Kornimate/medical-research-clean huggingface dataset:
cost-effective analysis of two approximation devices in closure of gastrointestinal defects

Conditions: Gastrointestinal Neoplasms

Summary: this is a prospective, randomized research trial that aims to evaluate the clinical results of two different approximation methods to close the tissue defect caused by removing gastrointestinal polyps.

closure of gi defects after endoscopic resection decreases the rate of post resection bleeding. traditionally, standard tts clips have been used to close gi wall defects with some success. however, complete apposition of the resection wall edges occurs only 68% of the time. endoscopic suturing with the traditional overstitch device can achieve complete closure in almost 100% of defects. however, this device is costly, requires the use of a double channel therapeutic endoscope, and at times can be difficult to maneuver. recently, a novel fda approved tts tissue helix and suture device (x-tack) was developed to overcome the challenges of the traditional overstitch device. animal models have demonstrated the x-tack system is superior to tts in effecting large mucosal defects and maintain similar durability. at bcm, we have been using the x-tack system routinely in closure of gi defects.

Eligibility criteria:
inclusion criteria: * patient is greater than or equal to 18 years of age. * patient can provide informed consent. * patient is referred for endoscopic mucosal resection (emr) or endoscopic submucosal dissection (esd) of gastric, small bowel, or colorectal lesion. * post resection defect \> 3cm. * lesion 2cm or greater from the dentate line. exclusion criteria: * patient is \< 18 years of age. * patient refused and/or unable to provide consent. * patient is pregnant. * patient is currently incarcerated

Keywords: closure of gi defects
q-tip test and urodynamic study

Conditions: Stress Urinary Incontinence

Summary: urethral hypermobility, which can be assessed with q-tip test, has been considered to be partly responsible for pathogenesis of women with stress urinary incontinence (sui). nonetheless, q-tip test has lost favor due to patient discomfort. thus, the purpose of this study was to search a surrogate for assessment of urethral hypermobility by correlating the q-tip angle and the urodynamic variables in women with sui.

all women with sui and underwent q-tip testing were reviewed. patient characteristics, degree of prolapse determined by pelvic organ prolapse quantification system, q-tip angle, the results of urodynamic studies, the urinary distress inventory (udi-6) questionnaire and incontinence impact (iiq-7) questionnaire were reviewed from their medical records. spearman correlation test, and univariate and multivariate backward stepwise linear regression analysis were performed as appropriate.

Eligibility criteria:
inclusion criteria: * all women with stress urinary incontinence, who underwent both q-tip testing and urodynamic study, and completed the urinary distress inventory (udi-6) questionnaire and incontinence impact (iiq-7) questionnaire exclusion criteria: * women who had incomplete exam or questionnaires
animal-assisted therapy in the residential treatment of schizophrenia and addictions

Conditions: Diagnosis, Dual (Psychiatry)

Summary: animal-assisted therapy (aat) is a complementary intervention of therapy that has shown positive results in the treatment of various pathologies. this study assesses the viability of the implementation and the efectiveness of an aat program in patients diagnosed with substance abuse disorder and associated mental disorders (dual pathology).

animal assisted therapy (aat) is a complementary intervention to therapy that presents positive results in the treatment of different pathologies. the study assesses the implementation and effectiveness of a taa program in patients diagnosed with substance use disorder and schizophrenia spectrum disorder.

Eligibility criteria:
inclusion criteria: * meeting dsm-5 criteria for substance abuse disorder and the presence of schizophrenia * voluntary participant in the study and having signed the informed consent exclusion criteria: * patients whose functioning could be altered by factors not specifically related to addictive pathology or mental disorder (severe cognitive impairment, intellectual deficiency or language barrier) * animal-specific phobia

Keywords: animal-assisted therapy everyday life skills schizophrenia residential treatment dual pathology
study of cabozantinib treatment in patients with unresectable, locally advanced or metastatic renal cell carcinoma who progressed after previous treatment with checkpoint inhibitors

Conditions: Locally Advanced or Metastatic Renal Cell Carcinoma

Summary: to understand the epidemiology, treatment patterns and outcomes of patients with metastatic renal cell carcinoma (mrcc). data from mrcc patients who received cabozantinib versus non-cabozantinib tyrosine kinase inhibitor (tki) (a type of targeted cancer drug) immediately after check point inhibitor (cpi) treatment (a type of immunotherapy that blocks proteins that stop the immune system from attacking the cancer cells) in us community oncology practices will be analyzed.


Eligibility criteria:
inclusion criteria: * evidence of metastatic renal cell carcinoma (mrcc) during the study period (may 01, 2016 to march 31, 2020); * patients who received cabozantinib or non-cabozantinib tki regimens during identification period (may 01, 2016 to september 30, 2019); * patients who received cpis, as monotherapy, or in combination with a cytotoxic t-lymphocyte-associated antigen 4 (ctla-4) inhibitor (e.g. ipilimumab+nivolumab), as the latest treatment for mrcc administrated before cabozantinib or other tki therapy; * patients ≥ 18 years of age as of their index date * patients who received care at a us oncology network site * patients with ≥ 2 visits within the us oncology network. exclusion criteria: * patients enrolled in a clinical trial at any time during index period * patients receiving treatment for another documented primary cancer diagnoses during the study period
minimally invasive superficial venous insufficiency surgery and digital sedation

Conditions: Superficial Venous Insufficiency

Summary: virtual reality has been shown to reduce the pain experienced during medical procedures. the aim of this study is to determine to what extent the use of this technique could make it possible to defer the administration of neuroleptanalgesia during the endovenous thermal treatment of superficial varicose veins in addition to local anaesthesia by tumescence.

the main objective of the study is to test the non-inferiority of the effect of sedation by the virtual reality device on the intensity of maximum intraoperative pain compared with the usual neuroleptanalgesic treatment, tolerating a margin of non-inferiority of 0.5 points.pain will be assessed on an ens immediately at the end of the surgical procedure. prospective, randomised, open-label, single-centre study in two parallel groups of 200 patients. maximum duration of patient participation in the study = 2 days.

Eligibility criteria:
inclusion criteria: * patient aged 18 or over, who has read and signed the consent form for participation in the study after a reflection period (approximately 1 hour). * outpatients with superficial venous insufficiency for which a surgical indication has been given * patient requiring sedation associated with local anesthesia exclusion criteria: * contraindication to local anesthesia or any of the sedatives used in the protocol * hearing or visual impairment contraindicating use of the virtual reality headset * pregnant or breast-feeding patients * unbalanced epilepsy * patients under court protection, guardianship or curatorship * patients not affiliated to the french social security system * patient unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-french-speaking patient
a clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of js401

Conditions: Hyperlipidemia

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single-dose of js401 in healthy volunteers with normal or mildly elevated triglycerides.


Eligibility criteria:
inclusion criteria: 1. healthy male or female subjects aged 18\~60 (inclusive) at the time of signing the icf, with no less than 1/3 of either gender; 2. fasting tg≥1.1mmol/l (100 mg/dl) and ≤ 5.0mmol/l (450mg/dl) at screening; (3) fasting ldl-c at screening\> 1.8 mmol/l (70 mg/dl). exclusion criteria: 1. have a medical history or clinical evidence that the subject has obvious concomitant diseases (including but not limited to: cardiovascular, respiratory, digestive, urinary, neurological, blood, immunological, endocrine and metabolic, infection, etc.), or any clinically significant abnormalities found in physical examination, laboratory examination, and ecg examination, which are judged by the investigator to not meet the standards of clinical health or are not suitable for participating in clinical trials; 2. acute or chronic infection requiring hospitalization or undergoing systemic parenteral therapy (antiviral/bacterial/fungal/parasitic, etc.) within 60 days prior to randomization; 3. positive for syphilis antibodies, or positive for human immunodeficiency virus (hiv) antibodies, or positive for hepatitis c virus (hcv) antibodies, or positive for hepatitis b virus surface antigen (hbsag) at screening; 4. history of substance abuse within 12 months prior to screening, or positive urine drug screening at screening; 5. history of alcohol dependence within 6 months prior to screening, or positive breath test for alcohol at screening
accelerated vs standard approach to continuous veno-venous hemodiafiltration post-hemoperfusion (asap) in severe acute diquat poisoning

Conditions: Diquat Poisoning

Summary: diquat (1,1'-ethylene-2,2'-bipyridinium) is a bipyridine herbicide that shares a similar physicochemical structure and redox cycling mechanism with paraquat. upon ingestion, it is rapidly absorbed and distributed to gastrointestinal tract, kidneys, liver, skeletal muscle, lungs, myocardium, and central nervous systems. patients with severe diquat poisoning often develop toxic encephalopathy, circulatory collapse, and multi-organ dysfunction. extracorporeal treatments, including hemoperfusion, hemodialysis, and continuous kidney replacement therapy (ckrt), are widely employed to manage diquat poisoning. continuous veno-venous hemodiafiltration (cvvhdf), the most frequently used ckrt modality, is primarily indicated for acute kidney injury (aki). aki occurs in up to 73.3% of patients with acute diquat poisoning, and nearly all patients with severe acute diquat are at risk of developing aki. in clinical practice, patients with severe acute diquat poisoning are typically defined as those with a plasma diquat concentration of ≥1000 ng/ml measured at the time of presentation to the emergency department (ed). however, the extracorporeal treatments in poisoning (extrip) workgroup has not issued any definitive recommendations on initiating extracorporeal treatments for diquat poisoning, and the optimal timing for starting cvvhdf has yet to be evaluated in clinical trials. currently, the standard practice delays initiation of cvvhdf until aki has developed. accordingly, this study proposes a pragmatic cluster-randomized controlled trial (rct) to determine whether, in severe acute diquat poisoning patients, accelerated initiation of cvvhdf following hemoperfusion is preferred compared to a standard approach in which cvvhdf is initiated only in the presence of aki or at the discretion of the treating clinician.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; and 2. a history of oral exposure to diquat solution, reported by patient(s) or their legal proxies; and 3. an exposure time (time form exposure to presentation at ed) ≤ 48 hours, reported by patient(s) or their legal proxies; and 4. plasma diquat concentration measured upon ed presentation ≥ 1,000 ng/ml. exclusion criteria: 1. evidence of co-ingestion of other toxic substances alongside diquat; and/or 2. withholding of cvvhdf due to limitations on the escalation of life-sustaining therapies; and/or 3. any ckrt within the previous 2 months; and/or 4. kidney transplant within the past 365 days; and/or 5. known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate calculated using serum creatine (egfrer) of less than 30 ml/min/1.73 m2 by the chronic kidney disease epidemiology collaboration (ckd-epi) equation, if pre-hospitalization serum creatine is available; and/or (6) treating clinician(s) believe(s) that either immediate or deferral of cvvhdf initiation is mandated; and/or (7) pregnant or breast feeding.

Keywords: diquat continuous kidney replacement therapy
real-time eye tracking and imaging of the eye in diabetic retinopathy patients

Conditions: Diabetic Retinopathy; Retinal Imaging

Summary: diabetic retinopathy (dr) is a leading cause of vision loss in working age canadians. current treatment consists of early detection and laser photocoagulation therapy for preventing progressive or severe vision loss. microaneurysms (ma) are the earliest, clinically visible changes of dr, which are visualized using specialized imaging technologies. pulsemedica is developing a three-dimensional (3d) retinal imaging system with real-time eye tracking capabilities. the purpose of this study is to assess the feasibility of pulsemedica's prototype device, the osnat800 imaging only (io), in providing real-time tracking of eye movements in patients with dr. it is hypothesized that the osnat 800 io will be able to perform real-time eye tracking while imaging patients with dr.


Eligibility criteria:
inclusion criteria: * between 18 and 70 years of age * male or female * diagnosed diabetic retinopathy * two eyes with clear ocular media exclusion criteria: * patients younger than 18 years and over 70 years of age * patients without diabetic retinopathy * opacification of cornea, lens, or vitreous
to evaluate effect of multi doses flibans 100 mg film-c tablets on single dose pk of digoxin 0.5 mg, healthy volunteers

Conditions: Healthy

Summary: the aim of this trial is to investigate the effect of multiple doses of flibanserin on the single dose pharmacokinetics of digoxin in healthy female and male volunteers. digoxin is a narrow therapeutic index drug for which a large number of relevant drug-drug interactions are known. flibanserin is now under evaluation in postmenopausal women which increases the likelihood that flibanserin and digoxin will be administered together in the clinical setting.


Eligibility criteria:
inclusion criteria: healthy male and female subjects
change on sleep quality of patients with fibromyalgia subjected to a protocol based on physical exercise and stretching

Conditions: Fibromyalgia; Sleep; Stretch

Summary: this study evaluates the effect to a muscle stretching program combined with physical exercise versus a physical exercise program in patients with fibromyalgia.

although classically this pathology was characterized by having an unknown etiology, current research suggests that the disease shows several abnormalities in the central pain processing. central sensitization is defined as changes in neuroplasticity of central nervous system as a result of persistent and intense sensory information nociceptive generated by peripheral and transmitted to the neurons in the dorsal horn of the cord through the nerves of the peripheral nervous system tissues, through a constant activity of c fibers and a-beta fibers. in recent years the theory that pain is responsible for other symptoms, is changing, and it is theorized that the quality of sleep directly influences in the symptoms. the treatment of fibromyalgia is based on trying to reduce pain and associated symptoms described above in order to improve the quality of life of these patients. almost all revisions studying the effects of physical activity in fibromyalgia agree that it is effective in reducing the overall impact on the disease and its symptoms. muscle strength training aim to improve the strength, endurance and muscle power. there are few conclusive studies on the benefits of stretching and flexibility exercises on the impact of fibromyalgia.

Eligibility criteria:
inclusion criteria: * be 18 years or more. * to be diagnosed with fibromyalgia according to the criteria established by the "american college of rheumatology", either on the basis of its publication of 1990 or the current revision of 2010. * accept to volunteer and give oral consent. before starting the intervention must be provided written informed consent. exclusion criteria: * do not present any pathology in which physical exercise is contraindicated. * do not suffer another serious somatic illness or severe psychological disorder. not suffer severe dementia (mmse \<10). * do not be participating at the time of the study in any other intervention of physical or psychological.
effect of digital cognitive training on the functionality of older adults with mild cognitive impairment (mci)

Conditions: Mild Cognitive Impairment; Aging

Summary: the purpose of this study is to investigate the effect of digital cognitive training in the functionality of older adults with mild cognitive impairment.

mild cognitive impairment (mci) is characterized by decline in one or more cognitive domains, including memory, attention, executive functions, language and visuospatial abilities, and in a significant portion of cases may evolve to alzheimer's disease. according to established diagnostic criteria, independence for daily life activities is preserved, but activities are carried out less effectiveness and efficiency, affected subjects usually take more time and make more mistakes, when compared to their pre-morbid performance. different studies have observed that impairments in functional performance in older adults with mci are associated with impairments in executive function. this study intends to verify the impact of the use of digital cognitive training for executive function on the functionality of older adults with mci. digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the internet using the brainhq platform. the active control group will play computer games available online. both groups will play for 1 hour at least 2 times per week. after baseline assessments, older adults with mci will be stratified by age, education, gender, functional measurement and cognitive assessment, and randomly assigned to the intervention group with digital cognitive exercises or to the control group with computer games, in a stepped wedge design. subjects will be evaluated at baseline and after completing 10 and 20 hours of intervention. after the first 10 hours of intervention both groups will be assigned to the intervention with digital cognitive exercises for additional 10 hours. both groups will be comparable in terms of personal contact with staff and computer time. our hypothesis is that the training using digital cognitive exercises will improve the executive function and that this gain has a positive impact on the functionality and accomplishment of the daily life activities of older adults with mci.

Eligibility criteria:
inclusion criteria: * age above 65 years old; * elderly enrolled in home for aged in wich the research is taking place; * montreal cognitive assessment above 21 points; exclusion criteria: * clinical diagnosis of alzheimer's disease; * serious medical or neurological condition preventing from participation in the study;
cva21 and pembrolizumab in nsclc & bladder cancer (vla-009 storm/ keynote-200)

Conditions: Non-small Cell Lung Cancer; Bladder Cancer

Summary: the purpose of this trial is to assess the ability of cva21, either alone (part a) or in combination with pembrolizumab (part b), to reach and to replicate in existing tumors (while sparing normal cells) and to establish a safe multi-dose schedule of the virus for the treatment of solid tumors where enhanced expression of icam-1 and/ or daf receptor occurs. this trial consists of 2 sequential parts: vla-009 (part a) conducted only in the uk and employed cva21 as a monotherapy in nsclc, castrate-resistant prostate cancer, melanoma and bladder cancer. vla-009 (part b) conducted in the us, aus and uk employs cva21 with pembrolizumab in nsclc and bladder cancer. both vla-009a and vla-009b are open-label, multi-center, ascending dose escalation (3+3 design) dose-finding and signal-seeking studies. part a of the study is now complete and closed to enrolment. part b is currently enrolling.


Eligibility criteria:
inclusion criteria: * histologically-confirmed (1) nsclc, (2) bladder cancer, (3) castrate-resistant prostate cancer which are metastatic, or (4) stage 3c or stage 4 melanoma. * vla009a: locally advanced and/or metastatic disease for which curative surgery and/or radiation therapy is not possible and judged not to be a candidate for the current standard of care treatment. vla009b: locally advanced and/or metastatic disease and judged to be a candidate for pembrolizumab to be used in combination with cva21. * all subjects in cohort 3 or phase 2 dose (p2d) must have a lesion accessible for fna or core or open biopsy on day 8 of the first treatment cycle. * no cva21 neutralising antibody (≤ 1:16) * measurable or evaluable disease exclusion criteria: * second primary malignancy within the past 2 years (except non-melanoma skin cancer, in situ carcinoma of the cervix, breast cancer) * concurrent immunosuppressive therapy and no known immunosuppressive disease other than primary tumour

Keywords: cavatak keynote-200 pembrolizumab lung cancer bladder cancer
efficacy of acupuncture in the treatment of moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study used a multicentre parallel three-armed randomised sham-controlled clinical trial methodology in order to objectively and normatively assess the efficacy of acupuncture on quchi the sea of blood the foot sanli and the sanyinjiao in the treatment of moderate-to-severe atopic dermatitis so as to obtain high-level evidence-based medical evidence. this study adopts a multi-centre, parallel, three-armed, randomized, sham-controlled clinical trial method, and will be conducted at yueyang hospital of integrative medicine affiliated with shanghai university of traditional chinese medicine, huashan hospital affiliated with fudan university, and seventh people's hospital affiliated with shanghai university of traditional chinese medicine. eligible patients with moderate-to-severe ad will be divided into three groups using stratified block randomisation in the ratio of 2:2:1: the acupuncture group, the sham-acupuncture group and the waitlisted control group. the total observation period is 9 weeks, including a 1-week introduction period, a 4-week treatment period and a 4-week follow-up period.


Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria for moderate to severe atopic dermatitis; * age ≥18 and ≤75 years old gender is not limited; ③ peak pruritus numerical rating scale (pp-nrs) score ≥4; ④ voluntarily participate in this trial and sign the informed consent form. exclusion criteria: * patients who are in the acute onset of the disease and have erosions exudates and secondary infections; * patients who have participated in other clinical studies in the past 3 months or are participating in other clinical studies; ③ patients with severe haematological diseases (e.g. platelet count \<50×109 /l) and other serious diseases that may affect operation and efficacy; * current systematic use of glucocorticosteroids discontinued for less than 7 days; immunosuppressants (cyclosporine methotrexate tretinoin etc.) discontinued for less than 1 month; dulprevirizumab discontinued for less than 1 month jak inhibitors discontinued for less than 2 weeks; * women who are pregnant or breastfeeding; ⑥ patients with a history of acupuncture treatment.