywords: bipolar i disorder (dsm-iv 296.01, dsm-iv 296.4, dsm-iv 296.61)
substance use interventions for truant adolescents

Conditions: Adolescent Problem Behavior; Truancy; Unsocialized; Marijuana Abuse; Truancy; Socialized; Substance Abuse; Alcohol Abuse

Summary: this study evaluates a brief motivation-building intervention for parents and teens to reduce truancy and substance use. it is hypothesized that the motivational intervention will result in better outcomes compared to an education-only intervention.

adolescents who use marijuana and are truant from school are a high-risk population with increased likelihood of substance use disorders, criminal justice involvement, and long-term impairments in vocational, family, and peer domains. this study will test a theory-driven intervention for early adolescent marijuana using, truant youth identified through rhode island truancy and family courts. adolescents will be randomly assigned to one of the 2 conditions: a motivational interview versus psychoeducation.

Eligibility criteria:
inclusion criteria: * the target child is in 6th-10th grade at the start of the project and living at home with at least one parent/guardian, * the teen must report 6 or more incidences of marijuana use in the last 90 days (an approximation of biweekly use) * by law, the teen must have at least 20 unexcused absences in an academic year to be in truancy court, and (4) parental consent and teen assent are obtained. exclusion criteria: * the family is not able to speak and understand english or spanish well enough to complete study procedures * developmental delay, as determined by school placements outside the regular classroom, that would affect comprehension of the intervention.

Keywords: brief intervention behavioral intervention juvenile justice motivational enhancement
cervical tsdcs on stroke patients

Conditions: Functional Recovery; Motor Rehabilitation

Summary: the present project aims to evaluate the facilitatory modulation of motor responses of the limb upper limb by tsdcs in patients with arm/hand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in acts of daily living.


Eligibility criteria:
group stroke: inclusion criteria: 1. age over 18 years; 2. first ischemic/hemorrhagic stroke (within 30 days of onset); 3. mild-to-moderate stroke (nihss scale score\<16). 4. residual function of the upper limb, assessed by the following scales: - mrc of the distal muscles of the upper limb: score between 2 and 4; - nhiss (items 5a and 5b): score between 1 and 3; 5. ability to give informed consent and understand instructions. exclusion criteria: 1. severe spasticity (ashworth scale score \> 2); 2. severe aphasia; 3. severe neglect; 4. history of disabling neurological disease; 5. history of epilepsy; 6. significant comorbidities; 7. contraindications to tsdcs. healthy group: inclusion criteria: 1. age over 18 years; 2. equalized in age with the patient group. exclusion criteria: 1. history of stroke progress; 2. history of severe neurological disease.
durability of antiviral activity in chronic hbv patients who showed complete response in l-fmau-301,302 or 303 trial

Conditions: Hepatitis B

Summary: the purpose of this study is to evaluate the durability of antiviral activity in chronic hepatitis b patients who showed complete response in l-fmau-301,l-fmau-302 or l-fmau-303 trial.


Eligibility criteria:
inclusion criteria: 1. the patients who have completed l-fmau-301, l-fmau-302 or l-fmau-303. 2. patients who have showed complete response (alt normalization and hbv dna \<4,700 copies/ml in l-fmau-301 or l-fmau-302, in addition, hbeag seroconverted to anti-hbe at the last two visits in l-fmau-301) after completion of l-fmau-301 or l-fmau-302 and treated with the clevudine. 3. patients who have showed complete response (alt normalization and hbv dna \<4,700 copies/ml, in addition hbeag seroconverted to anti-hbe at the last two visits who showed hbeag positiv at baseline) after completion of l-fmau-303 4. patients who were able to give written informed consent prior to study start and to comply with the study requirements. 5. patients with bilirubin levels less than 2.0 mg/dl, prothrombin time of less than 1.7 (inr), and a serum albumin level of at least 3.5 g/dl at the last visit in l-fmau-301, l-fmau-302 or l-fmau-303. exclusion criteria: 1. patients who have showed complete response but previously treated with placebo in the l-fmau-301, l-fmau-302. 2. patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy. 3. patients previously treated with interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for hbv infection. 4. patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy. 5. patients co-infected with hcv, hdv or hiv. 6. patients with a liver mass (hemangioma, nodule), biliary diseases except asymptomatic gb stone during the l-fmau-301, l-fmau-302 or l-fmau-303. 7. patients who were pregnant or breast-feeding. 8. patients with a significant gastrointestinal, renal, hepatic (decompensated), biliary diseases except asymptomatic gb stone, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. the patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor. 9. patients who were not suitable to the study if judged by an investigator.
efficacy and safety of trk-700 in patient with post-herpetic neuralgia

Conditions: Post-Herpetic Neuralgia

Summary: in post-herpetic neuralgia(phn) patients: * to conduct an explorative investigation of the efficacy and safety of repeated oral doses of trk-700 via a randomized double blind comparative study * to measure the plasma concentration of trk-700 and its metabolites


Eligibility criteria:
inclusion criteria: * patients with pain persisting for at least 3 months after the onset of herpes zoster * patients whose average pain score on the numerical rating scale (nrs) over the past 24 hours at preliminary enrollment is at least 4 exclusion criteria: * patients with another skin disease that may affect the evaluation of the pain at the site of phn * patients with pain other than phn that may affect the evaluation of pain * patients with pain that is suspected to be mainly psychogenic * patients who have received neurolytic or neurosurgical therapy for phn

Keywords: trk-700 post-herpetic neuralgia