Kornimate/medical-research-clean huggingface dataset:
evaluation, psychological intervention and follow-up study of anxiety and depression in stable copd patients

Conditions: COPD; Anxiety; Depression

Summary: this study expect to investigate psychological intervention (baduanjin qigong) in copd patients combined with anxiety and/or depression.

anxiety and depression is one of the most common complications of copd patients.this research use psychological questionnaires to evaluate the stage of copd patients with anxiety and/or depression(asymptomatic, subclinical，clinical). the subclinical type will divided into the treatment group of baduanjin qigong，and the control group. two groups are all receive the same psychological counseling, the treatment group also receive further treatment of baduanjin qigong under the guidance of medical staff. the treatment along for 1 year. two groups were followed up for 2 years, dynamically observe the stage of anxiety and depression,the number of exacerbations,lung function,etc.

Eligibility criteria:
inclusion criteria: * diagnosed of copd * in stable phase * fev1%predicted \<80. exclusion criteria: * cancer * severe cerebrovascular disease * severe arrhythmia,cardiac insufficiency * alzheimer's disease * mental illness * severe liver disfunction * severe renal disfunction * physical activity disable.

Keywords: copd baduanjin qigong depression anxiety
tahoe: intravitreal dexamethasone implant (ozurdex) for uveitic macular edema

Conditions: Macular Edema; Uveitis

Summary: the purpose of this study is to determine whether an intravitreal dexamethasone implant (ozurdex, allergan) is effective to manage macular edema secondary to non-infectious uveitis.

uveitis accounts for more than 10% of all cases of severe vision loss in developed countries, which makes it possibly the fourth leading cause of blindness in the united states. cystoid macular edema (cme) is the most structural complication of uveitis, resulting in visual impairment and blindness. if left untreated or undertreated over a period of years, cme may result in permanent photoreceptor damage of the macula and loss of central vision. further, cme may persist despite adequate control of the uveitis, and therefore, adjuvant therapy to specifically treat the cme may be required. we propose to study whether a sustained steroid delivery system (ozurdex, allergan) can treat uveitic macular edema. ozurdex has been proven to be effective for non-infectious posterior uveitis; and fda approved for posterior uveitis. the sustained delivery of the steroid and local delivery modality makes it an ideal candidate to manage macular edema in uveitis.

Eligibility criteria:
inclusion criteria: * uveitis cme with central subfoveal thickness \> 350 microns * non-infectious uveitis * visual acuity \> 20/32 exclusion criteria: * visual acuity worse than 20/200 * moderate or severe glaucoma (as defined as \>2 topical ocular medications) * infectious uveitis * patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infections, and fungal diseases. * aphakic eyes with rupture of the posterior lens capsule * anterior chamber intraocular lens and rupture of the posterior lens capsule * hypersensitivity to any components of the ozurdex

Keywords: uveitis macular edema
csppt- chronic kidney diseases study

Conditions: Hypertension; Hyperhomocysteinemia

Summary: the purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing renal function decline among the patients with primary hypertension when compared to enalapril maleate.

elevated blood concentration of homocysteine (hcy) has been suggested as a modifiable, independent risk factor for coronary artery disease, stroke, and deep vein thrombosis. prevalence of hyperhomocysteinemia and folic acid deficiency in china are significantly higher than those in europe and usa. the investigators' preliminary research demonstrated that blood concentration of hcy was negatively correlated to estimated glomerular filtration rate (egfr), a key index of kidney function. however, the question as to whether hcy-lowering therapy with folic acid can reduce the risk of chronic kidney disease(ckd) remains to be answered. this study, exploiting the hypertensive population of csppt trial (clinicaltrials.gov register number: nct00794885), is intended to compare the effects of enalapril maleate and folic acid tablets versus enalapril maleate in preventing renal function decline among the patients with primary hypertension. the results from this trial may have the potential to transform current clinical and public health findings into practice in the prevention of chronic kidney disease(ckd) in china.

Eligibility criteria:
inclusion criteria: * bp≥140/90 mmhg in both of the two screening visits or currently under anti-hypertension treatment; * 45-75 years old; * successful determination of methylenetetrahydrofolate reductase (mthfr) c677t genotype; * for pre-menopausal women, agreed to use contraceptives during the trial; * signed the written informed consent. exclusion criteria: * having a history of stroke; * having a history of myocardial infarction; * having a history of physician diagnosed heart failure; * post- coronary revascularization; * severe somatic disease such as cancer; * secondary hypertension; * congenital or acquired organic heart diseases; * contraindicated to angiotensin-converting enzyme inhibitor (acei); * having a history of acei adverse effects; * currently long-term use of folic acid or vitamin b12 or vitamin b6; * pregnant or child breastfeeding women; * severe mental disorders; * lab tests indicating abnormal liver or kidney function; * unwilling to participate the trial; * unwilling to change the current antihypertensive treatment.

Keywords: folic acid renal function decline hypertension hyperhomocysteinemia chronic kidney disease mthfr c677t genotype randomized controlled trial
impact of computerized decision support on racial/ethnic disparities in hypertension outcomes

Conditions: Hypertension

Summary: in response to the finding answers: disparities research for change call for proposals by the robert wood johnson foundation, we were funded to evaluate the effectiveness of a planned computerized decision support (cds) intervention aimed at medical providers to overcome clinical inertia when treating blood pressure for hypertensive patients. based on prior evaluation of the brigham and women's hospital (bwh) adult primary care clinics, we hypothesize that racial and ethnic differences in blood pressure outcomes are largely attributable in differences in providers' aggressiveness in managing patients with hypertension based on patients' race and ethnicity. within our network of 14 hospital and community-based brigham and women's hospital adult primary care clinics, we aim to determine if the use of cds to remind to medical providers of poorly controlled hypertensive patients to intensify their hypertension therapy will improve overall rates of blood pressure control and reduce the previously documented racial and ethnic disparities in blood pressure outcomes among our hypertensive patient population. clinics will first be stratified by location (hospital-based versus community-based) and within each strata will be randomized to either have their providers receive cds for hypertensive patients whose most recent blood pressure was uncontrolled or to usual care for hypertensive patients. more specifically, we will evaluate our planned intervention by utilizing an 18 month cluster-randomized controlled trial to examine the effectiveness the cds for intensification of hypertension therapy in: improving levels of blood pressure control, improving provider adherence with recommended changes in drug therapy, and reducing racial/ethnic disparities in the processes of hypertension care and outcomes among our patients receiving primary care for a diagnosis of hypertension.


Eligibility criteria:
inclusion criteria: * adult patients (\> 20 years) with icd-9 of hypertension with a minimum of 2 outpatient primary care visits in from 10/2008-10/2009 who receive care for hypertension in the outpatient practices at least once for hypertension from 10/2009-7/2001 exclusion criteria: * pregnancy, age \< 20 years, fewer than two hypertension-related visits from 10/2008-10/2009
safety study of the use of topical cyclosporine in the treatment of dry eye disease

Conditions: Primary Sjogren Syndrome; Secondary Sjogren Syndrome; Aqueous Deficient Dry Eye Disease; Evaporative Dry Eye Disease

Summary: in the present study the investigators aim to determine the efficacy of an immunomodulating topical medication, compared with a topical lubricant, on the treatment of dry eye disease (ded) due to primary or secondary sjögren's syndrome (aqueous deficient ded) and evaporative ded.

dry eye disease (ded) is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. it is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. ded prevalence is estimated around 15 -35% of the population over 50 years old. there is a wide variety of topic medications for the treatment of ded, though few aim the re-establishment of tear osmolarity equilibrium and reduction of damages to the ocular surface. the treatment of ded can include a medical treatment, such as tear substitution, tear preservation, production stimulation, anti-inflammatory; it can also include surgical treatment, as tarsorrhaphy and salivary gland transplant. considering tear substitutes and anti-inflammatory topical treatments, the purpose of our study is to determine efficacy of an immunomodulating topical medication containing 0.05% cyclosporine a (csa), compared to a topical lubricant (vitamin a, refresh endura®), on the treatment of dry eye disease (ded) due to primary or secondary sjögren's syndrome (aqueous deficient ded) and evaporative ded.

Eligibility criteria:
inclusion criteria: * patients diagnosed for mild to moderate aqueous deficient ded (added), defined as schirmer 1 \< 10mm; * patients diagnosed for mild to moderate evaporative ded (eded), defined as normal schirmer 1 and but \< 5 seconds; * patients submitted to refractive surgery, * patients capable of understanding instructions, signing the term of consent and available to attend all exam visits. exclusion criteria: * patients with punctual occlusion, * active ocular infection or inflammatory disease, * history of herpetic keratitis, * contact lens use during trial period, * patients with glaucoma, * any eyelid globe malposition abnormality.

Keywords: evaporative aqueous deficient dry eye disease
cannulation-related pain in dialysis patients with arteriovenous fistula

Conditions: Hemodialysis Access

Summary: it was conducted to investigate the effect of ice application to the kaleidoscope and hoku point on the management of cannulization-related pain in patients receiving hemodialysis treatment.

after obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of x,y, z hospitals were randomly divided into three groups (kaleidoscope application, ice application and control group). patients were made to sign written voluntary consent forms by the researchers.after the patients were transferred to the randomized program for the arrival days and tc numbers for the dialysis session, they were assigned to the experimental and control groups. the patients' pain levels were evaluated during 3 dialysis sessions.

Eligibility criteria:
inclusion criteria: comfortable reception of trill and murmur sound from arteriovenous fistula, • over the age of 18 and no communication problems, * having a place and time orientation, * no dizziness, exclusion criteria: * hemodialysis of the patient with arteriovenous graft and/or central venous catheter * pharmacological application was made to relieve pain 30 minutes before avf cannulation, * the patient has a covid - 19 infection * having visual, auditory and intellectual disabilities, * having a communication problem, * not willing and willing to participate in the study, as well as wanting to withdraw from the study at any stage of the study

Keywords: arteriovenous fistula nursing pain management
feasibility testing a meditation app with justice-involved youth on probation

Conditions: Emotion Regulation; Alcohol Use; Cannabis Use; Sexual Behavior; Aggression

Summary: this study is a randomized controlled trial (rct) testing the effects of a mindfulness-based intervention delivered to justice-involved youth on probation via smartphone app on youths' emotion regulation and hiv/sexually transmitted infection (sti) risk-taking behaviors (i.e., alcohol use, cannabis use, sexual behaviors, and aggressive behaviors).

the investigators will enroll 200 justice-involved youth on probation 13-18 years old of all genders who report regular access to an apple or android smartphone. following completion of a baseline questionnaire, participants will be individually randomized at a 1:1 ratio to 1 of 2 smartphone app conditions: (1) bodhi aim (action in mindfulness), a 30-day mindfulness-based intervention, or (2) hib (health in balance), a health promotion control app matched to bodhi aim for time and structure. follow-up assessments will occur at 1 and 6 months.

Eligibility criteria:
inclusion criteria: * 13-18 years old * on probation in the chicago cook county juvenile justice system exclusion criteria: * unable to understand the permission/consent/assent process * do not speak english, due to norming of instruments * do not assent/consent * legal guardian does not give permission for youth's participation if under 18 years old * do not have an apple or android phone * are detained * are in care of dcfs

Keywords: hiv prevention juvenile justice mindfulness mhealth
pharmacologic treatment of ptsd in sexually abused children

Conditions: Stress Disorders, Post-Traumatic

Summary: this study will evaluate the benefit of adding sertraline (zoloft®) to trauma-focused cognitive behavioral therapy (tf-cbt) for sexually abused children who have posttraumatic stress disorder (ptsd).

adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (ssris) in decreasing posttraumatic stress disorder (ptsd) symptoms; to date the ssris are the only medication class with demonstrated efficacy in treating all three ptsd symptom clusters (reexperiencing, avoidance, and hyperarousal). no studies have evaluated the impact of ssris on ptsd symptoms in children or adolescents. trauma-focused cbt has been shown in several studies to be efficacious in decreasing ptsd symptoms in sexually abused children and adolescents. many children and youth with ptsd are currently prescribed ssris and other medications. this study will evaluate whether adding the ssri sertraline provides additional benefits over tf-cbt treatment for sexually abused children and adolescents with ptsd. if adequate numbers of children with comorbid ptsd and depressive and/or anxiety disorders are included, it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders.

Eligibility criteria:
inclusion: 1. ages 10-17 years, inclusive 2. confirmed sexual abuse 3. at least 5 ptsd symptoms on ksads-pl, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal) 4. parent/primary caregiver available to participate in treatment 5. assent with parental consent to participate exclusion: 1. non-english speaking 2. schizophrenia or other severe psychotic disorder 3. mr (iq\<60) or pdd preventing cbt treatment 4. taking current psychotropic medication 5. documented substance dependence (substance abuse allowed)

Keywords: ptsd depression anxiety
nurse-led placement of peripheral venous catheters in overweight patients using standard or dynamic ultrasound-guided technique

Conditions: Overweight and Obesity; Emergencies

Summary: overweight and obesity may be associated with difficult intravenous access leading to longer procedure time and more placement attempts of peripheral venous catheters (pvc). dynamic ultrasound-guided short-axis needle tip navigation (dust) may facilitate the procedure. this was a prospective, randomized, non-blinded study to compare time and placement attempts for nurse-led standard (st) and ultrasound guided pvc placement in 90 emergency patients with a bmi ≥25kg/m2. consenting patients were randomized at a 1:1 ratio to receive pvc by either st or dust. application time was defined as the time from applying stasis to visible blood in the pvc flash-chamber. no difference in time was found (medians: st 42 s; dust 53.5 s, p = 0.535). there were on average 17 % less placement attempts in the dust-group (median 1 attempt; q1 = 1 q3 = 1) compared to the st-group (median 1 attempt; q1 = 1 q3 = 1.5), (p = 0.031). patients reported no differences in perceived pain (p = 0.955) or perceived satisfaction (p = 0.342). pain and subcutaneous infiltrations were the only side-effects reported (st-group 6, dust-group 5). dust does not decrease time to functional pvc but reduces the number of pvc placement attempts in patients with bmi ≥25 kg/m2.


Eligibility criteria:
inclusion criteria: * reets prioritization level of "orange", "yellow", "green" or "blue" * 18 years old * bmi ≥25 kg/m2 * need of pvc according to emergency department guidelines * able to give written informed consent exclusion criteria: * unable or unwilling to provide informed consent * life threatening patient status (reets prioritization level of "red") * immunosuppression * pregnant or lactating women * blood infections * puncture zone skin damaged (burns, eczema, infection)

Keywords: nurse led ultrasound emergency department overweight obesity
culture system for isolating circulating tumor cells_2

Conditions: Early Diagnosis; Diagnostic Techniques and Procedures

Summary: this culture system utilizes the special affinity difference of biomedical material coating for different cells to achieve the effect of isolating tumor cells from the blood sample. the coating of the system has the characteristic that to make the wbcs adhesion, but the cancer cells in the blood sample suspend in the culture medium, which achieves the effect of separating cancer cells from the blood. the supernatant with the cancer cells can further be isolated from the cultural system for related analysis and detection to achieve early diagnosis and screening.


Eligibility criteria:
inclusion criteria: * patients with lung cancer are between the ages of 20 and 70 * willing to sign the consent form under the informed consent exclusion criteria: * vulnerable subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.

Keywords: circulating cancer cells biomedical polymer material cell affinity difference white blood cell attachment
safety and efficacy of coaxial smart drain (redax tm) in uniportal-vats

Conditions: Pleural Effusion; Video Assisted Thoracic Surgery; Chest Tubes

Summary: the aim of the study is to evaluate efficacy and safety of "smart coaxial drain" (redax tm, poggio rusco, mantova, italia) in terms of total amount of effusion drained, incidence of residual effusion at chest x-ray and patient's comfort in uniportal- and biportal-vats upper lobectomies. in particular, to evaluate in uniportal-vats upper lobectomies the efficacy and safety of smart coaxial drains compared with standard silicone chest tubes.

at the end of lung surgery, usually surgeons placed one or more chest tubes. there are several types of chest tubes and the type used by surgeons depends on centre avaiability/ local practice or surgeon choice etc...coaxial smart drains are used in clinical practice since several years in thoracic surgery. in thoracoscopic (vats) surgery usually only one chest tube is placed. in this study, we evaluate the efficacy of placement of 28fr "coaxial smart drain" chest tube versus 28 fr standard chest tube after uniportal- or biportal-vats upper lobectomies in terms of total amount of effusion drained, incidence of residual effusion at chest x-ray and patient's confort.

Eligibility criteria:
inclusion criteria: * patients undergone upper right or left lobectomy in uniportal- or biportal-vats exclusion criteria: * patients undergone open surgery * patients undergone middle or lower lobectomies * patients undergone chest wall/or wedge resections
open-angle glaucoma subjects on one topical hypotensive medication randomized to treatment with one or two trabecular micro-bypass stents in conjunction with cataract surgery

Conditions: Open-angle Glaucoma

Summary: evaluation of intraocular pressure (iop) lowering effect of one istent versus two istents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.


Eligibility criteria:
inclusion criteria: * phakic study eye requiring cataract removal and posterior chamber intraocular lens (pc-iol) implantation * primary open-angle glaucoma (including pigmentary or pseudoexfoliative) exclusion criteria: * aphakic or pseudophakic with posterior or anterior chamber iols (pc-iols or ac-iols) (study eye) * prior stent implantations (study eye)

Keywords: open angle glaucoma pigmentary glaucoma pseudoexfoliative glaucoma
safety study of tofacitinib versus tumor necrosis factor (tnf) inhibitor in subjects with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: this post-marketing study is designed to compare the safety of tofacitinib versus tnf inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.


Eligibility criteria:
inclusion criteria: * moderate to severe rheumatoid arthritis * taking methotrexate without adequate control of symptoms * have at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular ra disease) exclusion criteria: * current or recent infection * clinically significant laboratory abnormalities * pregnancy

Keywords: post-marketing phase 4 open-label safety surveillance cp690550 xeljanz oral treatment
safety and tolerability of patisiran (aln-ttr02) in transthyretin (ttr) amyloidosis

Conditions: TTR-mediated Amyloidosis

Summary: this was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (aln-ttr02) in participants with transthyretin (ttr) mediated amyloidosis (attr).


Eligibility criteria:
inclusion criteria: * body mass index must be between 17 kg/m\^2 and ≤ 33 kg/m\^2; * women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use appropriate contraception; * males agree to use appropriate contraception; * diagnosis of ttr amyloidosis; * adequate blood counts, liver and renal function; * willing to give written informed consent and are willing to comply with the study requirements. exclusion criteria: * known human immunodeficiency virus (hiv) positive status or known or suspected systemic bacterial, viral, parasitic, or fungal infection; * received an investigational agent, other than tafamidis or diflunisal, within 30 days prior to first dose study drug administration; * prior liver transplant; * poor cardiac function; * considered unfit for the study by the principal investigator; * employee or family member of the sponsor or the clinical study site personnel.

Keywords: rnai therapeutic