Kornimate/medical-research-clean huggingface dataset:
dexmedetomidine pharmacokinetics in neonates during therapeutic hypothermia

Conditions: Hypoxic-ischemic Encephalopathy

Summary: the goal of this proposal is to profile the pharmacokinetics of dexmedetomidine in newborns ≥36 weeks post-menstrual age during therapeutic hypothermia for hypoxic-ischemic encephalopathy.

the goal of this proposal is to determine the pharmacokinetics (pk) of dexmedetomidine (dex) in newborns in the neonatal intensive care unit (nicu) receiving therapeutic hypothermia (th) for moderate to severe hypoxic-ischemic encephalopathy (hie). in newborns with hie, th for 72 hours is the standard therapy to mitigate brain damage. most hie patients receive mechanical ventilation during th and are thus sedated with morphine. unfortunately, morphine has negative side effects and does not specifically prevent shivering. prevention of shivering is critical to success of th, as shivering negates cooling. dex is a particularly promising alternative sedative because it does prevent shivering and is already used in nicus for sedation and pain management. in newborns, dex pk data in the setting of th is not available and needs to be determined to properly dose dex for hie patients.

Eligibility criteria:
inclusion criteria: 1. newborns 36 weeks gestation or older with moderate to severe hypoxic-ischemic encephalopathy identified and treated with therapeutic hypothermia in the seattle children's hospital neonatal intensive care unit. 2. cooled infants who are initially intubated and mechanically ventilated. 3. infants anticipated to require 72 hrs of continuous sedation and/or treatment to prevent shivering. 4. subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the institutional review board (irb)/independent ethics committee (iec). exclusion criteria: 1. known chromosomal anomalies. 2. newborns without central lines (e.g., lines not needed or unable to be successfully placed) or without a peripheral arterial line. 3. patients with known cyanotic congenital heart defects 4. patients who are participating in another clinical trial. 5. patients who received dex prior to enrollment in the study 6. at the discretion of the investigator, subjects in whom the risk of dexmedetomidine treatment is expected to exceed its benefits.

Keywords: dexmedetomidine neonate pharmacokinetics therapeutic hypothermia hypoxic-ischemic encephalopathy adrenergic agents adrenergic agonists analgesics adrenergic alpha-2 receptor agonists central nervous system agents central nervous system depressants
confocal laser endomicroscopy and optical coherence tomography for diagnosing ild.

Conditions: Interstitial Lung Diseases

Summary: often, assessing a classifying diagnosis in patients with interstitial lung disease provides a diagnostic challenge. currently hrct, endoscopic or surgical video assisted thoracoscopic surgery(vats) assessment including lung biopsies are diagnostic tools for patients with suspected ild. however, tissue acquisition is associated with morbidity in these patients with an already compromised pulmonary function. in clinical practice this results in the fact that only a minor part of patients with an indication for tissue acquisition are actually undergoing biopsies. the aim of this study is to determine ild-characteristics on imagign collected with minimal invasive novel optical techniques, to examine whether the addition of novel optical techniques to the diagnostic process of ild could potentially limit the need for a tissue- (surgical) diagnosis and/or reduce the sampling error rate of biopsies by providing additional information on biopsy location.

novel probe based optical techniques such as confocal laser endomicroscopy (pcle) and optical coherence tomography (poct) are non-invasive optical techniques, compatible with conventional diagnostic bronchoscopes and provide non-invasive, real-time information on the airway wall and the alveolar compartment. therefore, immediate validation of optical measurements during a biopsy is possible. optical techniques might either obviate the need for an tissue biopsy or improve the diagnostic yield of conventional biopsy methods and make surgical lung biopsies that are associated with high morbidity and costs redundant. hypothesis: novel optical techniques (pcle and poct) provide real time information about the characteristics of the mucosa and/or the alveolar compartment in ild.

Eligibility criteria:
inclusion criteria: * 18 years of age * supected ild and referred for diagnostic bronchoscopic procedure with cryobiopsy exclusion criteria: * smoked in the last 6 months * inability and willingness to provide informed consent * inability to comply with the study protocol

Keywords: optical coherence tomography confocal laser endomicroscopy
impact of environmental exposures on tumor risk in sdhx-mutation carriers

Conditions: SDH-Related Familial Paraganglioma; SDHx-Related Syndromes; SDH Gene Mutation; Environmental Exposure

Summary: the primary objective of the pgl.expo-2 study is to test the hypothesis that exposure (occupational, environmental and/or domestic) to succinate dehydrogenase inhibitors (sdhi) could contribute to tumor emergence in subjects carrying a germline mutation in one of the sdhx genes.the primary endpoint will be the proportion of subjects (cases or controls) exposed to sdhi and the association with paraganglioma risk. in addition, a blood sample (10 ml on edta) will be proposed to the participants to the study

patients will be selected from subjects with a mutation in one of the sdhx genes. the cases will have developed a tumor, while the controls will be tumor-free. controls will be matched to the cases according to age and type of gene affected. past exposures will be sought through a telephone questionnaire. in addition, a blood sample (10 ml on edta) will be proposed to the participants to the study

Eligibility criteria:
inclusion criteria: * cases: sdhx mutation carriers diagnosed for a sdhx-related tumor * controls: sdhx mutation carriers with no sdhx-related tumor exclusion criteria: * incapacity to exercise free and informed consent for the study * patient under tutorship or guardianship or legal safeguard

Keywords: hereditary paraganglioma sdhx gene mutation environmental exposure
study of the effect of etavopivat on cerebral hemodynamic response in children with sickle cell disease

Conditions: Sickle Cell Disease

Summary: an open-label, single arm study in patients 12 to 21 years of age with scd to evaluate the effects of etavopivat on cerebral and muscle hemodynamics.

this study is a pilot, open-label, single-arm study to evaluate the effect of etavopivat on cerebral hemodynamics, as measured by frequency domain near-infrared spectroscopy/diffuse correlation spectroscopy (fdnirs/dcs) in participants 12 to 21 years of age with sickle cell disease (scd). cerebral blood flow (cbf), oxygen ejection fraction (oef), and cerebral metabolic rate of oxygen (cmro2) will be assessed fdnirs/dcs in participants prior to, periodically throughout, and after 24 weeks of treatment with etavopivat. approximately 12 participants will be enrolled. the duration of study treatment will be 24 weeks. the study duration for individual participants may last up to 36 to 38 weeks and includes the screening period (up to 4 weeks before study treatment), the 24-week treatment period, a safety follow-up visit at 4 weeks (+ 7 days) after the last dose of study drug, and an end of study (eos) visit approximately 8 weeks (± 7 days) after the last dose of study drug. a participant is considered to have completed the study if he or she has completed all phases of the study including the last visit or the last scheduled procedure shown in the schedule of events.

Eligibility criteria:
inclusion criteria: * homozygous hemoglobin ss (hbss) or hemoglobin s/beta0 thalassemia (hbs/β0 thal) * hemoglobin (hb): hb ≤ 9.0 g/dl at baseline * concomitant hydroxyurea (hu) therapy is allowed if the dose has been stable for at least 3 months with no anticipated need for dose adjustments during the study and no sign of hematological toxicity exclusion criteria: * any one of the following requiring a medical facility visit within 14 days prior to signing the informed consent form: * vaso-occlusive crisis (voc) * acute chest syndrome (acs) * splenic sequestration * dactylitis * requires chronic transfusion therapy * abnormal tcd in the last 12 months * rbc transfusion within 60 days of screening * severe renal dysfunction at the screening visit or on chronic dialysis * hepatic dysfunction * clinically relevant cardiac or pulmonary disease- e.g., congenital heart defect, uncompensated heart failure, or any unstable cardiac condition, arrhythmic heart condition, pulmonary fibrosis, pulmonary hypertension * major surgery involving the stomach or small intestine * chemotherapy or radiation within the past 2 years * history of overt clinical stroke within previous 2 years or any history of an intracranial hemorrhage * clinically significant bacterial, fungal, parasitic, or viral infection currently receiving or that will require therapy * female who is breast feeding or pregnant
motivational interviewing and addiction

Conditions: Internet Addiction; Game Addiction, Video

Summary: the increasing use of the internet makes understanding games among adolescents different by moving it to the virtual environment and increases the digital game addiction risk. especially among adolescents, digital games have become a popular activity and often a means of socialization. with the widespread use of smartphones, digital gaming has transformed from computer and console-based to a multi-platform activit. in addition, long-term digital games cause symptoms such as anxiety and depression through increased interpersonal loneliness and decreased relationships. this situation has caused recent research to focus on the effects of digital gaming activities on individuals.

internet addiction and digital game addiction, which are the negative side of rapidly developing digital technologies and increasing internet accessibility, are of global concern. therefore, implementing interventions for internet and digital game addiction can be an effective approach to prevent physical, mental, environmental, and social problems caused by addiction. in this context, it is predicted that motivational interviewing may be an appropriate approach in combating internet and digital game addiction. motivational interviewing is a client-centered psychotherapeutic approach that helps the person with ambivalence make positive decisions, achieve specific and better goals, and increase internal motivation for change. it is thought that motivational interviewing could contribute to reducing addictive behaviors by evaluating the effect of motivational interviewing on both internet addiction and digital game addiction at the same time.

Eligibility criteria:
inclusion criteria: * being a ninth-grade student * being in the intention or pre-intention stage according the change assessment form * being addicted to digital games * having family approval * volunteering to participate in the research exclusion criteria: • having any physical and mental illness

Keywords: motivational interviewing adolescent digital game addiction problematic internet use
practical alternative to hospitalization

Conditions: Emergency Department; Health, Subjective; Health Care Utilization

Summary: the investigators test the path program to evaluate whether the program allows patients to spend more days at home in comparison to patients who receive regular care. the program will involve patients from penn presbyterian medical center with a set of diagnoses and will provide patients with enhanced services upon discharge from the emergency department.

the path program seeks to provide patients with enhanced services upon discharge from the emergency department, including visiting home nurses, visiting home physical and occupational therapists, scheduled frequent telephone visits with a medical provider, care coordination to arrange outpatient evaluation and testing, social work services, and other services. the purpose of this study is to evaluate whether the path program allows patients to spend more days at home in comparison to patients who receive regular care. the broad goal of this program is to provide patients with a personalized package of enhanced services following discharge from the emergency department. in some cases, patients enrolled in the path program are likely to be discharged home regardless of enrollment, but are deemed potentially high-risk for returning to the hospital due to their illness or other factors. in other cases, enrolled patients might otherwise have been hospitalized but decide with their clinician that recovery at home is possible with the increased supervision and care provided by path. for all patients, we seek to determine whether path is effective in expediting patient recovery from acute illness and reduce the time spent in hospital or nursing facilities.

Eligibility criteria:
inclusion criteria: * stable (patients are deemed stable by ed clinician and path clinician per review of vital signs, history, exam, test results, and functional status) * have active insurance * domiciled at home (patients must live in the community and not in nursing facility, shelter, or otherwise homeless) * safe home environment * live in penn medicine home health (pmhh) geographic catchment if enrolled in pmhh services exclusion criteria: * substance use disorder (no active untreated sud, including alcohol, opioids, cocaine, or stimulants) * serious mental health condition * police custody * homelessness * anticipated procedures or surgeries * iv access (patients with need for home infusion services or frequent blood testing after discharge must have standard level of iv access)
evaluation of anterior repositioning guided splint combined with or without i platelet-rich fibrin

Conditions: Temporomandibular Joint Disorders

Summary: the study aims to evaluate clinically and radiographically the effectiveness of arthrocentesis and injection of i-prf with wearing ars in comparison to arthrocentesis and ars only.

the patient will be seated at a 45° angle with the head turned toward the unaffected side. after preparing and disinfecting the target site with betadine, two points will be marked over the affected joint. local anesthesia will be administered to block the auriculotemporal nerve. using 19-gauge needles, the superior joint space will be distended with 2-3 ml of ringer's solution. another needle will be inserted into the distended compartment near the articular eminence to facilitate solution flow. lactated ringer's solution, connected to one needle, will be infused with sufficient pressure (200 ml in 15-20 minutes) to release adhesions. following the removal of one needle, 2 ml of injectable platelet-rich fibrin (prf) will be injected into the superior joint space. for the preparation of injectable prf, 20 ml of the patient's blood will be drawn and divided into two 10 ml vaccutainers. after centrifugation, the obtained prf will be aspirated into a 5 ml syringe, and 1.5 to 2 ml of prf will be injected into the superior joint space.

Eligibility criteria:
inclusion criteria: * adults aged 18 years and older. * history of unilateral or bilateral disc displacement without reduction (ddwor) of the temporomandibular joint (tmj) confirmed by mri. * presence of tmj pain and restricted maximum mouth opening. * no improvement with conservative treatment. * absence of mri contraindications. exclusion criteria: * patients having any systemic disease that could interfere with the tmj treatment or assessment. * patients having previous tmd treatment modalities or previous tmj surgery. * patients with a previous history of oral and or maxillofacial trauma. * patients that are contraindicated to perform mri. * completely or partially edentulous patients were also excluded.

Keywords: anterior repositioning guided splint injectable platelet-rich fibrin
pain neuroscience education as treatment in fibromyalgia affected patients

Conditions: Fibromyalgia

Summary: fibromyalgia (fm) is a chronic, complex and disabling clinical entity that has an average global prevalence of 2.7%. it occurs mainly in women in a 3: 1 ratio. it is characterized by persistent generalized pain, fatigue, unrefreshing sleep, cognitive dysfunction and numerous systemic symptoms such as dizziness, migraine, digestive alterations or sensory intolerances. at present there is no pharmacological treatment with specific indication for fibromyalgia. usually, non-curative treatments are recommended that alleviate the symptoms of the patients and improve their quality of life and functionality. the investigator's main goal is to evaluate the effectiveness at 1 year of a group educational intervention in neurobiology of pain in patients affected by fibromyalgia, in comparison with the evolution of a control group that will continue only with its usual treatments. this intervention will be carried out in the field of primary care and its effectiveness will be assessed by reducing or not having diagnostic criteria (reduction of areas of pain and of the severity of fibromyalgia symptoms), using the criteria for the diagnosis of fibromyalgia of the american college of rheumatology 2010 (acr 2010).

methodology of the project in group sessions of 14 patients, a health professional explained the neurological mechanisms that are behind the perception of pain, fatigue and illness from the recent knowledge in neuroscience about brain and pain, as well as the brain's ability to change patien´s behaviour thanks to neuroplasticity. there will be 5 sessions of 2 hours per week and another one per month. before the latter, a workshop of 2 hours of movement will be given. each week the contents of the class and other complementary materials will be sent to the patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of fibromyalgia stablished by the american rheumatology college criteria 2010, * older than 18 years * have signed the informed consent exclusion criteria: * psychiatric or neurological disorder which could prevent assimilate the training * refusal to participate in the trial

Keywords: fibromyalgia pain neurobiology education movement
the effect of blue-light filtering spectacle lenses on myopia progression in schoolchildren

Conditions: Myopia

Summary: the purpose of this study is to investigate if the blue-light filtering spectacle lenses promote myopia progression in schoolchildren.

the effect of blue light on ocular health has been studied extensively. shorter wavelength such as blue light could cause damage to the retina. the damage was more evident in the ageing eye. since the tablets and mobile with blue led backlight display are widely used, thus blue-light filtering spectacle lenses are now available in the market. however, whether this kind of lenses could affect the eye growth in schoolchildren is unknown. this study is then designed to investigate if the blue-light filtering spectacle lenses affect myopia progression in hong kong chinese schoolchildren. the schoolchildren will be randomly allocated to either blue-light filtering spectacle lens group (treated) or conventional spectacle lens group (control). their axial length and refraction will be monitored every 6 months for 2 years. the changes between two group will then be compared.

Eligibility criteria:
inclusion criteria: * refraction: myopia of -1.00 dioptres (d) to -5.00d * astigmatism: equal or less than -1.50d * anisometropia: equal or less than 1.00d * best corrected monocular visual acuity: 0.0 logmar or better after full correction * parents' understanding and acceptance of random allocation of grouping exclusion criteria: * any ocular and systemic abnormalities might affect visual functions or refractive development * prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.

Keywords: blue light filtering spectacle lens
fdg tumor heterogeneity during chemoradiation as a predictor of response in patients with cervical cancer

Conditions: Cervical Cancer; Uterine Cervical Cancer; Uterine Cervical Neoplasms

Summary: in this study, 50 evaluable patients will undergo one fdg-pet study during their chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment clinical fdg-pet/ct or fdg-pet/mr scans. from all fdg-pet studies, tumor volume, suvmax, fdghetero, and texture maps will be obtained. evaluating the changes in tumor suvmax and heterogeneity during treatment will aid in better understanding the role of these biological parameters in inadequate response to chemoradiation. other researchers, using mri imaging, have evaluated changes in the cervical tumor volume during treatment. the investigators expect there will be variation in how cervical tumors shrink and change during chemoradiation and therefore we are going to use multiple measures in addition to tumor volume to evaluate cervical tumor metabolic heterogeneity. being able to predict at diagnosis the patients who are at higher risk for persistent disease following chemoradiation would allow for future studies where these high risk patients could be specifically targeted with more aggressive therapy.


Eligibility criteria:
inclusion criteria: * patient must have biopsy-proven cervical cancer (figo stage-ib2-ivb). * patient must be at least18 years of age. * patient must be planning to receive chemoradiation therapy with cisplatin. * patient must have non-pregnant status if a female of childbearing potential. women who have had a tubal ligation at least 12 months prior to study entry or a hysterectomy will be considered not of childbearing potential. postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered not of childbearing potential. * patient may have distant metastatic disease provided the estimated survival is at least 1 year. * patient's tumor(s) must be fdg avid on baseline standard of care fdg-pet/ct or pet/mr imaging that was performed at barnes-jewish hospital clinical pet facility. * patient must be able and willing to give informed consent. * if the patient will be scanned on the pet/mr for the mid-treatment scan, they must be determined to be safe for exposure to the magnetic field. this will be determined the day of imaging by the technologist with the use of a screening form. if a patient is not safe for the pet/mr scanner, their mid-treatment images will occur on the pet/ct scanner in the center for clinical imaging research. exclusion criteria: * patient must have no other active cancer at the time of diagnosis of cervical cancer. * patient cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years. * patient must not be an uncontrolled diabetic with a glucose of ≥ 200mg/dl at the time of pet imaging.