Kornimate/medical-research-clean huggingface dataset:
telenursing and remote monitoring in idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: numerous studies show that remote monitoring and/or telenursing improves outcomes for patients especially those with chronic diseases. it is proposed that structured telenursing with non-invasive home monitoring of forced vital capacity and oxygen saturation in newly diagnosed patients with ipf will decrease hospitalizations for respiratory illness, increase compliance with therapies, and ultimately increase quality of life.

patients undergoing evaluation for and who are diagnosed with idiopathic pulmonary fibrosis at vanderbilt medical center from august 1, 2018, will be asked to participate. if agrees, and after signing the consent form, patients will be randomized into one of three arms: usual care, usual care with telenursing, or usual care with telenursing and remote monitoring. patients will be asked to remain in the study for a minimum of three years.

Eligibility criteria:
inclusion criteria: 1. patient must be newly diagnosed with ipf by a vanderbilt pulmonologist according to the 2011 american thoracic society guidelines. if the patient has been diagnosed by local pulmonologist and started on fda-approved treatment, then must have been started on treatment within 6 months of vanderbilt university medical center-based diagnosis. 2. willingness to complete quality of life and compliance questionnaires at 6-month intervals either via an on-line process (red cap survey) or paper-based. 3. willingness to participate in phone calls/video calls with the nurse practitioner or nurse case manager, if assigned to arm 2 or arm 3. 4. willingness to complete and monitor daily health assessments, if assigned to arm 3. 5. willingness to share objective data via a provided electronic web-based portal, electronically via email, fax, or regular mail. 6. willingness to notify, or allow notification, of study involvement with local pulmonary practices. exclusion criteria: 1. diagnosed with any other interstitial lung disease. 2. diagnosed and began treatment \> 6 months before the vumc-based diagnosis date.
renal and cardiovascular effects of terlipressin in patients with cirrhosis and ascites

Conditions: Cirrhosis; Ascites

Summary: the purpose of this study is to investigate the effect of terlipressin on myocardial perfusion and renal function. hypothesis: significant improvement of renal function reflected by: glomerular filtration rate (gfr), renal blood flow (rbf), excretion of salt and metabolites in the urine and related hormones and peptides in the blood. no effect on the systolic function of the heart.


Eligibility criteria:
inclusion criteria: * cirrhosis and ascites
improving participation after stroke self-management-rehabilitation

Conditions: Stroke

Summary: the overall goal of this proposed study is to evaluate the efficacy of a small-group, stroke-specific, self-management program delivered via telehealth to improve self-efficacy, activity performance, and quality of life in individuals with sub-acute stroke.


Eligibility criteria:
inclusion criteria: * less than 6 months post-stroke * age 45-85 years * completed inpatient rehabilitation services (if recommended) * living in the community with or without caregiver support (i.e., not living in a skilled nursing facility) * ability to read, write, and speak english * diagnosis of mild or moderate stroke (national institutes of health stroke score \<16) * able to use videoconferencing independently or with caregiver support exclusion criteria: * severe depressive symptoms as indicated by a score ≥21 on the patient health questionnaire * dementia symptoms as indicated by a score of \<23 on the montreal cognitive assessment * additional neurological diagnoses (e.g., brain malignancy, previous severe stroke) * (4) moderate or severe aphasia as indicated by a national institutes of health stroke scale aphasia score of ≥ 2 * inability to provide informed consent * any other condition not otherwise specified that the pi determines would render participation in this study as unsafe for the participant

Keywords: stroke self-management telehealth activities of daily living community engagement
postural control and psychosocial measures associations in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: balance deficits, gait abnormalities, impaired cognitive function, psychological disturbances and disconnection from community are key characteristics of multiple sclerosis (ms). thus, exploring the interrelationships and the primary risk factors related to clinical manifestations and consequences of ms is of definite clinical significance. the primary aims of the study are to evaluate the association interplay among balance, functional mobility, cognitive function, psychological well-being, and community participation in addition to identify the anticipated contributing factors that function as predictors of ms features.

this cross-sectional study will be carried out on sixty-four patients with ms. balance performance was evaluated by a standardized berg balance scale (bbs). functional mobility will be measured via the well validated timed up and go (tug) test. patients᾽ cognitive functions will be assessed by the montreal cognitive assessment (moca), which is a sensitive screening test for the diagnosis of mild cognitive impairment. the psychological well-being will be measured based on the hospital anxiety and depression scale (hads), which is widely employed to evaluate mood disturbances in clinical settings. furthermore, community participation and engagement constraints will be measured with the community integration questionnaire (ciq) as they clearly capture the extent of functional and social integration into the community.

Eligibility criteria:
inclusion criteria: participants will be screened for inclusion criteria to guarantee sample homogeneity and clinical applicability. first, all subjects will be diagnosed with ms confirmed by a neurologist according to the revised mcdonald criteria. these criteria have the highest sensitivity and specificity and therefore are considered the gold standard in ms diagnosis. second, participants will be be aged at least 18 years, so as to be able, cognitively and legally, to engage in the study as an informed study volunteer. third, relapse- and relapse related treatments should be stopped by at least 1 month before the assessment. this is crucial in order to maximize the control of the transient influence of aggravation of the symptoms on patients᾽ cognitive and motor performance. fourth, individuals will be eligible to participate in the study if they can ambulate, either independently or with the use of assistive device, as the study includes physical performance measures such as balance and gait. finally, the maximum edss-value will be below 6 (moderate disability) to ensure independence of gait without constant support, as this is necessary to ensure comparability of balance and cognitive function. exclusion criteria: -

Keywords: balance cognitive function depression multiple sclerosis
dexamethasone, can it replace ketoprofen in the strategy of intraoperative multimodal analgesia in paediatric surgery ? a prospective randomized double-blinded study. dexa op

Conditions: Postoperative Nausea and Vomiting

Summary: postoperative pain and nausea-vomiting (ponv) are the first causes of failure in ambulatory care in pediatric surgery. actually, the paracetamol/ketoprofen combination in intraoperative care is recommended for effective postoperative analgesia in children. however, intravenous ketoprofen doesn't have the marketing authorization for use in children less than 15 years old and its use is mainly justified by the absence of therapeutic alternatives. recently, findings from published studies suggest that dexamethasone (dxm), which is actually recommended to prevent ponv for children "at risk", at a dose of 0.1mg/kg, would have analgesic properties above 0.15 mg/kg comparable to non-steroidal anti-inflammatories (nsai). main objective : to examine the effects of intraoperative dxm (0.2mg/kg and 0.4mg/kg) on the intensity of postoperative pain in the post-anaesthetic care unit (pacu) compared to ketoprofen (1mg/kg). secondary objectives : to examine the effects of intraoperative dxm (0.2mg/kg and 0.4mg/kg) compared to ketoprofen (1mg/kg) on the anesthesia emergence delirium, the intensity of postoperative pain, the consumption of rescue analgesics and the side effects in the first 24 hours after surgery.

methodology : non inferiority, phase iii, therapeutic trial. prospective, randomized double-blinded, monocentric study. inclusion of 567 patients. inclusion will be performed by the anesthesiologist, the day of surgery during the preoperative visit. each patient will be randomised to receive intraoperative dxm (0.2mg/kg), dxm (0.4mg/kg) (max 20mg) or ketoprofen (1mg/kg) (max 100mg). the clinical data will be collected prospectively in an electronic database. if the hypothesis of non-inferiority is verified, it is planned to test the superiority of the hypothesis secondarily. treatment : single injection of dxm (mylan dexamethasone® 20 mg/5 ml or 4 mg/1 ml injection ampoule solution) at 0.2 mg / kg or 0.4 mg/kg or single injection of ketoprofen (medac ketoprofen ® 100 mg/4 ml injection ampoule solution) at 1 mg /kg after general anesthesia induction and before surgery incision.

Eligibility criteria:
inclusion criteria: * children, aged 1 to 16 years * undergoing surgery (orchiopexy, inguinal hernia, circumcision, adenoidectomy, tonsillectomy or orthopedic act with osteosynthesis) * parental consent exclusion criteria: * contraindication to nsai or dxm * hypersensitivity to ketoprofen, dxm, hypnovel or atarax * porphyria * long qt syndrome * renal or hepatic impairment * corticosteroid consumption the week before surgery * nsai consumption within 48 hours before surgery * iv induction for full stomach or myopathic patient. * french language not spoken by parents. * simultaneous participation in biomedical research on health products

Keywords: paediatric surgery
interval versus continuous exercise during pregnancy

Conditions: Pregnancy Related; Glucose, Low Blood; Fetal Heart Rate or Rhythm Abnormality Affecting Fetus; Fetal Blood Flow

Summary: the objective of this randomized cross-over design was to investigate the fetal well-being and maternal glycemic response to an acute bout of aerobic high-intensity interval training (hiit) and moderate-intensity continuous training (mict) with pregnant individuals.


Eligibility criteria:
inclusion criteria: * carrying a singleton pregnancy (i.e. greater than or equal to 20 weeks of gestation). * has access to a stationary bike * located within canada and/or within edmonton alberta exclusion criteria: * history of smoking within the last year * taking medications that may interfere with cardiovascular function. * high-order pregnancies, e.g. twins or above. * females with absolute contraindications (as outlined by the canadian guidelines for physical activity throughout pregnancy and the parmed-x questionnaire)
assessment of nfl and gfap levels, atrophy of the macula gcc by oct and whole brain atrophy by mri to predict evolution of neurological disability in ms patients

Conditions: Multiple Sclerosis

Summary: the investigators hypothesize that serum neurofilament-light chain (nfl) levels at baseline and decrease of the macular ganglion cell complex (gcc) thickness at one year vs. baseline are as good as progression of whole brain atrophy at one year vs. baseline to predict later evolution of neurological disability in multiple sclerosis patients.


Eligibility criteria:
inclusion criteria: * the patient has been correctly informed. * the patient must have given their informed and signed consent. * the patient must be insured or beneficiary of a health insurance plan. * the patient is at least (≥)18 years old. * the patient has experienced a cis, has currently a rrms or progressive ms with: * less than 10 years of disease duration; * with or without dmd; * edss score 0 - 7.0. exclusion criteria: * the patient is in an exclusion period determined by a previous study. * the patient is under judicial protection. * the patient refuses to sign the consent. * it is impossible to correctly inform the patient (inability to understand the study, language problem). * the patient is pregnant or breast-feeding. * patient has a bilateral optic neuritis or other significant ophthalmological antecedent. * patient with mri contra-indications. * patient has a contraindication to gadolinium injection * the patient has bilateral optic neuritis or other significant ophthalmological antecedent * patient is having a relapse or has had a relapse in the last 3 months * the patient has a severe psychiatric illness * the patient has severe chronic alcoholism

Keywords: gfap nfl
ultra-low dose oral ketamine for chronic pain in the primary care setting

Conditions: Chronic Pain

Summary: this project is a pilot study to evaluate the analgesic and opioid-sparing effects of ketamine in an ultra-low dose oral formulation as a novel intervention for treatment of chronic non-cancer pain in opioid-tolerant patients in the primary care outpatient setting.

chronic pain is a major national public health issue, affecting about 100 million adults in the united states. opioid pain medications are commonly used for treatment of chronic pain, but their use is fraught with consequences including an increasing prevalence of misuse, abuse, and overdose death, and side effects which lead to a reduced quality of life. an effective and safe medication that would improve control of chronic pain while reducing reliance on opioid medications would be valuable for patients, medical providers and society at large. ketamine, commonly used as an intravenous anesthetic agent, has been shown to have analgesic and opioid-sparing effects in the peri-operative period and in the palliative care setting. based on promising preliminary data from an open-label treatment trial, this project is a pilot study to evaluate the analgesic and opioid-sparing effects of ketamine in an ultra-low dose oral formulation as a novel intervention for treatment of chronic non-cancer pain in the primary care outpatient setting. the design of the proposed study is a randomized controlled two week parallel-group trial, with 32 patients receiving either the active treatment or placebo twice daily.

Eligibility criteria:
inclusion criteria: * age 18 years or older * routine use of an opioid medication for non-cancer pain for more than six months * a current average daily dose of greater than or equal to 20 mg morphine or equivalent * current prescription of an as-needed opioid suitable for downward titration during the study period * ability to provide informed consent ability to adhere to the study protocol exclusion criteria: * uncontrolled hypertension, cardiac arrhythmia or other known cardiac disease, * elevated intracranial pressure, * severe glaucoma, * schizophrenia, * diagnosed substance use disorder, or * other unstable medical or psychiatric illness or pregnancy.
maximizing trichiasis surgery success

Conditions: Trichiasis; Surgery

Summary: the purpose of this study is to determine whether the rate of post-operative trachomatous trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision height of 3 mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and trabut surgery.

in this trial the investigators will randomize 4,953 individuals with previously unoperated trichiasis on a 1:1:1 basis to bilamellar tarsal rotation trichiasis surgery with an incision height of 3 mm, bilamellar tarsal rotation trichiasis surgery with an incision height of 5 mm, or trabut surgery. participants will receive trichiasis surgery then will be followed at 1 day, 2 weeks, 6 weeks, and 12 months after surgery. some participants may be asked to attend a follow-up visit at 3-6 months. the primary outcome is development of post-operative trachomatous trichiasis (ptt) within 12 months after surgery. logistic regression analyses will be performed to compare the rates of ptt in the 3 versus 5 mm incision bilamellar tarsal rotation (bltr) groups, in the 3 mm bltr versus trabut group, and in the 5 mm bltr versus trabut group, adjusting for demographic characteristics and pre-operative trichiasis severity.

Eligibility criteria:
inclusion criteria: * at least one eyelid with previously unoperated upper eyelid trichiasis * willing to comply with all study procedures and be available for the duration of the study exclusion criteria: * inability to provide independent, informed consent * all eyes with previously unoperated trichiasis are phthisical
circulating tumor dna guided treatment monitoring in advanced lung cancer

Conditions: Non-small Cell Lung Cancer Metastatic

Summary: the study is a prospective randomized interventional study including patients with advanced non-small cell lung cancer, receiving immunotherapy, with the aim of optimizing treatment monitoring. the study aims to investigate the clinical utility of liquid biopsy monitoring in order to reduce the numbers of inefficient treatments and needless toxicity - and to explore the cost-effectiveness and cost-utility of introducing liquid biopsy monitoring in daily clinical practice.

lung cancer is the leading cause of cancer-related death worldwide with non-small cell lung cancer (nsclc) being the most common subtype. performance status deterioration due to progressive symptoms and toxicity by treatments are major challenges in managing advanced nsclc patients. moreover, standard treatment monitoring by radiologic scans is often imprecise. this technology has limited sensitivity as only a visible increase or decrease in tumor mass can be evaluated, making interpretation challenging and conclusions of whether patients benefit from treatment indefinite. interpretation of radiologic scans has been further challenged after implementation of immunotherapy, causing immunotherapy-induced recruitment of immune cells resembling increment in tumor size, called "pseudo-progression." more sensitive methods are highly needed to reduce ineffective treatments and needless toxicity. liquid biopsy has the potential to overcome these challenges by measuring molecular changes with high precision in a dynamic manner. recent studies have demonstrated its promising potential as a biomarker predictive of treatment efficacy and overall survival. in a recent real-life study, investigators found that ctdna measurements could reduce 33% of likely inefficient treatments and clarify 79% of non-conclusive ct-scans, highlighting the clinical potential. a randomized interventional multicenter study will be performed, investigating the true clinical potenial of liquid biopsy compared to standard monitoring by radiological scans. a total of 350 patients with advanced nsclc will be included in the study from three departments of clinical oncology. in the interventional arm, liquid biopsy monitoring will be the basis for treatment discontinuation before the standard two years of immunotherapy in patients reaching a complete molecular response in plasma. thus clarifying the question if treatment duration can be reduced for the benefit of patients and health cost.

Eligibility criteria:
inclusion criteria: * newly diagnosed, histologically verified, non-small cell lung cancer (nsclc) * advanced or locally advanced disease without curative intended treatment options * age \> 18 years * eastern cooperative oncology group (ecog) score of performance status (ps) 0-1 * measurable disease according to the irecist criteria version 1.1. * eligible to first line immunotherapy (monotherapy) * signed informed consent exclusion criteria: * targetable alterations in egfr, alk or ros-1 * other active cancers

Keywords: liquid biopsy treatment monitoring
p-15l bone graft in transforaminal lumbar interbody fusion with instrumentation

Conditions: Degenerative Disc Disease

Summary: the aim of this trial is to evaluate if p-15l bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (tlif) in subjects with degenerative disc disease (ddd). in addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.


Eligibility criteria:
inclusion criteria (abbreviated): skeletally mature adults between 22 and 80 years old (inclusive); back pain with radicular symptoms as evidenced by leg pain, confirmed by history and physical exam; oswestry low back pain disability questionnaire score of ≥ 35; involved disc(s) between l2 and s1; exclusion criteria (abbreviated): significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia; active malignancy; nondiscogenic source of symptoms (e.g. tumor, etc.); multiple level symptomatic degenerative disc disease where more than one level requires fusion; previous spinal instrumentation or a previous interbody fusion procedure at the involved level; more than one level to be fused
mind-body training for hand rehabilitation

Conditions: Arm Injuries; Hand Injuries

Summary: the objectives of this pilot study are to: (1) evaluate acute effects of biofeedback and mindfulness training on pain, anxiety, and stress during a hand therapy visit and (2) gain understanding of patient perceptions, preferences, and experiences with mind-body interventions.

each year more than $5.7 billion is spent on outpatient therapy, which is projected to grow 6% annually over the next decade. subsequently, healthcare reform is mandating more efficient, high-quality care to control spending. thus, the long-term goal of this work is to develop an integrative health intervention for hand therapy that improves efficiency, enhances outcomes and reduce costs. biofeedback and mindfulness training are two mind-body interventions that can increase patient engagement and self-efficacy. no research has investigated the integration of these mind-body interventions into treatment for hand therapy patients. this pilot research will explore the acute effects of these techniques in hand therapy patients. this study utilizes a repeated-measures crossover design with 20 participants to explore the effects of mindfulness training and the dynamic biofeedback with sonographic imaging on acute pain, anxiety, and stress. additionally, the study will evaluate hand therapy patient preferences and perceptions of mind-body techniques. this patient-centered, clinical translational work will provide valuable feasibility data regarding the direct, acute effects of mind-body interventions to inform the development and further study of an integrative hand rehabilitation approach. this responds to a need for best practices for maximizing the mind-body connection and the call to investigate innovative uses of mindfulness to enhance patient outcomes.

Eligibility criteria:
inclusion criteria: * referral to usc keck hospital hand clinic * upper extremity pathology resulting in decreased hand use * pain with activity greater than 4 out of 10 * scheduled to attend at least 2 therapy sessions per week * speak and read english * able to independently read and respond to questionnaires exclusion criteria: * cast or open wounds in the distal upper extremity * bilateral upper extremity pathology involvement * significant visual or hearing deficit