Kornimate/medical-research-clean huggingface dataset:
pilot trial of virtual and in-person step2

Conditions: Oncology

Summary: the goal of this clinical trial is to assess the feasibility of offering oncology patients a referral to the outpatient palliative care clinic based on virtual symptom screening before oncology clinic appointments, and to qualitatively explore factors patients consider when deciding to accept or defer a visit to this clinic. participants will be asked to complete questionnaires assessing quality of life, symptom burden, depression, anxiety, and satisfaction with care at baseline, 2, 4, and 6 months.

to improve equitable access to early palliative care based on symptom severity, the investigators developed symptom screening with targeted early palliative care (step) and demonstrated its feasibility in a previous trial. step was designed and tested before the covid-19 pandemic and was based on symptom screening using tablets/computers in oncology clinics and in-person visits in the palliative care clinic. in response to changes in hospital care as a result of the covid-19 pandemic, the investigators developed a novel, mixed in-person and virtually delivered intervention, step2. the investigators propose to test step2 in a single-arm pilot trial, enrolling outpatients with advanced cancer and a prognosis of 6 months to 3 years. participants will complete the edmonton symptom assessment system-revised (esas-r+) tool electronically before oncology appointments (as is usual care in ontario, canada); in addition, if patients report moderate to high symptom scores, they will receive nurse-led triage and targeted referral to specialized palliative care. quality of life, symptom burden, depression, anxiety and satisfaction with care will be assessed at baseline, 2, 4, and 6 months using questionnaires. the objectives of this study are 1) to assess the feasibility of the step2 intervention, including completion of virtual symptom screening before oncology clinic appointments and completing triggered palliative care visits by video as well as in person; and 2) to explore factors patients consider when deciding to accept or defer a visit to the outpatient palliative care clinic.

Eligibility criteria:
inclusion criteria: * age 18+ years * stage iv cancer (stage iii or iv for lung or pancreas cancers; hormone-refractory for prostate and er-positive breast cancers) * eastern cooperative oncology group (ecog) performance status 0-2 * oncologist-estimated prognosis of 6-36 months * willingness to complete routine online symptom screening at the princess margaret cancer centre exclusion criteria: * insufficient english literacy to complete study procedures * oncologist-determined poor cognitive status * already received or currently receiving specialized palliative care
retrograde application of bone marrow aspirate concentrate

Conditions: Heart Failure

Summary: the aim of our prospective randomised study is to assess the efficacy of the retrograde application of non-selected bone marrow autologous cells concentrate (bmac) in patients with heart failure with reduced ejection fraction of left ventricle (hfref) of ischemic aetiology. the evaluated preparation is concentrated bmac, obtained using harvest smartprep2 technology.

our assumption is that non-selected bmac administrations will lead to improvements in the left ventricular ejection fraction (lv ef), the left ventricular end-systolic and end-diastolic diameters and volumes (measured with magnetic resonance imaging) compared to standard heart failure therapy. furthermore, it will be associated with improved exercise tolerance in the six-minute corridor walk test and an improvement in the life quality of patients without increasing the incidence of severe ventricular arrythmias.

Eligibility criteria:
inclusion criteria: * patients with chronic heart failure and left ventricular ejection fraction ≤ 40% with coronary artery disease and with symptoms of heart failure in the nyha class ≥ 3 on standard heart failure therapy for 3 months and in a stabilised state for at least 1 month * age ≥18 years * informed, written consent by the patient * ability to comply fully with the study protocol * negative pregnancy test (and effective contraception) in women with childbearing potential exclusion criteria: * previous bone marrow disease (especially myelodysplastic syndrome or non-hodgkin's lymphoma) * acute myocardial infarction ˂ 1 week * active infection or antibiotics treatment ˂ 1 week * previous malingant ventricular arrhythmias without cardioverter-defibrilator (icd) implantation * anemia (htc≤28%), leukocythosis (≥ 14.000/mm3) or thrombocytopenia (≤50.000/mm3) * previous bleeding diathesis * need for hematopoietic growth factor treatment (e.g. erythropoetin, g-csf) * impossibility of aspiration 240ml of bone marrow * hepathopathy or cirrhosis (bilirubin, alt or ast ≥ 2,5x upper limit of normal) * terminal renal insufficiency or haemodyalysis * uncontrolled hypertension * need for high dose (\> 7.5mg/day) corticotherapy within the next 6 months * inability to stop anticoagulation therapy (\>72 hours) before bone marrow aspiration * known malignancies requiring actino or chemotherapy, or previous actinotherapy * patients with a bmi \>40 * known allergy to contrast agents * other comorbidities with a life expectancy of 6 months
analysis of impact on nasal obstruction by commercially available internal nasal stents

Conditions: Nasal Obstruction

Summary: commercially-available internal nasal stents placed inside the nostril should produce decreased nasal obstruction detectable subjectively (volunteers will fill out a survey) and objectively (degree of obstruction will be measured with a rhinomanometer which measure resistant of airflow while breathing through nose).

nasal rhinomanometry provides a measure of the airflow through the nose during inspiration and expiration. the effect of static obstructions, such as septal deviation, as well as dynamic obstructions, such as lateral nasal wall collapse, can be measured by the rhinomanometer. the effect of commercially available nasal stents on nasal airflow will be measured. in subjects chosen from the general population, some of whom may not complain of nasal obstruction, the airflow will be measured before and after the placement of removable nasal silastic stents. in addition, these subjects will complete a one question scale in the likert model to rate the degree of their subjective nasal obstruction; they will complete this both before and after placement of the stents. the results of the scale before and after application of the stents will be correlated with the objective measurements of airflow by rhinomanometry taken before and after stent insertion.several studies have measured the effect of external nasal splints (such as breathe-rite strips) on nasal airflow and nasal airway size (as measured by acoustic rhinometry), but few have studied internal nasal stents. no studies have correlated rhinomanometric evaluation of effect on nasal obstruction by nasal stents with the validated nose survey (nasal obstruction symptom evaluation). in patients with a chief complaint of nasal obstruction and who are noted to have anterior nasal obstruction, nasal stents may provide a satisfactory improvement in nasal airflow without surgical or medicinal intervention. for patients who are determined to be candidates for surgical intervention, the surgical procedure is tailored to their specific anatomic deformities, as determined by the staff facial plastic surgeon. while the patient's complaint of nasal obstruction as well as the surgeon's assessment of the nasal anatomy are important components in the determination of the need for surgical intervention, no studies have utilized the validated nose instrument of subjective complaint of nasal obstruction combined with objective measurements of dynamic airflow. rhinomanometric measurements can be used to further validate the nose instrument both preoperatively and postoperatively.

Eligibility criteria:
inclusion criteria: * 18 years or older exclusion criteria: * history of nasal surgery, currently using topical nasal steroid spray, over the counter decongestant, history of recurrent epistaxis or history of nosebleed within 2 weeks prior to data collection, currently pregnant

Keywords: nasal obstruction nasal stent
iclusig® (ponatinib) in clinical practice for the treatment of chronic myeloid leukemia or ph+ acute lymphoblastic leukemia in belgium

Conditions: Chronic Myeloid Leukemia; CML; Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia; Ph+ ALL

Summary: this prospective registry is initiated to follow up on the use of iclusig® in patients with cml or ph+ all in routine practice in belgium.


Eligibility criteria:
inclusion criteria: * patient with confirmed diagnosis of: * cml (chronic, accelerated or blast phase) who is resistant or intolerant to dasatinib or nilotinib; and for whom subsequent treatment with imatinib is not clinically appropriate; or who has the t315i mutation. * ph+ all who is resistant or intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who has the t315i mutation. * patients on treatment with iclusig® or prescribed for treatment with iclusig® during the registry (treatment decisions should be taken outside the registry). * written informed consent obtained from the patient, if still alive (npp participants that were still on iclusig® treatment on 01 march 2016, but who died before the start of this registry will be included without informed consent provided that a waiver is granted by the ethics committee for inclusion of these patients). exclusion criteria: • concurrently participating in a clinical study, at any time during the registry period, in which the patient is exposed to iclusig® or to another investigational product/ vaccine (pharmaceutical product/ device).

Keywords: chronic myeloid leukemia philadelphia chromosome positive acute lymphoblastic leukemia iclusig® ponatinib
hepatocyte matrix implant study

Conditions: Liver Disease; Liver Cirrhosis

Summary: this clinical investigation of the hepatocyte matrix implant is an evaluation blinded non-randomized and monocentric pilot study of phase i, which is conducted as a therapeutic investigation. randomization is not possible due to ethical and practical reasons. pending approval of the ethical committee the study will also be conducted in indonesia. this new treatment procedure has already been successfully used on the basis of compassionate use in germany. the hepatocyte matrix implant is a new patented procedure consisting of bio-matrix technology. a formaldehyde-free special matrix consisting of self-dissolving polymers is applied as a carrier substance and is cultivated with human autologous cells using a special technique. clinically the bioartificial liver replacement tissue for patients with end-stage hepatic disease has been developed as a first application. in this procedure autologous hepatocytic tissue and pancreatic tissue is removed (liver resection and pancreatic biopsy) from the patient in a first surgical procedure. the tissue is sent to a specialized cell culture laboratory. the laboratory is gmp certified for this procedure. the cells are processed according to sops in a special perfusion procedure and prepared on several platelets of matrices (platelets of 20 mm diameter and 4mm thickness). after completion of the laboratory process the biotissues are implanted into the mesentery of the small intestine during a second operation. the cells are growing controlled on the matrix, take on the capillaries of the patient and thus connect to the blood circulation. the implanted cells multiply by a specific factor and independently take over the metabolic function of the original liver after two to four weeks. in the following process the carrier matrix dissolves completely and implanted cells develop into liver cell tissue.


Eligibility criteria:
main inclusion criteria: * endstage liver disease * stable and non-improving liver condition for at least 3 month * alcoholic liver cirrhosis: proven alcohol abstinence for 6 month or more * patient in bad general condition main exclusion criteria: * pregnancy * drug addiction (except alcohol) * psychiatric disease * hiv positive * sepsis * peritoneal carcinosis * hereditary liver disease * acute liver failure

Keywords: hepatocyte matrix implantation endstage liver disease liver cirrhosis impaired liver parenchyma improvement of liver function
prevalence of internet gaming addiction in adolescent

Conditions: Addictive Behavior; Adolescent Behavior

Summary: excessive problematic use of the internet has been a topic of discussion in the academic literature for many years and has gained more attention recently. the majority of those at risk are in early adulthood. pathological internet use (piu) is also termed internet addiction disorder (iad), with both terms used to link internet use with addiction terminology. consistent with other psychiatric conditions such as depression symptoms, piu prevalence rates among adolescents vary widely from as low as 0.3% to 38%. likewise, piu prevalence among college students (young adults) showed a wide variation ranging from 3% to 34%, worldwide. nowadays, internet gaming addiction became a problematic issue in adolescent. this is a case -control study, aimed to evaluate the prevalence and risk factors of internet gaming addiction among adolescents and its relationship with emotion regulation and comorbid psychiatric disorders.


Eligibility criteria:
inclusion criteria: 1. both males and females were included. 2. age ranges from 10- 18 years. 3. willing of the parents or the caregivers to participate in the study. exclusion criteria: * children with intelligence quotient below 70. * children with history of substance use or psychiatric disorders. * children with medical or other neurological conditions.
evolution of physical activity, sedentary behavior and associated motivations after rehabilitation for chronic low back pain patients

Conditions: Chronic Low-back Pain

Summary: iin 2016, chronic low back pain (clbp) was the leading cause of years lived with disability worldwide. this condition impacts social interactions, work life, and can lead to an altered quality of life for patients. for these patients, physical activity (pa) can reduce pain, improve function and the rate of return to work. according to the french national authority for health, it is the main treatment in the management of these patients. nevertheless, the literature reports pa levels that are relatively comparable to those of the general population. considering that a large proportion of adults struggle to meet these thresholds, we can infer that the same is true for clbp patients. in addition to pa, the world health organization recommends that all adults should limit the amount of time spent in sedentary behaviors. thus, clbp patients should adopt an active lifestyle, characterized by regular pa and limited sedentary behaviors (sb). in view of these elements, it is essential to implement dedicated interventions. the literature reports mixed results with work focused on pa promotion. no study has focused on i) the reduction of cs, ii) the rehabilitation programs (rp) proposed in france. on the other hand, there is a need to better understand what determines engagement in such behaviors. among these determinants are several psychological variables related to behavioral intentions. a recent line of research indicates that beyond these motivational dimensions, which are explicit in nature, certain implicit processes are significantly associated with the adoption or non-adoption of certain health-related behaviors. this result has been observed in the context of chronic disease (respiratory patients, metabolic patients) but remains unexplored in patients with chronic low back pain. the aim of this study is to simultaneously question these different aspects: the effects of a rp on changes in pa and cs, in relation to motivational changes in a population of clbp patients.


Eligibility criteria:
inclusion criteria: * admitted to a rehabilitation program, * presenting chronic low back pain (i.e., \> 3 months), * age \> 18 years, * literacy. exclusion criteria: * inability or refusal to answer a questionnaire, * protected adults, * participation in another study * withdrawal of consent, * if deemed necessary by the principal investigator for the welfare and/or safety of the participant, * in the event of an occurrence of a non-inclusion criterion.

Keywords: rehabilitation sedentary motivation physical activity
levetiracetam in chronic neuropathic pain following spinal cord injury

Conditions: Injuries, Spinal Cord; Pain

Summary: purpose: to evaluate the efficacy and safety of levetiracetam on chronic neuropathic pain after spinal cord injury, and to examine its effect on spasms and evoked pain.

study design: randomized double-blind cross-over study of levetiracetam (keppra) against corresponding placebo with a 1 week baseline period followed by 2 x 5 weeks treatment periods separated by a 1 week wash-out period. methodology: levetiracetam and corresponding placebo is gradually increased during two weeks from 500 mg x 2 daily to 1500 mg x 2 daily (1000 mg x 2 daily is allowed if 1500 mg x 2 is not tolerated), and kept on that dose for three weeks. the study will be monitored by the gcp units of aarhus and copenhagen university.

Eligibility criteria:
inclusion criteria: * 1. age 18 or more * 2. neuropathic pain (that have lasted at least 3 month) after a spinal cord injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale exclusion criteria: * 1. pregnancy or lactation * 2. allergy to levetiracetam * 3. alcohol or substance abuse, mental disease, epilepsy, depression and psychiatric disorders, severe liver disease, decreased kidney function, and known concomitant cerebral damage

Keywords: spinal cord injury neuropathic pain spasms
a comparative open-label crossover study of respiratory-gated versus non-respiratory-gated transcutaneous auricular vagus nerve stimulation for the treatment of non-motor symptoms in parkinson's disease

Conditions: Parkinson Disease; Apathy; Sleep Disorder; Fatigue; Mood Disorders

Summary: the goal of this clinical trial is to compare the effects of different modes and frequencies of transcutaneous auricular vagus nerve stimulation (tavns) on non-motor symptoms in people with parkinson's disease. the main questions it aims to answer are: which mode and frequency of tavns is most effective in improving non-motor symptoms? are there any side effects or safety concerns with different tavns frequencies? researchers will compare three types of tavns: 25 hz non-expiratory gated, 25 hz expiratory gated, and 100 hz expiratory gated stimulation. participants will: receive each type of tavns in three 2-week cycles, with 2-month breaks between cycles undergo neuropsychological assessments, imaging, eye-tracking, and biological sample collection before and after each cycle.

this study employs a three-cycle crossover design to compare the effects of three different modes and frequencies of transcutaneous auricular vagus nerve stimulation (tavns). the interventions include: 25 hz non-expiratory gated tavns, 25 hz expiratory gated tavns, and 100 hz expiratory gated tavns. participants will be randomly assigned to one of three groups, with each group receiving a different intervention during each cycle, lasting 2 weeks per cycle. a 2-month washout period will be implemented between cycles to eliminate any carryover effects.the study design will include neuropsychological assessments, imaging, eye-tracking data collection, and biological specimen collection before and after each intervention.

Eligibility criteria:
inclusion criteria: * age: 40 years or older. * confirmed diagnosis of parkinson's disease (pd) per the united kingdom brain bank criteria by a neurologist specialized in movement disorders. * participants must be on a stable dose of all medications for at least 2 weeks, with no planned adjustments to anti-pd medications for the next 3 months. * in the second version of the non-motor symptoms scale (nmss-2) for parkinson's disease, a score of ≥1 is assigned to either question 4 or question 8. * participants must be in good mental health and capable of completing behavioral tests and transcutaneous auricular vagus nerve stimulation. exclusion criteria: * mini-mental state examination (mmse) score \<24. * history of head injury, stroke, or other neurological disorders. * includes implanted cardiac pacemakers post-dbs operation, local infections, ear loss, or metal implants at the stimulation site. * current use of nonsteroidal anti-inflammatory drugs (nsaids) or corticosteroids. * inability to complete follow-up assessments.
patient-centered cancer prevention in chinese americans

Conditions: H. Pylori Infection

Summary: this study will assess the efficacy, adoption, and impact of an integrated intervention to improve adherence to recommended stomach cancer prevention guidelines (h. pylori test-and-treat) for at-risk chinese americans in nyc. the integrated multifaceted theory-based intervention involves: 1) a health systems-level intervention using electronic health record (ehr)-based tools to facilitate h. pylori test-and-treat strategies; and 2) a community-engaged culturally and linguistically adapted chw-led patient navigation program we are currently pilot testing for feasibility and acceptability. using a 2-arm randomized controlled trial (rct) design, \> 144 chinese american patients across nyc safety net hospital endoscopy clinics and primary health centers will participate.


Eligibility criteria:
inclusion criteria: * self identifies as chinese american * is an outpatient aged 21 years and older (adult) * plans to continue to live in the region during the next 12 months; * is willing to be randomized to either treatment or control groups * has a confirmed diagnosis of h. pylori infection by at least one of the following methods: c-urea breath test, histology, rapid urease test or bacterial culture, fecal stool antigen test or other clinically approved h. pylori infection diagnostic test. exclusion criteria: * advanced chronic disease that would not allow the patient to complete follow-up or attend visits; * allergy to any of the study drugs; * pregnancy or currently breastfeeding * taking antibiotics or bismuth salts within 2 weeks before the study.

Keywords: h. pylori h. pylori infection
lipoprotein kinetics in t1d

Conditions: Type 1 Diabetes

Summary: the purpose of this research study is to understand how type 1 diabetes (t1d) increases the risk for cardiovascular diseases (heart attack and stroke). to this end, the investigators will compare apolipoprotein and triglyceride kinetics in people wtih t1d and healthy control participants.

not required

Eligibility criteria:
inclusion criteria: * age: ≥18 but ≤45 years * premenopausal/eumenorrheic and not pregnant or breastfeeding * non-obese (body mass index ≥18.5\<30.0 kg/m2) * fasting plasma triglyceride \<150 mg/dl additional inclusion criteria for control subjects: * fasting plasma glucose \<100 mg/dl * plasma glucose 2 h after a 75 g oral glucose challenge \<140 mg/dl * hba1c \<5.6%. additional inclusion criteria for subjects with t1dm: * stable insulin regimen (multiple daily insulin injections or continuous subcutaneous insulin) for at least 8 weeks before screening * no use of diabetes medications other than insulin * hba1c \<6.5%, basal (overnight fasted) * no severe symptomatic hypoglycemic event associated with a seizure or requiring help from other people or a medical facility in the 6 months prior to screening or metabolic testing exclusion criteria: * more than 1.5 h of structured exercise/week * use of tobacco products, excessive amounts of alcohol, or dietary supplements and/or medications known to affect lipid metabolism * hypothyroidism or other disorders known to affect lipid metabolism * conditions that would make it impossible to complete the study protocol