Kornimate/medical-research-clean huggingface dataset:
a study to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of zampilimab in adult kidney transplant recipients with chronic allograft injury

Conditions: Chronic Allograft Injury

Summary: the main purpose of the study is to investigate the safety and tolerability of repeat dosing with zampilimab in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (cai).


Eligibility criteria:
inclusion criteria: * functioning living or deceased donor allograft \>=1 year post-transplantation * baseline (screening) biopsy showing grade ii or iii interstitial fibrosis/tubular atrophy (if/ta) (\>=25% if/ta) * progressive loss in kidney function observed after the first year post-transplant, defined as an estimated glomerular filtration rate (egfr) decline of ≥3 ml/min/year for at least 24 months prior to screening, with a minimum of 2 documented measurements per year (minimum of 4 documented measurements in the 24-month period, performed at least 1 month apart) * an egfr \>=30 ml/min/1.73 m\^2 for a period of 6 months up to screening * stable standard of care concomitant medication for 3 months prior to screening * participant is male or female, \>=18 years of age exclusion criteria: * recipient of multi-organ transplant (with the exception of repeated kidney transplant recipients, and/or corneal transplant recipients) * screening biopsy shows evidence of significant active antibody-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the principal investigator (pi) * screening biopsy shows evidence of t cell-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the pi * screening biopsy shows evidence of de novo or recurrent glomerular disease that may affect the conduct of the study (eg, require change in treatment) according to the pi * proteinuria ≥1500 mg/g at screening * participant who has a history of biopsy-proven acute rejection or treatment for suspected acute rejection within 3 months prior to screening * participant has had major surgery (including joint surgery) within 6 months prior to screening, or has planned surgery within 6 months after the last dose of investigational medicinal product (imp) * participant has a current diagnosis of foot ulcer or diagnosis of chronic diabetic ulcer or history of delayed wound healing * participant has taken concomitant medication of sirolimus or everolimus within 3 months of screening

Keywords: chronic allograft injury ucb7858 kidney transplantation cai zampilimab
a chatbot to support substance use recovery

Conditions: Opiate-Related Disorders; Opiate Substitution Treatment

Summary: the goal of this clinical trial is to learn if/how an ai chatbot can support patients who in recovery for substance use, specifically those who are receiving medication for opioid use disorder. can the chatbot help lower drug use? can the chatbot help improve clinical appointment adherence? can the chatbot help patients build self-efficacy in leading their own recovery journey? will the chatbot help reduce workload burden for primary care teams? can the chatbot serve as a safe, useful and engaging tool to support patients? researchers will investigate the effects of using a chatbot to support follow-up care for patients in opioid use recovery. participants will: * receive access to a chatbot for 12 weeks that they can use to prepare for upcoming clinical appointments, find community resources, learn about urge-surfing and wellness techniques, and query for assistance with other recovery-related information and tasks * complete surveys and provide user feedback


Eligibility criteria:
inclusion criteria: * 18-65 years old * comfortable with reading, understanding, and communicating in english * receiving medication treatment for oud at mgh? * able to participate in a remote interview? * own or have reliable access to wi-fi or a cellular network * willing to use a mobile device to access the chatbot? exclusion criteria: * has any cognitive, visual, or auditory impairments that may prevent the participant from using the chatbot on a mobile device? * unstable medical condition that compromises the ability to safely participate
rapid prehospital access to ecpr in prague

Conditions: Out of Hospital Cardiac Arrest; Extracorporeal Cardiopulmonary Resuscitation

Summary: a prospective pilot feasibility study of prehospital ecpr in patients with refractory ohca

the aim of this pilot prospective study is to assess the feasibility and effectiveness of a prehospital extracorporeal cardiopulmonary resuscitation (ecpr) system for refractory out-of-hospital cardiac arrest (ohca) in prague, compared to a historical cohort of in-hospital ecpr recipients from the prague ohca trial.

Eligibility criteria:
inclusion criteria: * estimated age 18-70 years * refractory out-of-hospital cardiac arrest (3 unsuccessful defibrillations and/or at least 10 minutes of resuscitation in case of pulseless electrical activity) * witnessed cardiac arrest * ecpr team available * ecpr team alert within 20 minutes from the emergency call exclusion criteria: * unwitnessed cardiac arrest * asystole * etco2 less than 10 mmhg upon ecpr team arrival * known limitations of intensive care (do not resuscitate - dnr status) * known severe neurological impairment prior to cardiac arrest (mrs 4-6) * suspected or known pregnancy

Keywords: cardiac arrest ecpr ecmo prehospital
placental organoids development: application in the study of the human reproduction pathophysiology.

Conditions: Preeclampsia; Pregnancy Loss; Preterm Birth; Healthy

Summary: placental organoids represent an in vitro 3d reconstruction model of the human placenta and of its complex cellular organization to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.

placental organoids represent an in vitro 3d reconstruction model of the human placenta and of its complex cellular organization. placental organoid model can be used in the study of placental pathophysiology. in in particular, it provides a personalized model for sartorial in vitro evaluation of personalized therapeutic efficacy of different pharmacological therapies. in particular, with placental organoid it is possible to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.

Eligibility criteria:
inclusion criteria: * women with uncomplicated normal term pregnancy undergoing elective cesarean section for previous uterine surgery or breech presentation of the fetus; * patients with retained abortion and history of recurrent abortion sine causa at the end of the work-up of investigations performed according to eshre guidelines, undergoing revision of the uterine cavity; * patients diagnosed with preeclampsia, defined in accordance with the definitions of isshp, undergoing cesarean section; * patients with preterm onset, before 37 weeks gestational age, of spontaneous labor, undergoing cesarean section in labor for low weight or abnormal fetal presentation. exclusion criteria: * age \<18 years; * chronic infection with hiv or hcv; * ongoing malignant neoplasms; * multiple pregnancies; * inability to provide informed informed consent.
a study to evaluate the safety, tolerability, cellular kinetics, and pharmacodynamics of p-cd19cd20-allo1 in participants with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study aims to explore the safety, tolerability, cellular kinetics, and pharmacodynamics of p-cd19cd20-allo1 in participants with progressive multiple sclerosis (pms) and relapsing multiple sclerosis (rms).


Eligibility criteria:
inclusion criteria: * age 18-60 years (inclusive) at the time of signing informed consent form * diagnosis of progressive ms according to the revised mcdonald 2017 criteria, and: expanded disability status scale (edss) score at screening, from 3 to 6 inclusive evidence of disability progression and no relapses in the 2 years prior to screening - diagnosis of relapsing ms according to the revised mcdonald 2017 criteria, and: evidence of clinical relapses and mri activity within two years prior to screening while on a disease modifying therapy * edss score at screening, from 0 to 6 inclusive * no relapses within 45 days of screening exclusion criteria: * pregnant or breastfeeding, or intention of becoming pregnant within the timeframe in which contraception is required * participants who have confirmed or suspected progressive multifocal leukoencephalopathy (pml) * known or suspected history of hemophagocytic lymphohistiocytosis/ macrophage activation syndrome (hlh/mas) or neurotoxicity with prior therapies * known presence of other neurologic disorders that may mimic ms * history of currently active primary or secondary (non-drug-related) immunodeficiency * significant or uncontrolled medical disease which would preclude patient participation * high risk for clinically significant bleeding or any condition requiring plasmapheresis, iv ig, or acute blood product transfusions * history of recurrent serious infections or chronic infection * prior treatment with car t-cell therapy, gene-therapy product, total body irradiation, bone marrow transplantation, allograft organ transplant, or hematopoietic stem cell transplant at any point * any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period. * inability to complete an mri scan
effect of three different sensory interventions on pain level during heel blood collection in term infant

Conditions: Infant; Pain

Summary: background: healthy newborns undergo many painful procedures in the first hours of life. damage caused by painful procedures can lead to structural and functional changes that can affect adult life. various non-pharmacological methods have been reported in the literature for pain management. the aim of the study is to investigate the effect of the method that appeals to 3 different senses (mother's voice, breast milk smell, mother's contact) on the level of pain during heel blood collection. method: the population of the study consisted of babies who were hospitalized in a hospital's neonatal unit between december 2022 and may 2023 and who heel blood taken. the neonatal-infant pain (nips) scale and data collection form were used to obtain the data. 120 newborns who met the study criteria were randomly divided into group 1 (n=30) , group 2 (n=30), group 3 (n=30), control group (n=30). all intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. the mother called her baby between 40 and 60 decibels loudness for group 1. breast milk was dripped onto the gauze in an amount to wet the entire 2,5cm\*2,5cm sterile gauze and the gauze was then placed close to the baby's nose wings for group 2. skin-to-skin contact between mother and baby is provided for group 3. nips score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure for all groups.


Eligibility criteria:
inclusion criteria: * born between 37+0/7 - 41+6/7 gestational weeks, * gestational age and birth weight are compatible, * healthy newborns with stable vital signs. exclusion criteria: * hearing problems, * suction problem * congenital anomaly, * need hospitalization in the neonatal intensive care unit.

Keywords: infant pain mother's milk mother's voice skin contact
neurally adjusted ventilatory assist (nava) in noninvasive ventilation (niv)

Conditions: Respiratory Insufficiency

Summary: main hypothesis is that neurally adjusted ventilatory assist (nava) allows asynchrony reduction in non invasive ventilation (niv) in comparison with reference pressure support (psv) mode. the purpose of the protocol is to compare asynchrony rate between periods of pressure support and periods of nava.

after written information and consent, patients are randomised in two groups: nava first or psv first. they receive a nava catheter, which has exactly the same appearance as a standard naso-gastric catheter. a standardised set of 1 hour of non-invasive ventilation is started. depending on the randomisation group, patients start with a 30 minutes set of niv with nava settings or with a 30 minutes set of niv with psv settings. a 30-minute watch-out period is then delivered with no mechanical ventilation. then a second 30-minute set of niv in the other settings (nava or psv depending on the randomisation) is delivered. during each set of niv, flow, volume, pressure and eadi are recorded during 10 minutes, after a 10-minute period of equilibration. recordings will be processed by two blind investigators in order to count the number of asynchronies. in case of disagreement between investigators, a third one will be interviewed.

Eligibility criteria:
inclusion criteria: * - patient older then 18 years * patient requiring first non invasive ventilation set because of acute respiratory failure exclusion criteria: * patients protected by the law * pregnant women

Keywords: respiratory insufficiency respiration, artificial intermittent positive-pressure ventilation neurally adjusted ventilatory assist non invasive ventilation
assessing the tendons with shear wave elastography

Conditions: Tendinopathy

Summary: the purpose of this study is to utilize shear wave elastography (swe) to study the viscoelastic properties of tendons to understand the functional differences between normal/asymptomatic and symptomatic tendon states. the study will also assess the degree of tendon healing following standard of care treatment.

tendinopathy is a common affliction in athletes, recreational exercisers, the general population and even inactive people. tendon pathology presenting clinically is most commonly seen in the chronic state related to tendon degeneration manifested as intra-tendinous mucoid degeneration and chondroid metaplasia, which in many cases is accompanied by superimposed small intrasubstance/interstitial tears. then a vicious cycle of attempted inadequate healing with superimposed acute pathology ensues leading to significant pain and discomfort over time significantly limiting physical activity. the exact pathogenesis of this disease has not been clarified scientifically. the first part of this study aims to establish the difference between asymptomatic and symptomatic tendons among patients affected by moderate-to-severe, chronic (\>6 months of symptoms) tendinopathy in comparison to asymptomatic patients. after establishing a range of elastography normal to severe pathologic measurements, a second part of the study will focus on utilizing ultrasound elastography imaging follow up to assess degree of tendon healing after various standard of care treatments. the purpose of this prospective observational study is to utilize a ultrasound modality known as real-time shear wave elastography (swe) to study the viscoelastic properties of tendons, such as the achilles, patellar, quadriceps, epicondylar, and rotator cuff, to understand the functional differences between normal/asymptomatic (n=75) vs symptomatic (n=75) tendon states (total n=150). the secondary aim will be to assess the degree of tendon healing after standard of care treatment. the clinical implications are very significant because it will provide insights into the mechanism of tendon healing.

Eligibility criteria:
inclusion criteria for asymptomatic volunteers: * patients presenting at the study location with lower extremity pain without tendon involvement inclusion criteria for symptomatic volunteers: * patients presenting at the study location with a clinical diagnosis of tenalgia * diagnosis of tendinopathy confirmed by ultrasound exclusion criteria: * pregnancy * history of tendinopathy or surgery and morphologic abnormalities * history of systemic, metabolic, endocrine diseases, or psoriasis * history of treatment with corticosteroids, estrogens, long term quinolone antibiotics, and cholesterol drugs

Keywords: sonographic imaging shear wave elastography
promus element plus us post-approval study

Conditions: Coronary Artery Disease

Summary: this study is designed to observe clinical outcomes in patients receiving the promus element plus everolimus-eluting platinum chromium coronary stent system in routine clinical practice. patients will have symptomatic heart disease or documented silent ischemia. this is a prospective, open-label consecutively-enrolling study. clinical follow-up is through 5 years. approximately 2,689 patients are to be enrolled in up to 65 centers in the united states.

the wide-spread use of drug-eluting stents (des) has evolved as standard of care in de novo lesions. the promus element plus everolimus-eluting platinum chromium coronary stent system is indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries ≥2.25 mm to ≤4.00 mm in diameter in lesions ≤34 mm in length. the proposed study will compile real-world clinical outcomes data for the promus element plus everolimus-eluting platinum chromium coronary stent system in routine clinical practice. patients enrolled in this study are expected to follow antiplatelet therapy recommendations per american college of cardiology (acc)/american heart association (aha)/society for cardiovascular angiography and interventions (scai) guidelines for percutaneous coronary intervention (pci). recommended medications include aspirin, which should be taken for 3 days prior to the procedure or as a peri-procedural loading dose and then continued indefinitely. additionally, one of the following p2y12 antagonists may be given in a peri-procedural loading dose and in a maintenance dose per physician discretion: clopidogrel, prasugrel, ticagrelor, or ticlopidine.

Eligibility criteria:
inclusion criteria: * the population will include consecutive, consented patients. exclusion criteria: * there are no exclusion criteria in this all-comers study.

Keywords: drug-eluting stent des atherosclerosis everolimus
escalation antifungal prophylaxis for patients undergoing allogeneic hematopoietic stem cell transplantation

Conditions: Fungal Infection

Summary: this is single arm study to evaluate an escalation anti-fungal prophylaxis protocol for patients undergoing allogeneic stem cell transplantation. for all patients without documented proven or probable invasive fungal disease (ifd), patients will receive fluconazole during the treatment in the laminar air flow units (laf). after discharged from laf units, patients will receive anti-mold prophylaxis in case of haplo-identical or hla-matched unrelated donor transplantation to d+100 without active acute gvhd (agvhd). in case of active agvhd, the prophylaxis treatment will be extended until recovery of agvhd and tapering of immunosuppression. in case of hla-matched sibling donor, fluconazole will be continued to d+100 and anti-mold prophylaxis will be given in case of active agvhd.

based on caesar study, the ifd incidence increased significantly in patients with unrelated donor or hallo-donor hsct after patients being discharged from laf units. the overall incidence of ifd in patients with hla-matched sibling donor remain low unless in patients with active agvhd. in this single-arm prospective study, we plan to evaluate the feasibility and effect of an escalation anti-fungal prophylaxis protocol for patients undergoing allogeneic stem cell transplantation. for all patients without documented proven or probable invasive fungal disease (ifd), patients will receive fluconazole during the treatment in the laminar air flow units (laf). after discharged from laf units, patients will receive anti-mold prophylaxis in case of haplo-identical or hla-matched unrelated donor transplantation to d+100 without active acute gvhd (agvhd). in case of active agvhd, the prophylaxis treatment will be extended until recovery of agvhd and tapering of immunosuppression. in case of hla-matched sibling donor, fluconazole will be continued to d+100 and anti-mold prophylaxis will be given in case of active agvhd.

Eligibility criteria:
inclusion criteria: * patients undergo allogeneic hsct * conditioning regimens: myelo-ablative, reduced toxicity * no proven or probable ifd before hsct * no allergy to fluconazole, voriconazle and posaconazole * inform consent given exclusion criteria: * imparied liver function with (ast or alt\>3uln, tbil \>2uln)

Keywords: fungal infection, stem cell transplantation, prophylaxis
refining and implementing technology-enhanced family navigation to promote early access and engagement with mental health services for youth with autism

Conditions: Autism Spectrum Disorder; Implementation Science; Mental Health; Behavioral Health

Summary: this project, refining and implementing technology-enhanced family navigation to promote early access and engagement with mental health services for youth with autism (attain nav) is focused on adapting and implementing family navigation in primary care settings to help accelerate and facilitate engagement in mental health and community services for children with autism and their families.

efficient and effective access to and engagement with evidence-based mental health (mh) services for children with autism spectrum disorder (asd) is critically needed but requires a tailored approach. this project is critical in establishing integrated and sustainable local capacity to provide evidence-based mh care for children (ages 4-16 years) with asd+ (i.e., children with asd and co-occurring psychiatric disorders). specifically, the overarching goal of this mixed methods proposal is to collaboratively adapt family navigation (fn) content, navigator activities and training for children with asd+, identify and design technology enhancements to fn that will target key mechanisms to impact implementation, service and clinical outcomes, key interrelated outcomes for implementation research. the research team will leverage existing partnerships with primary care practices and lay health worker organizations in san diego county to establish a community-academic partnership that will guide adaptations to fn for children with asd+ (aim 1), co-design of the navigator-facing technology enhancements (aim 2) and trial the adapted and technology-enhanced fn (aim 3).

Eligibility criteria:
inclusion criteria: inclusion criteria for primary care providers 1. employed as staff at participating primary care practice 2. experience providing primary care to children with asd 3. for aim 3 only: has at least five eligible children on current caseload inclusion criteria for child/caregiver participants (aim 3 only) 1. child age 4-16 years. 2. child has a diagnosis of autism spectrum disorder documented in medical chart. 3. child is receiving primary care at a participating primary care practice. 4. child screens in the clinically significant range on the pediatric symptom checklist at baseline. 5. speaks english or spanish. 6. caregiver of an eligible child.