Kornimate/medical-research-clean huggingface dataset:
evaluation of prednisolone in a modified conjunctival allergen challenge model

Conditions: Chronic Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the effectiveness of the modified conjunctival allergen challenge (cac) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication, prednisolone, assessed by the following measures: chronic allergic inflammation assessed using confocal microscopy ocular itching conjunctival redness

prospective, single center, randomized, double-masked, placebo controlled study. subjects will be randomized to one of the following treatment arms to dose four times per day (qid) for 4 days between visits 3 and 4. prednisolone phosphate tears naturale ii ophthalmic solution (placebo) duration: approximately 2 weeks controls: artificial tears (tears naturale® ii)

Eligibility criteria:
inclusion criteria: * at least 18 years of age \& either sex, any race * willing and able to follow all instructions * positive history of ocular allergies * reproducible positive ocular allergic reaction induced by conjunctival allergen challenge exclusion criteria: * have planned surgery during trial period * female currently pregnant, planning a pregnancy or lactating * use of disallowed medications * have ocular infections, or ocular conditions that could affect study parameters * have moderate to severe dry eye * have used an investigational drug or device within 30 days of start of study * female that is currently pregnant, planning a pregnancy or lactating
taste assessment study of 2 atazanavir powder formulations in healthy subjects

Conditions: HIV

Summary: the purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral use (pou) formulations to the current atazanavir pou in healthy participants and to select 1 atazanavir pou that has the sweetness most similar to the current atazanavir pou.

this study is a taste assessment study designed to select a new atazanavir powder for oral use (pou) formulation that is similar in sweetness to the current pou formulation. participants were to taste and then spit out the pou formulations, without swallowing them. study classification: other. this is a taste study

Eligibility criteria:
key inclusion criteria: * healthy men and women, ages 18 to 49, inclusive * nonsmokers * women not pregnant or breastfeeding * participants who could match solutions of the same sweetness and provide consistent sweetness scores during the taste screening key exclusion criteria: * any significant acute or chronic medical illness * any acute or chronic condition that may have altered taste sensory perception * any major surgery or trauma within 4 weeks of day 1 * blood transfusion within 4 weeks of study participation * recent (within 6 months of day 1) drug or alcohol abuse as defined in the diagnostic and statistical manual, 4th edition, diagnostic criteria for drug and alcohol abuse * positive urine drug screen * positive urine screen for cotinine * positive hepatitis c antibody, hepatitis b surface antigen, or human immunodeficiency virus antibodies * clinically significant elevations in results of liver function tests above normal range
monitoring of systemic or organ perfusion for preterm infants

Conditions: Infant, Premature; Hypoperfusion in Newborn; Necrotizing Enterocolitis of Newborn; Sepsis Newborn; Oliguria; Hypotension

Summary: to investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants. it includes near-infrared spectroscopy (nirs), pulse oximetry with perfusion index (pi) and pleth variability index (pvi) and functional echocardiography.

hemodynamic observational comparisons will be performed in 6 episodes below on each patient. 1. first 24 hours after birth 2. during red blood cell (rbc) transfusion: from 4 hours before to 4 hours after the transfusion 3. suspicion of necrotizing enterocolitis: from the suspicion point for 48 hours 4. suspicion of sepsis: from the suspicion point for 48 hours 5. oligouria (\< 1 ml/kg/hour of urine): for 48 hours 6. hypotension (mean blood pressure \< 30 mmhg): for 48 hours

Eligibility criteria:
inclusion criteria: * premature infants with 32 weeks or less of gestational age or 1,500 g or less of birth weight exclusion criteria: * infants without the consent of their guardians
proton therapy for early stage breast cancer

Conditions: Early-Stage Breast Cancer

Summary: the purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.

radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. when standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. this is called partial breast radiotherapy. this study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.

Eligibility criteria:
inclusion criteria: * invasive ductal, medullary, papillary, colloid or tubular histologies * stages t1 or t2 (tumors \< or = 3 cm) from lumpectomy specimen. * no more then 3 positive nodes on axillary dissection or negative sentinel node. * negative surgical margins (\>2mm) exclusion criteria: * invasive lobular histology * previous chemotherapy for breast cancer * extensive intraductal component * collagen vascular disease * prior malignancy unless disease-free for 5 years * patients who are pregnant or lactating

Keywords: proton radiation breast cancer
spinal stimulation to treat low back pain

Conditions: Low Back Pain; Lumbar Back Pain; Lumbago

Summary: spinal cord stimulation (scs) has been used for almost 30 years to treat many intractable back pain conditions. it has demonstrated efficacy in the co-called failed back surgery syndrome (fbss) and a recent randomized controlled trial demonstrated significant superiority of scs over conventional medical therapy to treat patients with fbss. another trial has demonstrated superiority of scs over repeat surgery in the same patient population. however, the ability to reliably capture the low back with paresthesia coverage has remained challenging and elusive despite numerous strategies designed to overcome this limitation. strategies that have been introduced but so far with limited success include transverse multiple lead stimulation, high frequency stimulation, peripheral field stimulation, and dorsal root ganglion (drg) stimulation. to date, none of these strategies have been able to reliably overcome the long-term problems of paresthesia capture and pain relief of the low back. this proposal describes a new spinal stimulation technique designed to improve the likelihood of low back stimulation by targeting the nerve supply to the two most commonly affected pain producing structures in the back, the facet joints and the intervertebral disks. the technique has proven to be feasible in a cadaver model with ease of lead placement at the desired targets


Eligibility criteria:
inclusion: * patients with one sided low back pain * failed standard conservative care including medications, physical therapy, and/or injections * pain greater than 6 months exclusion: * pregnancy * previous spine surgery * pain radiating beyond/below the knee
mrgfus in the treatment of osteoarthritic knee pain

Conditions: Osteo Arthritis Knee; Osteoarthritis; Osteoarthritis, Knee

Summary: a double-blind placebo-controlled randomized clinical trial to evaluate the efficacy of magnetic resonance-guided focused ultrasound surgery (mrgfus) in the treatment of pain caused by knee osteoarthritis (oa)

osteoarthritis (oa) is a common, disabling, and costly disease, and the knee is one of the most affected joints. the predominant symptom is pain. effective and lasting non-invasive treatment approaches are missing. mr-guided focused ultrasound surgery (mrgfus) is a new minimally invasive technique which may represent a valid solution providing several advantages. the primary aim of this work will be to assess the efficacy of mrgfus in the treatment of pain caused by knee oa in 80 patients candidate for arthroplasty in a prospective, randomized, double-blinded, placebo-controlled clinical trial. different parameters related to pain, quality of life, function, and imaging will be collected and analyzed in a 12-month follow-up. the secondary aims will be focused on a) the evaluation of the effects on the joint organ and changes of biological features in response to mrgfus, and b) the impact of selective ablation of nociceptors on oa pain, based on the analysis of resected joint tissues.

Eligibility criteria:
inclusion criteria: * male and female aged 50-80 years * activity-related joint pain * patients who have not responded to previous treatments and patients candidate for surgery * kellgren-lawrence score 2-4 on x-rays * patients able to give their informed consent exclusion criteria: * prior surgery in the past 12 months or previous local treatment in the past 3 months * changes in medications used during the previous 2 months * corticosteroid use for more than 3 months within the preceding year * rheumatologic and neurological disorders * fibromyalgia * trauma, fracture or osteomyelitis of the investigated joints within the preceding year * pregnancy * patients with large scars potentially included in the ultrasound beam path * general contraindications to mri and/or to anaesthesiological procedures * presence of internal hardware or device potentially affecting mr thermometry * patients involved in other clinical studies

Keywords: osteoarthritis knee mrgfus exablate pain high-intensity focused ultrasound ablation
usefulness of the variation of the clif-c aclf score in patients with acute on chronic liver failure

Conditions: Acute-On-Chronic Liver Failure

Summary: patients with acute on chronic liver failure (aclf) have high short-term mortality. the use of a severity score could define the patient's prognosis and would help determine in whom the treatment is effective or futile.

acute on chronic liver failure (aclf) is a syndrome characterized by the presence of an acute decompensation of cirrhosis, associated with failure of at least one other organ or extra hepatic system. it is characterized by high mortality in the short term and its prevalence varies between countries and regions. it is an extraordinarily dynamic entity in which more than 50% of patients with less severe forms improve, while in those with 3 or more organ failures, the transplant rate is low and mortality is 90%. it is important to highlight that those patients with aclf who manage to be transplanted have the same survival as cirrhotic patients without aclf. there is no specific treatment, only life support and early determination of the precipitating factor and its eventual resolution. having tools that define the short-term prognosis of these patients, especially the variation of the score (clif-c aclf) during the first week, would have an important clinical relevance, because it can help define the patients who benefit from the supportive treatment and in whom the therapeutic effort is futile. the biomarker neutrophil gelatinase-associated lipocalin (ngal) is increased in plasma and urine in patients with aclf and could help improve the prognostic ability of the clif-c aclf score.

Eligibility criteria:
inclusion criteria: * acute on chronic liver failure exclusion criteria: * acute liver failure, terminal disease, pregnancy, previous liver transplant

Keywords: acute-on-chronic liver failure liver failure
role of the msct in evaluation of the congenital cardiovascular anomalies

Conditions: MSCT in Congenital Cardiovascular Disease

Summary: congenital heart diseases (chds) are considered as the most common congenital birth defects, comprising 1% of all live births . echocardiography remains a first-line non-invasive imaging tool for establishing the diagnosis and follow-up in most patients .this method is operator dependent and limited by an acoustic window . traditional angiography is typically utilized as the gold standard modality for diagnosing chd, but it is an invasive method and need general anseathsia with dose of radiation exposure .after recent developments in ct and mr technologies, cardiac catheterization is no longer necessary for diagnosis .

the interpretation of cardiovascular structures on cardiac ct scan studies is similar to that for echocardiography, however, it is not limited by the acoustic window or operator dependent like ultrasonography. in addition to the anatomic information, a cardiac ct scan provides hemodynamic information, including extracardiac and intra-cardiac shunts. it also enables the systematic evaluation of other thoracic structures like cardiovascular structures, the airways and the lungs by using maximum and minimum intensity projections to delineate the vascular and airway structures, respectively. extra-cardiac great vessels can be evaluated along their length; thus augmenting the role of cardiac ct scans in children with congenital heart diseases .inspite of the poorer temporal resolution of cardiac cta compared to echocardiography, yet the combination of rapid acquisition time, increased anatomic coverage, high spatial resolution, multiplanar reformation and 3d capability combined with a flexible ecg synchronization have improved the image quality of cardiac ct scans and minimizing the patient risks. multidetector computed tomography has greatly advanced the noninvasive diagnosis of these anomalies in pediatric patient, thus makes mdct an ideal non- invasive method for evaluating pediatric patients .

Eligibility criteria:
inclusion criteria: * patients suffering from congenital cardiovascular diseases diagnosed either clinically or by echocardiographic examination. exclusion criteria: * orthopenic patient patients with hypersensitivity to contrast , medium and poor renal function .
role of steroids and 10% hypertonic sodium chloride in adhesiolysis in post lumbar surgery syndrome patients

Conditions: Low Back Pain

Summary: to evaluate the effectiveness of steroids and/or 10% hypertonic sodium chloride in percutaneous adhesiolysis in managing chronic low back and/or lower extremity pain in patients with post lumbar surgery syndrome. to evaluate and compare the adverse event profile in all groups.

recruitment is indicated in patients with chronic low back pain and lower extremity pain secondary to post lumbar laminectomy syndrome, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections. this is a single-center, prospective, randomized, double-blind, equivalence, controlled trial performed in an interventional pain management referral center in the united states. the study involves 240 patients studied in 4 groups with 60 patients in each group. randomization includes sequence generation, allocation concealment, implementation, and blinding. data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. statistical methodology includes chi-squared statistics, fisher's exact test, t-test, and paired t-test with significance evaluated at p value \< 0.05.

Eligibility criteria:
inclusion criteria: inclusion criteria: * history of lumbar surgery of at least 6 months duration in the past * patients over the age of 18 years * patients with a history of chronic function-limiting low back pain with or without lower extremity pain of at least 6 months duration (post-surgery) * patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements. exclusion criteria: * facet joints, uncontrollable as sole pain generators * unstable or heavy opioid use (400 mg of morphine equivalents daily) * uncontrolled psychiatric disorders * uncontrolled medical illness * any conditions that could interfere with the interpretation of the outcome assessments * pregnant or lactating women * patients with a history or potential for adverse reaction(s) to local anesthetic, steroids, or hypertonic sodium chloride solution.

Keywords: chronic low back pain post lumbar laminectomy syndrome lower extremity pain local anesthetic steroid percutaneous lumbar adhesiolysis
long-term mortality in diabetics undergoing major surgery

Conditions: Diabetes Mellitus; Coronary Heart Disease; Major Non-cardiac Surgery

Summary: patients with cad and diabetes mellitus have a better prognosis than patients with cad and no diabetes mellitus. in acute coronary syndrome patients with an insulin therapy had a better survival than patients with oral antidiabetics. but there is not known wether perioperative therapy with insulin or oral antidiabetics is associated with higher risk for higher perioperative cardiac morbidity and mortality and worse long-term survival.

diabetes mellitus is an important risk factor for arteriosclerosis in general and for coronary artery disease. patients with cad have a worse prognosis if they have diabetes mellitus. but it is not known whether the treatment of dm has an influence on mortality or morbidity. in face of the high number of patients with dm and the therapeutic consequences this prospective study wants to compare short-time and long-time morbidity in patients with dm undergoing major non-vascular surgery. inclusion criteria are medically treated dm (insulin or oral antidiabetics) and major non cardiac surgery. the "normal" perioperative treatment of the study is not changed by the study itself.

Eligibility criteria:
inclusion criteria: * diabetes mellitus with insulin or oral antidiabetics * proven coronary artery disease or very high risk for it * major non-vascular surgery exclusion criteria: * emergency * no consent

Keywords: insulin-dependent diabetes mellitus non-insulin-dependent diabetes mellitus coronary artery disease long-term mortality
first-in-human and proof-of-mechanism study of arc19499 administered to hemophilia patients

Conditions: Hemophilia

Summary: the purpose of this study is to examine the safety, tolerability and the way the body handles various single and multiple doses of arc19499 in patients with hemophilia.


Eligibility criteria:
inclusion criteria: adult male patients ≥18 to ≤75 years of age. * hemophilia of any type or severity. * patients who are negative for hepatitis b surface antigen (hbsag), and human immunodeficiency virus (hiv) i and ii antibody tests at screening. * male patients who, with their partners, are willing to use 2 effective, methods of contraception (i.e., for both self and partner) throughout the study and for at least 3 months after discontinuation of study drug treatment. * all patients must be capable of understanding and complying with the protocol and must have signed the informed consent document. exclusion criteria: * female patients; * if on a prophylactic coagulation factor concentrate regimen, inability or unwillingness to discontinue prophylaxis during participation in this study. * existence of other co-existing bleeding disorder (e.g., von willebrand disease). * medical history of venous or arterial thromboembolism. * scheduled for elective surgical procedure during the conduct of this study. * use of an investigational drug within 30 days of study entry. * transaminase values \> 3 x upper limit of normal (uln) at time of screening. * haemoglobin \<12.0 g/dl. * participants who, in the opinion of the investigator, have a significant infection or known inflammatory process on screening. * participants who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders. * any medical condition the investigator believes would place the patient at increased risk as a result of participation in the study e.g. history of thromboembolic disease or stroke. * any medication the investigator considers may increase the risk of adverse effects during the study.

Keywords: hemophilia a hemophilia b pharmacokinetics pharmacodynamics tissue factor pathway inhibitor
clinical outcome measure at stryker spine

Conditions: Degenerative Disc Disease; Degenerative Scoliosis

Summary: this is a multicenter, prospective, retrospective, post market clinical follow-up (pmcf) study in subjects who have undergone or will undergo surgery utilizing one or more stryker devices according to stryker cleared instructions for use (ifu).

stryker spine has a broad portfolio of spinal devices used to stabilize the spine. this pmcf study is designed to collect data on the performance and safety of the devices over their lifetime of 24 months post-implantation. four protocols have been designed to aid in this process, a master and three sub-protocols. the sub-protocols are based on body region and indication: * s-s-102-a cervical: interbody devices (ibds), vertebral body replacement devices (vbrs), internal fixation devices, and vitoss * s-s-102-b thoracolumbar: ibds, vbrs, internal fixation devices, and vitoss * s-s-102-c adult spinal deformities: ibds, internal fixation devices, and vitoss each of the sub-protocols has its own specific performance endpoint and hypothesis, radiographical data assessments, and saps. safety data will be collected throughout the study.

Eligibility criteria:
inclusion criteria: • to be eligible to participate in the study, the potential subject must meet all inclusion criteria specific to the stryker system being evaluated, please contact one of the participating investigators or see the device-specific cleared ifu, for further details. exclusion criteria: • the exclusion criteria are based on the contraindications as presented in the stryker device cleared ifus, please contact one of the participating investigators or see the device-specific cleared ifu, for further details.

Keywords: device: cervical or thoracolumbar spinal fusion device: adult spinal deformities