Kornimate/medical-research-clean huggingface dataset:
a study of safety, tolerability, and pk of rhmbl in pediatric hematology/oncology pts with fever and neutropenia

Conditions: Cancer; Hematologic Diseases; Fever; Neutropenia

Summary: the goal of this clinical research study is to find the dose of ezn-2232 that can be given to mbl deficient pediatric cancer patients undergoing chemotherapy. the pharmacokinetics, pharmacodynamics, and safety of the study drug will also be studied.

mbl deficient patients will be randomized in a ratio of 1:1 to receive a single dose of either 0.5 mg/kg or 1.0 mg/kg of intravenous rhmbl. a total of 24 patients will be treated in each of the rhmbl arms, (12 in the 0.5 mg/kg and 12 in the 1.0 mg/kg. all patients are to receive anti-infectious prophylactic supportive therapy as per institutional standards

Eligibility criteria:
inclusion criteria: patients must meet all of the following criteria to be eligible for enrollment into the study: * children ages 2 to 17 receiving chemotherapy for hematological/oncological diseases. * patients must have documented mbl levels \<300 ng/ml in serum as evaluated in the screening protocol. * fever defined as an oral temperature equivalent of \>100.4°f (38°c). * neutropenia defined as an absolute neutrophil count ≤1,000/mm3 with the anticipation that the counts will fall below 500/mm3. * receiving broad spectrum antibiotics for fever and neutropenia. * patients with age-adjusted normal serum creatinine or a creatinine clearance \>60 ml/min/1.73m2. * informed consent of the patient, parent or legally authorized representative obtained prior to entry. * reliable and willing to make themselves available for the duration of the study and to abide by the study restrictions. exclusion criteria: patients meeting any of the following exclusion criteria will not be eligible for enrollment. * patients receiving the preparative regimen for a bone marrow or hematopoietic stem cell transplantation. * concurrent serious illness in the opinion of the principal investigator that could potentially interfere with protocol compliance. * patient is pregnant, breast feeding or planning a pregnancy during the course of the study. * sexually active male and female patients not using an acceptable barrier method of contraception or practicing abstinence throughout the study and for at least 30 days after receiving their last treatment unless the patient is surgically or medically sterile. * patients with moderate or severe liver disease, as defined by: ast or alt \>5 times upper limit of normal (uln) or total bilirubin \>2.5 times uln. * patients with poor venous access that would preclude intravenous drug delivery or multiple blood draws. * current participation in another clinical study with an investigational agent and/or use of an investigational drug (not including investigational use of an fda approved drug) in the 30 days before scheduled administration of rhmbl. * known allergic reactions to mbl or other human plasma products. * patients on hemodialysis unable to tolerate the volume of iv fluid on non-dialysis days.

Keywords: mbl deficient oncologic hematologic pediatric fever neutropenia
markers of severity (cd177,s100a8 &s100a12) in sever acute respiratory syndrome coronavirus 2(sars-cov-2) patients

Conditions: COVID-19

Summary: patients infected with covid-19 have a series of clinical manifestations, including fever, cough, myalgia or fatigue, dyspnea, even acute respiratory distress syndrome (ards), acute cardiac injury and secondary infection, and a lot of sever patients had to been admitted to the intensive care unit (icu) one of the hallmark of covid 19 is the cytokine storm that provokes primarily pneumonia followed by systemic inflammation. besides the positive viral nucleic acid analysis and the representative pulmonary ct findings (bilateral distribution of patchy shadows and ground glass opacity), most individual patients showed the changes in several immunological and biological markers . cd177 which is one of the most clinically important neutrophil alloantigen because: i) it is a neutrophil-specific marker representative of neutrophil activation, ii) it was the most highly differentiated expressed gene in patients, and iii) the protein can be measured in the serum, making its use as a marker clinically applicable. it is expressed on neutrophils, neutrophilic metamyelocytes, and myelocytes . given the contribution of the neutrophil activation pathway in the clustering of covid-19 patients, neutrophil-activation features that could act as possible reliable markers of disease evolution.


Eligibility criteria:
inclusion criteria: * covid 19 hospitalized patients (diagnosed by rt-pcr) exclusion criteria: * age below 18 years and above 80.
special investigation for renal cell carcinoma (rcc) of sunitinib malate (regulatory post marketing commitment plan)

Conditions: Carcinoma, Renal Cell

Summary: the objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the lpd (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

all the patients whom an investigator prescribes the first sunitinib malate(sutent) should be registered.

Eligibility criteria:
inclusion criteria: * patients need to be administered sunitinib malate (sutent) in order to be enrolled in the surveillance. exclusion criteria: * patients not administered sunitinib malate (sutent).
a study to assess the clinical efficacy and safety of daratumumab in participants with relapsed or refractory natural killer/t-cell lymphoma (nktcl), nasal type

Conditions: Lymphoma

Summary: the purpose of this study is to assess the clinical efficacy and safety of daratumumab in relapsed or refractory natural killer/t-cell lymphomas (nktcl).


Eligibility criteria:
inclusion criteria: * documented as histologically confirmed extranodal natural killer/t-cell lymphomas (nk/t)-cell lymphoma, nasal type according to the world health organization (who) classification and the pathology report will be verified by the sponsor * failed at least 1 line of chemotherapy and who, according to treating physician or investigator, is not candidate to receive other treatment modalities * at least 1 measurable site of disease * eastern cooperative oncology group (ecog) performance status score of 0, 1 or 2 and life expectancy greater than or equal to (\>=) 3 months exclusion criteria: * received daratumumab or other anticd38 therapies previously * previous allogenic stem cell transplant or autologous stem cell transplantation within 12 weeks before the first administration of the study drug * clinical symptoms of central nervous system involvement * known chronic obstructive pulmonary disease, known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification * clinically significant cardiac disease, including:myocardial infarction within 6 months before the first study agent administration, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, new york heart association class iii-iv); uncontrolled cardiac arrhythmia (common terminology criteria for adverse events \[ctcae\] \[most recent version\] grade 3 or higher) or clinically significant ecg abnormalities; screening 12-lead ecg showing a baseline qt interval as corrected qtc \>470 msec * seropositive for human immunodeficiency virus * seropositive for hepatitis b or hepatitis c * abnormal laboratory values according to protocol defined parameters at screening
pet/mr in radiotherapy for head and neck cancer pilot

Conditions: Head and Neck Cancer

Summary: this is a pilot non-intervention study that aims to introduce pet/mri, a state of the art new imaging technique, into the radiotherapy treatment pathway of patients with head and neck cancer. ultimately the investigators aim to establish appropriate scanning and image registration protocols, to allow progression to a randomized trial of adaptive radiotherapy dose escalation. the latter is thought to potentially improve outcomes in this group. ten patients with squamous cell carcinoma (scc) of the oropharynx, hypopharynx and larynx, planned for radical treatment with radiotherapy (+/-chemotherapy), will be recruited. study participants will have two pet/mri scans, with the radiotherapy immobilization devices in situ. the first will be done prior to the start of radiotherapy, the second half way through treatment. image quality will be assessed by comparing to standard diagnostic scans and different registration methods will be compared to establish the best way of incorporating pet/mr image data into the radiotherapy planning system. patient tolerability and workflow considerations will also be qualitatively assessed. furthermore, a planning study will be conducted to establish relevant treatment protocols for a subsequent dose escalation trial. pet/mri is an exciting new technology with a lot of potential in the context of adaptive radiotherapy dose escalation. within this pilot study the investigators aim to address the technical challenges of using it in this context prior to proceeding to a randomized trial.


Eligibility criteria:
inclusion criteria: * written, voluntary, informed consent * age ≥ 18 * eastern cooperative oncology group (ecog) performance status ≤ 2 * life expectancy \> 12 months * histologically proven scc of the oropharynx, hypopharynx and larynx * radical radiotherapy +/- chemotherapy indicated as the primary treatment modality * visible disease (\>1cm) at the primary site on any imaging modality performed within 4 weeks of starting radiotherapy treatment * staging pet/ct and diagnostic mri of the head and neck images need to be available for comparison. * adequate organ function and absence of other major concurrent illness, allowing the patient to tolerate scanning regime exclusion criteria: * inability to provide informed consent * impaired renal function (serum creatinine of \> 200) * severely impaired liver function * patients with allergies or contra-indications to the radio-tracer and/or contrast agent used in the study * severe claustrophobia or inability to tolerate pet or mri scans * general contra-indications to mri, as defined in mri safety departmental protocols * serious inter-current conditions or other non-malignant illnesses that are uncontrolled or whose control may be affected by participation in this study * any patient who has urinary or faecal incontinence * ecog performance status ≥ 3 * pregnant or breastfeeding women

Keywords: pet/mri
cardiac autonomic dysfunction as a sign of irreversible advanced heart failure

Conditions: Heart Failure

Summary: the main hypothesis is that autonomic dysfunction cannot improve among patients reaching end-stage heart failure. to evaluate this, patients admitted with acute decompensated heart failure in bispebjerg hospital, and history one or more admissions with the same condition within the prior year, will undergo repeated brief heart monitoring (10 min). baseline recordings (at admission) will be compared with equivalent measurements before discharge to explore whether heart rate variability increases. patients will be followed for six months after discharge from the hospital.

if the patient accepts to participate and signed the project informed consent, their clinical record will be followed until the last patient included has been followed for six months.

Eligibility criteria:
inclusion criteria: * 18-years age or older * admitted with acute decompensated heart failure for less than 48 h exclusion criteria: * pacemaker * not signed informed consent * other heart rhythm than sinus rhythm or atrial fibrillation

Keywords: heart failure decompensated
cellulite and magnetic resonance imaging

Conditions: Cellulitis

Summary: the purpose of this study is to compare the anatomy of subcutaneous structures in areas with and without cellulite on the buttocks of same subjects with a non invasive technique, magnetic resonance imaging.

a cross-sectional study was performed at a single center, in accordance with good clinical practice. thirty women aged 18 to 50 were included in this study. an experienced dermatologist evaluated all of the subjects in a standing position, with relaxed gluteus muscles, using the css classification. an area with cellulite and another without cellulite on the contralateral buttock were selected. the area with cellulite had an evident depressed lesion, whereas the area without cellulite had no depressed or raised lesions, the selected cellulite depression was marked with a positive symbol using a skin marking pen.

Eligibility criteria:
inclusion criteria: * written informed consent; * subjects agreeing to take part of all procedures of the study, after being fully informed on the objectives and nature of the investigations; * healthy female subjects over 18 years; * subjects presenting cellulite on the buttocks; * medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the product under investigation; * female subjects of childbearing age should present a negative urine pregnancy test and should be using an effective contraceptive method (3 months before the enrollment until the end of the study); * availability of the subject throughout the duration of the study (180 days); * subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol. exclusion criteria: * pregnant women or women intending to become pregnant during the study (next 3 months); * subjects participating in other clinical trials; * any condition that, in the opinion of the investigator, can compromise the evaluation of the study.
the development of de-novo stress urinary incontinence after stage ii-iii pelvic organ prolapse surgery

Conditions: Pelvic Organ Prolapse

Summary: surgery for stage ii-iii pelvic organ prolapse


Eligibility criteria:
inclusion criteria: * pelvic organ prolapse stage ii-iii * has no incontinence before surgery exclusion criteria: * had surgery before * pelvic organ prolapse stage i or iv

Keywords: sacrospinous ligament fixation stress urinary incontinence
monitoring of postprandial glycemic variability in healthy young infants

Conditions: Infant Conditions; Glucose Intolerance

Summary: to measure and quantify the postprandial glucose variations in response to a meal in the healthy 6-12 months old child and correlate this response with the composition of this meal.

14 full-term infants (boys and girls) aged six to twelve months and fed a diversified diet including infant formula, solid foods such as mixed meat and vegetable preparation or marketed preparations will be recruited. children will be recruited in the lausanne childrens hospital and only be included in the study whenin good general health. freestyle® libre pro interstitial glucose meter will be applied on the last day before discharge from the hospital after skin preparation with anesthetic cream (emla®) during hospitalization and measurements will be recorded during 2-5 days. it is not intended to measure capillary or venous blood glucose levels during this study. however, if blood is collected during hospitalization, blood glucose will be measured in parallel with the interstitial glucose measured with the device. the child will follow his usual diet without modifications. the amount of food consumed by the child as well as the length of the meals will be recorded by the parents. for meals made by the parents they will be asked to keep a sample not seen to analyze their carbohydrate content. the total carbohydrate content will be measured .

Eligibility criteria:
inclusion criteria: * term infants (boys and girls) * 6 to 12 months old * in good general health * nourished with diverse nutrition including infant formula, solid foods such as mixed meat and vegetable preparation or marketed preparations * infant child: if the child is breastfed partially, it can be included in the study. in this case, only samples of a food supplement will be collected for evaluation of the composition. * hospitalized at the lausanne children's hospital for non-severe reasons that do not affect or suspect to affect glucose metabolism * measures of feeding (time and compositions with samples) feasible for 3 consecutive days by the parents at home exclusion criteria: * child born premature * one or both parents with type 2 diabetes or gestational diabetes * child totally breastfed * chronic skin condition such as eczema, excessive dryness. * allergy known to adhesive plaster * infectious diseases affecting the skin (eg chickenpox, scarlet fever,) * disorders of cutaneous microcirculation * infants suffering from diseases affecting nutrition or digestion (diarrheal gastroenteritis) and children undergoing antibiotic treatment that may affect gastrointestinal absorption * magnetic resonance imaging (mri), computed tomography (ct), or diathermy therapy

Keywords: glucose variation infant nutrition interstitial glucose variation
impact of journal program on wellbeing of nicu parents

Conditions: Anxiety; Depression

Summary: the purpose of this study is to investigate the impact of a journaling program on rates of anxiety and depression in neonatal intensive care unit (nicu) parents.


Eligibility criteria:
inclusion criteria: * mother, father, and/or legal guardian of infant * \> 28 weeks gestation * at least 5 days anticipated admission in vanderbilt nicu exclusion criteria: * \< 28 weeks gestation * expected death or discharge within 5 days of admission * primary medical team feels that participation would be disruptive or detrimental to infant's care

Keywords: nicu parents journaling
bevacizumab (avastin) induced hypertension and correlation with tumor response, a chart review

Conditions: Cancer

Summary: 1.11 retrospectively evaluate for a correlation between tumor response and changes in systolic/diastolic/mean arterial blood pressures in patients treated with bevacizumab, with or without chemotherapy, with a wide variety of metastatic malignancies. 1.12 retrospectively evaluate for differences in tumor response between patients with and without pre-existing hypertension treated with bevacizumab plus or minus chemotherapy with a wide variety of metastatic malignancies. 1.21 determine if there were differences in bevacizumab induced hypertension rates between different tumor types. 1.22 evaluate for differences in bevacizumab induced hypertension rates between males and females. 1.23 examine if there were associations between a particular chemotherapeutic agent(s), that may have had an increased propensity of inducing hypertension when combined with bevacizumab.

this study is a retrospective chart review of all patients with metastatic cancer of any type treated with bevacizumab(with or without chemotherapy) at the university of new mexico cancer research \& treatment center within the last year to investigate if there is a correlation between bevacizumab induced hypertension and response rates. we will look at a wide variety of tumor types with a planned subset analysis to evaluate these correlations within individual tumor types. as mentioned above, grades of bevacizumab induced hypertension is typically reported according to the nci common terminology criteria for adverse events which will be included in our study but in addition we will also evaluate for incremental changes in systolic(sbp), diastolic (dbp), and mean arterial blood(map) pressures in mmhg. looking at these three variables will allow us to see if there is one component (sbp or dbp) or a combination of both (map) that may allow us to predict response. response will be measured by appropriate radiographic imagine (ct scan or x-rays) and/or appropriate tumor markers. in addition, as vegf appears to play a role in hypertension, we would like to look at pre-existing hypertension as a predictor for response and/or bevacizumab induced hypertension.

Eligibility criteria:
inclusion criteria: * patients treated with bevacizumab, with or without chemotherapy, with a wide variety of metastatic malignancies. * patients with and without pre-existing hypertension treated with bevacizumab plus or minus chemotherapy with a wide variety of metastatic malignancies. exclusion criteria: * not specified.
use of remote monitoring by smartphone in the care management of patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is the most common inflammatory rheumatism in adults, affecting nearly 0.4% of the general population. it is a real public health issue. international guidelines recommend strict control (remission or low disease activity) of the disease, to avoid joint destruction in order to reduce the functional impact of the disease in the long term and to improve the quality of life of the patients. this care is based on a close follow-up requiring regular visits with the specialist which represents an additional cost (transport, visits). in this context, tele-medicine is often proposed as a complementary approach in the management of these chronic patients. thus, the investigators propose to study the interest of a connected device by comparing a group of patients using this smartphone application, coupled with a hand dynamometer during the 6 months following initiation of a new dmard.


Eligibility criteria:
inclusion criteria: * • patients between 18 and 75 years old with rheumatoid arthritis according to 2010 acr (american college of rheumatology) / eular classification criteria * patients that need a treatment initiation for rheumatoid arthritis * patients with das 28 \> 3.2 (disease activity score ) * patients who agreed to participate in this study and provide the informed consent exclusion criteria: * • insufficient level of understanding to perform the measurement and self-report questionnaires * patients without an internet connection * difficulties in using a dynamometer due to a dominant-hand surgery done during the previous 12 months, carpal tunnel symptoms, or ulnar nerve compression, or cervicobrachial neuralgia, known presence of motor dysfunction of the upper extremity, or neurological disease * pregnancy
the etiology of new-onset status epilepticus

Conditions: Status Epilepticus

Summary: this study will help to identify the causes of new epilepsy and provide a basis for the development of a rational and standardized diagnosis and treatment plan to reduce the rate of disability and death.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of status epilepticus * sign the informed consent form exclusion criteria: * patients with previous epilepsy * missing information such as basic information and treatment history * long-term smoking, alcohol and drug abuse * pregnant and breastfeeding women
prior abdominal surgery: a potential risk factor for colonic diverticulosis or diverticulitis

Conditions: Diverticulosis, Colonic; Abdominal Adhesion; Diverticulitis

Summary: background \& aims: abnormal colonic pressure profiles have been associated with an increased risk of colonic diverticulosis. a surgical history is a known risk factor for abdominal adhesions, and these may lead to increased intraluminal colonic pressure. we assessed whether previous abdominal surgery is associated with colonic diverticulosis or diverticulitis. methods: the investigators analyzed data from a prospective study of patients undergoing colonoscopy for different indications from 2020 through 2021. patients completed a structured questionnaire concerning previous abdominal surgeries, dietary and lifestyle exposures including smoking and alcohol use, and co-morbidities.


Eligibility criteria:
inclusion criteria: * patients \> 18 years old who are going through colonoscopy in shamir medical center for any reason exclusion criteria: * inadequate preparation (boston bowel preparation quality scale \<6); * previous colonic resection based on history and colonoscopy; * previous colon cancer.