Kornimate/medical-research-clean huggingface dataset:
review of diagnostic yield of mri brain results in children under age 3 years

Conditions: Seizures; Development Delay; Anesthetic Neurotoxicity

Summary: the investigators aim to identify the frequency with which an elective brain mri yields and etiologic diagnosis to explain its indication. the protocol includes children undergoing elective brain mri with anesthesia prior to their third birthday.

on december 14, 2016 the fda issued a warning regarding elective anesthetics in children under three years of age. while a single, short exposure to general anesthesia may not have negative effects on behavior or learning, repeated or prolonged anesthetics may affect brain development. to that end, minimizing exposure to elective general anesthetics if procedures are not clearly indicated in young children appeals to reason.

Eligibility criteria:
inclusion criteria: * male or female aged 0-36 months who received anesthesia (volatile gas anesthesia) or iv sedation (propofol, dexmedetomidine, barbiturates, benzodiazepines, or other agents) for brain mri exclusion criteria: * mri without sedation, brain mri plus additional mri imaging, i.e. spine, heart, etc., sedated mri by a member of other department besides anesthesiology.

Keywords: pediatric mri indications anesthesia anesthetic neurotoxicity mri diagnostic yield
breast tumor oxygenation during exercise

Conditions: Breast Tumor

Summary: in the field of cancer treatment, it is generally accepted that the enhancement of oxygen delivery to tumors can augment the effect of anti-cancer therapies. in the case of chemotherapy, this enhancement might lead to a larger amount of a given dose of treatment reaching the tumor and having an effect.

while the benefits of exercise on overall health are widely documented, little is known about how exercise affects the progression or treatment of malignant neoplasms. tumors have a complex vascular network which is likely affected by the global changes in hemodynamics and perfusion that occur during moderate exercise. increased tumor oxygenation is clinically relevant as it may counteract the hypoxic tumor environment which is known to contribute to resistance to chemo- and radiation therapies, angiogenesis, invasiveness and metastasis, genomic instability, and resistance to cell death. the researcher can use noninvasive optical imaging technology called diffuse optical spectroscopy to safely and non-invasively quantify the dynamics of blood flow and metabolism in tumors and normal tissue of subjects undergoing supervised cycling exercise. the researcher can determine that exercise will measurably increase tumor oxygenation, and that this effect will be proportional to the intensity and/or duration of the exercise performed.

Eligibility criteria:
inclusion criteria: * tumor group, female, greater than 21 years of age but less than 70 years of age, current diagnosis of breast cancer stage 0 - iv or radiologically suspicious for breast cancer bi-rads score 4 or 5. * control group,female, greater than 21 years of age but less than 70 years of age, not currently diagnosed with breast cancer exclusion criteria: * under 21 years of age, pregnant or breastfeeding, contraindications for moderate exercise, history of heart, pulmonary, or musculoskeletal disease; physician instructions to restrict physical activity.
follow up after cryoablation of small renal masses.

Conditions: Carcinoma, Renal Cell

Summary: currently there is no consensus on post procedural follow up imaging following percutaneous cryoablation of renal tumors. interpretation of conventional contrast enhanced imaging (ct and mri) during follow up can be very challenging. the objective of this study is to evaluate the feasibility of early evaluation of the therapeutic effect by performing early follow up imaging after percutaneous mr-guided cryoablation of pt1a renal cell carcinoma using 111in-girentuximab-dota spect ct imaging.

with the growing number of small renal masses (srms) detected, a growing interest in minimal invasive treatment options for these lesions is seen as they come with several advantages compared to partial nephrectomy. current guidelines state that patients with a small renal mass unfit to undergo surgery, should be considered for minimal invasive ablative treatment. although percutaneous cryoablation is shown to be a safe and effective therapy for srm, there is no consensus on post procedural follow up imaging which should be aimed at evaluation of therapeutic effect of the intervention and the early detection of residual and recurrent disease. also interpretation of conventional contrast enhanced imaging (ct and mri) during follow up can be very challenging due to contrast enhancement not necessarily indicating residual or recurrent disease. the objective of this study is to evaluate the feasibility of early evaluation of the therapeutic effect by performing early follow up imaging after percutaneous mr-guided cryoablation of pt1a renal cell carcinoma 111in-girentuximab-dota spect ct imaging. therefore, before cryoablation, a targeting 111in-girentuximab-dota spect ct scan is performed. additional functional 111in-girentuximab-dota spect ct scan 4-6 weeks after percutaneous mr-guided cryoablation of small renal masses is performed. the latter will take place in case of proven targeting on the pre procedural 111in-girentuximab-dota spect ct scan. standard 1 and 3 months follow up mri after treatment is performed.

Eligibility criteria:
inclusion criteria: * \>50 years of age; * at least one untreated t1a tumour of one kidney (tumour ≤ 4 cm in greatest dimension); * signed irb-approved informed consent form. exclusion criteria: * pregnancy or breast feeding; * known hypersensitivity or haca against girentuximab. * administration of experimental medication for imaging purposes within three months before administration of indium-111-girentuximab for this study, except the administration of girentuximab labeled with a random isotope.

Keywords: cryosurgery carcinoma, renal cell diagnostic imaging diagnostic techniques, urological radionuclide imaging follow up
the coflex®community study: an observational study of coflex® interlaminar technology

Conditions: Spinal Stenosis

Summary: the purpose of the coflexcommunity observational study is to collect information on patients with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their outcomes and the cost-effectiveness of this procedure.


Eligibility criteria:
inclusion criteria: 1. patient is skeletally mature and has at least moderate impairment in function, experiences relief in flexion from his/her symptoms of leg/buttocks/groin pain, with or without back pain, and has undergone at least 6 months of non-operative treatment; 2. patient is treated surgically at 1 or 2 contiguous lumbar motion segments with the coflex interlaminar device from l1-l5 after decompression of stenosis at the affected level(s), where such use is not contraindicated as noted below. exclusion criteria: 1. prior fusion or decompressive laminectomy at any index lumbar level; 2. radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture); 3. severe facet hypertrophy that requires extensive bone removal which would cause instability; 4. grade ii or greater spondylolisthesis; 5. isthmic spondylolisthesis or spondylolysis (pars fracture); 6. degenerative lumbar scoliosis (cobb angle of greater than 25°); 7. osteoporosis; 8. back or leg pain of unknown etiology; 9. axial back pain only, with no leg, buttock, or groin pain; 10. morbid obesity defined as a body mass index \> 40; 11. active or chronic infection - systemic or local; 12. known allergy to titanium alloys or magnetic resonance imaging (mri) contrast agents; 13. cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction; 14. vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion; 15. patient is unwilling to complete his/her surveys.

Keywords: coflex interlaminar stabilization lumbar spinal stenosis neurogenic claudication decompression
safety of continuing anti-platelet agents during colonoscopic polypectomy: a prospective study

Conditions: Post-polypectomy Bleeding; Anti-platelet Therapy; Colonoscopy

Summary: at our va hospital, in general, it is the policy of our gi lab to not stop our patients anti-platelet therapy whenever they see us for a routine colonoscopy. we do this because we believe the risk of stopping these sort of medications outweigh the risks of a complication from a colonoscopy. therefore, we are enrolling patients who are either on clopidogrel or prasugrel or not on any anti-platelet/anti-coagulant therapy that come to our gi lab routine colonoscopies. we perform the procedure just like we normally would and then follow-up with the patient 7 and 30 days after their procedure.


Eligibility criteria:
inclusion criteria: * patients presenting to the gi lab for elective colonoscopy exclusion criteria: * patients on coumadin or other anti-coagulants * patients with inflammatory bowel disease
clinical study of ys110 in patients with malignant pleural mesothelioma

Conditions: Malignant Pleural Mesothelioma

Summary: the purpose of this study is to examine tolerability, safety, and pharmacokinetics of ys110 intravenous administration in patients with malignant pleural mesothelioma and to preliminarily examine the anti-tumor effect of ys110.


Eligibility criteria:
inclusion criteria: * patient with male or female aged ≥ 20 (and aged \< 75 in phase 1 part) * patients whose malignant pleural mesothelioma was histologically confirmed * patients who have advanced pleural mesothelioma that are refractory to existing anti-tumor drugs and who have no other standard therapies which should be prioritized * patients whose most recent major surgery (except exploratory thoracotomy or laparotomy) or drug or radiation therapy for malignant tumors, if any, was at least 4 weeks ago (at least 12 weeks ago for immunotherapy) at the subject enrollment * eastern cooperative oncology group (ecog) performance status (ps) 1 or less exclusion criteria: * patients whose toxicity findings in the previous treatment (antineoplastic agents) have not been yet restored * patients with tumor lesions in central nervous system confirmed in mri or ct
prevascar in african continental group scarring

Conditions: Scarring

Summary: there is considerable variation in scarring, within and between people, and between different ethnic groups. individuals with more pigmented skin are more prone to severe scarring than those traditionally termed white. prevascar is being developed by renovo for use as a potential treatment for reducing scarring. renovo's histological analysis of wounds and scars in human non drug studies demonstrates an increase in wound and scar width in subjects of african caribbean ancestry over a 12 month period. it is hypothesised that il-10 may be a potentially beneficial therapy for the reduction of scarring in non caucasians of african-caribbean ancestry. this renovo clinical trial will be carried out primarily to establish the effects of four doses of prevascar on 1cm incisional and excisional scars in subjects of african continental group ancestry, as compared to placebo, and to further investigate the safety and tolerance of intradermally injected prevascar in wounds.


Eligibility criteria:
inclusion criteria: * afro-caribbean male and female subjects between 18 and 85 years of age. exclusion criteria: * subjects who on direct questioning or examination have history or evidence of keloid scarring. * subjects who have evidence of any past or present clinically significant medical condition that would impair wound healing or trial assessments * subjects with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial. * subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit. * female subjects who are, or who become pregnant up to and including day 0 and/ or who are lactating. * in the opinion of the investigator, a subject who is not likely to complete the trial for whatever reason.
effects of an inpatient rehabilitation for patients with chronic obstructive pulmonary disease (copd) iii/iv

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determine if there is a change in the cat-score after an inpatient rehabilitation of three weeks and if it correlates with other common parameters.


Eligibility criteria:
inclusion criteria: * inpatient rehabilitation in schön klinik berchtesgadener land * stable copd(gold severity iii and iv with and without respiratory insufficiency) exclusion criteria: * severe exacerbation in the last four weeks * acute coronary syndrome * unability to cooperate

Keywords: copd cat rehabilitation chronic obstructive pulmonary disease gold iii/iv
study of nesiritide in diastolic heart failure.

Conditions: Diastolic Heart Failure

Summary: we hypothesize that nesiritide will have favorable effect in decreasing heart filling pressures and echocardiogram studies.

in previous studies, patients with systolic heart failure were given nesiritide and had reduced heart filling pressures. the fda has approved nesiritide for these patients. between one-third and one-half of patients with heart failure have diastolic heart failure. few of these patients have been studied while receiving nesiritide. a study is needed to test nesiritide on this specific type of heart failure. patients will undergo a heart catheterization and heart biopsy. patients will then be transferred to the intensive care unit for monitoring. an echocardiogram will be obtained, followed by an infusion of nesiritide for 24 hours. at the completion of the infusion, a repeat echocardiogram will be obtained.

Eligibility criteria:
inclusion criteria: elevated heart filling pressure. ejection fraction \>45%. blood pressure \>90. physician feels that the patient needs intravenous medication for heart failure. - exclusion criteria: patients receiving intravenous medication. patients with significant heart disease or who are unstable. patients with kidney failure or severe heart valve disease. -

Keywords: heart catheterization echocardiogram nesiritide
efficacy and safety of istent inject and inject w in the management of primary open-angle glaucoma

Conditions: POAG; MIGS

Summary: primary open-angle glaucoma (poag) is a chronic eye disease in which the only validated treatment is to lower intraocular pressure (iop). it is the 2nd leading cause of blindness worldwide. the istent® inject and inject w is an implantable device that is part of a new entity of so-called minimally invasive glaucoma surgery whose goal is to lower iop with minimal tissue disruption in order to avoid the complications of conventional glaucoma surgery. this surgery is used in conjunction with cataract surgery in france. the primary objective is to study the 1-year efficacy and safety of combined cataract and istent inject and inject w in the management of poag in an observational, retrospective, controlled study of a cohort of poag patients undergoing cataract surgery only.


Eligibility criteria:
inclusion criteria: * patient who have undergone combined phacoemulsification surgery and insertion of at least one istent® for chronic open-angle glaucoma in the ophthalmology department of the amiens university hospital or the saint-quentin university hospital (istent® group). * patient who have undergone simple phacoemulsification surgery in a patient with chronic open-angle glaucoma in the ophthalmology department of the amiens university hospital (control group). * patient with chronic open-angle glaucoma confirmed by gonioscopic examination, visual field, optical coherence tomography of the optic nerve, fundus examination, pachymetry and intraocular air pressure and/or applanation. exclusion criteria: * acute angle closure glaucoma, * chronic angle closure glaucoma, * uveitic glaucoma, * traumatic glaucoma, * exfoliative glaucoma. * previous filtering surgery on the operated eye. * intraoperative complication.

Keywords: poag istent inject migs
a clinical study aiming to validate the equipment: volusense pediatrics (vsp)

Conditions: Lung Disease

Summary: this is a cross-sectional observational study, aiming to validate the accuracy of tidal breathing measurements in infants made by volusense pediatrics, a lung function method based on electromagnetic inductance plethysmography, compared to an ultrasonic flowmeter. volusense pediatrics consists of a flexible vest placed around the torso of the baby, and changes in tidal volume and flow is measured. the study will enable a better understanding of the usefulness of this equipment. the equipment is made by volusense norway as, and is owned by haukeland university hospital.

all infants will be assessed at the pediatric department at haukeland university hospital, and all data obtained by the same two investigators (bentsen and olsen). the infants will be dressed in the appropriate-sized vest selected according to the length from the armpit to the hip of the child. care will be taken to ensure that the vest fits snugly around the torso and that the width of the copper wire zig-zag coveres the entire thorax and abdomen including the pubic region. the vest will be applied directly to the skin; neither body nor diaper will be worn underneath. the infants will then be fed before they will be placed supine in a cot and encouraged to sleep. no sedation will be used. once the infant has fallen asleep, data will be collected with vsp for 2-3 minutes before the exhalyzer d® neonatal facemask connected in series with the ultrasonic flow sensor will be placed gently, but firmly over the infant's mouth and nose, ensuring a good seal. once the facemask is in place, a marker will be inserted in the vsp recording. the exhalyzer d® measurement will be started about thirty seconds after the facemask has been put on, to allow adaptation to the facemask. simultaneous recording using both devices will then be done for about 1 minute before the mask will be removed. new markers will be inserted in the vsp recording as the exhalyzer d® measurement is started and stopped facilitating analysis of the same breathing cycles. data will be analysed and graphs will be created with spss version 22 (ibm spss statistics, new york, us) and medcalc version 13.1 (medcalc software, mariakerke, belgium). bland-altman plots will be used to visualize agreement between the two measurement techniques. for each pair of measurements, the pairwise mean of the breathing parameters will be plotted on the x-axis, and the pairwise difference expressed as a percentage of their mean value on the y-axis. the mean difference and the 95% limits of agreement and their confidence intervals will be represented by horizontal lines in the graphs.

Eligibility criteria:
inclusion criteria: * healthy term born or preterm born babies ≥ 2000 grams. exclusion criteria: * being in an unstable clinical condition. * weight \< 2000 grams.
observational study of blood treated with cytolin

Conditions: HIV Infections

Summary: primary objective: to determine the mechanism of cytolin's effect on hiv replication from blood drawn from hiv-positive and hiv-negative individuals after exposure to cytolin.

the initial phase of this in vitro study regarding the potential mechanisms of action of cytolin was completed in january 2011. given the data set to date, a decision has been made to extend the study. the extension will allow the company to further confirm and extend the initial findings regarding the potential mechanism of action of cytolin.

Eligibility criteria:
early hiv infection inclusion criteria: * hiv seropositive * viral load \< 100,000 copies/ml * cd4+ \> 350 cells/ul * ability and willingness to give written informed consent. control group inclusion criteria: * hiv seronegative subjects identified as hiv uninfected by a nonreactive hiv 1/2 elisa. * ability and willingness to give written informed consent. exclusion criteria: * presentation with an opportunistic infection or aids-defining illness. * receipt of investigational research agent within 30 days prior to study entry. * prior receipt of experimental hiv vaccine, sham vector or adjuvant. * receipt of immunosuppressive medications or immune modulators within the past six months. individuals taking corticosteroid nasal spray for allergic rhinitis, topical steroid or over the counter medications for acute, uncomplicated dermatitis for a period no longer than 14 days will not be excluded. * active drug or alcohol use, dependence or psychiatric illness that in the opinion of the study investigator would interfere with adherence to study protocol. * serious illness requiring hospitalization.

Keywords: hiv monoclonal antibody immune therapy pathogenesis cytotoxic t lymphocyte anti-cd4 anti-self viral replication acute infection
sofia-ltt study: a study of intermittent long term treatment with pegasys (peginterferon alfa-2a (40kd)) in patients with hbeag negative chronic hepatitis b (chb).

Conditions: Hepatitis B, Chronic

Summary: this 2 arm study will evaluate the efficacy and safety of intermittent treatment with pegasys in hbeag negative patients with chronic hepatitis b who have demonstrated virological and biochemical response after treatment with interferon alfa. after 48 weeks therapy with interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized into the pegasys or the observational group. those in the pegasys group will receive 4 therapeutic cycles of long term intermittent treatment with pegasys (135 micrograms sc weekly for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational arm will receive no specific antiviral treatment. the anticipated time on study treatment is 1-2 years, and the target sample size is 100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * liver disease consistent with chb; * evidence of chronic hbeag-negative chb prior to initial course of interferon alfa; * patients who have responded to previous 48 weeks treatment with interferon alfa. exclusion criteria: * coinfection with hcv, hdv or hiv; * decompensated liver disease, hepatocellular cancer, or evidence of a medical condition associated with chronic liver disease other than viral hepatitis; * any other systemic antiviral, antineoplastic or immunomodulatory treatment \<=6 months prior to first dose of randomized treatment.