Kornimate/medical-research-clean huggingface dataset:
single and multiple dose study in japanese subjects

Conditions: Gout

Summary: this study will explore the safety, tolerability, and serum uric acid lowering effect of rdea3170 in healthy japanese males to allow comparison with the western population.

while clinical studies of rdea3170 to date have been limited to a western population, it is recognized that both intrinsic and extrinsic factors may impact the pk, pd, safety, and dose response in different ethnic populations. the purpose of this study is to explore the safety, tolerability, pharmacokinetic (pk), and pharmacodynamic (pd) of single and multiple doses of rdea3170 in healthy japanese males, and to allow comparison of these parameters with the western population.

Eligibility criteria:
inclusion criteria: * able to understand the study procedures and the risks involved, and willing to provide written informed consent before the first study related activity. * healthy adult male subject born in japan. * subject has parents and grandparents who are japanese. * subject is in possession of a valid japanese passport. * all laboratory parameters should be within normal limits or considered not clinically significant by the investigator. * screening serum urate level ≥ 4.5 mg/dl. * subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures. * subject has a normal or clinically acceptable physical examination. * subject has no clinically relevant abnormalities in blood pressure, heart rate, and body temperature, per the investigator's judgment. exclusion criteria: * positive serology to human immunodeficiency virus (hiv-1 or hiv-2). * positive test for active hepatitis b or hepatitis c infection. * history or suspicion of kidney stones. * undergone major surgery within 3 months prior to day 1. * exposed to an investigational drug (or a medical device) within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to day 1 or is currently participating in another study of an investigational drug (or medical device). * prior exposure to rdea3170.
endothelial damage and angiogenesis biomarkers during covid-19

Conditions: Covid19; Angiogenesis; Endothelial Dysfunction; Cardiovascular Morbidity

Summary: severe sars-cov-2 disease is characterized by a progressive hypoxemic respiratory failure. autopsies from these patients show severe endothelial damage with extensive vascular thrombosis, microangiopathy, and occlusion of alveolar capillaries and, finally, evidence of new vessel growth through intussusceptive angiogenesis. this research aims to study endothelial damage and angiogenesis biomarkers and its association with major cardiovascular events.

to study the presence of endothelial damage and angiogenic biomarkers with major cardiovascular events, the investigators will perform an observational study to evaluate plasma biomarkers concentrations in covid-19 patients hospitalized in critical care units. after ethical review board approval, the investigators will select 40 patients admitted to intensive care units (icu). after patient written consent or if the participants are unable to consent, after a relative subrogated acceptance, the investigators will collect blood samples in the first 24 hrs and on the 10th day of hospitalization. venous blood samples are collected. after obtaining all samples, serum syndecan-1, thrombomodulin, ang-2, fgf basic, hgf, il-8, pdgf-bb, timp-1, timp-2, tnfα y vegf will be determined by a researcher blinded to the patient using commercially available elisa kits. the concentration of each biomarker at each sample time will be compared. the investigators will observe clinical outcomes after one, 3, 6, and 12 months after the hospitalization. the investigators found no previous data of this measurement in the covid-19 scenario. in this observational study, the investigators select a sample size on convenience for the primary outcome.

Eligibility criteria:
inclusion criteria: 1. patients older than 18 years 2. patient with a diagnosis of covid-19 confirmed by pcr 3. patient with radiological image suggestive of covid-19 with pending confirmation 4. need for ventilatory support with oxygen therapy by hfnc (high-flow nasal cannula) 5. need for invasive mechanical ventilation. exclusion criteria: 1. patient with an image suggestive of covid-19 with negative pcr 2. anticoagulation users before admission for any reason.

Keywords: syndecan-1 thrombomodulin vefg ang-2
targeting attention orienting to social threat to reduce social anxiety in youth

Conditions: Social Anxiety Disorder of Childhood

Summary: this two-site study is a test of attention bias modification treatment (abmt) among 260 youths ages 10 to 14 years with social anxiety disorder. one-half of participants will receive 8 sessions of computer administered abmt and the other half of participants will receive 8 sessions of computer administered neutral control task (nct). the investigators hypothesize that a biomarker of attention to social threat measured using electroencephalography (eeg) and ratings of social anxiety severity will be lower in participants who receive abmt compared to participants who receive nct.


Eligibility criteria:
inclusion criteria: * be between ages 10 and 14 years * meet dsm5 criteria for a diagnosis of social anxiety disorder * presence of any coexisting psychiatric diagnoses must be of lesser severity than social anxiety disorder * have no current psychotropic medication other than a stable dose of stimulant or non-stimulant medication for coexisting adhd exclusion criteria: * meet dsm5 criteria for autism spectrum disorder, intellectual disability, bipolar disorder, tourette's disorder, psychotic disorders, or substance use disorders * show high likelihood of hurting self or others * be a victim of undisclosed abuse requiring investigation/ supervision by the department of social services * have an uncorrected vision or physical disability that interferes with the ability to click a mouse button rapidly and repeatedly * have a history of neurological illness, including seizures/epilepsy, or head injury with loss of consciousness \> 5 minutes
diagnostic characterization and evolution of "triple negative" thrombocytosis (castette)

Conditions: Myeloproliferative Neoplasm

Summary: evaluation of event free survival in patients with triple-negative thrombocytosis

patients with non-reactive thrombocytosis, explored at least by bone marrow biopsy and ngs panel will be included. clinical and biological characteristics as well as evolution will be recorded retrospectively.

Eligibility criteria:
inclusion criteria: * patients with non reactive thrombocytosis for at least 6 months * availability of bone marrow biopsy and ngs panel exclusion criteria: * unable to consent
impact of long covid-19 on the health and quality of life of military personnel (active or retired) and their families

Conditions: COVID-19

Summary: severe and sometimes irreversible sequelae are observed in people who have developed a severe form of covid-19 (pulmonary, cardiovascular, renal, neurological sequelae among others). more than 10% of individuals who contracted the disease, even in a mild form, still have at least one of the initial symptoms at six months, also known as prolonged symptoms or long covid syndrome. the most frequently observed symptoms are asthenia, neurological disorders (headache, anosmia, ageusia, etc.), cardio-thoracic disorders, pain, digestive or skin disorders. very recently, the first results of a british prospective cohort study (phospcovid) indicate that more than half of the covid-19 survivors who were hospitalised experienced a very severe to moderate deterioration in their mental and/or physical health five months after hospitalisation. women are particularly affected. another american study shows that 85% of non-hospitalised covid-19 patients developed at least 4 neurological symptoms impacting their quality of life. the most common are: "brain fog" (81%), headaches (68%), numbness or tingling (60%), taste impairment (59%) and loss of smell (55%). these disabling symptoms may persist for weeks or months, deteriorating the quality of life of patients and making it difficult for some to return to a normal life. on the basis of current knowledge concerning the long-term sequelae of sars-cov-2 infection, it seems necessary to offer these subjects a specific care pathway and to adapt their living and working conditions beyond their medical care. the present study is aimed at measuring the impact of long covid on the health and quality of life of the defence community (military personnel and their families).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years-old * be affiliated to the french military health insurance exclusion criteria: * age \< 18 years-old

Keywords: quality of life long covid
the effect of epidural anesthesia on the optic nerve sheath diameter in preeclampsia

Conditions: Preeclampsia

Summary: this study aims to assess the effect of epidural anesthesia on the optic nerve sheath diameter in parturients with preeclampsia.

this prospective observational study will be performed in parturients, either with or without preeclampsia, who scheduled to undergo elective cesarean delivery under epidural anesthesia. epidural anesthesia will be done according to the standard technique. optic nerve sheath diameter (onsd) will be measured before and after the epidural injection of anesthetic solutions using ultrasonography. the investigators will assess whether epidural anesthesia has effect on optic nerve sheath diameter of pregnant women, and the investigators will also compare onsd between healthy parturients and parturients with preeclampsia. the investigators will evaluate the relationship between onsd and disease severity of preeclampsia.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo planned cesarean section under epidural anesthesia if they have a singleton pregnancy, complicated by severe preeclampsia. severe preeclampsia was defined using the american college of obstetricians and gynecologist task force on hypertension in pregnancy recommendations * controls will be healthy pregnant women at term (\>37 weeks), with a singleton pregnancy, no signs or symptoms of preeclampsia and no intrauterine fetal growth restriction, who are planned to undergo elective cesarean delivery under epidural anesthesia exclusion criteria: * contraindication to epidural anesthesia * morbid cardiovascular disease * cerebrovascular disease * known fetal anomaly * any signs of onset of labor * body weight \ 100 kg * height \ 190cm * eye disease * infection or trauma near the eyes * abnormality of intracranial pressure due to intracranial pathology
pre-visit prioritization for complex patients with diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: patients with type 2 diabetes are increasingly complex. lack of time to address all patient and provider priorities during primary care visits represents a barrier to effective primary care. the investigators propose to design, implement, and evaluate in a randomized clinical trial a web-based tool linked to the electronic health record (ehr) that will enable complex patients to easily define care priorities for their upcoming visit.

patients with type 2 diabetes are increasingly living with multiple concurrent conditions and complicated medical regimens. for these patients, diabetes management decisions and treatment goals must be addressed within the larger context of other competing health concerns. in parallel, clinical advances have led to a substantial increase in the number of tasks that primary care providers must perform during each visit. these twin trends present a formidable challenge to effective diabetes primary care. we hypothesize that among complex patients not meeting diabetes management goals, a web-based health it tool to help patients explicitly prioritize all health issues (both related and unrelated to diabetes) and then submit these priorities directly into the electronic health record (ehr) for a scheduled visit with their primary care provider will result in more effective diabetes management over time. to test this hypothesis, we propose to design, implement, and evaluate in a randomized clinical trial a web-based tool linked to the ehr that will enable complex patients to easily define care priorities for their upcoming visit.

Eligibility criteria:
primary care physicians (pcps) at kaiser permanente northern california with potentially eligible patients (type 2 diabetes and hba1c \> 8.0%) wil be recruited and consented to participate in this study. pcps will review lists of potentially eligible patients of theirs (defined below). patients approved by pcp's allocated to the intervention arm will be sent a secure message on the pcps behalf asking them to review the pre-visit prioritization questionnaire to identify top priorities for discussion at the next scheduled visit. patient inclusion criteria: * current adult member (\> 21 years old) * diagnosis of type 2 diabetes with most recent hba1c \> 8.0% * english as primary language * registered on kp.org. patient exclusion criteria: * excluded by pcp, and/or: terminal illness, in hospice care or reside in a long-term care facility, severe mental illness (e.g. schizophrenia or personality disorder), currently or recently pregnant, and/or significant dementia

Keywords: electronic medical records primary health care diabetes mellitus, type 2
comparison of two needles (19g flex versus 22g standard) for pancreatic solid tumors diagnosis

Conditions: Adenocarcinoma of Head of Pancreas

Summary: the purpose of this study is to compare the diagnostic gain between 22g standard needle vs 19g flex needles transduodenal punctures of masses of the pancreatic head.

the negative predictive value of fine needle aspiration under ultrasound endoscopy (eus-fna) for the diagnosis of solid pancreatic masses is about 70 - 80 % with the 22g standard needle. pancreatic adenocarcinoma is known to have a severe prognosis and a low rate of survival even after curative surgery. the study of pancreatic solid tumors is one the main diagnostic problem present in the investigators daily practice. in most of non operated patients, eus-fna is the sole possibility to confirm the diagnosis of malignancy which is required to initiate chemotherapy and/or radiotherapy. to improve the performances of the eus-fna, new needles are now disposable either with a cutting window design (echotip procore-cook medical) or flexible 19g needle (19g expect flex - boston-scientific). the goal is to obtain more tissue material with the possibility of a histologic study without increasing the risk of the puncture which is very low (complications rate \< 1%). the problem concerns the lesion of the head of the pancreas requiring a trans-duodenal access for the puncture . in this position, the needle is very difficult to push out the operator channel and, in some cases, the puncture is quite impossible with stiff needles as "procore" or standard 19g. thus, the interest of flexible 19g needle is to be used in difficult technical cases as transduodenal access for head pancreatic tumors, with a good safety and more efficacy than 22g needles.

Eligibility criteria:
inclusion criteria: * patient with solid tumor of pancreas who has to receive a biopsy under endoscopic ultrasound (eus) * patient who understands the study procedures, risks and voluntarily agrees to participate by giving written informed consent exclusion criteria: * patient who participates in an other study * patient mentally or legally incapacitated * patient with contraindications to the achievement of upper gastrointestinal endoscopy * patient with haemorrhagic disease, disorder of hemostasis and coagulation (tp\ 40sec and platelets \<60000/mm3) * patient with anticoagulant or antiaggregating treatment that could not be stopped for the endoscopic procedure * patient with pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging) * patient pregnant or lactating women

Keywords: fine needle aspiration under ultrasound endoscopy solid pancreatic tumors head of pancreas 19g flex needle 22g standard needle
pd-1 knockout engineered t cells for metastatic renal cell carcinoma.

Conditions: Metastatic Renal Cell Carcinoma

Summary: this study will evaluate the safety of pd-1 knockout engineered t cells in treating metastatic advanced renal cancer. blood samples will also be collected for research purposes.

this is a dose-escalation study of ex-vivo knocked-out, expanded, and selected pd-1 knockout-t cells from autologous origin. patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. after the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. biomarkers and immunological markers are collected and analyzed as well.

Eligibility criteria:
inclusion criteria: * pathologically verified stage iv renal cancer with measurable lesions (on ct: longest diameter of tumoral lesion \>=10 mm, shorted diameter of lymph node \>=15 mm; measurable lesions should not have been irradiated) * progressed after all standard treatment * performance score: 0-1 * expected life span: \>= 6 months * toxicities from prior treatment has resolved. washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy * major organs function normally * women at pregnant ages should be under contraception * willing and able to provide informed consent exclusion criteria: * pathology is mixed type * emergent treatment of tumor emergency is needed * poor vasculature * coagulopathy, or ongoing thrombolytics and/or anticoagulation * blood-borne infectious disease, e.g. hepatitis b * history of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician * with other immune diseases, or chronic use of immunosuppressants or steroids * compliance cannot be expected * other conditions requiring exclusion deemed by physician
cognitive behavioral therapy for core autism symptoms in school-aged children: a randomized, controlled trial

Conditions: Autism Spectrum Disorder

Summary: this study is designed to examine the efficacy of a cognitive behavioral therapy (cbt) program for treating core autism symptoms, social and emotional problems, and adaptive behavior deficits in children with autism spectrum disorders.


Eligibility criteria:
inclusion criteria: * 7 - 11 years of age * meet research criteria for a diagnosis of autism, asperger syndrome, or pdd-nos * meet dsm-iv criteria for one of the following anxiety disorders: separation anxiety disorder, social phobia, obsessive-compulsive disorder * if taking medication, have maintained a stable dose for 1 month prior to baseline assessment exclusion criteria: * child has an iq of less than 80 * begin taking new medication(s) or current medication dose changes either (1) less than 1 month prior to baseline assessment, or (2) during the study period * for any reason the child or parents appear unable to participate in the treatment program
thromboelastography to assess hemostatic changes in patients undergoing elective cesarean delivery.

Conditions: Hemorrhage

Summary: the purpose of the study is to assess the coagulation changes that occur in patients undergoing elective cesarean delivery using thromboelastography (teg). we will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.

the purpose of the study is to assess the coagulation changes that occur in patients undergoing elective cesarean delivery using thromboelastography (teg). teg is a point-of-care device which measures the viscoelastic properties of clot formation. this device can provide rapid and detailed information about coagulation changes in the perioperative period. we will compare coagulation data collected from the study to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.

Eligibility criteria:
inclusion criteria: * all obstetric patients with singleton pregnancies admitted to the labor and delivery unit at lucile packard hospital who undergo elective cesarean delivery. * we will select 100 healthy asa 1 patients with singleton pregnancies who are scheduled for uncomplicated elective cesarean delivery, with no anticipated risk of obstetric hemorrhage. exclusion criteria: * patients with underlying coagulation disorders. * patients with thrombocytopenia. * patients with pregnancy-induced hypertension, pre-eclampsia. * patients requiring the following medications prior to surgery: nsaids, aspirin, anticoagulants. * patients requiring non-elective cesarean delivery. * patients with significant obstetric or medical disease. * no patients \<18 years of age will be recruited.
hrqol of life after ecmo due to covid-19.

Conditions: ARDS; COVID-19 Pneumonia; Extracorporeal Membrane Oxygenation

Summary: we intend to prospectively investigate physical and mental state (hrqol) by means of quantitative telephone interviews after hospital discharge in patients surviving covid-19 ards and ecmo therapy.


Eligibility criteria:
inclusion criteria: * patients surviving covid-19 ards and ecmo therapy exclusion criteria: * no consent