Kornimate/medical-research-clean huggingface dataset:
immune effects of oral insulin in relatives at risk for type 1 diabetes mellitus (tn20)

Conditions: Type 1 Diabetes

Summary: the study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (t1d).

a minimum of 40 eligible participants will be identified for study participation from the trialnet pathway to prevention study. participants must have a relative with type 1 diabetes and be positive for insulin autoantibodies and at least one other autoantibody. all participants will receive active treatment of recombinant insulin treatment in capsules of either 67.5 mg daily or 500mg every other week. participants will need to visit the study site up to eleven times over one year for blood tests and other study procedures. during the beginning treatment phase there are two visits one month apart for those given the 67.5 mg dose, and three visits two weeks apart to titrate the dose for those in the 500mg treatment group. there are three additional treatment visits at months 2, 3, and 6 and 4 additional visits for follow-up at months 7, 8, 9 and 12. the primary outcome is the change in immune function as assessed by change in level or quality of t lymphocyte or autoantibody biomarkers measured between 13 and 26 weeks compared to baseline. .

Eligibility criteria:
inclusion criteria: * participants in trialnet natural history/pathway to prevention study (tn01); is relative of proband with type 1 diabetes * between ages 3-45 with normal oral glucose tolerance test (ogtt) or between ages 3-7 with an abnormal ogtt * confirmed positive for insulin autoantibodies within previous six months * confirmed positive for one or more other autoantibodies on two separate occasions within the past six months exclusion criteria: * diagnosed with type 1 diabetes * history of treatment with insulin or oral hypoglycemic agent * history of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months * ongoing use of medications known to influence glucose tolerance * pregnant or intending to become pregnant while on study or lactating

Keywords: oral insulin
intensity modulated radiation therapy for head and neck cancer

Conditions: Nasopharyngeal Neoplasms

Summary: many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in the nasopharynx. the dose of radiation delivered to the cancer is limited by tolerance of these normal tissues. standard radiation treatment techniques using three or four radiation beams cannot avoid delivering some dose of radiation to these normal tissues that do not need to get radiation. intensity modulated radiation therapy (imrt) uses many hundreds of computer-controlled radiation beams aimed at your cancer to try to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to your cancer and to areas that your doctor thinks may have cancer cells. the doctors at princess margaret hospital are conducting this study in order to test whether the use of imrt techniques can improve the chance of controlling your cancer in the head and neck region.


Eligibility criteria:
inclusion criteria: * confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma requiring primary radiation * less than 70 yrs of age * stage t1-t4; n0-n3; m0 * kps less than 70 * no prior rt to h\&n or chemotherapy for h\&n * no other malignancy except non-melanomatous skin cancer * no distant mets * no contraindication to rt or chemotherapy * adequate organ function * informed consent exclusion criteria * major medical or psychiatric illness, which would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.
audio-based mental health intervention study

Conditions: Depressive Symptoms

Summary: this is a study on an audio-based digital intervention designed to reduce symptoms of depression. participants who experience at least moderate symptoms of depression will be invited to participate in the study. participants will be randomly assigned to receive one of two audio-based digital interventions. the experimental intervention based on behavioral activation treatment for depression. the control intervention is based on self-monitoring. depression symptoms and related mental health symptoms, as well as experiences with the intervention, will be assessed at baseline (pre-randomization), mid-intervention (1 week post-randomization), post-intervention (2 weeks post-randomization) and follow-up (5 weeks post-randomization)


Eligibility criteria:
inclusion criteria: * adult age 18 or older * score in the moderate or higher range on the bdi-fastscreen * moderate or higher depression confirmed by diamond interview * proficient english reading, writing, and speaking ability * able to provide consent * provide informed consent exclusion criteria: * below 18 years of age * score below the moderate range on the bdi-fastscreen * diamond interview does not confirm moderate or higher depression * unable to read, write, and speak in english * unable to provide consent * do not provide informed consent

Keywords: digital interventions mhealth depression behavioral activation podcasts self-help
molecular adsorbent recirculating system (mars®) in hypoxic hepatitis

Conditions: Hypoxic Hepatitis; Ischemic Hepatitis; Shock Liver; Hypoxic Liver Injury; Acute Liver Failure

Summary: hypoxic hepatitis (hh) is reported to be the most frequent cause of elevated aminotransferase levels in hospital. up to 10 % of critically ill patients develop hh during the course of their intensive care unit (icu) stay. occurrence of hh is a life threatening event and icu-mortality is reported to be up to 60%. early therapeutic intervention is of central prognostic importance in patients with hh to improve the hemodynamic impairment as early as possible, to reduce hyperammonemia and hepatic encephalopathy, to avoid progression of organ failure and to improve outcome. studies reported that molecular adsorbent recirculating system (mars®) therapy improved the hemodynamic situation in patients with acute and acute on chronic liver failure. the study hypothesis is that mars® therapy in critically ill patients with severe hh improves hepatic hemodynamics and function and consecutively the course of the disease. 40 patients with suffering of severe hh with aminotransferase levels \> 40 times the upper limit of normal of more than 12 hours will be randomized 1:1 to mars® therapy (n=20) or conventional therapy (n=20). 4 mars®-sessions will be performed on three consecutive days, each for at least 12 hours. treatment will be continued under special circumstances. the maximum duration of the treatment phase is 7 days. the primary endpoint is the difference of the indocyanine plasma disappearance rate at day 7. the expected duration of the study is 2 years.


Eligibility criteria:
inclusion criteria: * presence of severe hypoxic hepatitis with aminotransferase levels \> 40 times the upper limit of normal * duration of hypoxic hepatitis more than 12 hours * age \>/= 18 years exclusion criteria: * age \< 18 years * pregnancy * dnr - order * liver cirrhosis * cardiopulmonary resuscitation with unknown neurological outcome and/or hypoxic brain damage * expected survival of less than 24 hours
molecular analysis and treatment options of sclc

Conditions: Small-cell Lung Cancer; Small Cell Lung Cancer, Combined Type; Small Cell Lung Carcinoma; Small Cell Lung Cancer Extensive Stage; Small Cell Lung Cancer Limited Stage

Summary: small cell lung cancer (sclc) is an aggressive disease that is characterized by rapid growth and the early development of metastases. patients typically respond to initial chemotherapy but quickly experience relapse, resulting in a poor long-term outcome. therapeutic innovations that substantially improve survival have historically been limited, and reliable, predictive biomarkers are lacking. ongoing research has advanced the understanding of molecular categories and the immunologic microenvironment of sclc, which in turn has helped improve disease classification and staging. considering the role of molecular alterations has not yet fully to be defined in the treatment of sclc, there is an urgent recognition that molecular alterations in the sclc are important to predict response and survival for novel therapies and ongoing clinical trials. advances in research have revealed critical information regarding biologic characteristics of the disease, which may lead to the identification of vulnerabilities and the development of new therapies. further research focused on identifying biomarkers and evaluating innovative therapies will be paramount to improving treatment outcomes for patients with sclc. in summary, identification of (genetic) biomarkers in sclc is increasingly essential to perform molecular diagnostics and individualized treatments. this project aims to create a registry of patients with sccl to further the characterization of molecular alterations and develop (novel) treatments based on the detection.


Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of sclc * 18 years of age or older * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * histologically proven diagnosis of non-sclc
single incision laparoscopic appendectomy in the community utilizing conventional instruments

Conditions: Appendicitis

Summary: there is a move to "scarless surgery" and this achieved by doing laparoscopic abdominal surgery though a single small umbilical incision. a technique for laparoscopic appendectomy done through a single incision utilizing conventional instruments has been developed. the operative risk of the single incision approach is no different that the standard three incision laparoscopic appendectomy. the goal is to study the operative time, length of hospital stay, and complications from this operation.


Eligibility criteria:
inclusion criteria: * all patients undergoing appendectomy for acute appendicitis exclusion criteria: * pregnancy
spg block for acute pediatric migraine

Conditions: Migraine in Children; Sphenopalatine Neuralgia; Migraine in Adolescence

Summary: this is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache.

this is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache. excluded populations include those with sickle cell, concern for cns infection

Eligibility criteria:
inclusion criteria: - frontal migraine headache exclusion criteria: * non-english speaking * known pregnancy * sickle cell hemaglobinopathy * concern for cns infection * acute febrile illness * non-frontal headaches * concern for increased intracranial pressure
reset aim 1b: restarting safe education and testing for children with medical complexity - covid-19 testing in school with children and staff

Conditions: Children With Medical Complexity (CMC); COVID-19

Summary: the coronavirus disease 2019 (covid-19), caused by the sars-cov-2 virus, is a worldwide pandemic that has resulted in large-scale quarantines in cities, states, and countries throughout the world. sars-cov-2 is a respiratory virus that is most commonly spread via contact with infective respiratory droplets and aerosols produced by coughing, sneezing, talking, and singing. children with medical complexity (cmc), i.e., children with multiple severe chronic conditions, high resource use, severe functional limitations, and substantial family-identified service needs, are a medically vulnerable population for the development of severe covid-19. deciding to send cmc to school poses a major dilemma to families wanting to minimize severe covid-19 risk. school personnel also face risks when cmc attend school. despite these challenges, achieving in-person school attendance is critical for cmc. compared to non-cmc, academic and social development for most cmc hinges on being at school. severe intellectual and developmental disability impairs one's ability to engage with online platforms. health-promoting services delivered at school, e.g., physical, occupational, and speech therapy, are likely less effective when delivered virtually. parents of cmc, already disproportionately unemployed due to their child's care needs, experience added employment strain when their child is out of school. the study objective is to increase the safe return to school for cmc by 1) evaluating the feasibility of school-based covid-19 testing strategies and 2) identifying parent and staff perceptions of testing and school attendance. a related study (reset aim 1a, nct04895085) will evaluate the same factors in home-based testing strategies in cmc exclusively.


Eligibility criteria:
inclusion criteria: * parents and staff must be at least 18 years of age. * staff must have a classroom role (e.g., teacher, aide, playground assistant) * parents and staff must be proficient in english. * parents and staff must have access to a web-enabled device (phone, tablet, or computer). * staff, parent and child must be residents of wisconsin. * parent/child must be enrolled at wecp for the 2021 and/or 2022 school year. exclusion criteria: * failure to meet all inclusion criteria

Keywords: in-school covid testing caregiver school staff in-person school attendance
phase iii study of intramuscular tak-816 in healthy infants

Conditions: Healthy Volunteers; Haemophilus Influenzae Type b, Prevention

Summary: the purpose of this study is to evaluate the safety and immunogenicity of intramuscular tak-816 in healthy japanese infants.

the vaccine being tested in this study is called tak-816. tak-816 was being tested to evaluate its safety and immune response after intramuscular (im) injection with tak-816. this study evaluated adverse events and the seroprotection rate and geometric mean titer (gmt) of anti-polyribosylribitol phosphate (prp)-antibodies in participants who were administered tak-816 im. the study enrolled 31 participants. all participants received 3 doses of tak-816 im at 4-week intervals as part of the primary vaccination and 1 booster vaccination 52 weeks after the third dose of the primary vaccination. this multi-center trial was conducted in japan. the overall time to participate in this study was 64 weeks. participants made multiple visits to the clinic including a final visit 4 weeks after last dose of study drug for a follow-up assessment.

Eligibility criteria:
inclusion criteria: 1. healthy japanese infants. 2. male or female infants aged 2-6 months (≥2 and \<7 months) at the time of the first dose of investigational product (excluding hospitalized infants). 3. infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period. 4. the legal guardian signed and dated a written, informed consent form prior to the initiation of any study procedures. exclusion criteria: 1. any serious acute illness. 2. any underlying cardiovascular, renal, hepatic, or hematologic disease, and/or developmental disorder. 3. history of possible haemophilus influenzae type b (hib) infection. 4. previously diagnosed immunodeficiency. 5. documented history of anaphylaxis to any ingredients of the investigational product (e.g., diphtheria toxoid). 6. a history of convulsions. 7. previous administration of another hib vaccine. 8. treatment with any live vaccine during the 27 days before the first dose of tak-816 or with any inactivated vaccine during the 6 days before dosing. 9. prior participation in any clinical study or post-marketing clinical study. 10. previously receipt of blood transfusions, gamma globulin preparations (except monoclonal antibody products not containing any components of hib as antigens), systemic immunosuppressive therapy, or systemic corticosteroids, or a plan to receive any of these products during the study period. 11. presence of thrombocytopenia or coagulopathy. 12. children considered ineligible for the study for other reasons by the investigator or subinvestigator.

Keywords: drug therapy safety and immunogenicity of hib vaccine
study of the relationships between apolipoprotein b-48 kinetics and expression of genes that regulate intestinal lipid metabolism in men with the metabolic syndrome (smb48)

Conditions: Metabolic Syndrome X

Summary: several lines of evidence indicate that a significant proportion of cardiovascular disease (cvd) events are attributable to the presence of a cluster of metabolic abnormalities and perturbations, defined as the metabolic syndrome. it has been estimated that approximately 25% of the north american adult population is living with the metabolic syndrome. recent studies show that overaccumulation of atherogenic triglyceride-rich lipoproteins (trl) seen in insulin-resistant patients is partly due to increased production rate of intestinally derived apolipoproteinb-48-containing lipoproteins. this is of interest because substantial evidence exists indicating that elevated levels of intestinal lipoproteins are associated with increased cvd risk. however, as indicated in the body of this grant proposal, the underlying mechanisms that lead to intestinal overproduction of lipoproteins in insulin-resistant states are poorly understood. the general objective of the proposed research is to investigate the mechanisms by which the metabolic syndrome affects apolipoproteinb-48 secretion in human. the primary hypothesis is that insulin resistance will be associated with higher levels of intestinal lipoproteins because of an increased secretion of these particles.


Eligibility criteria:
inclusion criteria: subjects with metabolic syndrome: * men aged between 18-60 years * waist circumference \>102 * hdl-cholesterol \< 1.1 mmol/l * triglycerides \> 1.7 mmol/l * fasting blood glucose \>6.1 mmol/l * normal blood pressure (\<130/85) controls: * men aged between 18-60 years * waist circumference \>102 * hdl-cholesterol \> 1.1 mmol/l * triglycerides \< 1.7 mmol/l * fasting blood glucose \<6.1 mmol/l * normal blood pressure (\<130/85) exclusion criteria: * women * men \ 60 years * smokers (\> 1 cigarette/day) * body weight variation \> 10% during the last 6 months prior to the study baseline * subjects with a previous history of cardiovascular disease * subjects with type 2 diabetes * subjects with a monogenic dyslipidemia * subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa * subjects with endocrine or gastrointestinal disorders * history of alcohol or drug abuse within the past 2 years * subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
safety of 40k pegylated recombinant factor ix in non-bleeding patients with haemophilia b

Conditions: Congenital Bleeding Disorder; Haemophilia B

Summary: this trial is conducted in europe, japan and the united states of america (usa). the aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of pegylated recombinant factor ix (nonacog beta pegol) in non-bleeding patients with haemophilia b.


Eligibility criteria:
inclusion criteria: * diagnosed with haemophilia b (baseline level of factor ix less than or equal to 2%) * history of at least 150 exposure days to any factor ix products * body mass index (bmi) below 30.0 kg/m2 (inclusive) exclusion criteria: * history of factor ix inhibitors * platelet count less than 50,000 platelets/microlitre (assessed by laboratory) * kidney or liver dysfunction * scheduled surgery requiring factor ix replacement therapy, during the trial period
rapid computerized visual acuity test

Conditions: Vision Disorders; Refractive Errors; Retinal Disease; Cataract; Corneal Disease

Summary: a novel computerized visual acuity test was developed and tested on both healthy persons and patients with ocular conditions. visual acuity outcomes of the computerized test will be compared to the early treatment diabetic retinopathy study (etdrs) in measures of reproducibility, accuracy and numbers of questions.


Eligibility criteria:
inclusion criteria: - age 18 years old and older exclusion criteria: * visual acuity \<0.2 decimal for the patient group * visual acuity \<0.5 decimal for the healthy group
first in man study with slv341

Conditions: Diabetes

Summary: first in man study with single and multiple rising doses with slv341


Eligibility criteria:
inclusion criteria healthy exclusion criteria not healthy

Keywords: first in man slv341 diabetes
impact of online patient feedback (oq) to therapist

Conditions: Drug Addiction; Drug Abuse

Summary: dropout represents one of the largest problems in substance abuse treatment. international and nordic research show that only 20 - 40 % of substance abusers complete treatment as intended. at the same time, one of the most consistent factors of favourable post-treatment outcome is treatment completion. in spite of the serious and continuous challenge dropout represents the phenomena is not well understood and there is a need to explore more of the factors that influence dropout and how it can be counteracted. as also stated: "...effective methods for reducing the problem of dropouts from treatment is one more area in need of further research" (nou 2003:4, s 77). for the general field of mental health one of the most important innovations involves providing therapists with patient feedback about their progress. the most well-established and widely researched feedback system is the outcome questionnaire (oq-45.2). the system has been shown to improve treatment outcomes, including reduced treatment dropout and length of treatment, but the system is yet to be utilized with a substance abusing patient group. the aim of the present study is to examine the usefulness of oq-45.2 with substance abusing patients.

hypotheses and research questions 1. the oq-45.2 feedback will be effective in identifying patients at risk of dropout of substance abuse treatment. 1a. the condition were feedback is withheld from the therapist, will correctly identify patients who will dropout. research question: is there variation in the accuracy of dropout prediction as a function of age, gender differences or type of substance abuse? 2. the oq-45.2 feedback will be effective in reducing dropout in outpatient substance abuse treatment. 2a. the feedback condition will result in less dropout than the no-feedback condition. research question: is there a variation in the oq-45.2 preventive dropout effect due to age, gender or type of substance abuse? 3. the oq-45.2 feedback will shorten length of inpatient substance abuse treatment. 3a. the feedback condition will identify patients who are ready to terminate therapy. research question: is there variation in identification of patients ready to terminate as a function of age, gender differences or type of substance abuse?

Eligibility criteria:
inclusion criteria: * primary diagnosis of addiction, f10-19, using the international classification of diseases, admitted in 2011-2014 for treatment at the department of addiction treatment - youth, oslo university hospital exclusion criteria: * ongoing psychoses, severe language difficulties

Keywords: psychotherapy drug addiction drop-out oq-45.2 clinical trial randomized controlled trail