Kornimate/medical-research-clean huggingface dataset:
first-in-human study to evaluate amg 579 in healthy subjects and patients with stable schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to assess the safety and tolerability of amg 579 following a single oral dose administration in healthy subjects (part a) and in patients with schizophrenia or stable schizoaffective disorder (part b). the study in healthy subjects (part a) concluded, and following a protocol amendment, enrolled only patients with schizophrenia or stable schizoaffective disorder (part b).


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia (chronic, all types) or schizoaffective disorder according to diagnostic and statistical manual of mental disorders, 4th edition text revision (dsm-iv-tr) criteria and by mini international neuropsychiatric interview (m.i.n.i.) 6.0 for schizophrenia and psychotic disorders studies * body weight greater or equal to 50 kg and body mass index (bmi) between 18 and 38.0 kg/m2, inclusive, at screening * patient is judged by the investigator to be likely to tolerate being off of antipsychotic medications for the duration of the trial (for patients withdrawing from or currently not taking antipsychotic medications) * clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks within enrollment. if patient is on antipsychotic medications, they must be on second generation oral antipsychotic therapy (eg, ziprasidone, quetiapine, olanzapine, etc) for at least 8 weeks within enrollment and at least one month within enrollment on a stable dose exclusion criteria: * hospitalized for psychiatric symptoms in the 3 months within enrollment * patients with evidence of mental retardation by history or clinical examination or known premorbid iq ≤ 70 * current risk of self-harm or violence as determined by the investigator, or current risk of suicide or history of suicidal behavior within 12 months of enrollment, and/or ongoing suicidal ideation as assessed using columbia-suicidal severity rating scale (c-ssrs) at screening (eg, any response of "yes" to the suicidal ideation questions on the c-ssrs in the past 12 months). additional critera apply. eligibility criteria for healthy subjects (part a) not outlined above.

Keywords: single dose, safety, healthy subjects, schizoaffective disorder, amg 579
study of efficacy and safety of vigadexa in treating inflammation and infection post-cataract surgery

Conditions: Cataract

Summary: to demonstrate that the combination formulation of moxifloxacin/dexamethasone eye drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.


Eligibility criteria:
inclusion criteria: * ≧18 years of age * able to sign an informed consent and complete all required visits * intends to have a cataract extraction surgery followed by implantation of a posterior chamber intraocular lens (iol) * intraocular pressure (iop) ≦ 20 millimeters mercury (mmhg) exclusion criteria: * uncontrolled glaucoma or iop * use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of iol in the study eye * use of steroid during the study or within 14 days prior to enrollment

Keywords: cataract
high dose vitamin d supplementation in children with sickle cell disease

Conditions: Sickle Cell Disease; Vitamin D Deficiency; Health Related Quality of Life; Hand Grip Strength; Bone Mineral Density

Summary: suboptimal vitamin d status is well reported in sickle cell disease (scd) patients and associated with a negative impact on health-related quality of life (hrql). the investigators enrolled 42 scd patients and 42 healthy controls, subjects within each group received monthly oral vitamin d3 dose according to the baseline status of vitamin d as follows: sufficient: 100,000 iu, insufficient: 150,000 iu, and deficient: 200,000 iu. the investigators assessed safety and efficacy on normalization of vitamin d level, bone mineral density (bmd), hand grip strength (hgs), and hrql.


Eligibility criteria:
inclusion criteria: * children with scd (hbss, hemoglobin sickle beta zero (hbsβ0) thalassemia genotype), aged ≤ 18 years old, male or female study participants who were at a steady state (≥ one month from blood transfusion and ≥ 14 days from any acute sickle complication as hospitalization for vaso occlusive crisis (voc) or acute chest syndrome (acs)), stable hb level near their usual baseline and stable dose of hydroxyurea (hú) mg/kg for at least 90 days prior to enrollment. * a control group of 42 healthy age and sex-matching children exclusion criteria: * scd patients who are on chronic blood transfusion therapy * comorbid chronic conditions * use of medications known to interfere with calcium or vitamin d absorption or metabolism * known hypercalcemia or vitamin d hypersensitivity * use of vitamin d therapy to treat vitamin d deficiency or rickets * urolithiasis, liver or renal impairment, and malabsorption disorders. * obese children with body mass index (bmi) \> 85th percentile for age and sex
prevalence of diabetic retinopathy and impact of genetic factors in the development of diabetic retinopathy of patients with type 1 and 2 diabetes mellitus in slovakia

Conditions: Diabetic Retinopathy; Diabetic Macular Edema; Diabetes Mellitus

Summary: the aim of the study is to find out prevalence and individual stages of diabetic retinopathy in patients with type 1 and type 2 dm verified based on complex ophthalmologic measurements in slovak republic. the outcome of the project will be epidemiology survey, prevalence of diabetic retinopathy (dr) and diabetic macular edema (dme) in relation to type and duration of diabetes mellitus and risk factors. project will also identify genetic factors linked with the diseases.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * signed informed consent for epidemiological research * signed informed consent for genetic research * patients with dm - type i and ii regardless of the dm duration * all dm patients must be included regardless of presence of eye complications in patient´s anamnesis or during the examination by the diabetologist subgroups analysis * patients with dm - type i and ii and dm duration ≥ 20 years * patients with dm - type i and ii and dm duration \< 5 years and dr in history exclusion criteria: * age at the time of inclusion into the \<18 years * gestational dm or secondary-induced diabetes * diabetic ketoacidosis or hyperosmolar coma * alcohol abuse or acute alcohol intoxication
diagnostic value of molecular cytological analysis (cma) and shear wave elastography shearwave (swe) in patients with a thyroid nodule with indeterminate cytology: feasibility study

Conditions: Thyroid Node; Indeterminate Cytology; Surgery Indication

Summary: the purpose of the study is to investigate the contribution of molecular cytological analysis (cma) and shear wave elastography shearwave (swe) in the diagnosis of nodules with indeterminate cytology (ic)


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients with thyroid nodules ≥ 15 mm with an indeterminate cytology (ic) older than 6 months, for which a surgical indication was raised * vesicular lesion of undetermined significance * follicular neoplasm or hurthle cells * lesion suspicious for malignancy * confirmation of indeterminate cytology (ic) replay centralized * patient affiliated to a social security scheme * informed consent and signed exclusion criteria: * thyroid node \<15 mm * nodules coalescing preventing proper individualization of targeted nodule * indeterminate cytology older than six months * nodules with indeterminate cytology not, ie non-diagnostic cytology, benign and malignant cytology cytology * major subject to a measure of legal protection or unable to consent * refusal to participate

Keywords: thyroid elastography swe indeterminate cytology
placental insufficiency microcirculation quantification by ultrafast doppler (microdoppler placenta)

Conditions: Preeclampsia and Intrauterine Growth Restriction

Summary: to identify fetuses small for their gestational-age who have reached their appropriate growth potential from growth-restricted fetuses due to placental insufficiency is uneasy. intra uterine growth restriction (iugr) increases the risk for indicated preterm delivery, neonatal mortality and morbidity. therefore, improving the knowledge of the placental perfusion is essential to better identify and manage fetal chronic oxygen deprivation associated with placental insufficiency. thus, the investigators propose to study placental microcirculation with a more efficient doppler than conventional doppler use in clinical practice. the ultrafast doppler is being able to map placental blood flow and could have potential impact in placental insufficiency diagnosis and prevention. moreover, this doppler could discriminate maternal and fetal vascularization. the hypothesis is that ultrafast doppler could help clinician to diagnose and manage preeclampsia and iugr during pregnancy.


Eligibility criteria:
inclusion criteria: * patient who accepted to participate in the study * woman over 18 years old * affiliated to a social security scheme * mono-fetal pregnancy * patients with normal pregnancy between 11 and 42 weeks of amenorrhea * patients hospitalized for preeclampsia and / or intrauterine growth retardation, beyond 20 weeks of amenorrhea exclusion criteria: * minors, adults under guardianship, protected persons * not affiliated to a social security scheme * multiple pregnancy

Keywords: microdoppler placenta preeclampsia intrauterine growth restriction
bare platinum coils versus second-generation hydrocoils

Conditions: Aneurysm, Ruptured; Intracranial Aneurysm

Summary: comparison of clinical and radiological outcomes between bare platinum coil group and second-generation hydrogel coils for treatment of ruptured intracranial aneurysms.

the investigators aimed to analyze whether the use of second-generation hydrogel coils for the treatment of ruptured intracranial aneurysms improves clinical and angiographic outcomes compared with the use of bare platinum coils.

Eligibility criteria:
inclusion criteria: * 19 year old or older * untreated ruptured intracranial aneurysms with an anatomy such that endovascular treatment with either bare platinum or second-generation hydrogel coils was considered feasible. * person who agreed to study exclusion criteria: * contrast allgery (+) * combined other intracranial lesions (tumor, moyamoya disease, cerebral vascular diseases) * ineligible for coil embolization

Keywords: aneurysms embolization rupture
terps trial for de novo oligometastic prostate cancer

Conditions: Prostate Cancer; Oligometastatic Disease

Summary: this research is being done to see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.

this study will compare the effects, good and/or bad, of using the standard of care treatment (systemic therapy + primary prostate radiation) compared to standard of care treatment plus stereotactic ablative radiation therapy (sabr) to metastatic lesions for prostate patients. the researchers are also trying to learn if the addition of sabr will affect recurrence rates. presence of circulating tumor cells, gut bacteria, and quality of life will be assessed for both groups.

Eligibility criteria:
inclusion criteria: 1. patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are seen on imaging. up to five lesions are allowed on advanced functional imaging such as fluciclovine (axumin), choline or psma pet-ct scan. 1. ct or mri scan within 6 months of enrollment 2. bone scan within 6 months of enrollment 3. fluciclovine (axumin), choline, or psma pet-ct scan within 6 months of enrollment (pet-ct scan is reasonable for study entry imaging as an alternative to ct/mri scan and bone scan) 2. histologic confirmation of malignancy (primary or metastatic tumor). 3. patient may have had prior systemic therapy and/or adt associated with treatment within 9-months of enrollment. 4. psa \> 0.5 but \<100. 5. patient must be ≥ 18 years of age. 6. patient must have a life expectancy ≥ 12 months. 7. patient must have an ecog performance status ≤ 2. 8. patient must have the ability to understand and the willingness to sign a written informed consent document exclusion criteria: 1. castration-resistant prostate cancer (crpc). 2. prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy 3. spinal cord compression or impending spinal cord compression. 4. suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis). 5. patient receiving any other investigational agents. 6. inability to receive any form of systemic therapy in the opinion of a treating medical oncologist . 7. unable to lie flat during or tolerate pet/mri, pet/ct or sabr. 8. no radiographical evidence of cranial metastasis. 9. refusal to sign informed consent.
effect of nitrate-rich beetroot juice on exercise performance in heart failure patients

Conditions: Systolic Heart Failure

Summary: nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and submaximal exercise performance in healthy adults. investigation for similar effects in patients with heart failure has not previously been conducted. this was a randomized, double-blind, placebo controlled trial. following ingestion of the active agent or placebo, subjects with systolic heart failure underwent submaximal steady state exercise with gas exchange analysis followed thirty minutes later by a six minute walk test. second testing sessions were performed ten days. there were no significant differences in the treatment and placebo arms in average oxygen consumption or six minute walk distance. in conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich beetroot juice concentrate, there is no significant difference with regard to oxygen consumption during submaximal steady state exercise or six minute walk testing distance. further study is warranted to determine the true efficacy of nitrate consumption in this population with adjustments in acute or chronic dosing, exercise duration, or intensity.


Eligibility criteria:
inclusion criteria: * local institutional beneficiaries between the ages of 18 and 80 * documentation of left ventricular systolic dysfunction with ejection fraction \< 40% by any modality within the past six months * documentation of new york heart association class ii or iii status. exclusion criteria: * \> 80 years of age * unable to adequately or safely perform treadmill exercise * pulmonary disease deemed significant enough to be a limitation to exercise * greater than moderate stenotic or regurgitant valvular heart disease * presence of atrial fibrillation or other uncontrolled arrhythmias * uncompensated heart failure * continuously paced rhythms * pregnant females * chronic nitroglycerine use (oral isosorbide di or mono-nitrate, or topical nitroglycerine) * phosphodiesterase inhibitor (sildenafil or tadalafil) use within a week

Keywords: nitrate-rich beetroot juice heart failure exercise performance oxygen consumption
effect of feed warming method on feeding tolerance in the preterm infant born at less than 30 weeks gestation

Conditions: Enteral Feeding

Summary: the temperature of milk fed to infants in the neonatal intensive care unit (nicu) has been shown to vary greatly, and is influenced by individual provider practice. the clinical effect of varying milk temperatures on preterm infant feeding tolerance has not been well studied. the purpose of this study is to examine the effect of warming method, water bath versus commercial warmer and its impact on feeding tolerance. sample population will include eighty-six infants born at 30-0/7 weeks or less, and admitted to the neonatal intensive care unit at advocate children's hospital, park ridge within 48 hours of birth and remain in the study for a minimum of 28 days. after obtaining consent, eligible infants will be assigned to a control (water bath) or experimental (commercial warmer) group using a randomized sampling scheme. after warming, and just prior to feeding, milk temperatures will be taken and recorded by a trained data recorder. feeding tolerance will be measured based on gastric residual volume and length of time required to achieve full feeds. based upon the available evidence, the study investigators hypothesize that warming feeds to a consistent temperature range using commercially available milk warmer will improve feeding tolerance and decrease time to full feedings in preterm infants.


Eligibility criteria:
inclusion criteria: * preterm infants born at less than or equal to 30 0/7 weeks gestation * infants will be enrolled within the first 48 hours of life exclusion criteria: * gastrointestinal anomalies * lethal malformations * parental denial of consent or request for removal from study

Keywords: enteral feeding infant, premature
the effects of integrative neuromuscular training on physical function in overweight children

Conditions: Obesity; Childhood Obesity

Summary: childhood obesity is an ongoing and increasing issue, resulting in changes in body mass which cause biomechanical alterations in the lower limbs. exercise interventions have been effectiveness at causing positive changes to the lower limbs gait, strength and functioning but children often report lack of enjoyment from the sessions which inhibits long term changes. this intervention takes a neuromuscular exercise approach whilst considering the psychological needs of children to motivate them to participate in the intervention and physical activity.


Eligibility criteria:
inclusion criteria: * children aged 8-11 years old * overweight/obese children exclusion criteria: * children who have not given consent or had parental consent to participate * children who fall outside of the selected age range * children who have a physical or mental impairment that will affect their ability to participate in the procedures in the laboratory and intervention settings
quality of life following ecmo

Conditions: Extracorporeal Membrane Oxygenation; Quality of Life

Summary: the objective of the study is to determine the quality of life of patients in the years following treatment with extracorporeal membrane oxygenation (ecmo). the study population will include all adults treated with any configuration of ecmo at duke university medical center during the period of jan 1, 2009 and dec 31, 2015. patient's will be contacted by direct mail, in conjunction with a surgeon who performed their ecmo procedure or managed them while on ecmo, and asked to complete a validated survey (whoqol-bref) which assesses quality of life. in addition, patients will be asked to opt-in to participate in a phone survey in which they can give a narrative about their icu experience and answer specific questions regarding long-term comorbidities. data will be stored in a secure online server which is hipaa compliant and analyzed by the department of anesthesiology statistical support services. de-identified data will be shared with the who as specified in their usage agreement.


Eligibility criteria:
inclusion criteria: * va or vv ecmo performed during retrospective study period exclusion criteria: * pediatric
indirect endovenous systemic ozone for new coronavirus disease (covid19) in non-intubated patients

Conditions: COVID

Summary: systemic medical ozone has proved to help in several viral diseases, chronic obstructive pulmonary disease and chronic inflammation process. the investigators are sure that its application to covid-19 patients, as an adjuvant therapy, will improve the health status of these individuals.

due to the extreme world situation caused by covid19 pandemic, the investigators consider unethical not to try any treatment option with a justified rationale. the investigators have explained that medical ozone therapy has a clear scientific basement thanks to all preclinical and clinical investigation already published. it can be classified as chemical stressor that produces a modulation in the redox balance and immunity. moreover, it is easy and safe to administer with insignificant side effects. the efficacy in viral diseases has been proved in publications together the modulation of interleukin 6 and other proinflammatory cytokines that could potentially help in covid19 patients. the improve of exchange of gases and microcirculation will surely contribute to enhance this patients' health status. as explained above, the investigators propose to carry out a randomized control trial to evaluate the safety and efficacy of systemic ozone (indirect endovenous) in these patients.

Eligibility criteria:
inclusion criteria: * covid19 virus detected in oro/nasopharynx * mild ill according who numeric scale * mild ill according berlin criteria * non intubated patients * signed informed consent exclusion criteria: * patients treated with systemic ozone in the last 6 months * patients treated before with systemic ozone and referring any side effect * glucose-6-phosphate-dehydrogenase deficit * other severe concomitant disease apart from covid19 * psychiatric disease specified in axis i of l diagnostic and statistical manual of mental disorders, 5 edition, but major depression * patients not capable of understanding the study methods and targets * pregnant woman

Keywords: ozone therapy covid19
effect of different irrigation activating techniques on irrigant penetration depth and on post-operative pain

Conditions: Irrigation Activation

Summary: irrigation activation in endodontics is considered now a very important step for the success of root canal treatment. in this study, the investigator will examine the effect of two recent activation systems ( xp-endo finisher file and the new sonic eddy system) in comparison with the conventional needle irrigation on irrigant penetration depth into root canals using radiopaque contrast media and digital radiography and on the postoperative pain after single-visit endodontic treatment using a visual analog scale.


Eligibility criteria:
inclusion criteria: * asymptomatic vital/non vital teeth requiring root canal treatment. * teeth with sound periodontal apparatus. * teeth without pus or inflammatory exudates draining through the canal. * teeth without anatomic variations. * teeth with sinus tract. * teeth without history of trauma. * patients not on analgesics or sedative medication prior to root canal therapy exclusion criteria: * • patients with any systemic diseases. * pregnant or lactating patients. * immunocompromised patients. * apparently thin roots in which apical preparation with #40 file would be overzealous. * patient allergic to anything used in this procedure especially rubber dam material and iohexol (radiographic contrast media). * teeth with calcified canals. * patients with acute apical periodontitis, acute apical abscess, and weeping canals. * necrotic painful teeth with the absence of sinus tract for drainage.