Kornimate/medical-research-clean huggingface dataset:
how young is too young for virtual reality? determining usability and acceptability in ages 2-6 in the emergency department

Conditions: Child, Preschool

Summary: children who present to the emergency department often require painful procedures (intravenous catheterization, laceration repair, fracture reduction, etc.). virtual reality (vr) has been presented as a way of managing pain and anxiety in children undergoing painful procedures but most studies are limited to children 6 or older. the present study seeks to determine the youngest age (2-6) of future subjects in research of vr and clinical care. virtual reality is an immersive experience using sight, sound, and position sense. using vr may enhance distraction during the painful procedure and may reduce attention to pain. investigators will instruct and observe children age 2-6 in using a vr device and document how easy the device is to use for the child. the children will have the opportunity to select an application and play with the device for 10 minutes before being asked about their experience with the device. parents/guardians will also be asked about their child's experience with the device.


Eligibility criteria:
inclusion criteria: 1. children age 2-6 years of age 2. patients arrived with a legal guardian to the emergency department 3. parents will sign a consent form and children will agree verbally to participate 4. triage category 4 or 5 (lowest acuity) exclusion criteria: 1. children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, neurological or other condition limiting communication) 2. facial features or injury prohibiting wearing the vr goggles 3. painful procedures in the emergency before being approached (such as blood testing, iv, catheterization, immunization, laceration repair) 4. child is suffering pain or distress at a level that prohibit focusing on the study for 20 minutes, as assessed by the research assistant

Keywords: virtual reality
behavioral trial studying programmed training to improve advocacy skills for individuals with traumatic brain injury

Conditions: Brain Injuries

Summary: the midwest advocacy project (map) is a community-based multiple-site randomized practical behavioral trial of advocacy skill training for individuals with traumatic brain injury (tbi), their families, and significant others. the purpose is to evaluate the efficacy of a 4-session advocacy training program to improve behavioral advocacy skills compared to self-directed advocacy training of the same session frequency. groups will be randomly assigned to either a programmed group or a self-directed group in collaboration with the brain injury associations of minnesota, iowa, and wisconsin each year over the 5 year study period. the primary outcome is pre-post measures of written and verbal advocacy skill measured by the advocacy behavior rating scale. it is hypothesized that subjects who receive programmed advocacy training will show greater positive change on pre-post measures of advocacy skill measures than subjects receiving self-directed training.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * moderate-severe tbi as indicated by one of the following: * post traumatic amnesia (pta) \> 24 hours * or loss of consciousness \> 30 minutes * or neuroimaging evidence of trauma-related intracranial abnormality * or the family/significant other of an individual with tbi meeting the above criteria * 1 or more years post-injury * functional english speaker * signed consent to participate exclusion criteria: * severe cognitive impairment as indicated by one or more of the following: * disorientation to person or year * unable to complete pre-program interview because of severe communication limitations * unable to remember important information given in the course of the pre-program interview, such as, time and place of program, number of sessions, and contact person * unable to complete the pre-program interview because of loss of emotional control, such as, extended tearfulness, sustained anger, verbal attack on interviewer

Keywords: brain injury traumatic brain injury training teaching curriculum
testing tumor tissue and blood to help select personalized treatments for patients with suspected lung cancers

Conditions: NSCLC

Summary: this collaborative screening protocol, developed by the lung cancer mutation consortium (lcmc) and supported by the thoracic surgery oncology group (tsog), is designed to determine the feasibility of comprehensive molecular profiling to detect actionable oncogenic drivers in patients with suspected early stage lung cancers scheduled to undergo biopsies to establish the diagnosis of lung cancer. the primary purpose of this testing is to determine the presence of 12 oncogenic drivers (mutations in egfr, brafv600e , met exon 14, kras g12c and her2, rearrangements in alk, ret, ntrk, egfr exon 20 insertion and ros1, and amplification of met and her2) that can serve as targets making patients eligible for upcoming targeted neoadjuvant therapy trials. the ultimate goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no actionable driver mutation is detected. thoracic surgery oncology group (tsog) is a network of surgeons within north american thoracic surgery academic centers aligned with the goal of enhancing patient care through administration of multi-site trials focused on recent advances in lung cancer. tsog has aligned with the lcmc4 sites to enroll the lcrf-leader screening trial. tsog's involvement will be essential in trial enrollment and ultimate interpretation of the multimodal clinical and translational data collected as part of this study. we estimate we will detect an actionable oncogenic driver in 33% of cases. the remaining 66% of patients will represent a cohort identified by their care teams as candidates for other potential neoadjuvant therapies which may include checkpoint inhibitors such as atezolizumab, durvalumab, nivolumab, and pembrolizumab or other novel agents. the targeted therapy treatment trials will be conducted independently of the lcrf-leader screening trial, evaluating for efficacy. if none of the 10 oncogenic drivers are detected, the patient will be offered participation in any clinical trial of neoadjuvant therapy available at their treating institution or standard of care therapy. for patients not enrolled on a targeted treatment trial, circulating tumor dna in blood (ctdna) will be collected at 3 time points: before neoadjuvant treatment, after neoadjuvant treatment but before surgery, and after surgery. this initiative will be correlated with various clinical outcomes. prespecified clinical data will be collected for correlation with these circulating biomarkers.


Eligibility criteria:
inclusion criteria: * clinical stage ia2-iii lung cancers * potentially resectable if lung cancer suspicion confirmed pathologically * operable exclusion criteria: * no concurrent malignancy * no prior lung cancer within last 2 years * purely ground glass pulmonary opacity
dual guidance structure for evaluation of patients with unclear diagnosis in centers for rare diseases

Conditions: Rare Diseases; Orphan Diseases

Summary: in people suffering from a rare disease the diagnostic process and the confirmation of a final diagnosis is often ongoing for many years. factors contributing to delayed diagnosis include the limited knowledge of health care professionals about rare diseases and their symptoms but also a psychiatric or psychosomatic (co-)morbidity obscuring the symptoms of the rare disease. the project zse-duo will evaluate whether a combination of an expert in somatic medicine and a psychiatric/psychosomatic specialist will increase the rate of assured diagnoses in patients approaching a center of rare diseases (primary outcome), accelerate the process until a diagnosis is made, reduce the costs of diagnosing a patient, and lead to a higher satisfaction of patients and health care professionals. furthermore, the project will evaluate whether the use of psychosomatic screening tools at registration of a patient in a center for rare diseases will help to guide the diagnostic process. two cohorts of 682 patients each will be sequentially recruited over 9 plus 9 months: the control group cohort (cg based on somatic expertise) and the experimental group cohort (eg combined psychosomatic/somatic expertise included will be persons from the age of at least 12 years presenting with symptoms and signs which are not explained by current diagnoses (as judged by the patient's primary care physician and a specialized physician at the center for rare diseases zse evaluating the medical records). patients will be recruited from 11 german centers for rare diseases associated with university hospitals in the cities of aachen, bochum, frankfurt, hannover, magdeburg, mainz, münster, regensburg, tübingen, ulm and würzburg. recruitment will be supported by a collaboration with the german patient organization representing many rare disease organizations achse e.v. and a collaboration with the insurance companies techniker krankenkasse, ikk gesund plus and aok hessen who also provide data on costs of care. data collection and analysis will be coordinated and performed by the institute for clinical epidemiology and biometry at the university of würzburg, the institute for epidemiology, social medicine and science of health care systems in hannover, and the department of medical psychology in hamburg. the project is funded by the innovationsfond of the federal joint committee in germany.


Eligibility criteria:
inclusion criteria: * first contact with the center for rare diseases for unclear diagnosis * suspicion of a rare disease but no established diagnosis * attending the center for rare diseases as an outpatient * written informed consent exclusion criteria: * age \<12 years * incomplete medical records including summary letters, imaging studies, blood tests etc. * pre-diagnosed disease(s) explaining all symptoms

Keywords: psychosomatic unclear diagnosis
understanding host-pathogen interaction in the respiratory mucosa during pregnancy

Conditions: Pregnancy Related; Innate Inflammatory Response

Summary: the clinical presentation of the ongoing coronavirus disease-19 (covid-19) pandemic in pregnant women is unique with more asymptomatic infection, higher morbidity when symptomatic, yet without a difference in mortality rate. this is strikingly different from the high mortality observed during the past influenza a pandemics. though both influenza a virus (iav) and sars-cov-2 are single-stranded rna viruses, the exquisite vulnerability of pregnant women to influenza a but not covid-19 remains a mystery. our objective, therefore, is to determine the mechanisms that predispose pregnant women to severe influenza a but confer protection against sars-cov-2 infection by examining the viral entry factors and innate immune response mechanisms in the nasal epithelium of pregnant vs. non-pregnant age-matched women.


Eligibility criteria:
inclusion criteria: * healthy, uncomplicated pregnant subjects in the third trimester ((≥ 28 ≤ 41 weeks' gestation) * healthy non-pregnant adult female volunteers between the ages of 18 - 45 years. * between 18-45 years old * able to provide consent exclusion criteria: * patients in labor * critically ill patients needing intubation and mechanical ventilation * patients with fever or influenza-like illness * h/o epistaxis or rhinosinusitis * nasal polyposis and deviated nasal septum * preeclampsia and chronic hypertension * use of anti-hypertensives * ongoing seasonal allergy * h/o asthma * recent recovery from sars-cov-2 or influenza a infection (≤ 4 weeks) * recent receipt of either covid-19 or influenza a vaccine (≤ 4 weeks) * use of immunosuppressive medications * use of inhaled corticosteroids * use of hormonal contraceptives in non-pregnant population * allergy to local anesthetic
aspirin for prevention of preeclampsia

Conditions: Preeclampsia

Summary: prophylaxis with low-dose aspirin has been recommended to prevent preeclampsia, the rationale being that hypertension and abnormalities of coagulation in this disease are caused in part by an imbalance between vasodilating and vasoconstricting prostaglandins. low-dose aspirin therapy inhibits thromboxane production more than prostacyclin production and therefore should protect against vasoconstriction and pathologic blood coagulation in the placenta. initially, several single-center trials, mostly among women at increased risk for preeclampsia, demonstrated a substantial reduction in the risk of proteinuric hypertension as well as reductions in the incidences of preterm birth, infants small for gestational age, and perinatal death,

this will be a randomized control trial to estimate the efficacy of two doses (80 mg versus 160 mg) of aspirin for prevention of preeclampsia in high-risk pregnant women identified in the first trimester to be at high risk.

Eligibility criteria:
inclusion criteria: * pregnant women presenting prior to 17+0 weeks' gestation. * moderate to high risk of preeclampsia. * one or more of the following: previous history of preeclampsia, antiphospholipid antibodies, pre-existing diabetes, pre-existing hypertension, pre-existing renal disease, autoimmune disease, nulliparity, family history of preeclampsia, elevated bmi \> 25, and maternal age \ 35. * give written informed consent. exclusion criteria: * multiple gestations, * fetal aneuploidy * major fetal structural anomaly * bleeding disorder * allergy to aspirin * women already on aspirin or heparin.

Keywords: preeclampsia low dose aspirin high risk pregnancy
platelet-rich plasma versus corticosteroid injection for the treatment of femoroacetabular impingement

Conditions: Femoroacetabular Impingement

Summary: the purpose of this study is to compare the clinical response of intra-articular platelet rich plasma (prp) versus corticosteroid injection in patients affected by femoroacetabular impingement (fai).

this study will determine if prp treatment of fai improves (i) patient reported outcome scores and (ii) hip functional stability compared to standard corticosteroid treatment and if prp treatment of fai reduces (i) radiographic and (ii) biochemical markers of joint inflammation and cartilage degradation.

Eligibility criteria:
inclusion criteria: * patients with symptomatic fai * clinical and radiographic evidence of fai * patients able to provide consent to study participation * completion of 6 weeks of physical therapy program exclusion criteria: * established osteoarthritis (kellgren-lawrence \> 3) * minimum joint space \> 2 mm as measured on ap radiograph * hip dysplasia (center edge angle \< 20° on ap radiograph) * patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer or diabetes * patients with ongoing infection including hiv and hepatitis * patient with history of osteomyelitis/septic arthritis * anticoagulation therapy * patients who are pregnant or breast feeding * patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular paget's disease of the femur or tibia, hemophilic arthropathy, infectious arthritis, charcot's knee joint, villonodular synovitis, and synovial chondromatosis * patients taking immunosuppressant medication * patients with abnormal hematology or serum chemistry lab results * patients receiving injection to treatment knee within 2 months of study enrollment * bmi greater than 35 or less than 20
examining the effects of processed music on chronic pain

Conditions: Pain

Summary: chronic pain is a common ailment in aging populations and often co-occurs with altered regulation of the autonomic nervous system. nociceptive pathways (i.e., those that transmit pain signals) are integrated with autonomic circuits throughout the body and therapies that are successful in reducing pain concurrently alter autonomic functions, even when they are not directly designed to do so. it is possible that interventions that target the autonomic circuits that regulate pain responses may help reduce pain in chronic pain sufferers. the proposed study will examine whether an intervention that targets the autonomic nervous system via filtered music can reduce pain, a hypothesis derived from the polyvagal theory. the polyvagal theory describes how function and structure of the vertebrate autonomic nervous system changed during evolution. the theory is named for the vagus, a major cranial nerve that regulates bodily state. an evolutionary "old" branch of this nerve innervates structures below the diaphragm and its dysfunction is linked to lower body organ and tissue pain. regulation of the vagus nerve is linked with specific auditory cues based on our evolutionary heritage and the physics of the middle ear. this study is designed to test whether processed music designed to stimulate vagal function can decrease chronic pain. the listening project protocol, the processed music used in this intervention, has previously been shown to effectively stimulate the function of the vagus nerve (see stimulus description below). specific aims: aim i: to examine whether the listening project protocol, a non-invasive audio intervention, can be effective for reducing chronic pain in a sample of older adults. hypothesis: five 1-hour sessions of the listening project protocol will reduce pain aim ii: to examine whether increased regulation via the autonomic nervous system accounts for the decrease in pain if the intervention is successful. hypothesis: pain reduction will coincide with improved autonomic function by the myelinated vagus nerve (measured by respiratory sinus arrhythmia, see below) as well as decrease in the reactivity of autonomic functions in everyday experiences (measured by the body perception questionnaire, see below)


Eligibility criteria:
inclusion criteria: * participants must self-report as suffering from chronic pain exclusion criteria: * individuals who do not read or speak proficient english * individuals with substantial, uncorrected hearing loss
evaluation of novel optical smartphone application for blood pressure measurements in critically ill patients

Conditions: Hypotension

Summary: evaluation of a novel mobile application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) based on collected optical signals on patient's finger treated in intensive care unit patients

the purpose of the study is to compare the blood pressure values measured by a novel mobile phone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the radial arterial line) all patients admitted in the intensive care unit at erasme hospital brussels, belgium will be recruited and if they have an arterial line for at least two days the optibp application is a mobile application installed on a mobile phone which is a non-invasive data-logger intended to acquire physiological data from patients. by applying the patient's finger on a smartphone's camera, a movie is generated and transformed into values of diastolic, mean and systolic blood pressure. three measures will be taken (spaced by one minute) with both methods each hour for 5 hours and this will be done for 2 days. the patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (arterial line). then, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the novel mobile application. the goal is therefore to compare blood pressure values as obtained by the analysis of the data recorded by the optibp mobile application, against simultaneous measurements provided by the arterial line (gold standard)

Eligibility criteria:
inclusion criteria: * all intensive care unit patients with an arterial catheter for at least 48 hours * informed consent as documented by signature exclusion criteria: * patients or families that cannot sign informed consent * patients in emergency situation, and unstable * dyshythmia like bigeminy, trigeminy, isolated ventricular premature beats (vpb), atrial fibrillation * lesion or deficiency on hand, preventing index obstruction of smartphone's camera * known contact dermatitis to nickel/chromium
safety and tolerability study of inno-406 to treat chronic myeloid leukemia or acute lymphocytic leukemia

Conditions: Chronic Myeloid Leukemia; Acute Lymphocytic Leukemia

Summary: the purpose of this study is to determine the safety and effectiveness of inno-406 in adult patients with imatinib-resistant or intolerant philadelphia chromosome-positive (ph+) leukemias.

the purpose of this study is to determine the safety, tolerability and pharmacokinetic profile of inno-406 when administered as a daily oral agent in adult patients with imatinib-resistant or intolerant philadelphia chromosome-positive (ph+) leukemias.

Eligibility criteria:
inclusion criteria: 1. have a confirmed diagnosis of ph+ all or cml in chronic, accelerated, or blastic phases that are either resistant to or intolerant of imatinib therapy. 2. be ≥18 years old. 3. have an eastern cooperative oncology group (ecog) performance status of ≤2. 4. have an estimated life expectancy of ≥12 weeks. 5. be male or non-pregnant, non-lactating female. patients who are fertile must agree to use an effective barrier method of contraception while on therapy and for 90 days following discontinuation of study drug. 6. have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential). 7. have acceptable pre-treatment clinical laboratory results. exclusion criteria: 1. have received chemotherapy ≤1 week from the start of therapy, with the exception of hydroxyurea and corticosteroids. 2. have received imatinib ≤3 days prior to enrollment or have not recovered from side effects of imatinib therapy. 3. have impaired cardiac function. 4. have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment. 5. have clinically significant acute or chronic liver or renal disease considered unrelated to tumor. 6. have impaired gastrointestinal function that may significantly alter drug absorption (e.g., uncontrolled vomiting, ulcerative colitis, malabsorption, or small bowel resection). 7. are pregnant or lactating. 8. have psychiatric disorder(s) that would interfere with consent, study participation, or follow-up. 9. have not recovered from acute toxicity of all previous therapy prior to enrollment. 10. have any other severe concurrent disease and/or uncontrolled medical conditions, which, in the judgment of the investigator, could predispose patients to unacceptable safety risks or compromise compliance with the protocol. 11. have a history of another primary malignancy that is currently clinically significant or requires active intervention.