Kornimate/medical-research-clean huggingface dataset:
ga68 v/q pet/ct for pulmonary embolism diagnosis: a diagnostic accuracy study vs ct pulmonary angiography

Conditions: Pulmonary Embolism

Summary: this study evaluates the diagnostic accuracy (sensitivity, specificity) of v/q pet/ct for the diagnosis of pulmonary embolism (pe), using ct pulmonary angiography as a reference standard.

v/q pet/ct imaging is now possible by substituting 99mtc with 68ga, a positron-emitting radionuclide, using the same carrier molecules as conventional v/q imaging. ventilation imaging can be performed with 68ga-carbon nanoparticles using the same synthesis device as technegas. perfusion imaging can be performed with 68ga-macroaggregated albumin (68ga-maa).technical advantages of pet compared to spect include higher sensitivity, higher spatial and temporal resolution and superior quantitative capability. this offers the opportunity to improve the accuracy of v/q imaging in patients with suspected pe, while decreasing the acquisition time. the aim is to perform a formal diagnostic accuracy study of v/q pet/ct for pe, using ctpa as a reference standard. patients with suspected acute pe undergo ctpa and v/q pet/ct imaging within 24 hours. v/q pet/ct images are not used for patients management. after completion of inclusion, central readings of scans will be conducted independently.

Eligibility criteria:
inclusion criteria: * patient with suspected first episode of acute pe, * age ≥ 18 years . * insured patient. exclusion criteria: * patients with a clinically suspected massive pe. * contraindication to contrast media (including renal insufficiency with creatinine clearance \< 30 ml/min). * inability to perform ctpa and v/q pet/ct within 24 hours. * history of deep vein thrombosis or pe * unable/unwilling to give informed consent. * pregnancy / breast-feeding. * patient under guardianship or curatorship
pulmonary rehabilitation in patients with sarcoidosis

Conditions: Stage 4 Pulmonary Sarcoidosis

Summary: the primary objective of the study is to assess the improvement of daily activity in subjects with stage iv pulmonary sarcoidosis one year after the conduct of a pulmonary rehabilitation program. the secondary objectives are the following: * assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program * assess the improvement of exercise capacity by tests used in medical practice * assess the correlation between daily activity and exercise capacity * assess the improvement of dyspnea * assess the improvement of quality of life and psychological state

the primary objective of the study is to assess the improvement of daily activity in subjects with stage iv pulmonary sarcoidosis one year after the conduct of a pulmonary rehabilitation program the secondary objectives are the following : * assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program * assess the improvement of exercise capacity by tests used in medical practice * assess the correlation between daily activity and exercise capacity * assess the improvement of dyspnea * assess the improvement of quality of life and psychological state

Eligibility criteria:
inclusion criteria: * stage iv sarcoidosis * no hospitalization for respiratory distress in the 3 months preceding the inclusion * dyspnea on exertion * age over 18 years exclusion criteria: * physical disability does not allow the creation of a rehabilitation program * inability to give written consent to the study * refusal of contraception in women of childbearing age * inability to participate in the entire study * no cover by the social security system * inability to perform self-questionnaires etude the trial does not include special populations include: * pregnant women * breastfeeding women * people in emergencies * persons unable to consent * persons deprived of liberty

Keywords: sarcoidosis, pulmonary rehabilitation
a phase 3 safety and efficacy study of fovista® (e10030) intravitreous administration in combination with lucentis® compared to lucentis® monotherapy

Conditions: Age-Related Macular Degeneration

Summary: the objectives of this study are to evaluate the safety and efficacy of intravitreal administration of fovista® administered in combination with lucentis® compared to lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (amd).

subjects will be randomized in a 1:1 ratio to the following dose groups: * fovista® 1.5 mg/eye + lucentis® 0.5 mg/eye * fovista® sham + lucentis® 0.5 mg/eye subjects will be treated for a total of 24 months with active fovista® or sham in combination with lucentis® with the primary endpoint at 12 months. primary efficacy endpoint: the primary efficacy endpoint is the mean change in visual acuity (etdrs letters) from baseline at the month 12 visit. safety endpoints: safety endpoints include adverse events, vital signs, ophthalmic variables \[ophthalmic examination, intraocular pressure (iop), fluorescein angiogram (fa), optical coherence tomography (oct)\], ecg, and laboratory variables. approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).

Eligibility criteria:
inclusion criteria: * subjects of either gender aged ≥ 50 years * active subfoveal choroidal neovascularization (cnv) secondary to amd * presence of sub-retinal hyper-reflective material (sd-oct) exclusion criteria: * any prior treatment for amd in the study eye prior to the day 1 visit, except oral supplements of vitamins and minerals * any prior intravitreal treatment in the study eye prior to the day 1 visit, regardless of indication (including intravitreal corticosteroids) * any intraocular surgery or thermal laser within three (3) months of trial entry. any prior thermal laser in the macular region, regardless of indication * subjects with subfoveal scar or subfoveal atrophy are excluded * diabetes mellitus

Keywords: wet amd choroidal neovascularization fovista® e10030 lucentis®
protein synthesis in midthigh muscles pet/ct

Conditions: Sarcopenia

Summary: the purpose of this study is to test a new imaging technique to help scientists study sarcopenia, the process by which muscle becomes weaker with age.


Eligibility criteria:
inclusion criteria: * young healthy women aged 25-35 years and older healthy women above 70 years old. exclusion criteria: * no cardiac disease, not taking medication for high blood pressure asthma hiv any other cardiac conditions

Keywords: study sarcopenia, which muscle becomes weaker with age
a study to evaluate the safety and tolerability of sb-656933-aaa following repeated doses in healthy adult subjects

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to assess safety of sb-656933 following repeat dosing for 14 days.

a randomised, double-blind, placebo controlled, dose ascending, parallel group study to evaluate the safety, tolerability, steady state pharmacokinetics and pharmacodynamics of sb-656933-aaa following repeated doses in healthy adult subjects. the pharmacokinetic interaction between repeated doses of sb-656933-aaa and single dose of simvastatin will also be assessed.

Eligibility criteria:
inclusion criteria: * healthy adult female, aged 18-65 years. * female must not be able to have children. * non-smoking for the last 6 months. exclusion criteria: * any serious medical condition. * hepatitis b or c and/or hiv positive. * currently on hrt, or other medication except paracetamol. * body mass index \>30.

Keywords: copd, cd11b, cxcr2, safety, repeat dose, tolerability. sb-656933,
determining whether there is a change in time taken to return to homeostatic temperature with repeated exposure to a cold stressor

Conditions: Needle Phobia; Needle Fear; Injection Fear

Summary: there has been previous research suggesting cold has an effect on pain relief, however there is limited knowledge on the relationship between exposure time of a cold stressor and how long it takes to return to homeostatic temperature and normal response to cold, in addition to whether location site affects this. the skin's thermal response to a cold stimulus is not fully understood. this provides precedent for potentially using cold stressors as a way to provide pain free injections. 5 participants will be exposed to a block of copper on the skin at -2°c for 30 seconds, and a thermal camera will be used to identify the amount of time it takes for the skin to return to its homeostatic temperature. the participant will then be left for 30 seconds before the experiment is repeated to identify if there is a change in the response to cold after the first exposure. if increased sensitivity in the response to cold occurs, the experiment will be repeated by adding an additional 30 seconds between repeats to identify the minimum time required between exposures that doesn't result in increased sensitivity. this will occur until there are two consecutive times with no increased sensitivity. this will occur on both the forehead and on the deltoid of the arm, two areas where injections are common. the cold stressor will be block of copper metal which will be cooled to this temperature.

a thermal imaging camera is used to identify the 'normal' temperature of the skin on the forehead. a cooled block of copper is then placed onto the skin of the forehead at a temperature of -2°c for 30 seconds. a timer is then used to measure how long it takes for the skin on the forehead to return to its normal temperature. this is then repeated twice with a minute in between each measurement to identify if there is a change in the response to cold, where it takes more/less time to return to normal levels. if the time taken to return to normal changes, the participant will be given 30 minutes to rest, and then repeat the experiment with an additional minute between repeats. this will continue until there is no change in the amount of time it takes for the skin to return to normal on the forehead once exposed to the cold conditions to identify a sensitivity time due to a change in the response to cold. this will be tested on 5 patients. this will also be tested on the outer deltoid, where injections usually occur in your arm.

Eligibility criteria:
inclusion criteria: * able to give informed consent * above 18 years old exclusion criteria: * skin conditions or irregularities, or on medication that affects temperature regulation

Keywords: pain cold skin response injections
burnout and resilience in hospital-based nursing and medical personnel and trainees

Conditions: Stress; Burnout

Summary: aims to look at associations between work stress, burnout and resilience in hospital-based nurses and medical professionals in several eu countries.

healthcare professionals, in particular, hospital-based nursing and medical staff, especially surgical specialities, are experiencing symptoms of burnout as never before. within healthcare, job commitment is at stake leading to staff shortages which places further stress on the health care system, creating a vicious cycle of stressful work environment. this is the context of the present study, and our aim is to explore quantitatively how factors like resilience, work-setting factors like job support, autonomy and leadership contribute to burnout in hospital-based nursing and medical personnel. these factors have been found to be predictive of burnout with few studies looking at synergistic interactions between these predictors. a survey design will be used for quantitative data collection. this study will also include qualitative interview-based study to complement the quantitative study.

Eligibility criteria:
inclusion criteria: * hospital-based nurses and doctors exclusion criteria: * non-hospital based healthcare professionals, under 18 and over 66, non-medical hospital staff

Keywords: stress burnout resilience crosssectional healthcare workers nurses doctors surgeons observational healthcare professionals work stress
metacognitive training as a serious game

Conditions: Schizophrenia and Related Disorders; Psychotic Disorders; Delusions

Summary: the project aims to evaluate the efficacy of a therapeutic video game that incorporates elements from metacognitive training on delusions and jumping-to-conclusions in patients with psychotic disorders.

the study is an international, multicenter study and is being conducted in switzerland (university of basel) as well as in germany (university of lübeck). a total of 36 participants will be included. the estimated duration of the study is 15 months. all participants play a video game from the genre "third person adventure". a character is navigated through a fantasy world using a keyboard and mouse. in the fantasy world, "stations" in the form of glowing gems are sought where players have to solve different tasks. participants are randomized to receive either the therapeutic video game with metacognitive training content or another video game with attention and memory tasks ("control intervention"). the control intervention does not include metacognitive tasks. metacognitive training is an approach for the treatment of psychotic disorders, particularly delusions. the focus of metacognitive training is on thought distortions (so-called "cognitive biases") that are more pronounced in people with psychosis. the control intervention includes easily understandable, playful tasks. the intervention will take 4 appointments within 2 weeks.

Eligibility criteria:
inclusion criteria: * aged between 18 and 40 * diagnosis of a psychotic disorder and current delusions or a history of delusions exclusion criteria: * language skills insufficient for assessments * iq \< 70 * secondary psychotic disorders that are clearly induced by general medical conditions or substance use. * previous participation in meta-cognitive training for psychosis

Keywords: psychotic disorders delusions metacognitive training schizophrenia
precision medicine intervention in severe asthma (prism) study

Conditions: Severe Asthma

Summary: the korea-uk precision medicine intervention in severe asthma (prism) study aims to identify molecular phenotypes of severe asthma by analyzing multi-omics data including genomics, epigenomics, transcriptomics, proteomics, metagenomics, and metabolomics.

this is a prospective, observational cohort study. the participants are composed of the patients having severe asthma treated with biologic agents or conventional medication. once enrolled, regular evaluation of clinical characteristics and obtainment of samples for omics analysis is conducted to identify clinically relevance molecular signals in severe asthmatics.

Eligibility criteria:
inclusion criteria: * male or female subject aged between 18 years and 80 years * give written informed consent prior to participation in the study including all procedures * comply with study protocol requirements * able to read, comprehend, and write at a sufficient level to complete study related materials * able to complete the study and all measurements * all patients have been through a severe asthma protocol that have ascertained the diagnosis of severe asthma, maximised treatments and ensured adherence to therapy. * stable asthma therapy for at least a month before screening exclusion criteria: * as a result of medical interview, physical examination or screening investigation the investigators consider the subject unfit either because of risk to the subject due to the study or the influence this may have on the study results. * a history of recreational drug use or allergy which in the opinion of the investigators contraindicates their participation. * participation within 3 months in any a trial testing a new molecular entity or drug. * those, in the opinion of the investigator, who may prove non-compliant with study procedures. * within 4 weeks of screening visit been hospitalized or required high dose oral corticosteroid (\>30 mg prednisolone per day) therapy, asthma not been stable. * patients who have had prior treatment with bronchial thermoplasty, defined as completion of all thermoplasty treatment sessions within 6 months of screening * history of significant pulmonary disease other than severe asthma. * history of pulmonary eosinophilic syndrome or hyper eosinophilic syndrome. * history of bronchopulmonary aspergillosis

Keywords: biologics, multi-omics analysis
tulip retrain study

Conditions: Prostate Cancer

Summary: this prospective clinical study aims to retrain and validate the pcavision ai algorithm for the detection and localization of clinically significant prostate cancer (cspca) using multiparametric ultrasound (mpus) with two different ultrasound contrast agents: sonovue and optison. data will be collected using a commercial version of the logiq e10 ultrasound machine, with full histopathological correlation in patients undergoing radical prostatectomy.

the pcavision cad system was initially developed using sonovue contrast and a research-only ultrasound machine (logiq e10 r3). in this study, the algorithm will be retrained using data acquired from the logiq e10 r4, a commercially available system, and using both sonovue and optison as contrast agents. the goal is to enhance generalizability and enable broader clinical adoption. the study includes two cohorts: patients scheduled for radical prostatectomy (for training and voxel-level validation) and patients with a negative prostate mri (for patient-level specificity evaluation). all participants will undergo 3d transrectal mpus with both contrast agents in a single session. full prostate histology from rp specimens will serve as the reference standard.

Eligibility criteria:
inclusion criteria: * male ≥18 years * cohort 1: histologically confirmed prostate cancer scheduled for radical prostatectomy * cohort 2: negative multiparametric prostate mri (pi-rads ≤ 2) exclusion criteria: * severe pulmonary hypertension * cardiac right-to-left shunt * known allergy to sonovue or optison * contraindication for ultrasound contrast agents

Keywords: mpus ceus pcavision cad optison sonovue radical prostatectomy ai diagnosis
efficacy and safety of intranasal morphine for pain after elective orthopedic surgery

Conditions: Pain, Postoperative

Summary: multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.

multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study of repeated intermittent prn dosing for 24 hours of intranasal (in) morphine nasal spray (mns075) 7.5 mg and 15 mg, 7.5 mg iv morphine infusions and placebo (either in or iv), in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.

Eligibility criteria:
inclusion criteria: * over 18 years old * scheduled (within two weeks of the screening visit) to undergo elective orthopedic surgery (e.g., bunionectomy, arthroscopic knee surgery, rotator cuff repair) * moderate to severe pain within 8 hours following completion of the required surgery exclusion criteria: * previous anaphylactic or serious allergic reaction to shellfish or opioids * history of sleep apnea other inclusion/exclusion criteria may apply

Keywords: pain, postoperative surgery, orthopedic morphine
prolonged grief and suicide among veterans

Conditions: Prolonged Grief Disorder; Suicidality

Summary: the primary research question in this study will ask, among those receiving outpatient mental health services (mhs) at the eastern colorado healthcare system (echcs)/denver veterans affairs medical center (vamc), how many suffer from prolonged grief disorder (pgd)? here, it is hypothesized that pgd will occur within the sample. a secondary aim of this study will be to investigate how often pgd co-occurs with posttraumatic stress disorder (ptsd) and/or depression. also, while pgd has been shown to have an effect on self-directed violence (sdv) among civilians (prigerson, bridge et al., 1999), no studies yet have examined the relationship between pgd and sdv among veterans. therefore, it also is hypothesized that as pgd severity increases among the veteran sample, risk for sdv will increase as well. additional research aims also will be addressed in this study. for one, it will be assessed which grief symptoms are most often reported among the veteran sample. also, no study has yet to examine if there are neuropsychological differences between pgd and ptsd. therefore, another research question here is whether pgd indeed is neuropsychologically different from ptsd. here, the exploratory hypothesis is that pgd sufferers will respond to a measure of multiple components of cognition (e.g., planning, sequencing, concentration, multitasking, and memory efficiency) in a manner that is significantly different from ptsd sufferers.


Eligibility criteria:
inclusion criteria: * age 18 and above * not currently active duty in any branch of the military * english-speaking * ability to adequately respond to specific questions regarding the informed consent procedure. * active case in mental health services (mhs) at the eastern colorado healthcare system (echcs)/denver veterans affairs medical center (vamc) exclusion criteria: * currently active duty in any branch of the military * non-english-speaking * inability to adequately respond to questions regarding the informed consent procedure.