Kornimate/medical-research-clean huggingface dataset:
89zr-labeled kn035 pet imaging in patients with pd-l1 positive solid tumors

Conditions: Solid Tumor, Adult

Summary: this is a single arm study to evaluate the safety and biodistribution of 89zr-labeled kn035 (89zr-kn035) pet imaging in patients with pd-l1 positive solid tumors.

after being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. patients will receive an injection of 89zr-kn035 and will undergo pet/ct scanning to determine uptake of 89zr-kn035 in tumor lesions.

Eligibility criteria:
inclusion criteria: 1. patients voluntarily signed informed consent; 2. age 18-75, male or female; 3. patients diagnosed with solid tumors confirmed by histopathology or cytology; 4. at least one measurable solid lesion has been examined by 18f-fdg pet/ct (recist1.1 standard); 5. patients with biopsy-proven pd-l1 positive; 6. ecog score ≤ 0\~1; life expectancy of at least 3 months; 7. women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects. exclusion criteria: 1. currently or within the first 28 days before the first dose to participate in another therapeutic clinical trial. if participating in a non-interventional clinical trial, it is not be excluded; 2. patients with systemic or locally severe infections (ctcae ≥ 2); 3. patients with allergies or allergies to any component of the imaging agent or antibody; 4. patients who cannot undergo pet/ct imaging; 5. intolerance of intravenous administration, as well as difficulties in venous blood collection (if having the medical history of fainting during acupuncture, and blood phobia); 6. symptomatic congestive heart failure (nyha class ii-iv) or symptomatic or poorly controlled arrhythmia; 7. patients have significant qt/qtc interval prolongation during the screening period; 8. received anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biological therapy) within 4 weeks prior to first dose; 9. patents have not recovered to ctcae grade 0 or 1 from the adverse events due to cancer therapeutics administered; 10. patients need to receive other anti-tumor treatments during the trial period； 11. previously received cd137 agonist or immune checkpoint blocking therapy; 12. patients with diabetes who have a fasting blood glucose greater than 10 mmol/l; 13. hiv antibody positive, active hepatitis b/c, and tb positive; 14. patients are regular users (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol); 15. patients with symptomatic ascites, pleural effusion, or hydropericardium; 16. pregnant or lactating women, or planning to become pregnant or have children during this trial.
detecting hpv dna in anal and cervical cancers

Conditions: Cervical Cancer; Anal Cancer; HPV-Related Anal Squamous Cell Carcinoma; HPV-Related Cervical Carcinoma; HPV-Related Carcinoma; Uterine Cervical Cancer

Summary: this is a research study for individuals who have cancer associated with human papillomavirus (hpv) and are being treated with radiation as part of standard care for their cancer. doctors leading this study will use blood tests to find out if they can detect the hpv virus in the blood of study participants before, during, and after radiation treatment. they will also collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in the future that could provide more information about hpv-associated cancers and how they respond to treatment. participation in this study will last approximately 2 years.


Eligibility criteria:
inclusion criteria: * stage i-iii anal cancer or stage i-iva cervical cancer that is p16+ based on immunohistochemistry. * age ≥ 18 years * planned to undergo radiation therapy as definitive treatment, with or without concurrent systemic therapy exclusion criteria: * anal carcinoma not associated with hpv-16, 18, 31, 33, or 35 will be removed from the * planned to undergo radiation therapy as an adjuvant or post-operative therapy

Keywords: hpv radiation treatment cervical cancer anal cancer uterine cervix
development and pilot testing of a novel preschool executive function curriculum

Conditions: Executive Dysfunction

Summary: executive function (ef) skills are a set of essential cognitive abilities that enable individuals to demonstrate their knowledge and talents, effectively complete tasks and navigate social interactions through flexible regulation of their thinking, behavior and emotions. ef is strongly linked to academic readiness and long-term educational outcomes. children's ef is impacted by poverty-related experiences and is also impaired in the increasing number of children with developmental and emotional disabilities. interventions targeting ef skills hold particular promise for improving children's educational trajectories by leveraging brain plasticity in the preschool period. we will directly target ef skills in preschoolers with poor ef. this project will address a key source of the achievement gap by meeting the needs of children at the highest risk, those who: 1) show early signs of ef impairment; 2) live in low-income communities and 3) are at risk for developmental and emotional disabilities (dd/ed). the intervention is a downward extension of unstuck and on target for elementary school (uot; cannon, kenworthy, alexander, werner, \& anthony, 2018), an ef intervention shown to be effective at increasing children's learning behaviors, as delivered by school staff. the research team will partner with key stakeholders to revise and iteratively refine uot-p through a development trial, utilizing participant, teacher and parent feedback. the results of this trial will be leveraged to enable the team to apply for future federal funding for a randomized comparative effectiveness trial (nih, institute of educational sciences, patient-centered outcomes research institute).


Eligibility criteria:
inclusion criteria: enrolled as a student at a participating school site or as a patient at a participating clinic site * chronological age between 3-6 years at enrollment * english as a primary language * roughly age-appropriate core language skills as determined by referring school staff or provider * identified by school staff or provider as having problems with flexibility exclusion criteria: no longer enrolled at participating school or clinic site • insufficient english fluency or language skills to complete intervention

Keywords: young children intervention preschool
lifetech ceraflex™ post-market surveillance study

Conditions: Patent Foramen Ovale; Atrial Septal Defect; Patent Ductus Arteriosus

Summary: the purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the lifetech ceraflex™ occluders for patients with secundum type atrial septum defect (asd), patent foramen ovale (pfo) or patent ductus arteriosus (pda).

this study is designed as a post-market, prospective, multi-center, non-interventional clinical study to collect data regarding procedural success, clinical performance and cost-effectiveness of the lifetech ceraflex™ occluders in patients with secundum asd, pfo and pda. patients will be recruited in up to 12 investigational centers located in europe and the middle east. to avoid bias in the study population the following measures will be taken: * all sponsor or designee and external study personnel will be trained on the latest version of the clinical investigation plan (cip) and related study materials. * patients will be screened to confirm study eligibility with pre-defined inclusion/exclusion criteria prior to enrollment. * this study will follow consecutive screening and enrollment. the study will enroll 120 patients. the patient population will consist of up to approximately 40 consecutive enrolled patients with a confirmed secundum type asd, up to approximately 40 enrolled patients with pfo and up to approximately 40 enrolled patients with pda resulting in a significant shunt and in need of an intervention. these estimated upper limits per therapy group can however be exceeded depending on the enrollment trend, to account for a minimum of 10 patients to be enrolled per therapy group and a total study population of 120 enrolled patients.

Eligibility criteria:
inclusion criteria to participate in this study, the patient must meet all of the following inclusion criteria: 1. confirmed asd, pfo or pda and patient characteristics consistent with the corresponding ifu and sizing guidelines; 2. the patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has signed the applicable consent form, approved by the appropriate ethics committee (ec)/irb (where required); 3. the patient agrees to comply with requirements of the study including the 12 months followup. exclusion criteria patients will be excluded if any of the following conditions apply: 1. any contra-indication mentioned in the corresponding ifu; 2. currently participating in another investigational drug- or device study.

Keywords: ceraflex occluder
regional anaesthesia for painful injuries after disasters

Conditions: Lower Limb Injuries; Fracture

Summary: the goal of the rapid study is to fundamentally transform the way serious injuries are managed after earthquakes and other disasters by introducing a novel and cost-effective method for pain control. the study will enroll patients in the aftermath of a major earthquake to determine whether regional anesthesia, either with or without ultrasound-guidance, can reduce suffering from lower limb injuries, the most common earthquake-related injury, above and beyond the current standard of care for pain control in these settings.

the regional anaesthesia for painful injuries after disasters (rapid) study aims to evaluate whether regional anesthesia (ra), either with or without ultrasound (us) guidance, can reduce pain from earthquake-related lower limb injuries in a disaster setting. the proposed study is a blinded, randomized controlled trial among earthquake victims with serious lower extremity injuries in a resource-limited setting. after obtaining informed consent, study participants will be randomized in a 1:1:1 allocation to either: standard care (parenteral morphine at 0.1 mg/kg); standard care plus a landmark-guided fascia iliaca compartment block (ficb); or standard care plus an us-guided femoral nerve block. general practice humanitarian response providers who have undergone a focused training in ra will perform nerve blocks with 20 ml of 0.5% levobupivacaine. us sham activities will be used in the standard care and ficb arms and a normal saline injection will be given to the control group to blind both participants and non-research team providers. the primary outcome measure will be the summed pain intensity difference calculated using a standard 11-point numerical rating scale reported by patients over 24-hours of follow-up. secondary outcome measures will include overall analgesic requirements, adverse events and participant satisfaction.

Eligibility criteria:
inclusion criteria: * adult patients (18 years or older) presenting to an msf field hospital with one or more lower limb injuries . exclusion criteria: * multi-system trauma * severe respiratory distress * hypotension * altered mental status * active infection at the sight of injection * known current pregnancy * unable to provide informed consent. * known allergies to local anesthetic agents or narcotic pain medication * receiving antithrombotic therapy or with a preexisting coagulopathy * likely to receive regional anesthesia for alternative reasons within two hours of screening

Keywords: anesthesia
titan™ reverse shoulder system

Conditions: Osteoarthritis of the Shoulder

Summary: the integra® titan™ reverse shoulder system (trs) is a semi-constrained total shoulder construct. when used under the conditions and purposes intended the trs will relieve pain and restore some functional joint motion to the affected shoulder. the purpose of this study is to assess the short, mid and long term outcomes of the titan™ reverse shoulder system.


Eligibility criteria:
inclusion criteria: * subjects with grossly deficient rotator cuff with severe arthropathy or subjects with failed joint replacement with grossly deficient rotator cuff * subjects with a shoulder joint anatomically and structurally suited to receive the device * subjects at least 21 years of age and skeletally mature at the time of surgery * subject provided consent to participate in the clinical study (having signed the informed consent form) exclusion criteria: * subjects without a functional deltoid muscle * subjects with active local or systemic infection * subjects with inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components * subjects with poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid * subjects with muscular, neurologic, or vascular deficiencies that compromise the affected extremity * subjects with known metal allergies * subjects are known to be at risk for lost to follow-up, or failure to return for scheduled visits * subjects who are prisoners * female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods

Keywords: osteoarthritis rheumatoid arthritis post traumatic arthritis avascular necrosis severe fractures
safety and immunogenicity of three commercially available influenza vaccines in children aged 6 to <36 months

Conditions: Influenza

Summary: this phase iv protocol is designed to evaluate the safety, clinical tolerability and immunogenicity of the 2005-2006 formulation of three widely used conventional influenza vaccines in children aged 6 to 35 months


Eligibility criteria:
inclusion criteria: * children of 6 months to \<36 months of age, whose parents or legal guardians have given written informed consent prior to study entry exclusion criteria: * any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) * other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, surgery planned during the study period. * known or suspected impairment/alteration of immune function * history of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function

Keywords: influenza children vaccine
furcation therapy with enamel matrix derivative

Conditions: Chronic Periodontitis

Summary: objective: to clinically evaluate mandibular furcation treated with beta tricalcium phosphate/hydroxyapatite (βtcp/ha) isolated or combined with enamel matrix derivative (emd + βtcp/ha) and emd alone. material and methods: 39 patients, presenting at least one mandibular class ii furcation defect, probing pocket depth (ppd) ≥ 4 mm and bleeding on probing, were included. the defects were assigned to the βtcp/ha group 1 (n = 13); open-flap debridement (ofd) + βtcp/ha filling; βtcp/ha + emd group 2 (n = 13); ofd + βtcp/ha + emd filling; and emd group 3 (n = 13) ofd + emd filling. plaque (pi) and gingival index (gi), ppd, relative gingival margin position (rgmp), vertical and horizontal attachment level (rvcal and rhcal), and furcation diagnosis were evaluated at baseline, 6 and 12 months.

although enamel matrix derivative (emd) has been used to promote periodontal regeneration, little is known of its effect on the microbiome. therefore, this investigation aimed to identify the changes in periodontal microbiome following treatment with emd using a deep-sequencing approach. thirty-nine patients having mandibular class ii buccal furcation defects were randomized to beta-tricalcium-phosphate/hydroxyapatite graft (bone group), emd+bone or emd alone. plaque was collected from furcation defects at baseline, 3 and 6 months post-treatment. bacterial dna was analyzed using terminal restriction fragment length polymorphism (t-rflp) and 16s pyrotag sequencing. 169,000 classifiable sequences were compared to homd using the qiime and phylotoast pipelines. statistical comparisons were made using parametric tests. at baseline, a total of 422 species were identified from the 39 defects, belonging to fusobacterium, pseudomonas, streptococcus, filifactor and parvimonas. all three regenerative procedures predictably altered the disease-associated microbiome, with a restitution of health-compatible species. however, emd and bone+emd groups demonstrated more long-term reductions in higher number of species than in bone group (p\<0.05), especially disease-associated species e.g. selenomonas noxia, f.alocis, and fusobacterium. emd may promote periodontal regeneration by predictably altering a dysbiotic subgingival microbiome, decreasing pathogen richness and increasing commensal abundance.

Eligibility criteria:
inclusion criteria: * untreated chronicperiodontitis exclusion criteria: * diabetes pregnancy current smoking
trustworthy artificial intelligence for improvement of stroke outcomes

Conditions: Stroke, Acute; Stroke, Ischemic; Stroke

Summary: stroke is a leading cause of death and disability worldwide. the clinical validation of explainable and interpretable artificial intelligence (ai) solutions to assist a timely, personalised management of the acute phase of stroke, would have a major impact since it can greatly reduce the disability levels of patients. also, the prediction of long-term outcomes is a crucial factor as it may determine critical decisions such as the discharge destination for the patient. moreover, compliance with guideline-based secondary stroke prevention has been demonstrated to reduce stroke recurrence, but currently, only 40% of patients are adherent to preventive treatments 3 months after stroke. therefore, patients´ outcomes can improve with proper patient communication and engagement packages. ai may have a dramatic impact on stroke patient journey, improving predictions, resulting in a better choice of secondary stroke strategies, as well as using evidence-based information to promote better adherence to treatment and reduction of vascular risk factors. the aim of this multicentre observational prospective study is to develop and validate ai-based tools to predict short and long-term outcomes in ischemic stroke patients. specifically, this study aims to demonstrate the accuracy of ai models in predicting the functional outcome of ischaemic stroke patients as measured by the national institutes of health stroke scale (nihss, 0-42) and the modified rankin scale (mrs, 0-6) scores at hospital discharge and at 3, 6 and 12 months after discharge. prospective ischemic stroke patients from 3 large european centres will be recruited. the training and testing of local ai models will be performed using hospitalization data, collected during the standard of care procedures for stroke patient pathways, and outpatient monitored data from a remote home-care system (nora app) during the follow-up after discharge. these local models will then be integrated into a federated learning system, where only a global ai model, derived from combined insights of all local models, is shared across participating hospitals. the individual local models and the original data are not shared, ensuring data privacy and security. the accuracy and performance of prospectively optimized ai models in predicting clinical outcomes over a 12-month follow-up period will be evaluated and compared to the actual outcomes of the patients.


Eligibility criteria:
inclusion criteria: 1. subject is 18 years of age or older 2. diagnosis of acute ischemic stroke 3. signature of the informed consent form by the patient or a next of kin exclusion criteria: * no exclusion criteria are contemplated for this study.
behavioral activation and medication optimization in older adults undergoing cardiac procedures

Conditions: Cardiac Surgery; Older Adults; Depression; Anxiety

Summary: this hybrid 1 study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing cardiac surgery (compared with usual care), while examining implementation outcomes.


Eligibility criteria:
inclusion criteria: * adults ≥ 60 years * scheduled major cardiac procedure * phq-ads ≥ 10, indicating clinically significant depression or anxiety symptoms exclusion criteria: * barrier to communication (unable to read, speak, and understand english) * severe cognitive impairment screened by the sbt (short blessed test) \>10 * acutely suicidal * previous participation in this study or cpmh feasibility study 202101103.

Keywords: behavioral activation medication optimization cardiac surgery perioperative mental health
comparison of diagnostic performances of 3d flair, dir and psir sequences in optic neuritis

Conditions: Multiple Sclerosis; Demyelinating Diseases

Summary: ultimately improve the care of patients suffering from multiple sclerosis (1st cause of acquired non-traumatic disability in adults) and nmo spectrum diseases by using more efficient mri sequences than the flair sequence commonly used in detection of optic neuritis. in the literature, many studies have already focused on comparing the sensitivity of detection of white matter demyelination plaques using flair, psir or dir sequences. some authors have shown better sensitivity of the psir sequence in the detection of demyelinating lesions of the marrow in multiple sclerosis compared to conventional sequences. others have shown better performance of the combined use of psir and dir sequences compared to the flair sequence in the detection of cortical lesions in multiple sclerosis. however, in the context of optic neuritis, few comparative studies comparing these three sequences have been carried out: a 2022 study showed better diagnostic sensitivity of optic neuritis of the dir sequence compared to the flair sequence. a possible better diagnostic performance of a sequence not used in current practice in the detection of optic neuritis (psir and dir sequences), would be possible to justify their use on a larger scale and ultimately improve patient care.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject suffering from multiple sclerosis or an nmo spectrum disease * subject having received an mri including 3d flair, 3d dir and 3d psir sequences * brain mris of eligible subjects acquired between april 1, 2019 and november 30, 2021. * no opposition to the reuse of its data for scientific research purposes. exclusion criteria: * presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes. * artifacts not allowing satisfactory interpretation

Keywords: multiple sclerosis demyelinating diseases