Kornimate/medical-research-clean huggingface dataset:
cytokine adsorption during complex cardiac surgery: a controlled randomized trial

Conditions: Post-cardiac Surgery; Inflammation; Organ Dysfunction Syndrome; Cardiac Disease; Cardio-Pulmonary Bypass

Summary: this prospective single-centre randomized controlled trial aims at evaluating the safety and efficacy of hemoadsorption with ha-380® during cardio-pulmonary bypass in 40 patients undergoing complex cardiac surgery.

cardiopulmonary bypass (cpb) is an extracorporeal circuit used to divert blood from the heart and lungs and take over their functions during cardiac surgery. cardiac surgery with cpb can induce a major inflammatory response, largely mediated by cytokines. in the most severe cases, this inflammation can lead to vasoplegia, hypotension and potentially end-organ damage. the investigators hypothesised that the removal of inflammatory mediators (e.g. cytokines) from the blood during cpb could reduce the development of postoperative complications in patients with significant inflammation during cardiac surgery. patients undergoing complex cardiac surgery will be enrolled preoperatively and randomised 1:1 to receive either the investigational hemoadsorption treatment plus standard care (intervention group) or standard care alone (control group). patients allocated to the intervention group will have an ha-380® cartridge (jafron biomedical, guangdong, china) inserted into the cpb during circuit set-up. hemoadsorption treatment will be performed throughout the duration of the cpb procedure. for each patient, 4 blood samples will be taken for cytokine measurements (at the start of cpb, at the end of cpb, at icu admission and 24 hours later). data on vital signs, organs support, demographics and medical history will be collected in the electronic medical record.

Eligibility criteria:
inclusion criteria: 1. adults (≥18 years old at study inclusion) 2. planned for one of the following cardiac surgical procedures: heart transplantation after l-vad (left ventricular assist device) implantation, or surgical repair of a type a aortic dissection, or urgent (within a few days) or emergent (within 24 hours) procedure for acute infectious endocarditis, or cardiac surgery likely to require \>180 min cpb time as estimated by the surgical team 3. signed informed consent exclusion criteria: 1. indication to receive hemoadsorption during cpb for drugs removal 2. women who are pregnant or breastfeeding (pregnancy test done as standard of care) 3. previous enrolment into the current study 4. off-pump procedure 5. chronic immunosuppression 6. known allergy to heparin or heparin induced thrombocytopenia 7. severe thrombopenia (platelets count before surgery \< 20g/l) 8. patient who does not want to be informed of incidental findings 9. participation in another study with investigational drug within the 30 days preceding and during the present study 10. participation in another conflicting research study

Keywords: post-pump syndrom cytokine hemoadsorption post-operative organ failure
study of acute autoimmune encephalitis with positive antibodies in eastern france

Conditions: Acute Autoimmune Encephalitis

Summary: the number of acute encephalitides diagnosed each year is gradually increasing, reaching approximately 5 to 10/100,000 per year; more than 50% of etiologies currently remain unknown. the majority of them are acute encephalitis of infectious origin, but it is estimated that 20% of encephalitis in northern europe is related to an autoimmune mechanism with the majority of encephalitis with anti-nmda ac discovered recently in 2007. the study of a large american encephalitis cohort showed a death rate of 3% to 7% in cases of autoimmune encephalitis. furthermore, delay in the initiation of effective treatment (tumor removal or immunotherapy) beyond 4 weeks is associated with a poor prognosis at 1 year. it is therefore necessary to better understand the signs of autoimmune encephalitis in order to recognize the disease quickly and to start a treatment quickly; in order to improve the management and the prognosis of these children.


Eligibility criteria:
inclusion criteria: * age between 0 and 17 years at diagnosis * patient diagnosed between 01/01/2006 and 31/12/2018 with autoimmune encephalitis in one of the participating university hospitals (besançon, nancy, strasbourg, reims and dijon) * presence of clinical criteria of clinical and/or radiographic encephalitis * presence of one or more antibodies in the blood or csf * parental authority holders and their child of childbearing age having given their consent for the use of the child's data for this research exclusion criteria: * refusal to participate in the study * absence of consultation at any of the study centers * absence of clinical and/or radiographic criteria for encephalitis. * absence of antibodies found in blood or csf

Keywords: acute autoimmune encephalitis encephalitis autoimmune encephalitis
therapies for recovery of hand function after stroke

Conditions: Stroke; Upper Extremity Paresis; Hemiplegia

Summary: after a stroke, it is very common to lose the ability to open the affected hand. the purpose of this study is to compare the effects of three different therapies on recovery of hand function after stroke and determine if any one is better than the other.

a single-blinded randomized controlled trial will be carried out to assess and compare the effects of 12 weeks of contralaterally controlled functional electrical stimulation (ccfes), cyclic neuromuscular electrical stimulation (cnmes), and task oriented training. dexterity, upper limb impairment, and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 weeks. the treatment dose will be the same for all three groups: 10 sessions per week of self-administered treatment at home plus 2 sessions per week of group-specific occupational therapy in the lab.

Eligibility criteria:
inclusion criteria: * 6 to 24 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke * unilateral upper limb hemiparesis with finger extensor strength of grade no more than 4 out of 5 on the medical research council (mrc) scale * score of at least 1 and no more than 11 out of 14 on the hand section of the upper extremity fugl-meyer assessment * adequate active movement of the shoulder and elbow to position the hand in the workspace for table-top task practice (necessary for the lab task practice sessions) * able to follow 3-stage commands * able to recall at least 2 of a list of 3 items after 30 minutes * skin intact on the hemiparetic arm * surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have too much flexor spasticity) * able to hear and respond to cues from stimulator * not receiving occupational therapy (no concomitant ot) * full voluntary opening/closing of the contralateral (less affected) hand * demonstrates ability to follow instructions for operating the stimulator or have a caregiver who will assist them exclusion criteria: * co-existing neurologic diagnosis of peripheral nerve injury, parkinson's disease, spinal cord injury, traumatic brain injury, or multiple sclerosis * uncontrolled seizure disorder * brainstem stroke * uncompensated hemineglect * severe shoulder or hand pain * insensate forearm or hand * history of potentially fatal cardiac arrhythmias with hemodynamic instability * implanted electronic systems (e.g. pacemaker) * botulinum toxin injections to any upper extremity muscle within 3 months of enrolling * pregnant women due to unknown risks of surface nmes during pregnancy * lack of functional passive range of motion of the wrist or fingers of affected side * diagnosis (apart from stroke) that substantially affects paretic arm and hand function * deficits in communication that interfere with reasonable study participation * lacking sufficient visual acuity to see the stimulator's display * concurrent enrollment in another investigational study

Keywords: stroke rehabilitation therapy electrical stimulation hand
exercise capacity and recovery in addison's disease

Conditions: Addison's Disease

Summary: exposure to stress alters the activity of the adrenomedullary, adrenocortical and sympathetic nervous system, depending on the type and intensity of the stressor. physical exercise represents a stress condition influencing many systems in the body. given a workload of at least 70-85% of vo2max, exercise is a potent stimulus of the hypothalamic-pituitary-adrenal (hpa)-axis. the increased endogenous cortisol secretion results in important metabolic and cardiovascular effects to maintain cellular and organ homeostasis. patients with addison's disease are not able to meet the increased demand of adrenal steroids in case of physical exercise, which may result in an impaired exercise capacity and a prolonged post-exercise recovery. we hypothesize that a hydrocortisone stress dose increases exercise capacity and improves post-exercise recovery in patients with addison's disease.


Eligibility criteria:
inclusion criteria: * addison's disease * 18-50 years * stable glucocortiocid replacement therapy exclusion criteria: * presence of intercurrent (acute) infectious disease * mental impairment (major depressive, anxiety, panic, adjustment, bipolar, psychotic, posttraumatic or borderline personality disorder) * presence of the following chronic diseases: diabetes mellitus, chronic obstructive pulmonary disease, renal failure, chronic anaemia, malignancy, rheumatoid arthritis * presence of the following cardiovascular conditions: unstable angina pectoris, history of myocardial infarction, uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, symptomatic (severe) aortic stenosis, uncontrolled symptomatic heart failure, acute myocarditis or pericarditis, left main coronary stenosis, moderate stenotic valvular heart disease, tachyarrhythmias or bradyarrhythmias, hypertrophic cardiomyopathy and other forms of outflow tract obstruction, high-degree atrioventricular block * history of pulmonary embolus or pulmonary infarction * known aortic aneurysm * severe hypertension (\>170/100 mm hg) * medication that affects cardiovascular function (beta-blocker, calcium antagonist, ace-inhibitors, aldosterone-antagonists)

Keywords: exercise capacity addison's disease
depocyt therapy in patients with neoplastic meningitis from lymphoma or a solid tumor

Conditions: Meningeal Neoplasms

Summary: the purpose of this study is to find out how well an experimental drug called depocyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). depocyt is a new slow-release form of the cancer drug called ara-c (cytarabine). cytarabine has been used for many years to treat cancer.


Eligibility criteria:
* diagnosed (or previously diagnosed) with lymphoma or a solid tumor (not leukemia) * diagnosed with neoplastic meningitis * if female, not pregnant and will not become pregnant while on-study * no other experimental therapy within 21 days of participation

Keywords: neoplastic meningitis cerebrospinal fluid csf meningeal meninges cns leptomeningeal neoplasms
treatment of intrabony defects with simvastatin and antimicrobial photodynamic therapy

Conditions: Simvastatin; Photodynamic Therapy; Periodontal Diseases

Summary: antimicrobial photodynamic therapy (apdt) is characterized by the association of photosensitizing agents, promoting the generation of reactive oxygen species like free radicals and singlet oxygen, which are cytotoxic to certain bacteria. simvastatin (smv) enhances alkaline phosphatase activity and increases the expression of bone sialoprotein, osteocalcin, and type i collagen and is shown to have an anti-inflammatory effect by decreasing the production of c-reactive protein (crp), il-6, and il-8. smv is also reported to stimulate vegf release in a dose-dependent manner which promotes osteoblast differentiation and bone nodule formation. the aim of this study is to evaluate the adjunctive effects of smv with and without apdt in chronic periodontitis patients.


Eligibility criteria:
inclusion criteria: * patients were all healthy and free from any systemic disease; * no history of antibiotic therapy or periodontal treatment for at least 6 months preceding the study; * patients were willing and able to return for multiple follow-up visits; * good levels of oral hygiene exclusion criteria: * pregnant and lactating female patients, * smokers, * alcoholics, * those receiving any medication that could affect healing of soft or hard tissue
this is a study to evaluate the pharmacokinetics and safety of ibi362 in chinese adolescents with obesity

Conditions: Adolescents With Obesity

Summary: the study is a first-in-pediatric assessment of the safety, tolerability, and pharmacokinetic characteristics of multiple doses of ibi362 in chinese adolescent subjects with obesity. it employs a multicenter, randomized, double-blind, and placebo-controlled trial design. the study plans to enroll 36 adolescents (aged ≥12 years and \<18 years) with obesity who have experienced less than a 5% decrease in body mass index (bmi) after at least 12 weeks of diet and exercise control.


Eligibility criteria:
inclusion criteria: 1. male or female subjects who are aged ≥12 years and \<18 years at the time of signing the informed consent; 2. at screening, the body mass index (bmi) meets the obesity criteria according to "ws/t586-2018 screening criteria for overweight and obesity in school-age children and adolescents"; 3. subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in bmi (as reported by the subject, parent, or legal guardian); 4. able to maintain a stable diet and exercise lifestyle during the study period; 5. capable of understanding the procedures and methods of this study, willing to strictly adhere to the clinical trial protocol to complete this trial, with both the subject and the parent or legal guardian voluntarily signing the informed consent form. exclusion criteria: 1. prepubertal subjects (tanner stage i) 2. subjects for whom the investigator suspects an allergy to the study drug or any of its components, or subjects with a history of allergies 3. use of other weight-loss medications or treatments prior to screening 4. evidence or history of other medical conditions prior to screening: * hba1c ≥ 6.5% at screening or a previous diagnosis of type 1 or type 2 diabetes * presence of retinopathy at screening * history of severe hypoglycemia or recurrent symptomatic hypoglycemia * obesity secondary to disease or medication, including hypercortisolism (e.g., cushing's syndrome) * previous bariatric surgery * history of moderate to severe depression; or history of serious psychiatric illness * previous suicidal ideation or suicide attempt
a study of taurine in patients with first-episode psychosis receiving antipsychotic treatment

Conditions: Psychotic Disorders

Summary: the purpose of this study is to determine whether taurine 4g is effective with antipsychotic medication in the treatment of first episode psychosis.taurine may have an effect on cognition and symptoms. we are examining changes in symptoms and cognition over a 3 month period.

the core rationale of this study will be to prospectively investigate whether taurine will improve and /or protect cognitive functioning and improve symptomatology in a cohort of 128 first episode psychosis patients.this is a randomized, double blind placebo controlled add on standard therapy trial of taurine 4g , in young patients between 18-25 presenting to orygen youth health a sub program of melbourne health and rapps, a subprogram of southern health with a first psychotic episode . taurine will be compared with placebo added to standard treatment for a period of 12 weeks in a double blind fashion.primary outcome measures will be psychopathology and cognition (matrics. secondary outcome measures will be tolerability and safety measures (drop-out rates, general side effect scale (uku). patients who give informed consent will be randomised to receive treatment with taurine 4g daily or placebo for 12 weeks. patients will be randomised by a dynamic randomisation method called minimization which allocates patients to treatment group by checking the allocation of similar patients already randomised, and allocating the next treatment group "live" to best balance the treatment groups across all stratification variables. the minimization will be carried out by the nhmrc clinical trials centre in sydney , and the patient will be randomized to either placebo or vitamin. each patient will collect their tablets from the clinical trials pharmacy. the clinical trials pharmacy will dispense either vitamin or placebo. all study personnel and participants will be blinded to treatment assignment for the duration of the study.

Eligibility criteria:
inclusion criteria: * male and females * between 18 and 25 years of age * first episode psychosis * attending orygen youth health, a geographical based catchment area service for young people aged between 15 and 25. exclusion criteria: * organic disorders presenting with a psychotic syndrome (e.g. brain tumour, temporal lobe epilepsy, hiv encephalopathy) * mental retardation (unable and/or unlikely to give appropriate information of symptomatology or side-effects (iq approximately lower than 80) * history of clinically significant physical illness (e.g. terminal cancer, renal dialysis) * history of brain surgery * history of brain infarction * pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception.

Keywords: first episode psychosis
an effectiveness and safety study with rwj-333369 (carisbamate) for the study of postherpetic neuralgia (phn).

Conditions: Postherpetic Neuralgia; Neuralgia; Herpes Zoster

Summary: the purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200 mg of rwj-333369 given twice daily compared with placebo in the treatment of postherpetic neuralgia.

postherpetic neuralgia is a distressing syndrome of neuropathic pain that continues for at least 3 months after the resolution of the varicella-zoster rash (shingles), can last up to years later, and for which therapies are often limited by incomplete pain relief and side effects. this is a randomized (study medication is assigned by chance), double-blind (neither the investigator or the patient know the name of the assigned study medication), placebo-controlled, crossover, parallel-group, multicenter study to determine the effectiveness and safety of 200 mg of rwj-333369 given twice daily for 4 weeks compared with placebo in patients with postherpetic neuralgia (phn). the study hypothesis is that 200 mg of rwj-333369 given twice daily for 4 weeks will be more effective than placebo in reducing pain due to phn, as measured by average daily phn pain scores. patients will receive 200 mg of rwj-333369 or matching placebo tablets, given in equally divided doses twice daily by mouth, with or without food, for 4 weeks in each of the 2 treatment periods.

Eligibility criteria:
inclusion criteria: * diagnosis of postherpetic neuralgia (phn) with a history of varicella-zoster rash (shingles), persistent pain for at least 6 months after the healing of the rash * experienced postherpetic neuralgia pain on a daily basis for the past 3 months * women must be postmenopausal for at least 2 years, sexually abstinent, or if sexually active, be practicing an effective method of birth control, and have a negative serum pregnancy test at screening. exclusion criteria: * history of a poor response to 3 or more medications for postherpetic neuralgia (phn), with poor response defined as treatment with medications in the following categories of therapy for at least 1 month at therapeutic dosages without at least moderate improvement, as judged by the study doctor: antiepileptic drugs, antidepressants, serotonin norepinephrine uptake inhibitors (snris), opioid analgesics, or lidocaine patch * currently taking tricyclic antidepressants, coumadin (warfarin), or continued treatment with an antiepileptic drug for any indication, note: if taking these medications, to be eligible for the study, they must be tapered and discontinued * past neurolytic treatment (destruction of nerves by the application of chemicals, heat or cold, neurosurgery, intrathecal pumps, or spinal cord stimulators for phn pain * currently using herbal topical creams or ointments for pain relief within 48 hours, capsaicin within 6 months, or systemic corticosteroids within 3 months of the baseline period * prior exposure to rwj-333369 (carisbamate).

Keywords: pain following the healing of rashes and blisters herpes virus rash varicella-zoster virus shingles.
intrathecal hydromorphone for postoperative pain of anorectal surgery

Conditions: Acute Pain; Post Operative Pain; Anorectal Disorder; Analgesia

Summary: anorectal problems, such as hemorrhoids, fistula, fissures, etc., often require surgical treatment. patients often have postoperative pain after these surgeries, which increases discomfort and hospital length of stay. the efficacy of oral non-opioids in the treatment of such pain is poor. hydromorphone is an opioid analgesic commonly used orally or intravenously for postoperative pain management. we designed this trial to investigate the efficacy and safety of intrathecal (delivery directly to the spinal cord during spinal anesthesia) single dose hydromorphone versus intrathecal placebo in treating postoperative pain among human subjects after anorectal surgery, but also the recovery of postoperative motor capacity in these human subjects.


Eligibility criteria:
inclusion criteria: * 1. clinical diagnosis of anorectal disease, ready to undergo elective surgery * 2. american society of anesthesiologists(asa) physical status i-ii * 3. desire to have a spinal anesthesia * 4. must be able to follow the medication dose and visit schedule exclusion criteria: * 1. any contraindications to spinal anesthesia and intrathecal analgesia. * 2. complex co-morbidities, including 1. severe infection, 2. respiratory insufficiency, 3. history of psychiatric or neurological disorders and other cognitive impairments * 3. chronic pain syndrome or current opioid use \>10mg oral morphine equivalents/day * 4. allergy or intolerance to hydromorphone, nsaids and cox-2 selective inhibitor * 5. clinical diagnosis of obstructive sleep apnea syndrome(osas) * 6. history of drug abuse * 7. women who are breastfeeding or pregnant * 8. participation in other clinical trials within three months * 9. already participated in this study once * 10. not considered suitable for the clinical trial by the investigators

Keywords: hydromorphone intrathecal opioid post operative pain anorectal surgery placebo