Kornimate/medical-research-clean huggingface dataset:
rituximab-induced hypogammaglobulinemia in multiple sclerosis

Conditions: Multiple Sclerosis; Hypogammaglobulinemia

Summary: b cells are considered major contributors to multiple sclerosis (ms) pathogenesis, a role that has taken on renewed importance with the advent of b-cell-depleting therapies. rituximab is being increasingly utilized as an off-label treatment option across ms patients . in addition, there have been increasing reports of rituximab causing hypogammaglobulinaemia and antibody deficiency across a variety of conditions including ms and related neuroinflammatory disorders. therefore, the purpose of this study is to evaluate the rate of hypogammaglobulinemia in rituximab-treated ms adult patients and to assess the correlation with vaccination response during the treatment.

this is a prospective study which will be conducted in an educational medical hospitals in sari, iran.adult patients with diagnosis of multiple sclerosis compatible with 2017 mcdonald criteria and history of treatment with rituximab at least 3 times( 18 month) , enrolled to this study.demographic patients' characteristics, including age, sex, vital sign, past medical history, drug history, will be recorded. disease duration prior to rituximab, total rituximab dose, prior immunomodulatory drugs, adverse drug reactions, the time interval between the last rituximab infusion and need for intravenous immunoglobulin replacement therapy and infections are recorded. moreover, we will assess igg and igm levels, vzv titer at before rituximab administration and 6, 12, 18, months following the initiation of next dose of rituximab.

Eligibility criteria:
inclusion criteria: 1. diagnosis of multiple sclerosis compatible with 2017 mcdonald criteria 2. history of treatment with ritximab at least for 18 month 3. written informed consent exclusion criteria: 1. history of ivig intake in 3 past month 2. history of plasmapheresis in 3 past month 3. unknown vaccination history 4. any indication for concurrent use of immunomodulator or immunosuppressor drug

Keywords: rituximab varicella zoster hypogammaglobulinemia
a study of pegasys (peginterferon alfa-2a (40kd)) in patients with chronic hepatitis b.

Conditions: Hepatitis B, Chronic

Summary: this single arm study will assess the efficacy and safety of pegasys in patients with chronic hepatitis b who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. all patients will receive pegasys, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-70 years of age; * chronic hepatitis b; * hepatitis b virus (hbv) dna \>100,000 copies/ml. exclusion criteria: * previous antiviral or interferon-based therapy for chronic hepatitis b in past 6 months; * evidence of decompensated liver disease; * history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis; * coinfection with hepatitis a, c or d, or hiv.
effects of adding chickpeas to the american diet on fecal microbiota composition and markers of inflammation

Conditions: Inflammation

Summary: this prospective study will assess the effects of adding legumes, especially chick peas, to the diet of healthy adults on the commensal bacteria from feces of human subjects and resulting self-reported gi symptoms as well as markers of immune function.

short-term active feeding study: the investigators will provide various chickpea products to participants for a 14 day chickpea enhanced diet. subjects will receive specific meal plan instructions for the consumption of 5 servings/week of chickpeas. chickpea products will be sourced from commercial providers. while participants will be told to substitute chickpea products for other diet ingredients, the subjects will be free to choose what to substitute according to their preferences. subjects will keep daily food records and will be told that chickpea consumption will be monitored in their fecal samples (qpcr). fecal samples will be collected before the start (day 1), during (day 7-9) and at the end (day 14) of the intervention using a stool collection kit (sigma). participants will complete our gi health questionnaire on a weekly basis to determine tolerance to increased chickpea intake. an open ended questionnaire will be administered after participants have completed the short-term study protocol to assess any issues with compliance to chickpea intake. all individuals that increased their chickpea intake from their usual diet by at least 3 servings/week will be included in the analysis.

Eligibility criteria:
inclusion criteria: * good health * no systemic antibiotics during the preceding two months * no medication suppressing immune function * willingness to provide basic demographic as well as medical history data exclusion criteria: * gastric ulcers * inflammatory bowel disease (ibd) or irritable bowel syndrome (ibs) * chronic constipation/diarrhea * body mass index (bmi) \> 30 * dietary restrictions that prevent legume intake * currently on any medication that can affect gi transit time * consumption of \>3 servings/week of chickpeas or \>6 servings/week of legumes before study begins

Keywords: gut microbiota
vr glasses during induction of labour for pain and anxiety relieve

Conditions: Virtual Reality; Induction of Labor Affected Fetus / Newborn; Extra Amniotic Balloon

Summary: in the current study, the investigators aim is to test the distraction affect of "virtual reality" (vr) technology on pain and anxiety in pregnant women who undergo through an induction of labour with an extra-amniotic balloon catheter

insertion of extra-amniotic balloon (eab) is a recommend mechanical method of induction of labour. this method of induction causes the cervix to dilate through mechanical pressure on the cervix. during the procedure of insertion the women is lying on her back. insertion of eab is performed by conventional means. the insertion of eab can involve discomfort, pain and anxiety before and during the procedure. while there are numerous studies which describe interventional, pharmacological and non-pharmacological means for pain and anxiety relieve during latent and active phase of labour, there is no sufficient evidence for pain and anxiety relieve during the pre-labour and through induction of labour period. the "virtual reality" (vr) technology is a simple non-invasive technology. the advantage of vr is that it can distract the patient's attention from pain and anxiety by exposure to a virtual reality environment. this technology uses processes of sight, and hearing that requires attention. many studies have already investigated the use of vr technology in various medical procedures, such as dental treatment, infusion, pediatric treatment, burns, trauma, chemotherapy, diagnostic hysteroscopies and other medical procedures that are common to the patient's experience of pain and anxiety.

Eligibility criteria:
inclusion criteria: * pregnant women going through mechanical induction of labour with extra-amniotic balloon exclusion criteria: * women with history of migraine, headache, epilepsy, vestibular disorders * women suffering from seasickness ,motion sickness, vertigo, nausea, vomiting, seizures

Keywords: virtual reality induction of labor extra amniotic balloon
intraoperative implementation of the hypotension probability indicator

Conditions: Intraoperative Hypotension

Summary: reducing intraoperative hypotension using flotraciq with hpi software.

intraoperative hypotension occurs often. even short durations of hypotension are suggested to be associated with increased risk for renal insufficiency and myocardial ischemia. currently treatment of these hypotensive episodes is not proactive. edwards lifesciences has developed an algorithm using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. hypothesis: the use of this algorithm will alter treatment of hypotension and reduces the incidence of hypotension.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * planned for elective non-cardiac non-day surgery with an expected duration of more than 2 hours * planned to receive general anaesthesia * planned to receive an arterial line during surgery * aim for map of 65 mmhg during surgery * being able to give written informed consent prior to surgery exclusion criteria: * aim for map other than 65 mmhg at discretion treating physician * significant hypotension before surgery defined as a map \<65 * right- or left sided cardiac failure (e.g. lvef\<35%) * known cardiac shunts (significant) * known aortic stenosis (severe) * severe cardiac arrhythmias including atrial fibrillation * requiring dialysis * liver surgery * vascular surgery with clamping of the aorta * perioperative goal directed therapy (pgdt) protocol

Keywords: intraoperative hypotension hypotension probability index hpi
bolster: building out lifelines for safety, trust, empowerment and renewal

Conditions: Gynecologic Cancer; Gastrointestinal Cancer

Summary: this research study is evaluating a new intervention, bolster, which was designed to provide more support for patients with gynecologic and gastrointestinal cancers and their caregivers after a hospitalization.

hospitalizations can be difficult for patients with cancer, especially when they are transitioning home. patients and caregivers are often expected to perform complex medical and nursing tasks with little or no preparation. patients and caregivers report high levels of unmet needs for information about how best to manage symptoms and new medical procedures (such as managing new tubes, lines or drains). the study team has developed a research project which aims to address these needs. if a patient agrees to participate in the study, she will take part in a program called bolster (building out lifelines for safety, trust, empowerment and renewal). bolster will provide patients and caregivers with education and skills training, symptom management, and support across care settings.

Eligibility criteria:
patient inclusion criteria * adults (≥18 years old); * gyn or gi cancers receiving anti-neoplastic therapy; * hospitalized, recently hospitalized (i.e. within the first 2 visits after a hospitalization), or recent outpatient placement of tube, line, or drain (e.g. pleurx catheter); * plan to receive ongoing care at dfci; * willingness to be audio taped for the study (for monitoring of study fidelity). * have complex care needs (e.g. an ostomy, ileostomy, a gastric tube, percutaneous nephrostomy tubes, a pleurx catheter, or need for total parenteral nutrition) patient exclusion criteria * unable to read and respond to questions in english; * cognitive impairment; * unable to complete the baseline interview; * plan for immediate hospice referral caregiver inclusion criteria * adults (≥18 years old); * family member or friend of an eligible patient; * willingness to be audio taped for the study (for monitoring of study fidelity); * willingness to participate in study visits caregiver exclusion criteria: * unable to read and respond to questions in english, * cognitive impairment * unable to complete the baseline interview

Keywords: ovarian cancer bowel blockage ascites supportive care nursing mobile health m-health tele-health palliative care symptom management gastrointestinal cancer gynecologic cancer complex care needs
a trial of a hospital policy of tranexamic acid use to reduce transfusion in major non-cardiac surgery

Conditions: Major Non-cardiac Surgeries

Summary: a phase iv trial of a hospital policy of tranexamic acid to reduce transfusion in major non-cardiac surgery.

the traction trial is a national multi-centre phase iv randomized cluster-crossover trial of tranexamic acid versus placebo. over the duration of the study, participating centres will be centrally and randomly allocated to receive either txa or matching placebo at 1-month intervals for a total of 8 months. as our pragmatic trial is designed to define practice, we have selected co-primary outcomes that evaluate effectiveness in the context of safety. our co-primary outcomes are the: 1. proportion of patients transfused rbcs 2. incidence of dvt or pe (collectively called venous thromboembolism (vte) within 90 days of surgery.

Eligibility criteria:
cluster-level inclusion criteria: hospital sites will be included in the trial if anesthesia and hospital leadership agree to manage patients as per the policy being implemented and evaluated in the trial. patient-level inclusion criteria: * patients \>/= 18 years of age undergoing major non-cardiac surgery (a state of hyperfibrinolysis) * inpatient surgeries with an estimated \>/= 5% risk of rbc transfusion, including open surgeries or laparoscopic surgeries with an estimated duration of \>/= 3 hours examples of eligible surgeries could include (but are not limited to): 1. general surgery (esophagectomy, gastrectomy, gastric repair, small bowel repair or resection, ostomy formation, colon/rectum repair or resection, colostomy, splenectomy, hepatectomy, pancreatectomy, resection of abdominal mass) 2. orthopedics (hip fracture repair, pelvic fixation, femur repair / fixation, shoulder / humerus open reduction internal fixation, lower extremity amputation) 3. spine (vertebrectomy, surgery involving \>/= 3 levels) 4. otolaryngology (glossectomy, mandibulectomy, radical laryngectomy) 5. thoracic (lung resection or decortication) 6. vascular (arterial bypass / endarterectomy / aneurysmorrhaphy involving the aorta or proximal vessels off the aorta) 7. gynecology (hysterectomy) 8. urology (nephrectomy, cystectomy, prostatectomy, pelvic exenteration) 9. plastic surgery (large neoplasm resections, burns or debridements) 10. surgeries anticipated to be associated with 5% or greater risk of rbc transfusion in hospital as per the surgical team. exclusion criteria: * active thromboembolic disease (ie, patient is anticoagulated for thromboembolic disease prior to admission) * pregnancy * cardiac surgery and hip and knee arthroplasty where txa is standard-of-care * surgeries with free flap reconstruction * trauma surgeries where txa was administered within the previous 3 hours.

Keywords: tranexamic acid (txa) venous thromboembolism (vte) deep vein thrombosis (dvt) transfusion perioperative bleeding
fit for two: incorporating wearable trackers into clinical care for pregnant women with diabetes (fft)

Conditions: Physical Activity; Type 2 Diabetes Mellitus

Summary: this study will investigate the feasibility of an intervention to increase physical activity in pregnant women with diabetes by incorporating a brief in-person counseling session and fitbit activity trackers into routine clinical care

this is a small, one-armed pilot study testing a physical activity intervention for pregnant patients with diabetes. the intervention will use both counseling and technology (a fitbit physical activity tracker and smartphone app) to create an individualized, interactive program for each patient. the primary aims of the study are to assess the feasibility of recruiting patients and implementing the program in the clinical setting, and the acceptability of the program for patients and clinicians. participants will receive a counseling session based on the principles of motivational interviewing to help them set physical activity and step goals, then the interventionist will help them personalize the fitbit app to their goals. participants are instructed to continue adaptive goal setting and email their goals and activity weekly to their physicians. in addition to assessing feasibility and acceptability, we will also evaluate change in activity to explore potential efficacy.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes or gestational diabetes * currently pregnant * in week 5-25 of gestation * under active (\<100 minutes/week of physical activity) * access to a smartphone exclusion criteria: * any medical condition that would make unsupervised activity unsafe or unfeasible, as determined by their physician * moving from the area within 3 months

Keywords: feasibility
targeting the sensory disturbance in autism spectrum disorder

Conditions: Autistic Disorders Spectrum

Summary: this study aims to establish a cognitive-behavior therapy (cbt) based virtual exposure (vr) exposure program to train asd adults coping with everyday sensory scenarios. through the practice and training, the asd participants may learn the strategy to deal with the common sensory scenarios and master the anxiety around the exposure. the anticipatory anxiety and the maladaptive behaviors may be decreased along with the process of desensitization, while the functional impairment related to sensory sensitivity can partly be recovered.


Eligibility criteria:
inclusion criteria: * young adult aged between 18 and 45 years who had a diagnosis of asd from a licensed mental health or medical professional based on dsm-5; * has sensory and social problems as reported by the participant and the caregiver; * is motivated to participate in the treatment; * is fluent in chinese; * has a full-scale iq \> 70 on wais-iv; * scored ≧ 26 on the caregiver-reported autism spectrum quotient (aq), indicating clinical impairment associated with asd. exclusion criteria: * a history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases; * visual impairment and/or hearing impairment that would preclude participation in the cbt-based vr exposure program

Keywords: autism spectrum; sensory disturbance; intervention; virtual reality; cognitive behavior therapy
medico-economic evaluation of therapeutic adaptation guided by the soluble suppression of tumorigenicity 2 (sst-2) biomarker in the management of patients with acute heart failure

Conditions: Heart Failure

Summary: management of patients with heart failure remains a major health concern because of the high rate of rehospitalization, mortality and induced-cost. biomarkers could help to guide the management of patients with heart failure (hf). soluble suppression of tumorigenicity 2 (sst2) appears as a promising biomarker. as a working hypothesis, we postulate that sst2 values monitoring could be an helpful guide for medical management in an attempt to reduce hospital readmission.

methods : icame is a multicentric, blinded prospective randomized controlled trial. 710 patients originated from 10 centers will be included over a period of 12 months and follow-up for 24 months. all patients have an external evaluation at 6, 12, 18 and 24 months. they were randomized into the usual treatment group (unknown sst2 level) or the interventional treatment group, for whom sst2 level was known at all external consultation and used to guide the treatment. the primary endpoint was the qaly (quality adjusted life years). the secondary endpoints were the cost-efficacy ratio, cost to avoid an hospitalization for heart failure, the readmission rate for any cause at 1 month and at two years, and the evolution of cardiac remodelling determined by the collagene biomarkers.

Eligibility criteria:
inclusion criteria: * 18 years or older * hospitalization for heart failure (ntprobnp(n-terminal pro-brain natriuretic peptid) ≥450 pg/ml (ou bnp ≥400 pg/ml) exclusion criteria: * waiting for heart transplantation * scheduled valve surgery * no fluent french * not able to provide informed consent * hemodynamic instability * poor outcome during the first week. * pregnancy * participating to other study

Keywords: heart failure biomarker guided therapy
optimizing exercise training in prevention and treatment of diastolic heart failure

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: aim of the clinical multicenter study (optimex-clin) is to assess the optimal exercise intervention in patients with heart failure with preserved ejection fraction (hfpef; also termed diastolic heart failure) that will best improve peak oxygen uptake (peak vo2) and additionally diastolic function (assessed echocardiographically). the investigators hypothesize that exercise training reverses hfpef and that intensity of exercise training is more important than duration.


Eligibility criteria:
inclusion criteria: * sedentary (structured exercise \< 2x 30 min/wk) * at least 40 years old * preserved systolic function lvef \> 50% * signs and symptoms of heart failure class nyha ii or iii * diastolic dysfunction (e/é \> 15 or e/é 8-15 and nt-probnp \> 220 pg/ml) * clinically stable for \>= 6 weeks * optimal medical treatment for \>= 6 weeks * written informed consent exclusion criteria: * non- hfpef causes for hf symptoms (significant valvular or coronary disease, uncontrolled hypertension or arrhythmias, primary cardiomyopathies) * significant pulmonary disease (fev1 \< 50% predicted, copd gold iii-iv) * inability to exercise or conditions that may interfere with exercise intervention * myocardial infarction in the previous three months * signs of ischemia during exercise testing * comorbidity that may influence one- year prognosis * participation in another clinical trial

Keywords: diastolic heart failure, heart failure with preserved ejection fraction, exercise
how safe are our pediatric emergency departments?

Conditions: Adverse Effects; Adverse Drug Event

Summary: patient safety is an internationally recognized health care priority. canadian data suggests that about 8% of adults admitted to hospital experience unintended harm (or 'adverse events') from the health care provided during their hospital stay. on a national level, this represents almost 25,000 preventable deaths among hospitalized adults each year. the emergency department is recognized as a high-risk environment for adverse events but most patient safety research is not specific to the emergency department. as well, the vast majority of people treated in the emergency department are sent home after their visit; yet safety research focuses primarily on people who are admitted to hospital. finally, although children have also been identified as particularly high risk for suffering adverse events, very little research has been done on how often these events occur among children who visit the emergency department. our study will address this gap in our knowledge about patient safety and provide important information on the frequency, severity and preventability of adverse events occurring among children in the emergency department. this information will help us to improve the safety of emergency department care for all canadian children.


Eligibility criteria:
inclusion criteria: * age less than 18 years * patients from all pediatric canadian triage acuity scale categories (pedsctas; 1:resuscitation; 2:emergent, 3:urgent, 4:semi-urgent, 5:non-urgent). exclusion criteria: * insurmountable language barrier that prevents informed consent and follow-up by telephone. * children and families that will be unavailable for telephone follow-up in the three weeks after their emergency department visit (e.g., no telephone in the home, travelling out of the country, etc.).

Keywords: patient safety pediatrics emergency medicine