Kornimate/medical-research-clean huggingface dataset:
hepasphere™ microspheres prospective registry

Conditions: Metastatic Colorectal Cancer

Summary: hepasphere™ microspheres loaded with irinotecan received ce mark for the indication of use in embolization of metastatic colorectal cancer (mcrc) to the liver in 2015. the purpose of this registry is to demonstrate the safety and efficacy of hepasphere microspheres loaded with irinotecan for the treatment of colorectal liver metastasis and add to the understanding of the use and value of this treatment in 'real life' usage conditions.

this prospective, post-market study was designed to evaluate the median overall survival (mos) of subjects with metastatic colorectal cancer (mcrc) to the liver treated with hepasphere microspheres loaded with the chemotherapeutic agent irinotecan. this treatment process is referred to as transarterial chemoembolization (tace). subjects with confirmed colorectal cancer liver metastases that were ineligible for surgical hepatic tumor resection and that had not undergone prior tace for this indication were considered for study participation. patients that met eligibility criteria, wanted to participate in the study, and signed the informed consent form (icf) made up the study subject population. all study subjects were in one cohort and were not blinded to treatment. per protocol, all subjects completed a baseline visit to collect medical history information, lab assessments, and have a baseline mri. following this baseline visit subjects were to have two tace cycles (i.e., tace cycle 1, tace cycle 2), with tace cycle 2 occurring within 2-4 weeks following tace cycle 1. a tace cycle is defined as one tace procedure for subjects with unilobar disease or two tace procedures for subjects with bilobar disease (i.e., one for each lobe of the liver). following completion of tace cycle 1 and tace cycle 2, additional tace cycles could be performed at the investigator's discretion for residual or new disease. when subjects had completed two tace cycles and were no longer indicated for further tace cycles (at the investigator's discretion), they entered follow-up. the study ended and analysis began when all enrolled subjects had (1) completed two-year (24 months) follow-up from the date of tace cycle 1, (2) been deemed lost to follow up, or (3) died, whichever occurred first.

Eligibility criteria:
inclusion criteria: * histologically or radiologically confirmed colorectal cancer metastases to the liver * patient is able to have either ct or mri imaging * hepatic tumor burden ≥50% of total tumor burden * hepatic tumor burden ≤50% of total liver volume * not suitable for treatment by resection or percutaneous ablation at time of tace treatment * life expectancy ≥ 3 months * who performance status ≤ 2 exclusion criteria: * previous treatment with any form of hepatic transarterial embolization * total bilirubin ≥ 3.0 mg/dl * any contraindication for irinotecan administration * partial or complete thrombosis of the main portal vein * cardiovascular or respiratory failure * any other condition deemed exclusionary by the investigator

Keywords: colorectal cancer liver metastases transarterial chemoembolization
development of a multifunctional rehabilitation device for persons with parkinson's disease

Conditions: Parkinson Disease

Summary: the researchers have developed a multifunctional rehabilitation device that will be tested in this feasibility trial across three sub-studies: (i) dual session in-lab; (ii) multi-session in-lab and (iii) in the participant's home. a long-term outcome is to test possible benefits of this device (if accepted by the user parkinson population) on motor and cognitive functions in a clinical trial in a future study. participants who receive a device during the in-home trial will have the option to keep the device for up to two years in an open label extension. during this extension, participants can optionally provide feedback on their user experience such as discomfort.

the primary purpose of this feasibility study is to assess human user acceptance of the device during 2 lab sessions (aim 1) from which the persons will proceed to 5 lab sessions (aim 2) and during in-home use (aim 3). the in-home aim will also include control persons to allow exploratory collection of clinical data that may provide preliminary outcome data to properly power a future phase 2 randomized clinical trial. the open label extension will provide information on the efficacy of using the device long-term. while 45 persons may appear to be a larger than normal number for a device feasibility trial, because parkinsons patients have a wide range of clinical symptoms, in order to acquire any meaningful data, some "spread" must be achieved. for example, 3 individuals in several different symptomatic categories. further, there is some chance of attrition. lastly, to be clear, details of device design may continue to be modified throughout the study.

Eligibility criteria:
inclusion criteria: * parkinson's disease * willing and able to comply with study requirements exclusion criteria: * parkinson's disease dementia * parkinsonism plus syndromes * inability to stand, step, or walk without an assistive device * history of symptoms in stance that preclude safe and comfortable participation, such as severe dizziness and lightheadedness, severe orthostasis, severe symptomatic leg or back musculoskeletal pain, painful neuropathy, significant ankle edema, or medication side effects * history of symptomatic cardiovascular or pulmonary disease interfering with stance * history of active rheumatic arthritis * history of uncontrolled chronic pain syndrome * any other history of medical or psychiatric comorbidity precluding safe participation in the project * venous stasis or severe varicosities

Keywords: feasibility device testing
neurofeedback for post-traumatic stress disorder

Conditions: Post-traumatic Stress Disorder

Summary: a two-arm randomized pilot of standard neurofeedback and a waiting list for patients with treatment resistent ptsd.

this study will be a randomized-controlled pilot and in a later study virtual reality based neurofeedback will be tested. in this study 30 subjects will be randomised into one of two arms of the study. treatment as usual (tau) entails both psychotherapy, medication and other interventions. 1. tau + neurofeedback using a pc-screen (experimental group) 2. tau as a waiting list (control group) - the participants in the control group will be offered to choose one of the two experimental treatments at the end of the trial. the 30 participants will be randomized to one arm of the study (15 participants per group). the subjects will be recruited from psychiatric outpatient care at sahlgrenska university hospital, crisis and trauma center gothenburg and psychiatric care center in tranås, jönköping. participants in the experimental group will have 24 sessions in total, (twice a week. 12 week period) with a trained neurofeedback specialist or trained neurofeedback physician. before session 1 and after session 24, a clinician will fill in the clinical scales and questionnaires.

Eligibility criteria:
inclusion criteria: * caps cutoff \>44 * stable psychopharmacological treatment (stable dose, no planned changes during the course of the trial) * audit cut off \<16 * dudit cut off \<8 * already undergone at least one treatment with psychotherapy and/or pharmacological treatment for a minimum of 6 months. * 18 years or older exclusion criteria: * diagnosis of traumatic brain injury (tbi) affecting capability to give informed consent * ongoing traumatic exposure (such as domestic violence) * balance problems * active suicide risk or life-threatening self-harm * a diagnosis of schizophrenia or psychotic disorder * ongoing compulsory care * if the patient changes dose or medication strategy during the trial. * if the neurofeedback treatment is identified as a primary reason for worsening of participant's well being.

Keywords: neurofeedback electroencephalogram (eeg)
study to evaluate the safety and efficacy of jte-051 in subjects with moderate to severe plaque psoriasis

Conditions: Plaque Psoriasis; Skin Diseases

Summary: study to evaluate the efficacy, safety, tolerability and pharmacokinetics of jte-051 administered for 12 weeks in subjects with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * diagnosed with moderate to severe plaque psoriasis at least 6 months prior to visit 1 * plaque-type psoriasis covering ≥10% of body surface area (bsa) at visit 1 and visit 2; * psoriasis area and severity index (pasi) score ≥12 at visit 1 and visit 2; * static physician's global assessment (spga) score ≥3 at visit 1 and visit 2; * body mass index (bmi) ≤40 at visit 1. exclusion criteria: * medical history of treatment failure to any systemic agents for plaque psoriasis; * presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions at (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at visit 1; * presence or history of any itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin (e.g., drug induced pruritus, significant other systemic diseases with itch) within 12 months prior to visit 1; * history of a clinically-significant infection (e.g., that required oral antimicrobial therapy) within 8 weeks prior to visit 2; * history of infections requiring hospitalization or parenteral antibiotic, antiviral, antifungal or antiparasitic therapy within 6 months prior to visit 2 and no history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis);

Keywords: jte-051 psoriasis
inflammation and cerebral oxygenation in preterm newborns following fetal red blood cell transfusion compared to adult red blood cell transfusion

Conditions: Preterm Newborns

Summary: among diseases associated with premature birth, retinopathy of prematurity (rop) is one of the most important causes of childhood blindness. rop develops in the immature retina as a consequence of prolonged exposure to hyperoxia. a body of evidence suggests a connection between rop and the number of red blood cell (rbc) transfusions. moreover, in newborns receiving repeated transfusions, fetal hemoglobin (hbf) progressively declines. our nicu participate to the born (umbilical blood to transfuse preterm neonates) trial, a double-blind, multi-center, randomized controlled trial with the aim of evaluating if preterm newborns randomized to receive cord blood (cb)-transfusions have a lower incidence of rop, compared to newborns transfused with adult rbc cells. in the context of born trial, with this ancillary incontra study, the investigators aim to explore the inflammatory burden, potentially impacting on development of the preterm newborn comorbidities, following cb-rbc transfusions, compared to adult rbc transfusions. to estimate the change in pro-inflammatory cytokine (il-1β, il-8, tnf-α) and mcp-1, mif, s-icam levels levels circulating in preterm newborns before and after transfusion, moreover, we want to monitor cerebral oxygenation and oxygenation delivery to the brain during and after the transfusion of the two different rbc products. moreover, the investigators aim to monitor cerebral oxygenation and oxygenation delivery to the brain during and after the transfusion of the two different rbc products.


Eligibility criteria:
inclusion criteria: * gestational age (ga) at birth \< 28 weeks * signed informed consent of parents. exclusion criteria: * maternal-fetal immunization, hydrops fetalis * major congenital malformations associated or not with genetic syndromes * previous transfusions * hemorrhage at birth requiring transfusion (within 12 hours from birth) * congenital viral infections * outborn infants who received rbc transfusions before admission to the neonatal intensive care units participating to the study * health care team deeming it inappropriate to approach the infant's family for informed consent * severe iga deficiency * any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.

Keywords: preterm newborn packed rbc inflammation markers
this study will compare the effect of starch containing to non-starch containing intravenous fluid on blood loss during coronary artery bypass graft surgery

Conditions: Bloodloss

Summary: the overall aim of this study is to determine if there is a bleeding risk associated with the use of starch-containing fluids during cardiac surgery. the specific purpose of this study will be to examine, in a prospective randomized double-blind placebo-controlled fashion, the effects of colloid (hes 130/0.4) vs. crystalloid (ringer's lactate) on bleeding in patients undergoing cardiopulmonary bypass for cardiac surgery. the primary end point of this trial will be chest tube output at 24 hours. in addition, a range of secondary end points focusing on transfusion parameters, as well as other important end-organ outcomes, will be determined.


Eligibility criteria:
inclusion criteria: * male or female, 18 - 85 years of age, inclusive * willing and able to provide informed consent * elective primary coronary artery bypass graft (cabg) requiring cardiopulmonary bypass, isolated valve repair, or isolated valve replacement surgery, or combined single valve plus cabg. exclusion criteria: * emergency surgery (\< 12 hours from determination of need for surgery) * significant other concomitant surgery (including, but not limited to, multiple valve replacement, cea, planned circulatory arrest, etc.) * lvef \< 25 % * preoperative use of inotropes * preoperative intraoartic balloon pump (iabp) * renal dysfunction: serum creatinine \>140 μmol/l * hepatic dysfunction: ast or alt \> 2.5 x upper limit normal; or otherwise known hepatic disease * preoperative hb \< 100 g/l * platelet count \<100,000/mm3, * inr \> 1.3; ptt \> 38 sec (with the exception of patients receiving preoperative heparin) * history or family history of bleeding disorder * patients currently receiving: eptifibatide (integrilin) within 12 hours danaparoid, enoxaparin sodium (lovenox) or other low molecular weight heparin within 24 hours ,clopidogrel (plavix) within 7 days ,warfarin (coumadin) within 5 days, ticlopidine (ticlid) within 7 day * dermatological syndromes with pruritus * planned neuraxial anesthetic technique * receipt of an investigational drug or device, within 30 days prior to study treatment * pregnant or breast feeding females

Keywords: colloid cabg cardiopulmonary bypass bleeding
effect of dietary habits on metabolic health

Conditions: Overweight; Obesity; Prediabetes; Meals

Summary: the goal of this application is to understand the connection between people's eating habits and the risk for developing diabetes, obesity, and cardiovascular disease.

more than a third of u.s. adults are obese (bmi greater than 30), 8-12% of adults suffer from type 2 diabetes, and up to 30% of adults have pre-diabetes. recent research studies have suggested that it is not just what we eat, but also when we eat that may put us at risk for obesity and type 2 diabetes. skipping breakfast and eating late at night have been associated with an increased risk for obesity and type 2 diabetes (t2d), substantiated by recent animal and human experimental studies showing that altered meal timing itself, without changes in caloric intake, can influence weight regulation and impaired glucose tolerance. this research will determine in prediabetic and non-diabetic participants whether delaying meal times worsens glucose tolerance, leads to physiological changes favoring a positive energy balance, and increases caloric intake. this research will provide mechanistic insights into the metabolic consequences of changing meal timing and may help in evidence-based approaches to improve dietary interventions in the fight against obesity and t2d.

Eligibility criteria:
inclusion criteria: * bmi between 25 and 37.9 kgm-2 * adults with regular sleep-wake timing * non-smokers * completion of medical and psychological screening tests * able to spend 14 consecutive days in the sleep laboratory exclusion criteria: * bmi \ 37.9 kgm-2 * history of neurological or psychiatric disorder * history of sleep disorder or regular use of sleep-promoting medication * current prescription, herbal, or over-the-counter medication use * traveling across 2 or more time zones within past 3 months * donating blood within past 8 weeks * worked night or rotating shift work within past 3 years * hearing impairment * drug or alcohol dependency

Keywords: dietary habits circadian metabolism feeding behavior
a phase iiib study of intermittent versus continuous hormone deprivation treatment with eligard

Conditions: Prostate Cancer

Summary: phase iiib, open-label, randomized, controlled multi-centre study. induction therapy phase for 6 months where all subjects receive 2 eligard depot injections. those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous eligard treatment for 36 months. following this treatment period, subjects will enter a long-term follow-up period for 48 months.


Eligibility criteria:
inclusion criteria: at study entry (visit 1): * written informed consent * male subjects aged \>=18 and \<80 years old * locally advanced (stage t3 or t4) prostate cancer or relapsing prostate cancer following radical prostatectomy or,relapsing prostate cancer following radiotherapy * gleason score of \>=6 * ecog performance status of 0-2. * life expectancy at least 5 years at randomization (visit 4): * two successive decreasing serum psa levels \<=1 ng/ml exclusion criteria: at study entry (visit 1): * any suspected second primary tumors * evidence of metastatic disease * other malignancy within the last 5 years except * acute spinal cord compression, uni- or bilateral ureteric obstruction * any concurrent biological response modifier therapy * concurrent chemotherapy * less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy * less than 6 months since prior 5-alpha reductase inhibitor treatment * other concurrent hormonal therapy * any concurrent radiotherapy * testosterone at screening \<= 1.7 mm or 50 ng/dl * clinically significant elevation of serum creatinine or liver enzymes * hypersensitivity to gnrh or other gnrh analogues or leuprorelin acetate * hypersensitivity to casodexâ 50 mg.

Keywords: prostate cancer prostate specific antigen
hn-quest: a study of head and neck imaging biomarkers

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: this is a multi arm, single center, investigator initiated study to investigate online adaptive radiotherapy and biomarker development in patients with newly diagnosed hnscc (head and neck squamous cell carcinoma) receiving curative therapy. the study will consist of two prospective arms. in arm 1 up to 100 hnscc patients receiving (ct)rt (computed tomography-based radiation therapy) will receive up to weekly non-contrast mri (magnetic resonance imaging) scans during treatment. arm 2 consists of two cohorts. in cohort a up to 20 healthy volunteers will undergo non-contrast mri at two time points. in cohort b up to 53 patients planned to receive curative (chemo) radiotherapy for hnscc will undergo two baseline mri scans, one mri in week 2 and week 4, and final mri scan 6-8 weeks after completion of treatment.

the purpose of this study is to develop and investigate novel and established mr (magnetic resonance) imaging sequences as predictive and prognostic radiotherapy biomarkers. radiotherapy is a fundamental treatment modality for head and neck squamous cell carcinoma (hnscc) with a majority of patients receiving radiation as part of their care pathway. although treatment is effective, there remains a risk of failure particularly in those presenting with locally advanced disease. in addition, significant proportion of patients receiving radiotherapy will suffer long-term side effects related to their treatment. the addition of concurrent chemotherapy improves the efficacy of radiotherapy, but at the cost of increased treatment related toxicity. the treatment related toxicity and risk of treatment failure means there is a compelling clinical need to personalize therapy based on a patient's early response to radiotherapy.

Eligibility criteria:
inclusion criteria for cancer patients: * age \>/= 18 years * histologically proven head and neck squamous cell carcinoma * primary or nodal disease \> 3cm for biomarker imaging * eastern cooperative oncology group (ecog) performance status 0-2 * planned for curative surgery or (chemo)radiotherapy * willingness to undergo repeat mri * able to receive and understand verbal and written information regarding study and able to give written informed consent * adequate renal function: calculated creatinine clearance \>/= 30ml/min * be able to lie comfortably on back for 1 hour exclusion criteria for cancer patients: * as judged by investigator evidence of systemic disease that makes unsuitable for study * contra-indication for serial mri scans * previous solid tumor treated within last 5 years * pregnancy * history of significant obstructive airway disease * history of gadolinium contrast allergy inclusion criteria for healthy volunteers * age \>/= 18 years * able to receive and understand verbal and written information regarding study and able to give written informed consent * willingness to undergo repeat mri exclusion criteria for healthy volunteers * unwillingness to sign informed consent * contra-indication for mri * underlying significant respiratory disease
clinical performance of two daily disposable contact lenses - study 1

Conditions: Refractive Errors

Summary: the purpose of this study is to evaluate end of day (eod) visual acuity (va) at distance when wearing precision1™ contact lenses compared to acuvue® moist contact lenses.

the expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (screening, dispense, exit).

Eligibility criteria:
inclusion criteria: * able to understand and sign an approved informed consent form * successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day * best corrected va of logmar 0.10 or better in each eye * willing to discontinue artificial tears and rewetting drops during the study * able to wear contact lenses within the protocol-specified sphere power range * other protocol-specified inclusion criteria may apply. exclusion criteria: * any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the investigator * any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator * history of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea * wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment * previous 3 years or current wearers of acuvue moist or dailies total1® contact lenses * other protocol-specified exclusion criteria may apply.

Keywords: contact lens vision correction visual acuity daily disposable contact lens