Kornimate/medical-research-clean huggingface dataset:
a study of darbepoetin alfa in patients with myelodysplastic syndrome (mds)

Conditions: Blood Cancer; Myelodysplastic Syndromes; Myelodysplastic Syndromes (MDS)

Summary: the primary objectives of the trial are to assess erythroid response to darbepoetin alfa, as determined by changes in hemoglobin and/or red blood cell (rbc) transfusion-dependence and to describe the safety profile of darbepoetin alfa in patients with mds. the secondary objective is to assess bone marrow progenitor bfu-e growth before and after treatment with darbepoetin alfa.


Eligibility criteria:
inclusion criteria:- diagnosis: * bone marrow aspirate/biopsy-proven mds for \> 2 months prior to enrollment. * mds french-american-british (fab) subtypes refractory anemia (ra), ra with ringed sideroblasts (rars), ra with excess blasts (raeb), and non-proliferative chronic myelomonocytic leukemia (cmml) \[wbc \< 12,000/ml\]. * patients must have an untransfused hemoglobin \< 10.0 g/dl and/or patients must be red cell transfusion-dependent for a period of at least 2 months prior to study entry. - laboratory: * bilirubin \< or = to 2 mg/dl * alt/sgpt \< or = to 2.5 x the upper limit of normal (uln) * normal renal function (stanford: serum creatinine \< 1.2 mg/dl \[male\], \< 1.0 mg/dl \[female\]; vanderbilt: \< 1.5 mg/dl). * age: \> or = to 18 * other: * ecog performance status 0-2. * patients may receive standard supportive care, including transfusions and antibiotics as required. * patients must be r-huepo naive or must not have received prior treatment with r-huepo \> or = to 40,000 u/week for more than 4 weeks. exclusion criteria:- patients with secondary mds or prior allogeneic bone marrow transplant.
safety, efficacy, pharmacokinetic and pharmacodynamic study of glpg0974 in subjects with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: * approximately 45 patients suffering from mild to moderate ulcerative colitis will be examined for any side effects (safety and tolerability) that may occur when taking glpg0974 or matching placebo (2:1 ratio) for 28 days. * during the course of the study, patients will also be evaluated for improvement of disease activity by different efficacy measures, the amount of glpg0974 present in the blood determined (pk) and the effects of glpg0974 on selected biomarkers (pd) in the blood, colon biopsies and faeces will be explored.


Eligibility criteria:
key inclusion criteria: * men or women between 18 to 75 years of age inclusive, on the day of signing the informed consent with a documented history of uc. * presence of mild-to-moderately active ulcerative colitis as evidenced by clinical signs and endoscopy. * medication: 5-asa. * absence of infectious colitis. key exclusion criteria: * history of sensitivity to any component of the study drug * any concurrent illness, condition, disability or clinically significant abnormality (including lab tests) that represents a safety risk , may affect the interpretation of data, or may prevent the subject to safely complete the assessments * positive serology for hiv 1 or 2 or hepatitis b or c, or any history of hiv or hepatitis. * history of active infections requiring intravenous antibiotics within the past four weeks prior to randomization. * history of bowel surgery, or presence or history of intestinal malignancy. * suspicion of crohn's disease, indeterminate colitis, microscopic colitis, ischaemic colitis or radiation-induced colitis. * history of lower gi bleeding disorder, other than uc. * a history of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal (other than uc), pulmonary or metabolic disease. * history of tuberculosis (tb) infection. * treatment with systemic corticosteroids within 1 week prior to randomization. * treatment with tnf-α inhibitors or other biologics within 2 months prior to randomization. * treatment with immunosuppressants, initiated or changed within 3 months prior to randomization . * current use of probiotic or prebiotic preparations * regular daily use of nsaids, within 7 days prior to randomization. * administration of any experimental therapy within 90 days or 5x the half-life. * history of drug or alcohol abuse. * pregnant or lactating women. * medical, psychiatric, cognitive, or other conditions that compromise the subject's ability to complete the study.
pilot testing a patient safety display in the hospital setting

Conditions: Catheter-Related Infections; Pressure Injury

Summary: this is a feasibility pilot study to introduce and evaluate an intervention designed to increase clinician awareness of their patients' urinary catheters, vascular catheters, and pressure injuries. this intervention, the "patient safety display" will be evaluated in one hospital unit.

this project will introduce and evaluate an intervention designed to increase clinician awareness of their patients' urinary catheters, vascular catheters, and pressure injuries. a "patient safety display" will be implemented in half of the patient rooms in one hospital unit. the patient safety display will display catheter and pressure injury data pulled real-time from the electronic medical record onto a tablet mounted at the patient bedside. this is an intervention-control design study that will be conducted with patients and clinicians at michigan medicine. the proposed intervention, the patient safety display, will provide clinicians with key catheter and skin information at the bedside when pertinent clinical decisions are being made.

Eligibility criteria:
inclusion criteria: * hospitalized in specific hospital unit of interest or providers caring for patient in that unit exclusion criteria: * patients not in unit of interest and providers not caring for patients on that unit

Keywords: catheter-related infections pressure injury patient safety
phase 1 study of anti-glycation agent gly-230 in healthy subjects

Conditions: Diabetes

Summary: to test the safety of gly-230 and to evaluate how long drug stays in blood after taking it by mouth.


Eligibility criteria:
inclusion criteria: * men age 18-55 * negative drug screen * normal ekg, clinical chemistries, cbc, urinalysis, and * give written informed consent exclusion criteria: * active concomitant serious medical or surgical disease, * hepatic or renal laboratory values above reference range, ise of other experimental drug within previous 30 days
a gene transfer therapy study to evaluate the safety and efficacy of delandistrogene moxeparvovec (srp-9001) in participants with duchenne muscular dystrophy (dmd)

Conditions: Duchenne Muscular Dystrophy

Summary: the study will evaluate the safety and efficacy of gene transfer therapy in boys with dmd. it is a randomized, double-blind, placebo-controlled study. the participants who are randomized to the placebo arm will have an opportunity for treatment with gene transfer therapy at the beginning of the second year.


Eligibility criteria:
inclusion criteria: * is ambulatory and from 4 to under 8 years of age at time of randomization. * definitive diagnosis of dmd based on documented clinical findings and prior genetic testing. * ability to cooperate with motor assessment testing. * stable daily dose of oral corticosteroids for at least 12 weeks prior to screening, and the dose is expected to remain constant throughout the study (except for modifications to accommodate changes in weight). * raavrh74 antibody titers are not elevated as per protocol-specified requirements. * a pathogenic frameshift mutation or premature stop codon contained between exons 18 and 79 (inclusive), with the exception of mutation fully contained within exon 45. exclusion criteria: * exposure to gene therapy, investigational medication, or any treatment designed to increase dystrophin expression within protocol specified time limits. * abnormality in protocol-specified diagnostic evaluations or laboratory tests. * presence of any other clinically significant illness, medical condition, or requirement for chronic drug treatment that in the opinion of the investigator creates unnecessary risk for gene transfer. other inclusion or exclusion criteria could apply.

Keywords: muscular dystrophies duchenne muscular dystrophy dmd north star ambulatory assessment (nsaa) ambulatory pediatric gene-delivery
assessment of psychological strain and perioperative fear in intravitreal injections

Conditions: Age-related Macular Degeneration; Stress

Summary: 1. intravitreal injection can induce perioperative stress for the patients. 2. different factors can modulate the pre-operative fear and physiologic reaction.

the aim of the study is to assess the influence of perioperative factors on objective outcome measures, which indicate the physiologic stress reaction.

Eligibility criteria:
inclusion criteria: * first intravitreal injection received ever exclusion criteria: * no known affective or mental disorder * condition does not allow standardized survey

Keywords: intravitreal injection
validity and reliability of the 2-minute step test in patients with lumbar spinal stenosis

Conditions: Spinal Stenosis

Summary: the aim of this study was to investigate the validity and reliability of the 2 minute step test (2mst) in patients with symptomatic degenerative lumbar spinal stenosis and to explore its correlation with objective assessment methods, namely the 2 minute walk test (2mwt) and the 6 minute walk test (6mwt).

this cross-sectional study will include 55 volunteers aged 18-80 years who present to the istanbul physical medicine and rehabilitation training and research hospital outpatient clinics and are diagnosed with lumbar spinal stenosis (lss) through mri. the demographic characteristics of the patients will be recorded, and their walking distances will be inquired about. the severity of the disease will be determined by examining the levels of stenosis on lumbar mri scans. all patients will be initially assessed using the 2mst (2-minute step test), 2mwt (2-minute walk test), 6mwt (6-minute walk test), vas (visual analogue scale), and odi (oswestry disability index). to measure test-retest reliability, the 2mst will be administered again with a 7-day interval between assessments.

Eligibility criteria:
inclusion criteria: * patients aged 18-80 who have been diagnosed with lumbar spinal stenosis based on magnetic resonance images. exclusion criteria: * uncontrolled hypertension * decompensated heart failure * presence of systemic diseases affecting lower extremity functions * presence of degenerative diseases affecting lower extremity functions * peripheral artery disease causing vascular claudication * psychiatric illness * neuromuscular disease * pregnancy * cognitive impairment

Keywords: exercise test spinal stenosis physical fitness
evaluation of cataract surgery outcome

Conditions: Cataract; High Myopia

Summary: the purpose of this study is to evaluate the visual outcome of the cataract surgery, including best uncorrected and corrected visual acuity, spherical equivalent, wavefront aberration and other measurements.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of cataract * must be able to cooperate with the ophthalmic examination exclusion criteria: * clinical diagnosis of mental illness * mentally disabled
prevention of traumatic brain injury in youth and adolescents

Conditions: Focus of Study: Bicycle Helmet Wearing Compliance

Summary: the hypothesis was that the implementation of a safe kids east central brain injury prevention program targeting children and caregivers admitted to the georgia health sciences university children's medical center is feasible and that short-term treatment effects of injury prevention education on the child or adolescent and the caregiver will increase bicycle helmet use.

the overarching goal of this project is to reduce traumatic brain injury in children and adolescents by promoting bicycle helmet use via an inpatient educational program. the safe kids east central injury prevention educational program was customized for hospitalized subjects and their caregivers. the investigators hypothesized that this program would increase bicycle helmet use.

Eligibility criteria:
inclusion criteria: * hospitalized in-patients in the children's medical center; * projected length of stay \>24 hours; * mentally and physically fit to complete the educational program; * history of regular (\>1x per week) bicycle riding; * all racial/ethnic groups.
clinical study to test the efficacy and safety of adapalene, 0.1%

Conditions: Acne Vulgaris

Summary: the purpose of this study is to determine whether adapalene, 0.1% is safe and effective in the treatment of acne vulgaris.

this study will compare the efficacy and safety of adapalene, 0.1% and vehicle in the treatment of subjects with acne vulgaris. this is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an investigator's global assessment (iga) score of 3 (moderate) or 4 (severe) are eligible for enrollment. one nodule may be present at inclusion. acne lesions are evaluated on the face only. subjects presenting with facial and truncal acne vulgaris can participate in this study. subjects will be randomized in a 1:1 ratio to adapalene, 0.1% or vehicle.

Eligibility criteria:
inclusion criteria: * subjects with moderate or severe acne vulgaris, * 20-50 papules and pustules in total on the face excluding the nose * 30-100 non-inflammatory lesions on the face excluding the nose. * negative urine pregnancy test for all females. exclusion criteria: * subjects with more than one acne nodule. * subjects with any acne cyst on the face. * subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment. * subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. * subjects who are pregnant, nursing, or planning a pregnancy.

Keywords: acne vulgaris adapalene
renal perfusion assessment in the endovascular treatment of renal artery stenosis

Conditions: Renal Artery Stenosis

Summary: the clinical benefits of endovascular treatment in renal artery stenosis remain controversial. this study uses arterial spin labelling mri and flat-panel detector parenchymal blood volume imaging to observe the change in renal perfusion after endovascular treatment in renal artery stenosis.


Eligibility criteria:
inclusion criteria: * patients who provided informed consent * patients who were diagnosed with ras by cta, mra, or doppler ultrasonography * patients who were aged 18 years or older * patients whose intervened renal arteries were not completely occluded (confirmed by dsa) * the stenosis percentage exceeding 70% * patients who had uncontrolled blood pressure or impaired renal function * paitents whose affected kidney did not have total loss of function exclusion criteria: * were pregnant * had a history of renal transplantation or renal artery bypass surgery * were allergic to iodine contrast medium * had other contraindications of endovascular treatment * contraindications of mri examinations * had technical failure in the endovascular treatment.

Keywords: renal artery stenosis renal perfusion
foundational ingredients of robotic gait training for people with spinal cord injury during inpatient therapy

Conditions: Spinal Cord Injuries

Summary: the first project compares the dose of robotic gait training (rgt) with usual care gait training for patients with spinal cord injury (sci) undergoing rehabilitation at baylor scott \& white institute for rehabilitation (bswir).

spinal cord injury (sci) due to trauma is estimated to affect 288,000 - 500,000 americans, with about 17,700 new cases annually. recovery of walking is a primary rehabilitation goal for patients and encouraged by therapists due to its relationship to quality of life, impact on health, psychological profile, and social participation after sci. recent technological advances with exoskeleton devices specifically for gait training may yield better walking recovery outcomes compared with usual care intervention approaches, such as body-weight support treadmill training (bwstt) and overground gait training with braces, yet limited evidence exists for those with sci. aim 1: use a community-based participatory research approach to develop an robotic gait training (rgt) program that meets the unique needs of people after incomplete sci during inpatient rehabilitation. this will be achieved by establishing and engaging an advisory board of key stakeholders to review evidence-based literature, advise the research team on the unique aspects and goals of inpatient rehabilitation for people with sci, review the rgt, and make recommendations for amendments to the rgt program based on our interim and final outcomes of the study over the funding period. aim 2: prospectively examine the efficacy of rgt compared to usual care gait training during inpatient rehabilitation in people with incomplete sci. aim 3: compare the intensity of rgt and usual care gait training during inpatient rehabilitation.

Eligibility criteria:
inclusion criteria: * 16 - 85 years of age * all types of incomplete spinal cord injury (sci) (traumatic and non-traumatic) * acute/subacute phase of recovery * medically stable as deemed by physician * undergoing medical care and inpatient rehabilitation at bsw * both genders and all races and ethnicities * meet the ekso robotic exoskeleton frame limitations * continence of or a program for bladder and bowel management exclusion criteria * moderate to severe traumatic brain injury (tbi) * degenerative diagnoses * wound located in proximity to the exoskeleton frame * severe osteoporosis/-penia as shown with dual energy x-ray absorptiometry (dxa) * pre-morbid developmental disability, significant psychological diagnosis, or other cognitive impairment

Keywords: gait training exoskeleton physical therapy physical rehabilitation and medicine inpatient rehabilitation robotic gait training randomized control trial
validation of vascuqol-6 spanish version

Conditions: Peripheral Artery Disease

Summary: vascuqol (vq) is a specific questionnaire to assess the quality of life of patients with critical limb ischemia which is also used as an index in vascular registries. the original version has 25 items (vq-25), divided into 5 subscales or domains: pain, symptoms, activity, social and emotional. the shortened version, vascuqol-6 (vq-6) is made up of 6 questions and 4 possible answers, which score from 1 (worst quality of life perceived by the patient) to 4 (best quality of life perceived by the patient). the total score is between 6 and 24, and a higher value is related to better health. while the vq-25 questionnaire has been translated and validated in 21 languages, the shortened version vq-6 has been translated and validated in some languages, not including spanish. as it is a fast and easy-to-use tool iwhich has demonstrated statistical validation to measure pad in other versions of the same questionnaire (other languages), a cross-cultural adaptation and statistical validation of the questionnaire from english to spanish will be carried out.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age * with a diagnosis of peripheral arterial disease (intermittent claudication and critical lower limb ischemia) * whose first language is spanish * who sign the informed consent. exclusion criteria: * patients with cognitive impairment that difficults understanding of the questionnaire
interest of the spect-ct scan suvspect in the new generation of gamma-cameras with semiconductor

Conditions: Thyroid Diseases; Heart Diseases; Bone Diseases; Brain Diseases; Kidney Diseases

Summary: since 2017, a revolution began in the departments of nuclear medicine, with the routine use of gamma-cameras with semiconductor. these gamma-cameras (which obtained the ce-marking in 2016), offer a technological breakthrough by providing an additional information. they allow "to quantify" for the 1st time in clinical routine conditions, the quantity of radioactivity, by means of a "suvspect", in a volume of interest, while respecting the recommendations of best practice of the learned societies of french nuclear medicine (sfmn), european (eanm) and american (snm), without injection of tracer nor acquisition or additional irradiation. the suvspect is therefore an indicator of the quantity of tracer in a given volume of acquisition. until now, the interpretation criteria of scintigraphies are based on the homogeneity of distribution of a tracer in the explored organ (for single organs such as the heart or the thyroid, for example) or in the asymmetry of distribution of the tracer (for the double organs, such as the kidney or the joints). this new gamma-camera allows to study the distribution of the radio-tracers in "list" mode, allowing to retrospectively reconstruct the images in various ways (for example, by modifying the size of the matrix of acquisition, the energy windows, the time of acquisition). therefore, we can simulate and propose modifications in current procedures. every patient referred to our department of nuclear medicine to undergo a scintigraphy with a tracer of nuclear medicine (with a marketing authorization) can, while benefiting from an examination by this gamma-camera, to be the object of this study, and to profit from this additional information. so, without changing the diagnosis or the usual care, we wish to take advantage of this additional information to improve the criteria of interpretation of our examinations. this possibility being new, there is no available bibliography (our department is the 5th department of nuclear medicine in europe to equip itself with this large field-of-view gamma-camera czt, the dnm 670, made by general electric), while 2961 articles speak about the suvmax (in pet) in pubmed.


Eligibility criteria:
inclusion criteria: - informed adult patients referred to our department of nuclear medicine for a nuclear medicine exploration exclusion criteria: * refusal to participate * patient under guardianship

Keywords: nuclear medicine spect-ct scan gamma-camera with semiconductor
peri-operative analgesia for single-incision laparoscopic appendectomy

Conditions: Appendicitis

Summary: laparoscopic appendectomy is a very common intervention in pediatric surgery. to improve outcomes, some teams have developed the use of single-site laparoscopic appendectomy (silap). nevertheless, there is no consensus yet and no published data on the better perioperative analgesia, and different modalities including general intravenous analgesia, locoregional pre-operative analgesia and local analgesia can be used.

the aim of this retrospective study is to describe the different types of perioperative analgesia routinely used and to compare them to determine the more efficient one for early postoperative pain relief.

Eligibility criteria:
inclusion criteria: * all patients operated on for appendectomy by silap, aged 15 years and under in our pediatric surgical center. exclusion criteria: * patients aged 16 years or more. * patients with concomitant pathologies potentially inducing hyper- or hypoesthesia (e.g. cancers, spinal cord injury, etc...) * patients with contraindications for the use of iv analgesics. * patients operated on for appendectomy through 3-ports laparoscopy or open surgery. * opposition of the patients and their representative to the study.

Keywords: appendectomy single-site laparoscopy analgesia pain peri-operative management