Kornimate/medical-research-clean huggingface dataset:
combination of sulfonylureas and insulin glargine outpatient therapy for unstable diabetes and impending dka

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to compare two simple and safe emergency department discharge therapy for type 2 diabetes patients with severe hyperglycemia and with no indications for inpatient admission.

this study is an open label randomized controlled trial in adult dm2 patients seen in ed services at john h. stroger hospital of cook county serving a largely uninsured/underserved population. individuals more than 18 years of age with dm2, either with new onset dm2 or known diabetics who did not take oral hypoglycemic agents for more than 2 weeks, presenting with fasting blood glucose (fbg) 300-500 mg/dl or random blood glucose (rbg) 400-700 mg/dl and who did not have any exclusion criteria listed in table 1, were eligible for the study. subjects were randomized to one of the two fixed dose treatment groups: 1) glipizide xl 10 mg orally daily prior to breakfast (g group), 2) glipizide xl 10 mg orally daily along with insulin glargine 10 units at bedtime, subcutaneously (g+g group).

Eligibility criteria:
inclusion criteria: * individuals more than 18 years of age with dm2, either with new onset dm2 or known diabetics who did not take oral hypoglycemic agents for more than 2 weeks, presenting with fasting blood glucose (fbg) 300-500 mg/dl or random blood glucose (rbg) 400-700 mg/dl and who did not have any exclusion criteria listed in table 1, were eligible for the study. exclusion criteria: * acute metabolic complications (diabetic ketoacidosis, hyperosmolar hyperglycemia associated with dehydration). * acute complications of chronic cardiovascular, neurological, renal, and other diabetic complications. * any subject with unstable vitals signs (temperature \> 101 degrees f, systolic blood pressure \ 180 mm hg, diastolic blood pressure \ 110 mm hg, heart rate \ 120 beats/minute). * electrolyte imbalances (serum bicarbonate level \ 150 meq/l, serum potassium \ 5.5 meq/l). * evidence of an impaired sensorium and/or dementia. * age \> 75 years * subjects with any acute medical illness. * type 1 diabetes or type 2 diabetics weighing less than 120 lbs * current addiction to illicit substances or alcohol abuse * pregnant or lactating subjects

Keywords: hyperglycemia glucose toxicity glargine glipizide
monitoring community trends in heart failure

Conditions: Cardiovascular Diseases; Heart Failure, Congestive; Heart Diseases

Summary: to examine temporal trends from 1995 and 2000 in the incidence rates of heart failure, its therapeutic management, and changes over time in the hospital and long-term survival of patients with heart failure.

background: heart failure is estimated to contribute to nearly 1 million hospitalizations and approximately 250,000 deaths annually in the u.s. the number of new cases of heart failure in the u.s. is estimated to exceed 400,000 annually. though reliable estimates of the magnitude, incidence, and mortality of heart failure remain sorely lacking, heart failure is associated with a grim prognosis. however, little recent data exist, particularly from a community-wide perspective, to determine whether the incidence or survival associated with heart failure, and the management of this clinical syndrome, has changed over time. design narrative: the study uses residents of the worcester (ma) metropolitan area (1990 census 437,000) and examines changes over time in these and additional outcomes for patients with validated heart failure during 1995 and 2000. complimenting the hospital surveillance of heart failure, newly diagnosed cases of heart failure occurring in members of the largest hmo in central massachusetts during 1995 and 2000 will be identified and monitored over time. to accomplish the study objectives, the medical records of residents of the worcester metropolitan area hospitalized with a discharge diagnosis of heart failure and related diagnostic rubrics will be individually reviewed and validated according to pre-established diagnostic criteria. the use of traditional criteria for heart failure as well as development of new criteria for the epidemiological study of heart failure will be an important focus of this observational study. records for additional hospitalizations and death certificates will be reviewed to examine trends in long-term survival of discharged hospital patients through the year 2005.

Eligibility criteria:
no eligibility criteria
a study to assess safety,and tolerability of 2 doses of azd9773 (cytofab™) in japanese with severe sepsis/septic shock

Conditions: Severe Sepsis; Septic Shock

Summary: the two co-primary objectives of this study are to assess in japanese patients with severe sepsis and/or septic shock: 1) the safety and tolerability of two different doses of intravenous azd9773 and 2) the pk of azd9773. the secondary objective is to make a preliminary assessment of the pharmacodynamics of two different doses of intravenous azd9773 in japanese patients with severe sepsis and/or septic shock.


Eligibility criteria:
inclusion criteria: * japanese adults with a first episode of sepsis during this hospitalisation and objective evidence of infection that requires parenteral antibiotics. * at least 2 of 4 sirs criteria in the 24 hours before organ dysfunction (must include either fever or elevated white blood cells \[wbc\]) * cardiovascular or respiratory dysfunction. exclusion criteria: * immunocompromising comorbidities or concomitant medications: 1. advanced human immunodeficiency virus (hiv) infection (cd4 ≤50/mm3). 2. haemopoietic or lymphoreticular malignancies not in remission. 3. receiving radiation therapy or chemotherapy. 4. any organ or bone marrow transplant within the past 24 weeks. 5. absolute neutrophil count \<500 per μl. 6. high dose steroids or other immunocompromising drugs. * concomitant diseases: 1. deep-seated fungal infection or active tuberculosis. 2. severe chronic liver disease associated with portal hypertension, cirrhosis, chronic ascites or child-pugh class c. 3. history of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease. 4. neuromuscular disorders that impact breathing/spontaneous ventilation. 5. quadriplegia. 6. cardiac arrest in the past 30 days. 7. new york heart association functional class iii or iv due to heart failure or any disorder. 8. burns over \> 30% of body surface area in the past 5 days. * medication and allergy disqualifications. 1. treatment with anti-tnf agents within the last 8 weeks. 2. previously received ovine derived products (crofab™, digifab™). 3. sheep product allergy or allergy to papain, chymopapain.

Keywords: tnf neutralisation
a study to evaluate the relationship of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma

Conditions: Lymphoma, Mantle-Cell

Summary: the purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma.

this is a european multinational, retrospective, non-interventional study of participants with relapsed or refractory mantle cell lymphoma (r/r mcl). potential sites will be identified where r/r mcl participants have been treated with lenalidomide. site inclusion will be limited to countries where lenalidomide is reimbursed for this indication.

Eligibility criteria:
inclusion criteria: received at least one dose of lenalidomide commencing after 08 july 2016 for the treatment of relapsed refractory mantle cell lymphoma. informed consent of the patient or an authorized third person or authority, if required by law, given prior to data collection. patient must be ≥18 years of age at the time of signing the informed consent form. exclusion criteria: 1) patients will be excluded if they were participating in an interventional clinical trial during the treatment period under observation in this post authorization safety study.

Keywords: mantle cell lymphoma mcl revlimid non-interventional pass cc-5013 relapsed refractory tfr tumor flare reaction high tumor burden
sleep technology intervention to target cardiometabolic health

Conditions: Elevated Blood Pressure; Habitual Sleep Duration of Less Than or Equal to 7 Hours

Summary: the goal of this study is to test the efficacy of a behavioral sleep extension intervention on sleep duration, cardio-metabolic disease risk factors, and health behaviors among adults with elevated blood pressure/hypertension and short sleep duration.

half of u.s. adults have at least one cardio-metabolic disease (cmd), including hypertension (htn), heart disease, stroke, or diabetes. even with advances in screening, education, and medication management, controlling these chronic diseases remains challenging. despite the well-established negative effects of short sleep duration, surprisingly few studies have tested the benefits of sleep extension and even fewer studies evaluate the science of sleep extension interventions. therefore, the goal of this study is to test the efficacy of a behavioral sleep extension intervention on sleep duration, cmd risk factors, and health behaviors among adults with elevated bp/htn and short sleep duration.

Eligibility criteria:
inclusion criteria: * age 18-65 * 24h abp readings indicating elevated blood pressure (bp) or hypertension (24h average systolic (sbp) of 115-145 mmhg or diastolic (dbp) of 75-90 mmhg). patients taking antihypertensive medications will be permitted if stable dose for \>8 weeks * time in bed \<8 hours and habitual sleep duration \<7 hours via actigraphy; * smartphone user * able to read/write in english. exclusion criteria: * high risk or presence of moderate to severe comorbid sleep disorders (i.e., obstructive sleep apnea ahi 15 or greater, restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight obstructive sleep apnea at the baseline/screening * resistant hypertension, defined as \>4 antihypertensive medications or taking medications and standardized in lab bp \>130 mmhg sbp or 80 mmhg dbp at screening history of cognitive or neurological disorders (e.g. dementia, parkinson's, multiple sclerosis) * bmi\>50 kg/m2 or arm circumference greater than extra large cuff * presence of major psychiatric disorders (e.g. schizophrenia, bipolar disorder) * alcohol abuse on the audit-c (score \>4 for men, \>3 for women) * drug use on the nida-modified assist (score \>3),90 * moderate to severe depressive symptoms (phq-8 \>10) * unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis) * overnight work more than 1x per month * use of hypnotic or stimulant medications * situations that would significantly impact the ability to extend sleep, including overnight caregiving responsibility for children under the age 1, elderly or disabled adults \>1x per week * inability to read or write in english * pregnancy/desire to become pregnant during the study period.
gamma-linolenic acid supplementation study

Conditions: Weight Trajectory

Summary: weight regain following weight loss is common. in rodent models of obesity and pilot studies in humans, increasing membrane arachidonic acid content improves fuel partitioning and prevents weight regain. this study aims to understand the effect of gamma-linolenic acid (gla) supplementation on weight loss maintenance in virta health patients.

the primary purpose of this research is to determine if gla supplementation reduces weight regain over 24 months in virta health patients. the secondary purpose is to determine the effect of gla supplementation on diabetes-related outcomes.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 yrs * patients referred to virta health by employers or insurers * weight loss greater than or equal to 7% of initial weight and current bmi \> 25 kg/m2 * willing to take 3 supplement capsules daily * able to understand study procedures and willing to provide informed consent * english-speaking exclusion criteria: * patients who are pregnant or lactating * patients who are taking or are prescribed orlistat
accuracy evaluation of artificial intelligence assisted liver tumor ablation path planning

Conditions: Liver Tumor

Summary: ct-guided microwave ablation is one of the important treatment methods for primary or metastatic liver tumors. it has the advantages of minimally invasive, safe, and economical. for liver tumors with a diameter of less than 3 cm, it can be comparable to surgical resection. however, different doctors have different levels of experience, leading to a high risk of residues after ablation and even complications. the key is to fail to plan the needle placement reasonably. the past research on path planning was mostly conducted by the engineering team, so that the actual clinical needs were not considered comprehensively, and the sample size of verified cases was small, which limited the application of existing models in the clinical application. in previous study, we used artificial intelligence to segment the upper abdominal organs and construct the constraint function to establish the ablation path planning model, and initially verified the effectiveness of the path planning model in a small number of cases. now it is planned to expand the number of patients enrolled to evaluate the accuracy of the ablation path planning model that we have established.


Eligibility criteria:
inclusion criteria: 1. 18-70 years old patients with liver tumors, not limited to primary liver cancer or secondary liver metastases; 2. the number of tumors is less than 5; 3. the diameter of the tumor is less than 3 cm; 4. no local treatment of intrahepatic tumors has been done in the past. exclusion criteria: 1. diffuse liver tumor; 2. multiple lesions in the liver\> 3cm, which cannot be completely ablated; 3. patients with lymph node metastasis and distant metastasis outside the liver; 4. other situations where the researcher believes that it is necessary to withdraw from the study

Keywords: liver tumor ablation path planning artificial intelligence accuracy evaluation
study of the collaborative life skills program

Conditions: Attention Deficit Hyperactivity Disorder Symptoms

Summary: this study tests the effectiveness of a newly developed integrated school-home behavioral intervention for behaviors related to attention deficit hyperactivity disorder (adhd). the intervention is implemented by school-based mental health professionals within school settings.


Eligibility criteria:
inclusion criteria: * attending a participating school and in 2-5th grade * referral by lsp as a child with apparent adhd-related problems * ≥ 6 symptoms (item score ≥ 2) of inattention or hyperactivity-impulsivity on the pooled parent and teacher child symptom inventory * ≥ 3 on the impairment rating scale by parent and teacher (cross-situational impairment) * fsiq or viq ≥ 80 (necessary for cognitive demands of the child skills curriculum) * caretaker consents to participate in treatment, child assents to participate exclusion criteria: * presence of conditions that are incompatible with this study's treatment. * severe visual or hearing impairment, * severe language delay, * psychosis, * pervasive developmental disorder * parent or child does not read or speak english or does not read or speak spanish for our spanish language implementation of cls (inability to complete assessment measures or participate in group treatments). * child is in an all-day special education classroom (children in these classrooms are frequently receiving intensive behavior modification programs such that the intervention would be expected to require modification for use in these settings) * children taking psychotropic medication for any reason other than to treat adhd * children planning to change (start or stop) psychotropic medication * children who have changed a regimen of psychotropic medication (started or stopped) within 30 days prior to screening

Keywords: attention deficit hyperactivity disorder psychosocial intervention behavioral intervention school-home collaborative intervention
study of health promotion in patients with early-stage breast or prostate cancer

Conditions: Breast Cancer; Depression; Fatigue; Malnutrition; Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: telephone counseling by a nutritionist and a personal trainer may improve physical function and quality of life in patients who have early-stage breast cancer or prostate cancer. purpose: randomized clinical trial to compare the effectiveness of a home-based, diet and exercise-based counseling program with that of a standard home-based counseling program in promoting health in patients who have early-stage breast cancer or prostate cancer.

objectives: * compare the efficacy of a diet and exercise-based home-based counseling program versus a standard home-based counseling program for improving physical function at 6 and 12 months for patients with early-stage breast or prostate cancer. * compare the effects of these home-based programs on diet quality, physical activity, weight status, depression, and quality of life of these patients. * compare the factors, such as gender, race, and social support, that interact with these home-based programs to predict program efficacy in these patients. outline: this is a randomized, multicenter study. patients are randomized to 1 of 2 arms. * arm i: patients receive home-based telephone counseling by a personal nutritionist and a personal trainer. * arm ii: patients receive home-based standard health telephone counseling in unrelated areas of cancer care (e.g., sun exposure, screening, and falls prevention). in both arms, counseling continues every 2 weeks for 6 months. patients are followed at 6 months. projected accrual: a total of 420 patients (210 per arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of early-stage breast or prostate cancer within the past 18 months * dietary and physical activity habits and baseline functional status that places patient at risk * potentially able to increase physical activity and to follow a low-fat, plant-based diet * hormone receptor status: * not specified patient characteristics: age: * 65 and over sex: * male or female menopausal status: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * able to speak and write english * no other malignancy within the past 5 years except nonmelanoma skin cancer * no other illness or condition that would preclude adherence to a plant-based diet or exercise prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified

Keywords: stage i breast cancer stage ii breast cancer stage i prostate cancer stage ii b prostate cancer stage ii a prostate cancer male breast cancer fatigue malnutrition psychosocial effects of cancer and its treatment depression
addressing barriers to palliative care use in bladder cancer

Conditions: Muscle-Invasive Bladder Carcinoma; Bladder Cancer Stage II; Bladder Cancer Stage III; Bladder Cancer Stage IV

Summary: investigators plan to establish an in-depth understanding of knowledge and beliefs about palliative care in advanced bladder cancer patients and their caregivers, and to identify factors associated with positive and negative experiences with palliative care services among those who have received them.


Eligibility criteria:
inclusion criteria: * eligibility for both patient and caregiver participants will include: * age ≥18 years * able to speak and read english * cognitively able to participate in study tasks * willing to participate in surveys, semi-structured interviews, and/or focus groups * able to participate in either a zoom meeting or phone interview * able to complete an emailed or paper survey * patient participants: a diagnosis of muscle-invasive or locally advanced bladder cancer (stages ii-iv). exclusion criteria: * patients and caregivers will be excluded if unable to provide verbal or written consent

Keywords: bladder
mitomycin c therapy for patients with primary sclerosing cholangitis

Conditions: Primary Sclerosing Cholangitis

Summary: the purpose of this study is to determine the effectiveness and safety of mitomycin c in the treatment of primary sclerosing cholangitis (psc).


Eligibility criteria:
inclusion criteria: * ages 18 or older * previously established diagnosis of primary sclerosing cholangitis exclusion criteria: * american society of anesthesiologists class 4 or greater * serum creatinine \>= 1.7 mg/dl, egfr \<= 30 ml/min, or dialysis dependence * serum hemoglobin \<= 7 g * left ventricular ejection fraction \<= 30% * dyspnea with minimal exertion (or supplemental oxygen dependence) * history of bone marrow disease * prior recipient of organ transplantation * ongoing chemotherapy * obstruction of the upper gi tract * pregnant or lactating * inability to provide informed consent

Keywords: mitomycin c
single-dose study to describe the pharmacodynamics (pd) and safety of sarilumab (regn88/sar153191) and tocilizumab in adults with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: the main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.


Eligibility criteria:
inclusion criteria: 1. patients with ra as defined by the 2010 revised american college of rheumatology (acr) 2. acr class i-iii functional status, based on the 1991 revised criteria 3. treated for a minimum of 12 weeks with methotrexate with a stable dose of mtx for at least 8 weeks prior to screening visit exclusion criteria: 1. patients less than 18 years of age or minimum legal age 2. prior treatment with any biologic anti-interleukin 6 (il-6) or il-6 receptor (il-6r) antagonists 3. use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening 4. use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks prior to randomization 5. participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer 6. treatment with oral/ biologic dmards (disease-modifying antirheumatic drugs), other than mtx, within a certain amount of time prior to screening visit 7. active or suspected tb or at high risk of contracting tb 8. fever, or chronic, persistent, or recurring infections requiring active treatment 9. hiv positive note: the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.