Kornimate/medical-research-clean huggingface dataset:
a virtual post-discharge intervention for patients with ckd

Conditions: Chronic Kidney Diseases

Summary: this pilot, interventional study is testing a combination of remote, virtual interventions, delivered to patients at home to patients with chronic kidney disease (ckd), with the goal of reducing admissions to hospital.

chronic kidney disease and kidney failure increase the risk of hospitalizations. many hospital admissions are potentially avoidable. this pilot, interventional study is testing a combination of remote, virtual interventions, delivered to patients at home, with the goal of reducing admissions to hospital. the hypothesis for this pilot work is that the proposed interventions will be adopted by patients and will improve mental health, physical function, quality of life, and disease self-management, which are all key potential mediators of hospital readmission risk in patients with chronic kidney disease.

Eligibility criteria:
inclusion criteria: * adults with ckd (defined as an estimated glomerular filtration rate \<30ml/min/1.73m2, including hemodialysis) * able to provide informed consent. * ongoing follow-up by the st joseph's hospital hamilton kidney care clinic or dialysis program and with a recent hospital admission. exclusion criteria: * unable to speak or understand english. * significant cognitive impairment (as per the treating inpatient care team) * serious mental illness (schizophrenia, severe untreated bipolar disorder, psychosis, active suicidal ideation) * significant vision or hearing impairment that prevents use of the technology or participation in any of the intervention components. * being discharged to long-term care, rehab or complex care. * peritoneal dialysis * home hemodialysis * functioning kidney transplant
using real-time functional brain imaging to enhance recovery from tbi

Conditions: Traumatic Brain Injury; Post Traumatic Stress Disorder

Summary: in this randomized, controlled clinical trial, we will evaluate the effects of (1) a brain-training program that uses real-time neurofeedback in functional magnetic resonance imaging (fmri) to allow people to learn how to gain voluntary control over activity in targeted brain regions and/or (2) 8 weeks of computer-based cognitive training using a software program (cognitive remediation for brain injury (crbi)) versus control training tasks on cognitive learning and symptoms. in addition, the investigators will measure brain function (active and resting functional magnetic resonance imaging) and structure (high resolution magnetic resonance imaging) before and after treatment.


Eligibility criteria:
inclusion criteria: * mild tbi: pta/confusion≤1 hour immediately after injury; or loc \<30 min \[69\] confirmed by the ohio confirmed by the ohio state university tbi identification method-short form (osu tbi-id-sf). * age 18-45 years * right handed \[70\]. * minimum of 4 months and within 36 months post-injury * can participate in fmri and outcome assessment * adequate visual, auditory, sensory-motor function for training program. * fluent in english * persistent cognitive dysfunction confirmed by an objective measure exclusion criteria: * history of hypoxic event * pre-existing significant neurological (e.g. ms) or psychiatric (e.g. schizophrenia, bi-polar) disorders. * current illicit drug use or etoh abuse * contraindications to mri (metal, pregnant, pacemaker, claustrophobia, etc.). * unwilling or unable (e.g. language barrier) to participate * hospitalization during study * current med board for discharge, litigation/ + malingering test \[71\] * use of medications to enhance cognitive function (e.g. ritalin) * initial glascow coma score \<13 or penetrating head injury * subjects must not show suicidal ideation as measured by the columbia-suicide severity rating scale (c-ssrs; 111). subjects with a score of 4 or 5 (as recommended by the fda for treatment trials) will be excluded and referred for appropriate treatment. * subjects should not be enrolled in a concurrent tbi clinical trial.

Keywords: mtbi ptsd
treatment of chronic constipation in children with lactobacillus reuteri

Conditions: Constipation

Summary: lactobacillus reuteri (biogaia) may be beneficial for treatment of chronic constipation in children 4-10 years of age.

functional chronic constipation is very common in childhood and is responsible for 20% of the clinic visits in pediatric gastroenterology. constipation is defined by the rome iii criteria. the symptoms are difficult to treat in part of the patients and cause frustration to the patient and family. probiotics are increasingly used in the treatment of functional gastrointestinal disorders, including chronic constipation in adults and children. a recent study revealed that the administration of lactobacillus reuteri had a positive effect on bowel frequency in infants with chronic constipation. the study goal is to evaluate lactobacillus reuteri (biogaia) for treatment of chronic constipation in children 4-10 years of age, and to examine the influence of lactobacillus reuteri (biogaia) on constipation in different age groups of school aged children between 4-10 yrs of age.

Eligibility criteria:
inclusion criteria: 1. patients 4-10 years old with no underlying chronic illnesses or anatomical abnormalities of the gi tract, with parents agreeing to participate in the study and signing an informed consent. 2. chronic constipation defined by the rome iii criteria (must include 2 or more of the following in a child with a developmental age of at least 4 years with insufficient criteria for diagnosis of ibs: 1. two or fewer defecations in the toilet per week. 2. at least 1 episode of fecal incontinence per week. 3. history of retentive posturing or excessive volitional stool retention. 4. history of painful or hard bowel movements. 5. presence of a large fecal mass in the rectum. 6. history of large diameter stools that may obstruct the toilet). 3. normal thyroid function test and negative celiac serology (iga or igg in patients with iga deficiency), and no evidence of elevated rast test for milk. 4. parents or tutors signed informed consent to the child's participation the study. 5. willingness to comply with the protocol.

Keywords: constipation
big data analysis of osa patients on positive airway pressure (pap) treatment: real-life monitoring

Conditions: Obstructive Sleep Apnea; Positive Airway Pressure

Summary: the present study aims to determine to what extent remote monitoring of pap related to patients' clinical parameters is able to provide relevant data on predictors of compliance, subgroups of patients who may benefit from this technological tool, variations in ahi over time, occurrence of central events at the start of therapy and, in short, to shed new light on this disease and its treatment, all within the application of continuous positive pressure therapy in the real world. among the intended objectives is the identification of phenotypes involved in the use and efficacy of pap therapy: development of a predictive model, as well as the evaluation of the impact of long-term telemonitoring of patients with obstructive sleep apnea (osa). the study initially arose from the need to diagnose, treat and follow up patients with suspected osa in compliance with the social distancing rules imposed by the covid-19 pandemic. it is an ambispective cohort study, with retrospective data collection from the start date of the pandemic (march 2020) to december 2021, and prospective data collection from the approval of the protocol to december 2022.


Eligibility criteria:
inclusion criteria: * all patients diagnosed with osa since march 2020 with indication for treatment with pap have been telemonitored on an ongoing basis since initiation of therapy continuing to be telemonitored at the current time. exclusion criteria: * undiagnosed osa patients

Keywords: telemonitoring big data
brain stimulation for anxiety and depression in youth

Conditions: Anxiety Disorders; Depression

Summary: in this open-label trial, the overall aim is to determine if tms treatment can improve anxiety and depression in a broad group of children and youth referred by physicians.

the literature suggests the peak age of mental disorder onset within the general global population is 14.5 years; a recent meta-analysis of 192 epidemiological studies also reported approximately 83% of individuals with neurodevelopmental disorders experienced onset by the age of 18 years. further, approximately 52% of individuals with anxiety or fear-related disorders, 48% with feeding or eating disorders or problems, 45% with obsessive-compulsive or related disorders, 28% with stress disorders, and 12% with mood disorders experienced onset by the age of 18 years. this high prevalence of mental disorders within the child and youth population is contributing to the need to explore additional treatment opportunities. interventions for mental disorders commonly include psycho-social and pharmacological approaches, though these therapies are largely modelled after adult populations. however, pharmacotherapy may be accompanied by side-effects, and adverse experiences with psychotropic medications at a young age may contribute to poor long-term adherence to other psychiatric therapies. another proposed intervention strategy for mental disorders involves non-invasive brain stimulation, including transcranial magnetic stimulation (tms). tms can be used to measure neurophysiology or a cortical area or be used to elicit changes in neural population activation with the use of repetitive tms (rtms) or theta-burst stimulation (tbs). both tms and tbs have been well-tolerated in children, with only mild transient side effects noted, and has been approved for use in adolescents by the fda. this study will evaluate the feasibility and acceptability of tms in a broad group of referred children and adolescents.

Eligibility criteria:
inclusion criteria: 1. aged between 6 and 18 years old; 2. diagnosis of anxiety or depression made by a qualified medical professional. exclusion criteria: 1. status epilepticus in past 12-months; 2. presence of any disease, medical condition, or physical condition that, in the opinion of the study investigator may compromise, interfere, limit, affect, or reduce the participant's ability to complete the study; 3. hospitalization for suicide attempt within the past 3 months; 4. tms-related contraindications, including implanted medical devices (e.g., pacemaker), metallic implants excluding non-ferromagnetic metals (e.g., metal dental wires), current pregnancy; 5. if actively taking prescription medication, no changes in medication for at least 3 months prior to entry into the study, with no anticipation of change in the frequency or dose over the duration of the study, unless changes to medication are required for participant safety; 6. unable to understand instructions in english.
prineo (dermabond protape) versus sutures for full-thickness surgical incisions

Conditions: Surgical Incisions

Summary: this is a prospective, controlled, randomized, multi-center clinical study of up to 80 subjects with full thickness surgical incisions. each incision included in the study will be segmented into two halves; each half will be randomized to receive final skin closure with either prineo (dermabond protape) or intradermal sutures. subjects will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * be in good general health in the opinion of the investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications; * be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty or body lift procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure; * be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub during the first 12 - 25 days of the study; * agree to return for all follow-up evaluations specified in this protocol \[7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)\], six (± 1 month) and twelve months (± 1 month)\]; * agree not to schedule any additional elective surgical procedures that involve an incision that is randomized for inclusion in this study, until their participation in this study is complete; and * sign the informed consent. exclusion criteria: * have peripheral vascular disease; * have insulin dependent diabetes mellitus; * be known to have a blood clotting disorder; * be receiving antibiotic therapy for pre-existing condition or infection; * be known to be hiv-positive or otherwise immunocompromised; * have known personal or family history of keloid formation or hypertrophy; * be currently taking systemic steroids; * have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives * have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and * be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrolment in this study.

Keywords: abdominoplasty body lift plastic surgery skin closure wound healing dermabond
first-line gemcitabine plus cisplatin in locally advanced (iiic stage) breast cancer patients

Conditions: Breast Cancer

Summary: the goal of the study is to investigate of the prognostics and predictive role of tubb3 expression in locally advanced breast cancer

using combination of gemcitabine plus cisplatine as first line treatment patients with locally advanced breast cancer with high tubb3 expression

Eligibility criteria:
inclusion criteria: iiic stage breast cancer patients exclusion criteria: other stages breast cancer patients

Keywords: breast cancer tubb3 gene ercc1 gene rmm1 gene prognosis and predictive
evaluation of potential accumulation of gadolinium (dotarem and multihance) in the french observatory of multiple sclerosis (www.ofsep.org/)

Conditions: Multiple Sclerosis

Summary: several recent studies have shown an increase in the signal intensity of the unenhanced t1-weighted magnetic resonance images in the brain of patients with normal renal functions and a breakdown of the blood-brain barrier. this hyper-intensity was specifically related to an accumulation of gadolinium based contrast agent. these studies were mainly conducted in patients with primary or secondary brain tumor. multiple sclerosis is a particular model since it involves patients with a break of the blood-brain barrier, a long life expectancy, and who received many injections of contrast enhancing agents. in this context, it appears fundamental to know whether contrast agents accumulate in the brain for this disease. the french observatory of multiple sclerosis is particularly suited to test this hypothesis, with homogeneous mri data over several centers in france, and optimized sequences of 3d-t1 without injection. the purpose of this study is to evaluate the accumulation of two commonly used gadolinium based contrast materials (dotarem and multihance) in patients with multiple sclerosis, who received at least 5 injection of exclusively one of these contrast material.


Eligibility criteria:
* inclusion criteria: * clinical diagnosis of multiple sclerosis * at least 5 mr imaging with the same gadolinium based contrast agent (either dotarem or multihance) * have performed an unenhanced t1-weighted image before gadolinium based contrast agent injection according to the ofsep protocol * exclusion criteria: * never experienced other contrast agent then the one specified by the group to which they belong (either dotarem, or multihance)

Keywords: multiple sclerosis gadolinium based contrast agent mri dentate nucleus
effect of low tidal ventilation on intraoperative bleeding in laparoscopic major hepatectomy

Conditions: Ventilator Lung; Liver Cirrhosis; Hepatocellular Carcinoma; Blood Loss, Surgical

Summary: this randomized controlled study's objective is to find a safer mechanical ventilation strategy to reduce intraoperative bleeding in liver cancer patients undergoing laparoscopic major liver resection. the hypothesis is that low tidal volume ventilation in laparoscopic major hepatectomy results in less bleeding.

patients are randomized into the conventional tidal volume (tidal volume \[ml\]= ideal body weight \[kg\]\* 10\~12) group and low tidal (tidal volume \[ml\]= ideal body weight \[kg\] \* 6\~8) volume group and ventilated accordingly throughout the surgery. all patients undergo general anesthesia with propofol, remifentanil, and rocuronium and are intubated with an endotracheal tube (id 7.0 for females, id 7.5 for males). anesthesia is maintained with sevoflurane, end tidal co2 is targeted between 30-35mmhg. the radial artery is cannulated and connected to the flotrac sensor and goal directed fluid therapy is done. the estimated blood loss is checked as the primary outcome. in addition postoperative complications, transfusion amounts, operation time, satisfaction of the surgeon and participants are also recorded.

Eligibility criteria:
inclusion criteria: * patients with hepatocellular carcinoma scheduled for laparoscopic major hepatectomy, defined as resection of more than 30% of non-anatomical resection or more than 3 segments exclusion criteria: * asa class \>4 * patients with chronic obstructive pulmonary disease * patients with child-pugh score c * patients with arrythmia
efficacy and safety of hva regimens as salvage treatment in rraml

Conditions: Refractory Acute Myeloid Leukemia; Relapsed Acute Erythroid Leukemia; Salvage Treatment; HVA Regimen

Summary: up until now, there is not well acepted treatment for relapsed/refractory (rr) acute myeloid luekemia (aml), which has low complete response and poor survival. according to different guildlines, clinical trial is the first choice for the treatment of rraml. high expression of bcl-2 and hypermethylation are very important factors for drug resistance in aml. lots of studies have reported combination of bcl-2 inhibitor with hypomethylating agents (hma) showed a promising efficacy in elder or unfit patients with newly diagnosed aml, however, presented not that exciting curing effect in rraml. it is known that overexpression of mcl-1 and bcl-xl is the main reason for leukemia cells being resistant to bcl2 inhibitors. since homoharringtonine (hht) could downregulate mcl-1 and bcl-xl in leukemia cells, there might be a synergic effect for combination of bcl-2 inhibitors with hht, which has been proven in the treatment of lymphoma. yet, there is not a report for the use of this combination in aml. in this single arm multi-centers prospective study, adult patients with rraml are included and treated with bcl-2 inhibitor venetoclax at a dose of 400mg per day for 14 days, combined with azacitidine (aza) at a dose of 75mg/m2 per day for 7 days, and hht 1mg/m2 per day for 7 days, and then the eficacy and safety of hva regimens as salvage treatment in rraml are assessed.


Eligibility criteria:
inclusion criteria: patients with rraml patients with the age of 18-65 years old exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)
mometasone furoate aqueous (mk-0887/sch 032088) nasal spray vs placebo and flonase® in seasonal allergic rhinitis patients (i94-001)

Conditions: Rhinitis, Allergic, Seasonal

Summary: the purpose of this study is to evaluate the efficacy and safety of mometasone furoate (sch 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. flonase (fluticasone propionate) nasal spray 200 mcg once daily has been chosen as the active control for this study.


Eligibility criteria:
inclusion criteria: * 2-year history of seasonal allergic rhinitis * positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year) * good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis exclusion criteria: * women who are pregnant or breastfeeding * women of childbearing potential who are not using an acceptable form of birth control * significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study * use of any chronic medication which could affect the course of seasonal allergic rhinitis * asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment) * current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip * upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (uri) within the 7 days prior to screening * dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator * has rhinitis medicamentosa * investigational drug use within the previous 30 days * nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow * immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least one month prior to the screening visit * history of multiple drug allergies, allergy to antihistamines or corticoids * history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study
a study of gardasil (v501) in preadolescents and adolescents (v501-018)

Conditions: Human; Papillomavirus Infections

Summary: this study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of human papilloma virus (hpv).

the original base protocol (v501-018)(nct00092547) was extended in amendments v501-018-05 and -06 to provide 37 months of follow-up. additionally, subjects in the placebo group during the base study were given 3 doses of open-label gardasil™ (v501) at months 30, 32, and 36. the study was extended again in amendment v501-018-10(nct00092547), titled "a long term immunogenicity, safety, and effectiveness study of gardasil (human papillomavirus \[types 6, 11, 16, 18\] recombinant vaccine) among adolescents who received gardasil at 9-18 years of age" to allow a follow-up period to month 126.

Eligibility criteria:
inclusion criteria: * healthy adolescents and preadolescents with no prior sexual history exclusion criteria: * subjects with compromised immune system or have a history of severe allergic reaction