Kornimate/medical-research-clean huggingface dataset:
optic nerve sheath diameter and intracranial pressure (icp) in children

Conditions: Intracranial Hypertension

Summary: the use of optic nerve sheath diameter (onsd) measurements as a non invasive test for raised icp has many potential benefits. this includes having assessments that can be made at the bedside instead of requiring patient transport to ct or mri, which in itself can cause a rise in icp. if onsd represents an acute and sensitive measurement of elevated icp, it may prove useful in the emergency department (ed) setting in the evaluation of shunts used for cerebrospinal fluid (csf) diversion. the investigators hypothesize that onsd will correlate with measured icp and thus be a reliable tool for the bedside assessment of icp. the investigators further hypothesize that onsd changes will correlate with changes in icp, making it a useful bedside tool for assessing icp changes over time. this is a prospective, observational study using a convenience sample. children who are 0 - 18 years old who have an invasive intracranial icp monitoring device admitted to the hospital pediatric intensive care unit (picu) are eligible for participation in the study. children who are 0-18 years old who are determined to require a shunt revision following evaluation in the ed will also be included in the study. 10. after the invasive intracranial pressure monitoring device is placed, for every recruited patient, onsd measurements will be taken and the icp will be recorded 8 hours post placement and then repeated 3 times a day until the intracranial pressure monitoring device is removed.12. for ventriculoperitoneal (vp) shunt revision patients, the investigators will obtain a measurement just before surgery, immediately post-op, and then 12 hours, 24 hours, and 36 hours post-op. if the patient is otherwise ready for discharge prior to 36 hours, the measurement may be omitted or done early so as to not unnecessarily prolong the hospitalization


Eligibility criteria:
inclusion criteria: * children between 0 years and 18 years of age * children who are determined to need an invasive intracranial monitoring device in the ed and admitted to the picu * children who undergo vp shunt revisions at the study site exclusion criteria: * children with an invasive intracranial monitoring device that is malfunctioning * prior adverse reactions to ultrasound gel * pre-existing ophthalmologic conditions that could cause a baseline increase in onsd, including glaucoma or severe ocular trauma * children with ocular or facial trauma that would impede onsd measurements
cetuximab and vemurafenib plus folfiri for braf v600e mutated advanced colorectal cancer (improvement)

Conditions: Colorectal Cancer

Summary: this clinical trial aims to evaluate the efficacy, safety of folfiri with vemurafenib and cetuximab in advanced colorectal cancer patients with braf v600e mutation.


Eligibility criteria:
inclusion criteria: * patients have histologically or cytologically confirmed advanced or recurrent crc; * patients with brav v600e mutation/kras wt based on the ngs or arms-pcr detection of tumor tissue; * patients have measurable disease as defined by recist 1.1 as determined by investigator; * patient with a history of radiotherapy at least 3 months before on the day of providing consent, but the measurable lesion should not be within the scope of radiotherapy; * patients without a history of receiving vemurafenib or cetuximab; * patients with age of 18-75yr; * patients with a performance status of 0,1or 2 on the eastern cooperative oncology group.； * patients with life expectancy of more than 12 weeks; * patients must have the ability to understand and sign the written informed consent voluntarily; * female of childbearing potential who are negative in a pregnancy test within 14 days before enrollment. both male and female patients should agree to use an adequate method of contraception (total abstinence, an intrauterine device or hormone releasing system, an contraceptive implant and an oral contraceptive) starting with the first dose of study therapy through 120 days after the last dose of study therapy. duration will be determined when the subject is assigned to treatment. exclusion criteria: * patients with kras/nras mutation; * patients with major surgery or severe trauma within 4 weeks before the first medication; * patients with hypersensitivity to the components in the study protocol;； * patients who are ready to give birth or are pregnant.。 * patients with brain metastases 。 * bone marrow, liver and kidney function did not meet the requirements of chemotherapy as follows： * neutrophil count\<1,500/mm3； * platelet count \<80,000/mm3； * total bilirubin \>1.5-times the upper limit of normal； * alt/ast\>2.5-times the upper limit of normal for patients without liver metastases; (5.0-times the upper limit of normal for patients without liver metastases) * creatinine \>1.5-times the upper limit of normal； * patients with cancers other than advanced colorectal cancer within five years prior to the start of treatment in this study. cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor were excluded;； * patients without legal capacity or limited civil capacity;

Keywords: flofiri vemurafenib cetuximab braf v600e mutation advanced colorectal cancer
pembrolizumab in combination with eftilagimod alpha and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcoma - eftisarc-neo trial

Conditions: Neoadjuvant; Immunotherapy; Sarcoma,Soft Tissue; Radiation Therapy

Summary: this is a phase ii single-arm single-stage study evaluating efficacy and safety of pembrolizumab in combination with a soluble lag-3 protein, eftilagimod alpha (efti) and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas. this study will determine the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the combination treatment.

systemic therapy with pembrolizumab and eftilagimod alpha and radiotherapy are administered concurrently. systemic treatment lasts for 9 weeks (study week 1-9). radiation therapy lasts for 5 weeks (5 days per week) in weeks 2-6. surgery takes place 5-6 weeks after completion of radiation therapy (week 11-12). any adjuvant treatment (chemotherapy, immunotherapy, radiation therapy) after surgical treatment is not allowed. patients will be then followed up regularly for a period of 24 months.

Eligibility criteria:
inclusion criteria: * primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) soft tissue sarcoma * grade 2 or 3 tumors according to fédération nationale des centres de lutte contre le cancer (fnclcc); * size of the primary tumor \&gt;5 cm at instrumental staging (ct, mri), or locally recurrent of any size; * measurable disease based on recist 1.1; * non-metastatic disease; exclusion criteria: * ewing sarcoma, alveolar and embryonal rhabdomyosarcoma * previous treatment with eftilagimod alpha, anti-pd-1 or anti-pd-l1; * prior radiotherapy to tumor-involved sites;

Keywords: soft tissue sarcoma immunotherapy
adaptive radiotherapy in non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: the investigators group uses an individualised radiation dose approach in which the dose is escalated up to pre-defined tissue constraints (see below). the target dose to the tumor is 69gy. however, this dose cannot be reached in approximately 30% of the patients, even with an imrt (intensity modulated radiotherapy) technique, because the mld (mean lung dose) constraint of 20gy is reached at a ttd (total treatment dose) below 69gy. in this study, the investigators will adapt the treatment by performing a new (pet)-ct at day 12 during radiotherapy and in case of a decreased planning target volume (ptv), the dose mey be increased.

eligible patients will receive concurrent chemo-radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an mld (mean lung dose) of 20 +/- 1gy, irrespective of lung function. other dose constraints: spinal cord max: 54gy, brachial plexus (dmax):66gy. in concurrent with chemotherapy, radiotherapy will be delivered as follows: 1. first three weeks /30 fractions:twice-daily fractions of 1.5gy, with 8h to 10h as interfraction interval, 5 days per week. total dose: 45gy/30 fractions. 2. thereafter: once-daily fractions of 2.0gy, 5 days per week until the target dose has been reached. in sequential or radiotherapy alone schedules, twice-daily 1.8gy with an interfraction interval of at least 8h will be delivered. the radiation doses will be specified according to icru 50. lung density corrections will be applied, as well as all standard qa procedures. technical requirements are the same as in standard practice at maastro clinic. chemotherapy schedules allowed: 1. 1-2 cycles induction chemotherapy: any third generation schedule is allowed. the type will be registered. 2. concurrent part: (day 1=first day of radiotherapy) 1. cisplatin-vinorelbine 2. cisplatin-docetaxel 3. cisplatin-etoposide 4. cisplatin-pemetrexed in non-squamous histologies q3 week; 3 cycles when the calculated creatinin clearance is less than 60 ml/min, cisplatin may be substituted for carboplatin. in case the ttd(total treatment dose)=69gy cannot be reached because of a limiting mld, a fdg-pet-ct will be performed at day 12 during radiotherapy. gtv's (gross tmor volume), ctv's (clinical target volume) and ptv's (planning target volume) will be delineated and a new plan calculated. the endpoint will be the proportion of patients that will receive 69gy.

Eligibility criteria:
inclusion criteria: * histological or cytological proven nsclc * uicc stage i-iii, or solitary metastases (\<6), which are amendable for radical local treatment * performance status 0-2 * imrt technique exclusion criteria: * not nsclc of mixed nsclc and other histologies (e.g. small cell carcinoma) * stage iv, except for solitary (\<6) metastases * performance status 3 or more

Keywords: radiotherapy nsclc stage ii-iii non-small cell lung cancer
effect of diltiazem administration on cp-945,598 pharmacokinetics

Conditions: Obesity

Summary: a recently completed clinical drug interaction study of cp-945,598 with ketoconazole, a potent cyp3a inhibitor, showed that coadministration of cp-945,598 with ketoconazole results in an approximately 5-fold increase in cp-945,598 total exposure (auc) and 4-fold increase in cmax. therefore, the sensitivity of cp-945,598 pharmacokinetics (pk) to less potent cyp3a inhibitors needs to be characterized to support labeling and registration. diltiazem is a known substrate and moderate mechanism-based inhibitor of the cyp3a enzyme system and was chosen as the moderate cyp3a inhibitor for this study as it is a clinically relevant medication likely to be prescribed concomitantly with cp-945,598 given the increased risk of hypertension and cardiovascular disease in the obese patient population.


Eligibility criteria:
inclusion criteria: * no clinically relevant abnormalities based upon medical history, physical exam, 12-lead ecg, and clinical lab tests * body mass index (bmi) \~ 27-40 kg/m2, inclusive * personally signed inform consent document exclusion criteria: * evidence or history of significant acute or chronic disease * pregnant or nursing females * screening pr interval \> 220 msec * sitting blood pressure \<= 90 mmhg systolic or \<= 60 mmhg diastolic
minimally invasive management during endodontic retreatment

Conditions: Teeth, Endodontically-Treated

Summary: the study compares the prognosis of cases treated with "selective root retreatment" to the cases treated with traditional retreatment approach

post-treatment apical periodontitis is an inflammatory disorder of peri-radicular tissues caused by either persistent or secondary intra-radicular infection .conventionally, nonsurgical retreatment has been believed to be an ''all or none'' treatment approach in which the endodontist has to remove all restorations from the tooth and to remove the obturation materials from all the canals in order to perform thorough disinfection of the entire root canal system. nowadays, all operations in the medical field are aimed basically at the conservation of the human body. the alternative concept allows the endodontist to formulate clinical treatment decisions with respect to the presence of periapical pathosis related to individual roots rather than the tooth as a whole. the literature is lacking the clinical outcome studies dealing with the prognosis of cases treated with "selective root retreatment" concept so the aim of this study was to compare the prognosis of such cases in comparison to the traditional retreatment approach.

Eligibility criteria:
inclusion criteria: * endodontically treated teeth * multirooted teeth * radiographic evidence of periradicular infection related to one root exclusion criteria: * medically compromised patients * fused roots * root resorption * root fracture
sero-epidemiology of priority arboviruses in french guiana

Conditions: Arbovirus Infections

Summary: dengue is an important public health problem despite the efforts of local health authorities to mitigate the impact of epidemics and the epidemiology of dengue evolved from an endemo-epidemic to a hyper-endemic state. in late 2013, the first local transmission of chikungunya virus in the americas was identified in caribbean countries and territories including french guiana. rapidly, more than 16,000 suspected local health authorities had reported cases. in may 2015, the pan american health organization (paho) issued an alert regarding the first confirmed zika virus infections in brazil. the emergence of zika virus in south america led to a rapid spread throughout south and central america, reaching french guiana in december 2015. with the increasing frequency of epidemics related to arbovirus and the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus have become social, political, and public health challenges that require specific and non-available immune status information.

french guiana is a 250,000 inhabitant's french overseas department located in south america, the epidemiology of arboviruses has recently evolved and marked by important outbreaks. dengue remains an important public health problem despite the efforts of local health authorities to mitigate the impact of epidemics and the epidemiology of dengue evolved from an endemo-epidemic to a hyper-endemic state. in late 2013, the first local transmission of chikungunya virus in the americas was identified in caribbean countries and territories including french guiana. rapidly, more than 16,000 suspected local health authorities had reported cases. in may 2015, the pan american health organization (paho) issued an alert regarding the first confirmed zika virus infections in brazil. the emergence of zika virus in south america led to a rapid spread throughout south and central america, reaching french guiana in december 2015. with the increasing frequency of epidemics related to arbovirus and the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus have become social, political, and public health challenges that require specific and non-available immune status information.

Eligibility criteria:
inclusion criteria: * guiana resident for at least 6 months and present during the entire study period * age between 2 and 75 years old exclusion criteria: * subject under guardianship or deprived of liberty by judicial decision * subject with any pathology or health problem not compatible with blood sampling
chaplain-delivered compassion meditation to improve quality of life in patients receiving a stem cell transplant

Conditions: Lymphoma; Plasma Cell Myeloma

Summary: this clinical trial tests whether chaplain-delivered compassion centered spiritual health (ccsh) works to improve quality of life in patients receiving a stem cell transplant. compassion centered spiritual health (ccsh) is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. by centering the mind, controlling negative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others, compassion centered spiritual health (ccsh) may help improve response to stress and reduce inflammation.

primary objective: i. to examine the feasibility, adoption, extent of implementation, and fidelity of chaplain-delivered compassion centered spiritual health (ccsh). outline: patients undergo 4 to 8 sessions (2-4 per week) of compassion centered spiritual health (ccsh) over 30 minutes with a chaplain while impatient.

Eligibility criteria:
inclusion criteria: * patient: within 6 weeks of scheduled hematopoietic stem cell transplant (hsct) * patient: \> 18 years of age * patient: speak and read english * chaplain: emory healthcare chaplain exclusion criteria: * chaplain: there will be no exclusion criteria and no consequence to the chaplains for refusing to volunteer * patient: neurologic or cognitive problems that preclude chaplain-delivered compassion centered spiritual health (ccsh)
italian study on the cardiovascular effects of systolic blood pressure control - cardiosis study

Conditions: Hypertension

Summary: multicenter, prospective, randomised, open study comparing the effect of the following two strategies in hypertensive subjects \> 55 years and poorly controlled (systolic blood pressure \>= 150 mmhg) by antihypertensive treatment: * usual strategy: reduction of systolic blood pressure to below 140 mmhg, independently of diastolic blood pressure levels; * intensive strategy: reduction of systolic blood pressure to below 130 mmhg, independently of diastolic blood pressure levels. during the initial run in period two qualifying visits at distance of 7-14 days will be carried out to establish whether blood pressure remains uncontrolled (systolic blood pressure \>=150 mmhg)by current drug treatment. at the end of the second visit eligible patients will be admitted to the study and the following examinations will be carried out: clinical visit, routine laboratory tests, 12-lead ecg. at this point eligible patients will be randomised to one of the two blood pressure goals outlined above. subsequent clinical visits will be carried out at 4 month-intervals up to the end of the study (4, 8, 12, 16, 20, 24 months).

study partially sponsored by: boehringer ingelheim, sanofi-aventis, pfizer

Eligibility criteria:
inclusion criteria: * written informed consent to the study * age \>= 55 years at randomization. there is no upper age limit * systolic blood pressure \>= 150 mmhg in 2 visits at distance of 7-14 days, irrespective of diastolic pressure. duration of treatment before visit 1 must be at least 12 weeks * at least one additional risk factor including the following: * current cigarette smoking * total cholesterol \>= 20 mmg/dl, or high density lipoproteins (hdl) \ = 130 mg/dl * family history of cardiovascular disease in male first degree relative \< 55 years or female first degree relative \< 65 years * previous tia or stroke * previous coronary artery disease * history of peripheral occlusive arterial disease (claudication intermittens associated with angiographic or echographic evidence of \> 60% stenosis) exclusion criteria: * diabetes (fasting glucose \> 125 mg/dl in two samples or ongoing diabetic treatment) * renal failure, defined by a serum creatinine \> 2.0 mg/dl * chronic atrial fibrillation or flutter * clinically significant hepatic or hematological disorders, alcoholism, drug addiction * causes precluding ecg interpretation for lvh: complete right or left bundle block, wolff-parkinson-white syndrome, previous q-wave myocardial infarction * any disease causing reduced life expectancy * unwilling to participate * significant (more than traces of) valvular heart disease

Keywords: hypertension systolic blood pressure
thyroid function in critically ill patients with acute kidney injury

Conditions: Secondary Hypothyroidism

Summary: the objective of this study was to assess the changes in thyroid hormones and its activity during crrt in patients with acute kidney injury.

after approval from the local bioethics committee of the medical university of gdańsk in poland, the study was carried out between february 2019 and february 2020 among 32 patients admitted to icu. there was no need to obtain written consent from the patients since the study was observational with no therapeutic intervention and decisional incapacity caused either by sedative drugs or severe condition of the patient. patients with acute kidney injury and indications for initiation of continuous renal replacement therapy (crrt) were included to this study irrespective of their gender, race and age. exclusion criteria were patients with previous end-stage chronic kidney disease treated with dialysis. after decision to implement crrt the serial blood samples were collected into two red-top tube (no anticoagulant or preservative) before initiation of crrt and at 1,2,3,6,9,12,15,18-day following. last samples were collected 3 days after the end of crrt. level of tsh, ft3 and ft4 were checked from the first tube after collecting the blood. second tube was kept frozen until levels of trh, tt3, tt4, rt3 could be measured. in all the patients high-dose continuous veno-venous hemodiafiltration (cvvhdf) with citrate anticoagulation was performed. blood flow and dialysis dosage were the same for every patient depending on their weight. the weight was rounded up or down and patients were assigned to the nearest group.

Eligibility criteria:
inclusion criteria: patients with acute kidney injury and indications for initiation of continuous renal replacement therapy (crrt) exclusion criteria: exclusion criteria were patients with previous end-stage chronic kidney disease treated with dialysis or with history of hypothyroidism.

Keywords: renal replacement therapy thyroid hormones acute kidney injury intensive care unit
measurement and analysis of macular retinal pigment epithelium (rpe) elevations with cirrus hd-oct vs. color fundus photography

Conditions: Drusen Stage Macular Degeneration

Summary: the objective of this study is to compare the areas designated as elevated retinal pigment epithelium (rpe) by the cirrus hd-oct versus those designated as drusen on color fundus photographs (cfps).

this is a prospective, multiple site study. ocular history and examination will be conducted on consented subjects to determine further participation in the study. subjects qualified to continue will undergo color fundus photography and imaging of their study eye using the cirrus hd-oct.

Eligibility criteria:
inclusion criteria: * males or females 50 years of age or older diagnosed to have dry amd with macular drusen. * drusen should not be combined with other lesions such as geographic atrophy (ga) or choroidal neovascularization. * able and willing to make the required study visits. * able and willing to give consent and follow study instructions. exclusion criteria: * history of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye. * evidence of other retinal diseases of the eye, including wet amd, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction upon dilated examination, or upon evaluation of retinal photos. * thick media opacity or inability to fixate that precludes obtaining acceptable scans. * concomitant use of hydrochloroquine and chloroquine. * unable to make the required study visits. * unable to give consent or follow study instructions.

Keywords: drusen dry amd oct imaging