Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of sivelestat sodium and dexamethasone in the treatment of ards

Conditions: Acute Respiratory Distress Syndrome

Summary: the goal of this clinical trial is to evaluate the efficacy and safety of sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ards. the main questions it aims to answer are: * is sivelestat sodium more effective in the treatment of patients with moderate to severe ards compared with placebo? * is dexamethasone more effective in the treatment of patients with moderate to severe ards compared with placebo? participants will receive sivelestat sodium, dexamethasone or placebo. researchers will compare the efficacy and safety of sivelestat sodium, dexamethasone and placebo.


Eligibility criteria:
inclusion criteria: * patients with moderate-to-severe ards in the acute exacerbation phase who meet the diagnostic criteria for moderate-to-severe ards * receiving tracheal intubation for mechanical ventilation within 72 hours after an episode of moderate-to-severe ards * ards onset to randomized grouping within 72 hours (starting at the time of onset documented in the medical record) * patient volunteers to participate in the study and signs an informed consent form exclusion criteria: * pregnancy or breastfeeding * brain death * advanced cancer or other terminal disease * history of allergy to sivelestat sodium and dexamethasone * severe chronic obstructive pulmonary disease * history of severe cardiovascular disease, such as heart failure, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled cardiac arrhythmia, uncontrolled hypertension, or history of heart or cerebral infarction within the past six months * organ transplant or allogeneic stem cell transplant recipients * fatal active fungal infections * neuromuscular disease that affects voluntary breathing * genetic or acquired severe immunodeficiencies such as human immunodeficiency virus (hiv) infection, chronic granulomatous disease, severe combined immunodeficiencies * patients and/or legal representatives who sign a do not resuscitate (dnr) advance directive, or who abandon treatment * participating in other clinical trials
the jetstream g3™ calcium study

Conditions: Peripheral Arterial Disease

Summary: to investigate the treatment effects with the jetstream g3 system in moderate to severely calcified peripheral artery disease in the common femoral, superficial femoral or popliteal arteries using intravascular ultrasound (ivus).


Eligibility criteria:
inclusion criteria: 1. the patient is ≥ 18 years of age. 2. patient has claudication determined to be due to femoropopliteal lesion(s) requiring revascularization. 3. the target lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries. 4. the reference vessel lumen (proximal to target lesion) is ≥ 3.0mm. 5. the patient is an acceptable candidate for percutaneous intervention using the jetstream g3 system in accordance with its labeled indications and instructions for use. 6. the patient has signed approved informed consent. 7. moderate or severe vessel obstructive intraluminal calcification as demonstrated by ivus and angiography. exclusion criteria: 1. patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent. 2. patient is unable to take appropriate anti-platelet therapy. 3. patient has no distal runoff vessels. 4. deep wall calcium. 5. interventional treatment is intended for in-stent restenosis at the peripheral vascular site. 6. patient has target vessel with moderate or severe angulation (e.g., \>30 degrees) or tortuosity at the treatment segment. 7. patient has a history of coagulopathy or hypercoagulable bleeding disorder. 8. patient is receiving hemodialysis or has impaired renal function (creatinine is \> 2.5 mg/dl) at the time of treatment. 9. patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months. 10. patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days. 11. patient is pregnant or nursing a child. 12. intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the jetstream g3 system. -

Keywords: pad, peripheral arterial disease, calcium, atherectomy, jetstream
open and endovascular surgical treatment for artery injuries

Conditions: Artery Injury

Summary: traumatic injuries of peripheral arteries are often associated with multiple injuries, massive hemorrhage, state of shock, and loss of blood supply, as well as with high mortality. traditionally, an open surgical approach is suggested for the management of artery injury. with the advancement of endovascular techniques, the traditional open vascular exposure and vessel repair are no longer the only option available. the purpose of this study is to compare the effectiveness, long-term safety and explore the safety and efficacy factors between open and endovascular surgical techniques.


Eligibility criteria:
inclusion criteria: injuries in the peripheral arteries; loss of blood supply to the remote area; high-risk emergency artery reconstruction; participate in the study voluntarily, accept follow up study. - exclusion criteria: bleeding can be easily control; there is contraindications for surgical operation. -

Keywords: artery injury surgery endovascular repair peripheral arteries
efficacy of alicaforsen in pouchitis patients who have failed to respond to at least one course of antibiotics

Conditions: Pouchitis

Summary: a phase iii, multi-centre, double-blind randomised controlled trial in subjects with chronic antibiotic refractory pouchitis. subjects will undertake a \<2 week screening period to provide baseline data and be assessed for eligibility. at the baseline visit (day 1) eligible subjects will be randomised on a 1:1 basis to either a) 240 mg alicaforsen enema or b) matching placebo. study drug will be administered once nightly (on going to bed) up to and including week 6. following the day 1 visit, subjects will return to the clinic for safety and efficacy assessments at week 3, 6, 10, 18 and 26. subjects may receive certain permitted medications as per entry criteria, which must remain at stable doses throughout the trial. introduction of any new medication for pouchitis, or a dose change to an existing concomitant medication for pouchitis, other than those detailed in the protocol, will not be permitted. clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary card. subjects will undergo endoscopic examination of their pouch (during screening, and at weeks 6 and 10). where technically feasible, each endoscopy will provide at least one biopsy sample for histopathology. in addition to endoscopic, histopathologic and symptomatic assessments, quality of life will be assessed. bloods for routine assessment, including haematology and biochemistry will be taken. bloods and stool samples will be collected to evaluate relevant biomarkers.


Eligibility criteria:
inclusion criteria: 1. written informed consent; 2. male or female subjects, 18 years of age who have undergone an ipaa for uc 3. history of pouchitis 4. overall pdai score \> 7 5. must have chronic antibiotic refractory pouchitis exclusion criteria: 1. lack of effective contraception 2. women who are pregnant or breastfeeding; 3. strong analgesia nsaid use 4. change in dose of the following permitted meds during screening and study: oral 5-aminosalicylate (5 asa), oral steroids,, immunosuppressant therapy. 5. rectal products 6. biological agents: anti-tumour necrosis factor (anti - tnf) therapy and / or vedolizumab; are not permitted within 8 weeks of the screening visit. 7. all other agents targeted to pouchitis, including experimental agents, must have been discontinued at least 8 weeks prior to the screening visit, or for a period equivalent to 5 half-lives (t½) of the agent (whichever is longer) 8. anal sphincter dysfunction 9. infections to cytomegalovirus or clostridium difficile 10. other gi pathology (inc. intestinal malabsorption, pancreatic maldigestion etc) and differential diagnoses 11. clinically significant and/or persistent illness; which in the investigators opinion, would exclude entry into the trial
safety and efficacy of recommended antimalarial in the democratic republic of the congo

Conditions: Malaria

Summary: despite all efforts, malaria remains a public health concern, in particular in the democratic republic of the congo (drc). the national malaria control program recommends artemisinin-based combination treatments (acts), in particular artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated malaria. previous studies indicated that acts are still effective, with efficacy above the required threshold of 90%. it is required to assess regularly the efficacy of antimalarial drugs. i in case of increasing failure rates, alternative options can be decided ontime. the purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (asaq winthrop®) and artemether-lumefantrine (coartem dispersible®) at day 28 in the treatment of uncomplicated plasmodium falciparum malaria in six surveillance sites around drc.

this is a phase iv, randomized, open label, 2-arm trial. it will be performed in six malaria sentinel site around the democratic republic of the congo. children aged 6 to 59 months with confirmed plasmodium falciparum uncomplicated malaria will be enrolled after informed consent granted by a parent or guardian. they will be randomized to receive either artesunate-amodiaquine or artemether lumefrantrine during 3 days (directly observed treatment) and then followed up until day 28. at each visit, clinical examination will be done and malaria testing as well. hemoglobin level will be measured on recruitment day and then every two weeks until day 28.

Eligibility criteria:
inclusion criteria: * children aged 6 to 59 months * monoinfection with plasmodium falciparum with asexual parasite count of 2,000 to 200,000/µl * axillary temperature ≥ 37.5 °c * ability to swallow oral medication * ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule; * informed consent from a parent or aguardian * living within the study catchment area exclusion criteria: * presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of who; * body weight \< 5kg * hemoglobin level \< 5g/ dl or hematocrit \< 15% * presence of severe malnutrition * presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, hiv/aids); * regular medication, which may interfere with antimalarial pharmacokinetics; * malaria treatment within 2 days prior to recruitment * history of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatment
etokimab in adults with chronic rhinosinusitis with nasal polyps (crswnp)

Conditions: Chronic Rhinosinusitis

Summary: a study to evaluate the safety and efficacy of multiple doses of etokimab in adults with chronic rhinosinusitis with nasal polyps.

this study is a randomized, placebo controlled, double-blind, multi-dose study to assess the efficacy of two different dose regimens of etokimab compared to placebo in adults with moderate-to-severe chronic sinusitis with nasal polyposis (crswnp). during the screening period, all subjects will undergo evaluation for eligibility. a centralized reader will be used to confirm the diagnosis of crswnp as assessed by nasal endoscopy, computed tomography (ct) scan of sinuses, and symptom scoring to reduce the risk of interpretation variation. participants will also be provided mometasone furoate nasal spray (mfns) for use during the trial and are required to undergo a minimum run-in period of 20 days prior to day 1 with approximately 80% compliance. participants will be randomly assigned on day 1 to one of the three treatment arms in a 1:1:1 ratio.

Eligibility criteria:
inclusion criteria: * clinically confirmed diagnosis of crswnp * nasal polyp score (nps) ≥ 4 out of a maximum score for both nostrils (with at least a score of 1 for each nostril). * 22 item sino-nasal outcome test (snot-22) score \> 15. * presence of at least two of the following symptoms prior to screening: nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell * body mass index (bmi) of 18 to 42 kg/m\^2 (inclusive) and total body weight \> 50 kg (110 lb). bmi=weight (kg)/(height \[m\^2\]). exclusion criteria: * use of investigational drugs or prohibited therapy for this study within 8 weeks before screening or 5 half-lives, whichever is longer. * have experienced severe life threatening anaphylactic reactions. * participation in any interventional study for the treatment of crswnp in the 3 months before screening. * if female, is pregnant or lactating, or intend to become pregnant during the study period. * history (or suspected history) of alcohol or substance abuse. * current smokers or former smokers with a smoking history of ≥ 10 pack years. if a patient has less than 10 pack years smoking history, he or she should have quit smoking at least 2 months before screening to enroll in the study. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: anb020 etokimab crswnp
use of thermal and 3d imaging to quantify arthritis

Conditions: Rheumatoid Arthritis; Juvenile Rheumatoid Arthritis

Summary: one of the biggest challenges in caring for patients with rheumatoid arthritis (ra) and juvenile rheumatoid arthritis (jra) is quantifying the degree of disease activity in any given joint. we have built a prototype device using well-established sensors to rapidly quantify surface swelling and heat in arthritic joints. the goal of our studies is to test the hypothesis that this imager can improve the clinical assessment of arthritis.


Eligibility criteria:
inclusion criteria: * at least 4 years of age exclusion criteria: * less than 4 years of age

Keywords: ra jra
efficacy of intersectional short pulse stimulation for terminating seizures

Conditions: Seizures; Focal Epilepsy

Summary: this is a study which seeks to develop a novel therapeutic approach, intersectional short pulse (isp) stimulation for seizure termination. the device embodiment of isp is a scalp eeg recording system which also delivers spatially precise electrical stimulation in short pulses to the targeted brain region. the study team has already collected safety and tolerability data in human subjects, demonstrated isp efficacy in terminating seizures in rodents, and have tested the efficacy of this device to modulate normal human brain activity. now this study proposes to test the device's efficacy in stopping seizures in a within-subject randomized, sham-controlled study design.


Eligibility criteria:
experiment 3: epilepsy patients inclusion criteria: * adult patients (age 18-65). * fluent in english. * epilepsy patients with poorly controlled (\>=2 seizures per week). * focal onset seizures. * seizure onset zone in the mesial temporal or neocortical onset as determined by \>2 concordant criteria, without discordant criteria (semiology, mri brain, and eeg). * able to give informed consent. exclusion criteria: * patients with skull defects. * patients with implanted neurostimulator or other implanted cerebral hardware. * patients with multifocal onset epilepsy. * patients who are non-verbal or incapable of providing informed consent. * current substance abuse. * pregnancy. * patients with non-mri compatible implants (for experiments 2 and 3).
effect of electroconvulsive therapy (ect) and transcranial magnetic stimulation(tms) on brain derived neurotrophic factor (bdnf) in depressed patients.

Conditions: Depression

Summary: to investigate the change in brain derived neurotrophic factor (bdnf) between pre and post treatment for patients with depression with either ect or tms.


Eligibility criteria:
inclusion criteria: * mdd or bipolar disorder; * current depressive episode, ham-d17\>17 and ymrs\<8; * recommended to receive ect or tms as part of clinical care; * male/female; * age 18-65; * inpatient or outpatient; * comorbid dysthymic disorder, gad, or social anxiety will be included; * able to give written consent and agree. exclusion criteria: * current manic, hypomanic, or mixed episode, ymrs\>7; * current schizophrenia, anorexia, bulimia, substance dependence (current within past 6 months excluding caffeine and nicotine); * tms or ect in the last 3 months; * any other primary diagnosis; * uncontrolled medical illness; * epilepsy or severe personality disorder at the discretion of the investigators; * 3 weeks prior to first blood test, antidepressants, mood stabilizers, antipsychotics can not be added or increased; * pregnant women or women of childbearing potential not willing to use appropriate contraception, nursing women; * known intolerance or lack of response to treatment receiving as judged by the investigator; * medical conditions that would affect serum levels of bdnf; * involvement in planning and conduct of the study.
management of pediatric craniopharyngioma by a combination of partial surgical resection, and protontherapy (craniopharyngioma)

Conditions: Craniopharyngioma

Summary: prospective, open labelled, phase ii, monocenter trial to combine partial surgery resection and protontherapy to management paediatric craniopharyngioma.

this study is phase ii prospective, open labelled, phase ii, monocenter. the main objective is to evaluate the fractionated high precision radiotherapy with a dose of 59,5 gy (1,7 gy daily, 5 fractions per week).

Eligibility criteria:
inclusion criteria: * histologically documented craniopharyngioma * age range between 3 and 16 years * landsky performance status \> 60 * incomplete surgical resection or simple biopsy * solid and/or cystic aspect on imaging * irradiation performed at the time of presentation or of local progression * signed informed consent by parents or by legal representative (with copy to each participating center) exclusion criteria: * previous history of radiotherapy (including stereotactic) administered to the head and neck region * severe vasculopathy * participation to a concurrent study * contra-indication to general anesthesia in children below 5 years * patient non-compliant to a minimum 30 mn immobilisation * patient deprived of freedom or under guardianship * patient not expected to be followed in a long run

Keywords: craniopharyngioma protontherapy
sexual disability in low back pain and physiotherapy

Conditions: Low Back Pain; Sex Disorder

Summary: a treatment centered on the person uses an approach capable of considering all the components of disability, from a physical, psychological and social point of views. some studies have shown that sexual function is disturbed in subjects with low back pain (lbp) and sexual disability can contribute to a deterioration in quality of life. it has also been shown that, in sexually active patients complaining of lbp, sexuality is a significant mediator of the relationship between pain intensity and depressive symptoms. the oswestry disability index (odi) includes a specific item to investigate sexual function (item #8). a previous study of ours confirmed the relationship between sexual disability detected by the odi and the presence of depression, avoidance of activities and rumination (ferrari et al. 2019 - digital object identifier: 10.1589/jpts.31.360). the discussion on sexual disability among patients and healthcare professionals is very limited, although patients require more involvement from clinicians, especially physiotherapists, as evidenced by our previous qualitative study (ferrari et al. 2020 - digital object identifier: 10.1080/09638288.2020 .1817161). although studies on this topic have highlighted the importance of this disability in the life of subjects complaining of lbp, little has been investigated on clinical behaviors of the physiotherapists in this area.

the goal of this observational study is to learn about the clinical behaviors of italian physiotherapists in the management of lbp-related sexual disability. the main questions it aims to answer are: * the knowledge of this topic; * the ways in which sexual disability is detected in patients complaining of lbp (oswestry disability index, specific open or closed questions, patient' reporting, etc.); * the difficulties and obstacles in the management of sexual disability; * the suggestions provided to the patient; * the therapeutic strategies (procedures for pain modulation, exercises addressed to lumbar mobility, strength, endurance, etc.); * the possible involvement of the patient' partner; * the outcome measures. the hypothesis of this survey is to highlight the degree of attention and competence of italian physiotherapists with respect to this topic, the critical issues and therapeutic strategies for the management of lbp-related sexual disability. participants will answer to a online questionnaire.

Eligibility criteria:
inclusion criteria: * being a physiotherapist registered with aifi * carrying out physiotherapy treatments on subjects with low back pain * agreement to voluntarily sign informed consent to participate in the study * agreement to voluntarily sign consent to data processing exclusion criteria: * inability to understand written italian * being a retired physiotherapist

Keywords: sexual disability physical therapy low back pain
hydroxychloroquine for the first thrombosis prevention in antiphospholipid antibody positive patients

Conditions: Antiphospholipid Syndrome

Summary: in this multi-center international study, our aim is to determine the effectiveness of hcq for primary thrombosis prophylaxis in persistently apl-positive but thrombosis-free patients without systemic autoimmune diseases.

randomized to receive hcq or no treatment in addition to their standard regimen. 11 study visits and 10 phone visits over 5 years. this study was terminated at 2 years due to low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.

Eligibility criteria:
inclusion criteria: * persistent(at least 12 weeks apart)apl-positivity within 12 months prior to the screening defined as: * acl igg/m (\>40u,medium-to-high titer,and/or greater than the 99th percentile)and/or * aβ2gpi igg/m(\>40u, medium-to-high titer, and/or greater than the 99th percentile)and/or * positive la test based on the international society of thrombosis \& haematosis recommendations selected exclusion criteria: * history of thrombosis (arterial, venous, and/or biopsy proven microthrombosis * history of transient ischemic attack confirmed by a neurologist * sle diagnosis based on the acr classification criteria \> 4/11 * other systemic autoimmune diseases diagnosed based on acr classification criteria * current hydroxychloroquine or another antimalarial treatment (-3 months) * current warfarin treatment (-3 months) * current heparin therapy( -3 months) * current pregnancy * history of hydroxychloroquine eye toxicity * history of hydroxychloroquine allergy * known glucose-6-phosphate dehydrogenase deficiency

Keywords: antiphospholipid autoantibodies antiphospholipid positive