Kornimate/medical-research-clean huggingface dataset:
evaluation of fibrin sealant 2 in vascular surgical procedures

Conditions: Peripheral Vascular Disease

Summary: a comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.


Eligibility criteria:
inclusion criteria: * male and female subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g. femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using uncoated or heparin-coated ptfe grafts and polypropylene sutures (size 5-0 or 6-0) with a 1:1 needle-to-thread ratio. * following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the sas. * subjects must be willing to and capable of participating in the study, and provided written informed consent. exclusion criteria: * subjects undergoing re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than uncoated or heparin-coated ptfe. * subjects undergoing emergency surgery. * subjects with any intra-operative findings that may preclude conduct of the study procedure. * subjects with known intolerance to heparin, blood products or to one of the components of the study product. * subjects unwilling to receive blood products. * subjects with autoimmune immunodeficiency diseases (including known hiv). * subjects who are known, current alcohol and / or drug abusers. * subjects who have participated in another investigational drug or device research study within 30 days of enrolment. * female subjects who are pregnant or nursing.
hiv, buprenorphine, and the criminal justice system

Conditions: Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome; Opiate Addiction; Drug Dependence

Summary: the aims of stride were changed as of july, 2014. the revised project, called stride2, has a longitudinal, non-randomized, observational study design. the population under study consists of individuals living with hiv who are dependent on opioids.

presented in the results section are the summary of outcomes from the stride rct that were collected prior to the change in study design. the stride study became stride2 (nct03583138). those individuals originally enrolled in the stride rct will be followed for 12 months. stride2 will assist in identifying and monitoring individuals' hiv risk behaviors and provide resources to seek treatment for their hiv care and substance use. the goal of stride2 is to examine if there are differences in hiv, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on methadone, suboxone, or in some other treatment.

Eligibility criteria:
inclusion criteria: * hiv+ * age ≥18 yrs * meets dsm-iv criteria for opioid dependence * has medical entitlements in dc * able to provide informed consent * able to communicate in english or spanish exclusion criteria: * being prescribed an opiate medication for a chronic pain condition or expressing the need to be placed on chronic pain medical conditions for a documented pain condition * currently receiving methadone dosing of over 30 mg per day and uninterested in changing to buprenorphine * ast and alt \>5x the upper limit of normal (ast≥175, alt≥195) * pregnant or unwilling to use contraception (including ocps, patch, depo-provera, condoms, etc.) * breastfeeding or unwilling to stop breastfeeding * subject is part of another pharmacological research study * liver dysfunction (acute hepatitis, liver failure or hepatic dysfunction) * suicidal ideation * hypersensitivity to buprenorphine

Keywords: hiv aids opiate addiction drug dependence buprenorphine
rct of carvedilol versus variceal band ligation in the primary prophylaxis of oesophageal variceal haemorrhage

Conditions: Portal Hypertension

Summary: aim to compare carvedilol with variceal band ligation in the prevention of first variceal bleed. end points of trial primary: variceal hemorrhage secondary: death study design randomised controlled clinical trial. results analysed for the above end points on an intention-to-treat basis.

patients from the gastroenterology section of the aga khan university, karachi, with liver cirrhosis and on endoscopy having grade ii, or larger oesophageal varices and who have not bled previously from varices. method all suitable patients will be recruited after informed consent is given. randomisation of treatment is by sealed envelopes prepared in batches of 20. carvedilol this will be administered as a once daily dose of 12.5mg. variceal band ligation endoscopy will be performed ever two weeks until eradication of oesophageal varices. eradication is achieved when no varices or only grade i varices (varices which are small and flatten on air insufflations in the oesophagus) are present. subsequent endoscopy sessions will be progressively less frequent, at intervals of 3 months, 6 months and 12 months thereafter. should varices recur, the protocol for eradication as described above will be re-instituted. follow-up this will take place in a dedicated clinic. first visit is six weeks after initiation of treatment and three monthly thereafter. clinical and laboratory parameters will be obtained at each visit. all patients with alcoholic liver disease will be asked to provide an up-to-date status on drinking. treatment will cease upon reaching any of these end-points: variceal haemorrhage, death or liver transplantation. duration of follow-up is defined as time from randomisation to the above end points or to the last follow-up date available.

Eligibility criteria:
inclusion criteria: * patients with liver cirrhosis and on endoscopy having grade ii, or larger oesophageal varices and who have not bled previously from varices. exclusion criteria: * age \ 75 years. * pregnant or lactating patients: patients of childbearing age who are not on contraception. * allergy to carvedilol. * already on beta blockers or nitrates. * presence of malignancy that will significantly affect survival. * presence of severe systemic illness e.g. cardiorespiratory, active sepsis. * psychiatric disease or learning difficulty that will prevent the granting of informed consent. * presence of obstructive airways disease.

Keywords: carvedilol variceal band ligation primary prophylaxis
immunophenotyping of blood cells in the diagnosis work-up of myelodysplastic syndromes

Conditions: Myelodysplastic Syndromes

Summary: myelodysplastic syndromes (mds) are a heterogeneous group of hematological malignancies characterized by cytopenia(s), dysplasia in one or more major myeloid cell lines and progression to acute leukemia. morphological analysis of peripheral blood (pb) and bone marrow (bm) remains the cornerstone of the diagnosis. preliminary studies identified flow cytometry (fc) markers on red cells, platelets and circulating leukocytes that are expressed differently in mds and in controls. however, these markers have been evaluated separately. the investigators propose to test in a large cohort of patients these markers, and to combine the most relevant ones in order to define a pb fc-based diagnosis score that would discriminate between mds and non-clonal hematopoiesis and would avoid useless bone marrow samples in elderly


Eligibility criteria:
inclusion criteria: 1. patient who have been orally informed, and given a short written information notice about the study 2. adult patient\>18 years 3. for whom a blood sample analysis is routinely prescribed 4. presenting cytopenia on at least one lineage according to the 2016 who classification (hemoglobin level\<100 g/l and/or platelets \<150 g/l and/or neutrophils\<1g/l). 5. for whom a bone marrow analysis for morphology assessment and cytogenetics have to be performed, because of suspicion of mds.t the results of this bone marrow evaluation will classify the patients in group 1 (mds diagnosis) and group 2 (no mds according to the 2016 who criteria), defining the two populations of this validation cohort for whom the fc score will be calculated. exclusion criteria: 1. transfused patients (less than 3 months) in rbc or platelets units
a comparative study between preservative with benzalkonium chloride vs preservative free eye drops on the ocular surface

Conditions: Ocular Surface Disease; Dry Eye Syndromes

Summary: study the effect of different concentrations of benzalkonium chloride on the ocular surface of non-dry-eyed patients post cataract surgery.

60 eyes of will be included in this study. * 20 eyes will receive regular tobradex 0.1mg/ml bak 5 times per day (group 1). * 20 eyes will receive dexathalm multidose 0.05mg/ml bak 5 times per day (group 2). * 20 eyes will receive single dose unit dexathalm no bak 5 times per day (group 3). preoperative assessment: all selected patients will receive thorough explanation of the study design and aims, an informed consent will be obtained from all patients. tear break up time (tbut) will be measured non-invasively by ocular surface analyzer. ocular surface disease index will be calculated by filling a questionnaire. 12-item questionnaire provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. postoperative: 1. all patients will be examined at day1, 1 week and 3 week postoperative. 2. at 3 weeks re-evaluate i. tbut by non-invasive ocular surface analyzer ii. osdi by filling the questionnaire.

Eligibility criteria:
inclusion criteria: * patients undergoing uncomplicated cataract surgery * cataract grade: (locsiii): no2nc2,c3,p2 exclusion criteria: preoperative non-invasive tbut\<10 seconds. patients who have rheumatoid arthritis or autoimmune diseases affecting corneal surface. involutional entropion or ectropion preoperative postoperative significant corneal edema requiring medication.
wound closure study in carpal tunnel and trigger finger surgery

Conditions: Carpal Tunnel Syndrome; Trigger Finger

Summary: does a difference in patient satisfaction and cosmetic outcome exist between wound closure with absorbable or non-absorbable sutures.

the study will involve randomizing patients to wound closure with absorbable or non-absorbable sutures. we will if scar formation (symptoms and aesthetics) if different between the two types of closures as determined by the patient and observer scar assessment scale version 2.0 (posas) and the patient-rated wrist/hand evaluation (prwhe), between absorbable and non-absorbable suture for wound closure of open carpal tunnel release and trigger finger pulley release.

Eligibility criteria:
inclusion criteria: * any patient greater than or equal to 18 years of age. * any patient undergoing primary open carpal tunnel release or primary trigger finger pulley release exclusion criteria: * any patient identified outside of the proposed study time period. * any patient receiving revision surgery * patients who have had prior ipsilateral palmar or finger surgery * patients with dupuytren's disease
the effectiveness of two different feedbacks in core stabilization education for chronic nonspecific low back pain

Conditions: Low Back Pain, Mechanical, Biofeedback, Pain, Chronic

Summary: abstract. insufficient motor control mechanism of transversus abdominus and multifidus muscles is the most important cause of the chronic nonspecific low back pain (cnlbp). recently, applications sre developed that generates audio and vibrant stimuli in response to anteroposterior and mediolateral rotations and can be adapted according to subject-specific movement sensitivity. objective. the objective of this study was to compare effects of a biofeedback application that is alternative to physiotherapist feedback in core stabilization training of patients with chronic nonspecific low back pain. design. this study was a parallel group randomized controlled trial with outcome assessment. patients. the participants were 38 patients with chronic (≥12 weeks) nonspecific low back pain. interventions. patients were randomly assigned to receive either physiotherapist feedback or perfect practice (level belt pro inc.) biofeedback. patients in both groups received 12 sessions, 30 minutes of three weekly graded functional core education trial. measurements. primary outcome measures were muscle strength (transversus abdominus and multifidus) pain intensity (visual analog scale) and functional level (revised oswestry disability index); secondary outcomes were flexibility (modified schober test), range of motion (universal goniometer), proprioception (active reposition test), patient beliefs (fear avoidance beliefs questionnaire), psychological status (beck depression index), and quality of life(36 item short-form health survey questionnaire \[sf-36\]). limitations. outcome measures for muscle strength did not include objective assesment. keywords. chronic low back, core stabilization training, biofeedback, pain, function


Eligibility criteria:
inclusion criteria: * age between 25 and 65 years * continuous or recurrent episodes of pain in the lower back lasting for more than 12 weeks (chronic) * no specific cause for pain complaints * no other pathologic complaints or immobility * sufficient auditory and visual communication skills and * sufficient knowledge of the turkish language exclusion criteria: * any chronic disorder that may prevent exercise, * personal history of neurologic or rheumatologic disease, * pregnant or lactating women, * patients with malignancy or a lumbar comorbidity * terminal or progressive disease and any other musculoskeletal condition * surgery in the last 6 months and * any type of treatment for low back pain within past 6 months

Keywords: low back pain, mechanical, biofeedback, pain, chronic
one-year trial of oral ziprasidone in bipolar patients with metabolic syndrome

Conditions: Bipolar Disorder

Summary: the purpose of this study is to explore the impact of ziprasidone hcl on the distribution of metabolic syndrome (ms) risk factors in a population of bipolar patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

the trial was terminated prematurely on december 14, 2010, due to inability to recruit the planned number of subjects and shifting organizational priorities. the decision to terminate the trial was not based on any safety or efficacy concerns.

Eligibility criteria:
inclusion criteria: * subject must present at least 2 of the following risk factors of ms at screening: elevated waist circumference: \>102 cm in men and \>88 cm in women; elevated triglycerides (tgs): ≥1.7 mmol/l (≥150 mg/dl); reduced hdl-cholesterol: \<1.03 mmol/l (\<40 mg/dl) in men and \<1.3 mmol/l (\<50 mg/dl) in women; elevated fasting glucose: ≥ 5.6 mmol/l. * according to the clinical judgment of the investigator, the risk factors for ms have developed in close temporal relationship to starting an antipsychotic medication. * substitution to a less metabolically disruptive antipsychotic medication is considered exclusion criteria: * subjects with contraindication(s) to the use of ziprasidone according to canadian prescribing information. * subjects with a history of treatment resistance. * subjects with any medical condition (e.g. pre-existing diabetes, pre-existing dyslipidemia, thyroid pathology) or taking any concomitant medication (e.g. topiramate or other weight loss-promoting agents, hypoglycemic agents, hypolipemic agents), that may confound the evaluation of the study drug. * body mass index ≥ 40 at baseline.

Keywords: ziprasidone bipolar disorder metabolic syndrome
leveraging electronic health record tools to improve the evidence-based treatment of children hospitalized with bronchiolitis

Conditions: Bronchiolitis

Summary: the goal of this experimental study is to learn whether different types of best practice advisories (bpas) that direct clinicians to reference clinical guidelines embedded in the electronic health record (ehr) increase the delivery of evidence-based care in children presenting to the hospital with bronchiolitis. the main questions it aims to answer are: * do bpas improve clinicians' delivery of guideline-concordant care in bronchiolitis? * do interruptive bpas improve guideline-concordant care of bronchiolitis more than non-interruptive bpas? researchers will compare the treatment and outcomes of patients whose clinicians did not receive a bpa, to those whose clinicians received a non-interruptive bpa, to those whose clinicians received an interruptive bpa. patients will continue to receive standard hospital care for bronchiolitis. clinicians will: * retain access to an ehr-embedded clinical guideline for bronchiolitis care * be exposed to either no bpa, a non-interruptive bpa, or an interruptive bpa promoting the ehr-embedded clinical guideline (randomized per patient encounter)

bronchiolitis, a viral respiratory illness affecting infants and toddlers, is the most common reason children less than 2 years old are hospitalized. however, many children admitted with bronchiolitis receive unnecessary treatments that do not hasten recovery and may even cause harm. despite evidence that the best treatment for bronchiolitis is supportive care (i.e. oxygen and hydration support), clinicians continue to overuse certain therapies, leading to longer hospital stays, higher costs, and increased stress for families. the investigators will study the effects of bpas, which are real-time alerts within the ehr. the bpas in this study promote the use of an evidence-based care guideline for bronchiolitis that is embedded within the ehr. there are multiple bpa designs commonly used in ehrs: 1) interruptive bpas, which require clinicians to interact with the alert to continue the clinician's workflow; and 2) non-interruptive bpas, which appear as visual cues but do not require clinicians to alter workflows.

Eligibility criteria:
patient inclusion criteria: * children \<=24 months of age presenting to the emergency room and/or hospitalized (under observation or inpatient status) with bronchiolitis at one of three study sites. patient exclusion criteria: * current encounter is birth-encounter * currently hospitalized in an icu * hospitalized with length of stay \>14 days clinician inclusion criteria: * physicians and advanced practice providers entering the patient's chart or orders entry activity for emergency department (ed) and inpatient encounters clinician exclusion criteria: * physicians and advanced practice providers who do not enter the patient's chart or orders entry activity

Keywords: best practice advisory clinical decision support clinical guideline clinical pathway
the clinical comparison of somofilcon a 1 day and nelfilcon a daily disposable contact lenses

Conditions: Ametropia

Summary: this subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon a 1 day soft contact lens with the nelfilcon a daily disposable lens when used on a daily wear, daily disposable basis.

this will be a randomized, subject-masked, crossover, bilateral study, controlled by cross-comparison. this will compare the clinical performance and subjective acceptance of the somofilcon a 1 day soft contact lens with the nelfilcon a daily disposable lens when used on a daily wear, daily disposable basis. subjects will use each lens type for a week in random sequence. follow-up visits for each lens will be performed after one week of wear. lenses will be worn on a daily wear, daily disposable wear schedule.

Eligibility criteria:
inclusion criteria: * they are of legal age (18) and capacity to volunteer. * they understand their rights as a research subject and are willing and able to sign a statement of informed consent. * they are willing and able to follow the protocol. * they agree not to participate in other clinical research for the duration of this study. * they have a contact lens spherical prescription between -1.00 to - 6.00d (inclusive) * they have a maximum of -1.00dc ocular astigmatism in each eye. * they can be satisfactorily fitted with the study lens types. * at dispensing, they can attain at least 0.20 logmar distance high contrast visual acuity in each eye with the study lenses within the available power range. * they currently use soft contact lenses or have done so in the previous six months. * they are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day). * they own a wearable pair of spectacles. exclusion criteria: * they have an ocular disorder which would normally contra-indicate contact lens wear. * they have a systemic disorder which would normally contra-indicate contact lens wear. * they are using any topical medication such as eye drops or ointment. * they have had cataract surgery. * they have had corneal refractive surgery. * they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. * they are pregnant or breast-feeding. * they have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. * they have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel, or they have any immunosuppressive disease (e.g. hiv), or a history of anaphylaxis or severe allergic reaction. * they have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study. * they currently wear either the clariti 1day or the dailies aquacomfort plus lens.
measuring cell-free dna (cfdna) levels in people with follicular lymphoma

Conditions: Follicular Lymphoma

Summary: the researchers are doing this study to measure and test cell-free dna (cfdna) in the blood before, during, and after first-line treatment for follicular lymphoma. they will look at whether cfdna levels are related to a person's response to the usual first-line treatment for follicular lymphoma. researchers also want to understand how different genetic changes in follicular lymphoma relate to a person's response to the usual first-line treatment.

this is a non-therapeutic protocol aimed to assess the ability of the s cfdna assay to detect clinical response in fl when compared to conventional approaches for assessing response, such as pet-ct scans. study assessments will include: 1) identification of the mutations present in the primary tumor, 2) identification of these mutations in the peripheral blood samples collected before initiation of standard therapy, after 2 cycles of therapy, at the completion of 6-8 cycles of induction therapy, and then every 6 months for a total of 2 years from the initiation of therapy using a cfdna assay. for patients who receive rt, peripheral blood samples will be collected before initiation of rt, and then 3 months, 6 months, 12 months, 18 months and 24 months post rt using a s cfdna assay.

Eligibility criteria:
inclusion criteria: * ≥18 years of age at time of signing informed consent. consent is permitted from either the participant or from a legally authorized representative (lar) on their behalf. * histology-confirmed follicular lymphoma grade 1-3a, verified by the enrolling institution * ability to adhere to the study visit schedule and all the protocol requirements * measurable fdg-avid disease * not applicable for retrospective patients in cr exclusion criteria: * patients receiving second or greater line of therapy (except in retrospective cohort of long-term survivors of fl \[i.e. \>10 years out from frontline treatment\])

Keywords: cell-free dna 20-199