Kornimate/medical-research-clean huggingface dataset:
predicting fluid responsiveness in mechanically ventilated critically ill children using transthoracic echocardiography

Conditions: Fluid Therapy; Hemodynamics; Hypovolemia; Shock

Summary: initial fluid resuscitation remains the first treatment step for most children experiencing circulatory failure and/or systemic hypotension. only one-half of these patients respond to fluid administration by a significant increase in cardiac output. a positive fluid balance is a poor prognostic factor that increases mortality. there are few markers validated in children to assess volume reactivity by dynamic ultrasound parameters mainly based on heart-lung interaction. in this work, the investigators propose to investigate whether dynamic parameters validated in adults, such as the superior vena caval collapsibility and the variability of cardiac output during an end-expiratory and end-inspiratory occlusion, are also reliable indicators of volume responsiveness in sedated children under controlled-mode ventilation.

after standardized volume expansion, patients who present an increase of cardiac index measured by transthoracic echocardiography greater than or equal to 15% of baseline measurement will be considered responders . a previous similar study using respiratory variations in aortic blood flow to predict fluid responsiveness in ventilated children reported a roc curve area 0.85, while the prevalence rate of circulatory failure was 50%. given these assumptions, a sample size of 38 subjects per group (responders / no responders) was estimated to provide a auc equivalent. a total of 76 subjects should be included.

Eligibility criteria:
inclusion criteria : * patient \< 18 years (child and neonate) * sedated and mechanically ventilated under controlled-mode ventilation * in whom fluid administration was planned by the attending physicians exclusion criteria : * high-frequency oscillatory ventilation * cardiac arrhythmia * congenital heart defect

Keywords: children critically ill fluid therapy fluid responsiveness hemodynamics hypovolemia shock echocardiography
combination topical therapy for treatment of scalp actinic keratoses

Conditions: Actinic Keratoses

Summary: the aim of this study is to determine the effectiveness of combination calcipotriene 0.005% foam and 5% fluorouracil cream for the treatment of actinic keratoses on the scalp. the data obtained will be compared with the current standard of care, monotherapy with 5% fluorouracil cream. a recent randomized, double-blind clinical trial (nct02019355) compared 0.005% calcipotriol ointment and fluorouracil 5% cream with vaseline plus fluorouracil 5% cream for a 4-day treatment of actinic keratoses on the face, scalp and upper extremities. they found that calcipotriol plus 5-fu versus vaseline plus fluorouracil 5% cream led to an 87.8% versus 26.3% mean reduction in the mean number of actinic keratoses. our study will independently assess the effectiveness of combination treatment (calcipotriene 0.005% foam and fluorouracil 5% cream) on scalp actinic keratoses in a case series of up to 15 eligible participants. participants will complete a 4-night application of combination treatment with follow-up immediately after and 8 weeks later.


Eligibility criteria:
inclusion criteria: * age of at least 40 years. * presence of four to fifteen clinically typical, visible, and discrete actinic keratoses in 25 cm2 on the scalp. * ability and willingness of the patient to participate in the study (informed consent is obtained) exclusion criteria: * treatment area is within 5 cm of an incompletely healed wound or a suspected basal-cell or squamous-cell carcinoma * treatment area contains hypertrophic/hyperkeratotic lesions, cutaneous horns, or lesions that had not responded to repeated cryotherapy * recent (within a month) use of medications that could interfere with evaluation of the treatment area (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet b phototherapy, other therapies for actinic keratoses, or oral retinoids) * premenopausal women (to avoid any risk of pregnancy) * history of hypercalcemia or clinical evidence of vitamin d toxicity (avoidance of calcipotriene toxicity).
sugammadex and cognitive function

Conditions: Post Operative Cognitive Dysfunction

Summary: post operative cognitive dysfunction (pocd) is recognized as a frequent complication after both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. the aim of this study is to examine the possible effect of the novel reversal agent sugammadex versus neostigmine/ atropine combination on cognitive function of adult patients after elective surgery during the early post operative period as well as at discharge.


Eligibility criteria:
inclusion criteria: * patients aged \>40 years old * asa i-iii * patients scheduled for elective surgery with general anaesthesia. exclusion criteria: * neuro-, vascular-, orthopedic- or cardiac surgery * known psychiatric or disease of the cns * history of craniotomy * receiving tranquillisers or antidepressants on a regular basis pre-operatively * alcoholism or drug dependence * history of stroke * refusal of patient * inability to read or write * mmse \< 22 pre-operatively

Keywords: cognitive function
a study to investigate the safety and efficacy of uc-mscs in pediatric patients with cerebral palsy

Conditions: Cerebral Palsy; Periventricular Leukomalacia

Summary: udi-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (pvl) multiple times to investigate its safety and efficacy.

this is the first study of udi-001 to be administered to children. pediatric patients with cerebral palsy attributed to pvl are enrolled to the study and umbilical cord derived mesenchymal stromal cells (uc-mscs) are administered to those patients multiple times intravenously. safety and efficacy of uc-mscs are evaluated for 52 weeks after the first administration.

Eligibility criteria:
inclusion criteria: * age \>= 12 months and \< 24 months corrected age at the time of informed consent * diagnosed with cerebral palsy * diagnosed with pvl * gmfcs level between ii and iv * able to obtain written informed consent from parents (legal representative) exclusion criteria: * presence of progressive neurological disease * presence of congenital anomaly * diagnosed with grade 3 or more severe intraventricular hemorrhage * body weight \< 5kg * profound intellectual disorder * complication of serious infection such as sepsis * requirement of mechanical ventilation * complication of serious organ failure such as kidney, liver or heart diseases or others and considered to be inappropriate * diagnosed with or suspected of hypsarrhythmia * positive for hbv, hcv, hiv or htlv-1 * patients who have received cell therapy * patients who have undergone selective dorsal rhizotomy or received botulinum toxin products within a certain period of time
lingual nerve injury in patients with difficult intubation

Conditions: Difficult Intubation; Lingual Nerve Injuries

Summary: the aim of this study is to investigate the incidence of lingual nerve injury and related factors in difficult intubation cases. demographic data of difficult intubation cases and body mass indices, thyromental and sternomental distances, mallampati classification, neck circumference, maximum mouth opening be recorded.numbness of the tongue and metallic taste will be questioned

the lingual nerve is the anterior descending branch of the posterior trunk of the mandibular division of the trigeminal nerve. lingual nerve injury is a recognised complication of orotracheal intubation and has been associated with forceful laryngoscopy. although left-sided neuropraxia has been reported, right-sided lesions are thought to be more common because the standard macintosh laryngoscope exerts pressure on the right side of the tongue. lingual nerve injury following orotracheal intubation was first described in 1971 by teichner who reported a right-sided neuropraxia which was attributed to direct pressure from the laryngoscope.

Eligibility criteria:
inclusion criteria: all adult patients undergo general anesthesia who have difficulty in intubation will be included in the study. the same number of patients without intubation difficulties will be included in the study as a control group. exclusion criteria: 1. patients who are not intubated under general anesthesia 2. patients undergoing regional anesthesia or peripheral nerve block 3. patients with laryngeal mask placed will not be included in the study.

Keywords: difficult intubation lingual nerve injury body mass index
a study to evaluate ethanol-induced symptoms and safety in breast cancer patients

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate ethanol-induced symptoms and safety in breast cancer patients with neoadjuvant/adjuvant chemotherapy including non-ethanol formulation docetaxel before and after surgery


Eligibility criteria:
inclusion criteria: * those who voluntarily signed a written personal information collection and usage agreement after receiving an explanation about the objective and method, etc. of this clinical study. * those are confirmed to have primary breast cancers through histological diagnosis and one of the following are applicable. * those who need neoadjuvant chemotherapy as breast cancer patients * those who need adjuvant chemotherapy after breast cancer surgery * those who are scheduled to administer non-ethanol formulation docetaxel according to chemotherapy * those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion. exclusion criteria: * those are diagnosed with other primary cancer that can influence the treatment or prognosis of primary breast cancers. * those are diagnosed with secondary breast cancers. * those with stage 0/1 (tis, n0, m0) or stage iv (any t, any n, m1) breast cancers.
partial removal of caries dentines

Conditions: Dental Caries

Summary: the aim of this multicenter randomized controlled clinical trial is to evaluate the effectiveness of an alternative treatment for deep caries lesions in public health services. the alternative treatment consists of partial removal of carious dentine followed by restoration. the subjects were assigned to test or control groups: test - carious dentine partial removal and restoration in one session, and control - stepwise excavation. the stepwise excavation consists of partial removal of carious tissue from the cavity floor, indirect pulp capping with calcium hydroxide cement; temporary filling; cavity re-opening after 60 days, removal of the remaining soft carious tissue and filling. each group was divided according to the filling material: amalgam or resin. the radiological exams are being performed before and after the treatment and then annually. clinical evaluation of the restorations is performed right after the treatment and then annually (modified usphs system). all evaluations are performed by calibrated and trained dentists.


Eligibility criteria:
inclusion criteria: * patients ≥ nine years old; * permanent molars with primary deep caries lesion reaching dentine inner half (radiographic exam); * pulpal sensibility positive (cold test); * absence of spontaneous pain; * absence of periapical alterations (radiographic exam); * negative percussion test. exclusion criteria: * subjects with general diseases affecting their caries experience; * caries lesion evolving an entire cusp; * caries lesion with cervical margin in dentine.

Keywords: deep caries lesion dentine caries removal dental restoration stepwise excavation
prevalence of epstein-barr virus infection

Conditions: Lymph Node Excision Biopsy

Summary: this will be a cross sectional, pilot study to determine the burden of ebv related lymphomas in this population. patient information including demographics and hiv status, history of hiv infection, hiv viral load and cd4 counts and art history will be retrieved from the integrated patient management system (ipms) lymph node excision biopsy samples, collected at nhl between 2012 and 2017, from the patient with a diagnosis of lymphoma will be retrieved using ipms from national health laboratory and analyzed by immunohistochemistry.

lymph node excision biopsy samples,which have been formalin fixed and paraffin embedded, of 50 hiv-infected and 50 hiv-uninfected patients from the patient with a diagnosis of lymphoma, will be retrieved using ipms from national health laboratory. archived diagnostic biopsy material will be collected from nhl between 2012 and 2017 (5 years). they will be analyzed by immunohistochemistry using lmp-1/ebna1/enna2 staining, either alone or combined which indicates a diagnosis of ebv infection. we will compute rates of ebv associated lymphomas among hiv infected and hiv uninfected individuals using descriptive statistics. the students t-test will be used for continuous variables while the pearson's chi squared test (or fisher's exact test where appropriate) will be used to compare categorical variables. significance will be assigned for p values of 0.05 or less

Eligibility criteria:
inclusion criteria: * all available lymph node biopsy samples with a diagnosis of lymphoma and complete data of hiv status, hiv viral load and cd4 counts and art history will be retrieved from ipms. exclusion criteria: * samples with incomplete data
effect of multimodal monitoring cluster management on patients with severe traumatic brain injury

Conditions: Multimodal Monitoring

Summary: traumatic brain injury (tbi) is a serious global health problem, with about 27 million new cases each year. severe head trauma can lead to intracranial hypertension and a range of complications such as cerebral edema and hypoxia of brain tissue. intracranial pressure monitoring is key to modern tbi treatment, but this approach does not fully reflect all relevant pathophysiological changes. multimodal monitoring allows for a more comprehensive assessment of the severity of tbi and guidance for individualized treatment to improve patient outcomes by integrating different monitoring methods. although more research is needed to confirm its efficacy, multimodal monitoring has been recognized as an important clinical decision support tool in neuroscience intensive care. future studies may further optimize this approach to monitoring and provide a more effective treatment strategy for patients with tbi.


Eligibility criteria:
inclusion criteria: 1.age \>18 years, 2.diagnosis of an acute brain injury (abi) due to tbi, 3.gcs with eyes response = 1 (no eyes opening) and motor score ≤5 (not following commands) at the admission to intensive care unit (icu) or neuro-worsen-ing within the first 48 hours with no eye opening and the motor score decreased to ≤5. - exclusion criteria: 1. have had a major stroke before. 2. pregnant or likely to become pregnant. 3 in the opinion of the treatment team, the decrease in gcs (glasgow coma scale) score is solely due to intoxication, sedation, or extracranial injury. 4 participants are unlikely to comply with all study procedures, including follow-up, in the opinion of the investigator. 5. have an underlying medical condition with a life expectancy of less than 6 months. 6. there are pre-existing contraindications to mri examination. 7 suffer devastating tbi, either progressing to brain death at the time of recruitment, or the treating medical team does not commit to continuous, comprehensive aggressive treatment.
avoiding low-value treatments in older women with early-stage breast cancer: piloting a patient decision aid

Conditions: Breast Cancer

Summary: the aim of this study is to learn whether participants find a patient guide to breast cancer treatment decisions acceptable and appropriate for use.

this study seeks to adapt and pilot test de-implementation strategies targeting low-value breast cancer treatments which have persisted despite national recommendations. breast cancer is an ideal setting in which to study de-implementation given it is common, well-studied, typically presents at an early-stage, and care is provided primarily in a community setting.

Eligibility criteria:
inclusion criteria * early stage breast cancer that is hormone receptor positive (hr+) and human epidermal growth factor negative (her2-) * meet criteria for omission of sentinel lymph node biopsy (slnb) * receiving care at michigan medicine exclusion criteria * non-english speaking * male patients (current data does not support omission of slnb in men)

Keywords: de-implementation strategies
ischemic preconditioning to prevent acute kidney injury

Conditions: Acute Kidney Injury

Summary: the purpose of this study is to learn about the impact of ischemic preconditioning in reducing contrast induced kidney damage in people with pre-existing kidney problems who are undergoing cardiac catheterization procedures.

ischemic preconditioning is thought to work by down-regulating pro-inflammatory gene expression and up-regulating anti-inflammatory gene expression in leukocytes. there is a local release of vasodilators, including adenosine and nitric oxide that are thought to have renal protective effects \[16\]. more is known regarding ischemic preconditioning in the heart, where it has been shown to decrease the adenine nucleotide pool, increase creatine phosphate and intracellular glucose, decrease atp depletion, and lactate and h+ accumulation. this leads to sodium maintenance of the transmembrane sodium gradient that prevents intracellular edema. ischemic preconditioning is thought to yield protection in the first minutes of reperfusion. activation of the adenosine a1, bradykinin, and opioid receptors is thought to trigger protection. this is supported by the interference with protection if an adenosine receptor antagonist is administered. the role of reactive oxygen species as part of the protective mechanism has also been described via mitochondrial mkatp channels which lead to increased production of protective superoxide. protein kinase c may also be involved in the protective mechanism of ischemic preconditioning, however the exact mechanism is unknown and controversial.

Eligibility criteria:
inclusion criteria: * stage iii-iv chronic kidney disease (with serum creatinine at or above 1.4 mg/dl and egfr 15-55 ml/min/1.73m2 calculated by the modification of diet in renal disease formula) * undergoing planned coronary angiography (including both cardiac and peripheral vascular) and/or intervention at kumc exclusion criteria: * patients with normal renal function (stage 0 to 2 chronic kidney disease and/or serum creatinine less than 1.4 mg/dl) * inability or unwillingness to provide consent * patients undergoing hemodialysis or peritoneal dialysis therapy * patients with renal artery stenting * hemodynamically unstable patients * patients with acute or acute on chronic heart failure * patients who are unable to undergo the study procedure due to any upper extremity problems such as prior amputation, prior radical mastectomy, etc * patients who have not been hydrated prior to procedure using the standard protocols
partnering to enhance emerging adults' response to programs

Conditions: Alcohol Use, Unspecified

Summary: the goal of this clinical trial (ct) is to learn more about emerging adults' and their peers. here, we will see how co-participating with a peer in health program might impact brain and behavior change over time. eligible youth will be invited to come in for a "participation day," during which they and a peer will independently complete questionnaires. with a peer, they will then complete a short health program, and undergo a brain scan (fmri) while completing activities. our study team will reach out to each participant individually again 3, 6, and 12 months later to learn about health behaviors over time.


Eligibility criteria:
inclusion criteria: * within the specified age range * agree to be contacted for the 3, 6, and 12 month follow ups * provide fully informed consent exclusion criteria: * left-handed * evidence of brain injury/illness and/or neurological, neurodevelopmental disorder including psychosis and related medications (e.g., antipsychotics; neuroleptics) * loss of consciousness ≥ 2 minutes * other fmri contraindications (e.g., unremovable metal on/in body, pregnant)
lipodystrophy connect patient registry

Conditions: Lipodystrophy

Summary: lipodystrophy connect is an online survey tool designed to collect demographic data and health information from individuals with lipodystrophy.

lipodystrophy is a heterogeneous group of rare and inherited syndromes characterized by the complete or partial loss or absence of subcutaneous adipose tissue. people living with lipodystrophy lack the fat tissue required for normal metabolic function. to enhance knowledge of the underlying biology of these conditions and to institute effective clinical treatments, the lipodystrophy community has developed a mechanism for individuals with any of the lipodystrophy conditions to enroll in a lipodystrophy registry called lipodystrophy connect. the objective of such a registry is to create a platform that connects all of the lipodystrophy community, including persons with lipodystrophy, family members, healthcare providers, researchers, drug companies, advocacy groups, federal research organizations, and regulators. a patient registry will provide the foundation for a resource to meet the current and future needs of the lipodystrophy community as well as accelerate the rate of research and development of therapies that improve the quality of life of those with lipodystrophy. lipodystrophy connect is an online survey tool that collects basic demographic information and health information from people with any rare form of lipodystrophy.

Eligibility criteria:
inclusion criteria: * adults, \> 18 years of age, with a diagnosis or suspected diagnosis of lipodystrophy, who are willing and able to provide informed consent, or for whom a legally authorized representative gives permission on behalf of the person to participate. * minors (less than 18 years of age) with a diagnosis of lipodystrophy with a parent(s) or legally authorized representative who provides informed consent to participate and enter registry information on behalf of the minor. note: minors who are 7-17 years of age will be asked to provide assent to participate. * adults \> 18 years of age, without lipodystrophy, who are willing and able to provide informed consent and are family members of patients diagnosed with familial partial lipodystrophy (fpl) or congenital generalized lipodystrophy (cgl) and want to provide information about themselves. exclusion criteria: * a person who does not have a suspected or confirmed diagnosis of lipodystrophy. * a person who has a known diagnosis of hiv-associated lipodystrophy.

Keywords: lipodystrophy lipodystrophy, congenital generalized berardinelli-seip congenital lipodystrophy congenital generalized lipodystrophy generalized lipodystrophy lipodystrophy, familial partial partial lipodystrophy lipodystrophy, partial, acquired acquired lipodystrophy