Kornimate/medical-research-clean huggingface dataset:
rebecca - research in rehabilitation after breast cancer

Conditions: Anxiety; Depression; Adverse Effects; Health Behavior

Summary: the purpose of this study is to examine if a psychosocial intervention including a nurse navigator and systematic symptom screening may reduce psychological and physical symptoms as well as health behavior after breast cancer.

in this pilot study with a randomized controlled trial design, we examine the effect of an intervention optimizing and integrating rehabilitation for breast cancer on psychological and physical symptoms as well as health behavior after breast cancer. in the intervention group, we systematically screen for psychological and physical symptoms as well as health behavior (smoking alcohol and physical activity) not in line with the recommendations. patients who screen positive are offered a sequence of sessions with a navigator nurse who monitor rehabilitation needs, supports the patient, educate in self-management of symptoms and refer to existing rehabilitation services as well as to up to 6 free sessions with a psychologist specialized in cancer patients. the rehabilitation services that the nurse refers to include several hospital departments and municipality services as well as general practice and by thorough follow-up on the patients use of these, the intervention aims at developing an integrated treatment and rehabilitation trajectory. the control group receives standard care.

Eligibility criteria:
inclusion criteria: * diagnosis of primary breast cancer at breast oncology clinic, rigshospitalet, copenhagen, denmark * lives in copenhagen municipality * score ≥7 on distress thermometer * able to read and understand danish * not pregnant * expected survival more than 6 months * physically able to participate in rehabilitation * no severe psychiatric disease demanding treatment * no severe cognitive problems (e.g. dementia or confusion)

Keywords: neoplasms rehabilitation anxiety depression adverse effects health behavior
asthma and technology in emerging african american adults

Conditions: Asthma

Summary: the purpose of the athena project is to test a mobile health intervention to help african american young adults better manage their asthma. the program has four components: 1) a web-based, mobile asthma program delivered to participants' mobile device, 2) meetings with an asthma nurse via video conference, 3) text messaging, and 4) physical activity tracking. participants will be randomly assigned to one or more of these components to better meet the needs of young adults with asthma.

asthma causes substantial morbidity and mortality in the united states, particularly among african american emerging adults (aaea; ages 18-30), but very few asthma programs have targeted this population. interventions that provide education and address underlying motivation for managing asthma may be most effective. however, face-to-face interventions are often difficult to implement, especially among emerging adults. mobile asthma management interventions may help improve asthma control and allow people to live healthier lives. during this project, the research team will use an innovative strategy to develop a mobile asthma management intervention using the most effective combination of a smart phone app delivering personalized asthma information (mes), nurse-delivered asthma education (sa), text messaging (sms), and physical activity tracking (pat). the purpose of this proposal is to develop an effective mhealth intervention to improve asthma management and asthma control in aaea. investigators will assess the ability of multiple technologic components to assist and improve traditional asthma education. upon completion of the study, investigators will have an empirically-supported mobile asthma management intervention to improve asthma control for aaea. it is hypothesized that post-intervention, participants with uncontrolled asthma will show clinically-significant improvement in asthma control and improvements in asthma management behaviors, quality of life, symptoms, adherence, and exacerbations will also be observed.

Eligibility criteria:
inclusion criteria: * african american, 18-30 years of age, uncontrolled asthma (defined by a score of less than 19 on the act), own or have access to a cell phone for the duration of the study, have a primary care physician (pcp) exclusion criteria: * significant cardiopulmonary disease (including chronic obstructive pulmonary disease), a greater than 20 pack per year smoking history, developmental delay or mental illness such that participation in the program would not be possible, pregnancy

Keywords: african american young adult ehealth mobile health
electronic platform for diabetic patients activation

Conditions: Hypoglycemia; Hypoglycemia Acute

Summary: the purpose of this study is to assess the efficacy of an electronic platform for doctor-patient communication in order to reduce severe and non-severe hypoglycemia events as well as inadvertent hypoglycemia events.

this is an open randomized clinical trial without drugs. patients with type 2 diabetes and treated with insulin will be included. patients allocated in the intervention group will use the electronic platform as a communication channel with their health provider during the time between visits. the name of the platform is ti.care (https://ti.care/es) and it will be a complement of the control visits to resolve doubts through chats, email or video call. health providers will answer the patient requests.

Eligibility criteria:
inclusion criteria: * aged over 17 years * patients with type 2 diabetes diagnosis * patients who start insulin treatment or with intensification of treatment * patients who sign informed consent exclusion criteria: * patients with type 1 diabetes diagnosis * life expectancy less than one year * pregnancy * patients with dementia * patients with treatment different to insulin * patients who, in the opinion of the researcher, cannot follow the recommendations of the self-care health education plan.
repository for sepsis and postresuscitation samples

Conditions: Cardiac Arrest; Sepsis

Summary: the objective of this study is to find a new therapeutic strategy by investigating the serial serum samples of patients with sepsis or postresuscitation state.


Eligibility criteria:
inclusion criteria: * age over 16 years old * admitted to icu * diagnosed as having sepsis or as postresuscitation status * definition of sepsis: 2 or more sirs criteria + infection is suspected * definition of postresuscitation status: survived from non-traumatic cardiac arrest exclusion criteria: * refusal to participate * dnar status

Keywords: cardiac arrest sepsis biological markers anti-inflammation agents antioxidants
trial of otelixizumab for adolescents and adults with newly diagnosed type 1 diabetes mellitus (autoimmune): defend-2

Conditions: Diabetes Mellitus, Type 1

Summary: defend-2 is a phase 3 confirmatory study for the phase 3 defend-1 study. the study objective is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo. insulin secretion will be assessed using mixed meal-stimulated c-peptide. subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3 otelixizumab, 1/3 placebo). these study agents will be administered as an addition to insulin, diet, and other standard of care treatments.

the following visits are required: * screening visits: 2 to 3 appointments will be conducted to determine eligibility. at 2 of these visits participants will drink a liquid meal and have blood tests done over the post-meal period. participants will also be required to wear a continuous glucose monitor for a short period of time. * dosing visits: 8 outpatient visits on consecutive days, each lasting about 2-4 hours. * follow-up visits: weekly for the first month, then every 2 weeks for 3 months, followed by monthly visits through 1 year. there will be 3 visits in the second year. * the total duration of the study is 2 years. * glucose test strips and glucose monitors will be provided to participants for the duration of the study. frequent glycemic monitoring will occur through lab testing and blood glucose self-monitoring to help facilitate tight glycemic control in all subjects. subjects will be asked to intermittently record their insulin doses using a telephone or web based system and continuous glucose monitoring will be performed every 6 months.

Eligibility criteria:
inclusion criteria: * ages 12-17 * diagnosis of diabetes mellitus, consistent with ada criteria * no more than 90 days between diagnosis and administration of study compounds * requires insulin for type 1 diabetes mellitus, or has required insulin at some time between diagnosis and administration of study compounds. in canada, has to be using insulin at the time of dosing. * stimulated c-peptide level greater than 0.20 nmol/l and less than or equal to 3.50 nmol/l * positive for one or more of the autoantibodies typically associated with t1dm: antibody to glutamic acid decarboxylase (anti-gad); antibody to protein tyrosine phosphatase-like protein (anti-ia-2); zinc transporter autoantibodies (znt8); insulin autoantibodies (iaa). a subject who is positive for insulin autoantibodies (iaa) and negative for the other autoantibodies will only be eligible if the subject has used insulin for less than 7 days total. exclusion criteria: •other, significant medical conditions based on the study doctor's evaluation

Keywords: new onset type 1 diabetes juvenile diabetes t1dm type 1 diabetes
rituximab for refractory or relapsed focal segmental glomerulosclerosis or minimal change disease

Conditions: Focal Segmental Glomerulosclerosis; Minimal Change Disease

Summary: various studies have been conducted to identify effective treatment strategies for primary focal segmental glomerulosclerosis (fsgs) and minimal change disease (mcd) so far. in the light of these studies, corticosteroids and calcineurin inhibitors have been the treatment of choice and mycophenolic acid derivatives have been seen as a second line agent. however, treatment options in refractory or relapsed cases are still under debate. recently, rituximab has become an alternative in those patients. therefore, a study based on registry data was conducted to evaluate the efficacy and safety of rituximab in adult patients suffering from a relapsed or refractory primary fsgs or mcd.


Eligibility criteria:
inclusion criteria: * having biopsy-proven focal segmental glomerulosclerosis or minimal change disease. * showing resistance to or relapsing after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives. * having a history of rituximab use (375 mg/m2/wk for 1-4 weeks) following resistance to or relapse after aforementioned agents. exclusion criteria: * not providing or withdrawing consent.

Keywords: focal segmental glomerulosclerosis minimal change disease rituximab
sintilimab, pegaspargase plus gemox for untreated extranodal nk/t-cell lymphoma

Conditions: Extranodal NK/T-cell Lymphoma

Summary: this is a single-arm phase 2 study designed to evaluate the safety and efficacy of sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (p-p-gemox regimen) as first-line treatment for patients with enktl. the primary endpoint is the complete response rate (crr) in the intention-to-treat population.the secondary endpoints were overall response rate (orr), progression-free survival (pfs), overall survival (os), and adverse events.


Eligibility criteria:
inclusion criteria: * histopathologically confirmed diagnosis of extranodal nk/t-cell lymphoma (enktl) by the study center. * age between 18 and 75 years. * at least one of the following risk factors: age ≥ 60 years; presence of b symptoms; ecog performance status ≥ 2; elevated lactate dehydrogenase (ldh); baseline ebv-dna \> 500 copies/ml. * ecog performance status of 0 to 3. * adequate bone marrow function: absolute neutrophil count (anc) ≥ 1.5 × 10⁹/l (≥ 1.0 × 10⁹/l in cases with bone marrow involvement); platelet count (plt) ≥ 80 × 10⁹/l (≥ 50 × 10⁹/l in cases with bone marrow involvement); hemoglobin (hgb) ≥ 80 g/l. * adequate organ function: alanine aminotransferase (alt) \ 50%. exclusion criteria: * aggressive nk-cell leukemia. * central nervous system lymphoma. * history of any of the following within 6 months: acute myocardial infarction; unstable angina; congestive heart failure; uncontrolled symptomatic arrhythmia; complete left bundle branch block; second- or third-degree atrioventricular block; long qt syndrome or corrected qt interval (qtc) \> 480 ms. * uncontrolled active infection. * pregnant or breastfeeding women.
infant feeding practice and gut comfort study

Conditions: Healthy Infants

Summary: multi-country, cross-sectional, observational study in diverse geographic locations all over the world.

this is a cross-sectional single time point study. infants and caregivers who come to a clinic for a routine health visit who wish to participate in the study by signing the consent form and meet all inclusion criteria/exclusion criteria will be enrolled. at the visit, a research staff member will assist the parents to complete (i) feeding practice and gut comfort questionnaire and (ii) infant gastrointestinal symptom (igsq)-13 items. additionally, infant's anthropometrics (weight, length, head circumference) will be recorded. these anthropometrics will be measured by the researcher as part of the routine visit.

Eligibility criteria:
inclusion criteria: * healthy full term (37-42 weeks of gestation) singleton infant. * postnatal age ≥ 6 weeks and ≤ 4 months * parent as primary caregiver and ≥ 18 years old * exclusively/predominantly breastfeeding or exclusively/predominantly formula feeding of the same type/brand, for at least the past 2 weeks. * evidence of personally signed and dated informed consent document by the infant's parent(s). exclusion criteria: * chronic illness necessitating medical follow up * acute ongoing or recent (last 2 weeks) illness necessitating medical follow up * any known case of food allergy (e.g milk) * caregivers who are not likely to comply with the study procedures
children with adhd and emotional dysregulation

Conditions: Attention Deficit Hyperactivity Disorder; Disruptive Mood Dysregulation Disorder

Summary: studies have shown that children with attention deficit hyperactivity disorder (adhd) and emotional dysregulation are characterized by high severity of adhd, comorbid behavior disorders and increased risk of chronic difficulties. new studies have shown promising results by focusing on improving emotional regulation. we lack knowledge about differences in symptom patterns, stability of symptoms over time, comorbid disorders, neurocognitive functions, knowledge and regulation of emotions, psychosocial risk factors and reactions to stress. children 6 to 12 years admitted to specialist and diagnosed with adhd will be recruited. adhd children with and without emotional dysregulation defined as fullfilling the criteria for the diagnosis disruptive mood dysregulation disorder (dmdd) with regard to differences in symptom patterns, stability of symptoms over time, comorbid disorders, neurocognitive functions, knowledge and regulation of emotions, psychosocial risk factors and reactions to stress..

children referred to outpatient psychiatric service will be informed about the study and asked to participate. the clinical assessments in the study will be those that are recommended as good clinical practice, so results will be included in the diagnostic work for the patient. the data security will follow the norwegian rules and be monitored by rec and the data inspectorate of the hospital.

Eligibility criteria:
inclusion criteria: * referred to outpatient psychiatric service. * iq within normal range. * child and parents: good enough understanding of norwegian language to give valid answers in interviews and tests. exclusion criteria: * iq below normal range. * child and parents: not good enough understanding of norwegian language to give valid answers in interviews and tests. * unresolved crisis in the family.
glycemic instability after spine surgery

Conditions: Hyperglycemia

Summary: analyzing peri operative changes in blood glucose levels from non-diabetic patients undergoing spine surgery

background: blood glucose (bg) dysregulation is a well-known situation in medical or surgical severe circumstances. however bg levels following spine surgery have never been described before. our primary purpose is to measure postoperative changes in bg levels of non-diabetic patients undergoing spine surgery. methods: non-diabetic consecutive adult patients undergoing spine surgery are going to be prospectively included during a 6 months period. bg capillary measures are collected from the preoperative fasting period to the end of postoperative day 3, six times a day. three main glycemic parameters are calculated: delta day 0 (dd0), day 2 mean (d2), and hyperglycemic index (hgi). in the peri operative period, no change in oral intake nor in intravenous fluids is prescribed. patients are followed-up for three months postoperatively for any early adverse event, requiring or not surgical revision.

Eligibility criteria:
inclusion criteria: * non diabetic spine surgery candidate exclusion criteria: * infection or history of infection of surgical site, past medical history of diabetes mellitus, defined as chronic glucose intolerance either insulin-dependent or non insulin-dependent at the time of operation, and patients with preoperative random bg levels greater than 126 mg/dl considering they could also represent undiagnosed diabetes

Keywords: blood glucose postoperative complications spine orthopedic surgery
tapering of rituximab based on interval prolongation compared to disease activity-guided dose reduction in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the goal of this open label multicenter randomized controlled pragmatic superiority trial is to investigate the optimal treatment/tapering strategy with rituximab for patients with rheumatoid arthritis. the main questions it aims to answer are: * what is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of reducing patient reported disease impact? * what is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of therapeutic efficacy? participants will be randomized to one of two study arms: * tapering based on disease-activity guided dose reduction (experimental arm) * tapering based on interval prolongation (active comparator arm)


Eligibility criteria:
inclusion criteria: * able and willing to give written informed consent and participate in the study before any study procedure. * age ≥ 18 years. * understanding and able to write in dutch or french. * diagnosis of rheumatoid arthritis according to the 2010 american college of rheumatology/european league against rheumatism (acr/eular) classification criteria for rheumatoid arthritis. * previous response to rituximab, defined as a minimum of one successful rituximab cycle (= a moderate/good eular response 16 weeks after the first administration of rituximab). * current treatment with rituximab. * need for a subsequent rituximab cycle according to the belgian reimbursement criteria for the use of rituximab in rheumatoid arthritis (das28 score ≥3.2). * stable dose of methotrexate or other conventional synthetic disease-modifying antirheumatic drugs (dmards) 4 weeks prior to baseline. exclusion criteria: * current treatment with another biological dmard than rituximab. * current treatment with a targeted synthetic dmard. * pregnancy or pregnancy wish. * presence of an absolute contraindication to treatment with rituximab, according to the label of rituximab and according to medical judgement.

Keywords: rheumatoid arthritis rituximab tapering disease impact
resistance exercise for depression trial

Conditions: Major Depressive Disorder

Summary: depression is a leading cause of disability worldwide and current treatments are ineffective for many people. this trial will investigate the efficacy of a 16-week high vs low dose resistance exercise training program for the treatment of major depressive disorder (mdd) in 200 adults.

frontline treatments for major depressive disorder (mdd), including psycho- and pharmacotherapy, have limited effectiveness, and there is a critical need to develop and test novel, efficacious treatments for mdd and simultaneously work to optimize its benefits. resistance exercise training (ret) is a promising but understudied treatment approach. this trial will investigate the efficacy of ret for treatment of mdd in a 1:1 randomized controlled trial (n=200) of 16 weeks of high vs low progressive ret in adults with dsm-5 diagnosed mdd. further, this project will explore potential mechanisms leading to symptom improvement, including changes in cerebrovascular function (i.e., cerebral blood velocity and pulsatility) and self-efficacy, while also using supervised machine learning tools to predict depression changes, cerebrovascular changes, and participant adherence. upon completion, this study will build towards identifying and translating mechanistically driven behavioral treatments to reduce the global burden of mental illness.

Eligibility criteria:
inclusion criteria: * be diagnosed with dsm-5 mdd, confirmed via structured clinical interview for dsm-5 (scid). * have current depressive symptoms of at least mild severity defined by the hamilton rating scale of depression 17 greater than or equal to 8 (hamd; using the grid-hamd evaluated by trained, masked raters) * be ages 18-65 * either not taking any mental health medications or seeking other mental health treatment (e.g., behavioral, psychological) or be on a stable mental health medication and/or treatment regimen for the past 8 weeks, and intend to maintain that regimen for the duration of the study * safe to exercise based on physical activity screening questions or physician clearance * willing to be randomized to either condition * have a smartphone exclusion criteria: * currently pregnant, nursing, or planning to become pregnant during the trial * class iii+ obesity * diagnosed with lifetime or current psychosis, mania, or bipolar disorder, via the scid * diagnosed with current substance use disorder, via the scid * active suicidal ideation with specific plan and intent ('5' score on suicidal ideation from columbia suicide severity rating scale), which would necessitate immediate emergent care * exhibit behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) that would significantly interfere with study participation, as assessed by clinical research personnel * currently meets resistance exercise recommendations (2 days per week) for the last 8 weeks * self-reporting a concussion/traumatic brain injury within the last 3 months * having cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes

Keywords: resistance exercise training strength training