Kornimate/medical-research-clean huggingface dataset:
omega-3 polyunsaturated fatty acids in youth with adhd

Conditions: Attention Deficit Hyperactivity Disorder; ADHD

Summary: n-3 polyunsaturated fatty acids(n-3 pufas) is important in balancing the immune function and crucial for the developing brain. deficiency in n-3 pufas might be linked to the poor cognitive performances resulting in inattention and hyperactivity in youth with attention deficit hyperactivity disorder (adhd). n-3 pufas appears to be a promising treatment that is safe, beneficial to youth with adhd. in this proposal, investigators aim the test the hypothesis that n-3 polyunsaturated fatty acids will be more effective than placebo in improving cognitive function in youth with adhd after 12 weeks of intervention.

this is a 1-year study and a randomized, double-blind, and placebo controlled clinical the study. investigators plan to enrol 100 subjects from child and adolescent psychiatry outpatient clinic of china medical university hospital.participants will be randomized into omega-3 polyunsaturated fatty acids or placebo group.the intervention period is 12 weeks. evaluation of the cognitive function ( using continuous performance test 3rd edition ) of the subjects who are enrolled into the study will take place at baseline and after the 12th week. the symptom severity of adhd will be measured with swanson, nolan, pelham questionnaire (snap-iv) at baseline, 2,4,8, and 12 weeks. the plasma level of n-3 polyunsaturated fatty acids, blood and salivary inflammatory markers will also be measured at the beginning and at the end of the study.

Eligibility criteria:
inclusion criteria: * dsm-5 diagnosed adhd * age 6-18 years old at time of enrolment * conner's rating scares (cprs) with scores \>= 2 standard deviations * drug native or no medication use for past 6 months * signed informed consent exclusion criteria: * intelligence quotient \<70 * comorbid other psychiatric disorders, such as autism spectrum disorders, anxiety disorders, conduct disorders, schizophrenia, major depressive disorders and bipolar spectrum disorders * comorbid physical disorders, such as thyroid dysfunction, cerebral palsy * current using omega-3 supplements * allergy to omega-3

Keywords: adhd n-3 polyunsaturated fatty acids children adolescents
18f-dpa-714 pet/mr in dysfunctional brain diseases

Conditions: Brain Disease

Summary: this is a diagnostic pilot study that recruited 25 normal volunteers and 40 patients with dysfunctional brain diseases and performed 18f-dpa-714 pet/mr imaging to evaluate the correlation between the multimodal imaging features of dysfunctional brain diseases, to explore the potential pathological mechanisms of neuroimmune activation, and to further analyse the value of pet/mr-based multimodal imaging in the diagnosis and differential diagnosis of dysfunctional brain diseases. and further analyse the diagnostic and differential diagnostic value of pet/mr-based multimodal imaging in dysfunctional brain diseases.


Eligibility criteria:
inclusion criteria: * dysfunctional disorders diagnosed according to the guidelines include: cognitive disorders, movement disorders, disorders of consciousness-like disorders, and autoimmune encephalitis. signing the pet/mr informed consent form to volunteer for this study exclusion criteria: * minors, pregnant women, nursing mothers, those with severe liver or kidney insufficiency, history of allergy to contrast media or other drugs. diagnosis of viral encephalitis, acute myelitis, idiopathic epilepsy, antibody-negative aie; diagnosis of any major disease; history of alcohol or drug abuse/dependence; history of cardiorespiratory disease, oncology, haematological disorders, poorly controlled chronic diseases; contraindications to pet/mr examination. history of head trauma, history of surgery. history of other neurological disorders.

Keywords: 18f-dpa-714 pet/mr cognitive impairment dyskinesia disorders of consciousness autoimmune encephalitis
craving assessment in patients with alcohol use disorder using virtual reality exposure

Conditions: Alcohol Use Disorder

Summary: alcohol use disorder (aud) is a burdensome clinical disorder with high relapse rates. virtual reality (vr)-based therapeutic and diagnostic approaches have received increasing attention in the treatment of aud but evidence on the induction of craving via vr scenarios is still needed. craving for alcohol is associated with psychological and physiological responses. this single-arm clinical study will be conducted including n=60 patients with aud. using a head-mounted display (hmd), patients will be confronted with three different vr scenarios (neutral vs. two target situations) while heart rate, heart rate variability (hrv), pupillometry and electrodermal activity (eda) will be measured continuously. subjective craving levels will be assessed pre-/during/post-exposure to each vr scenario.


Eligibility criteria:
inclusion criteria: * age: 18-65 years * diagnosis of alcohol dependence according to icd-10 (f10.2) * completed in-patient withdrawal treatment during the last 3 months * history of alcohol craving, confirmed via craving questionnaires * able to provide written informed consent exclusion criteria: * substance dependence other than alcohol and nicotine * current alcohol intoxication (randomly tested via measurement of breath alcohol concentration) * unable to understand the study information, consent form or principles of the study * abstinence for less than 7 days or on-going consumption of alcohol * severe neuropsychiatric disorder, e.g. schizophrenia spectrum disorders, bipolar affective disorder or substantial cognitive impairment * serious illnesses influencing brain-/heart-function with influence on physiological study parameters. * acute suicidality (or acute endangerment of others) * concurrent pharmacological treatment targeting aud (i.e. benzodiazepines) or craving (i.e. acamprosate, disulfiram, naltrexone, nalmefene) and further medication significantly influencing heart frequency.
acupuncture for the treatment of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to study the efficacy of acupuncture used as an adjunct measure for patients with refractory ra

the study employs a randomized, prospective, double-blind, placebo-controlled trial to evaluate the effect of electroacupuncture, traditional chinese acupuncture and sham acupuncture in patients with refractory ra. all patients received 20 sessions over a period of 10 weeks. six acupuncture points were chosen. primary outcome is the changes in the pain score. secondary outcomes included the changes in the acr core disease measures, das 28 score and the number of patients who achieved acr 20 at week 10.

Eligibility criteria:
inclusion criteria: * fulfilled the american college of rheumatology (acr)\[10\] criteria of ra * active disease affecting the hands and wrists defined as having at least 4 tender joints and 2 swollen joints * early morning stiffness of greater than 45 minutes * esr \> 28 mmhg or crp \> 10 * patients taking disease modifying anti-rheumatic drugs (dmards) were eligible if they were on a stable dose for at least 3 months before screening. * patients on stable doses of one non-steroidal anti-inflammatory drug (nsaid) or up to 10 mg daily prednisone were also included. exclusion criteria: * under the age of 18 years * pregnancy * previously had acupuncture * localized skin infections * anticoagulated * bleeding diathesis * intra-articular corticosteroid within 4 weeks preceding the study * any severe chronic or uncontrolled co-morbid disease * fear of needles

Keywords: acupuncture electroacupuncture rheumatoid arthritis
integrated clinical-radiological analysis of hypoxia markers in pediatric osteosarcomas

Conditions: Osteosarcoma in Children

Summary: the aim of this pilot study is therefore to retrospectively measure the volume and percentage of necrosis on diagnostic mri in t1 sequence and in parallel to study the expression of immunohistochemical markers of hypoxia (hif-1α, caix , hif-2α, ps6, phosphomtor, cd163 and cd68) on diagnostic biopsies of high-grade osteosarcomas from 2007 to 2018 in the strasbourg center, focusing on the pediatric population. the investigators will systematically carry out a correlation analysis between these different parameters and with the clinical data of these same patients (response to chemotherapy, presence of metastases or not and overall and recurrence-free survival). this will eventually make it possible to highlight new prognostic markers at diagnosis.


Eligibility criteria:
inclusion criteria: * subject ≤ 20 years at diagnosis * subject having been treated for osteosarcoma in the os2006 protocol or treated according to * supported at strasbourg university hospitals between 05/01/2007 and 10/31/2018 * availability of its diagnostic tumor material stored in paraffin * having an mri diagnostic evaluation comprising the injected t1 sequences necessary for the analysis of the volume / necrotic proportion. exclusion criteria: * opposition of the patient (or his legal representatives if he is a minor) to participate in the study * diagnosis other than osteosarcoma * biological tissue from a patient who does not meet all the inclusion criteria * patient under legal protection * patient under guardianship or guardianship

Keywords: osteosarcoma necrosis immunohistochemical markers of hypoxia hypoxia chemotherapy metastasis
a study to assess the impact of multiple doses of azd6234 on a single dose of combined oral contraceptive in female participants

Conditions: Healthy Participants

Summary: this study will assess the effect of multiple doses of azd6234 on the effect of single doses of combined oral contraceptive ethinyl estradiol (ee)/levonorgestrel (levo) in healthy female participants with overweight or obesity.

this is a phase i, open-label, single-sequence, single-cohort study which will be performed at multiple study sites in healthy females of childbearing and non-childbearing potential. the purpose of this study is to investigate the effect of azd6234 on the pharmacokinetics (pk: the way the body absorbs, distributes, metabolizes, and eliminates a medicine), safety and tolerability of azd6234 with combined oral contraceptive, ethinyl estradiol/levonorgestrel (ee/levo). the study will consist of 5 periods which include, screening, start, up-titration, maintenance, and follow-up periods.

Eligibility criteria:
inclusion criteria: * all participants must have a negative pregnancy test at the screening visit and on admission to the clinical unit. * women of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception. o hormonal contraceptives and estrogen-containing hormonal methods of birth control are not permitted due to potential effect and influence on the results using a combined oral contraceptive assessment. * females of non-childbearing potential must be confirmed at the screening visit. * have a body mass index (bmi) ≥ 25 kg/m2 inclusive and weigh at least 60 kg. exclusion criteria: * history of any clinically important disease or disorder (gastroparesis, deep vein thrombosis, previous surgery of the upper gastrointestinal tract, cardiovascular disease, neuromuscular or neurogenic disease, severe vitamin d deficiency, type i or type ii diabetes mellitus, glycated hemoglobin (hba1c) ≥ 6.5%) at screening. * history or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * any clinically important illness, medical/surgical procedure, or trauma. * any laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis. * any positive result on screening for serum hepatitis b surface antigen (hbsag), hepatitis b core antibody (hbcab) or human immunodeficiency virus (hiv). * abnormal vital signs. * any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiogram (ecg), at screening. * current smokers or those who have smoked or used nicotine products. * known or suspected history of alcohol or drug abuse or excessive intake of alcohol. * history of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity. * statin treatment within 4 weeks prior to the start of study treatment. * current use of estrogen-containing products.

Keywords: obesity overweight oral contraceptives pharmacokinetics drug interaction
effects of power wheelchair soccer for individuals presenting with physical impairments

Conditions: Neuromuscular Diseases; Cerebral Palsy

Summary: this study is a prospective interventional study. it will be conducted at a single center with participants who have neuromotor impairments. the primary objective is to assess and measure the clinical and psychosocial effects of a season of power wheelchair soccer among its participants presenting with severe motor impairments due to neuromuscular lesion. a maximum of twenty participants will be recruited and included in the same group. data collection will be performed before, during, and after the wheelchair soccer season. the study will span the entire season, starting in november 2023 and ending in june 2024. clinical and psychosocial assessments will be conducted every 3 months. each assessment session will last 2 hours per participant. before and after the wheelchair soccer season matches, we will evaluate parameters related to the physical load of the sport. these evaluations will last 10 minutes per participant.


Eligibility criteria:
inclusion criteria: * being a male or female between the ages of 12 and 50. * presenting with severe motor impairments due to neuromotor and/or musculoskeletal impairment. * using a power wheelchair in everyday life. * being part of a power wheelchair soccer team. * committing to participating in the 2023-2024 season of their sport within the team. exclusion criteria: * practicing another adaptive sport outside of power wheelchair soccer in a regular way (once a week or more). * occasionally practicing power wheelchair soccer (twice a month or less). * presenting with severe cognitive impairments affecting understanding of instructions on how to answer questionnaires and undertake tests. * presenting with contraindications towards the practice of an adaptive sport such as power wheelchair soccer. * participating in another study at baseline.
comparative volumetric assessment of alveolar ridge preservation utilizing different bone grafting materials

Conditions: Tooth Fractures; Tooth Injuries; Tooth Diseases

Summary: this study is intended to provide statistically robust evidence that symbios demineralized cortical-cancellous granule mix, symbios osteograf ld-300, and osteograf/n-300 combined with symbios osteoshield collagen resorbable membrane can adequately support the alveolus during ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the overlying soft tissues. additionally, a comparison between each material will be made, providing further evidence of each materials' ability to preserve the alveolus. it is intended to define in objective terms the response of the hard and soft tissues to ridge augmentation.


Eligibility criteria:
inclusion criteria: 1. provision of informed consent 2. ≥ 18 years and ≤ 75 years 3. good physical health (asai/ii) 4. extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required 5. teeth adjacent (mesial and distal) to study site must consist of two stable natural teeth with minimal restorations, without signs of periodontal bone loss (\> 3 mm) and/or significant soft tissue deficiencies exclusion criteria: 1. buccal plate dehiscence and/or fenestration \>3mm at study site following extraction 2. untreated rampant caries and uncontrolled periodontal disease 3. inadequate oral hygiene (estimated plaque score \>20%) 4. smokers using more than 10 cigarettes or equivalent per day 5. smokeless tobacco use or e-cigarette use 6. compromised physical health and/or uncontrolled or severe systemic diseases including: asa iii/iv metabolic bone disease history of malignancy history or radiotherapy or chemotherapy for malignancy in the past 5 years history of autoimmune disease long-term steroidal or antibiotic therapy uncontrolled diabetes known alcohol or drug abuse 7. systemic or local disease or condition that would compromise post-operative healing 8. use of any substance or medication that will influence bone metabolism 9. known pregnancy 10. unable or unwilling to return for follow-up visits for a period of 6 months 11. unlikely to be able to comply with study procedures according to investigators judgement 12. involvement in the planning and conduct of the study 13. previous enrollment or randomization of treatment in the present study
a clinical trial to evaluate the efficacy and safety of ckd-825 in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: to evaluate the efficacy and safety of ckd-825 in patients with atrial fibrillation

a multi-center, randomized, double-blind, placebo control, therapeutic confirmatory, phase iii trial to evaluate the efficacy and safety of ckd-825 in patients with atrial fibrillation

Eligibility criteria:
inclusion criteria: * outpatients aged ≥ 19 years with persistent or permanent atrial fibrillation * patients with modified ehra(the european heart rhythm association score of atrial fibrillation) score ≥ 2a * patients with resting hr ≥ 80 beats per minute(bpm) * patients with 24-h mhr ≥ 80 bpm on holter ecg exclusion criteria: * treatment with antiarrhythmics within 2 weeks(those who had washout period can be included) * pacemaker or implantable cardioverter defibrillator * catheter ablation for atrial fibrillation within 12 weeks before first investigational product(ip) administration * treatment for heart failure (new york heart association functional class 4) * myocardial infarction or unstable angina pectoris within 12 weeks before first ip administration * wolff-parkinson-white syndrome * hepatic or renal disorder * systolic blood pressure \< 90 mmhg or diastolic blood pressure \< 60 mmhg * uncontrolled diabetes(hba1c \> 9%)

Keywords: atrial fibrillation
a trial of nnc0109-0012, an anti-il-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to methotrexate

Conditions: Inflammation; Rheumatoid Arthritis

Summary: this trial is conducted in europe, north america and south america. the aim of this trial is to investigate the clinical efficacy of nnc0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (ra) with inadequate responses to methotrexate (mtx) while on a stable background of mtx therapy.


Eligibility criteria:
inclusion criteria: - informed consent must be obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - a documented diagnosis of ra at least 6 months prior to screening visit, according to the american college of rheumatology (eular/acr 2010 criteria) or by standard criteria (acr 1987) if diagnosis was made earlier than 2010 - active ra, characterised by: a. more than 5 tender and more than 5 swollen joints based on a 28 joint count b. c-reactive protein (crp) above or equal to 1.0 mg/dl (10 mg/l) - patients can be on methotrexate with or without hydroxychloroquine/chloroquine: a. methotrexate treatment (above or equal to 15.0 mg/week) for at least 16 weeks, (above or equal to 15.0 mg/week to below or equal to 25 mg/week) for at least 8 weeks prior to screening. patient can be on mtx as low as 10 mg/week only if due to mtx intolerance b. hydroxychloroquine (200-400 mg/day per os, oral dosing (p.o.)) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit exclusion criteria: - patients with arthritis due to other autoimmune diseases than ra - any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis) - history of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy - patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit - females of childbearing potential who are pregnant or breast feeding or intend to become pregnant - any other disease or clinically significant abnormality in laboratory parameters which, according to the investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective
therapeutic plasma exchange to alleviate hyperinflammatory condition during severe covid-19 infections

Conditions: Intensive Care Units; ARDS, Human; Covid19

Summary: severe covid-19 (coronavirus disease 2019) infections generate major but inappropriate production of cytokines and, in some cases, generate anti-ifn (interferon) auto-antibodies, inducing acute respiratory distress syndrom (ards). therapeutic plasma exchange (tpe) have been reported to be efficient for improving the hyperinflammatory condition state and the respiratory function, which has been described in case reports or small series. the study aims to remove cytokines during cytokine storm and anti-ifn auto-antibodies (when present) to prevent developpement of an inappropriate immune response and to improve the clinical response to reanimation treatment, in particular the respiratory parameters leading to a rapid improvement of clinical status. to that aim, the study investigates to compare a treatment using tpe plus usual treatments in intensive care unit (experimental arm) versus usual treatments in intensive care unit (routine arm) in a randomised trial.


Eligibility criteria:
inclusion criteria: * age \> 18 years * hospitalized for covid-19 confirmed by reverse transcriptase-polymerase chain reaction (rt-pcr) or scanner * patients with pao2/fio2 between 100 and 200 mmhg requiring non invasive ventilation or high flow oxygen * at least two biological results suggesting a cytokine storm or hyperinflammatory condition state among : c-reactive protéine (crp)\>50mg/l, procalcitonin (pct)\>1µg/l, fibrinogen\>5g/l, d-dimer \>1000ng/ml, ferritin \> 800ng/ml during the last 72 hours. * treatment with corticosteroids (at least 2 intakes of dexamethasone 6 mg or equivalent with another form of corticosteroids) * patient affiliated to a social security or similar scheme * information and written consent from the patient or if not possible from a confident person exclusion criteria: * ventilated intubated patients * patient with advanced cancer and without curative possibility * bacterial or viral (hiv) infection explaining the worsening (the main reason) * body mass index \> 40 * impossibility to put a central venous catheter according to investigator's judgement * severe hemodynamic instability with mean arterial pressure \< 65 mmhg (whatever the noradrenaline dosage used) * immunoglobulin a (iga) deficiency with anti-iga antibodies * inclusion in another study that could interact with the covidep study (investigator's judgement) * patient under legal protection measure * pregnant or breastfeeding women * in case of allergy to amotosalen (psoralens) or ai-ffp (amotosalen inactivated fresh frozen plasma) , use se-ffp (secured fresh frozen plasma)

Keywords: covid19 therapeutic plasma exchange cytokine storm hyperinflammatory condition anti-ifn antibodies