Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety, tolerability, efficacy and pk of ides in kidney transplantation

Conditions: End Stage Kidney Disease

Summary: this study will assess the safety and efficacy of ides in the transplantation setting. each patient will receive one dose of ides. if the crossmatch test is negative at the time of transplantation, the patient will be transplanted with a kidney from a deceased or living donor. the starting dose will be 0.25 mg/kg bw, given as a single intravenous infusion prior to surgery.

this study will assess the safety and efficacy of the igg degrading cysteine protease ides in the transplantation setting. patients with dsas will be treated with ides prior to transplantation. each patient will receive one dose of ides. if the crossmatch test is negative after ides treatment, the patient will be transplanted with a kidney from a deceased or living donor. two to four dose groups are planned. each group will contain 2 patients with the possibility to extend the group to up to 4 patients per group if required for safety and/or efficacy evaluation. the starting dose will be 0.25 mg/kg bw, given as a single intravenous infusion prior to surgery with the possibility to increase the dose in higher dose groups.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ckd and in dialysis with preformed anti-hla antibodies (non-dsa, dsa or both), negative t-cdc cxm and at least one antibody mfi \> 3000 exclusion criteria: * prior malignancy within 2 years excluding adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ and prostate cancer gleason \<6 and prostate-specific antigen (psa) \<10 ng/ml. * any positive result on screening for serum hepatitis b surface antigen, hepatitis c antibody and human immunodeficiency virus (hiv * clinical signs of ongoing infectious disease. * severe other conditions requiring treatment and close monitoring, e.g. cardiac failure \> new york heart association (nyha) grade 3, unstable coronary disease or oxygen dependent chronic obstructive pulmonary disease (copd) * history of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the study, or influence the results or the patient's ability to participate in the study * hypogammaglobulinemia defined as any values of p-total igg less than 3 g/l * history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to ides (e. g streptokinase and/or staphylokinase) * has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 4 months of the first administration of investigational product in this study. * patients consented and screened but not dosed in previous studies are not excluded
youth php pilot transdiagnostic treatment implementation and effectiveness study

Conditions: Emotional Disorder

Summary: the purpose of this study is to examine patient effectiveness outcomes of a transdiagnostic treatment for youth emotional disorders, implemented in a partial hospitalization program (php). participants will be youth between ages 6 to 17 and their families, as well as clinicians, participating in the php program at children's hospital colorado. additionally, the research team will study modifications to the transdiagnostic intervention that are required to feasibly and effectively deliver it in a php setting.


Eligibility criteria:
inclusion criteria: inclusion criteria for patient participant involves: * youth between the ages of 6 and 17 * participation in treatment in the children's hospital colorado (chco) php program * presence of at least one caregiver available and willing to participate in the study. inclusion criteria for clinician participants involves: --psychologist, licensed master's-level clinician (i.e., "behavioral health clinician"), or unlicensed "behavioral health specialist" providing clinical services through the chco partial hospitalization program during the period of study enrollment exclusion criteria: patients will be excluded from the study if: * they are a ward of the state * are not enrolled in the children's hospital colorado php program. clinicians will be excluded from the study if: --they are not providing clinical services through the children's hospital colorado php program
neuropsychological care for maintaining quality of life after radiation therapy in patients with brain metastases

Conditions: Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Solid Neoplasm

Summary: this phase ii trial studies the effect of neuropsychological evaluation and intervention in maintaining quality of life after radiation therapy in patients with cancer that has spread to the brain (metastases). quality of life refers to the overall enjoyment of life. it holds varying meanings for different people and may evolve over time. for some individuals it implies autonomy, empowerment, capability, and choice; for others, security, social integration, or freedom from stress or illness. neuropsychological evaluation is used to examine the cognitive (thinking) consequences of brain damage, brain disease, and severe mental illness. deterioration of both quality of life and cognitive function is common when receiving radiation to the brain. neuropsychological evaluation with a certified neuropsychologist may improve quality of life or cognitive function after radiation therapy.

primary objective: i. to evaluate the efficacy of neuropsychological assessment and follow up on preventing decline of quality of life (qol) as evaluated by the functional assessment of cancer therapy scale-brain (fact-br) score (validated qol tool for brain metastases). secondary objectives: i. to evaluate the efficacy of early neuropsychological assessment and neurocognitive rehabilitation by a neuropsychologist on prevention of neurocognitive decline in patients treated with radiation to brain metastases as evaluated by the hopkins verbal learning test-revised (hvlt-r) delay recall, trail making test a/b (tmt a/b), and controlled oral word association test (cowat), and patient reported outcomes measurement information system (promis)-8 assessment. ii. to identify subsets of patients treated with whole brain radiation therapy (wbrt) or stereotactic radiosurgery (srs) who receive greater benefits of neuropsychologic evaluation through examining baseline fact-br, hvlt-r, tmt a/b, cowat, and promis-8 completed prior to radiation therapy delivery. outline: patients are randomized to 1 of 2 arms. arm i: patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months. arm ii: patients receive usual care. after completion of standard of care radiation therapy, patients are followed up at 3, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * stage iv histologic diagnosis of solid tumor * patient will be treated with radiation therapy for brain metastases * primarily english-speaking patient * graded prognostic assessment (gpa) \>= 2 (estimated survival \> 6 months) exclusion criteria: * patient received prior whole brain radiation therapy to the brain * patient has multiple sclerosis, alzheimer's, dementia, or mental disability
assessment of remnant liver function in alpps by gd-eob-dtpa enhanced mri

Conditions: Liver Function Failure; Liver Malignant Tumors

Summary: insufficient future liver remnant (flr), which may render post-hepatectomy liver failure, is one of the major obstacles for performing liver resection for patients with liver malignants. associating liver partition and portal vein ligation (alpps) was introduced to induce rapid and extensive liver hypertrophy, which offers the opportunity for removing the liver malignancy in the second stage operation for patients with insufficient flr at their first stage operation. feasibility of the second stage of alpps has been assessed mostly on the basis of laboratory parameters and volumetry by the 3d reconstruction of ct. meanwhile, part of the patients who underwent the second stage alpps still experienced postoperative liver failure, even in patients with sufficient flr volume. in other words, this volumetric increase may not reflect the increase of liver function. and the laboratory parameters can only partly reflect the global liver function but not the regional liver function. therefore, the combination of volumetric and global liver function tests might be unsuitable for predicting flr function after first stage alpps because function is distributed unequally between left and right liver lobe. the gd-eob-dtpa-enhanced liver mri, which has remarkable potential to evaluate regional liver function and could therefore be an ideal diagnostic test for performing volumetric and functional measurement after the first stage alpps in one examination. thus we performed this clinical trial in order to evaluate the efficacy of gd-eob-dtpa-enhanced liver mri in evaluating the flr liver function after the first stage alpps.

the clinical data and follow up information of the patients who underwent laparoscopic alpps in department of general surgery, peking university third hospital were collected. the indication for the performance of the first and second alpps was evaluated by multi-disciplinary team (mdt). the liver function evaluation indexes of gd-eob-dtpa enhanced liver mri such as re (relative enhancement of the liver)=（si20min-siunenhanced）/ siunenhanced and other related indexes were calculated. si referred to signal intensity. si20 min referred to the signal intensity in the hepatocyte phase (20 min after the injection). the relationship between the indexes and postoperative liver failure as well as other complications were analyzed.

Eligibility criteria:
inclusion criteria: * future liver remnant volume \<30%; * indocyanine green clearance (icg) rate \<20% at 15 minutes; * child a liver function, serum platelet count \> 50×109/l; * good general condition. exclusion criteria: * complete right portal vein thrombosis; * serum platelet count \< 50×109/l; * clinical signs of portal hypertension such as ascites, and/or intra-abdominal varices.

Keywords: gd-eob-dtpa enhanced mri alpps liver failure
safety and pharmacokinetic study of embeda in children ages 7-17 with pain

Conditions: Moderate-severe Pain

Summary: safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.

subjects, once stabilized to embeda, need only complete a minimum of 2 of the 6 week study duration to satisfy the pk endpoint. a safety follow-up visit is required at 1 week post-last dose.

Eligibility criteria:
inclusion criteria: * children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid analgesic. * be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to \>20 mg per day of morphine, for a period of 3 consecutive days immediately prior to first day of dosing. exclusion criteria: * columbia-suicide severity rating scale (c-ssrs) for suicidal ideation and behavior in past year. * hypersensitivity to morphine, naltrexone. * a life expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally. * undergone surgery within 3 days prior to the first day of dosing.

Keywords: pediatric pain indication controlled release morphine
study for consolidation period of chronic hepatitis b

Conditions: Hepatitis B

Summary: the investigators aim to clarify the issue of adequate duration of consolidation period of chronic hepatitis b infection with antiviral treatment with tenofovir which could strike a balance between durable hbeag seroconversion and avoiding long-term inevitable serological or virological recurrence.

according to practice guidelines of american association of the study of liver diseases, in patients of hbeag-positive chronic hepatitis b, treatment should be continued until the patient has achieved hbeag seroconversion and undetectable serum hbv dna and completed at least 6 months of additional treatment after appearance of anti-hbe. also several other current guidelines of anti-viral treatment of chronic hepatitis b infection suggest that nucleos (t) ide analogues treatment can be stopped following 6 to 12 months of consolidation therapy after hbeag seroconversion. however, there is a paucity of data available about the long-term durability of tenofovir induced hbeag seroconversion as well as antiviral treatment associated resistance risk. 2. primary end points: hbeag seroconversion was defined as loss of hbeag with concurrent appearance of hbeab. serological recurrence was defined as reappearance of hbeag. virological recurrence was defined as an increase of hbv dna level to greater than 10,000 copies/ml after hbeag seroconversion with previously hbv dna levels less than 10,000 copies/ml. 3. aims: to clarify the issue of adequate duration of consolidation period which could strike a balance between durable hbeag seroconversion and avoiding long-term inevitable serological or virological recurrence. 4. study design: a single-center cohort study which randomly allocating two different extended tdf treatment periods after hbeag seroconversion - 12 months, and 18 months across patient groups. then data will be collected about outcomes at a specific follow-up time.

Eligibility criteria:
inclusion criteria: * adult patients with chronic hbv infection (hbsag-positivity for at least six months and hbeag-positivity for at least three months) and serum hbv dna levels ≥1000000 copies/ml (cobas amplicor hbv monitor assay) at screening as well as serum alt levels \>1.3 times the uln (43 iu/l) on at least two occasions in the previous 6 months and at screening. exclusion criteria: * co-infection with hcv, hdv, or hiv and treatment with (pegylated) interferon or other nucleos (t) ide analogues for less than six months before the start of tenofovir treatment.

Keywords: hepatitis b virus, tenofovir
aerosol particle concentrations among different oxygen devices for spontaneous breathing patients with tracheostomy

Conditions: Transmission, Patient-Professional

Summary: for spontaneous breathing patients with tracheostomy, whose lower airway is directly opened to the room air, the aerosol particles generated by the patients would be directly dispersed into the room air, which might be an direct resource of virus transmission. however, the transmission risk has not been evaluated and the appropriate humidification therapy is unknown. thus this study is aimed to investigate the aerosol particle concentrations among different oxygen devices for spontaneous breathing patients with tracheostomy, in order to reflect the transmission risk.

the transmission route of the sars-cov-2 virus remains controversial, and concerns persist of potentially increased virus transmission when utilizing high-flow devices and aerosol devices among covid-19 patients. for spontaneous breathing patients with tracheostomy, whose lower airway is directly opened to the room air, the aerosol particles generated by the patients would be directly dispersed into the room air, which might be an direct resource of virus transmission. however, the transmission risk of tracheostomy during spontaneous breathing has not been evaluated and the appropriate humidification therapy is unknown. thus this study is aimed to investigate the aerosol particle concentrations among different oxygen devices for spontaneous breathing patients with tracheostomy, in order to reflect the transmission risk.

Eligibility criteria:
inclusion criteria: * adults; * tracheostomy; * able to spontaneous breathing without ventilator support exclusion criteria: * confirmed diagnosis of covid-19 within recent two weeks; * non-english speaking; * refuse to participate in the study; * palliative care; * receiving ecmo; * unable to connect with tracheostomy adapter, such as laryngectomy tube

Keywords: aerosol generating procedure tracheostomy oxygen therapy
evaluation the impact of self-stigma reduction program on psychosocial outcomes among people diagnosed with schizophrenia

Conditions: Stigmatization

Summary: backgrounds: research evidence suggests that people diagnosed with schizophrenia (pdws) experience higher level of stigma compared with other forms of mental illness, and they are prone to internalize stereotype, which exacerbates severity of psychiatric symptoms, reduces their psychosocial treatment adherence. the purpose of the study to evaluate the effectiveness of stigma reduction program on the perceived stigma, psychiatric symptoms, compliance with psychosocial intervention and self-efficacy. methods: a randomized controlled trial was conducted from november 2017 to december 2018 with 278 pdws. participants aged 18 years or older with dsm-iv schizophrenia or schizoaffective disorder, from four outpatient mental health clinics in jordan, were randomly assigned to receive 13 sessions of a booklet form of stigma reduction program (n = 140) (psycho-education, cognitive behavioural therapy and social skills training), and treatment as usual \[tau\] (intervention, n = 140), or tau (control, n = 138). participants were assessed at baseline, immediately post-intervention (post-treatment1) and at six months follow-up. the primary outcome measure was change in stigma perception. secondary outcomes were psychiatric symptoms, compliance with psychosocial interventions and self-efficacy.


Eligibility criteria:
eligibility criteria * adults aged 18 or over diagnosed with schizophrenia or schizoaffective disorder according to the diagnostic and statistical manual of mental disorders, 5th edition (dsm-v) (american psychiatric association, 2013). * all participants had to be able to read and write english or arabic * willing and able to consent. exclusion criteria were: - people diagnosed with schizophrenia who had a learning disability, with known organic mental disorder, substance abuse
non interventional study to investigate the safety and effectiveness in patients with relapsed and refractory multiple myeloma treated with elranatamab under the actual use.

Conditions: Relapsed and Refractory Multiple Myeloma (RRMM)

Summary: to investigate the safety and efficacy in patients with relapsed and refractory multiple myeloma treated with elranatamab under the actual use.

the objective of this study is to assess the safety and efficacy in patients with relapsed and refractory multiple myeloma (rrmm) treated with elranatamab under the actual use. * primary objective: confirm whether the onset status (the number of patients, incidence, grade, seriousness, timing of onset, duration, treatment and outcome) of cytokine release syndrome (crs) and immune effector cell-associated neurotoxicity syndrome (icans) is comparable to that in the clinical studies and whether adverse reactions were appropriately treated. * secondary objective: confirm the onset status of any adverse reaction (including unknown adverse reaction) to long-term treatment with elranatamab and the overall response (orr) as efficacy assessment and evaluate them in terms of benefit-risk. conditions for approval; because of the extremely limited number of patients treated in japanese clinical studies, a drug use investigation in all patients should be conducted to understand the background information of patients on elranatamab, early collect data on the safety and efficacy of elranatamab, and take measures necessary for the proper use of elranatamab until the data of a certain number of patients are accumulated.

Eligibility criteria:
inclusion criteria: patients who have received at least one dose of elranatamab.

Keywords: rrmm
a study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: the purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gmg).


Eligibility criteria:
inclusion criteria: * study participant must meet one of the following: 1. completed mg0003 \[nct03971422\] 2. required rescue therapy during the observation period in mg0003 or 3. completed at least 6 visits in mg0004 \[nct04124965\] * body weight ≥35 kg at baseline (day 1) * study participants may be male or female exclusion criteria: * study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal fc receptor (fcrn) medications * study participant with a known tuberculosis (tb) infection, at high risk of acquiring tb infection, or latent tuberculosis infection (ltbi), or current/history of nontuberculous mycobacterial infection (ntmbi) * study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in mg0003, or mg0004, or permanently discontinued study drug in either study * study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of rozanolixizumab * study participant with severe (defined as grade 3 on the myasthenia gravis-activities of daily living (mg-adl) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis

Keywords: ucb7665 generalized myasthenia gravis rozanolixizumab gmg
aadi glaucoma shunt - a quality control study

Conditions: Glaucoma

Summary: to prospectively investigate the effect and safety of implantation of the aadi glaucoma tube in eyes with medically intractable glaucoma in the period 2019 to 2020, at the department of ophthalmology, odense university hospital. the device will be implanted in eyes instead of the bearveldt drainage device. patients and data are prospectively registered to evaluate the effect and safety of the aadi device.


Eligibility criteria:
patients referred to glaucoma shunt implant (baerveldt) will recieve the aadi glaucoma shunt

Keywords: aadi; glaucoma tube shunt
event - evaluation of the influence of htee

Conditions: Postoperative Heart Insufficiency

Summary: compromised tissue oxygenation during surgery may negatively influence patient outcome. primary cause of insufficient tissue oxygenation is reduced cardiac output due to hypovolemia and/or reduced cardiac contractility. in cardiac surgery patients especially, postoperative pericardia effusion and/or tamponade may further compromise cardiac function. today, hemodynamically instable patients are often monitored by means of pulmonal artery catheters or transpulmonary thermodilution. however, these methods only allow quantification of functional limitations. underlying causes may be investigated by relatively recent technology through hemodynamically focussed transesophageal echocardiography (claritee(r) imacor) that also provide the possibility of continuous monitoring. it has been reported that a training program consisting of six hours may enable physicians who are unexperienced in the field of echocardiography to apply this new method. up to now, there is no evidence whether this methods is associated with improved postoperative outcome. therefore we hypothesize that continuous hemodynamically focussed transesophageal echocardiography positively influences patient outcome (primary hypothesis). furthermore, its application may decrease hospital expenses (secondary hypothesis).


Eligibility criteria:
inclusion criteria: * elective, cardiac surgery * hemodynamic instability or placement of htee/picco (pulse contour continuous cardiac output) /pac (pulmonary arterial catheter) within 12 hours of icu admission exclusion criteria: * pregnant/breastfeeding women

Keywords: transesophageal echocardiography tee toe cardiac surgery